Executive Summary

No.
LM-JS-CE-04
Changzhou Lookmed Medical Revision: A/1
Instrument Co., Ltd.
Effective: 2020-03-18
Technical File of Disposable Skin Staplers Page: Page 1 of 38
CE Technical File
Disposable Skin Staplers
Drafted by:
Reviewed by:
Approved by:
File number: LM-JS-CE-04
Revision: A/1
Changzhou Lookmed Medical Instrument Co., Ltd.
Address: Building 3, Building 5, No.10 Chenghe Road, Lijia Town Industry Zone, Wujin,
Changzhou City, 213176, Jiangsu, China.
Tel: +86-0519-88315607 Fax: +86-0519-88315605
No. LM-JS-CE-04
Documents Revision History
Rev. Date Revision History Signature
A/0 2018-01-18 Initial version
A/1 2020-03-18 MDR update

No. LM-JS-CE-04
Table of Contents
TABLE OF CONTENTS.................................................................................................................................................. 3
FILE DIRECTORY.......................................................................................................................................................... 4
CHAPTER I ADMINISTRATIVE INFORMATION............................................................................................................ 6
1.1 INFORMATION OF THE MANUFACTURER............................................................................................................. 6

1.2 EC AUTHORIZED REPRESENTATIVE..................................................................................................................... 7
1.3 EC DECLARATION OF CONFORMITY.................................................................................................................... 8
1.4 CONFORMITY ASSESSMENT PROCEDURE............................................................................................................. 9
CHAPTER II DEVICE DESCRIPTION............................................................................................................................ 10
CHAPTER III INFORMATION TO BE SUPPLIED BY THE MANUFACTURER................................................................ 20
CHAPTER IV DESIGN INFORMATION........................................................................................................................21
4.1 FLOW CHART OF DESIGN AND DEVELOPMENT.................................................................................................. 21

4.2 DESIGN HISTORY FILES.................................................................................................................................. 21
4.3 DESIGN PROCESS.......................................................................................................................................... 26
4.4 DESIGN REVIEW........................................................................................................................................... 26
4.5 DESIGN VERIFICATION....................................................................................................................................26
4.6 DESIGN VALIDATION...................................................................................................................................... 28
CHAPTER V MANUFACTURING INFORMATION....................................................................................................... 29
5.1 PRODUCTION PROCESS FLOW CHART AND QUALITY CONTROL POINTS....................................................................29

5.2 KEY PROCESSES AND SPECIAL PROCESSES AS WELL AS CONTROL OF EACH PROCESS................................................ 29
5.3 PRODUCTION ENVIRONMENT AND FACILITY INTRODUCTION................................................................................. 30
5.4 PRODUCTION SPECIFICATION.......................................................................................................................... 31
CHAPTER VI GENERAL SAFETY AND PERFORMANCE REQUIREMENT.................................................................... 32
6.1 GENERAL SAFETY AND PERFORMANCE REQUIREMENT......................................................................................... 32

6.2 APPLICABLE STANDARDS................................................................................................................................ 32
CHAPTER VII BENEFIT-RISK ANALYSIS AND RISK MANAGEMENT.......................................................................... 35
CHAPTER VIII PRE-CLINICAL EVALUATION REPORT................................................................................................. 36
CHAPTER IX CLINICAL EVALUATION REPORT........................................................................................................... 37
CHAPTER X TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE.................................................... 38

No. LM-JS-CE-04
File directory
Folder Contents File No. Rev.
00_Technical documents Master Technical File LM-JS-CE-04 A/1
01_Administrative EC Rep. agreement LM-JS-CE-04-0102 /

information DOC LM-JS-CE-04-0103 A/1
EN ISO13485 Certificate SX 60131213 0001 /
MDD Annex II Certificate HD 60132647 0001 /
02_ Device description
03_ Labels and IFU Labelling LM-JS-CE-04-0301 A/1
IFU LM-JS-CE-04-0302 A/1
04_Design information Design and development control
procedure
05_Manufacturing Cleaning room test report CZ2017QR0008
information Cleaning room monitoring report in CCF20191015_0004
2018
management procedure for clean LM/QP-6.4 C/0
room
Final cleaning validation report (for /
20190626-01
plastic parts)
Final cleaning validation report (for /
20190629-01-PF
metal parts)
06_GSPR checklist General safety and performance requi LM-JS-CE-04-0601 A/1
rements checklist
07_Risk management Risk management plan LM-JS-CE-04-0701 A/1
Risk management report LM-JS-CE-04-0702 A/1
/ Pre-clinical evaluation report LM-JS-CE-04-0800 A/1
08_Pre-c / Conformity Statements of Standard LM-JS-CE-04-0806 A/1
linical Request of EN ISO 14630-2012
evaluati 0801_Biocompati Biocompatibility evaluation report LM-JS-CE-04-0801 A/1
on bility evaluation Biocompatibility test report 2012QW156 /
report
0802_Type Type examination report 2017SJ0136 /
examination
0803_Usability Usability Checklist LM-JS-CE-04-0803-01 A/1
evaluation Usability evaluation report LM-JS-CE-04-0803-02 A/1
0804_Package Packaging process validation report No. 20190630-03-PF /
Aging test report SDWH-M201501495-1 /
Transportation test report No. 20151027-01 /
0805_Sterilizatio EO sterilization re-validation report No. 190628-01 A/1
n EO test report 2017SJ0136 /
Sterility test report 2017SJ0136 /
EO Sterilization Subcontract /
Agreement
No. LM-JS-CE-04
Folder Contents File No. Rev.

EN ISO 13485 certificate of the SX 60128917 0001 /
subcontractor Valid until: 2021-06-29
09_ / Clinical evaluation plan LM-JS-CE-04-0901 A/1
Clinical / Clinical evaluation report LM-JS-CE-04-0902 A/1
evaluati Literatures / /
on Equivalent device / /
information
10_PMS PMS plan LM-JS-CE-04-1001 A/1
PMS report LM-JS-CE-04-1002 A/1
No. LM-JS-CE-04
Chapter I Administrative information

1.1 Information of the Manufacturer
Name of Changzhou Lookmed Medical Instrument Co., Ltd.

Manufacturer:
Address: Building 3, Building 5, No.10 Chenghe Road, Lijia Town Industry
Zone, Wujin, Changzhou City, 213176, Jiangsu, China.
Tel: +86-0519-88315607
Fax: +86-0519-88315605
E-mail: lookmed8@gmail.com
Web site: http://www.lookmed.cn
Contact Person: Mr. Hua Haiyu
Brief introduction: Changzhou Lookmed Medical Instrument Co., Ltd. has been
focused on research and development of medical instruments for
a long time. The company has a wealth of professional knowledge
and experience on the medical equipments, the quality of the
products are of the lead position in domestic level. Our company
maintains a long-term relationship with foreign research
institutions, and follow the international advanced products
closely, make great efforts to introduce and develop foreign
advanced products to promote the localization of medical
devices.
The main products are digestive tract series consumption
equipment, endoscope accessory, surgical instruments, medical
polymer materials and consumables.
 Folder 01_Administrative information,

