Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical and material properties of a breathing mask, with no mention of AI/ML capabilities or data processing.

Therapeutic

Yes
The device is described as "sleep apnea breathing therapy mask" that "deliver[s] pressurized air to prevent apnea from occurring," which directly indicates its therapeutic purpose in treating sleep apnea.

Diagnostic

No

Explanation: The device is a sleep apnea breathing therapy mask, which is an accessory used for channeling airflow during therapy. It is not described as performing any diagnostic functions; its purpose is to deliver pressurized air to prevent apnea, not to detect or diagnose it.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components such as a frame, cushion, elbow, swivel, and headgear, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is a "non-invasive accessory used for channeling airflow... to a patient from a positive airway pressure (PAP) device". This describes a device used in vivo (on a living person) for therapeutic purposes (sleep apnea breathing therapy).
Device Description: The description details the physical components of a mask designed to interface with a PAP device and deliver air. This aligns with an in vivo medical device.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The device's function is purely mechanical and related to delivering air to the respiratory system.
Performance Studies: The performance studies focus on standards related to medical devices for breathing therapy, biocompatibility, and reprocessing, not on analytical or diagnostic performance metrics typically associated with IVDs (like sensitivity, specificity, etc.).

In summary, the device is a therapeutic medical device used directly on a patient, not a device used to perform tests on biological samples in vitro.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The sleep apnea breathing therapy mask is a non-invasive accessory used for channeling airflow (with or without supplemental oxygen) to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bi-level system.

-The mask is to be used by patients (weighing>30kg), intended for single patient reuse in the home environment.
-The mask is intended for single-patient use in the hospital or institutional environment.

Product codes

BZD

Device Description

These masks act as an interface for CPAP/BPAP device and deliver pressurized air to prevent apnea from occurring. The masks consist of several parts which includes frame, cushion, elbow, swivel, and headgear. The frame provides support for the mask, the cushion provides the seal, the elbow is designed to provide a vent for exhaust gas and a valve to prevent asphyxiation. The swivel can be rotated 360 degrees, which can help prevent pipe winding. The size of the connector port of the swivel is consistent with ISO standards and can be connected to any tube which conforms to the same standard. The headgear is used to fasten the mask to the face. The masks can be disassembled without any tools.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Nose, Mouth and Nose

Indicated Patient Age Range

patients (weighing>30kg)

Intended User / Care Setting

single patient reuse in the home environment. single-patient use in the hospital or 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)

Non-clinical tests were conducted to verify that the subject devices met all design specifications and is substantially equivalent to the predicate. The test results demonstrated that the proposed device complies with the following standards and guidance:

A ISO 17510:2015 Medical devices -- Sleep apnoea breathing therapy -- Masks and application accessories
ISO 5356-1:2004 Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets
A ISO 10993-1:2009 Biological evaluation of medical devices- part 1: Evaluation and testing within a risk management process
ISO 10993-5:2009 Biological evaluation of medical devices- part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices-part 10: Tests for irritation and skin sensitization
A ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
ISO 18562-2:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
ISO 18562-3:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds
ISO 18562-4:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications —Tests for leachables in condensate.
FDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, 2015

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

Not Found

Predicate Device(s)

AirFit F20(K170924), AirFit N20(K161978), Swift™ FX Nasal Pillows (K090244)

Reference Device(s)

BMC-NM (K133009)

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

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July 2, 2021

Suzhou Yuyue Medical Technology Co., Ltd. Sun Wei R&D engineer No. 9 Jinfeng Road, Suzhou Science & Technology Town Suzhou, Jiangsu 215163 China

Re: K203347

Trade/Device Name: Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillows Mask. Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: May 28, 2021 Received: June 3, 2021

Dear Sun Wei:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

1

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 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K203347

Device Name

Sleep Apnea Breathing Therapy Mask: YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillows Mask

Indications for Use (Describe)

The sleep apnea breathing therapy mask is a non-invasive accessory used for channeling airflow (with or without supplemental oxygen) to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bi-level system.

