Technical File CVC

Secret File CE-CVCB-001
Design Dossier
Disposable central venous catheter kit
(Revision: 4/0)
Issue in 2019-09-29 Inure in 2019-09-29

Beijing Target Medical Technologies, Inc.
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Beijing Target Medical Technologies, Inc. CE-CVCB-001
Design Dossier of Disposable Central Venous Catheter Kit Revision:4/0
CONTENTS
Chapter Contents Page No.
1 Introduction 1
2 Essential principles and evidence of conformity 2
3 Product descriptions 3
4 Market history 21
5 Design Verification & Validation 22
6 Clinical evidence 42
7 Risk Management 42
8 Manufacturing Process 43
9 Final Conclusions 49
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1 Introduction
1.1 Manufacturer
Beijing Target Medical Technologies, Inc., Ltd. (brief as “Target Medical”)
Holder Add: No. 60, Shunren Rd. Shunyi District, Beijing 101300, P.R. China
Holder Tel: +86 89493813
Holder Fax: +86 89419091
Contact person: Liu Jieqiong
Holder Website: http://www.tiandihexie.com/
1.2 EU Authorized Representative

Name: Lepu Medical (Europe) Coöperatief U.A.
Add: Abe Lenstra Boulevard 36, 8448 JB, Heerenveen, the Netherlands
Tel: +31-515-573399
Fax: +31-515-760020
1.3 Manufacturing facilities

1.3.1 Design location
Beijing Target Medical Technologies, Inc., Ltd.
Add: No. 60, Shunren Rd. Shunyi District, Beijing 101300, P.R. China
Tel: +86 89493813
Fax: +86 89419091
Website: http://www.tiandihexie.com/
1.3.2 Production location

Beijing Target Medical Technologies, Inc., Ltd
Add: No. 60, Shunren Rd. Shunyi District, Beijing 101300, P.R. China
Tel: +86 89493813
Fax: +86 89419091
Website: http://www.tiandihexie.com/
1.3.3 Sterilization location

Name: Beijing Target Medical Technologies, Inc.
Add: No. 60, Shunren Rd., Shunyi District, Beijing, 101300, P.R China
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Tel: 86 10-89493813
Fax: 86 10-89419091
Certificate No.: Q8 073322 0012 Rev.00
Notified Body No.: 0123
Sterilization Station of Target is certified to EN ISO 13485:2016and ISO 13485:2016, certificate

number is No. Q8 073322 0012 Rev.00, issued by TUV SUD Product Service GmbH, is valid
until 2022-03-31. Additionally, it is certified to EN ISO 11135:2014, certificate number is No.
Q8 073322 0012 Rev.00, issued by TUV SUD Product Service GmbH, is valid until 2022-03-
31. For all certificates, see Appendix 1.1.
1.4 Worldwide regulatory status of product

Until now, the Disposable Central Venous Catheter Kit had got the registration of CFDA.
1.5 Regulatory contacts

1.5.1 Notified body of CE certification
TÜV SÜD Product service GmbH
Ridlerstr 65, D-80339 München, Germany
Notified Body number: 0123
1.5.2 Declaration of conformity

The draft declaration of conformity (CE-CVCB-004) is included in Appendix 1.2
2. Essential principles and evidence of conformity

2.1 List of applicable international and other standards
The standards applicable for this product are referenced in Appendix 2.1 List of applicable
standards (document CE-CVCB-007).
2.2 Essential requirements checklist

The Essential requirements check list is included in Appendix 2.2 Safety and performance
principals (document CE-CVCB-002).
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3. Product descriptions
3.1 Product name
Product Names: Disposable Central Venous Catheter Kit
Trade Name: SAFECATH
3.2 General device description
3.2.1 Indications for use
The single and multiple-lumen catheters permit venous access to the adult and paediatric central
circulation for the administration of medicines, blood sampling and pressure monitoring.
3.2.2 Contraindications
 Infection in the puncture site,
 a serious bleeding tendency, such as coagulation disorder and the ongoing
anti-coagulation treatment.
 Persistent shock
 Impeded or injured puncture channel
 Abnormity at puncture or dissection site such as an enlarged thyroid gland or other
tumors
 Critical condition of emphysema
 Distinctive aberrance at puncture site, such as burns, etc.
3.2.3 Classification and conformity assessment route

Classification:
Product and accessory classification UMDNS- Code
Disposable central venous catheter kit Class Ⅲ 16615
Disposable central venous catheter Class Ⅲ, Rule 7 10729
guide wire Class III, Rule 6 11925
Introducer needle Class IIa, Rule 6 12727
Blue introducer syringe Class IIa, Rule 6 15256
Dilator Class IIa, Rule 6 15215
Heparin cap Class IIa, Rule 2 16081
Scalpel Class IIa, Rule 6 12252
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Syringe Class IIa, Rule 2 13940

Stanch clip Class I, Rule 1 10875
Catheter clamp Class I, Rule 1 10875
Rigid fastener Class I, Rule 1 10875
Conformity assessment route: Annex IX of MDD 93/42/EEC
3.2.4 Photographs of Product
Disposable Central Venous Catheter Kit Contains Disposable Central Venous Catheter、guide
wire、Introducer needle、blue introducer syringe、 dilator、Heparin cap、Stanchclip、Catheter
clamp、Scalpel、Syringe、Rigid fastener.
name picture
Disposable central
venous catheter
single lumen
OD:1.05~2.1mm
Effective
length130~600mm
Disposable central
venous catheter
Double lumen
OD: 1.35~3.85mm
Effective length：
50~300mm
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Disposable central
venous catheter
Multi lumen
OD: 1.85~2.35mm
Effective length：
80~300mm
guide wire
OD: 0.46~0.97mm
Length:450~700m
m
7
blue introducer
syringe
5ml
Introducer needle
MMN1870
External diameter：
1.25mm；
Effective length：
70mm
MMN2038
External diameter：
0.9mm；
Effective length：
38mm
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Dilator
External
diameter：
5F
1.65mm
6F
2.00mm
7F
2.30mm
8F
2.70mm
12F
4.00mm
Heparin cap
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Stanch Clip
Catheter Clamp
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Rigid fastener
Scalpel
Model：11#
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Syringe
Syringe size：5ml
Needle size：7#
3.2.5 Principle of operation

