AIRSOFT F15

K132901 · Resmed, Ltd. · BZD · Jun 9, 2014 · Anesthesiology

Device Facts

• Record ID: K132901
• Device Name: AIRSOFT F15
• Applicant: Resmed, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Jun 9, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The AirSoft F15 is a noninvasive accessory used for channeling airflow (with or without supplemental oxygen) to a patient from a positive airway pressure (PAP) device such as continuous positive airway pressure (CPAP) or bilevel system. The AirSoft F15 is: • to be used by patients (weighing >66 lb (30 kg)) for whom positive airway pressure therapy has been prescribed • intended for single-patient reuse in the home environment and multipatient reuse in the hospital/institutional environment.

Device Story

AirSoft F15 is a vented full-face mask covering mouth and nose; connects to positive airway pressure (PAP) devices (CPAP/bilevel) via standard air delivery hose. Device channels airflow to patient; includes diffuse vent holes for CO2 flushing; features 360-degree rotating elbow with anti-asphyxia valve (AAV) for safety during flow interruption. Held in place by adjustable headgear. Used in home (single-patient) or hospital/institutional (multipatient) settings; operated by patients or healthcare professionals. Provides interface for PAP therapy; benefits patient by maintaining airway pressure to treat respiratory conditions. Healthcare providers use device to deliver prescribed therapy; performance monitored via PAP device settings.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing only, including pressure-flow characteristics, CO2 washout (dead space) performance, biocompatibility (ISO 10993), and mechanical integrity/durability testing under simulated use and abuse scenarios. Cleaning and disinfection protocols were validated for multi-patient reuse.

Technological Characteristics

Vented full-face mask; silicone-alternative conforming cushion; adjustable headgear; 360-degree rotating elbow with anti-asphyxia valve; standard ISO 5356-1:2004 conical connectors. Materials evaluated per ISO 10993-1 (genotoxicity, cytotoxicity, implantation, sensitization, irritation). Designed per ISO 14971 risk management. Non-sterile, reusable.

Indications for Use

Indicated for patients weighing >66 lb (30 kg) prescribed positive airway pressure therapy (CPAP or bilevel) for noninvasive delivery of airflow, with or without supplemental oxygen. Intended for single-patient home use or multipatient hospital/institutional use.

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

• Quattro Air (K123979)
• Ultra Mirage FFM (K023244)

Submission Summary (Full Text)

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K132901 JUN 0 9 2014

# RESMED

AirSoft F15 Traditional 510(k)

