The AirFit N20 channels airflow non-invasively 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 66 lb (30 kg) 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

Device Description

The AirFit N20 is an externally placed vented respiratory mask covering the patient's nose. It provides a seal such that pressure from a positive air pressure (PAP) source is directed to the patient's airway non-invasively via the nose. The mask connects to the positive pressure source through a conventional air tubing via a standard conical connector. The mask is held in place with adjustable head straps.

The AirFit N20 comprises 4 subassemblies: headgear, frame, cushion and elbow/short tube. The exhaust port is incorporated into the elbow/short tube assembly. The cushion and headgear are available in various sizes to fit a wide patient population.

The AirFit N20 is a prescription device supplied non-sterile.

AI/ML Overview

This document is a 510(k) premarket notification for the ResMed AirFit N20, a vented nasal mask, seeking clearance for expanded reprocessing claims. It is an FDA regulatory submission, not a study report describing an AI/ML device. Therefore, the requested information regarding acceptance criteria and a study proving an AI/ML device meets them cannot be provided as the document does not pertain to such a device.

The document discusses the substantial equivalence of the AirFit N20 with added reprocessing claims to a previously cleared predicate device. It details non-clinical testing performed to demonstrate that the expanded reprocessing claims do not affect the intended performance or raise new questions of safety or effectiveness.

Here's a breakdown of the non-clinical testing mentioned, which serves as the "study" demonstrating the device meets its expanded claims, though it is not an AI/ML study:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (related to expanded reprocessing claims)	Reported Device Performance (after expanded reprocessing)
Bioburden Efficacy: Cleaning and microbicidal efficacy must be maintained.	The device meets the same cleaning and microbicidal bioburden efficacy performance as the predicate device.
Performance Specifications: Maintain original performance specifications (Mask Pressure-Flow, mechanical integrity).	The device continues to meet the same performance specifications as the predicate device. This included: - Mask Pressure-Flow tests per ISO 17510:2015. - Relevant mask mechanical integrity tests: visual inspection, assembly integrity, headgear connection integrity, simulated body weight crush test, and free fall drop test.
Residual Toxicity: Device must remain safe after reprocessing.	Demonstrated using appropriate Cytotoxicity biocompatibility tests, performed in accordance with ISO 10993-5:2009.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated in terms of number of devices/units tested. The document refers to "the subject device" implying a representative sample was used for the non-clinical tests.
Data Provenance: The tests were conducted internally or by contracted labs as part of the regulatory submission process by ResMed Ltd. (Australia) for their device. This is prospective testing for regulatory clearance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

This is not applicable as this is not an AI/ML device study. Ground truth in this context would refer to established standards and test methods (e.g., ISO standards, biocompatibility protocols) against which the physical device performance is measured. The "experts" would be the engineers, scientists, and technicians conducting and interpreting these non-clinical tests. Their specific numbers and qualifications are not provided in this regulatory summary.

4. Adjudication Method for the Test Set:

Not applicable as this is not an AI/ML device study. Decisions are based on objective measurements against predefined acceptance criteria from international standards (e.g., ISO 17510:2015, ISO 10993-5:2009).

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:

Not applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used:

Established
standards and validated test methods:
- Bioburden efficacy test protocols (implicitly following relevant standards for cleanliness and disinfection).
- ISO 17510:2015 for Mask Pressure-Flow tests.
- Specific mechanical integrity test protocols (visual inspection, assembly integrity, etc.).
- ISO 10993-5:2009 for Cytotoxicity biocompatibility tests.
The ground truth is the performance of the predicate device and the specified limits/requirements within the applicable standards.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device; there is no "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable. This is not an AI/ML device.

Summary

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Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is a symbol of medicine and healing. The logo also includes the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the caduceus symbol.

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

September 28, 2017

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

Re: K171212

Trade/Device Name: AirFit N20 Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: August 28, 2017 Received: August 30, 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.

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

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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

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

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

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

Sincerely,

Tara A. Ryan -S

for

Tina Kiang, PhD 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K171212

Device Name AirFit N20

Indications for Use (Describe)

The AirFit N20 channels airflow non-invasively 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 66 lb (30 kg) 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.

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	September 28, 2017
Company Name /Owner	ResMed Ltd1 Elizabeth Macarthur DriveBella Vista, NSW, 2153 Australia
Prepared & submittedby	Mr. Kim Kuan LEESenior Regulatory Affairs ManagerTel: + 61 2 8884 2232Fax: + 61 2 8884 2004kim.lee@resmed.com.au
Official Contact	Miss Sheila BruschiSenior Manager, Regulatory AffairsResMed Corp.9001 Spectrum Center BlvdSan Diego CA 92123 USATel: +1 858 836 5934Fax: +1 858 836 5519sheila.bruschi@resmed.com
Device Trade Name	AirFit N20
Device Common Name	Vented Nasal Mask
Classification &Classification Name	21 CFR 868.5905, 73 BZD (Class II)Accessory to Noncontinuous Ventilator (IPPB)
Legally MarketedPredicate Devices	AirFit N20 (K161978)
Device Description	The AirFit N20 is an externally placed vented respiratory maskcovering the patient's nose. It provides a seal such that pressure froma positive air pressure (PAP) source is directed to the patient's airwaynon-invasively via the nose. The mask connects to the positivepressure source through a conventional air tubing via a standardconical connector. The mask is held in place with adjustable headstraps.The AirFit N20 comprises 4 subassemblies: headgear, frame, cushionand elbow/short tube. The exhaust port is incorporated into theelbow/short tube assembly. The cushion and headgear are availablein various sizes to fit a wide patient population.The AirFit N20 is a prescription device supplied non-sterile.
Intended Use	The AirFit N20 channels airflow non-invasively to a patient from apositive airway pressure (PAP) device such as a continuous positiveairway pressure (CPAP) or bilevel device.The AirFit N20 is:• to be used by patients weighing more than 66 lb (30 kg) 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

