AirFit N20

K161978 · Resmed, Ltd. · BZD · Nov 17, 2016 · Anesthesiology

Device Facts

• Record ID: K161978
• Device Name: AirFit N20
• Applicant: Resmed, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Nov 17, 2016
• 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 non-invasive vented nasal mask for delivering PAP therapy. It consists of a silicone cushion, polymeric frame, four-point foam-padded headgear with magnetic clips, and an elbow/short tube assembly with an integrated exhaust port. The device connects to standard PAP tubing via a 22mm swivel. Used in home or hospital settings, it is operated by patients or clinicians to channel airflow to the patient's airway. The mask provides a seal around the nose and upper lip. It is a prescription-only, non-sterile device. The design includes an optional multi-hole elbow and modified vent geometries to minimize CO2 rebreathing. The device is cleaned/reprocessed between uses. It benefits patients by providing a stable interface for respiratory support.

Clinical Evidence

No clinical data was relied upon. Substantial equivalence was demonstrated through bench testing, including CO2 rebreathing, total mask flow, flow resistance, through impedance, mechanical integrity (simulated use/abuse), and biocompatibility (ISO 10993 series). Reprocessing validation included cleaning and disinfection efficacy testing.

Technological Characteristics

Materials: silicone elastomer, polymeric frame, foam-padded fabric headgear. Connection: ISO 5356-1 compliant 22mm swivel. Design: 4 subassemblies (headgear, frame, cushion, elbow/short tube). Exhaust: integrated port in elbow. Standards: ISO 17510:2015, ISO 10993-1/5/10/12. Non-sterile, prescription-only.

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 (K153673)

Reference Devices

• Mirage Vista Mask (K031047)
• Mirage Swift (K032433)
• AirFit P10 (K132013)
• AirFit N10 (K132887)

Submission Summary (Full Text)

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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 [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 at its toll-free number [phone] or [phone] 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)

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

| Date Prepared | Nov 16th, 2016 |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 (K153673) |
| Device Description | The modified ResMed AirFit N20 is a non-invasive vented respiratory<br>mask that provides a silicone air seal around the patient's nose and<br>upper lip. The mask is held in place with adjustable head straps. Air<br>flow from a positive air pressure (PAP) source is directed to the<br>patient's airway non-invasively. It connects to a conventional PAP<br>device air delivery hose via a standard 22mm swivel.<br><br>The modified AirFit N20 comprises 4 subassemblies: headgear,<br>frame, cushion and elbow/short tube. The exhaust port is<br>incorporated into the elbow/short tube assembly. For home use, the<br>mask may be cleaned in warm soapy water.<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<br>positive airway pressure has been prescribed<br>• intended for single patient re-use in the home environment and<br>multi-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 with<br>ISO 17510:2015: Medical devices – Sleep apnoea breathing therapy<br>Masks and application accessories.<br>The scope of non-clinical testing conducted to support the substantial<br>equivalence claim of modified AirFit N20 to the previously cleared<br>predicate AirFit N20 device included:<br>• CO2 rebreathing<br>• Total mask flow<br>• Flow resistance<br>• Through impedance |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Mechanical integrity performance of the new device was verified by<br>testing to simulated normal use and reasonable abuse scenarios<br>including:<br>• home cleaning for single patient reuse<br>• reprocessing for multi-patient reuse<br>• transportation<br>• storage |
| | Biocompatibility evaluation was conducted in accordance with<br>ISO 10993-1, ISO 10993-5, ISO 10993-10 and ISO 10993-12 on<br>modified components that were manufactured using new materials<br>with patient exposure classifications of permanent external<br>communicating device (tissue) and /or permanent skin contact.<br>Predication on the predicate AifFit N20 device (K153673) and other<br>reference devices was relied upon where the modified components<br>were manufactured using previously cleared predicate materials.<br>Reference devices include Mirage Vista Mask (K031047), Mirage<br>Swift (K032433), AirFit P10 (K132013) and AirFit N10 (K132887). |
| | Validation of reprocessing included a combination of cleaning efficacy<br>testing, disinfection efficacy testing and predication based on<br>previously validated Master Components. Post disinfection and<br>sterilization performance testing and residual toxicity evaluation were<br>also completed to demonstrate functional performance of the modified<br>device. |
| | Verification confirmed that the modified device met the predetermined<br>acceptance criteria and the performance is substantially equivalent to<br>the previously cleared predicate AirFit N20 (K153673). |
| Clinical Data | Clinical data was not relied upon to demonstrate Substantial<br>Equivalence to the predicate device. Bench testing demonstrates that<br>the modified AirFit N20 mask device performs in an equivalent<br>manner and is as safe and as effective as the previously cleared<br>predicate AirFit N20 device (K153673). |
| Substantial<br>Equivalence<br>Conclusion | The modified AirFit N20 is substantially equivalent to the previously<br>predicate AirFit N20 device (K153673):<br>• it has the same intended use<br>• it has similar technological characteristics<br>• it has similar performance characteristics<br>• the differences do not raise any new questions of safety or<br>effectiveness<br>• it is at least as safe and as effective as the predicate device |