-The mask is to be used by patients (weighing>30kg), intended for single patient reuse in the home environment. -The mask is intended for single-patient use in the hospital or institutional environment.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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3

510(k) Summary

Company Name/Owner	Suzhou Yuyue Medical Technology Co., Ltd.
Contact person/Author	Sun Wei (Mr.)
Date prepared	06/30/2021
Contact details	Address: No.9 Jinfeng Road, Suzhou Science &
Technology Town, 215163 Suzhou, Jiangsu,
PEOPLE'S REPUBLIC OF CHINA
Tel: +86-512-67373001
Fax: +86-512-67373008
Trade name	Sleep Apnea Breathing Therapy Mask:
YF-01 Full Face Mask, YF-02 Full Face Mask,
YF-03 Full Face Mask, YN-02 Nasal Mask,
YN-03 Nasal Mask, YP-01 Nasal Pillows
Mask
Common name	Sleep Apnea Breathing Therapy Mask
Classification name	Non Continuous Ventilator (IPPB)
Class II (21 CFR §868.5905)
Product code BZD (Anaesthesiology)
Predicate device	Full Face Mask: AirFit F20(K170924)
Nasal Mask: AirFit N20(K161978)
Nasal Pillows Mask: Swift™ FX Nasal
Pillows (K090244)

4

Description

These masks act as an interface for CPAP/BPAP device and deliver pressurized air to prevent apnea from occurring. The masks consist of several parts which includes frame, cushion, elbow, swivel, and headgear. The frame provides support for the mask, the cushion provides the seal, the elbow is designed to provide a vent for exhaust gas and a valve to prevent asphyxiation. The swivel can be rotated 360 degrees, which can help prevent pipe winding. The size of the connector port of the swivel is consistent with ISO standards and can be connected to any tube which conforms to the same standard. The headgear is used to fasten the mask to the face. The masks can be disassembled without any tools.

Indications for use

The sleep apnea breathing therapy mask is a non-invasive accessory used for channeling airflow (with or without supplemental oxygen) to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bi-level system.

-The mask is to be used by patients (weighing>30kg), intended for single patient reuse in the home environment.

-The mask is intended for single-patient use in the hospital or institutional environment.

Substantial equivalence comparison with predicate device

Detailed substantial comparison was made between subject device and predicate device. Please refer to below tables for details.

5

Table 1: Comparison table between full face mask and AirFit F20

	Subject Device	Predicate Device
Comparison Elements	YF-01 Full Face Mask
YF-02 Full Face Mask
YF-03 Full Face Mask	AirFit F20	Comment
Classification
Regulation	868.5905	868.5905	Identical
Product Code	BZD	BZD	Identical
510(k) Number	K203347	K170924
Indications for use	The sleep apnea breathing therapy mask is a
non-invasive accessory used for channeling
airflow (with or without supplemental
oxygen) to a patient from a positive airway
pressure (PAP) device such as a continuous
positive airway pressure (CPAP) or bi-level
system.

-The mask is to be used by patients
(weighing>30kg), intended for single patient
reuse in the home environment.

-The mask is intended for single-patient use
in the hospital or institutional environment. | The AirFit F20 is a non-invasive
accessory used for channeling airflow
(with or without supplemental oxygen)
to a patient from a positive airway
pressure (PAP) device such as a
continuous positive airway pressure
(CPAP) or bilevel system.

The AirFit F20 is:
• to be used by patients weighing more
than 66 lb (30 kg) for whom positive
airway pressure therapy has been
prescribed
• intended for single-patient reuse in
the home environment and
multi-patient reuse in the | Different