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| 510(k) SUMMARY<br>[As required by 21 CFR 807.92(c)] | |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Sent | May 14th, 2014 |
| Company Name/<br>Owner | ResMed Ltd<br>1 Elizabeth Macarthur Drive<br>Bella Vista NSW 2153 Australia |
| Submitter Name | Mr. Jean-Nicolas Boudaud<br>Regulatory Affairs Manager, Patient Interface<br>[phone] (phone)<br>[phone] (fax)<br>[e-mail] |
| Correspondent Details/<br>Official Contact | Mr. Jim Cassi<br>Vice President - Quality Assurance Americas<br>9001 Spectrum Center Blvd<br>San Diego CA 92123 USA<br>Tel: [phone] |
| Trade/Device Name | AirSoft F15 |
| Device Common Name | Vented Full Face Mask |
| Regulation Number | 21 CFR 868.5905 |
| Regulation Name | Noncontinuous Ventilator (IPPB) |
| Regulatory Class | Class 2 |
| Product Code | BZD |
| Predicate Devices | Quattro Air (K123979)<br>Ultra Mirage FFM (K023244) |
| Description | The AirSoft F15 Mask system is an externally placed mask covering<br>the mouth and the nose of the patient. It provides a seal such that<br>positive pressure from a positive pressure source is directed to the<br>patient's nose and/or mouth. It is held in place with an adjustable<br>headgear that straps the mask to the face.<br>AirSoft F15 can be cleaned by the patient in the home environment<br>and reprocessed by professionals in the hospital/institutional<br>environment.<br>AirSoft F15 is intended to be used under the conditions and<br>purposes indicated in the labelling provided with the product.<br>AirSoft F15 is a prescription device supplied non-sterile. |
| Intended Use | The AirSoft F15 is a noninvasive accessory used for channeling<br>airflow (with or without supplemental oxygen) to a patient from a<br>positive airway pressure (PAP) device such as continuous positive<br>airway pressure (CPAP) or bilevel system. |
| | The AirSoft F15 is: |
| | • to be used by patients (weighing >66 lb (30 kg)) for whom<br>positive airway pressure therapy has been prescribed |
| | • intended for single-patient reuse in the home environment<br>and multipatient reuse in the hospital/institutional<br>environment. |
| Intended Use<br>comparison | Comparison with predicate Quattro Air (K123979)<br>The new device and the predicate Quattro Air mask have identical<br>intended uses. Both are intended to be used with Positive Air<br>Pressure therapy equipment, in the same environments for use and<br>for an identical patient population. |
| Technological<br>Characteristics<br>comparison | Comparison with the predicate Quattro Air (K123979)<br>AirSoft F15 broadly reuses the technological characteristics and design<br>features of the previously cleared ResMed Quattro Air Full Face Mask |
| | • Both devices have very similar physical properties and operating<br>principle |
| | • Both masks are offered in various sizes and are provided with<br>very similar adjustable headgears. They aim to fit the same<br>patient population |
| | • Both masks incorporate diffuse type vent holes to provide<br>continuous air leak to flush out and minimize the amount of CO2<br>re-breathed by the patient. The design of the mask components<br>is such that the incorporation of these vent-holes does not<br>interfere with the intended performance of the mask |
| | • Both masks are equipped with a common elbow component,<br>which can freely rotate through 360 degrees and includes an<br>anti-asphyxia valve (AAV) to enable the patient to breathe<br>fresh air in the event that airflow from the flow generator is<br>impeded |
| | • Both masks connect to a conventional air delivery hose<br>between the mask and the positive airway-pressure source<br>via standard conical connectors (ref: ISO 5356-1:2004). The<br>swivel connector can also rotate freely through 360 degrees |
| | The main differences between the predicate Quattro Air (K123979)<br>and the new AirSoft F15 mask system are: |
| | • the sealing interface - the predicate device utilizes a<br>conventional silicone cushion interface whereas the new<br>AirSoft F15 mask system utilizes an alternate conforming<br>material |
| | • the design of certain components (e.g. frame) and how<br>components interface with each other (e.g. retention features, |
| 10th September. 2013 | 510(k) Page # 35 |

510(k) Page # 34

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location and shape of these interfaces)

In addition, the AirSoft F15 Mask system was developed within a risk management process in accordance to ISO 14971:2007, Medical devices - Application of risk management to medical devices. Both devices are designed and manufactured under the same 21 CFR 820 compliant Quality system.

### Performance Data Comparison with the predicate Quattro Air (K123979) Performance data is provided to demonstrate that the AirSoft F15 design choices do not impact the fundamental scientific concept nor the therapeutic effects of the new device when compared to the predicate.

Both the new mask and the predicate device are designed to operate on the same Full Face Mask ResMed flow generator settings. The pressure-flow characteristics and flow impedance of both devices are identical in the labelled performance range for each device.

Comparison with the predicate Ultra Mirage FFM (K023244) CO2 washout performance testing of the AirSoft F15 demonstrates that it is substantially equivalent to the predicate Ultra Mirage FFM (K023244).

Non-Clinical test data

Extensive testing was performed pre and post cleaning or disinfection of the AirSoft F15 mask to demonstrate that the new device is substantially equivalent to the predicate Quattro Air (K123979) when used in accordance with the supplied instructions for use.