Such catheters are typically introduced using percutaneous entry techniques, such as the
well-known Seldinger techinique. After skin disinfection, local anesthetic is applied if
required. The location of the vein is then identified by landmarks and the introducer needle
assembled the Blue introducer syringe filled with normal saline is introduce into theselected
vein. Once puncture is confirmed, then the guide wire is inserted from the end of the Blue
introducer syringe and passed to required position, after which the introducer needle should
be withdrawn. A dilator may be passed over the guidewire to slightly enlarge the tract, and
the catheter itself is then passed over the guidewire, which is then removed. Transfusion can
be performed immediately after the end of the catheter is connected with the port.
3.2.6 Variants
3.2.6.1 Model names and configurations
The specification model of the central venous catheter kit are classified by the central venous
catheters.
The serial numbers of the central venous catheter kit are as follows
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MM CVC BJ × ×× ××
Effective length
External diameter
Lumen number
Kit
Central venous catheter
The logo of our company
Fig1 Classification methods of central venous catheter kit
According to lumen numbers of catheters, the kits are classified into signal-lumen, double-
lumen and triple-lumen central venous catheter kits.
Model name(s) Model No(s) Variant(s)

Single Lumen Catheter MMCVCBJ1 ——
Two-Lumen Catheter MMCVCBJ2 ——
Triple Lumen Catheter MMCVCBJ3 ——
3.2.6.2 Functional component

A central venous catheter (CVC) is a long, soft, thin, hollow tube placed into a large vein in the
neck (internal jugular vein), chest (subclavian vein) or groin (femoral vein). A central venous
catheter is much like an intravenous (IV) catheter that is placed in a small vein in an arm, except
that a central venous catheter is longer and is placed in a large vein leading to the heart. It is used
to administer medication or fluids, obtain blood tests (specifically the "mixed venous oxygen
saturation"), and directly obtain cardiovascular measurements such as the central venous
pressure. Certain medications, such as inotropes and amiodarone, are preferably given through
a central line. Intensive treatment of patients with onc-hematological diseases often relies on the
use of venous access devices, expecially in pediatric age, when the positioning of CVC
represents an essential step in the management of these patients to allow the infusion of
chemotherapy agents, blood products, total parenteral nutrition(TPN), intensive care,
therapeutic drugs and to perform blood sampling.
A central venous catheter is made up of three main parts, including body, extension line and
adapter. Polyurethane(PU), is high degree of biocompatibility, makes up the body of the
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catheters. The body is radiopaque to help confirm catheter tip location in the patient by chest X-
ray. To reduce the chance for vessel trauma, and have a special soft-tip which is more pliantthan
the rest of the catheter. The extension line is also made up of PU, the end of which is linked to a
female Luer adapter.
Dependent on its use, the catheter is monoluminal, biluminal or triluminal, dependent on the actual
number of extension line or lumens (1, 2 and 3 respectively).
This kind Central Venous Catheter kit possesses the following features:
Central Venous Catheter reduces the risk and vascular trauma due it specially formulated and
biocompatible Polyurethane material which provides strength during insertion and also softens
at body temperature to conform to the body tissues.
Soft flexible guide wire provides good torque to ensure firm insertion and also prevents vessel
perforation .
Specially designed soft & beveled tip for smooth & easy insertion of catheter. Clear
and definite marking facilitates correct placement of catheter tip .
Radio-opaque Catheter.
Table1-Technical data of Central Venous Catheter
Peak
Peak Tensile
Model External effective Nominal Tensile of
Outer Lumen of Soft
(MMCVCJ diameter length flowrate
Diameter numbers Catheter
) （GorF） (mm) (ml/min) tip(N)
(mm)
body(N)
1-14-15 14G 2.1 150 1 110 ≥15 ≥5
1-14-20 14G 2.1 200 1 100 ≥15 ≥5
1-14-30 14G 2.1 300 1 95 ≥15 ≥5
1-16-15 16G 1.7 150 1 54 ≥10 ≥4
1-16-20 16G 1.7 200 1 52 ≥10 ≥4
1-16-30 16G 1.7 300 1 40 ≥10 ≥4
1-18-15 18G 1.3 150 1 21 ≥10 ≥4
1-18-20 18G 1.3 200 1 18 ≥10 ≥4
1-18-30 18G 1.3 300 1 14 ≥10 ≥4
1-20-13 20G 1.05 130 1 20 ≥5 ≥4
1-20-20 20G 1.05 200 1 15 ≥5 ≥4
2-40-05 4F 1.35 50 2 20/14 ≥10 ≥4
2-40-08 4F 1.35 80 2 17/11 ≥10 ≥4
2-50-08 5F 1.7 80 2 38/17 ≥10 ≥4
2-50-13 5F 1.7 130 2 36/13 ≥10 ≥4

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2-50-20 5F 1.7 200 2 30/10 ≥10 ≥4
2-70-15 7F 2.35 150 2 90/24 ≥15 ≥5
3-55-08 5.5F 1.85 80 3 53/6/6 ≥15 ≥5
3-55-13 5.5F 1.85 130 3 21/7/8 ≥15 ≥5
3-70-15 7F 2.35 150 3 64/28/28 ≥15 ≥5
3-70-30 7F 2.35 300 3 43/12/11 ≥15 ≥5
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Specifications of the other components:
Central Venous Tissue

Guide Wire Introducer Needle Catheter Clamp
Catheter Dilator
Specification Specs. Qt'y Specs. Qt'y Specs. Qt'y Specs. Qt'y

