SWIFT FX NANO

K123789 · Resmed, Ltd. · BZD · Mar 29, 2013 · Anesthesiology

Device Facts

• Record ID: K123789
• Device Name: SWIFT FX NANO
• Applicant: Resmed, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Mar 29, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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

Device Story

Swift FX Nano is a vented nasal mask interface for positive airway pressure therapy (CPAP/bilevel). It channels airflow from a pressure source to the patient's nose via a silicone cushion interface and adjustable headgear. Used in home or hospital settings by patients prescribed respiratory support. Connects to standard air delivery hoses via conical connectors. Incorporates vent holes to flush CO2. Healthcare providers use the mask to deliver prescribed therapy; the device benefits patients by providing a noninvasive seal for airway pressure delivery. Design includes molded plastic, silicone, and fabric/nylon components.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and efficacy were demonstrated through bench testing, including CO2 performance, flow impedance, and biocompatibility testing (ISO 10993-3, -5, -6, -10).

Technological Characteristics

Vented nasal mask; silicone cushion interface; molded plastic and fabric/nylon headgear. Connects via standard conical connectors. Biocompatibility per ISO 10993-1. Risk management per ISO 14971:2007. Pressure-flow characteristics and flow impedance identical to predicate devices.

Indications for Use

Indicated for patients >66 lbs (30 kg) prescribed positive airway pressure therapy via CPAP or bilevel systems. Suitable for single-patient home use or multi-patient 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

• Swift FX (K090244)
• Mirage FX (K102746)
• Ultra Mirage II (K050359)

Submission Summary (Full Text)

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K123789

Swift FX Nano Traditional 510(k)

| 510(k) SUMMARY<br>[As required by 21 CFR 807.92(c)] | | MAR 2 9 |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Date Prepared | March 28th, 2013 | |
| Submitter Name | Mr. Kim Kuan LEE | |
| 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] | |
| Device Trade Name | Swift™ FX Nano | |
| 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 FX (K090244)<br>Mirage FX (K102746)<br>Ultra Mirage II (K050359) | |
| Description | The Swift FX Nano 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.<br><br>Swift FX Nano is safe when used under the conditions and<br>purposes intended as indicated in the labeling provided with the<br>product.<br><br>Swift FX Nano is a prescription device supplied non-sterile. | |
| Intended Use | The Swift FX Nano channels airflow noninvasively to a patient<br>from a positive airway pressure device such as a continuous<br>positive airway pressure (CPAP) or bilevel device.<br>The Swift FX Nano is:<br>to be used by patients (> 66 lbs / 30 kg) for whom positive<br>airway pressure has been prescribedintended 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 FX<br>The new device and the predicate mask, provide a seal via<br>silicone interface. The new device design incorporates a cushion<br>that seals around the patient's nose whereas the predicate Swift<br>FX design comprises pillows that seal under the nasal nares. Both<br>masks are offered in various sizes to ensure adequate fit over the<br>extended patient population.<br><br>Both masks incorporate vent holes to provide continuous air leak<br>to flush out and minimize the amount of CO2 re-breathed by the | |
| Technological<br>Characteristics<br>comparison | Comparison with predicate Mirage FX<br>The new device and the predicate Mirage FX mask provide a seal<br>via a silicone interface that covers over and around the patient's<br>nose. Both the new and predicate masks are offered in various<br>cushion sizes to ensure adequate fit over the extended patient<br>population. | |
| Performance Data | Comparison with predicate Ultra Mirage II<br>The CO2 performance of the new device and the predicate device<br>are substantially equivalent. | |
| Clinical Data | Use of vented nasal masks with CPAP or Bilevel therapy is<br>proven technology and is well accepted by the medical<br>community. Bench testing is sufficient to demonstrate safety and<br>efficacy of the new Swift FX Nano, as was the case with the<br>predicate devices. | |

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RESMED

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patient. The design of the mask components is such that the incorporation of these vent-holes does not interfere with the intended performance of the masks.

Both masks connect to a conventional air delivery hose between the mask and the positive airway-pressure source via standard conical connectors.

Both masks are constructed using molded plastic and silicone components and fabric / nylon headgear. All the components of both masks are fabricated using materials deemed safe. (ref: ISO 10993-1).

Materials that contact the heated humidified gas pathway are considered to be external communication permanent duration (tissue/bone/dentin). The biological tests for warm wet air path application, in accordance with FDA Guidance #G95-1 were:

- ISO 10993-3 Genotoxicity, .
- ISO 10993-5 Cytotoxicity, .
- ISO 10993-6 Implantation and .
- ISO 10993-10 Sensitisation and Irritation. .

The biological tests for materials considered to have permanent skin contact, in accordance with FDA Guidance #G95-1, were:

- ISO 10993-5 Cytotoxicity .
- ISO 10993-10 Sensitisation and Irritation .

In addition, development of the Swift FX Nano device complies with ISO 14971:2007, Medical devices - Application of risk management to medical devices.

Both the new mask and the predicate device are designed to operate on the same Pillows, Mirage or Swift ResMed flow generator settings. The pressure-flow characteristics and flow impedance of both devices are identical.

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

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## Substantial Equivalence Conclusion

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- The new Swift FX Nano is as safe and effective as the predicate devices:
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- it has the same intended use; י
- it has identical technological characteristics to the predicate devices;
- the new device did not raise any new questions of safety or effectiveness;
- it is at least as safe and effective as the predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

March 29, 2013

ResMed Limited C/O Mr. Jim Cassi Vice President Quality Assurance Americas 9001 Spectrum Center Boulevard SAN DIEGO CA 92123

Re: K123789

Trade/Device Name: Swift™ FX Nano Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: February 22, 2013 Received: February 25, 2013

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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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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kwame O. Ulmer -S for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Enclosure

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Indication for Use

1023789 510(k) Number (if known): Swift™ FX Nano Device Name: Indication for Use

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

The Swift FX Nano is:

- to be used by patients (>66lb / >30kg) 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 (Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use (Part 21 CFR 807 Subpart C) |
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH; Office of Device Evaluation (ODE) |
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| 6th Dec, 2012 | Albert E. Moyal (for LS) 17 |
| | (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices |
| 510(k) Number: | K123789 |