AirFit P30i CER PDF

CLINICAL EVIDENCE REPORT TO SUPPORT THE SCONE SYSTEM (D638-180 Rev. 2.
0)
Title: CLINICAL EVIDENCE REPORT
Project/Product: SCONE
Number: D638-180
Revision: 1.0
1 PURPOSE 2
2 SCOPE 2
3 INTENDED USE STATEMENT 2
4 REFERENCES 3
5 DEFINITIONS 4
6 OVERVIEW 4
7 CLINICAL EVALUATION 5
8 CONCLUSION 14
Proprietary Information, not to be reproduced or made available to third parties without prior consent from
ResMed and not to be used in any unauthorised way.  ResMed Ltd 2019
Objective ID: A4387251 Page 1 of 14
CLINICAL EVIDENCE REPORT TO SUPPORT THE SCONE SYSTEM (D638-180 Rev. 1.0)
Rev Author Change Details Review

1.0 Simon Lewi Original Issue >D638-180-1#1
2.0 Sumudu Herath Updated to include P30i throughout >D638-180-1#2
document
1 PURPOSE
To summarise and evaluate the clinical data used to support the intended use statement and
marketing claims of the Scone nasal cradle (AirFit N30i) and Scone nasal pillows (AirFit P30i) mask
systems. To demonstrate conformity to the Essential Requirements via compliance to harmonised
standards and performance criteria.
2 SCOPE
The evaluation of the clinical data is applicable to the ResMed Scone project which includes the
release of the AirFit N30i and AirFit P30i mask systems.
3 INTENDED USE STATEMENT

The Scone nasal cradle and nasal pillows mask systems channels airflow non-invasively to a
patient from a positive airway pressure (PAP) device such as a continuous positive airway
pressure (CPAP) or bi-level device.
The Scone mask systems are:
 to be used by patients weighing more than 66 lb. (30 kg) for whom positive airway
pressure has been prescribed
 intended for single-patient re-use in the home environment and multi-patient re-use in the
hospital/institutional environment.
Company Confidential
Date last saved: 18-Jun-19 Objective ID: A4387251 Page 2 of 14
4 REFERENCES
4.1 AWI101-016 Device Specific Clinical Evidence
4.2 ResMed Generic Clinical Evidence (Obj ID: A187071)
4.3 APQ101 Product Development Procedure
4.4 D638-003 Scone MRD
4.5 D638-008 Scone Clinical and Human Factors Requirements Document
4.6 D638-010 Scone Regulatory Strategy
4.7 D638-011 Scone Regulatory Plan
4.8 D638-001 Scone Risk Management Plan
4.9 D638-016 Scone System Risk Analysis
4.10 D638-100 Scone External Clinical Study 1 Protocol
4.11 D638-103 Scone External Clinical Study 1 Report
4.12 D638-124 Scone Cradle Mask System Clinical Study 2 Protocol
4.13 D638-139 Scone Cradle Mask System Clinical Study 2 Report
4.14 D638-142 Scone Cradle Mask System Clinical Study 3 Protocol
4.15 D638-166 Scone Cradle Mask System Clinical Study 3 Report
4.16 D638-159 Scone Nasal Pillows Clinical Study (1) Protocol
4.17 D638-175 Scone Nasal Pillows Mask System External Clinical Study (1) Report
4.18 D638-171 Scone Nasal Pillows Clinical Study (2) Protocol
4.19 D638-179 Scone Nasal Pillows Clinical Study (2) Report
4.20 D638-148 Scone Cradle Usability Evaluation (1) Report
4.21 D638-161 Scone Cradle Usability Evaluation (2) Protocol
4.22 D638-174 Scone Cradle Usability Evaluation (2) Report
4.23 D638-184 Scone Pillows Usability Evaluation (1) Protocol
4.24 D638-185 Scone pillows Usability Evaluation (1) Report
4.25 638028 AirFit N30i P30i User Guide GLO Eng Ref
4.26 D638-111 Scone Verification Report
4.27 D638-188 Scone Pillows Verification Plan, Protocol & Report
4.28 D638-137 Scone ISO17510 Compliance Report