1-14- Introducer
0.035″×60㎝ 1 8F×9㎝ 1 1 φ2.1 1
15 Needle18
1-14- Introducer
0.035″×60㎝ 1 8F×9㎝ 1 1 φ2.1 1
20 Needle18
1-14- Introducer
0.035″×70㎝ 1 8F×9㎝ 1 1 φ2.1 1
30 Needle18
1-16- Introducer
0.035″×60㎝ 1 7F×9㎝ 1 1 φ1.5 1
15 Needle18
1-16- Introducer
0.035″×60㎝ 1 7F×9㎝ 1 1 φ1.5 1
20 Needle18
Single- 1-16- Introducer
0.035″×70㎝ 1 7F×9㎝ 1 1 φ1.5 1
Lumen 30 Needle18
1-18- Introducer
0.021″×60/50/45㎝ 1 5F×5㎝ 1 1 φ1.3 1
15 Needle20
1-18- Introducer
0.021″×60/50/45㎝ 1 5F×5㎝ 1 1 φ1.3 1
20 Needle20
1-18- Introducer
0.021″×60/50/45㎝ 1 5F×5㎝ 1 1 φ1.3 1
30 Needle20
1-20- Introducer
0.021″×60/50/45㎝ 1 5F×5㎝ 1 1 φ1.0 1
13 Needle20
1-20- Introducer
0.021″×60/50/45㎝ 1 5F×5㎝ 1 1 φ1.0 1
20 Needle20
2-40- Introducer
0.021″×60/50/45㎝ 1 5F×5㎝ 1 1 φ1.3 1
05 Needle20
2-40- Introducer
0.021″×60/50/45㎝ 1 5F×5㎝ 1 1 φ1.3 1
08 Needle20
2-50- Introducer
0.021″×60/50/45㎝ 1 6F×5㎝ 1 1 φ1.7 1
Double- 08 Needle20
Lumen 2-50- Introducer
0.021″×60/50/45㎝ 1 6F×5㎝ 1 1 φ1.7 1
13 Needle20
2-50- Introducer
0.021″×60/50/45㎝ 1 6F×5㎝ 1 1 φ1.7 1
20 Needle20
2-70- Introducer
0.035″×60㎝ 1 8FB×9㎝ 1 1 φ2.3 1
15 Needle18
3-55- Introducer
0.021″×60/50/45㎝ 1 6F×5㎝ 1 1 φ1.7 1
08 Needle20
3-55- Introducer
0.021″×60/50/45㎝ 1 6F×5㎝ 1 1 φ1.7 1
Triple- 13 Needle20
Lumen 3-70- Introducer
0.035″×60㎝ 1 8FB×9㎝ 1 1 φ2.3 1
15 Needle18
3-70- Introducer
0.035″×70㎝ 1 8FB×9㎝ 1 1 φ2.3 1
30 Needle18
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The basic structure is as follows:
D- Outside diameter L- Effective length 1- Delta 2- Extension line 3- Hub
Introduction of the guide wire
The Disposable guide wire is mainly used in the process of interventional therapy for guiding and
orienting when the medical and implant devices enter the human organs. It is composed of core
wire, safety wire and spring coil, which are made of 304 stainless steel.
Guide wire can be divided into fixed and movable – core guide wire based on its structure. The
internal core of fixed core wire is fixed and welded at both ends. So the hardness, soft length
and shape of the wire head are not movable. There are two kinds of head shapes, erect and J. The
erect guide wire has changed soft length on its head, from 3.0 cm to 3.5 cm, so that it can be divided
into soft erect, long soft erect, long long soft erect and especially long soft erect wire.The
bending radius of J type guide wire head is generally 1- 15 mm. Since the core wire of movable core
guide wire is only welded and fixed on its tail but not head, the softness, soft length and shape of the
wire head are changeable when pulling back the internal core. This kind of guide wire is especially
convenience for super-selective catheterization or passing acute angle of the blood vessel division.
The diameter of the guide wire is generally around 0.018- 0.038 inches ( 0.45- 0.97 mm ).
Most thin wire is 0.010 inches and most thick one is 0.052 inches. The length varies from 40 to
450 cm according to different functions. Guide wire fit for central venous catheter is fixed, withits
external diameter around 0.018- 0.038 inches and length 45~70cm.
Table2-The technical data of Guide wire:
Model Peak Tensile

Outer Diameter (mm) length (mm)
(MMNJF ) （N）
18045 0.018 (0.46) 45 -

18060 0.018 (0.46) 60 -
18070 0.018 (0.46) 70 -
21045 0.021 (0.53) 45 -
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21060 0.021 (0.53) 60 -

21070 0.021 (0.53) 70 -
25045 0.025 (0.64) 45 ≥5
25060 0.025 (0.64) 60 ≥5
25070 0.025 (0.64) 70 ≥5
32045 0.032 (0.81) 45 ≥10
32060 0.032 (0.81) 60 ≥10
32070 0.032 (0.81) 70 ≥10

35045 0.035 (0.89) 45 ≥10
35060 0.035 (0.89) 60 ≥10
35070 0.035 (0.89) 70 ≥10
38045 0.038 (0.97) 45 ≥10
38060 0.038 (0.97) 60 ≥10
38070 0.038 (0.97) 70 ≥10
Spring wire core

安全丝 wire
coil
绕丝芯丝
MMNJF guide wire

Introduction for the introducer needle
The disposable introducer needle is mainly used for interventional diagnosis and therapy. It
punctures anterior wall of the blood vessel and guides the guide wire into blood vessels. As the
central venous catheter puncture sites are usually at subclavian vein, internal jugular vein, it can
reduce the damage and hemorrhage to structures near to blood vessel, using introducer needle.
The needle is 3.8~ 7 cm long and its external diameter is from NO. 18- 21 (0.8~ 1.25 mm).The
needle is made of 304 stainless steel and its injection adapter is made from polycarbonates.
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MMN introducer needle
Introduction of Blue introducer syringe

Blue introducer syringe for the introduction of a catheter guide wire into a patient's body, said
introduction syringe comprises a hollow syringe barrel including a fluid chamber, a plunger movable
between an advanced position defining a distal end and retracted position defining a proximal end
and slidably disposed within said fluid chamber, a guide passage means formed longitudinally
through and engaged with a distal end of said hollow syringe barrel and said plunger, said guide
passage means including an aperture disposed within said fluid chamber anda valve assembly
disposed in operative relationship relative to said guide passage means to prevent passage of fluid
through said guide passage means during flushing or aspirating of said catheter introduction syringe
or during the introduction or withdrawal of catheter guide wire through said guide passage means
and to permit fluid to flow from the patient's body into said fluid chamber through said aperture,
said guide passage means being configured to maintain the catheter guide wire in a substantially
straight configuration while the catheter guide wire is disposed within said guide passage means.
Introduction of Scalpel
Scalpel consisted of hilt，sheath and blade，The material of blade is 304 stainless steel， the
module is 11#，Hilt material is ABS，Sheath material is PP. Scalpel mainly used for percutaneous
central venous catheter the epidermis when speak, the calpel is the whole
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process of catheter auxiliary parts required application, Can also be used to for catheter kit without
shear equipment accessories use, catheter after completing suture fixation of cutting work relict.
Scalpel
Introduction of Syringe
Syringe mainly component are barrel, core bin and piston. Barrel and core bin are made of
PP.Piston material is Synthetic rubber. The main purpose of the product:1. Used for washing
catheter before placed catheter. Central venous catheter percutaneous catheter ago, first to catheter
flushing work, flush to check the pod unblocked, each chamber catheter from internal air,
thoroughly wash catheter inside possible particles. 2. when the puncture equipment of CVC Kit is
Y needle, syringe and Y needle combination percutaneous ,and in the process of taking back the
puncture blood, used to determine the correct tip into the vascular site. 3.
When successful and percutaneous catheter through the puncture site to complete the work place,
the application of the syringe on the catheter withdrawing the cavity inspection to ensure proper
catheter placement in the bloodstream. 4. Complete the catheter placement is confirmed, with all
cavity catheter syringe of saline or heparin saline flush and drain the blood in the catheter memory
to ensure catheter prior to use in the absence of the normal flow of the cavity with and without
thrombosis. 5. May need to be administered to patients when the work.
Syringe
Insertion
Generally, a central venous catheter is surgically inserted into a major vein, such as the superior vena
cava. Such catheters are typically introduced using percutaneous entry techniques, such as the well-
known Seldinger techinique. In the Seldinger technique, the skin is cleaned, and local anesthetic
applied if required. The location of the vein is then identified by landmarks or with theuse of a
small ultrasound device. A hollow needle is advanced through the skin until blood is aspirated; the
color of the blood and the rate of its flow help distinguish it from arterial blood (suggesting that an
artery has been accidentally punctured).
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A blunt guidewire is passed through the needle, and the needle is then removed. A dilating device may
be passed over the guidewire to slightly enlarge the tract, and the catheter itself is then passed over the
guidewire, which is then removed. All the lumens of the line are aspirated (to ensure that they are all
positioned inside the vein) and flushed.
For jugular and subclavian lines, a chest X-ray is typically performed to ensure the line is positioned
inside the superior vena cava and, in the case of insertion through the subclavian vein, that there is no
resultant pneumothorax.
3.2.6.3 Materials
In Table 3-1 is a list of materials used and if in direct contact with blood or tissues.
The Disposable central venous catheter kit manufactured by Target selects 304 stainless steel, PP,
nylon, and polycarbonate with good biocompatibility, which is commonly used in clinic for several
years.
Table 3-1 Main Raw Materials & Suppliers
Products Assembly unit Materials Supplier

