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 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 hospital/institutional environment.

Device Description

The AirFit F20 is an externally placed vented mask covering the mouth and the nose of the patient. It provides a seal such that pressure from a positive pressure source is directed to the patient's nose and/or mouth. The mask connects via a standard conical connector to a conventional air delivery hose, which in turn connects to the positive pressure source. The mask is held in place with an adjustable headgear that straps the mask to the face.

The AirFit F20 mask system comprises four subassemblies: cushion, frame, elbow and headgear. The elbow incorporates the vent array and anti-asphyxia valve safety features. The cushion and headgear are available in various sizes to fit a wide patient population.

AirFit F20 is a prescription device supplied non-sterile.

AI/ML Overview

This document is an FDA 510(k) clearance letter for a medical device called AirFit F20, a non-invasive accessory for positive airway pressure (PAP) devices. It does not contain information about an AI/ML device or a study involving human readers and AI assistance.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance using AI, as the provided text pertains to a traditional medical device submission and does not involve AI or ML.

The document discusses the substantial equivalence of the AirFit F20 to a previously cleared predicate device (AirFit F20 (K153563)) based on:

Intended Use: Same
Operating Principle: Same
Design and Materials: Similar
Performance: Similar pressure-flow characteristics and flow impedance
Operating Environments: Same (home and hospital/institution)
Manufacturing Processes: Similar

The main differences from the predicate device relate to reprocessing claims for multi-patient reuse and material changes to certain components. Non-clinical data validation testing was conducted to demonstrate that these changes do not raise new questions of safety or effectiveness. This validation included:

Bioburden efficacy tests
Performance tests (visual inspection, total mask flow, AAV activation/deactivation, assembly integrity, mask-to-headgear connections) before and after reprocessing
Residual toxicity tests
Biocompatibility tests for material changes (Cytotoxicity, Sensitization, Irritation, Genotoxicity, Acute systemic toxicity, Material-mediated Pyrogenicity, Implantation, Leachables testing)

In summary, the provided text describes a 510(k) clearance for a non-AI medical device and therefore does not contain the information needed to answer your specific questions about AI acceptance criteria and study details.

Summary

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January 3, 2018

ResMed Ltd % Sheila Bruschi Regulatory Affairs, Senior Manager ResMed Corp (Registration Number: 3007573469) 9001 Spectrum Center Boulevard San Diego, California 92123

Re: K170924

Trade/Device Name: AirFit F20 Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: December 1, 2017 Received: December 4, 2017

Dear Sheila Bruschi:

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.

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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); 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.

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.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Tina
Kiang-S

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K170924

Device Name AirFit F20

Indications for Use (Describe)

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 hospital/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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Date Prepared	December 29, 2017
Company Name / Owner	ResMed Ltd1 Elizabeth Macarthur DriveBella Vista NSW 2153 Australia
Submitter Name	Ms. Johanna WrightDirector, Regulatory AffairsResMed LtdTel: +612 8884 1000Fax: +612 8884 2004johanna.wright@resmed.com.au
Official Contact	Ms Sheila BruschiDirector, Regulatory AffairsResMed Corp9001 Spectrum Center BlvdSan Diego CA 92123 USATel: +1 858 836 5934Fax: +1 858 836 5519sheila.bruschi@resmed.com
Device Trade Name	AirFit F20
Device Common Name	Vented Full Face Mask
Classification Name	Noncontinuous Ventilator (IPPB) (21 CFR 868.5905,Product Code BZD)
Predicate Device	AirFit F20 (K153563)
Device Description	The AirFit F20 is an externally placed vented mask covering themouth and the nose of the patient. It provides a seal such thatpressure from a positive pressure source is directed to thepatient's nose and/or mouth. The mask connects via a standardconical connector to a conventional air delivery hose, which in turnconnects to the positive pressure source. The mask is held inplace with an adjustable headgear that straps the mask to theface.
	The AirFit F20 mask system comprises four subassemblies:cushion, frame, elbow and headgear. The elbow incorporates thevent array and anti-asphyxia valve safety features. The cushionand headgear are available in various sizes to fit a wide patientpopulation.
	AirFit F20 is a prescription device supplied non-sterile.
Intended Use	The AirFit F20 is a non-invasive accessory used for channelingairflow (with or without supplemental oxygen) to a patient from apositive airway pressure (PAP) device such as a continuouspositive airway pressure (CPAP) or bilevel system.

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The AirFit F20 is:

to be used by patients weighing more than 66lb (30kg) for whom positive airway pressure therapy has been prescribed
. intended for single-patient reuse in the home environment and multi-patient reuse in the hospital/institutional environment.

The AirFit F20 device has the following similarities to the previously cleared predicated device AirFit F20 (K153563):

same intended use ●
same operating principle ●
similar design and materials which incorporates: ●
- a silicone interface providing a seal around the nose l and the mouth:
- vent holes providing continuous air leak to flush out and minimize the amount of CO2 re-breathed by the patient:
- anti-asphyxia valves (AAV) to enable the patient to breathe fresh air in the event that airflow from the flow generator is impeded;
- elbow which connects to a conventional air delivery hose via standard conical connector;
- molded plastic and silicone components and fabric/foam headgear - all deemed biologically safe (ref: ISO 10993-1);
- Both masks are offered in various sizes to ensure adequate fit over the extended patient population.
. similar performance i.e both masks operate on the same flow generator settings and have similar pressure-flow characteristics and flow impedance.
. same operating environments i.e reuse in the home and hospital / institution environments
. similar manufacturing processes

The following are the main differences between the subject AirFit F20 and the previously cleared predicated device (AirFit 20 (K153563)):

. all components of the mask system can be reprocessed:
- -In the predicate device. the cushion can be reprocessed via high level thermal disinfection, high level chemical disinfection, and STERRAD sterilization, while the elbow can be reprocessed via STERRAD sterilization.
- In the subject device, the elbow, frame and headgear can all be processed via high-level thermal disinfection. The cushion maintains the same reprocessing methods as the predicate device.
Material changes to the elbow, frame, and headgear ● assemblies

Non-Clinical Data Validation testing has demonstrated that the material changes and expansion of the multi-patient reuse reprocessing claims does not raise new questions of safety or effectiveness.

Similarities and Differences with the Predicate Device

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Non clinical testing included:

Bioburden efficacy tests which demonstrated that the ● modified device meets the same cleaning and microbicidal bioburden efficacy performance as the predicate device.
. Performance tests before and after the additional reprocessing claims to demonstrate that the modified device continues to meet the same performance specifications as the predicate device, including:
- -Visual inspection
- -Total mask flow
- AAV activation / deactivation -
- Assembly integrity "
- -Mask to headgear connections
Residual toxicity tests, including cytotoxicity testing per ● ISO 10993-5, which demonstrated that the modified device remains as safe as the predicate device if the reprocessing steps provided in the labelling are followed
. For the material changes requiring additional testing, the following biocompatibility tests were conducted:
- Cytotoxicity testing per ISO 10993-5 "
- Sensitization testing per ISO 10993-10 -
- Irritation testing per ISO 10993-10 -
- Genotoxicity per ISO 10993-3 -
- -Acute systemic toxicity per ISO 10993-11
- Material-mediated Pyrogenicity per ISO 10993-11 -
- Implantation per ISO 10993-6 -
- Leachables testing per ISO 10993-17 -

Substantial Equivalence Conclusion

The new AirFit F20 is substantially equivalent to the predicate device:

it has the same intended use -
it has similar technological characteristics -
it has similar performance characteristics -
the difference do not raise any new questions of safety or effectiveness
it is at least as safe and as effective as the predicate device.

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).