Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical characteristics and standard performance metrics of a CPAP mask, with no mention of AI or ML.

Therapeutic

No.

The device is a mask that channels airflow from a positive airway pressure device, which is a therapeutic device, but the mask itself is an accessory, not a therapeutic device.

Diagnostic

No

This device is a CPAP mask designed to channel airflow from a positive airway pressure device for treatment, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is made of "hard PC plastic and soft silicone rubber materials," indicating it is a physical hardware device, not software only.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
Skynector CPAP Mask Function: The Skynector CPAP Mask is a device that channels airflow to a patient for respiratory support. It is an external device that interfaces with the patient's airway, not a device that analyzes biological samples.
Intended Use: The intended use clearly states it "channels airflow non-invasively to a patient." This is a therapeutic/supportive function, not a diagnostic one.
Device Description: The description focuses on the physical design and materials for delivering air, not on analyzing biological samples.
Lack of IVD-related information: The document does not mention any analysis of biological samples, chemical reactions, or diagnostic markers, which are characteristic of IVDs.

The Skynector CPAP Mask is a respiratory support device, specifically a component of a positive airway pressure system.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Skynector CPAP Mask channels airflow non-invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system.

The Skynector CPAP Mask is to be used by adult patients (>661b />30kg) for whom positive airway pressure has been prescribed.

The Skynector CPAP Mask is intended for single patient re-use in the home environment and/or multi-patient reuse in the hospital / institutional environment.

Product codes (comma separated list FDA assigned to the subject device)

BZD

Device Description

The Skynector CPAP masks are designed based on human facial shape and structure, and the operating characteristics during application, they are injection mold of hard PC plastic and soft silicone rubber materials, with high level of air tightness, convenient operation and comfortable to wear, etc. They are used for the interfacing devices that are used to provide users with Continuous Positive Airway Pressure (CPAP) ventilation or biphasic positive airway pressure (BiPAP) ventilation treatment.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Mouth and nose (for Full-Face Mask); Nose (for Nasal Mask)

Indicated Patient Age Range

adult patients (>66lb />30kg)

Intended User / Care Setting

Home environment and/or multi-patient reuse in the hospital / institutional environment.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The performance test based on ISO 17510-2:2007 are as follow:

001_Connecting Test Report for the Connector Used on FM-05 Apnea Mask
002_Leak rate test report
003_Resistance to flow (Pressure drop) test report
004_Anti-asphyxia valve pressure test report
005_Breathing during single fault condition-Determination of the inspiratory and expiratory resistance
006_CO2 re-breathing test report
007_Vibration and noise test report
008_Dead space test report

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K113127, K092835

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol with three human profiles facing right, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 24, 2015

Sky Wise Medical Instrument (Shenzhen) Co., Ltd. C/O Field Fu Official Correspondent Shenzen Joyantech Consulting Co., Ltd. 4th Floor, Jinhui Building Nanhai BLVD. Nanshan District Shenzhen, Guang Dong, 518000 CHINA

Re: K150685

Trade/Device Name: Skynector CPAP Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: Class II Product Code: BZD Dated: July 17, 2015 Received: July 23, 2015

Dear Mr. Fu:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply

1

with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith M.S. Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K150685

Device Name Skynector CPAP Mask

Indications for Use (Describe)

The Skynector CPAP Mask channels airflow non-invasively to a patient from a positive arway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system.

The Skynector CPAP Mask is to be used by adult patients (>661b />30kg) for whom positive airway pressure has been prescribed.

The Skynector CPAP Mask is intended for single patient re-use in the home environment and/or multi-patient reuse in the hospital / institutional environment.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

3

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

4

SECTION 05 510(k) Summary

This summary of 510(K) safety and effectiveness information is submitted as Required by requirements of SMDA and 21 CFR §807.92.

1 Administrative Information

| Date of Summary

prepared	Feb, 28, 2014
Manufacturer
information	Company title:
Sky Wise Medical Instrument (Shenzhen) Co.
Ltd.
Company address:
No 12 South Ping Xi Road Xinsheng
Community, Longgang Street, Longgang
District, Shenzhen, Guangdnog, China
Phone: +86-755-28491103
Fax: +86-755-28494339
Contact Person: Hu hanhan
E-mail: 942526346@qq.com
Submission
Correspondent	Shenzhen Joyantech Consulting Co., Ltd.
4th Floor, Jinhui Building, Nanhai BLVD,
Nanshan District, Shenzhen, Guangdong,
China.
Contact person: Mr. Field.Fu
E-Mail: cefda13485@163.com
QQ: 670312758
Website: www.cefda.com
Image: Joyantech logo
Establishment registration
number	No.