4.29 D638-017 Scone System Specification
4.30 Complaints database search (AirFit N10, N20, N20 CL, Mirage Activa, Activa LT, Mirage
FX, Mirage Micro, Mirage SoftGel, Mirage/Ultra, Swift FX Nano) July 2016 – June 2018
(Obj ID: A4387858)
4.31 Complaints database search (AirFit P10, Swift FX, Swift LT) December 2016 - December
2018 (Obj ID: A4510351)
5 DEFINITIONS
Item Definition
Clinical Data Safety and/or performance information that are generated from the clinical
use of a medical device
Clinical Evaluation The assessment and analysis of clinical data pertaining to a medical device to
verify the clinical safety and performance of the device when used as
intended by the manufacturer
Clinical Evidence The clinical data and the clinical evaluation report pertaining to a medical
device
Clinical Any systematic investigation or study in one or more human subjects,
Investigation undertaken to assess the safety and/or performance of a medical device
Bench Testing Validation and verification testing done on the Scone mask system,
Scone Project name of the AirFit N30i (nasal cradle) and P30i (nasal pillows) mask
systems
Dreamwear Philips Respironics nasal cradle mask
Dreamwear Gel Philips Respironics nasal pillows mask
Pillows
Usability Refer to studies where patients are taking home an unreleased (non
evaluation/Clinical TGA/ FDA approved) product and using it for treatment. It was referred as
Study usability evaluations at the beginning of the project and clinical studies
afterwards.
Category 1 Complaints that are related to the occurrence of adverse events that may
complaint meet the criteria for mandatory notification to regulatory authorities.
Category 2 Complaints related to product quality e.g. malfunctions that are unexpected,
complaint abnormal or not previously observed.
PBT Polybutylene terephthalate
6 Overview
The clinical data used to support the release of Scone includes:
 ResMed’s Generic Clinical Evidence (Ref 4.2).
 Usability evaluation/Clinical Study reports
 Post market reports of similar products
 Bench testing results
7 Device Description
The AirFit N30i and AirFit P30i share all components with the exception of the nasal cushion (as
shown in Figure 1 below).
Figure 1. AirFit N30i and P30i assembled and exploded view
Mask Fit Range

