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 Pillow Mask

K203347 · Suzhou Yuyue Medical Technology Co., Ltd. · BZD · Jul 2, 2021 · Anesthesiology

Device Facts

• Record ID: K203347
• 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 Pillow Mask
• Applicant: Suzhou Yuyue Medical Technology Co., Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Jul 2, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Non-invasive interface for CPAP/BPAP devices; delivers pressurized air to prevent apnea. Components: frame, cushion, elbow, swivel, headgear. Elbow includes vent for exhaust and anti-asphyxiation valve. Swivel allows 360-degree rotation to prevent tube winding. Connects to standard 22mm tubing. Used in home or hospital settings by patients. Disassembled without tools for cleaning. Benefits: provides secure seal for effective PAP therapy delivery; improves patient compliance through ergonomic design.

Clinical Evidence

Bench testing only. Compliance verified against ISO 17510:2015 (mask performance), ISO 5356-1:2004 (connectors), ISO 10993 series (biocompatibility), and ISO 18562 series (breathing gas pathway safety).

Technological Characteristics

Non-invasive mask interface; 22mm conical connector per ISO 5356-1. Materials evaluated per ISO 10993-1, -5, -10 and ISO 18562-1, -2, -3, -4. Pressure range 4-30 cmH2O (full face/nasal) or 4-20 cmH2O (nasal pillows). Passive device; no energy source or software.

Indications for Use

Indicated for patients weighing >30kg requiring non-invasive positive airway pressure (PAP) therapy (CPAP or bi-level) for sleep apnea. Intended for single-patient reuse in home or hospital/institutional settings.

Regulatory Classification

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.

Predicate Devices

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

Reference Devices

• BMC-NM (K133009)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bolder font, and "ADMINISTRATION" in a smaller font below.

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 ([e-mail]) or phone [phone] 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) | |
|------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 16px;"> <input checked="true" type="checkbox"/> </span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 16px;"> <input type="checkbox"/> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"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."

