AirFit N20

K171212 · Resmed, Ltd. · BZD · Sep 28, 2017 · Anesthesiology

Device Facts

• Record ID: K171212
• Device Name: AirFit N20
• Applicant: Resmed, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Sep 28, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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 Story

AirFit N20 is a vented nasal mask for non-invasive delivery of positive airway pressure (PAP) therapy. Device consists of four subassemblies: silicone cushion, polymeric frame, foam-padded fabric headgear, and elbow/short tube assembly with integrated exhaust port. Mask connects to standard PAP tubing via ISO 5356-1 compliant conical connector. Used in home or hospital settings by patients weighing >66 lb. Healthcare provider or patient secures mask to face using adjustable head straps to create air seal around nose. Device channels pressurized air to patient airway; exhaust port flushes CO2. Enables treatment of respiratory conditions requiring PAP. Subject device expands reprocessing claims to include high-level chemical (Cidex OPA) and thermal (90°C water) disinfection for multi-patient reuse.

Clinical Evidence

Bench testing only. No clinical data. Testing included bioburden efficacy, mask pressure-flow (ISO 17510:2015), mechanical integrity (crush/drop tests), and residual toxicity (ISO 10993-5:2009) to validate safety after high-level chemical and thermal disinfection.

Technological Characteristics

Vented nasal mask; silicone elastomer cushion; polymeric frame; foam-padded fabric headgear; ISO 5356-1 compliant swivel connector. Non-sterile. Materials biocompatible per ISO 10993-5:2009. Mechanical performance per ISO 17510:2015.

Indications for Use

Indicated for patients weighing >66 lb (30 kg) prescribed positive airway pressure therapy via CPAP or bilevel devices.

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 N20 (K161978)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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 /<br>Owner | ResMed Ltd<br>1 Elizabeth Macarthur Drive<br>Bella Vista, NSW, 2153 Australia |
| Prepared & submitted<br>by | Mr. Kim Kuan LEE<br>Senior Regulatory Affairs Manager<br>Tel: + 61 2 8884 2232<br>Fax: + 61 2 8884 2004<br>[e-mail] |
| Official Contact | Miss Sheila Bruschi<br>Senior Manager, Regulatory Affairs<br>ResMed Corp.<br>9001 Spectrum Center Blvd<br>San Diego CA 92123 USA<br>Tel: [phone]<br>Fax: [phone]<br>[e-mail] |
| Device Trade Name | AirFit N20 |
| Device Common Name | Vented Nasal Mask |
| Classification &<br>Classification Name | 21 CFR 868.5905, 73 BZD (Class II)<br>Accessory to Noncontinuous Ventilator (IPPB) |
| Legally Marketed<br>Predicate Devices | AirFit N20 (K161978) |
| Device Description | The AirFit N20 is an externally placed vented respiratory mask<br>covering the patient's nose. It provides a seal such that pressure from<br>a positive air pressure (PAP) source is directed to the patient's airway<br>non-invasively via the nose. The mask connects to the positive<br>pressure source through a conventional air tubing via a standard<br>conical connector. The mask is held in place with adjustable head<br>straps.<br><br>The AirFit N20 comprises 4 subassemblies: headgear, frame, cushion<br>and elbow/short tube. The exhaust port is incorporated into the<br>elbow/short tube assembly. The cushion and headgear are available<br>in various sizes to fit a wide patient population.<br><br>The AirFit N20 is a prescription device supplied non-sterile. |
| Intended Use | The AirFit N20 channels airflow non-invasively to a patient from a<br>positive airway pressure (PAP) device such as a continuous positive<br>airway pressure (CPAP) or bilevel device.<br>The AirFit N20 is:<br>• to be used by patients weighing more than 66 lb (30 kg) for whom positive airway pressure has been prescribed<br>• 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 the<br>expansion of the multi-patient reuse reprocessing claims do not affect<br>intended performance of the mask nor raise new questions of safety<br>or effectiveness. |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Non clinical testing included:<br>Bioburden efficacy tests which demonstrated that the subject<br>device meets the same cleaning and microbicidal bioburden<br>efficacy performance as the predicate device. Performance tests before and after the additional<br>reprocessing claims to demonstrate that the subject device<br>continues to meet the same performance specifications as<br>the predicate device. These included Mask Pressure-Flow<br>tests per ISO 17510:2015 and relevant mask mechanical<br>integrity tests such as visual inspection, assembly integrity,<br>headgear connection integrity, simulated body weight crush<br>test and free fall drop test. Residual toxicity testing which demonstrated that the subject<br>device remains safe after reprocessing. This was<br>demonstrated using the appropriate Cytotoxicity<br>biocompatibility tests, performed in accordance with ISO<br>10993-5:2009. |
| Substantial<br>Equivalence<br>Conclusion | The subject AirFit N20 is substantially equivalent to the previously<br>predicate AirFit N20 device (K161978):<br>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 or<br>effectiveness it is at least as safe and as effective as the predicate device |