The AirFit N30i and P30i are offered in four cushion sizes (Small, Small Wide, Medium and Wide) to
cover a wide range of the patient population. The mask frame is offered in two sizes (Small and
Standard) with or without soft fabric sleeves. The headgear is adjustable and available in one size
only.
Cushion Assembly
The AirFit N30i cushion assembly consists of a soft silicone nasal cradle cushion (shown in grey in
Error! Reference source not found. below) permanently over-moulded onto a transparent
polycarbonate chassis (shown in orange).
Figure 1. AirFit N30i Nasal Cradle cushion Figure 3. AirFit P30i Nasal Pillows Cushion
Similarly, the AirFit P30i cushion assembly consists of a soft silicone nasal pillows cushion (shown in
grey in Figure 3 above) permanently over moulded to a PBT clip (shown in orange). The pillows
cushion has a removable vent module which is detailed later in this section.
The single wall membrane of the N30i nasal cradle cushion has a variable wall section with different
thicknesses at specific locations, optimised for seal and comfort for various anthropometric and facial
features. Figure 4 below shows some of the main design features of the N30i cradle cushion in terms
of cushion performance (comfort, seal and stability).The thicknesses shown are for the AirFit N30i
medium cushion only, although each of the four cushion sizes contains the same cushion regions.
Figure 4. AirFit N30i cushion design features
The shape of the nose bridge allows for the top portion (nose tip) of the general membrane to stretch
away from the bottom portion (top lip). This is to allow for a nose with a longer length to still be
comfortably accommodated by the cushion.
The P30i nasal pillows cushion shares the same geometry as the AirFit P10- a released product that
is mature within the market.
The AirFit N30i nasal cradle cushion assembly has vent holes in the chassis component (Figure 6).
Venting provides CO2 wash out and also contributes in meeting total mask flow. Venting is achieved
by circular holes in a pattern on either side of the chassis. The pattern of the vent holes helps to
reduce noise and diffuse the flow concentration. The size of the vent holes is optimized to achieve
balance between noise reduction and CO2 washout even at high levels of humidification. Location of
vent holes avoids hole blockage during side sleep and also not weakening the middle section.
Figure 6. AirFit N30i cushion chassis with vent holes pictured and interface to mask frame
The interface between the cushion assembly and the mask frame provides easy connection and
disconnection (Figure 6).The interface also provides sealing between the two parts. The AirFit N30i
and the AirFit P30i share the same interface between the cushion assembly and mask frame.
The P30i cushion assembly has two vent module variants, a multi-hole and diffuse vent. The circular
vent holes in both vent module varients are arranged in a similar fashion to the N30i but have been
adjusted to better suit the gemomtry of the nasal pillows cushion. The Multi-hole vent variant is
offered in the Sleep Lab Mask (SLM) to allow for multi patient multi use whereas the Diffuse vent is
offered in the home use configuration (single patient multi use). The diffuse vent module is
comprised of three distinct components (vent base, diffuser and vent cover) as pictured in Figure 7.
The diffuser is made of a polyester felt (HL025-WHT) and helps to further reduce noise and diffuse
flow concentration. The multi-hole vent is a single component (Figure 8).
Figure 7. AirFit P30i Diffuse Vent Module- exploded view Figure 8. AirFit P30i Multi-hole Vent Module
Mask Frame
The mask frame assembly is a hollow silicone component that provides the air path between the
elbow assembly and the cushion assembly in both the AirFit N30i and P30i mask systems. It works
with the back strap to provide a stable and adjustable mask system that fits a wide range of head
anthropometrics.
The mask frame assembly contains two polycarbonate clips at each end which snap onto the chassis
of the cushion assembly to provide a secure attachment. The polycarbonate clips are overmoulded in
silicone including a lip seal which seals against the body of the chassis to provide an airtight
interface.