File: LM-JS-CE-04-0101_Legal document
No. LM-JS-CE-04
1.2 EC Authorized Representative

Since the registration address of the manufacturer is located outside the area of EEA,
Switzerland and Turkey, a single authorized representative located in EEA, Switzerland and
Turkey is appointed to Disposable Skin Staplers , which is:
Name: OBELIS S.A

Bd. Général Wahis, 53
Address:
1030 Brussels, Belgium
Tel: +32.2.732.59.54
Fax: +32.2.732.60.03
E-mail: mail@obelis.net
Web site: www.obelis.net
The agreement with the appointed EU authorized representative has been signed and is
provided in the attachment:
File: LM-JS-CE-04-0102_MDD agreement
No. LM-JS-CE-04
1.3 EC Declaration of Conformity
Declaration of Conformity is supplied in attachment

File: LM-JS-CE-04-0103_DOC for Disposable Skin Staplers
No. LM-JS-CE-04
1.4 Conformity assessment procedure

The manufacturer’s quality management system for design/development, manufacturing and
distribution of Disposable Skin Staplers has also been established in accordance with EN
ISO13485 and Regulation (EU) 2017/745(MDR). The conformity assessment procedure would
be MDR Annex II, III and XI (Part A, Sec. 10) and related Notified Body concerned is as below:
Name: TÜV Rheinland LGA Products GmbH
Address: Tillystraße 2, 90431, Nürnberg, Germany
CE identifier: 0197
No application has been lodged with any other Notified Body for the same product type and
conformity assessment route.
The MDD Annex V and EN ISO 13485:2016 certificate is in attachment:
 Folder 01_Administrative information

File No. File Name Certificate No. Issue Date Expiry Date
LM-JS-CE-04-0104 MDD Annex V DD 60132648 0001 2018-09-17 2023-06-20
Certificate
LM-JS-CE-04-0105 EN ISO13485 SX 60131213 0001 2018-09-17 2021-06-20
Certificate
No. LM-JS-CE-04
Chapter II Device Description

2.1 Device Name
Disposable Skin Staplers
2.2 Trade Name
The trademark logo of this company’s product is .
2.3 Product Models
Model list:
Table 2.1 Model list of Disposable Skin Stapler
Disposable Skin Stapler
LMPF-10W LMPF-10A LMPF-10B
Disposable Skin Staple Remover (Optional)
LMPF-CA LMPF-CB
Model description:
LM PF – X X
Closed Size (Type W, Type A and Type B)
Number of Staples
Lookmed Disposable Skin Staplers Product Code
For example: LMPF-35W, indicated as: Disposable Skin Staplers , number of staples is 35, Type W (closed
size 7.3 x 4.0), manufactured by Changzhou Lookmed medical instruments Co., Ltd.
Model list: LMPF-CA, LMPF-CB

LM PF – C X
Model (A or B)
Code of Disposable Skin Staple Remover
Lookmed Disposable Skin Staplers Product Code
For example: LMPF-CA, indicated as: Disposable Skin Staple Remover, Model A, manufactured by
Changzhou Lookmed medical instruments Co., Ltd.
2.4 Planned Device variants
No. LM-JS-CE-04
Now we don’t have other model of this product, If we modify or improve this device in the future, or
change the model, we will inform the notified body immediately.
2.5 Product description
The Disposable Skin Staplers are sterile and specially designed for the closure of skin in a wide variety of
surgical procedures. It is designed to be fired from multiple angles. The flat, dimpled staple top span is
designed to ensure proper staple formation.
The Disposable Skin Staplers consist of Handle, Trigger, Cartridge, Pusher, Feeder and Staple. According to
the staple size of closed position, the Disposable Skin Staplers have three different staple sizes: Type W,
Type A and Type B. According to numbers of staples, the device has six specifications: 10, 15, 25, 35, 45,
55. Different staple numbers are applicable for the different length of incision.
The material of staples is stainless steel 00Cr18Ni14Mo3 (Surgical grade 316L stainless steel), which meet
the provisions of EN ISO 5832-1:2016 Implants for surgery – Metallic materials – Part 1: Wrought stainless
steel.
The Disposable Skin Staple Remover is an accessory of Disposable Skin Staplers, consist of Upper jaw,
Lower jaw and Handle. It is designed to provide fast and easy removal of all brands of surgical skin staples.
The metal part of the remover is made of stainless steel 06Cr19Ni10, and the handle of the remover is
made of ABS plastic.
The device made by our company has been available on the China market for more than four year, and EU
market, other market for more than two years.
Product features:
 Stapler handle design gives good texture to the product & provides good comfort for the surgeon’s
hand.
 Angled head design provides clear view to ensure precise staple placement. Also angle head design
helps the staple to enter easily into the tissues.
 The elaborate design of the staple release mechanism actuates the stapler very efficiently.
 Easy to use, reduce learning curve.
 3 staples width options
 Clear plastic cartridge
Benefits:
 Wound closure flexibility
 Enhanced cosmesis
 Enhance staple count visibility
2.6 Product Group
GMDN definition:
Disposable Skin Stapler:
Skin stapler/staple, bioabsorbable
A sterile hand-held manual, surgical instrument preloaded with non-bioabsorbable skin staples designed
to approximate free edges of skin from an incision or wound. This stapler is a manually-powered device
designed to mechanically deliver the staples; the staples are made of metal [e.g., stainless steel or
No. LM-JS-CE-04
titanium (Ti)] and intended to be removed once the wound has sufficiently healed. This is a single-use
device.
Disposable Skin Staple Remover:
Surgical staple remover, single-use
A sterile surgical instrument that is used to remove skin staples after the healing process has progressed
sufficiently to permit the borders of the wound or incision to remain together without assistance. It is a
tweezers-like device made of high-grade stainless steel with blades at the distal end activated by lever
action designed for grasping, opening, and removing surgical staples. This is a single-use device.
2.7 Product pictures
Figure 1. Disposable Skin Stapler Figure 2. Disposable Skin Staple Remover

