(231 days)
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.
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.
This document describes the non-clinical testing performed to demonstrate substantial equivalence for the Sleep Apnea Breathing Therapy Masks (YF-01, YF-02, YF-03 Full Face Mask; YN-02, YN-03 Nasal Mask; YP-01 Nasal Pillows Mask). The study focuses on comparing the subject devices to predicate devices based on various technical specifications and adherence to recognized standards.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly provide a separate table of defined acceptance criteria alongside reported device performance in the format requested. Instead, it presents a comparative analysis with predicate devices across several technical specifications. The "Comment" column often describes whether the subject device meets relevant standard requirements or how differences are deemed acceptable.
However, based on the comparative tables provided across pages 5-13, we can infer the acceptance criteria are generally that the subject device's performance is comparable to or better than the predicate devices, and/or meets relevant international standards.
Here's a summary of the technical specifications and reported performance for the Subject Device for the Full Face Mask comparison (YF-01, YF-02, YF-03 Full Face Mask vs. predicate AirFit F20), as an example:
| Acceptance Criterion (Inferred) | Reported Subject Device Performance (YF-01, YF-02, YF-03 Full Face Mask) |
|---|---|
| Classification Regulation: 868.5905 | 868.5905 |
| Product Code: BZD | BZD |
| Indications for Use: Comparable or narrower to predicate (no alteration of intended use, no safety/effectiveness issue) | Non-invasive accessory for channeling airflow (with/without O2) from PAP device (CPAP/bi-level), for patients >30kg, single patient reuse in home, single-patient use in hospital/institutional. |
| Principle: Positive Airway Pressure (PAP) | Positive Airway Pressure (PAP) |
| Patient usage type: Comparable or narrower to predicate (no alteration of intended use, no safety/effectiveness issue) | Single-patient reuse in home, single-patient use in hospital/institutional. |
| Pressure source action body site: Mouth and Nose | Mouth and Nose |
| Breathing Tube connection: 22mm conical connector | 22mm conical connector |
| Pressure Range: Meets standard, comparable to predicate | 4-30 cmH2O |
| Pressure-Flow Cure: Similar to predicate (no safety/effectiveness issue) | (Image: Pressure-Flow Cure - Not explicitly detailed in text, but stated as "Similar") |
| Dead space (largest): Meets relevant standard requirement, comparable or less than predicate (no safety/effectiveness issue) | 208mL |
| Resistance to Flow: Meets relevant standard requirement (no safety/effectiveness issue) | at 50 L/min: 0.5 hPa; at 100 L/min: 1.5 hPa |
| Inspiratory and expiratory resistance with Non-Rebreathing Valve open-to-atmosphere: Meets Clause 2.1 of ISO 17510:2015 (pressure < 10 cmH₂O) | Inspiratory at 50 L/min: ≤2 cmH₂O; Expiratory at 50 L/min: ≤2 cmH₂O |
| Sound: Sound pressure level < 30 dBA (quiet, no sleep interference, no safety/effectiveness issue) | A-weighted sound power level < 38 dBA (uncertainty 3 dBA); A-weighted sound pressure level at 1 m < 30 dBA (uncertainty 3 dBA) |
| Operating environment: Comparable to predicate (no safety/effectiveness issue) | +5°C to +40°C (41°F to 104°F); 10%~90% relative humidity non-condensing |
| Storage and transport environment: Comparable to predicate (no safety/effectiveness issue) | -20°C to +60°C (-4°F to 140°F); 10%~90% relative humidity non-condensing |
Similar tables are provided in the document for Predicate Device AirFit N20 against YN-02, YN-03 Nasal Mask and Predicate Device Swift™ FX against YP-01 Nasal Pillows Mask. The acceptance criteria are consistent across all comparisons, emphasizing meeting relevant standards and comparability to predicate devices without raising new safety or effectiveness concerns.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes non-clinical tests conducted to verify design specifications and substantial equivalence. These tests are typically laboratory-based assessments of performance characteristics.