The Airfit N30i and P30i share the same headgear. It fits through the slots in the headgear tabs of
the mask frame assembly and fold back on themselves with the use of Velcro. This interface has
enough clearance to allow easy adjustment of the headgear length whilst on the head. The lower
sections of the mask frame (that contact the cheeks) can be covered with optional fabric sleeves for
comfort.
Figure 9. Mask frame components (AirFit N30i and P30i)
The AirFit N30i and the AirFit P30i share the same mask frame. The mask frame assembly consists
of two main parts (9). The concertina section (either side of the elbow interface to the headgear tabs)
which is moulded flat and the lower conduit (from the headgear tabs to the polycarbonate clips). The
concertina section has been designed to given some stretch on the head under tension to adapt to
different sizes and shapes of heads. The lower conduit section is moulded in to conform to the face,
providing stability and comfort. The headgear tab provides the interface between the conduit
assembly and the headgear for the AirFit N30i and P30i.
Elbow Assembly
The AirFit N30i and P30i share the same elbow assembly. The elbow assembly (pictured in Figure
10) comprises a 90 degree angled, tubular body with a rotating interface at either end that together
create a pneumatic connection between the air tubing and the AirFit N30i and P30i via the frame. The
swivel connects to the air tubing and is assembled to the elbow body via a permanent snap interface
that allows free rotation and controlled leak between the components.
The elbow body provides the air path between the tube and mask frame along with a secondary vent
location for the AirFit N30i and P30i mask systems. It has retaining features for the swivel and elbow
circlip components and both ends provide textured, cylindrical bearing surfaces to allow smooth
rotation of the mating components.
The elbow circlip is assembled to the elbow body and forms buttons with catches that engage with
mating features on the elbow ring. This facilitates a quick, one-handed disconnection interface that
enables the user to easily untether from therapy without removing the mask by depressing the
buttons and disengaging the elbow body assembly from the elbow ring. Therapy can be easily
resumed with one hand by reinserting the elbow body assembly into the elbow ring that remains fitted
to the mask frame.
The elbow ring consists of the elbow ring base mould and the elbow ring over mould. The elbow ring
provides an air tight connection to the frame by using an interference fit to the soft silicone
component that is removable for cleaning. The lip seal contacts the end of the elbow body, controlling
leak while allowing axial rotation.
Figure 10. AirFit N30i and P30i elbow assembly
Headgear
The AirFit N30i and P30i headgear assembly (pictured in Figure 11) provides the interface between
the back of the patient’s head and the rest of the mask system. The adjustable headgear is intended
to wrap around the occiput (sloping back section of head), providing stability to the system. A hooktab
is welded to each of the side straps, which can be looped through slots on either side of the mask
frame and reattached to the outer side of the headgear, providing the adjustment and the retention
force necessary for the function of the system.
Figure 11. AirFit N30i and P30i headgear
8 Clinical Evaluation
Background
Scone/AirFit N30i (nasal cradle) and Scone Pillows/AirFit P30i (nasal pillows) are mask systems
that channel airflow noninvasively to a patient from a positive airway pressure (PAP) device such
as a continuous airway pressure (CPAP) or bilevel device. Scone is the project name for the AirFit
N30i and AirFit P30i mask systems. The Scone mask systems are similar to the Philips Respironics
Dreamwear nasal cradle and nasal pillows masks, and functions the same as existing nasal pillows
masks on the market.
Risk Assessment
The Clinical Representative of the Scone XFT assessed the current status of ResMed's clinical
data which supports the device's proposed indications for use. No additional clinical data was
deemed to be required to support the Scone nasal cradle and nasal pillows mask systems. There
are no outstanding clinical issues (Refs 4.8 & 4.9).
Review of available Clinical data