Blue soft tube TPU
Central Catheter body TPU
venous Delta PVC
catheter Extension line TPU
Lepu Medical Technology
Stanch clip ABS (Beijing) Co., Ltd
Catheter clamp PVC
Rigid fastener PP
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Shenzhen Haikangda
Guide Guide wire 304 stainless steel
Technology Co., Ltd.
wire
Coil and protection PE Lepu Medical Technology
Coil booster PP (Beijing) Co., Ltd
Pipe card PP
Protection cap PE
3.2.6.4 Drawings
The main Drawing list of Disposable Central Venous Catheter Kit is shown as Table 3-2:
Table 3-2 Main drawing list of disposable central venous catheter kit
Products Assembly unit Item number

Central venous catheter MMCVC-I-00
Blue soft tube MMCVC-I-01
Tube MMCVC-I-02
Extension Line CVC-01
Delta CVC-02
Catheter Clamp CVC-03
Central venous catheter Hub CVC-04
Delta block-triple lumen CVC-05
Delta block-single lumen CVC-06
Delta block-double lumen CVC-07
Stanch clip CVC-08

Needle MMN-I-001
Introducer needle
Injection adapter MMN-I-002
Guide wire GW-0
Coil and protection tube GW-1
Double-link Tube clamp GW-2
Guide wire
Triple-link Tube clamp GW-3
Protection cap GW-4
Coil booster GW-5
Tube seat KZG-1
Dilator
Tube MMCVC-1-1.02
Bar LZG-00
Blue Syringe Large cap LZG-01
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Inside and outside pipe LZG-02

Black rubber plug LZG-04
Bobbin LP0709001
Main subject LP08020
Heparin cap
End cover LP08021
Barrel CVCB-ZSQ-01
Syringe
Core Bin CVCB-ZSQ-02
Piston CVCB-ZSQ-03
Needle hub CVCB-ZSZ-01
Needle
Needle tube CVCB-ZSZ-02
Blade CVC-PPT-01
Scalpel Hilt CVC-PPT-02
Sheath CVC-PPT-03
3.2.7 Joint use devices
Below is a list of accessories, adapters, and other devices or equipments intended to be used in
combination with the Disposable Central Venous Catheter Kit.
 Heparin cap
 Needless connector
 Disposable infusion set
 Syringe
 Disposable blood pressure transducer
 Guide wire
The Essential Requirements are met when the device is attached or used with these accessories.
Reference documents see Appendix 3.1 CE-CVCB-048 Statement of joint use medical device of
Disposable Central Venous Catheter Kit
4 Market history
Lepu Medical Technology (Beijing) Co., Ltd is a Sino-America joint-venture established in 1999,
which was certified as a high- tech enterprise by the Beijing Municipal Science and Technology
Commission. It is mainly engaged in development, production and sale of the medical equipments.
Beijing Target Medical Technologies, Inc. is a wholly owned subsidiary company of Lepu
Medical Technology (Beijing) Co., Ltd.
Beijing Target Medical Technologies, Inc. is the first manufacture in China engaged in development,
production and sale of the central venous catheters. In 2000, it readily got its registration certificate
authorized by State Food and Drug Administration. Beijing Target Medical Technologies, Inc. is the
only company who own the Hot Melt Adhesive Technique in China. It is a high- tech enterprise with
standard management and reliable quality certified by the Beijing
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Municipal Science and Technology Commission. It has now taken a leadership role in the domestic
industry of medical consumptive material for anesthesia nursing with the registered capital reaching
to 41 million yuan.
The central venous catheters of the company entered the national market on February, 2001 after getting
the trial production of registration certificate for medical equipment approved by the State Food and
Drug Administration. In July 2003, the company won the medical devices permitted production
registration certificate from the State Food and Drug Administration. In May 2005, the company re-
registered and obtained the permitted production of registration certificate for medical equipment
again. Since appearing on the market, the production has been more and more widelyused, and the
good equality of the products has been fully and effectively verified. The quality control system of
the company has passed the “GB/T19001-2016, YY/T 0287- 2017” national medical industry standard
certification in October 2004 and the Europe Rhine TUV quality system authentication in October,
2008.
Depending on the requirement of clinical application, central venous catheter and accessories that may
be required in Catheter Insertion such as guidwire, introducer needle and so on, are packeted in one
package, forming a central venous catheter kit. This production has been approved to achieve a good
therapeutic effect in General Hospital of Beijing Military Command, 302 military hospital and other
departments authored by the State Food and Drug Administration and the State Bureau of Quality and
Technical Supervision. Right now there are around 40 professional staffs including technicians,
producers and quality control personnel in the company. In order to fully guarantee the safety and
efficiency, the company has already established central venous catheter production line and laboratory
with standard management and advanced facilities.
5 Design Verification & Validation

Target Medical states that the Disposable Central Venous Catheter Kit doesn’t incorporate a medicinal
substance or viable materials of animal tissue and/or blood derivatives of human origin.
5.1 Biological evaluation