2.8 Intended use
The Disposable Skin Staplers is designed for the closure of skin of human body in trauma and surgical
incision.
The Disposable Skin Staple Remover is used to remove the staples after the suturing or healing process.
2.9 Intended Users
Healthcare surgical personnel with Disposable Skin Staplers and Disposable Skin Staple Remover using
experience.
2.10 Intended Patient population and medical conditions
This device is suitable for children and adult patients.
Age: no restrictions for age of the patients;
Weight: no restrictions for weight of the patients;
Health: patients undergoing small skin wound/incision;
Nationality: multiple;
Patient status: PATIENT is not the OPERATOR;
2.11 Contraindications
1) It is prohibited to use the disposable skin stapler when the distance between skin incision and interior
tissue is less than 5mm.
2) The skin stapler should be used for skin closure only of the epidermis and is not intended for use
within the body or for deeper layers of the corium (dermis) or other connective tissue.
3) The disposable skin stapler is not suitable for the incision, which is required for relaxation suture after
operation.
No. LM-JS-CE-04
4) The staples contain Stainless steel, which may cause an allergic reaction in some patients;
2.12 Cautions and Warnings

This product is intended for use by surgeons who have been trained in Disposable Skin Staplers.
1) When using the product, the aseptic operation specification should be strictly followed.
2) Carefully inspect device and package before use; Never use it if the package has been damaged.
3) This product is supplied with sterile for clinical use, sterilized by ethylene oxide. Please check the
sterilization indicator on the sterilization package of this product. “Red” means the product has been
sterilized by EO, Direct use; "Blue" means that the product has not been sterilized by ethylene oxide,
and cannot be directly used clinically.
4) Use the product before the expiry date marked on the label. The shelf life of the product is 2 years.
Don’t use the product if the shelf life has expired.
5) Only surgeons with rich experience and familiar with Disposable Skin Stapler can operate this device.
Before operation, physicians should consult relevant literatures, books, documents to understand the
technology, complications and risks of Disposable Skin Stapler.
6) This product should be stored in a cool, dry, clean, well ventilated environment without corrosive gas.
7) This device can only be used on the single patient in a single procedure.
8) Please read the user manual carefully before use, and pay attention to the manufacturing date and
batch number of the product.
9) Don’t reuse. Don’t re-sterilization.
10) The staples were composed of stainless steel, and categorically not MRI compatible.
11) To use the skin stapler properly, squeeze the trigger completely and release.
12) Do NOT pull or lift up the stapler when releasing the trigger.
13) Fully squeeze and release trigger before lifting.
14) Failure to completely squeeze the handle can result in incomplete staple formation and insufficient
wound approximation.
2.13 Potential adverse reaction
1) Scarring
2) Difficult removal
3) Wound dehiscence: Incision edges separate during staple removal
4) Patient experiences pain when staples are removed
2.14 Principle of operation
The Disposable Skin Staplers has an ejector spring that automatically disengages the staple to dispenses
one staple each time the instrument trigger is activated. The staples first penetrate the skin and are then
formed, thus holding the tissue together.
2.15 Product Structure
The Disposable Skin Staplers consist of Handle, Trigger, Cartridge, Pusher, Feeder and Staple. According to
the staple size of closed position, the Disposable Skin Staplers have three different staple sizes: Type W,
No. LM-JS-CE-04
Type A and Type B. According to numbers of staples, the device have six specifications: 10, 15, 25, 35, 45,
55.
The Disposable Skin Staple Remover is an accessory of Disposable Skin Staplers, consist of Upper jaw,
Lower jaw and Handle.
The illustration of structure and components is given in as follows:
 Disposable Skin Staplers
Figure 3. Disposable Skin Staplers

1. Handle 2. Trigger 3. Cartridge 4. Pusher 5. Feeder 6. Staple
 Disposable Skin Staple Remover
Figure 4. Disposable Skin Staple Remover

1. Upper jaw 2. Lower jaw 3. Handle
2.16 Product Specification

Specification
Table 2.2 Specificaiton
No. LM-JS-CE-04
Unit: mm
Staples Num
Option
Dimensions before forming ber
Dimensio al (Skin
Mo Typ (L x h) of
Spec. Diam Toler ns after Toler Staple
del e L Tole H Stapl
eter ance forming ance Toler Remov
ran es
(L1 x H1) ance er)
ce
13.1 ±0. 3.5 ±0.1 LMPF-
10, W 0.6 7.3 x 4.0 10,
2 CA
15, 15,
LM 25, 13.1 3.5 25, LMPF-
A 0.6 ±0.1 7.0 x 4.5 ±0.6
PF 35, 35, CA
45, 45,
11.3 2.7 LMPF-
55 B 0.6 5.5 x 3.5 55
CB
2.17 Main raw materials
 Disposable Skin Staplers

Table 2.3 Main raw materials list of Disposable Skin Staplers
Contact
Contact
No. Part Name Material Designation Standard Patient’s
Duration
Body
Staple EN ISO Short
1 00Cr18Ni14Mo3, Soft tissue
5832-1:2016 term
EN ISO /
2 Pusher 06Cr18Ni9 No
7153-1:2016
3 Handle ABS No /
Transient
4 Cartridge ABS Skin/wound
 Disposable Skin Staple Remover

Table 2.4 Main raw materials list of Disposable Skin Staple Remover
Material Contact Contact
No. Part Name Standard
Designation Patient’s Body Duration
1 Upper jaw Stainless steel EN ISO Transient
06Cr19Ni10 skin
2 Low jaw 7153-1:2016
3 Handle ABS skin Transient
2.18 Performance index

Table 2.5 Performance list
No. Item Description
1. The shape of disposable skin staplers should be smooth, clear, free of blade,
Appearance burr and flaw.
No. LM-JS-CE-04
The marks on the outer surface of device are clear, no dislocation or skew
and other defects.
The riveting position of the stapler shall be firm.
The tip of staples should be sharp, the surface of staples shall be without
burrs, fee of dents.
2. Size The basic size of the device shall meet the provisions of Table 2.2, and
Figure 3.
3. Hardness The hardness of Pusher and Feeder should be not less than 330 HV0.2.
4. Performance The number of staples should be the same as that indicated in Table 2.2.
While being under using, each part of disposable skin staplers should be
movable, be free of lock and not loosen.
The device should have good suturing performance, and the loaded staples
shall be fired normally, and after firing, they shall be able to penetrate the
test material smoothly to form a rectangle without distortion and
deformation.
The each parts of staple remover shall be moved smoothly, the formed
staples can be removed smoothly, and the surface of the test material shall
not be damaged.
5. Corrosion The staples shall have the good performance of corrosion resistance.
resistance
6. Surface Surface of metal parts, Ra≤0.8μm
roughness
7. Sterility The devices are sterilized through the validated EO sterilization process after
final packaging, and the product shall be sterile with SAL 1.0x10-6.
8. EO residual The EO residual shall be less than 10μg/g.
9. Peel strength of Peel strength: The peel strength of the packaging seal shall be between 0.1
the package N/mm and 0.5N/mm.
The two peeled contact surface should be smooth and continuous without
any delamination or tear.
The sterile package should be intact, there should be no channels or
perforation in the sealing area.
10. Chemical The chemical composition of staples should meet the provisions of EN ISO
composition 5832-1:2016.
11. The cytotoxicity of the device shall be no more than Grade 1.
The device shall have no delayed type hypersensitivity.
The intradermal reaction of score of the device shall be no more than 1.0.
The device shall have no acute systemic toxicity.
Biocompatibility
The device shall have no Material mediated pyrogenicity.
The staples shall have no subacute toxicity.
The local effects after implantation of score of staples shall be no greater
than 1.
12. Shelf life 3 years.
2.19 Accessories
Disposable Skin Staple Remover
2.20 Use in conjunction with other medical devices
None.
No. LM-JS-CE-04
2.21 Previous and similar generation of the device