2 Device Information

| Type of 510(k)

submission:	Traditional
Trade Name:	Skynector CPAP Mask
Model:	FM-02, NM-03

5

Version:A/0

Product: Skynector CPAP Mask

Ventilator, Non-Continuous (Respirator). Classification name: Anesthesiology Review Panel: BZD Product Code: Device Class: ll 868.5905 Regulation Number: |

3 Predicate Device Information

| Sponsor: | ResMed Limited;
Respironics, Incorporated. |
|----------------|----------------------------------------------------------|
| Device: | Mirage Quattro Full Face Mask;
ComfortGel Nasal Mask. |
| 510(K) Number: | K113127, K092835 |

4 Device Description

The Skynector CPAP masks are designed based on human facial shape and structure, and the operating characteristics during application, they are injection mold of hard PC plastic and soft silicone rubber materials, with high level of air tightness, convenient operation and comfortable to wear, etc. They are used for the interfacing devices that are used to provide users with Continuous Positive Airway Pressure (CPAP) ventilation or biphasic positive airway pressure (BiPAP) ventilation treatment.

5 Intended Use

The Skynector CPAP Mask channels airflow non-invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system.

The Skynector CPAP Mask is to be used by adult patients (>661b />30kg) for whom positive airway pressure has been prescribed.

The Skynector CPAP Mask is intended for single patient re-use in the home environment and/or multi-patient reuse in the hospital /institutional environment.

6 Indications for Use

6

The Skynector CPAP Mask channels airflow non-invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system.

The Skynector CPAP Mask is to be used by adult patients (>661b />30kg) for whom positive airway pressure has been prescribed.

The Skynector CPAP Mask is intended for single patient re-use in the home environment and/or multi-patient reuse in the hospital /institutional environment.

7 Technological characteristics of the proposed device compared to the predicate device

The proposed device and the Predicate device have the same intended use, design principle, and similar material composition. The differences don't impact safety and effectiveness of the device. The proposed device is substantially equivalent to the predicate devices. The compared details are listed in tables below:

	Subject Device:	Predicate Device:	Remarks:
	Device:
Skynector CPAP Full-face Mask
Manufacturer:
Sky Wise Medical
Instrument(Shenzhen) Co.,Ltd.	Device:
Mirage Quattro Full
FaceMask
Manufacturer:
ResMed LTD.
	510(k) Number:
To be determined	510(k) Number:
K113127
Intended
Use	The Skynector CPAP Mask
channels airflow non-
invasively to a patient from a
positive airway pressure
device such as a continuous
positive airway pressure
(CPAP) or bi-level system.
The Skynector CPAP Mask is
to be used by adult patients
(>66lb / >30kg) for whom
positive airway pressure has
been prescribed.	The Mirage Quattro channels
airflow non-invasively to a
patient from a positive
airway pressure device such
as a continuous positive
airway pressure (CPAP) or
bi-level system.
The Mirage Quattro is to be
used by adult patients (>30
kg) for whom positive
airway pressure has been
prescribed.	Both masks are
noninvasive and
the meanings of
intended use are
same.
	Subject Device:	Predicate Device:	Remarks:
	intended for single patient re-
use in the home environment
and/or multi-patient reuse in
the hospital /institutional
environment.	single-patient re-use in the
home environment and
multi-patient re-use in the
hospital/institutional
environment.
Patient
Population	Patients(>30 kg)	Patients > 66 lbs/30 kg	Same
Environment
of use	Home or Hospital/institutional
Environment	Home or
Hospital/institutional
Environment	Same
Product
Code	BZD	BZD	Same
Provided
Sterile or
Non-Sterile	Provided Non-Sterile	Provided Non-Sterile	Same
Patient
Usage
Type	Single Patient Use in the
home or multi-patient use in
the hospital/institutional
environment.	Single Patient Use in the
home or multi-patient use in
the hospital/institutional
environment.	Same
Design	Face interface and headgear	Face interface and headgear	Same
Material	FM-02:
bracket, swivel, connector,
elbow: Polycarbonate;
forehead pad, cushion, valve:
Silicone Rubber;
pick off port:
Polyvinylchloride;
faceplate: Polypropylene;
headgear: nylon, polyester.
FM-03:
bracket, faceplate, swivel,
connector, support arm
assembly, elbow:
Polycarbonate:
forehead pad, cushion, valve:
Silicone Rubber;
pick off port:
Polyvinylchloride;
headgear: nylon, polyester.
FM-05:	Moulded plastic and silicone
components and fabric /
nylon headgear.	All the
materials
composed the
Skynector
CPAP masks
were evaluated
per ISO 10993-