Pressure-flow characteristics and through impedance of the new mask were tested for comparison to the predicate devices and the relevant published data to ensure clinicians are able to prescribe the appropriate therapy when using the new device.

The CO2 performance (physical and functional dead space) of the new device was also tested and demonstrated substantially equivalent to the predicates. This ensures the new mask design provides adequate venting to flush out the expired CO2.

As was the case with the predicates, the AirSoft F15 materials not previously cleared by FDA were subject to appropriate biocompatibility evaluations according to ISO 10993-1. Materials used the construction of components that:

- contact the heated humidified gas pathway have been . classified as permanent "external communicating devices" (with tissue/bone/dentin)
- contact the patient during the therapy have been classified as permanent "skin contact"

As relevant and to support the biocompatibility evaluation of each mask component, following biological effects (selected in accordance with FDA guidance #G95-1) were assessed:

10th September, 2013

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RESMED

- . Genotoxicity (ISO 10993-3) Cytotoxicity (ISO 10993-5) . Implantation (ISO 10993-6) . Sensitization (ISO 10993-10) . Irritation (ISO 10993-10) . Mechanical integrity and performance of the new device was tested to simulated normal use and reasonable abuse scenarios. The device was also tested to demonstrate that it can withstand the effects of storage temperature, humidity and transportation shock & vibration. Validation of cleaning and reuse was completed to establish that the device can be reused by a single patient (at home), or by several patients in the hospital/institutional environment. Following validated disinfection protocols and after the number of cycles indicated in the published data for the AirSoft F15 mask, it was confirmed that the device continued to function as intended. The device was shown to be substantial equivalent to the predicate devices. Clinical Data Use of Full Face masks with CPAP or Bilevel therapy equipment is proven technology and is well accepted by the medical community. So was the case for the predicate devices, bench testing was sufficient to demonstrate substantial equivalence to the predicate devices. The new AirSoft F15 Mask System is substantially equivalent to the Substantial Equivalence Conclusion nominated predicate devices: it has the same intended use; .
- it has similar technological and performance characteristics to . the predicates.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human services, featuring three curved lines or shapes.

#### Public Health Service

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

June 9, 2014

ResMed Ltd. c/o Jim Cassi Vice President-Quality Assurance Americas ResMed Corp. 9001 Spectrum Center Boulevard San Diego CA 92123

Re: K132901

Trade/Device Name: AirSoft F15 Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: June 4th, 2014 Received: June 4th, 2014

Dear Mr. Cassi:

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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Page 2 - Mr. Cassi

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 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

Sincerely yours,

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

Image /page/5/Figure/7 description: The image shows the FDA logo with the text "Tejashri Purohit-Sheth, M.D." written on both sides of the logo. The text on the right side of the logo also includes "Clinical Deputy Director DAGRID/ODE/CDRH FOR". The logo is made up of three letters, F, D, and A, with the letters being stylized and interconnected.

Erin I. Keith, M.S. 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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AirSoft F15 Traditional 510(k)

# Indication for Use

510(k) Number (if known): K132901 Device Name: AirSoft F15 Indication for Use

The AirSoft F15 is a noninvasive accessory used for channeling airflow (with or without supplemental oxygen) to a patient from a positive airway pressure (PAP) device such as continuous positive alrway pressure (CPAP) or bilevel system.

## The AlrSoft F15 is:

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

| Prescription Use | X |
|-----------------------------|--------|
| (Part 21 CFR 801 Subpart D) | |
| | AND/OR |
| Over-The-Counter Use | |
| (Part 21 CFR 807 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

## Concurrence of CDRH; Office of Device Evaluation (ODE)

Page 1 of_ 1

Image /page/6/Picture/11 description: The image shows a logo with the letters FDA. The letters are stylized with a triple-line effect, giving them a bold and somewhat retro appearance. The logo is in black and white, with the letters standing out against the background.

Anya C. Harry -S 2014.06.05 11:02:46 -04'00'

10" September 2013

510(k) Page# 15