2.18.1 Overview of identified previous generation of the devices
None.
2.18.2 Overview of identified similar devices available on the EU or international markets
Equivalent device information

Manufacturer Covidien (A Medtronic company)
CE certificate CE 0123, Certificate No. G1 074735 0083 Rev. 00
Product Name Appose™ ULC Single Use Skin Stapler
Appose™ Auto Suture Single Use Skin Staple Remover
Single Use Skin
Stapler Code Description
8886803512 Appose™ ULC Skin Stapler with 35
Regular staples
8886803712 Appose™ ULC Skin Stapler with 35
Wide staples
150462 Premium™ Single Use Skin Staple
Remover
Material
Part Material
Staple Stainless steel 316L
Jaw Stainless steel 302
Handle PC
Product figure
2.22 Package information

Currently, the company provide the blister box package for the Disposable Skin Staplers, the sterile blister
box are made of PET material and Tyvek Allover TA 5911C. The Paper plastic bag for the Disposable Skin
Staple Removers.
The primary packaging process is conducted in ISO class 8 cleaning room. The middle package is made of
white card packaging carton, the outer package is made of corrugated carton.
Package Disposable Skin Staplers Disposable Skin Staple Remover

contained contained
Primary package 1 pc Disposable Skin Staplers 1 pc Disposable Skin Staple Remover
Middle package 10pc primary package + 1 pcs 10pc primary package + 1 pcs IFU
IFU
Outer package 10 pc Middle packages 10 pc Middle packages
No. LM-JS-CE-04
2.23 UDI-DI
The Basic UDI-DI is the primary identifier of a device model. It is the DI assigned at the level of the device
unit of use. It is the main key for records in the UDI database and is referenced in relevant certificates and
EU declarations of conformity.
 UDI-DI: The UDI-DI is a unique numeric or alphanumeric code specific to a model of device and that is
also used as the ‘access key’ to information stored in a UDI database.
 UDI-PI: The UDI-PI is a numeric or alphanumeric code that identifies the unit of device production.
The different types of UDI-PIs include serial number, lot number, software identification and
manufacturing or expiry date or both types of date.
An UDI shall be assigned to the device itself or its packaging. The UDI shall contain two parts: an UDI-DI
and an UDI-PI. The UDI-DI shall be unique at each level of device packaging.
UDI-DI:
XXXXXXXXXXXX
UDI-PI:
XXXXXXXXXXXX
Now, the UDI is not available, We will apply the UDI on the label before May. 26, 2023 or earlier.
2.24 Classification
According to Regulation (EU) 2017/745(MDR) ANNEX VIII Rule 7, the Disposable Skin Staplers is
classified as a Class IIa medical device.
RULE 7 (5.3/1) VERDICT

All surgically invasive devices intended for short-term use are classified
as class IIa.
Rationale:
The Disposable Skin Staplers consist of skin stapler and staples, and
Disposable Skin Staple Remover. They are single use and non-active
medical.
The staples is a surgical invasive device, the staples normally intended for
suturing the skin continuous for less than 30days, they will be taken out,
so they are short-term use, according to Rule 7, the staples is classified to
class IIa;
and the skin stapler may be come into contact with patient’s skin, is a
Class IIa
non-invasive device, and normally intended for continuous for less than
60 minutes, it’s a transient use, according to Rule 1, it is classified to class
I.
The Disposable skin staple remover will be come into contact with
patient’s skin, it’s belong to non-invasive device, is normally intend for
continuous for less than 60minutes, according to the Rule 1, it is
classified to class I.
Thus according to Regulation (EU) 2017/745(MDR) ANNEX VIII, the
device is classified to Class IIa, Rule 7 (5.3/1).
2.25 Sterilization
EO sterilization
No. LM-JS-CE-04
2.26 Shelf life

2 years
2.27 Marketing history
The Disposable Skin Staplers manufactured by Changzhou Lookmed Medical Instrument Co., Ltd. have got
approval by NMPA (former CFDA) and sold in China market since 2015. The devices sold in China market
are identical to the CE marked device except for the labelling. Around 226170 sets devices have been sold
in China, and 889507 sets in other markets since 2018.
The device has got MDD approval for Disposable Skin Staplers (see model list) with MDD Annex V
certificate DD 60132648 0001 issued by TÜV Rheinland LGA Products GmbH (NB number 0197) in
2018-09-17.
No. LM-JS-CE-04
Chapter III Information to be supplied by the Manufacturer

On the label of the device, the symbols and information shall take consideration of the
following requirements:
 Annex I of Regulation (EU) 2017/745
 EN 1041:2008+A1:2013
 EN ISO 15223-1:2016
The draft labels are described in the attachments:

 Folder 03_ Labels and IFU,
 Draft label: file # LM-JS-CE-04-0301

 Instructions for Use (IFU): file # LM-JS-CE-04-0302
No. LM-JS-CE-04
Chapter IV Design information