The Disposable Central Venous Catheter Kit is made of high performance polymer, thermoplastic
polyurethane. Due to thermsensitivity, the catheter softens when expose to body temperature, with
excellent flexibility and resistance to bending. These materials are widely used in clinical treatment
both at home and aboard, and at present apply to medical devices with reliable performance and
outstanding biocompatibility.
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According to the requirements in EN ISO 10993-1:2018, Disposable Central Venous Catheter Kit is
categorized as external communicating and limited exposure device. So according to table A.1 from
EN ISO 10993-1:2018, the following biological evaluation tests are chosen for assessing bio-safety of
the product: cytotoxicity, sensitization, irritation or intracutaneous reactivity, systemic toxicity (acute),
and haemocompatibility (see applicable part of table A.1 from EN ISO 10993-1:2018 below).
Applicable Part of Table A.1 from EN ISO 10993-1:2018 - Evaluation tests for consideration
Medical device categorization by Biological effect
nature of body contact
intracutaneous reactivity
(see 5.2)
Haemocompatibility
Subchronic toxicity
(subacute toxicity)
Systemic toxicity
Contact duration
Genotoxiixity
Sensitization
Implantation
Cytotoxicity
Irritation or
(see 5.3)
(acute)
Category contact A-limited (≤24h)
B-prolonged (>24h to
30days)
C-permant (>30days)
External
Circulating
communicating B × × × × × × × ×
blood
device
Overall review of the biological evaluation testing performed is provided in Appendix 5.1 CE-CVCB-
011Biocompatibility Evaluation Report, Report QZFA200604901. This document provides a detailed
overview of biological safety testing performed.
From the results it is concluded that the Disposable Central Venous Catheter Kit are biologically safe.
This is further supported by absence complaints relating to biologically safety issues since marketing
the device.
5.2 Bench testing

Act as one of a sterilized medical device contacting with vascular lumen for a Short-term, Disposable
Central Venous Catheter Kit should be no energetic exchange with patients, resulting no harm for the
environment. The physical, chemical, and biological characters should be qualified in table 5-1:
Overall review of the performance testing of the Disposable Central Venous Catheter Kit isprovided
in Appendix 5.2 CE-CVCB-008 series-performance test report for Disposable Central
25
Venous Catheter Kit.Below, table 5-1 listed the test reports conducted by the authorities and the
detailed information see in appendix 5.2
26
Technical specification of Disposable Central Venous Catheter Kit

Design Input Design output
No. Product
Source Requirements Accept/Reject Criteria Design Verification
Specifications
Radio-detectabilit Parts of the catheter shall be Parts of the catheter shall be CE-0701-2015
1.1 ISO 10555-
y 1:2013/A1:2017 radio-detectable. radio-detectable. CE-0702-2015
CE-0703-2015
When examined by normal or When examined by normal or
corrected to normal vision, corrected to normal vision,
with a minimum x 2,5 with a minimum x 2,5 CE-0701-2015
According to EN magnification the external magnification the external CE-0702-2015
1.2 Surface
ISO 10555- appea rance of the effective appearance of the effective CE-0703-2015
1:2013/A1:2017 length of the catheter shall length of the catheter shall
appear free from extraneous appear free from extraneous
matter. matter.
27
According
corrosion
to ISO
resistance
10555- CE-0701-2015
1:2013/A1:2 No signs of corrosion occurred CE-0702-2015
1.3 NA
017 during the test. CE-0703-2015
Intravascular
Catheters -
Sterile and
Soft tip: Soft tip:
According
1.85mm>OD≥0.75mm:≥4N 1.85mm>OD≥0.75mm:≥4N
to ISO
≥1.85mm:≥5N ≥1.85mm:≥5N CE-0701-2015
10555-
Catheter body： Catheter body: CE-0702-2015
1.4 Peak tensile force 1:2013/A1:2
1.15mm>OD≥0.75mm:≥5N; 1.15mm>OD≥0.75mm:≥5N; CE-0703-2015
017
ISO 10555- 1.85mm>OD≥1.15mm:≥10N; 1.85mm>OD≥1.15mm:≥10N;
3:2013 OD≥1.85mm:≥15N OD≥1.85mm:≥15N
No leakage occurred from the CE-0701-2015

According No leakage occurred from the
1.5 Leakage hub assembly, or catheter CE-0702-2015
to ISO hub assembly, or catheter tube.
tube. CE-0703-2015
10555-
1:2013/A1:2
017
28
ISO 80369-
7:2017
Conical fittings
with a 6 % (Luer)
taper for syringes,
needles and
certain other
medical
equipment —
Part 1: General CE-0701-2015
requirements Dimensions of hubs are in Dimensions of hubs are in CE-0702-2015
1.6 Hubs ISO 80369-
7:2017 tolerance range. tolerance range. CE-0703-2015
Conical fittings
with 6 % (Luer)
taper for syringes,
needles and
certain other
medical
equipment -- Part
CE-0701-2015
According to ISO
1.7 Flowrate The nominal flow rate of 90% The nominal flow rate of 90% CE-0702-2015
10555-
CE-0703-2015
1:2013/A1:2017
CE-0701-2015
According to ISO
1.8 Power injection The nominal power injection NA CE-0702-2015
10555-
CE-0703-2015
1:2013/A1:2017
29
The design,numbei and

The design,numbei and
positioning of side holes shall
positioning of side holes shall CE-0701-2015
According to ISO be such as to minimize adverse
1.9 Side hole be such as to minimize adverse CE-0702-2015
10555- adverse effects on the catheter
adverse effects on the catheter CE-0703-2015
1:2013/A1:2017 and trauma to the
and trauma to the tissues.
tissues.
The distal tip shall be smooth, The distal tip shall be smooth,
CE-0701-2015
According to ISO rounded, tapered or similarly rounded, tapered or similarly
1.10 Distal tip CE-0702-2015
10555- finished in order to minimize finished in order to minimize
CE-0703-2015
1:2013/A1:2017 trauma to vessels during use. trauma to vessels during use.
Research on The tolerance of outside The tolerance of outside CE-0701-2015
1.11 Size equivalent diameter and effective length is diameter and effective length CE-0702-2015
products ±10％. is ±10％. CE-0703-2015
When examined by normal to When examined by normal to
Distance CE-0701-2015
According to ISO normal vision, the length normal vision, the length
1.12 markings and CE-0702-2015
10555-3:2013 marking and lumen marking marking and lumen marking
lumen markings CE-0703-2015
should be clearly seen. should be clearly seen.
2 Guide wire
30