The clinical data used to support the Scone nasal cradle and nasal pillows mask releases
includes:
(1) ResMed’s Generic Clinical Evidence (Ref 4.2)
(2) Relevant recent literature on the use of nasal masks for treatment of sleep apnea and/or
respiratory insufficiency
(3) ResMed’s released nasal masks (AirFit N10, N20, N20 CL, Mirage Activa, Activa LT, Mirage
FX, Mirage Micro, Mirage SoftGel, Mirage/Ultra, Swift FX Nano) and pillows masks( AirFit P10,
Swift FX and Swift LT) have a history of safe and effective use (by review of Complaints
Database and other post-market reports) (Ref 4.30 and Ref 4.31)
(4) User Evaluation/clinical Study Reports (Refs4.11, 4.13, 4.15, 4.17, 4.19, 4.20, 4.22 & 4.24)
(5) Labelling claims reflect the residual risks to the user and indicate the responsibilities of the
referring doctor
(6) Scone Project Risk Analysis (Ref 4.9)
(7) Bench testing results (e.g. showing clinical performance outcomes are meet the system
specification requirements, harmonised standards and state of the art) (Refs 4.26, 4.27 &
4.29).
8.1.1 ResMed’s Clinical Data Summary document

ResMed’s Generic Clinical Evidence document (Ref 4.2) provides an overall evaluation of the
clinical data supporting the generic classes of ResMed products. Scone is classified under
classification product code BZD (FDA product code) in the US and Class 2a for Europe and section
3 of ref 4.2 applies.
8.1.2 Recent Literature Review

The recent literature was reviewed from the last update of ResMed’s Generic Clinical Evidence
document (Ref 4.2) via ResMed’s internal Sleep Disordered Breathing Updates. The internal Sleep
Disordered Breathing Updates are created from searching Medline, a bibliographic database
produced by the United States National Library of Medicine. This review showed no publications
that identified previously unknown risks.
8.1.3 Similar Products Review