4.1 Flow Chart of Design and Development
4.2 Design History Files

4.2.1 Disposable Skin Staplers market investigation report
No. LM-JS-CE-04
The application in clinical of Disposable Skin Staplers is gradually expanding, and the growth
of Disposable Skin Staplers is the fastest in medical devices, and the market competition of
medical device is a global competition. The medical device market is one of the fastest
growing and most active market economies in the world economy. The US, Europe and Japan
together account for more than 85% of the global medical device market and are in an
absolute leading position. Among them, the US is the largest manufacturer and consumer of
medical devices in the world, and its consumption accounts for more than 40% of the world
market.
The Disposable Skin Staplers is designed for the closure of skin of human body in trauma and
surgical incision.
The Disposable Skin Staplers are sterile and specially designed for the closure of skin in a wide
variety of surgical procedures. It is designed to be fired from multiple angles. The flat,
dimpled staple top span is designed to ensure proper staple formation.
The Disposable Skin Staplers consist of Handle, Trigger, Cartridge, Pusher, Feeder and Staple.
According to the staple size of closed position, the Disposable Skin Staplers have three
different staple sizes: Type W, Type A and Type B. According to numbers of staples, the device
has six specifications: 10, 15, 25, 35, 45, 55. Different staple numbers are applicable for the
different length of incision.
The material of staples is stainless steel 00Cr18Ni14Mo3 (Surgical grade 316L stainless steel),
which meet the provisions of EN ISO 5832-1:2016 Implants for surgery – Metallic materials –
Part 1: Wrought stainless steel.
The Disposable Skin Staple Remover is an accessory of Disposable Skin Staplers, consist of
Upper jaw, Lower jaw and Handle. It is designed to provide fast and easy removal of all brands
of surgical skin staples. The metal part of the remover is made of stainless steel 06Cr19Ni10,
and the handle of the remover is made of ABS plastic.
Medtronic (U.S. Surgical Corporation, Covidien), B.Braun, U.S. Johnson & Johnson (Ethicon),
always represent the latest technology level of the Disposable Skin Staplers industry. The
Appose™ ULC Single Use Skin Stapler (made by Covidien) have been utilized for the last
several years as advanced Disposable Skin Staplers, offering Wound closure flexibility,
Enhanced cosmesis, Enhance staple count visibility.
Our company has the production technology and ability of manufacturing the Disposable Skin
Staplers , and is also a manufacturer of Disposable Skin Staplers and devices with independent
brands. It has a long production history, and a large scale of enterprises, independent R & D
technology, and great brand influence. So in the good technical ability as the foundation and
domestic leading Disposable Skin Staplers as the support, to develop Disposable Skin Staplers .
Under the influence of our brand's domestic market for many years, Disposable Skin Staplers
has a good market prospect. Therefore, our company developed this medical device. For
Disposable Skin Staplers products, our Company is about to develop more technology design
currently, bringing greater convenience to provide Wound closure flexibility, Enhanced
cosmesis, Enhance staple count visibility, reduce the risks of wound infection. Application of
new technology requires long-term clinical practice to demonstrate its safety and
effectiveness.
No. LM-JS-CE-04
4.2.2 Design and development planning

4.2.2.1 Project overview
1) All tasks of the product development shall be completed within the schedule;
2) In terms of product performance and quality, it should be in the leading position in
foerign and domestic similar products;
3) It can bring suitable economic profits to the company;
4) It should strictly control risks and quality during product development.
4.2.2.2 Resource requirements
1) Production equipment and tooling;
2) Inspection equipments;
3) Sales Dept.: responsible for Market investigation;
4) Technical Dept.: responsible for product design, providing drawings and organizing
review;
5) General office: responsible for the preparation of product technical standards, IFU
and other documents;
6) Quality Dept.: responsible for material inspection and product verification, and keep
relevant records;
7) Production Dept.: responsible for product organization and production, production
introduction and other works, trial production of prototype, keep relevant records;
8) Supply Chain Dept.: responsible for material purchasing, as the task interface of
outsourcing, outsourcing parts contact and ordering, and keep relevant records;
9) Human resources Dept.: responsible for personnel recuitment, training task
interface.
4.2.2.3 Design and developmetn stage and work contents

Design and development stage and work contents
No. Design stage Output files Design Design Design
review verification validation
1. Plan confirmation Desgin tasks √ √ √
2. Design Product drawing √ √
(Preliminary, BOM √
detailed, process) Trial production process √
3. Sample Product drawings √ √
preparation Product sample √
Product standards √
Process (Trial Implementation) √
Risk analysis √
Design IFU (draft) √
stereotype Packaging design √
4. Production Clinical evaluation √
finalization IFU
Manufacturing process
Process guidance
Inspection guidance
Purchasing list
Equipments manual
5. Small batch trial Disposable Skin Staplers
No. LM-JS-CE-04
production
6. Declaration /
Registration
4.2.3 Design and Development inputs

4.2.3.1 Intended use
The Disposable Skin Staplers is designed for the closure of skin of human body in trauma and
surgical incision.
The Disposable Skin Staple Remover is used to remove the staples after the suturing or
healing process.
Intended users: Healthcare surgical personnel with Disposable Skin Staplers experience.
4.2.3.2 Main performance and parameters
No. Item Description

1. The shape of disposable skin staplers should be smooth, clear, free of blade,
burr and flaw.
The marks on the outer surface of device are clear, no dislocation or skew
and other defects.
Appearance
The riveting position of the stapler shall be firm.
The tip of staples should be sharp, the surface of staples shall be without
burrs, fee of dents.
2. Size The basic size of the device shall meet the provisions of Table 2.2, and Figure
3.
3. Hardness The hardness of Pusher and Feeder should be not less than 330 HV0.2.
4. Performance The number of staples should be the same as that indicated in Table 2.2.
While being under using, each part of disposable skin staplers should be
movable, be free of lock and not loosen.
The device should have good suturing performance, and the loaded staples
shall be fired normally, and after firing, they shall be able to penetrate the
test material smoothly to form a rectangle without distortion and
deformation.
The each parts of staple remover shall be moved smoothly, the formed
staples can be removed smoothly, and the surface of the test material shall
not be damaged.
5. Corrosion The staples shall have the good performance of corrosion resistance.
resistance
6. Surface Surface of metal parts, Ra≤0.8μm
roughness
7. Sterility The devices are sterilized through the validated EO sterilization process after
final packaging, and the product shall be sterile with SAL 1.0x10-6.
8. EO residual The EO residual shall be less than 10μg/g.
9. Peel strength of Peel strength: The peel strength of the packaging seal shall be between 0.1
the package N/mm and 0.5N/mm.
The two peeled contact surface should be smooth and continuous without
No. LM-JS-CE-04
any delamination or tear.