{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 &<br>Technology Town, 215163 Suzhou, Jiangsu,<br>PEOPLE'S REPUBLIC OF CHINA<br>Tel: [phone]<br>Fax: [phone] |
| Trade name | Sleep Apnea Breathing Therapy Mask:<br>YF-01 Full Face Mask, YF-02 Full Face Mask,<br>YF-03 Full Face Mask, YN-02 Nasal Mask,<br>YN-03 Nasal Mask, YP-01 Nasal Pillows<br>Mask |
| Common name | Sleep Apnea Breathing Therapy Mask |
| Classification name | Non Continuous Ventilator (IPPB)<br>Class II (21 CFR §868.5905)<br>Product code BZD (Anaesthesiology) |
| Predicate device | Full Face Mask: AirFit F20(K170924)<br>Nasal Mask: AirFit N20(K161978)<br>Nasal Pillows Mask: Swift™ FX Nasal<br>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<br>YF-02 Full Face Mask<br>YF-03 Full Face Mask | AirFit F20 | Comment | |
| Classification<br>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<br>non-invasive accessory used for channeling<br>airflow (with or without supplemental<br>oxygen) to a patient from a positive airway<br>pressure (PAP) device such as a continuous<br>positive airway pressure (CPAP) or bi-level<br>system.<br><br>-The mask is to be used by patients<br>(weighing>30kg), intended for single patient<br>reuse in the home environment.<br><br>-The mask is intended for single-patient use<br>in the hospital or institutional environment. | The AirFit F20 is a non-invasive<br>accessory used for channeling airflow<br>(with or without supplemental oxygen)<br>to a patient from a positive airway<br>pressure (PAP) device such as a<br>continuous positive airway pressure<br>(CPAP) or bilevel system.<br><br>The AirFit F20 is:<br>• to be used by patients weighing more<br>than 66 lb (30 kg) for whom positive<br>airway pressure therapy has been<br>prescribed<br>• intended for single-patient reuse in<br>the home environment and<br>multi-patient reuse in the | Different<br><br>The inclusion of "single-<br>patient reuse" is a<br>narrower indication to the<br>"multi-patient, multi-use"<br>in the hospital /institutional<br>environment and does not<br>alter the intended use of<br>the device. Safety and<br>effectiveness issue will not<br>be raised. | |
| Principle | Positive airway pressure(PAP) | Positive airway pressure(PAP) | Identical | |
| Patient usage type | single-patient reuse in the home<br>environment. single-patient use in the<br>hospital or institutional environment. | single-patient reuse in the home<br>environment and multi-patient reuse in<br>the hospital/institutional | Different<br>The inclusion of “single-<br>patient reuse” is a narrower<br>indication to the “multi-<br>patient, multi-use” in the<br>hospital/institutional<br>environment and does not<br>alter the intended use of<br>the device. Safety and<br>effectiveness issue will not<br>be raised. | |
| Pressure source action<br>body site | Mouth and Nose | Mouth and Nose | Identical | |
| Technical Specifications | | | | |
| Breathing Tube<br>connection | 22mm conical connector | 22mm conical connector | Identical | |
| Pressure Range | 4-30 cmH2O | 3-40 cmH2O | Different<br>Safety and effectiveness<br>issue will not be raised. | |
| Pressure-Flow Cure | | | Similar, Safety and<br>effectiveness issue will not<br>be raised. | |
| Dead space (largest) | 208mL | 240mL | Different<br>The dead space of our masks<br>is less than AirFit F20. Both<br>meet relevant standard<br>requirement. Safety and<br>effectiveness issue will not<br>be raised. | |
| Resistance to Flow | at 50 L/min: 0.5 hPa<br>at 100 L/min:1.5 hPa | at 50 L/min: 0.2hPa<br>at 100 L/min:0.6 hPa | Different<br>The Resistance of our mask<br>is higher than AirFit F20.<br>Both meet relevant<br>standard requirement.<br>Safety and effectiveness<br>issue will not be raised. | |
| Inspiratory and<br>expiratory resistance<br>with the<br>Non-Rebreathing<br>Valve<br>open-to-atmosphere | Inspiratory at 50 L/min: ≤2 cmH₂O<br>Expiratory at 50 L/min: ≤2 cmH₂O | Inspiratory at 50 L/min: 0.6 cmH₂O<br>Expiratory at 50 L/min: 0.7 cmH₂O | Different<br>Both meet Clause 2.1 of ISO<br>17510:2015 which need the<br>pressure is less than 10<br>cmH₂O. Safety and<br>effectiveness issue will not | |
| pressure | | | be raised. | |
| Sound | DECLARED DUAL-NUMBER NOISE EMISSION<br>VALUES in accordance with ISO 4871. The A-<br>weighted sound power level of the mask is<br>less than 38 dBA, with uncertainty 3 dBA. The<br>A-weighted sound pressure level of the mask<br>at a distance of 1 m is less than 30 dBA, with<br>uncertainty 3 dBA. | DECLARED DUAL-NUMBER NOISE<br>EMISSION VALUES in accordance with<br>ISO 4871. The A-weighted sound power<br>level of the mask is 30 dBA, with<br>uncertainty of 3 dBA. The A-weighted<br>sound pressure level of the mask at a<br>distance of 1 m is 23 dBA, with<br>uncertainty of 3 dBA. | Different<br>The sound of our masks is<br>more than AirFit F20, but<br>the sound pressure level of<br>our masks is less than 30<br>dBA, they are quiet and<br>don't interfere with sleep.<br>Safety and effectiveness<br>issue will not be raised. | |
| Operating<br>environment | +5°C to +40°C (41°F to 104°F)<br><br>10%~90% relative humidity<br>non-condensing | 41°F to 104°F(5°C to +40°C)<br><br>15% to 95% non-condensing | Temperature is identical.<br>Humidity is different, but<br>very similar. Safety and<br>effectiveness issue will not<br>be raised. | |
| Storage and transport<br>environment | -20°C to +60°C (-4°F to 140°F)<br>10%~90% relative humidity<br>non-condensing | -4°F to 140°F (-20°C to +60°C)<br>Up to 95% non-condensing | Temperature is identical.<br>Humidity is different, but<br>very similar. Safety and<br>effectiveness issue will not<br>be raised. | |
| Comparison Elements | Subject Device | Predicate Device | Reference device | Comment |
| | YN-02 Nasal Mask<br>YN-03 Nasal Mask | AirFit N20 | BMC-NM | |
| Classification<br>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<br>mask is a non-invasive accessory used<br>for channeling airflow (with or<br>without supplemental oxygen) to a<br>patient from a positive airway<br>pressure (PAP) device such as a<br>continuous positive airway pressure<br>(CPAP) or bi-level system.<br>-The mask is to be used by patients<br>(weighing>30kg), intended for single<br>patient reuse in the home<br>environment.<br>-The mask is intended for single-<br>patient use in the hospital or<br>institutional environment. | The AirFit N20 channels airflow<br>noninvasively to a patient from<br>a positive airway pressure (PAP)<br>device such as a continuous<br>positive airway pressure (CPAP)<br>or bilevel device.<br>The AirFit N20 is:<br>• to be used by patients<br>weighing more than 66lb<br>(>30kg) for whom positive<br>airway pressure has been<br>prescribed.<br>• intended for single-patient re-<br>use in the home environment<br>and<br>multi-patient re-use in the<br>hospital/institutional environment | The BMC-NM Nasal Mask channel<br>airflow noninvasively to a patient<br>from a positive airway pressure<br>device such as a continuous<br>positive airway pressure (CPAP)<br>or Bi-level system.<br>The BMC-NM Nasal Mask are:<br>• To be used by adult patients<br>(66lbs/>30kg) for whom positive<br>airway pressure has been<br>prescribed.<br>• Intended for single-patient<br>reuse in home environment and<br>multi-patient re-use in the<br>hospital/institutional<br>environment. | Different<br>The inclusion of "single-<br>patient reuse" is<br>a<br>narrower indication to<br>the<br>"multi-patient,<br>multi-use" in the<br>hospital /institutional<br>environment and does<br>not alter the intended<br>use of the device.<br>Safety and effectiveness<br>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<br>environment. single-patient use in the<br>hospital or institutional environment. | single patient re-use in the<br>home environment and multi-<br>patient re-use in the<br>hospital/institutional | Single-patient reuse in home<br>environment and multi-patient<br>re-use in the hospital/institutional<br>environment. | Different<br>The inclusion of<br>a narrower indication |
| | | Environment. | | to the "multi-patient,<br>multi-use" in the<br>hospital/institutional<br>environment and does<br>not alter the intended<br>use of the device.<br>Safety and<br>effectiveness issue will<br>not be raised. |
| Pressure source action<br>body site | Nose | Nose | Nose | Identical |
| Technical Specifications | | | | |
| Breathing Tube<br>connection | 22mm conical connector | 22mm conical connector | 22mm entrainment valve<br>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<br>12hPa=34L/min<br>2hPa=50L/min<br>30hPa=68L/min | Similar<br>Safety and effective-<br>ness issue will not be<br>raised. |
| Dead space (largest) | 142mL | 103.3mL | 145ml | Different<br>The dead space of our<br>masks is bigger than<br>AirFit N20. Both meet<br>relevant standard<br>requirement.<br>In addition, the dead |

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

{9}---------------…