Based on the
testing
performed, the
differences will
not affect the
safety or
effectiveness of
the device. | |
| | Subject Device: | Predicate Device: | Remarks: | |
| | bracket, faceplate, swivel,
connector, support arm
assembly, cushion clip,
elbow: Polycarbonate;
forehead pad, cushion, valve:
Silicone Rubber;
pick off port:
Polyvinylchloride;
headgear: nylon, polyester. | | | |
| Number of
Pick off ports: | One | Two | The design
difference will
not affect the
safety or
effectiveness of
the device. | |
| Shape and
size of
faceplate | The shape of the faceplate
follows the contours of the
face allowing clearance of
facial features, covering the
mouth and nose for therapy.
The faceplate attaches to a
silicone cushion via a
retaining ring. | The shape of the faceplate
and cushion clip offered in
various sizes to ensure
adequate fit over the
extended patient population. | The design
difference will
not affect the
safety or
effectiveness of
the device. | |
| Shape and
size of
cushion | The cushions of the FM-02
and FM-05 are made of single
layer silicone with damping
groove to increase the
comfort.
The cushion of the FM-03 is
made of double layer silicone
to increase the comfortable fit. | The previously cleared mask
provides characteristics seal
via silicone interface. The
previously cleared mask
offered in various sizes to
ensure adequate fit over the
extended patient population. | Base on the
testing of
leakage, the
design
modification
will not affects
the safety or
effectiveness of
the device. | |
| Safety Valve | Contain an anti-asphyxia
valve (AAV) to enable the
patient to breathe fresh air in
the event that airflow from the
flow generator is impeded. | Contain an anti-asphyxia
valve (AAV) to enable the
patient to breathe fresh air in
the event that airflow from the
flow generator is
impeded. | Same | |
| Exhalation
device | No accessory exhalation
device is required. The full-
face masks incorporate
intentional vent holes to | No accessory exhalation
device is required. The
masks incorporate vents
to provide continuous air
flow to flush out and
minimize the amount of CO2 | Same | |
| | Subject Device: | Predicate Device: | Remarks: | |
| | reduce carbon dioxide re-
breathing. | re-breathed by the patient. | | |
| Anatomical
Sites | Mouth and nose | Mouth and nose | Same | |
| Patient
Circuit
Connection | 22 mm entrainment valve
elbow | 22 mm entrainment valve
elbow | Same | |
| Pressure
Range | 4-20 cmH2O | 4-40 cmH2O | Verification
testing of the
modified device
did not raise
any new
questions of
safety and
efficacy. | |
| Number of
Mask Sizes | FM-02: Three- small,
medium, and large
FM-03: Three- small,
medium, and large
FM-05: Three- small,
medium, and large | Four- extra small, small,
medium, and large | The difference
will not affect
its function and
effectiveness. | |
| Mask
Deadspace | size | FM-02
Full-
face
mask | Mirage
Quattro Full
Face Mask | The dead space
is calculated by
the identical
methods. The
dead space has
no pass/fail
criteria,
reportable value
only. It appears
a little larger
than the
predicate
device, but it
will not affect
its function and
effectiveness. |
| | L | 358 | 242 | |
| | M | 311 | No
information
available | |
| | S | 280 | No
information
available | |

Table 1: Device Comparison Table to K113127

7

Product: Skynector CPAP Mask

8

SEC_005:001_510K Summary

Product: Skynector CPAP Mask

9

Product: Skynector CPAP Mask

10

Version:A/0

	Subject Device:		Predicate Device:	Remarks:
Leak rate				This leak rate is
provided for the
healthcare
professional to
determine if it is
compatible with
CPAP or bi-
level therapy
device. It
appears the leak
rates of CPAP
mask is similar
with the Mirage
Quattro Full
Face Mask, leak
rate increases
stably when air
pressure
increases.
Pressure
Drop	Specifications
and models		Flow
(L/min)	Drop in
Pressure
(cmH2O)	Mirage
Quattro
Full Face
Mask	drop is
measured by the
same test
configuration. It
appears the
pressure drop of
the CPAP Full-
face mask is a
little larger than
	Full-Face
mask	FM-02L	100L/min	1.5	50L/min	face mask is a
little larger than
		FM-02M	50L/min	0.5	0.1cmH2O	the Mirage
Quattro Full
		FM-02S	50L/min	0.5	0.4cmH2O	Face Mask.
The pressure
Valve
Open to
Atmosphere	FM-02 Full-Face
mask:0.5cmH2O				Mirage Quattro
Full Face Mask:1.1cmH2O	drop is nominal
and it will not
affect its
function and
effectiveness.
The valve will
fully open to
atmosphere
when the mask
pressure reaches
the opening