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Submission reason Expansion of reprocessing claims

Comparison of technological characteristics with the previously cleared predicate AirFit N20 device Delivering treatment pressure generated from a positive airway device (PAP) device to the patient's airway is the technological principle of both the subiect AirFit N20 and the previously cleared predicate AirFitN20 (K161978) device.

The subiect and predicate devices have identical intended use and are based on the same technological elements as follows:

. Silicone elastomer cushions achieve an air seal around the patient's nose and upper lip.
. The cushion is held in place using a polymeric frame
. The frame is strapped to the patient's head using a foam padded fabric headgear and clips.
An elbow and short tube assembly delivers the treatment pressure from the PAP device tubing to the cushion and the patient's airway.
Exhaust ports flush out CO2. ●
. The masks can be disassembled for cleaning and reprocessing in accordance with the labelling.
. Use of polymeric construction materials for the pneumatic and structural components and foam padded fabrics for the head strap.
. Use of ISO 5356-1 compliant swivel for connection to the PAP delivery hose.
. Multiple size offerings to allow for adequate mask fit over the intended patient population.
. Similar performance i.e. both masks have similar operating pressure range, pressure flow and flow impedance characteristics and operate on the same "Pillows, Mirage or Swift" ResMed flow generator settings.
. Same operating environments i.e. reuse in the home and hospital / institution environments

The main difference between the subject AirFit N20 and the previously cleared predicated device AirFit N20 (K161978) is:

High level chemical disinfection claims (Alconox cleaning followed by Cidex OPA disinfection) were added to the diffused elbow and diffused short tube assemblies.
. High level thermal disinfection claims (Alconox cleaning followed by Hot Water disinfection (90°C, 1 min) were added to the multihole elbow and short tube assembly.

These differences do not affect substantial equivalence claim to the predicate device because non-clinical testing below demonstrates that the subject device has equivalent performance to and is as safe as the predicate device.

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Non-clinical data	Verification and validation testing has demonstrated that theexpansion of the multi-patient reuse reprocessing claims do not affectintended performance of the mask nor raise new questions of safetyor effectiveness.
	Non clinical testing included:Bioburden efficacy tests which demonstrated that the subjectdevice meets the same cleaning and microbicidal bioburdenefficacy performance as the predicate device. Performance tests before and after the additionalreprocessing claims to demonstrate that the subject devicecontinues to meet the same performance specifications asthe predicate device. These included Mask Pressure-Flowtests per ISO 17510:2015 and relevant mask mechanicalintegrity tests such as visual inspection, assembly integrity,headgear connection integrity, simulated body weight crushtest and free fall drop test. Residual toxicity testing which demonstrated that the subjectdevice remains safe after reprocessing. This wasdemonstrated using the appropriate Cytotoxicitybiocompatibility tests, performed in accordance with ISO10993-5:2009.
SubstantialEquivalenceConclusion	The subject AirFit N20 is substantially equivalent to the previouslypredicate AirFit N20 device (K161978):it has the same intended use it has the same technological characteristics it has the same performance characteristics the differences do not raise any new questions of safety oreffectiveness it is at least as safe and as effective as the predicate device

Non-clinical data

Verification and validation testing has demonstrated that theexpansion of the multi-patient reuse reprocessing claims do not affectintended performance of the mask nor raise new questions of safetyor effectiveness.

Non clinical testing included:Bioburden efficacy tests which demonstrated that the subjectdevice meets the same cleaning and microbicidal bioburdenefficacy performance as the predicate device. Performance tests before and after the additionalreprocessing claims to demonstrate that the subject devicecontinues to meet the same performance specifications asthe predicate device. These included Mask Pressure-Flowtests per ISO 17510:2015 and relevant mask mechanicalintegrity tests such as visual inspection, assembly integrity,headgear connection integrity, simulated body weight crushtest and free fall drop test. Residual toxicity testing which demonstrated that the subjectdevice remains safe after reprocessing. This wasdemonstrated using the appropriate Cytotoxicitybiocompatibility tests, performed in accordance with ISO10993-5:2009.

SubstantialEquivalenceConclusion

The subject AirFit N20 is substantially equivalent to the previouslypredicate AirFit N20 device (K161978):it has the same intended use it has the same technological characteristics it has the same performance characteristics the differences do not raise any new questions of safety oreffectiveness 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).