The inclusion of "single-
patient reuse" is a
narrower indication to the
"multi-patient, multi-use"
in the hospital /institutional
environment and does not
alter the intended use of
the device. Safety and
effectiveness issue will not
be raised. | |
| Principle | Positive airway pressure(PAP) | Positive airway pressure(PAP) | Identical | |
| Patient usage type | single-patient reuse in the home
environment. single-patient use in the
hospital or institutional environment. | single-patient reuse in the home
environment and multi-patient reuse in
the hospital/institutional | Different
The inclusion of “single-
patient reuse” is a narrower
indication to the “multi-
patient, multi-use” in the
hospital/institutional
environment and does not
alter the intended use of
the device. Safety and
effectiveness issue will not
be raised. | |
| Pressure source action
body site | Mouth and Nose | Mouth and Nose | Identical | |
| Technical Specifications | | | | |
| Breathing Tube
connection | 22mm conical connector | 22mm conical connector | Identical | |
| Pressure Range | 4-30 cmH2O | 3-40 cmH2O | Different
Safety and effectiveness
issue will not be raised. | |
| Pressure-Flow Cure | | | Similar, Safety and
effectiveness issue will not
be raised. | |
| Dead space (largest) | 208mL | 240mL | Different
The dead space of our masks
is less than AirFit F20. Both
meet relevant standard
requirement. Safety and
effectiveness issue will not
be raised. | |
| Resistance to Flow | at 50 L/min: 0.5 hPa
at 100 L/min:1.5 hPa | at 50 L/min: 0.2hPa
at 100 L/min:0.6 hPa | Different
The Resistance of our mask
is higher than AirFit F20.
Both meet relevant
standard requirement.
Safety and effectiveness
issue will not be raised. | |
| Inspiratory and
expiratory resistance
with the
Non-Rebreathing
Valve
open-to-atmosphere | Inspiratory at 50 L/min: ≤2 cmH₂O
Expiratory at 50 L/min: ≤2 cmH₂O | Inspiratory at 50 L/min: 0.6 cmH₂O
Expiratory at 50 L/min: 0.7 cmH₂O | Different
Both meet Clause 2.1 of ISO
17510:2015 which need the
pressure is less than 10
cmH₂O. Safety and
effectiveness issue will not | |
| pressure | | | be raised. | |
| Sound | DECLARED DUAL-NUMBER NOISE EMISSION
VALUES in accordance with ISO 4871. The A-
weighted sound power level of the mask is
less than 38 dBA, with uncertainty 3 dBA. The
A-weighted sound pressure level of the mask
at a distance of 1 m is less than 30 dBA, with
uncertainty 3 dBA. | DECLARED DUAL-NUMBER NOISE
EMISSION VALUES in accordance with
ISO 4871. The A-weighted sound power
level of the mask is 30 dBA, with
uncertainty of 3 dBA. The A-weighted
sound pressure level of the mask at a
distance of 1 m is 23 dBA, with
uncertainty of 3 dBA. | Different
The sound of our masks is
more than AirFit F20, but
the sound pressure level of
our masks is less than 30
dBA, they are quiet and
don't interfere with sleep.
Safety and effectiveness
issue will not be raised. | |
| Operating
environment | +5°C to +40°C (41°F to 104°F)

10%~90% relative humidity
non-condensing | 41°F to 104°F(5°C to +40°C)

15% to 95% non-condensing | Temperature is identical.
Humidity is different, but
very similar. Safety and
effectiveness issue will not
be raised. | |
| Storage and transport
environment | -20°C to +60°C (-4°F to 140°F)
10%~90% relative humidity
non-condensing | -4°F to 140°F (-20°C to +60°C)
Up to 95% non-condensing | Temperature is identical.
Humidity is different, but
very similar. Safety and
effectiveness issue will not
be raised. | |
| Comparison Elements | Subject Device | Predicate Device | Reference device | Comment |
| | YN-02 Nasal Mask
YN-03 Nasal Mask | AirFit N20 | BMC-NM | |
| Classification
Regulation | 868.5905 | 868.5905 | 868.5905 | Identical |
| Product Code | BZD | BZD | BZD | Identical |
| 510(k) Number | K203347 | K161978 | K133009 | |
| Indications for use | The sleep apnea breathing therapy
mask is a non-invasive accessory used
for channeling airflow (with or
without supplemental oxygen) to a
patient from a positive airway
pressure (PAP) device such as a
continuous positive airway pressure
(CPAP) or bi-level system.
-The mask is to be used by patients
(weighing>30kg), intended for single
patient reuse in the home
environment.
-The mask is intended for single-
patient use in the hospital or
institutional environment. | The AirFit N20 channels airflow
noninvasively to a patient from
a positive airway pressure (PAP)
device such as a continuous
positive airway pressure (CPAP)
or bilevel device.
The AirFit N20 is:
• to be used by patients
weighing more than 66lb
(>30kg) 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 | The BMC-NM Nasal Mask channel
airflow noninvasively to a patient
from a positive airway pressure
device such as a continuous
positive airway pressure (CPAP)
or Bi-level system.
The BMC-NM Nasal Mask are:
• To be used by adult patients
(66lbs/>30kg) for whom positive
airway pressure has been
prescribed.
• Intended for single-patient
reuse in home environment and
multi-patient re-use in the
hospital/institutional
environment. | Different
The inclusion of "single-
patient reuse" is
a
narrower indication to
the
"multi-patient,
multi-use" in the
hospital /institutional
environment and does
not alter the intended
use of the device.
Safety and effectiveness
issue will not be raised. |
| Principle | Positive airway pressure(PAP) | Positive airway pressure(PAP) | Positive airway pressure(PAP) | Identical |
| Patient usage type | single-patient reuse in the home
environment. single-patient use in the
hospital or institutional environment. | single patient re-use in the
home environment and multi-
patient re-use in the
hospital/institutional | Single-patient reuse in home
environment and multi-patient
re-use in the hospital/institutional
environment. | Different
The inclusion of
a narrower indication |
| | | Environment. | | to the "multi-patient,
multi-use" in the
hospital/institutional
environment and does
not alter the intended
use of the device.
Safety and
effectiveness issue will
not be raised. |
| Pressure source action
body site | Nose | Nose | Nose | Identical |
| Technical Specifications | | | | |
| Breathing Tube
connection | 22mm conical connector | 22mm conical connector | 22mm entrainment valve
elbow | Identical |
| Pressure Range | 4-30 cmH2O | 4-30 cmH2O | 4 to 30 hPa | Identical |
| Pressure-Flow Cure | Image: Pressure-Flow Cure | Image: Pressure-Flow Cure | 4hPa=19L/min
12hPa=34L/min
2hPa=50L/min
30hPa=68L/min | Similar
Safety and effective-
ness issue will not be
raised. |
| Dead space (largest) | 142mL | 103.3mL | 145ml | Different
The dead space of our
masks is bigger than
AirFit N20. Both meet
relevant standard
requirement.
In addition, the dead |