The sterile package should be intact, there should be no channels or
perforation in the sealing area.
10. Chemical The chemical composition of staples should meet the provisions of EN ISO
composition 5832-1:2016.
11. The cytotoxicity of the device shall be no more than Grade 1.
The device shall have no delayed type hypersensitivity.
The intradermal reaction of score of the device shall be no more than 1.0.
The device shall have no acute systemic toxicity.
Biocompatibility
The device shall have no Material mediated pyrogenicity.
The staples shall have no subacute toxicity.
The local effects after implantation of score of staples shall be no greater
than 1.
12. Shelf life 2 years.
4.2.3.3 Regulations
See 6.2 Applicable Standards
4.2.3.4 Mitigation measures

 Refer to Folder 07_Risk management
4.2.3.6 Information from Similar device

Sample, IFU of similar device from foreign and domestic.
4.2.4 Design and Development outputs

Technology Files: our company makes such files to guide the production as follows:
No. Document Name Document No.
1. Process of Disposable Skin Staplers LM/JS-04-01
2. Incoming material inspection procedure LM/JS-04-02
3. Package material incoming material inspection procedure LM/JS-04-03
4. WI of pusher assy. Heat welding LM/JS-04-04
5. WI of cartridge assembly LM/JS-04-05
6. WI of handle assembly LM/JS-04-06
7. WI of pre-cleaning process LM/JS-04-07
8. WI of Final-cleaning process LM/JS-04-08
9. WI of Total assy. Load staples LM/JS-04-09
10. WI of total assembly welding LM/JS-04-10
11. WI of trial firing LM/JS-04-11
12. Inspection procedure of final process LM/JS-04-12
13. WI of package heat sealing process LM/JS-04-13

No. LM-JS-CE-04
14. WI of packaging process LM/JS-04-14
15. WI for labelling LM/JS-04-15
16. Semi-Finish goods inspection procedure LM/JS-04-16
17. WI of ultrasonic welding process for Sleeve LM/JS-04-17
18. WI of heating process for inner ring and outer ring LM/JS-04-18
19. Purchasing list LM/JS-04-19
20. Finish goods inspection procedure LM/JS-04-20
21. Finish goods inspection procedure for disposable skin LM/JS-04-21

staple remover
22. WI of cartridge board assembly LM/JS-04-22
23. WI of handle assembly LM/JS-04-23
24. WI of load staples LM/JS-04-24
25. Risk analysis LM/JS-04-14
26. Technology requirements /
27. IFU /
28. Product drawing /
4.3 Design Process

We controlled the design & development processes in accordance with the requirements for
design and development, and kept relative records.
4.4 Design review
1) Design tasks;
2) Product drawings;
3) Production process;
4) Process procedure;
5) Operation reqirements and quality control requirements
6) Applicable standards
4.5 Design verification

4.5.1 Purpose
1) Design output meet the requirements of design input;
2) Identify existing problems, and propose solutions;
No. LM-JS-CE-04
4.5.2 References
Product Drawings, Product Standards, Purchasing list, Process procedure, Risk management,
Packaging design and Product IFU;
4.5.3 Review results
1) Product drawings: after examination, the drawing is basically correct and standardized,
and the drawing basically conforms to the standard of YY/T1415 product drawing and
design document of medical devices;
2) Product standard: the preparation of the registered product standard has been completed
in accordance with the requirements of the management measures for medical device
standard and the preparation specification for medical device registered product standard.
The model and size of Disposable Skin Staplers listed in the standard are determined
according to the requirements provided by the healthcare institute.
3) Purchase list: the materials ABS, stainless steel 304, stainless steel 00Cr18Ni14Mo3 listed
in the purchase list have national standards, and the materials have excellent biological
properties and corrosion resistance, which are not harm to human body. The purchase list
specifies the technical requirements for the above materials, which can ensure the quality
of the raw materials.
4) Conform the type examination report, ensure the product meet the technology
requirements.
5) Production process: On the basis of the sample trial production process, Process for
Disposable Skin Staplers , specification is compiled, including production links, production
process flow chart, technical parameters, operation points, quality control and inspection
frequency in the production process, process hygiene, safety and labor protection,
material consumption quota, production equipment, etc. According to this process,
products are manufactured smoothly.
6) Risk analysis: refer to risk management report;
7) Package design: The packaging design has been completed, and the text content is
consistent with the registered product, which conforms to the related standards.
8) Product IFU: comply with related standards.
4.5.4 Conclusion
1) According to the requirements of the design specification, the design output has been
completed. The design output documents (product drawings, product standards,
purchasing lists, process procedures, risk analysis, packaging design and product IFU) are
basically complete, correct and standardized, and meet the requirements of design
output.
2) We should continue to improve the production process in small batch production, and go
through the procedures of review and approval according to the document control
procedure. The product IFU and packaging design shall be revised and finalized after
products registration.
No. LM-JS-CE-04
4.6 Design validation

1) Brief description of trial production process:
According to the process flow chart, perform the trial production for 3 batches of the
device, product drawings, assembly process, process inspection, final inspection, the
product is in good conformity with the requirements.
2) Product standards review:
Meet the related standards requirements.
3) Perform the product inspection:
The Pilot products inspected by the company's inspectors, the results are qualified.
4) Application:
After the trial operation, pass the test.
5) Conclusion:
All three batches of the devices are qualified, meet the technology requirements.
No. LM-JS-CE-04
Chapter V Manufacturing information

5.1 Production process flow chart and quality control points
★: Key process; * : Special process;

: Quality check and verification; : Cleaning room
5.2 Key Processes and Special Processes as well as Control of Each Process
According to the process requirements of the products produced and the characteristics of
the products, the company determines that the Pre-cleaing, final-cleaning, Pusher assy.
Welding Total assembly welding, Heat-seal packaging and EO sterilization processes are
special process. Load staples process is key process.
Quality control points have been set for the above special processes.
The processes (final-cleaning, Pusher assy. Welding Total assembly welding, load staples,
Heat-seal packaging, etc.) requires that production, inspection and circulation are conducted
No. LM-JS-CE-04
in ISO Class 8 clean room (conform to EN ISO 14644-1:2015).

For more details of the process, refer to the associated documents of SOP, refer to 5.4. Folder:
05_Manufacturing information.
And the special process 5 EO sterilization is not conducted in-house but outsourced to the
subcontractor.
5.3 Production environment and facility introduction

Our Disposable Skin Staplers is a single-use sterile medical device, and according to the
requirements of the “Medical Device Good Manufacturing Practices - Appendix Sterile
Medical Devices”, the production environment of the product meets the requirements of ISO
Class 8 clean room according to EN ISO 14644-1; refer to the following tables for specific
indicators.
Monitoring
Monitoring item Technical requirement
frequency
Temperature 18~28℃ Once / shift
Relatively Humidity 45~65%RH Once / shift
Air change rate ≥15 times / hour Once / month
≥5Pa (between clean rooms (areas) of

different class)
Static pressure ≥ 10Pa (between clean room (area) and
Once / week
difference outdoors)
≥5Pa (Adjacent between clean room (area)
≥0.5um ≥5um
Airborne particle Once / quarter
≤3520000
≤29300 particles/m3
particles/m3
Airborne microbe ≤ 500 particles/m3 Once / quarter
≤ 100 CFU/4h, culture dish ф90mm,

Exposure time not more than 4 hours,
Settling microbe Once / week
indicated by the average number of colonies
Refer to the Cleaning room test report: # CZ2017QR0008.

