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 modified ResMed AirFit N20 is a non-invasive vented respiratory mask that provides a silicone air seal around the patient's nose and upper lip. The mask is held in place with adjustable head straps. Air flow from a positive air pressure (PAP) source is directed to the patient's airway non-invasively. It connects to a conventional PAP device air delivery hose via a standard 22mm swivel.

The modified AirFit N20 comprises 4 subassemblies: headgear, frame, cushion and elbow/short tube. The exhaust port is incorporated into the elbow/short tube assembly. For home use, the mask may be cleaned in warm soapy water.

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

AI/ML Overview

This document describes the regulatory submission for the ResMed AirFit N20, a non-invasive vented respiratory mask. The submission, K161978, is a modification of a previously cleared predicate device, AirFit N20 (K153673), aiming to demonstrate substantial equivalence.

Based on the provided information, the following can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Functional Performance:
CO2 rebreathing	Demonstrated to be in accordance with ISO 17510:2015. (Implied: Acceptable CO2 levels, comparable to predicate)	Verified to meet predetermined acceptance criteria and substantially equivalent to predicate.
Total mask flow	Demonstrated to be in accordance with ISO 17510:2015. (Implied: Flow characteristics comparable to predicate)	Verified to meet predetermined acceptance criteria and substantially equivalent to predicate.
Flow resistance	Demonstrated to be in accordance with ISO 17510:2015. (Implied: Resistance characteristics comparable to predicate) -----------------------------------------------------------	Verified to meet predetermined acceptance criteria and substantially equivalent to predicate.
Through impedance	Demonstrated to be in accordance with ISO 17510:2015. (Implied: Impedance characteristics comparable to predicate) -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Verified to meet predetermined acceptance criteria and substantially equivalent to predicate.
Operating pressure range	Similar to predicate	Similar performance to predicate.
Pressure flow	Similar to predicate	Similar performance to predicate.
Flow impedance characteristics	Similar to predicate	Similar performance to predicate.
PAP device settings ("Pillows, Mirage or Swift")	Operate on the same ResMed flow generator settings as predicate ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Operates on the same settings as predicate.
Mechanical Integrity:
Home cleaning for single patient reuse	Verified under simulated normal use and reasonable abuse scenarios. (Implied: Maintains integrity and function after home cleaning)	Verification confirmed it met predetermined acceptance criteria.
Reprocessing for multi-patient reuse	Verification under simulated normal use and reasonable abuse scenarios, including cleaning efficacy, disinfection efficacy, post-disinfection/sterilization performance, and residual toxicity evaluation. (Implied: Maintains integrity and function, remains safe for multi-patient reuse after reprocessing)	Verification confirmed it met predetermined acceptance criteria.
Transportation	Verified under simulated normal use and reasonable abuse scenarios. (Implied: Withstands transportation without damage or loss of function)	Verification confirmed it met predetermined acceptance criteria.
Storage	Verified under simulated normal use and reasonable abuse scenarios. (Implied: Maintains integrity and function during storage)	Verification confirmed it met predetermined acceptance criteria.
Biocompatibility:	In accordance with ISO 10993-1, ISO 10993-5, ISO 10993-10 and ISO 10993-12 for modified components using new materials with patient exposure classifications of permanent external communicating device (tissue) and/or permanent skin contact. (Implied: No unacceptable biological risks)	Evaluation conducted, relying on predication for components with previously cleared materials.
Material Specifications:	Use of polymeric construction materials for pneumatic and structural components and foam padded fabrics for the head strap. ISO 5356-1 compliant 22mm diameter swivel for connection to PAP delivery hose.	Similar to predicate.

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

The document does not explicitly state sample sizes for specific tests (e.g., number of masks tested for CO2 rebreathing, or number of cleaning/reprocessing cycles). It mentions "testing to simulated normal use and reasonable abuse scenarios," suggesting laboratory-based testing.

Data Provenance: The testing was conducted by ResMed Ltd, an Australian company, for a device intended for international markets (indicated by FDA submission). The data is retrospective in the sense that it's bench testing and verification/validation conducted by the manufacturer, not a prospective clinical trial. There is no mention of data from human subjects in the testing phase beyond what is implicitly covered by biocompatibility standards.

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

Not applicable. This is a medical device submission primarily relying on bench testing and engineering verification/validation against international standards (e.g., ISO 17510:2015, ISO 10993 series) and comparison to a predicate device, rather than human expert-established ground truth for a diagnostic output. The "ground truth" here is the adherence to established engineering specifications and safety standards.

4. Adjudication Method for the Test Set

Not applicable for this type of submission. The evaluation is based on objective measurements against pre-defined engineering and performance criteria and adherence to recognized standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This document explicitly states: "Clinical data was not relied upon to demonstrate Substantial Equivalence to the predicate device. Bench testing demonstrates that the modified AirFit N20 mask device performs in an equivalent manner and is as safe and as effective as the previously cleared predicate AirFit N20 device (K153673)." Therefore, an MRMC study is not relevant to this submission.

6. Standalone Performance (Algorithm Only without Human-in-the-loop Performance)

Yes, in the sense that the device's functional and mechanical performance was evaluated in isolation ("bench testing") against pre-defined specifications and standards. This is not an AI algorithm, but a physical medical device; its "standalone performance" refers to its intrinsic characteristics and operation.