Scone Cradle Similar Products Review
ResMed Complaints database: A review of ResMed’s complaints database was performed for
all ResMed’s nasal masks (AirFit N10, N20, N20 CL, Mirage Activa, Activa LT, Mirage FX, Mirage
Micro, Mirage SoftGel, Mirage/Ultra, Swift FX Nano) for the last 2 years (1st July 2016 - 30th June
2018).
A total of 5292 complaints were received in this period. The most common complaints received
were for physical damage (30%), physical damage – cushion (13%), leaking (11%), skin irritation
(11%) and contamination (10%).
There were 31 complaints (0.6% of total complaints received) related to patient safety for nasal
masks (Cat 1-Injury/Skin Breakdown/Mislabel) in the time period searched. The most common
problem codes assigned to each complaint were mislabel/incorrect label (46%), injury (29%), and
skin breakdown/wound (14%).
Based on description of the complaints, all 16 records of Mislabel were related to errors in lot
numbers, incorrect sizes displayed and incorrect mask provided (pillows instead of nasal). These
are not deemed to pose significant clinical risk to the patient.
There were 10 records of injury, which were reported to ResMed as rash, blister, wound, and tissue
damage. Based on assessment of the complaints and evaluation of the returned masks, these
injuries were found to be not related to or caused by the intended usage of the masks. The root
causes were likely to be over-tightening or persistent use of an ill-fitting mask, and using
inappropriate cleaning agents.
There were 5 records of skin breakdown/wound, which were reported to ResMed as skin damage,
swollen eyes, breakout, pressure sores and wound. A defect in the silicone was detected in an
AirFit N20 mask, which may have contributed to the pressure sores experienced by the patient.
However, other reports or skin breakdown were most likely to be due to over-tightening or
persistent use of an ill-fitting mask.
Scone Nasal Pillows Similar Products Review
ResMed Complaints database: A review of ResMed’s complaints database was performed for
all ResMed’s nasal pillows masks (AirFit P10, Swift FX, Swift LT)- for the last 2 years (31st
December 2016 - 31th December 2018).
A total of 2678 complaints were received in this period. The most common complaints received
were for physical damage (27%), skin irritation (22%), leaking (19%), poor fit (8%) and cases where
the device failure not specified (5%).
There were 18 complaints (0.7% of total complaints received) related to patient safety for nasal
pillows masks (Cat 1-Injury, Mislabel, Skin breakdown, skin irritation and death) in the time period
searched. The most common problem codes assigned to each complaint were injury (50%), Skin
breakdown (28%), skin irritation (11%), mislabel (11%) and death (5%).
Note: the complaint relating to the death was found to be caused by improper use of the product.
A review of other available post-market information (e.g. Medical Device Reports for the USA,
Australia and EU) was performed and is summarised below:
 USA: Searched MAUDE database (Dates: 1st May 2016 to 31st May 2018) for Product Codes:
BZD (292 records); Manufacturer: ResMed (>500 records), Fisher and Paykel (6 records), Philips
Respironics (52 records); Brand Name: Dreamwear (1 record), EasyLife (0 records), Wisp (3
records), TrueBlue (0 records), Eson nasal mask (1 record), Brevida (0 records), Pilairo Q (0
records), Zest (2 records), Opus nasal mask (0 records), BMC N4 (0 records), DeVilbiss nasal
mask (0 records), AirFit N10 (0 records), AirFit N20 (0 records), Nasal Mirage FX (0 records), Swift
FX Nano (0 records).
 Searched MAUDE database (Dates: 31st December 2016 to 31st December 2018) for Product
Codes: BZD (248); ResMed (>500 records), Fisher and Paykel (6 records), Philips Respironics (2
records); Brand Name: Dreamwear (2 records), Brevida (0 records), Pilairo Q (0 records), Opus
nasal pillow mask (0 records), BMC P2 (0 records), Aloha nasal pillow mask (0 records), AirFit P10
(0 records), Swift FX (2 records) and Swift LT (0 records).
Within this 2-year search period, there were no records of patient death or injury and malfunction
for ResMed’s nasal or Nasal pillows masks reported in the MAUDE database.
(http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM)
 Australia: Reviewed the “Alerts” and “Product Recalls” indices and the “DAEN - medical
device” database (Dates: 1st May 2016 – 2nd July 2018) (http://www.tga.gov.au/safety/index.htm)
There were no alerts or product recalls related to ResMed’s nasal mask within this search period.
The DAEN database was searched (Dates: 1st May 2016 to 7th March 2018) for the following
keywords: ResMed (18 records), Philips Respironics (3 records), Fisher & Paykel Healthcare (56
records), mask (28 records), nasal mask (0 records). (https://www.tga.gov.au/database-adverse-
event-notifications-daen)
The DAEN database was searched (Dates: 31st December 2016 to 6th September 2018) for the
following keywords: ResMed (5 records), Philips Respironics (0 records), Fisher & Paykel
Healthcare (11 records), mask (16 records), nasal pillow mask (0 records).
(https://www.tga.gov.au/database-adverse-event-notifications-daen)
No adverse events were reported for ResMed’s nasal and nasal pillow mask within this search
period.
 UK: Reviewed MHRA Medical Device Alerts and Field Safety Notice database (Dates: 1st May
2016 to 31th December 2018). (https://www.gov.uk/drug-device-alerts)
There were no medical device alerts or field safety notices for ResMed’s nasal and nasal pillows
masks.
Summary: The outcome of this post market review identified no new issues, safety concerns, or
unknown risks for nasal cradle and nasal pillows masks. There is a continuous history of safe and
effective use of ResMed’s nasal and nasal pillows masks.
8.1.4 Clinical Investigation