Refer to the Cleaning room monitoring report in 2018: # Routine environment monitoring
record, CCF20191015_0004.
Routine monitoring and control have been planned and implemented according to the
established procedures and work instructions:
Refer to management procedure for clean room: LM/QP-6.4, C/0.
No. LM-JS-CE-04
5.4 Production Specification
SOP for production

No. Document Reference No Version
1. Process of Disposable Skin Staplers LM/JS-04-01 B/1
2. Package material incoming material inspection LM/JS-04-03 B/0
procedure
3. WI of pusher assy. Heat welding LM/JS-04-04 B/4
4. WI of cartridge assembly LM/JS-04-05 B/1
5. WI of handle assembly LM/JS-04-06 B/0
6. WI of pre-cleaning process LM/JS-04-07 B/1
7. WI of Final-cleaning process LM/JS-04-08 B/4
8. WI of Total assy. Load staples LM/JS-04-09 B/1
9. WI of total assembly welding LM/JS-04-10 B/2
10. WI of trial firing LM/JS-04-11 B/1
11. WI of package heat sealing process LM/JS-04-13 B/2
12. WI of packaging process LM/JS-04-14 B/0
13. WI for labelling LM/JS-04-15 B/0
14. WI of ultrasonic welding process LM/JS-04-17 B/0
15. WI of heating process for inner ring and outer ring LM/JS-04-18 B/1
16. WI of cartridge board assembly LM/JS-04-22 B/0
17. WI of handle assembly LM/JS-04-23 B/0
18. WI of load staples LM/JS-04-24 B/0
SOP for Inspection

1. Inspection procedure of final process LM/JS-04-12 B/1
2. Incoming material inspection procedure LM/JS-04-02 B/5
3. Semi-Finish goods inspection procedure LM/JS-04-16 B/0
4. Finish goods inspection procedure LM/JS-04-20 B/3
5. Finish goods inspection procedure for disposable skin LM/JS-04-21 B/0
staple remover
Product Drawings

1. Disposable Skin Staplers
2. Disposable Skin Staple Remover
No. LM-JS-CE-04
Chapter VI General safety and performance requirement

6.1 General safety and performance requirement
The device has fulfilled all applicable General safety and performance requirements per
Annex I of Regulation (EU) 2017/745(MDR).
 Detailed information is given in the Folder 06_GSPR checklist.
6.2 Applicable standards

The following standards have been identified for compliance of GSPRs:
(Harmonized standards, international standards, partly applicable standards)
No. Standards Reference Content
Information supplied by the manufacturer with medical

1. EN 1041 2008+A1:2013
devices
Medical devices - Symbols to be used with medical device

2. EN ISO 15223-1 2016 labels, labelling and information to be supplied - Part 1:
General requirements (ISO 15223-1:2016)
Medical devices - Application of risk management to medical

3. EN ISO 14971 2012
devices
Sterilization of health-care products - Ethylene oxide

-Requirements for the development, validation and routine
4. EN ISO 11135 2014
control of a sterilization process for medical devices (ISO
11135:2014)
Sterilization of health care products - Biological indicators -

5. EN ISO 11138-1 2017
General requirements
Sterilization of health care products - Biological indicators -

6. EN ISO 11138-2 2017 Part 2: Biological indicators for ethylene oxide sterilization
processes (ISO 11138-2:2017)
Biological evaluation of medical devices — Part 1: Evaluation

7. EN ISO 10993-1 2018
and testing within a risk management process
Biological evaluation of medical devices -- Part 6: Tests for

8. EN ISO 10993-6 2016
local effects after implantation
Biological evaluation of medical devices — Part 5: Tests for

9. EN ISO 10993-5 2009
in vitro cytotoxicity (ISO 10993-5:2009)
No. LM-JS-CE-04
Biological evaluation of medical devices - Part 7: Ethylene

10. EN ISO 10993-7 2008/AC:2009 oxide sterilization residuals - Technical Corrigendum 1 (ISO
10993-7:2008/Cor 1:2009)
Biological evaluation of medical devices - Part 10: Tests for

11. EN ISO 10993-10 2013
irritation and skin sensitization (ISO 10993-10:2010)
Biological evaluation of medical devices — Part 11: Tests for

12. EN ISO 10993-11 2018
systemic toxicity (ISO 10993-11:2017)
Biological evaluation of medical devices - Part 12: Sample

13. EN ISO 10993-12 2012
preparation and reference materials (ISO 10993-12:2012)
Biological evaluation of medical devices – Part 18: Chemical

14. EN ISO 10993-18 2009
characterization of materials ( ISO 10993-18:2005)
Sterilization of medical devices- Requirements for medical

15. EN 556-1 2001/AC2006 devices to be designated “Sterile”- Part 1: Requirement for
terminally sterilized medical devices.
Packaging for terminally sterilized medical devices —Part 1:

16. EN ISO 11607-1 2017 Requirements for materials, sterile barrier systems and
packaging systems
Packaging for terminally sterilized medical devices — Part 2:

17. EN ISO 11607-2 2017 Validation requirements for forming, sealing and assembly
processes
Sterilization of health care products - Microbiological

18. EN ISO 11737-1 2018 methods - Part 1: Determination of a population of
microorganisms on products (ISO 11737-1:2018)
Sterilization of medical devices —Microbiological methods

19. EN ISO 11737-2 2009 —Part 2: Tests of sterility performed in the validation of a
sterilization process
Cleanrooms and associated controlled environments —Part

20. EN ISO 14644-1 2015
1: Classification of air cleanliness
Cleanrooms and associated controlled environments – Part

2: Monitoring to provide evidence of cleanroom
21. EN ISO 14644-2 2015
performance related to air cleanliness by particle
concentration
Cleanrooms and associated controlled environments

22. EN ISO 14698-1 2003 —Biocontamination control —Part 1: General principles and
methods
23. EN ISO 14698-2 2003 Cleanrooms and associated controlled environments

—Biocontamination control —Part 2 ： Evaluation and
No. LM-JS-CE-04
interpretation of biocontamination data
Clinical Evaluation: A guide for manufacturers and notified