11

SEC_005:001_510K Summary

Product: Skynector CPAP Mask

Version:A/0

	Subject Device:	Remarks:
		pressure and
remains fully
open as the
patient inhales
and exhales.
Valve
Close to
Atmosphere	FM-02 Full-Face
mask:0.8cmH2O	Mirage Quattro
Full Face Mask:1.6cmH2O	The valve will
fully close to
atmosphere
when the
activation
pressure is met
or exceeded.

Table 2: Device Comparison Table to K092835

Table 2: Device Comparison Table to K092835
	Subject Device:	Predicate Device:	Remarks:
	Device:
Skynector CPAP Nasal Mask
Manufacturer:
Sky Wise Medical
Instrument(Shenzhen)
Co.,Ltd.
510(k) Number:
To be determined	Device:
ComfortGel Nasal Mask
Manufacturer:
Respironics, Inc.
510(k) Number:
K092835
Intended
Use	The reusable CPAP masks
with headgear are intended
for use as patient interface
for a CPAP or bi-level
system by adult
patients(>30 kg) for whom
CPAP or bi-level therapy
has been prescribed. The
nasal mask covers the nose,
and it is to be for single-
patient re-use in the home
and multi-patient re-use in
the hospital/institutional
environment.	The ComfortGel Nasal Mask is
intended to provide an
interface for application of
CPAP or bi-level therapy to
patients. The mask is for single
patient use in the home or
multi-patient use in the
hospital/institutional
environment. The mask is to be
used by patients (>66lbs/30kg)
for whom CPAP or bi-level
therapy has been prescribed
using a CPAP or bi-level
system.	Both masks are
noninvasive and the
meanings of
intended use are
same.
Patient
Population	Patients(>30 kg)	Patients > 66 lbs/30 kg	Same
Environment
of use	Home or
Hospital/institutional
Environment	Home or Hospital/institutional
Environment	Same
Product
Code	BZD	BZD	Same

12

SEC_005:001_510K Summary

Product: Skynector CPAP Mask

	Subject Device:	Predicate Device:	Remarks:
Provided
Sterile or
Non-Sterile	Provided Non-Sterile	Provided Non-Sterile	Same
Patient
Usage
Type	Single Patient Use in the
home or multi-patient use in
the hospital/institutional
environment.	Single Patient Use in the home
or multi-patient use in the
hospital/institutional
environment.	Same
Design	Nasal interface and
headgear	Nasal interface and headgear	Same
Material	NM-01 :
bracket, faceplate, swivel,
support arm assembly,
quick clip, elbow:
Polycarbonate;
forehead pad, cushion:
Silicone Rubber;
headgear: nylon, polyester;
pick off port:
Polyvinylchloride.
NM-03:
bracket, faceplate, swivel,
support arm assembly,
cushion clip, elbow:
Polycarbonate;
forehead pad, cushion:
Silicone Rubber;
headgear: nylon, polyester;
pick off port:
Polyvinylchloride.	Faceplate: Polycarbonate
Face seal: Gel cushion with
polyester overlay
Cushion Flap: Silicone
Exhalation Elbow:
Polycarbonate
Exhalation Port: Delrin
Forehead Pad: Silicone
Headgear: UBL, Urethane
Foam, and Lycra	All the materials
composed the
Skynector CPAP
masks were
evaluated per ISO
10993-1.
Based on the testing
performed, the
modification will
not affect the safety
or effectiveness of
the device.
Number of
Pick off ports:	One	None	The design
difference will not
affect the safety or
effectiveness of the
device.
Shape and
size of
faceplate	The shape of the faceplate
follows the contours of the
face allowing clearance of
facial features, covering the
nose only for therapy.
The faceplate attaches to a
silicone cushion via a
retaining ring.	The shape of the faceplate
follows the contours of the face
allowing clearance of facial
features, covering the nose
only for therapy.
The faceplate attaches to a
silicone sealing flap via a
retaining ring.	Same