7. Type of Ground Truth Used

The "ground truth" for this device, as described in the submission, is based on:

International Standards: Primarily ISO 17510:2015 (Medical devices – Sleep apnoea breathing therapy Masks and application accessories) and ISO 10993 series for biocompatibility.
Engineering Specifications: Predetermined acceptance criteria derived from the device's design requirements and performance characteristics of the legally marketed predicate device (K153673).
Predicate Device Performance: The original AirFit N20 (K153673) serves as a benchmark for "similar performance."

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As noted above, there is no AI/ML training set.

Summary

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

November 17, 2016

ResMed Ltd % Sheila Bruschi Senior Manager, Regulatory Affairs, ResMed Corp. ResMed Corp. 9001 Spectrum Center Boulevard San Diego, California 92123

Re: K161978

Trade/Device Name: AirFit N20 Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: October 17, 2016 Received: October 18, 2016

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 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

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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 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 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 yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

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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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

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)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) SUMMARY
[As required by 21 CFFR 807.92(c)]

Date Prepared	Nov 16th, 2016
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 (K153673)
Device Description	The modified ResMed AirFit N20 is a non-invasive vented respiratorymask that provides a silicone air seal around the patient's nose andupper lip. The mask is held in place with adjustable head straps. Airflow from a positive air pressure (PAP) source is directed to thepatient's airway non-invasively. It connects to a conventional PAPdevice air delivery hose via a standard 22mm swivel.The modified AirFit N20 comprises 4 subassemblies: headgear,frame, cushion and elbow/short tube. The exhaust port isincorporated into the elbow/short tube assembly. For home use, themask may be cleaned in warm soapy water.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 whompositive airway pressure has been prescribed• intended for single patient re-use in the home environment andmulti-patient re-use in the hospital / institutional environment.

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Device modifications Submission reason

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 modified AirFit N20 and the previously cleared predicate AirFitN20 (K153673) device.

The modified and predicate devices are based on the following same technological elements:

Soft silicone elastomer cushions are used to 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 four point foam padded fabric headgear that employ self- aligning tactile magnetic clips.
A flexible and extensible elbow and short tube assembly delivers the treatment pressure from the PAP device tubing to the cushion and the patient's airway.
Exhaust ports are built into the elbow to continuously flush out and minimize the amount of CO2 rebreathed by the patient.
. 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 22mm diameter swivel for connection to the PAP delivery hose.
Multiple size offering to ensure adequate mask fit over the . extended 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
. Similar manufacturing processes

The following technological differences exist between the modified AirFit N20 and the previously cleared predicate AirFit N20 (K153673) are:

The modified AirFit N20 design incorporates an optional multi-. hole integrated elbow/short tube; the previously cleared AirFit N20 only has a diffused elbow/short tube assembly.
. Headgear fabric materials were modified.
Exhaust port vent geometries modifications were made to the . diffused elbow.
. Reprocessing claims expanded to include other components. In the predicate device only the cushion was labelled for reprocessing.

Verification and validation testing has demonstrated that these differences do not affect intended performance of the modified mask nor raise new questions of safety or effectiveness.

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Non-clinical data	The modified AirFit N20 was designed and tested in accordance withISO 17510:2015: Medical devices – Sleep apnoea breathing therapyMasks and application accessories.The scope of non-clinical testing conducted to support the substantialequivalence claim of modified AirFit N20 to the previously clearedpredicate AirFit N20 device included:• CO2 rebreathing• Total mask flow• Flow resistance• Through impedance
	Mechanical integrity performance of the new device was verified bytesting to simulated normal use and reasonable abuse scenariosincluding:• home cleaning for single patient reuse• reprocessing for multi-patient reuse• transportation• storage
	Biocompatibility evaluation was conducted in accordance withISO 10993-1, ISO 10993-5, ISO 10993-10 and ISO 10993-12 onmodified components that were manufactured using new materialswith patient exposure classifications of permanent externalcommunicating device (tissue) and /or permanent skin contact.Predication on the predicate AifFit N20 device (K153673) and otherreference devices was relied upon where the modified componentswere manufactured using previously cleared predicate materials.Reference devices include Mirage Vista Mask (K031047), MirageSwift (K032433), AirFit P10 (K132013) and AirFit N10 (K132887).
	Validation of reprocessing included a combination of cleaning efficacytesting, disinfection efficacy testing and predication based onpreviously validated Master Components. Post disinfection andsterilization performance testing and residual toxicity evaluation werealso completed to demonstrate functional performance of the modifieddevice.
	Verification confirmed that the modified device met the predeterminedacceptance criteria and the performance is substantially equivalent tothe previously cleared predicate AirFit N20 (K153673).
Clinical Data	Clinical data was not relied upon to demonstrate SubstantialEquivalence to the predicate device. Bench testing demonstrates thatthe modified AirFit N20 mask device performs in an equivalentmanner and is as safe and as effective as the previously clearedpredicate AirFit N20 device (K153673).
SubstantialEquivalenceConclusion	The modified AirFit N20 is substantially equivalent to the previouslypredicate AirFit N20 device (K153673):• it has the same intended use• it has similar technological characteristics• it has similar 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).