24. MEDDEV 2.7/1 Rev. 4
bodies under directives
Standard Guide for Accelerated Aging of Sterile Barrier

25. ASTM F1980-16 2016
Systems for Medical Devices
Medical device-Part 1: Application of usability engineering to

26. EN 62366-1 2015
medical devices
Medical devices-Quality management systems-

27. EN ISO 13485 2016
Requirements for regulatory purpose
ISTA 2A series partial simulation performance test

28. ISTA 2A 2011
procedure-Packaged-Products 150lb(68kg) or less
MEDDEV 2.12/1
29. 2013 Guidelines on a medical devices vigilance system
Rev 8
MEDDEV 2.12/2
30. 2012 Guidelines on post market clinical follow-up
Rev 2
Regulation (EU) 2017/745 of the European Parliament and of

the Council of 5 April 2017 on medical devices, amending
MDR (EU)
31. 2017 Directive 2001/83/EC, Regulation (EC) No 178/2002 and
2017/745
Regulation (EC) No 1223/2009 and repealing Council
Directives 90/385/EEC and 93/42/EEC
Plastics - Acrylonitrile-butadiene-styrene (ABS) moulding

32. EN ISO 19062-1 2015 and extrusion materials - Part 1: Designation system and
basis for specifications
Surgical and dental hand instruments - Determination of

33. EN ISO 13402 2000 resistance against autoclaving, corrosion and thermal
exposure (ISO 13402:1995)
Implants for surgery-Metallic materials- Part 1: Wrought
34. EN ISO 5832-1 2016 stainless steel
Surgical instruments – Metallic Materials -- Part 1: Stainless

35. EN ISO 7153-1 2016
steel
No. LM-JS-CE-04
Chapter VII Benefit-risk analysis and risk management

Lookmed has established and maintained on-going process for identifying hazards associated
with the device, estimating and evaluating the associated risks, controlling these risks, and
monitoring the effectiveness of the controls through the product life cycle.
The procedure for risk management has been defined in Risk Management Control Procedure
which is harmonized with EN ISO 14971:2012.
The purpose of this part is to document those risk management activities carried out
throughout the life cycle of the device, so as to ensure that the risks of the device have been
adequately identified and mitigated to at an acceptably low and safe level.
Risk management is performed per EN ISO 14971:2012, and the Risk management plan and
report is given as attachments:
 Folder 07_Risk management
No. LM-JS-CE-04
Chapter VIII Pre-clinical evaluation report

The performances and characteristics of the device have been determined based on the
intended purposes of the device, general safety and performance requirements and the
identified risks that might happen during the transport, storage and usage. Those factors and
the verification result thereof are summarized in the following sections to provide evidence of
conformity with the General Safety and Performance Requirements.
The Pre-clinical evaluation report is give as attachments:
 Folder 08_ Pre-clinical evaluation report
No. LM-JS-CE-04
Chapter IX Clinical evaluation report

Since the evaluated products, Disposable Skin Staplers are traditional low risk medical device
and sold & used over decades, its Risk-Benefit-Evaluation is demonstrated through long time
device using experiences.
The products’ performance and safety is also guaranteed through specific design following
relevant standards requirements, bench testing, and the implementation of quality
management system.
For applied products, through the comprehensive clinical literature databases and post
manufacturing experience, it is found that no new clinical risks are generated yet.
For example, Internet sides and homepages, and literature
http://www.ncbi.nlm.nih.gov/pubmed/ US National Library of Medicine National
Institute of Health
The Disposable Skin Staplers , manufactured under the observed controlled conditions as
described in intended use and the IFU, are safe in the field of corresponding surgical
operation aid and no risk above the acceptable level are introduced by them.
Therefore, the Disposable Skin Staplers , are considered to be acceptable for
Risk-Benefit-Evaluation since both effectiveness and safety are deemed to be acceptable.
 Please refers to Folder 09_Clinical Evaluation Report.
No. LM-JS-CE-04
Chapter X Technical documentation on Post-market Surveillance

Post-market surveillance is performed per Regulation (EU) 2017/745 MDR and MEDDEV 2.12
1/2, and the Post-market surveillance plan and report is given as attachments.
 See the Folder 10_PMS.

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Disposable Skin Staplers

File number: LM-JS-CE-04

Changzhou Lookmed Medical Instrument Co., Ltd.

Documents Revision History

Rev. Date Revision History Signature

A/0 2018-01-18 Initial version

A/1 2020-03-18 MDR update

CHAPTER I ADMINISTRATIVE INFORMATION............................................................................................................ 6

1.1 INFORMATION OF THE MANUFACTURER............................................................................................................. 6

CHAPTER II DEVICE DESCRIPTION............................................................................................................................ 10

CHAPTER III INFORMATION TO BE SUPPLIED BY THE MANUFACTURER................................................................ 20

CHAPTER IV DESIGN INFORMATION........................................................................................................................21

4.1 FLOW CHART OF DESIGN AND DEVELOPMENT.................................................................................................. 21

CHAPTER V MANUFACTURING INFORMATION....................................................................................................... 29

5.1 PRODUCTION PROCESS FLOW CHART AND QUALITY CONTROL POINTS....................................................................29

CHAPTER VI GENERAL SAFETY AND PERFORMANCE REQUIREMENT.................................................................... 32

6.1 GENERAL SAFETY AND PERFORMANCE REQUIREMENT......................................................................................... 32

CHAPTER VII BENEFIT-RISK ANALYSIS AND RISK MANAGEMENT.......................................................................... 35

CHAPTER VIII PRE-CLINICAL EVALUATION REPORT................................................................................................. 36

CHAPTER IX CLINICAL EVALUATION REPORT........................................................................................................... 37

CHAPTER X TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE.................................................... 38

01_Administrative EC Rep. agreement LM-JS-CE-04-0102 /

Folder Contents File No. Rev.

Chapter I Administrative information

Name of Changzhou Lookmed Medical Instrument Co., Ltd.

 Folder 01_Administrative information,

1.2 EC Authorized Representative

Name: OBELIS S.A

Web site: www.obelis.net

1.3 EC Declaration of Conformity

Declaration of Conformity is supplied in attachment

1.4 Conformity assessment procedure

The MDD Annex V and EN ISO 13485:2016 certificate is in attachment:

 Folder 01_Administrative information

Chapter II Device Description

Closed Size (Type W, Type A and Type B)

Lookmed Disposable Skin Staplers Product Code

Model list: LMPF-CA, LMPF-CB

Code of Disposable Skin Staple Remover

Lookmed Disposable Skin Staplers Product Code

2.7 Product pictures

Figure 1. Disposable Skin Stapler Figure 2. Disposable Skin Staple Remover

2.12 Cautions and Warnings

Figure 3. Disposable Skin Staplers

 Disposable Skin Staple Remover

Figure 4. Disposable Skin Staple Remover

2.16 Product Specification

2.17 Main raw materials

 Disposable Skin Staplers

 Disposable Skin Staple Remover

2.18 Performance index

2.21 Previous and similar generation of the device

Equivalent device information

2.22 Package information

Package Disposable Skin Staplers Disposable Skin Staple Remover

RULE 7 (5.3/1) VERDICT

2.26 Shelf life