- Sample size: Not explicitly stated for each test. The tests are general engineering and biocompatibility evaluations, implying multiple samples of the masks would have been tested as per standard protocols.
- Data provenance: Not explicitly stated, but based on the manufacturer's location (Suzhou, Jiangsu, China) and the submission to the FDA, it's likely the tests were conducted in China. These would be prospective tests performed specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable. The study is a non-clinical, technical performance and biocompatibility assessment of a medical device (sleep apnea breathing therapy masks). It does not involve human subjects, image interpretation, or clinical decision-making where expert ground truth would be established. The "ground truth" here is adherence to engineering standards and comparison against predicate device specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods like 2+1 or 3+1 refer to expert review processes, typically used in clinical studies or when establishing ground truth from human assessments, such as radiology interpretations. This document describes non-clinical engineering and biocompatibility testing. The "adjudication" is met by demonstrating compliance with recognized standards (e.g., ISO 17510:2015, ISO 10993 series) and comparability to predicate devices.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. The device described is a physical medical mask, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. The device is a physical mask for sleep apnea therapy, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by:
- International Standards: Adherence to standards such as ISO 17510:2015 (Medical devices -- Sleep apnoea breathing therapy -- Masks and application accessories), ISO 5356-1:2004 (Anaesthetic and respiratory equipment - Conical connectors), ISO 10993 series (Biological evaluation of medical devices), and ISO 18562 series (Biocompatibility evaluation of breathing gas pathways).
- Predicate Device Specifications: Comparative data showing that the subject device's technical specifications (e.g., pressure range, resistance to flow, dead space, sound, environmental conditions) are comparable to or within acceptable limits of legally marketed predicate devices.
- FDA Guidance: Compliance with relevant FDA guidance documents, such as "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, 2015."
8. The sample size for the training set
This section is not applicable. This is a physical medical device, not a machine learning or AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
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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.
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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
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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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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 CHINATel: +86-512-67373001Fax: +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 PillowsMask |
| 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 NasalPillows (K090244) |
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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.
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Table 1: Comparison table between full face mask and AirFit F20
| Subject Device | Predicate Device | |||
|---|---|---|---|---|
| Comparison Elements | YF-01 Full Face MaskYF-02 Full Face MaskYF-03 Full Face Mask | AirFit F20 | Comment | |
| ClassificationRegulation | 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 anon-invasive accessory used for channelingairflow (with or without supplementaloxygen) to a patient from a positive airwaypressure (PAP) device such as a continuouspositive airway pressure (CPAP) or bi-levelsystem.-The mask is to be used by patients(weighing>30kg), intended for single patientreuse in the home environment.-The mask is intended for single-patient usein the hospital or institutional environment. | The AirFit F20 is a non-invasiveaccessory used for channeling airflow(with or without supplemental oxygen)to a patient from a positive airwaypressure (PAP) device such as acontinuous positive airway pressure(CPAP) or bilevel system.The AirFit F20 is:• to be used by patients weighing morethan 66 lb (30 kg) for whom positiveairway pressure therapy has beenprescribed• intended for single-patient reuse inthe home environment andmulti-patient reuse in the | DifferentThe inclusion of "single-patient reuse" is anarrower indication to the"multi-patient, multi-use"in the hospital /institutionalenvironment and does notalter the intended use ofthe device. Safety andeffectiveness issue will notbe raised. | |
