MIRAGE FX

K102746 · Resmed, Ltd. · BZD · Dec 28, 2010 · Anesthesiology

Device Facts

• Record ID: K102746
• Device Name: MIRAGE FX
• Applicant: Resmed, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Dec 28, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Mirage 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 Mirage FX is: to be used by patients (> 66 lb/30 kg) for whom positive airway pressure has been prescribed . intended for single-patient reuse in the home environment . and multi-patient reuse in the hospital/institutional environment.

Device Story

Mirage FX is a vented nasal mask interface for noninvasive delivery of positive airway pressure (PAP) from CPAP or bilevel systems. Device channels airflow to patient's nose; held in place by adjustable headgear. Connects to standard air delivery hoses via ISO 5356-1:2004 conical connectors. Features integrated vent holes to flush CO2. Used in home (single-patient) or hospital/institutional (multi-patient) settings. Operated by patients or healthcare providers. Provides a seal via silicone interface to ensure effective therapy delivery. Benefits include noninvasive respiratory support for patients requiring PAP therapy.

Clinical Evidence

No clinical data. Safety and efficacy demonstrated via bench testing, including pressure-flow characteristics, flow impedance, and CO2 performance, compared against predicate devices. Vented nasal mask technology is well-established and accepted in the medical community.

Technological Characteristics

Materials: molded plastic, silicone, fabric/nylon (ISO 10993-1 compliant). Interface: silicone mask with adjustable headgear. Connectivity: standard conical connectors (ISO 5356-1:2004). Features: integrated vent holes for CO2 flushing. Non-sterile, reusable.

Indications for Use

Indicated for 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

• Mirage Micro Nasal Mask (K072940)
• Ultra Mirage II Nasal Mask (K050359)
• ComfortLite 2 (K082558)

Submission Summary (Full Text)

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## RESMED

K102746

Mirage FX Traditional 510k

## 510(k) SUMMARY [As required by 21 CFR 807.92(c)] Sept 17", 2010 Date Prepared DEC 2 8 2010 Submitter Mr. Kim Kuan Lee Official Contact Mr. David D'Cruz, V.P., US Medical & Regulatory Affairs 9001 Spectrum Center Blvd San Diego CA 92123 USA Tel: [phone] Mirage™ FX Device Trade Name Device Common Name/ Vented Nasal Mask; Classification Name Accessory to Noncontinuous Ventilator (IPPB) 21 CFR 868.5905, 73 BZD (Class II) Classification Predicate Devices Mirage Micro Nasal Mask (K072940) Ultra Mirage II Nasal Mask (K050359) ComfortLite 2 (K082558) Description The Mirage FX provides an interface such that airflow from a positive pressure source is directed to the patient's nose. The mask is held in place with adjustable headgear that straps the mask to the face. Mirage FX is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product. Mirage FX is a prescription device supplied non-sterile. Intended Use Comparison with predicate ComfortLite 2 The Mirage 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 Mirage FX is: to be used by patients (> 66 lb/30 kg) for whom positive ● airway pressure has been prescribed intended for single-patient reuse in the home environment . and multi-patient reuse in the hospital/institutional environment. The new device and the predicate mask have identical intended uses. Both devices are indicated for the same user population. Technological & non Comparison with predicate Mirage Micro clinical performance The new device and the predicate mask provide a seal via characteristics silicone interface. Both the new and predicate masks are offered in various sizes to ensure adequate fit over the extended patient population. Both masks incorporate vent holes to provide continuous air leak to flush out and minimize the amount of CO2 rebreathed

17 September, 2009

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## RESMED

| | by 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 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 new and predicate devices are constructed using<br>molded plastic and silicone components and fabric / nylon<br>headgear. Components of the new and predicate masks masks<br>are fabricated using materials deemed safe. (ref: ISO 10993-1). |
| | The pressure-flow characteristics and flow impedance of the<br>new devices was bench tested and demonstrated to be<br>substantially equivalent to the predicate device. |
| | Both the new and the predicate devices can be reused in the<br>home and hospital / institution environment. |
| | The main differences between Mirage FX and the predicate<br>Mirage Micro is in the number of components, their<br>design/geometry and how individual components interface with<br>each other. Both masks are designed and constructed under<br>ResMed's 21 CFR Part 820 compliant Quality Management<br>System. |
| Non clinical performance<br>Data | Comparison with predicate Ultra Mirage II<br>The CO2 performance of the Mirage FX has been demonstrated<br>through bench testing to be substantially equivalent to the Ultra<br>Mirage II. |
| 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<br>and efficacy of the Mirage FX, as was the case with the<br>predicate devices. |
| Substantial Equivalence<br>Conclusion | Mirage FX is substantially equivalent to the predicate devices:<br>- it has the same, intended use and is indicated for the same<br>user population;<br>- it has similar technological characteristics to the predicates;<br>- it does not raise new questions of safety and effectiveness;<br>- it is at least as safe and effective as the predicate devices. |

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Image /page/2/Picture/1 description: The image shows the 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 entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

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

Mr. David D'Cruz V.P. US Medical & Regulatory Affairs ResMed, Limited 9001 Spectrum Center Boulevard San Diego, California 92123

DEC 2 8 2010

Re: K102746

Trade/Device Name: Mirage™ FX Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BDZ Dated: December 20, 2010 Received: December 22, 2010

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 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. D'Cruz

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

Sincerely yours,

for

Anthony Watson, B.S., M.S., M.B.A. 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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Mirage FX Traditional 510k

## Indication for Use

510(k) Number (if known): Mirage™ FX Device Name: Indication for Use

DEC 2 8 2010

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

The Mirage FX is:

- to be used by 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.

Over-The-Counter Use_ AND/OR Prescription Use X (Part 21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (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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17 September, 2010

ing J. D'Souza

Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control and Dental Devicgs
\$10(k) Number: K102746

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