6

7

8

9

10

11

| | | space of our mask is
comparable with that
of the reference device
Safety and
effectiveness
issue will not be raised. |
|--|--|-------------------------------------------------------------------------------------------------------------------------------------|

| Resistance to Flow | at 50 L/min: 0.5 hPa
at 100 L/min:1.5 hPa | at 50 L/min: 0.3 hPa
at 100 L/min:1.3 hPa | at 50 L/min: 0.2 hPa
at 100 L/min:0.7 hPa | Different
The Resistance of our
mask is higher than
AirFit N20. Both meet
relevant standard
requirement. Safety
and effectiveness issue
will not be raised. |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sound | DECLARED DUAL-NUMBER NOISE
EMISSION VALUES in accordance with
ISO 4871. The A-weighted sound
power level of the mask is less than 38
dBA, with uncertainty 3 dBA. The A-
weighted sound pressure level of the
mask at a distance of 1 m is less than
30 dBA, with uncertainty 3 dBA. | DECLARED DUAL-NUMBER NOISE
EMISSION VALUES in accordance with
ISO 4871. The A-weighted sound
power level of the mask is 24 dBA,
with uncertainty of 3 dBA. The A-
weighted sound pressure level of the
mask at a distance of 1 m is 16 dBA,
with uncertainty of 3 dBA. | DECLARED DUAL-NUMBER NOISE EMISSION VALUES in
accordance with ISO 4871.
The A-weighted sound power
level of the mask is 32 dBA,
with uncertainty 3 dBA. The
A-weighted sound pressure
level of the mask at a
distance of 1 m is 24 dBA,
with uncertainty 3 dBA. | Different
The sound of our
masks is more than
AirFit N20, but the
sound pressure level of
our masks is less than
30 dBA, they are quiet
and don't interfere
with sleep. Safety and
effectiveness issue will
not be raised. |
| Operating
environment | +5°C to +40°C (41°F to 104°F) | 41°F to 104°F (5°C to 40°C) | 5 to 40 °C | Temperature is
identical. Humidity is
different, but very |
| | 10%~90% relative humidity non-condensing | 15% to 95% non-condensing | 10% to 93% relative humidity non-condensing | similar. Safety and effectiveness issue will not be raised. |
| Storage and transport environment | -20°C to +60°C (-4°F to 140°F)
10%~90% relative humidity non-condensing | -4°F to +140°(-20°C to +60°C)
up to 95% non-condensing | -20 to +55°C
10% to 93% relative humidity, non-condensing | Temperature is identical.
Humidity is different, but very similar.
Safety and effectiveness issue will not be raised. |

12

13

	Subject Device	Predicate Device	Comment
Comparison Elements	YP-01 Nasal Pillows Mask	Swift™ FX
Classification
Regulation	868.5905	868.5905	Identical
Product Code	BZD	BZD	Identical
510(k) Number	K203347	K090244
Indications for use	The sleep apnea breathing therapy mask
is a non-invasive accessory used for
channeling airflow (with or without
supplemental oxygen) to a patient from
a positive airway pressure (PAP) device
such as a continuous positive airway
pressure (CPAP) or bi-level system.