| Principle | Positive airway pressure(PAP) | Positive airway pressure(PAP) | Identical | |
| Patient usage type | single-patient reuse in the homeenvironment. single-patient use in thehospital or institutional environment. | single-patient reuse in the homeenvironment and multi-patient reuse inthe hospital/institutional | DifferentThe inclusion of “single-patient reuse” is a narrowerindication to the “multi-patient, multi-use” in thehospital/institutionalenvironment and does notalter the intended use ofthe device. Safety andeffectiveness issue will notbe raised. | |
| Pressure source actionbody site | Mouth and Nose | Mouth and Nose | Identical | |
| Technical Specifications | ||||
| Breathing Tubeconnection | 22mm conical connector | 22mm conical connector | Identical | |
| Pressure Range | 4-30 cmH2O | 3-40 cmH2O | DifferentSafety and effectivenessissue will not be raised. | |
| Pressure-Flow Cure | Similar, Safety andeffectiveness issue will notbe raised. | |||
| Dead space (largest) | 208mL | 240mL | DifferentThe dead space of our masksis less than AirFit F20. Bothmeet relevant standardrequirement. Safety andeffectiveness issue will notbe raised. | |
| Resistance to Flow | at 50 L/min: 0.5 hPaat 100 L/min:1.5 hPa | at 50 L/min: 0.2hPaat 100 L/min:0.6 hPa | DifferentThe Resistance of our maskis higher than AirFit F20.Both meet relevantstandard requirement.Safety and effectivenessissue will not be raised. | |
| Inspiratory andexpiratory resistancewith theNon-RebreathingValveopen-to-atmosphere | Inspiratory at 50 L/min: ≤2 cmH₂OExpiratory at 50 L/min: ≤2 cmH₂O | Inspiratory at 50 L/min: 0.6 cmH₂OExpiratory at 50 L/min: 0.7 cmH₂O | DifferentBoth meet Clause 2.1 of ISO17510:2015 which need thepressure is less than 10cmH₂O. Safety andeffectiveness issue will not | |
| pressure | be raised. | |||
| Sound | DECLARED DUAL-NUMBER NOISE EMISSIONVALUES in accordance with ISO 4871. The A-weighted sound power level of the mask isless than 38 dBA, with uncertainty 3 dBA. TheA-weighted sound pressure level of the maskat a distance of 1 m is less than 30 dBA, withuncertainty 3 dBA. | DECLARED DUAL-NUMBER NOISEEMISSION VALUES in accordance withISO 4871. The A-weighted sound powerlevel of the mask is 30 dBA, withuncertainty of 3 dBA. The A-weightedsound pressure level of the mask at adistance of 1 m is 23 dBA, withuncertainty of 3 dBA. | DifferentThe sound of our masks ismore than AirFit F20, butthe sound pressure level ofour masks is less than 30dBA, they are quiet anddon't interfere with sleep.Safety and effectivenessissue will not be raised. | |
| Operatingenvironment | +5°C to +40°C (41°F to 104°F)10%~90% relative humiditynon-condensing | 41°F to 104°F(5°C to +40°C)15% to 95% non-condensing | Temperature is identical.Humidity is different, butvery similar. Safety andeffectiveness issue will notbe raised. | |
| Storage and transportenvironment | -20°C to +60°C (-4°F to 140°F)10%~90% relative humiditynon-condensing | -4°F to 140°F (-20°C to +60°C)Up to 95% non-condensing | Temperature is identical.Humidity is different, butvery similar. Safety andeffectiveness issue will notbe raised. | |
| Comparison Elements | Subject Device | Predicate Device | Reference device | Comment |
| YN-02 Nasal MaskYN-03 Nasal Mask | AirFit N20 | BMC-NM | ||