corrected-to-normal vision corrected-to-normal vision
with minimum 2,5x with minimum 2,5x
According to BS
magnification, the external magnification, the external
2.1 Appearance EN ISO CE-0702-2015
appearance of the effective appearance of the effective
11070:2014/AMD
1:2018 length of the device shall length of the device shall
appear free from extraneous appear free from extraneous
matter. matter.
According to BS
corrosion No signs of corrosion occurred No signs of corrosion
2.2 EN ISO CE-0702-2015
resistanc during the test. occurred during the test.
11070:2014/AMD
e 1:2018
According to BS
Radio-detectabilit Parts of the catheter shall be Parts of the catheter shall be
2.3 EN ISO CE-0702-2015
y radio-detectable. radio-detectable.
11070:2014/AMD
Cross-section diameter D of Cross-section diameter D of
According to BS the guide wire: 0.46~0.97mm ± the guide wire: 0.46~0.97mm
2.2 Size EN ISO 10%; ± 10%; CE-0702-2015
11070:2014/AMD length L of the guide wire: length L of the guide wire:
1:2018
450~700mm ± 10% 450~700mm ± 10%
According to BS A safety wire shall be provided A safety wire shall be
2.3 Safety wire EN ISO unless the core wire is attached provided unless the core wire CE-0702-2015
11070:2014/AMD to the tip. is attached to the tip.
1:2018
31
According to BS
The guidewire shall not The guidewire shall not
2.4 Fracture EN ISO CE-0702-2015
fracture, loosen, or fail. fracture, loosen, or fail.
11070:2014/AMD
According to
The guidewire shall not The guidewire shall not
2.5 Flexing test BS EN ISO CE-0702-2015
fracture, loosen, or fail. fracture, loosen, or fail.
11070:2014/AMD
According to
0.55mm≤OD<0.75mm:≥5; 0.55mm≤OD<0.75mm:≥5;
2.6 Peak tensile force BS EN ISO CE-0702-2015
OD≥0.75mm:≥10 OD≥0.75mm:≥10
11070:2014/AMD
3 Introducer needle
corrected-to-normal vision corrected-to-normal visionwith
with minimum 2,5x minimum 2,5x magnification,
magnification, the external the external appearance of the
According to BS appearance of the effective effective length of the device
3.1 Surface EN ISO length of the device shall shall appear free from CE-0702-2015
11070:2014/AMD appear free from extraneous extraneous matter. The needle
1:2018
matter. The needle point shall point shall appear sharp and
appear sharp and free from free from feather edges, burrs,
feather edges, burrs, and and
hooks. hooks.
32
According to BS
corrosion No signs of corrosion occurred No signs of corrosion
3.2 EN ISO CE-0702-2015
resistanc during the test. occurred during the test.
11070:2014/AMD
e
According to BS
Radio-detectabilit Parts of the catheter shall be Parts of the catheter shall be
3.3 EN ISO CE-0702-2015
y radio-detectable. radio-detectable.
11070:2014/AMD
MMN1870：
OD：1.25mm±10％；
According to BS Design based on technical
L：70mm±10％；
3.4 Size EN ISO research on equivalent CE-0702-2015
MMN2038
11070:2014/AMD products
1:2018 OD：0.90mm±10％；
L：38mm±10％；
When examined under 2,5x When examined under 2,5x

According to BS magnification, the needle point magnification, the needle
3.5 Needle point EN ISO shall appear sharp and free point shall appear sharp and CE-0702-2015
11070:2014/AMD from feather edges, burrs, and free from feather edges, burrs,
1:2018
hooks. and hooks.
The union of the needle tube
Strength of union According to BS The union of the needle tube
and the needle hub shall not
3.6 of needle tube and EN ISO and the needle hub shall not CE-0702-2015
be loosened by a force of 20
needle hub 11070:2014/AMD be loosened by a force of 20 N.
1:2018 N.
33
4 Dilator
According to BS EN When examined by normal or

When examined by normal or
corrected-to-normal vision with CE-0702-2015
ISO corrected-to-normal vision with
minimum 2,5x magnification, the
4.1 appearance minimum 2,5x magnification, the
11070:2014/AMD external appearance of the
external appearance of the effective
effective length of the device shall
1:2018 length of the device shall appear
appear free from extraneous
free from extraneous matter. matter.
34
5F:
External
diameter:1.7mm±0.05mm
Inside
diameter:0.8mm±0.05mmL
：50mm±2.5mm；
6F:
External
diameter:2mm±0.05mm
Inside
L：50mm±2.5mm；
7F:
External
According to BS Design based on technical diameter:2.35mm±0.05mm CE-0702-2015
4.2 Size EN ISO research on equivalent Inside
11070:2014/AMD products diameter:1.2mm±0.05mm L：
1:2018 90mm±4.5mm；
8F:
External
Inside
L：90mm±4.5mm；
12F:
External
Inside
diameter:1.6mm±0.05mmL
：155mm±5mm；
35
According to BS The minimum force at break of The minimum force at break

Strength of union
EN ISO the dilator and the junction of the dilator and the junction CE-0702-2015
4.3 between hub and
11070:2014/AMD between the dilator and the between the dilator and the
dilator 1:2018
hub≥15N. hub≥15N.
5 Biocompatability
Sterile & Bacterial
endotoxin
EN ISO
11737-1:2006/AC
:2009
EN ISO
11737-
CE-CVCB-008
2:2009
5.1 Sterility Sterile Sterile Performance testing before and
GB/T 14233.2:
after aging
2005 Test method
for infusion,
transfusion,
injection
equipments for
medical use —
Part 2: Biological
36
Sterile &
Bacterial
endotoxin
EN ISO
11737-
1:2006/AC
CE-CVCB-008
5.2 Endotoxin :2009 ≤20EU/set. ≤20EU/set. Performance testing before and
EN ISO after aging
11737-
2:2009 Test
method for
infusion,
transfusion,
injection
equipments
for medical
use — Part 2:
Biological
test methods
37
Sterile & Bacterial

endotoxin
EN ISO
11737-1:2006/AC
:2009
EN ISO
11737-
CE-CVCB-008
Ethylene oxide 2:2009
5.3 ≤10μg/g ≤10μg/g Performance testing before and
residues GB/T 14233.2:
after aging
2005 Test method
for infusion,
transfusion,
injection
equipments for
medical use —
Part 2: Biological
38
Biocompatibility
EN ISO
Cytotoxicity
10993-1:2018
Intracutaneous
EN ISO
Reactivity
10993-3:2014
Sensitization
EN ISO
Acute systemic
10993-4:2017
toxicity
EN ISO
Bacterial Be safety as Limited exposure Be safety as Limited exposure
10993-5:2009 Biocompatibility Evaluation
5.4 Endotoxins (A) according to EN ISO (A) according to EN ISO
EN ISO Report
Blood 10993 10993
10993-7:2008/AC
Coagulation
:2009
Haemolytic
EN ISO
Mammalian Cell
10993-10:2013
Chromosome
EN ISO
Aberration
10993-11:2017
EN ISO
10993-12:2012
6 Chemical performance test
39
CE-CVCB-008
Reducing
6.1 ISO 1135-4：2015 ≤2ml 0.55ml Performance testing before and
substances,
after aging
ISO 1135-4：2015 CE-CVCB-008
Performance testing before and
6.2 pH ≤1 0.5
after aging
ISO 1135-4：2015 CE-CVCB-008