The mask is to be used by patients
(weighing>30kg), intended for single
patient reuse in the home environment.
The mask is intended for single-patient
use in the hospital or institutional
environment. | The Swift FX channels airflow
noninvasively to a patient from a
positive airway pressure (PAP)
device such as a continuous positive
airway pressure (CPAP) or bilevel
device. The Swift FX is:
to be used by adult patients (>66lb
/30kg) for whom positive airway
pressure has been prescribed.
intended for single-patient re-use
in the home environment and
multipatient re-use in the
hospital/institutional environment | Different
The inclusion of "single-
patient reuse" is a narrower
indication to the "multi-
patient, multi-use" in the
hospital /institutional
environment and does not
alter the intended use of the
device. Safety and
effectiveness issue will not be
raised. |
| Principle | Positive airway pressure(PAP) | Positive airway pressure(PAP) | Identical |
| Patient usage type | single-patient reuse in the home
environment. single-patient use in the
hospital or institutional environment. | single patient re-use in the home
environment and multipatient re-use in
the hospital/institutional environment | Different
The inclusion of
"single-patient reuse" is a
narrower indication to the
"multi-patient, multi-use"
in the hospital/institutional
environment and does not
alter the intended use of the
device. Safety and
effectiveness issue will not
be raised. |
| Pressure source action
body site | Nose | Nose | Identical |
| Technical Specifications | | | |
| Breathing Tube
connection | 22mm conical connector | 22mm conical connector | Identical |
| Pressure Range | 4-20 cmH2O | 4-20 cmH2O | Identical |
| Pressure-Flow Cure | Image: Pressure-Flow Cure graph | Image: Pressure-Flow Cure graph | Similar
Safety and effectiveness
issue will not be raised. |
| Dead space (largest) | | | Different |
| | 16mL | 106mL | The dead space of our masks
is less than Swift™ FX. Both
meet relevant standard
requirement.
Safety and effectiveness
issue will not be raised. |
| Resistance to Flow | at 50 L/min: 1.0 hPa
at 100 L/min:3.5 hPa | at 50 L/min: 0.4 hPa
at 100 L/min:1.4 hPa | Different
The Resistance of our mask
is higher than Swift™ FX.
Both meet relevant
standard requirement.
Safety and effectiveness
issue will not be raised. |
| Sound | DECLARED DUAL-NUMBER NOISE EMISSION
VALUES in accordance with ISO 4871. The A-
weighted sound power level of the mask is
less than 38 dBA, with uncertainty 3 dBA. The
A-weighted sound pressure level of the mask
at a distance of 1 m is less than 30 dBA, with
uncertainty 3 dBA. | NA | The sound pressure level of
our masks is less than 30
dBA, they are quiet and
don't interfere with sleep.
Safety and effectiveness
issue will not be raised. |
| Operating
environment | +5°C to +40°C (41°F to 104°F) | +41°F to 104°F (+5°C to +40°C) | Temperature is identical.
Humidity is different, but |
| | 10%~90% relative humidity
non-condensing | 15% to 95% relative humidity
non-condensing | Very similar. Safety and
effectiveness issue will not
be raised. |
| Storage and transport
environment | -20°C to +60°C (-4°F to 140°F)
10%~90% relative humidity
non-condensing | -4°F to 140°(-20°C to +60°C)
up to 95% relative humidity
non-condensing | Temperature is identical.
Humidity is different, but
Very similar. Safety and
effectiveness issue will not
be raised. |

Table 3 Comparison Table between Nasal Pillows Mask and Swift™ FX

14

15

16

17

Non-Clinical Tests

Non-clinical tests were conducted to verify that the subject devices met all design specifications and is substantially equivalent to the predicate. The test results demonstrated that the proposed device complies with the following standards and guidance:

A ISO 17510:2015 Medical devices -- Sleep apnoea breathing therapy -- Masks and application accessories
ISO 5356-1:2004 Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets
A ISO 10993-1:2009 Biological evaluation of medical devices- part 1: Evaluation and testing within a risk management process
ISO 10993-5:2009 Biological evaluation of medical devices- part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices-part 10: Tests for irritation and skin sensitization
A ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
ISO 18562-2:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
ISO 18562-3:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds
ISO 18562-4:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications —Tests for leachables in condensate.
FDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, 2015

Conclusion

The sleep apnea breathing therapy masks are substantially equivalent to the predicate devices.