| ClassificationRegulation | 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 therapymask is a non-invasive accessory usedfor channeling airflow (with orwithout supplemental oxygen) to apatient from a positive airwaypressure (PAP) device such as acontinuous positive airway pressure(CPAP) or bi-level system.-The mask is to be used by patients(weighing>30kg), intended for singlepatient reuse in the homeenvironment.-The mask is intended for single-patient use in the hospital orinstitutional environment. | The AirFit N20 channels airflownoninvasively to a patient froma positive airway pressure (PAP)device such as a continuouspositive airway pressure (CPAP)or bilevel device.The AirFit N20 is:• to be used by patientsweighing more than 66lb(>30kg) for whom positiveairway pressure has beenprescribed.• intended for single-patient re-use in the home environmentandmulti-patient re-use in thehospital/institutional environment | The BMC-NM Nasal Mask channelairflow noninvasively to a patientfrom a positive airway pressuredevice such as a continuouspositive airway pressure (CPAP)or Bi-level system.The BMC-NM Nasal Mask are:• To be used by adult patients(66lbs/>30kg) for whom positiveairway pressure has beenprescribed.• Intended for single-patientreuse in home environment andmulti-patient re-use in thehospital/institutionalenvironment. | DifferentThe inclusion of "single-patient reuse" isanarrower indication tothe"multi-patient,multi-use" in thehospital /institutionalenvironment and doesnot alter the intendeduse of the device.Safety and effectivenessissue 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 homeenvironment. single-patient use in thehospital or institutional environment. | single patient re-use in thehome environment and multi-patient re-use in thehospital/institutional | Single-patient reuse in homeenvironment and multi-patientre-use in the hospital/institutionalenvironment. | DifferentThe inclusion ofa narrower indication |
| Environment. | to the "multi-patient,multi-use" in thehospital/institutionalenvironment and doesnot alter the intendeduse of the device.Safety andeffectiveness issue willnot be raised. | |||
| Pressure source actionbody site | Nose | Nose | Nose | Identical |
| Technical Specifications | ||||
| Breathing Tubeconnection | 22mm conical connector | 22mm conical connector | 22mm entrainment valveelbow | 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/min12hPa=34L/min2hPa=50L/min30hPa=68L/min | SimilarSafety and effective-ness issue will not beraised. |
| Dead space (largest) | 142mL | 103.3mL | 145ml | DifferentThe dead space of ourmasks is bigger thanAirFit N20. Both meetrelevant standardrequirement.In addition, the dead |
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| space of our mask iscomparable with thatof the reference deviceSafety andeffectivenessissue will not be raised. |
|---|
| Resistance to Flow | at 50 L/min: 0.5 hPaat 100 L/min:1.5 hPa | at 50 L/min: 0.3 hPaat 100 L/min:1.3 hPa | at 50 L/min: 0.2 hPaat 100 L/min:0.7 hPa | DifferentThe Resistance of ourmask is higher thanAirFit N20. Both meetrelevant standardrequirement. Safetyand effectiveness issuewill not be raised. |
|---|---|---|---|---|
| Sound | DECLARED DUAL-NUMBER NOISEEMISSION VALUES in accordance withISO 4871. The A-weighted soundpower level of the mask is less than 38dBA, with uncertainty 3 dBA. The A-weighted sound pressure level of themask at a distance of 1 m is less than30 dBA, with uncertainty 3 dBA. | DECLARED DUAL-NUMBER NOISEEMISSION VALUES in accordance withISO 4871. The A-weighted soundpower level of the mask is 24 dBA,with uncertainty of 3 dBA. The A-weighted sound pressure level of themask at a distance of 1 m is 16 dBA,with uncertainty of 3 dBA. | DECLARED DUAL-NUMBER NOISE EMISSION VALUES inaccordance with ISO 4871.The A-weighted sound powerlevel of the mask is 32 dBA,with uncertainty 3 dBA. TheA-weighted sound pressurelevel of the mask at adistance of 1 m is 24 dBA,with uncertainty 3 dBA. | DifferentThe sound of ourmasks is more thanAirFit N20, but thesound pressure level ofour masks is less than30 dBA, they are quietand don't interferewith sleep. Safety andeffectiveness issue willnot be raised. |
| Operatingenvironment | +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 isidentical. Humidity isdifferent, 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°C10% to 93% relative humidity, non-condensing | Temperature is identical.Humidity is different, but very similar.Safety and effectiveness issue will not be raised. |
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| Subject Device | Predicate Device | Comment | |
|---|---|---|---|
| Comparison Elements | YP-01 Nasal Pillows Mask | Swift™ FX | |
| ClassificationRegulation | 868.5905 | 868.5905 | Identical |
| Product Code | BZD | BZD | Identical |
| 510(k) Number | K203347 | K090244 | |