13

SEC_005:001_510K Summary

Product: Skynector CPAP Mask

	Subject Device:	Predicate Device:	Remarks:
Shape and
size of
cushion	The cushions of the NM-01
and NM-03 are made of
double layer silicone to
increase the comfortable fit.	Gel cushion to allow for a
more comfortable fit and
improved mask performance
(fewer leaks).	The materials of
cushion are
different. The
design modification
will not affect the
safety or
effectiveness of the
device.
Safety Valve	N/A- nasal mask	N/A- nasal mask	Same
Exhalation
device	No accessory exhalation
device is required. An
exhalation vent is
integrated.	No accessory exhalation device
is required. 54 pin holes
exhalation ports are integrated.	Based on the testing
performed, the
design difference
will not affect the
safety or
effectiveness of the
device.
Anatomical
Sites	Nose	Nose	Same
Patient
Circuit
Connection	22 mm exhalation elbow	22 mm exhalation elbow	Same
Pressure
Range	4-20 cmH2O	4-30 cmH2O	Verification testing
of the modified
device did not raise
any new questions
of safety and
efficacy.
Number of
Mask Sizes	NM-01: Four- petite, small,
medium, and large;
NM-03: Three- small,
medium, and large.	Four- petite, small, medium,
and large	The difference will
not affect its
function and
effectiveness.
Mask
Deadspace			The dead space is
calculated by the
identical methods.
The dead space has
	size	NM-03
nasal
mask	The
ComfortGel
Nasal Mask		no pass/fail criteria,
reportable value
	L	180	142.6	only. It appears a
	M	160	121.3	little larger than the
predicate device,
but it will not affect
its function and
effectiveness.
	S	150	111.4	effectiveness.

14

SEC_005:001_510K Summary

Product: Skynector CPAP Mask

	Subject Device:	Predicate Device:	Remarks:
Leak rate			This leak rate is provided for the healthcare professional to determine if it is compatible with CPAP or bi-level therapy device. It appears the leak rates of CPAP mask is similar with the ComfortGel Nasal Mask, leak rate increases stably when air pressure increases.
Pressure
Drop	Specifications
and models Flow
(L/min) Drop in
Pressure
(cmH2O) ComfortGel
Nasal Mask Nasal
mask NM-03L 100L/min 0.3 50L/min NM-03M n 0.1cmH2O NM-03S 50L/min 0.1 100L/min
0.25cmH2O				The pressure drop is measured by the same test configuration. It appears the pressure drop of the CPAP Nasal mask is a little larger than the ComfortGel Nasal Mask. The pressure drop is nominal and it will not affect its function and effectiveness.
Valve
Open to
Atmosphere	N/A- nasal mask	N/A- nasal mask	Same
Valve
Close to
Atmosphere	N/A- nasal mask	N/A- nasal mask	Same

8 Brief discussions of the nonclinical tests

Skynector CPAP Masks conform to the following standards:

↑ ISO 5356-1:2004 Anaesthetic and respiratory equipment -- Conical connectors -- Part 1: Cones and sockets;

15

Product: Skynector CPAP Mask	Version: A/0
------------------------------	--------------

ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for ゃ In Vitro cytotoxicity;
� ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization;
& ISO 10993-6:2007 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation;
� ISO 10993-3:2003 Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity;
� ISO 17510-2:2007 Sleep apnoea breathing therapy - Part 2: Masks and application accessories;
ゃ ASTM D3045-92 Standard Practice for Heat Aging of Plastics Without Load.

| No. | The title of test report | Items or Annex in ISO
17510-2:2007 |
|-----|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| 01 | 001_Connecting Test Report for the Connector
Used on FM-05 Apnea Mask | Item 5.1 |
| 02 | 002_Leak rate test report | Annex B |
| 03 | 003_Resistance to flow (Pressure drop) test report | Annex C |
| 04 | 004_Anti-asphyxia valve pressure test report | Annex D |
| 05 | 005_Breathing during single fault condition-
Determination of the inspiratory and expiratory
resistance | Annex E |
| 06 | 006_CO2 re-breathing test report | Annex F |
| 07 | 007_Vibration and noise test report | Annex G |
| 08 | 008_Dead space test report | Not requested by
standard, but conducted
on predicate device |

The performance test based on ISO 17510-2:2007 are as follow:

9 Brief discussions of clinical tests

Not applicable.

10 Other information (such as required by FDA guidance)

No other information.

16

11 Conclusions

The subject device--- Skynector CPAP Masks (FM-02, NM-03) are respectively substantially equivalent to Mirage Quattro Full Face Mask(K113127), ComfortGel Nasal Mask(K092835).