Evaporation
6.3 ≤2.5mg 1.0mg Performance testing before and
residue
after aging
ISO 1135-4：2015 CE-CVCB-008
6.4 Heavy metals ≤0.1μg/ml 0μg/ml Performance testing before and
after aging
The package seal strength
should be no less than 1.5N;
There is no evidence of dye
penetration to the opposite
Package EN ISO Meet the requirement of EN side of the seal or to the Appendix 5.3 CE-CVCB-015
7
Performance 11607-2:2006, ISO 11607-2:2006 interior of the seal via a Package Validation Report
defined channel.
The Agar appearance with
samples should be free of a
red colony.
From the results it is concluded that the product specifications (conform the harmonized standards) are met and that the device performs as intended.
40
5.3 Packaging validation

5.3.1 Specifications for Packaging Materials
5.3.1.1 Unit Pack
The Disposable Central Venous Catheter Kit has one type of configuration – simple
configuration.Monolayer sterilized pack, with PVC Model Box. The products are put into the model
box, sealed with DuPont Tyvek dialyzing paper. This Pack is suitable for the EO sterilization,which
can effectively obstruct the bacterium. It can be easily rived when used.
5.3.1.2 Carton
Specifications： 520×300×470mm;
Technical Requirements：
a. Appearance clean, clear, and printing fine；
b. Printing information inerrable；
c. Size meets requirements.;
d. Material: Corrugated paper
After sterilization and desorption, the final release test is conducted to assurance the good
performance. 50 units of simple configuration type and five IFU are loaded in outer box for
transportation.
It has high pressure resistance and can protect product from damage during transportation and
preservation. The outer box is designed according to EN ISO 15223-1:2016 and EN 1041:2008. The
information, e.g., manufacture date, specification, is printed on the outer box. Appendix 5.3 CE-
CVCB-006 design draft of carton.
5.3.2 Labelling, Descriptions

The labels and artwork conform to the requirements of MDD Article 17, Annex I, section 13 and
aforementioned standards.Paper self-adhesive label is printed for package and pasted in the outside
of dialyzing paper. The basic information can be found on it (see Appendix CE-CVCB-006
design draft of label).
5.3.3 Instructions for Use
41
The IFU has been presented in Appendix 5.5 CE-CVCB-006 Instruction for use and complies with the
requirements of MDD Article 17, Annex I, section 13, EN ISO 15223-1, EN 1041, EN ISO 11070:2018.
5.4 Sterilization validation

The Disposable Central Venous Catheter Kit are all sterile products with EO sterilizationmethod
Fig. 5-5 Sterile Control Process
To ensure the sterile performance of EO Sterilization on above products, Beijing Target Medical
Technologies, Inc. who produced Disposable Central Venous Catheter Kit carried on the Sterile
Validation according to EN ISO 11135:2014. The EO Sterilization validation includes IQ/OQ/PQ,
mainly focus on the key Parameters. The detailed information is showed in Appendix 5.6 CE- CVCB-
013 Sterilization Validation Report for Disposable Central Venous Catheter Kit.
Meanwhile, the Sealing Validation of pouch is carried on to guarantee the perfect sealing performance
of anti-bacteria. The detailed information is showed in Appendix 5.7 CE-CVCB-014 Packaging
Validation Report.
Based on the results presented, it is concluded that the sterilization process ensures an SAL = 10 -6,
conform the requirements of ISO 11135-1 and EN 556.
42
5.5 Shelf life validation and stability studies

The Target Medical confirms the Expiry date of Disposable Central Venous Catheter Kit is two years,
that is to say, when product is to be stored as instruction for use claimed, the Beijing Target Medical
Technologies, Inc., Ltd. insures that within two years after sterilization, the device are sterile and all
performances meet the requirements of the product standard.
Disposable Central Venous Catheter Kit produced by Target Medical selects high performance
polymer material, including polyurethane (TPU), etc, which are high performance polymer material
commonly used in clinical treatment at home and abroad, and have good biocompatibility and size
stability verified per clinical trials for several years.
According to EN ISO 11607-1:2009, EN ISO 11607-2:2006, ASTM F1980-07, etc, the accelerate
aging of hemodialysis catheter kit indicates that when the products is aged in the condition of Q10=2.0,
55℃, 70%RH for 91 days (equivalent to practical storage time of two years).
Considering the properties of the force at break, Distal Tip, and sterility are vulnerable to aging test,
these properties have been mainly focused on. In addition, the other performances are alsoevaluated
to ensure the safety of product after aging test, like size, appearance, corrosion resistance, flowrate,
side holes, Freedom from leakage and endotoxin. The test results before and after aging suggests that
the product’s each performance indicator meets product requirements during two years aging test, and
has no statistically significant difference before and after aging. (See Appendix 5.2 series-
performance test report.)
6 Clinical evidence
Beijing Target Medical Technologies, Inc., Ltd. has provided a clinical evaluation document, in which
the results of a literature evaluation, clinical experience evaluation and the PMS strategy is
summarized. This is included under Appendix 6.1 CE-CVCB-005 clinical evaluation report .
The literature evaluation data of Disposable Central Venous Catheter Kit (section 6.1 of CE- CVCB-
005 clinical evaluation report.) demonstrates that the procedures and the placement of the devices are
well established. The data presented is relevant for the devices and supports the clinical safety.
From the multi evaluation of the Disposable Central Venous Catheter Kit, the efficacy and safety are
proved. It could be used in clinic.
43
7 Risk Management
Risk management on the design, use and production of the devices is performed by Target medical
conform the requirements of EN ISO 14971:2012. The resulting documents are included under
Appendix 7.1 CE-CVCB-003 Risk management report.
Assessing the remaining risk levels and comparing those with the clinical benefits of the devices, it
is concluded that the devices are safe for use.
44
8 Manufacturing Process
8.1 Description of manufacturing process and technologies
8.1.1 Central venous catheter production process flow chart
start
Notification of production tasks
Fill the process flow card
Collect raw
Blue-head welding
Head Shape
extending tube head

 Extending line welding shape, incision
Tube seat adhesion

Extending tube
seat welding/
Delta adhesion
adhesion
Tag printing
N Defective goods
check
processing
Y
Into
p r semi-finished
ocess products area
Note： key process  special process

Figure 8-1 Process Flowchart of Disposable Central Venous Catheter Kit
SUMMARY:
Production process and process flow notified
Raw materials prepared
The shape of the blue head of the end of the tube is given for subsequent welding
The extension line is welded with the tube port
The blue head at the end of the tube is welded with the extension line + port via delta adhesion
Label printing
Process quality control at adhesion/weld points
Semi-finished products
45
8.1.2 Guide wire production process flow chart
Collect raw material
check
Production of guide wire protection
package
N
check Defective goods
processing
Into semi-finished products area
Figure 8-2 Lead and guide wire production and

check process flow chart
SUMMARY: Guide wire is manufactured its protective equipment, like protective cap.
46
8.1.3 Introducer needle production process flow chart
Needle
Needle and injection adapter adhesive@
check
Defective
N goods
processing
Into semi-finished products
Figure 8-3 Introducer needle production and testing flow

chart
SUMMARY: For introductory needle the respective adapter is attached, inspected and diverted to semi-finished
products
47
8.1.4 Blue introducer syringe production flow chart
start
Core and rod component
Adhesive blue
tube assembly
Overall Lamination
N
Defective goods
check processing
Figure 8-4 Blue introducer syringe production and testing flow chart
SUMMARY: Raw material collected Core and rod assembly Blue adhesive is placed Assembles the above
inside the special syringe Final lamination of the process
48
8.1.5 Heparin Cap production flow chart
Start
Notification of production
tasks
Collect raw
material/Cleaning
Adjust ultrasonic welding
Rubber gasket assembly
Body/Cap assembly
welding@
Inspection Rejected products

treatment
Package
Sterilization
Inspection
Inspection Report
Finished product warehouse
Note:@Key process,★ special process