| Indications for use | The sleep apnea breathing therapy maskis a non-invasive accessory used forchanneling airflow (with or withoutsupplemental oxygen) to a patient froma positive airway pressure (PAP) devicesuch as a continuous positive airwaypressure (CPAP) or bi-level system.- The mask is to be used by patients(weighing>30kg), intended for singlepatient reuse in the home environment.- The mask is intended for single-patientuse in the hospital or institutionalenvironment. | The Swift FX channels airflownoninvasively to a patient from apositive airway pressure (PAP)device such as a continuous positiveairway pressure (CPAP) or bileveldevice. The Swift FX is:- to be used by adult patients (>66lb/30kg) for whom positive airwaypressure has been prescribed.- intended for single-patient re-usein the home environment andmultipatient re-use in thehospital/institutional environment | DifferentThe inclusion of "single-patient reuse" is a narrowerindication to the "multi-patient, multi-use" in thehospital /institutionalenvironment and does notalter the intended use of thedevice. Safety andeffectiveness issue will not beraised. |
| Principle | Positive airway pressure(PAP) | Positive airway pressure(PAP) | Identical |
| Patient usage type | single-patient reuse in the homeenvironment. single-patient use in thehospital or institutional environment. | single patient re-use in the homeenvironment and multipatient re-use inthe hospital/institutional environment | DifferentThe inclusion of"single-patient reuse" is anarrower indication to the"multi-patient, multi-use"in the hospital/institutionalenvironment and does notalter the intended use of thedevice. Safety andeffectiveness issue will notbe raised. |
| Pressure source actionbody site | Nose | Nose | Identical |
| Technical Specifications | |||
| Breathing Tubeconnection | 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 | SimilarSafety and effectivenessissue will not be raised. |
| Dead space (largest) | Different | ||
| 16mL | 106mL | The dead space of our masksis less than Swift™ FX. Bothmeet relevant standardrequirement.Safety and effectivenessissue will not be raised. | |
| Resistance to Flow | at 50 L/min: 1.0 hPaat 100 L/min:3.5 hPa | at 50 L/min: 0.4 hPaat 100 L/min:1.4 hPa | DifferentThe Resistance of our maskis higher than Swift™ FX.Both meet relevantstandard requirement.Safety and effectivenessissue will not be raised. |
| Sound | DECLARED DUAL-NUMBER NOISE EMISSIONVALUES in accordance with ISO 4871. The A-weighted sound power level of the mask isless than 38 dBA, with uncertainty 3 dBA. TheA-weighted sound pressure level of the maskat a distance of 1 m is less than 30 dBA, withuncertainty 3 dBA. | NA | The sound pressure level ofour masks is less than 30dBA, they are quiet anddon't interfere with sleep.Safety and effectivenessissue will not be raised. |
| Operatingenvironment | +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 humiditynon-condensing | 15% to 95% relative humiditynon-condensing | Very similar. Safety andeffectiveness issue will notbe raised. | |
| Storage and transportenvironment | -20°C to +60°C (-4°F to 140°F)10%~90% relative humiditynon-condensing | -4°F to 140°(-20°C to +60°C)up to 95% relative humiditynon-condensing | Temperature is identical.Humidity is different, butVery similar. Safety andeffectiveness issue will notbe raised. |
Table 3 Comparison Table between Nasal Pillows Mask and Swift™ FX
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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
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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
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ISO 10993-5:2009 Biological evaluation of medical devices- part 5: Tests for in vitro cytotoxicity
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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
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ISO 18562-2:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
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ISO 18562-3:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds
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ISO 18562-4:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications —Tests for leachables in condensate.
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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.
§ 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).