MIRAGE ECHO

K090490 · Resmed Corp · BZD · May 6, 2009 · Anesthesiology

Device Facts

• Record ID: K090490
• Device Name: MIRAGE ECHO
• Applicant: Resmed Corp
• Product Code: BZD · Anesthesiology
• Decision Date: May 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mirage Echo 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 Echo 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

Mirage Echo is a vented nasal mask interface for noninvasive delivery of positive airway pressure (PAP) from CPAP or bilevel systems. Device consists of a silicone interface, molded plastic components, and adjustable headgear. Used in home or hospital environments by patients prescribed PAP therapy. Mask connects to standard air delivery hoses via ISO 5356-1:2004 conical connectors. Integrated vent holes provide continuous air leak to flush CO2. Healthcare providers use the mask to facilitate prescribed therapy; patient benefits from noninvasive airway support. Device is prescription-only and supplied non-sterile.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and efficacy demonstrated through comparative bench testing of pressure-flow characteristics, flow impedance, and CO2 performance against predicate devices.

Technological Characteristics

Vented nasal mask. Materials: molded plastic and silicone (biocompatible per ISO 10993-1). Interface: silicone seal. Connectivity: standard conical connectors (ISO 5356-1:2004). Energy source: none (passive interface). Sterilization: supplied non-sterile. Design includes vent holes for CO2 flushing.

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

• Mirage Micro (K071808, K072940, K081321)
• Ultra Mirage II Mask (K050359)

Submission Summary (Full Text)

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K090490

Mirage Echo Traditional 510k

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| | <b>510(k) SUMMARY</b> [As required by 21 CFR 807.92(c)] | |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Date Prepared | February 20th, 2009 | |
| Official Contact | Mr. Steven Lubke,<br>Director, Regulatory Affairs | MAY - 6 2009 |
| Device Trade Name | Mirage™ Echo | |
| 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 | Mirage Micro (K071808, K072940, K081321)<br>Ultra Mirage II Mask (K050359) | |
| Description | The Mirage Echo 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. | |
| | Mirage Echo is safe when used under the conditions and<br>purposes intended as indicated in the labeling provided with the<br>product | |
| | Mirage Echo is a prescription device supplied non-sterile. | |
| Intended Use | The Mirage Echo channels airflow noninvasively to a patient<br>from a positive airway pressure (PAP) device such as a<br>continuous positive airway pressure (CPAP) or bilevel system.<br>The Mirage Echo 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 Mirage Micro<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 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 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 masks are constructed using molded plastic and silicone | |
| February 20, 2009 | | 19 |

February 20, 2009

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RESMED Mirage Echo Traditional 510k components and fabric / nylon headgear. All the 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 ResMed flow generator settings. The pressureflow 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 Mirage ECHO and the Mirage Micro 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. Use of vented nasal masks with CPAP or Bilevel therapy is Clinical Data proven technology and is well accepted by the medical community. Bench testing is sufficient to demonstrate safety and efficacy of the Mirage ECHO, as was the case with the predicate device. Comparison with predicate Ultra Mirage II Performance Data The CO2 performance of the new device and the predicate device are substantially equivalent. Substantial Equivalence Mirage Echo is substantially equivalent to the predicate Conclusion devices: it has the same intended use; it has similar technological characteristics to both .

predicates;

- it does not raise new questions of safety and effectiveness;
- it is at least as safe and effective as the predicate devices Mirage Micro and Ultra Mirage 11

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.

MAY - 6 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David D'Cruz Vice President, Clinical & Regulatory Affairs Resmed Corporation 14040 Danielson Street Poway, California 92064-6857

Re: K090490 Trade/Device Name: Mirage™ Echo Regulation Number: 868.5905 Regulatory Class: II Product Code: BZD Dated: February 20, 2009 Received: February 25, 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. 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.

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### Page 2- D'Cruz

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,

Svantner

Susan Runner, D.D.S., M.A. 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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## RESMED

Mirage Echo Traditional 510k

#### Indication for Use

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510(k) Number (if known):

Mirage™ Echo

Device Name: Indication for Use

The Mirage Echo 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 Echo 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<br>(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use<br>(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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| February 20, 2009 | 17 |
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| | (Division Sign-Off) |
| | Division of Anesthesiology, General Hospital<br>Infection Control, Dental Devices |
| 510(k) Number: | k090990 |