Figure 8-5 Process Flowchart of Heparin cap
SUMMARY: The ultrasonic welding for the body containing heparin is adjusted with the bottom to fit the catheter
and the cap is assembled with the body. After inspection, it is packaged and sterilized.
49
8.1.6 Disposable central venous catheter kit production process flow chart
Central venous
Guide wire
start
Dilator
Blue introducer syringe
Fill the process flow card Stanch clip
Collect raw material and semi-finished Heparin cap
package
check Defective goods

processing
N
 inner package
External
 Sterilization
N Collect the
check certificate and
check report
Into finished products area
end
Note： key process  special process
Figure 8-6 Disposable central venous catheter kit
SUMMARY: Semi-finished products (heparin cap, introductory needle, blue introductory

syringe, catheter and guide wire) are collected with the raw material (tissue dilator,
scalpel, retention clip, extension line clamp and catheter holder), packaged and
inspected for subsequent sterilization. Finally they are derived into finished products
50
After all components are produced, then load them in blister box, package, and sterilization, etc. the
final products are available.
According to ISO9001:2015 and EN ISO13485:2016, Target Medical has established Infrastructure

Control Procedure covering infrastructure (including equipment) procurement, inspection, work,
maintenance and so on. Accordingly all manufacturing and testing equipment should be strictly
installed, operated and verified to ensure that all the equipment can totally meet manufacturing
needs of disposable central venous catheter kit. Operation and maintenance instructions have been
established for main manufacturing and testing facilities. And also periodic maintenance is conducted
on production and testing facilities to ensure soundness and precision. Moreover production workers
and inspectors are regularly trained to guarantee that employee can correctly operate and use these
manufacturing and testing equipments.
This product directly contacts with blood, and requires sterilization. So the processes of ethylene oxide
sterilization and inner packaging sealing are both considered as special processes.
8.2 Manufacturing conditions

The disposable central venous catheter kit is mainly manufactured in clean room of class 10,000 or
above it (similar to the clean room of Class 8 according to the ISO 14644 series, Clean-rooms and
Associated Controlled Environments.) Before entering clean room, all operating personnel must be
sterilized with hands according to Management Regulations of Production.
A detailed overview of the control over the CEA is provided under Appendix 8.1 Test report of clean-
room.
9 Final Conclusions
Target medical concludes that the disposable central venous catheter kit is in compliance with the
requirements of the MDD, Annex I and as such is safe for use and performs as intende.
51
Version Revision history Author Date

Modify EU Authorized Representative
3/2 Guocheng Guan 6th, Jan., 2017
location
Add Design Verification &
3/3 Guocheng Guan 24th, Jan., 2019
Validation
Update certificate number,modify some
4/0 components name and add flowrate Guocheng Guan 29h, Sep., 2019
for each lumen
52

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Secret File CE-CVCB-001

Issue in 2019-09-29 Inure in 2019-09-29

Chapter Contents Page No.

2 Essential principles and evidence of conformity 2

5 Design Verification & Validation 22

1.2 EU Authorized Representative

1.3 Manufacturing facilities

1.3.2 Production location

1.3.3 Sterilization location

Sterilization Station of Target is certified to EN ISO 13485:2016and ISO 13485:2016, certificate

1.4 Worldwide regulatory status of product

1.5 Regulatory contacts

1.5.2 Declaration of conformity

2. Essential principles and evidence of conformity

2.2 Essential requirements checklist

3.2.3 Classification and conformity assessment route

Syringe Class IIa, Rule 2 13940

Conformity assessment route: Annex IX of MDD 93/42/EEC

3.2.4 Photographs of Product

3.2.5 Principle of operation

Model name(s) Model No(s) Variant(s)

3.2.6.2 Functional component

1-14-15 14G 2.1 150 1 110 ≥15 ≥5

1-14-20 14G 2.1 200 1 100 ≥15 ≥5

1-14-30 14G 2.1 300 1 95 ≥15 ≥5

1-16-15 16G 1.7 150 1 54 ≥10 ≥4

1-16-20 16G 1.7 200 1 52 ≥10 ≥4

1-16-30 16G 1.7 300 1 40 ≥10 ≥4

1-18-15 18G 1.3 150 1 21 ≥10 ≥4

1-18-20 18G 1.3 200 1 18 ≥10 ≥4

1-18-30 18G 1.3 300 1 14 ≥10 ≥4

1-20-13 20G 1.05 130 1 20 ≥5 ≥4

1-20-20 20G 1.05 200 1 15 ≥5 ≥4

2-40-05 4F 1.35 50 2 20/14 ≥10 ≥4

2-40-08 4F 1.35 80 2 17/11 ≥10 ≥4

2-50-08 5F 1.7 80 2 38/17 ≥10 ≥4

2-50-13 5F 1.7 130 2 36/13 ≥10 ≥4

2-70-15 7F 2.35 150 2 90/24 ≥15 ≥5

3-55-08 5.5F 1.85 80 3 53/6/6 ≥15 ≥5

3-55-13 5.5F 1.85 130 3 21/7/8 ≥15 ≥5

3-70-15 7F 2.35 150 3 64/28/28 ≥15 ≥5

3-70-30 7F 2.35 300 3 43/12/11 ≥15 ≥5

Specifications of the other components:

Central Venous Tissue

Specification Specs. Qt'y Specs. Qt'y Specs. Qt'y Specs. Qt'y

The basic structure is as follows:

D- Outside diameter L- Effective length 1- Delta 2- Extension line 3- Hub

Introduction of the guide wire

Model Peak Tensile

18045 0.018 (0.46) 45 -

21060 0.021 (0.53) 60 -

32070 0.032 (0.81) 70 ≥10

The basic structure is as follows:

Spring wire core

MMNJF guide wire

The basic structure is as follows:

MMN introducer needle

Introduction of Blue introducer syringe

Products Assembly unit Materials Supplier

Products Assembly unit Item number

Delta block-single lumen CVC-06

Delta block-double lumen CVC-07

Stanch clip CVC-08