SWIFT FX

K090244 · Resmed, Ltd. · BZD · Apr 13, 2009 · Anesthesiology

Device Facts

• Record ID: K090244
• Device Name: SWIFT FX
• Applicant: Resmed, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Apr 13, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Swift FX channels airflow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel system. The Swift FX is: to be used by adult patients (> 66 lb/30 kg) for whom positive airway pressure has been prescribed intended for single-patient re-use in the home environment and multipatient re-use in the hospital/institutional environment.

Device Story

Swift FX is a vented nasal mask interface for delivery of positive airway pressure (PAP) therapy; channels airflow from CPAP or bilevel systems to patient's nose. Device consists of silicone interface, molded plastic components, and fabric/nylon headgear; held in place by adjustable headgear. Features integrated vent holes to flush CO2. Connects to standard air delivery hoses via ISO 5356-1:2004 conical connectors. Used in home or hospital/institutional environments; operated by patient or healthcare provider. Provides noninvasive interface for PAP therapy; helps maintain airway pressure for prescribed treatment. Substantially equivalent to predicate masks in pressure-flow characteristics and flow impedance.

Clinical Evidence

Bench testing only. No clinical data provided. Vented nasal mask technology is well-accepted; bench testing demonstrated safety and efficacy equivalent to predicate devices.

Technological Characteristics

Materials: molded plastic, silicone, fabric/nylon headgear (ISO 10993-1 compliant). Interface: silicone nasal mask with vent holes for CO2 flushing. Connectivity: standard conical connectors (ISO 5356-1:2004) for air delivery hose. Operation: passive, non-powered, non-electronic. Sterilization: supplied nonsterile.

Indications for Use

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

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

• Swift LT (K073638)
• Ultra Mirage II Mask (K050359)

Submission Summary (Full Text)

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RESMED

| | <b>510(k) SUMMARY</b><br>[As required by 21 CFR 807.92(c)] |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | January 30th, 2009 |
| Official Contact | Mr. Steven Lubke,<br>Regulatory Affairs Director APR 13 2009 |
| Device Trade Name | Swift™ FX |
| Device Common Name/<br>Classification Name | Vented Nasal Mask;<br>Accessory to Noncontinuous Ventilator (IPPB) |
| Classification | 21 CFR 868.5905, 73 BZD (Class II) |
| Predicate Devices | Swift LT (K073638)<br>Ultra Mirage II Mask (K050359) |
| Description | The Swift FX provides an interface such that airflow from a<br>positive pressure source is directed to the patient's nose. The<br>mask is held in place with adjustable headgear that straps the<br>mask to the face. |
| | Swift FX is safe when used under the conditions and purposes<br>intended as indicated in the labeling provided with the product. |
| | Swift FX is a prescription device supplied nonsterile. |
| Intended Use | The Swift FX channels airflow noninvasively to a patient from a<br>positive airway pressure (PAP) device such as a continuous<br>positive airway pressure (CPAP) or bilevel system.<br>The Swift FX is:<br>to be used by adult patients (> 66 lb/30 kg) for whom<br>positive airway pressure has been prescribed<br>intended for single-patient re-use in the home environment<br>and multipatient re-use in the hospital/institutional<br>environment. |
| Technological<br>Characteristics<br>comparison | Comparison with predicate Swift LT<br>The new device and the predicate mask, provide a seal via<br>silicone interface. Both masks are offered in various sizes to<br>ensure adequate fit over the extended patient population. |
| | Both the masks incorporate vent holes to provide continuous air<br>leak to flush out and minimize the amount of CO2 rebreathed by<br>the patient. The design of the mask components is such that<br>the incorporation of these vent-holes does not interfere with the<br>intended performance of the masks. |
| | Both the masks connect to a conventional air delivery hose<br>between the mask and the positive airway-pressure source via<br>standard conical connectors (ref: ISO 5356-1:2004) |
| | Both the masks are constructed using molded plastic and<br>silicone components and fabric / nylon headgear. All the |

January 30, 2009

18

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components of both the masks are fabricated using materials deemed safe. (ref: ISO 10993-1).

Both the new device and the predicate are designed to operate on the same Mirage or Swift ResMed flow generator settings. The pressure-flow characteristics and flow impedance of both the new device and the predicate device are substantially equivalent.

Both the new device and the predicate device can be reused in the home and hospital / institution environment.

The main differences between Swift FX and Swift LT is in the number of components, their design/geometry and how individual components interface with each other. Both masks are designed and constructed under ResMed's 21 CFR Part 820 compliant Quality Management System.

Clinical Data Use of vented nasal masks with CPAP or Bilevel therapy is proven technology and is well accepted by the medical community. Bench testing is sufficient to demonstrate safety and efficacy of the Swift FX, as was the case with the predicate device.

| Performance Data | Comparison with predicate Ultra Mirage II<br>The CO2 performance of the new device and the predicate<br>device are substantially equivalent. | |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Substantial Equivalence<br>Conclusion | Swift FX is substantially equivalent to the predicate devices:<br>- it has the same intended use;<br>- it has similar technological characteristics to both<br>predicates;<br>- it does not raise new questions of safety and<br>effectiveness; | |

- it is at least as safe and effective as the predicate devices Swift LT and Ultra Mirage II

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 1 3 2009

ResMed Limited C/o Mr. David D'Cruz Resmed Corporation 14040 Danielson Street Poway, California 92064-6857

Re: K090244

Trade/Device Name: Swift™ FX Regulation Number: 21 CFR 868.5905 Regulatory Class: II Product Code: BZD Dated: January 30, 2009 Received: February 2, 2009

Dear Mr. D'Cruz:

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 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.

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Page 2- Mr. D'Cruz

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Suom Remm

Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

## Enclosure

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## Indication for Use

510(k) Number (if known):

Swift™ FX

Indication for Use

Device Name:

The Swift FX channels airflow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel system.

The Swift FX is:

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

Prescription Use **X** AND/OR Over-The-Counter Use

(Part 21 CFR 801 Subpart D) (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) | |
|--------------------------------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital Infection Control, Dental Devices | |
| 510(k) Number: | K090244 |
| Page | 1 of 1 |