Five clinical studies and three usability studies were performed as part of the Scone mask systems
development.
8.1.4.1 Scone External Clinical Studies
Scone External Clinical Study 1
The first external clinical study was conducted at the ResMed Sleep Research Centre, Bella Vista
and patients’ home, where the Scone mask system was evaluated against the Philips Respironics
Dreamwear mask system (Ref 4.10). The following areas were investigated:
 Mask seal, comfort, stability, usability and performance of the Scone mask compared to
Dreamwear.
 Participants completed mask evaluation questionnaires throughout the study.
 Objective data from each mask was also obtained from the participant’s CPAP device.
Scone passed all objectives according to Criterion 6 and in comparison with Dreamwear. Leak was
higher for Scone, but there was no significant difference in the AHI of Scone and Dreamwear.
There were six adverse events reported, five were related to soreness and one was related to
increased AHI (this patient was withdrawn from the study and referred to their physician). The
results and conclusions of this clinical study are summarised in Ref 4.11.
The second external clinical study was conducted at the ResMed Sleep Research Centre, Bella
Vista and at a centre in the US, as well as at patients’ home, where the Scone mask system was
evaluated against the Philips Respironics Dreamwear nasal mask system and the participants
current mask system (Ref 4.12). The following objectives were assessed:
 Apnoea-Hypopnea Index (AHI) and the seal, comfort, stability, usability and performance
of the Scone mask compared to Dreamwear and the participant’s current mask system.
Scone passed all objectives according to Criterion 6. There were no statistically significant
differences in ratings between the Scone and Dreamwear mask system for initial fitting, ease of
use, seal, comfort, stability, facial marks, noise, venting and overall performance. Leak was
higher for Scone, but there was no significant difference in the AHI of Scone and Dreamwear.
There were six adverse events reported, mostly related to soreness or headaches (one was due
to an unrelated dental procedure). The results and conclusions of this clinical study are
summarised in Ref 4.13.
The third external clinical study was conducted at the ResMed Sleep Research Centre, Bella Vista,
as well as at patients’ home, where the Scone mask system was evaluated against the Philips
Respironics Dreamwear nasal mask system and the participants current mask system (Ref 4.14).
The following objectives were assessed:
of the Scone mask compared to Dreamwear and the participant’s current mask system.
Scone passed all objectives according to Criterion 6. There were no statistically significant
differences in ratings between the Scone and DreamWear mask system for initial fitting, ease of
use, seal, comfort, stability, facial marks, noise, venting and overall performance. No statistically
significant differences were found with daily usage, AHI, AI, HI or leak between both mask
systems. There were four adverse events reported, mostly related to soreness. The results and
conclusions of this clinical study are summarised in Ref 4.15.
Scone Pillows External Clinical Study 1
The fourth external clinical study was conducted at the ResMed Sleep Research Centre, Bella
Vista, as well as at patients’ home, where the Scone nasal pillows mask system (Ref 4.16) was
evaluated against the participant’s current mask system
of the Scone mask compared to the participant’s current mask system.
Scone nasal pillows passed all objectives according to Criterion 6. There were no statistically
significant differences in rating between Scone pillows and the participants current mask. Usage
hours of Scone pillows was significantly higher than participants current mask, however there
was no statistical difference in AHI, AI, HI or leak between both masks. One adverse event was
reported- participant experience a nose bleed on the first night of use. PD investigation of the trial
mask showed no defect. The results and conclusions of this clinical study are summarised in Ref
4.17.
Scone Pillows External Clinical Study 2
The fifth external clinical study was conducted at the ResMed Sleep Research Centre, Bella
Vista, as well as at patients’ home, where Scone nasal pillows mask system was evaluated
against the Phillips Respironics Dreamwear gel nasal pillows mask system and participants
current mask system (Ref 4.18) The following objectives were assessed:
of the Scone nasal pillows mask compared to Dreamwear gel nasal pillows mask and the
participant’s current mask system.
Scone nasal pillows passed all objectives according to criterion 6. Scone was rated significantly
better than Dreamwear gel nasal pillows for initial overall comfort and venting (as perceived by
partners). There was no significant difference in rating for ease of use, seal, facial markings,
noise and overall performance. The objective leak values for Scone pillows was reported as
significantly worse than Dreamwear gel pillows. Investigation showed that the flow generator leak
reporting carries an inaccuracy due to an inherent difference in vent flow curves between the two
masks. Leak values for Scone pillows is overestimated whereas leak values for Dreamwear gel
nasal pillows is underestimated. With flow generator leak value calculation corrections applied,
Scone pillows is seen to out perform Dreamwear gel nasal pillows for leak. The results and
conclusions of this clinical study are summarised in Ref 4.19.
8.1.4.2 Scone Usability Studies
Scone Cradle Usability Studies
Two summative usability evaluations were conducted at the ResMed Sleep Research Centre,
Bella Vista, where the Scone mask system was evaluated (Refs 4.12 & 4.21). The following
objectives were assessed:
 To assess the ability of participants to perform tasks related to the Scone mask system.
 To assess the usability of the Scone mask system when performing tasks related to its
use.
The evaluations showed that the Scone Cradle Mask System passed most objectives assessed.
The system performed well in most areas pertaining to the ability or intuitiveness of performing
specific tasks for participants. No significant patient harm is anticipated for the areas where
participants found challenges. The results and conclusions of these usability studies are
summarised in Refs 4.20 & 4.22.
Scone Pillows Usability Study
One summative usability evaluation was conducted at ResMed Sleep Research Centre, Bella
Vista, where the Scone Pillows mask system was evaluated Ref 4.23. The following objective
was assessed:
 To assess the ability of participants to perform tasks related to the Scone pillows mask
system.
 To assess the usability of the Scone pillows mask system when performing tasks related
to its use.
The evaluations showed that the Scone Pillows mask system passed most objective
assessment. The system performed well in most areas pertaining to the ability or intuitiveness of
performing specific tasks for participants. The instructional video and user guide proved useful to
participant when successfully completing the tasks. No significant patient harm is anticipated for
the areas where participants found challenges. The results and conclusions of these usability
studies are summarised in Ref 4.24.
8.1.5 Labelling Claims

The AirFit N30i and P30i Combined User Guide labelling identifies any residual risks
associated with the use of these nasal masks (Ref 4.25). These include:
 Standard warnings for the use of nasal mask systems
 Standard warnings for the use of nasal pillows masks systems
 The need for the referring doctor to prescribe the accompanying Positive Airway Pressure
device
Risks have been mitigated as far as possible.
8.1.6 Bench Testing

Bench testing is summarized in (Ref 4.26, 4.27 and 4.29). These reports demonstrate that for
the clinically relevant performance parameters (eg. total mask flow, functional deadspace,
flow resistance, Flow Generator compatibility), the mask safety and efficacy was clinically
acceptable.
9 Conclusion
ResMed has deemed that the demonstration of conformity with Essential Requirements based on
clinical data is not appropriate. Vented masks for PAP or bilevel therapy have a long history and
are based on well-established technology and consistent claims with no significant innovative
aspects. Vented masks like the AirFit N30i and P30i work by simple physiological mechanisms.
They are a non-invasive accessory that provides a seal between the flow generator and the
patient’s nasal or oronasal passages, such that the therapeutic air pressure can be successfully
delivered. Vent holes are incorporated into their design to prevent patient expired CO2 from being
rebreathed.
Performance criteria and safety mitigations are clearly defined in harmonised standards and
guidance documents. The design of the AirFit N30i and P30i have taken into account
internationally recognised standards including harmonised standards for basic safety and essential
performance of sleep apnoea breathing therapy: Masks and application accessories. As such,
ResMed is able to demonstrate compliance with the Essential Requirements by meeting the
requirements of these internationally recognised standards.
However, the summary results from ResMed’s preclinical testing were reviewed and relevant
clinical data were evaluated to assess the state of the art in terms of safety and performance, with
the evaluation of these data demonstrating that the performance and safety of the AirFit N30i and
P30i for the intended purpose is supported, with all potential risks identified in the risk analysis
being adequately addressed by the preclinical and clinical data.
The risk analysis does not identify the need for clinical investigations, and there were no new
potential risks identified during the evaluation of the preclinical data and clinical data as part of this
clinical evaluation. The overall benefit-risk ratio for the vented masks remains favourable.
The evaluation and summation of the available clinical data provided above demonstrates that the
AirFit N30i nasal cradle mask and the P30i nasal pillows mask is suitable for the stated intended
use and marketing claims. The available evidence is sufficient to demonstrate conformity to the
Essential Requirements.

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CLINICAL EVIDENCE REPORT TO SUPPORT THE SCONE SYSTEM (D638-180 Rev. 2.

Title: CLINICAL EVIDENCE REPORT

Rev Author Change Details Review

3 INTENDED USE STATEMENT

4.1 AWI101-016 Device Specific Clinical Evidence

4.2 ResMed Generic Clinical Evidence (Obj ID: A187071)

4.3 APQ101 Product Development Procedure

4.4 D638-003 Scone MRD

4.5 D638-008 Scone Clinical and Human Factors Requirements Document

4.6 D638-010 Scone Regulatory Strategy

4.7 D638-011 Scone Regulatory Plan

4.8 D638-001 Scone Risk Management Plan

4.9 D638-016 Scone System Risk Analysis

4.10 D638-100 Scone External Clinical Study 1 Protocol

4.11 D638-103 Scone External Clinical Study 1 Report

4.12 D638-124 Scone Cradle Mask System Clinical Study 2 Protocol

4.13 D638-139 Scone Cradle Mask System Clinical Study 2 Report

4.14 D638-142 Scone Cradle Mask System Clinical Study 3 Protocol

4.15 D638-166 Scone Cradle Mask System Clinical Study 3 Report

4.16 D638-159 Scone Nasal Pillows Clinical Study (1) Protocol

4.18 D638-171 Scone Nasal Pillows Clinical Study (2) Protocol

4.19 D638-179 Scone Nasal Pillows Clinical Study (2) Report

4.20 D638-148 Scone Cradle Usability Evaluation (1) Report

4.21 D638-161 Scone Cradle Usability Evaluation (2) Protocol

4.22 D638-174 Scone Cradle Usability Evaluation (2) Report

4.23 D638-184 Scone Pillows Usability Evaluation (1) Protocol

4.24 D638-185 Scone pillows Usability Evaluation (1) Report

4.26 D638-111 Scone Verification Report

4.27 D638-188 Scone Pillows Verification Plan, Protocol & Report

4.28 D638-137 Scone ISO17510 Compliance Report

4.29 D638-017 Scone System Specification

Figure 1. AirFit N30i and P30i assembled and exploded view

Mask Fit Range

Figure 4. AirFit N30i cushion design features

Figure 9. Mask frame components (AirFit N30i and P30i)

Figure 10. AirFit N30i and P30i elbow assembly

Figure 11. AirFit N30i and P30i headgear

Review of available Clinical data

8.1.1 ResMed’s Clinical Data Summary document

8.1.2 Recent Literature Review

8.1.3 Similar Products Review

Scone Nasal Pillows Similar Products Review

8.1.4 Clinical Investigation

8.1.4.1 Scone External Clinical Studies

Scone External Clinical Study 1

Scone External Clinical Study 2

Scone External Clinical Study 3

Scone Pillows External Clinical Study 1

Scone Pillows External Clinical Study 2

8.1.4.2 Scone Usability Studies

Scone Cradle Usability Studies

Scone Pillows Usability Study

8.1.5 Labelling Claims

8.1.6 Bench Testing

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