MIRAGE MICRO

K071808 · Resmed, Ltd. · BZD · Oct 10, 2007 · Anesthesiology

Device Facts

• Record ID: K071808
• Device Name: MIRAGE MICRO
• Applicant: Resmed, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Oct 10, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Mirage Micro is a vented nasal mask for non-invasive delivery of positive airway pressure (CPAP or bilevel) to adult patients. Device consists of a dual-wall silicone interface, molded plastic components, and adjustable fabric headgear. It connects to standard air delivery hoses via ISO 5356-1:2004 conical connectors. Integrated vent holes flush CO2 to minimize rebreathing; luer ports allow for oxygen and pressure sensing. Used in home and hospital settings; operated by patients or clinicians. Device channels airflow from a pressure generator to the patient's nose, maintaining a seal via the silicone interface. Output is therapeutic airflow; healthcare providers monitor patient response to therapy. Benefits include effective, non-invasive respiratory support.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and efficacy were established through bench testing of CO2 performance, pressure-flow characteristics, and flow impedance, demonstrating substantial equivalence to predicate devices.

Technological Characteristics

Dual-wall silicone interface; molded plastic components; fabric headgear. Standard conical connectors (ISO 5356-1:2004). Integrated vent holes for CO2 flushing. Luer ports for oxygen/pressure sensing. Materials compliant with ISO 10993-1. Non-sterile, prescription device.

Indications for Use

Indicated for adult patients (>66lb / >30kg) requiring positive airway pressure therapy (CPAP or bilevel) delivered non-invasively via a nasal mask.

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

• Ultra Mirage II Mask (K050359)
• Meridian Nasal Mask (K050142)

Submission Summary (Full Text)

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K071808

OCT 】0 2007

## 510(k) SUMMARY
[As required by 21 CFFR 807.92(c)]

| Date Prepared | June 27, 2007 |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Mr. David Thomson,<br>Senior Regulatory Affairs Manager |
| Device Trade Name | Mirage Micro™ |
| Device Common Name/ Classification Name | Vented Nasal Mask;<br>Accessory to Noncontinuous Ventilator (IPPB) |
| Classification | 21 CFR 868.5905, 73 BZD (Class II) |
| Predicate Devices | Ultra Mirage II Mask (K050359)<br>Meridian Nasal Mask (K050142) |
| Description | The Mirage Micro provides seal such that airflow from a<br>positive pressure source is directed to the patient's nose.<br>The mask is held in place with adjustable headgear that<br>straps the mask to the face.<br>Mirage Micro is safe when used under the conditions and<br>purposes intended as indicated in the labeling provided<br>with the product.<br>Mirage Micro is a prescription device supplied nonsterile. |
| Intended Use | The Mirage Micro channels airflow non-invasively to a<br>patient from a positive airway pressure device such as a<br>continuous positive airway pressure (CPAP) or bilevel<br>system.<br>The Mirage Micro is:<br>- to be used by adult patients (>66lb / >30kg) for whom<br>positive airway pressure has been prescribed.<br>- intended for single patient re-use in the home and the<br>hospital/institutional environment. |
| Technological Characteristics comparison | <i>Comparison with predicate Ultra Mirage II</i><br>The new device and the predicate mask, provide seal via<br>dual wall silicone interface. Both masks are offered in<br>various sizes to ensure adequate fit over the extended<br>patient population.<br>Both the masks incorporate vent holes to provide<br>continuous air leak to flush out the dead space within the<br>mask and minimize the amount of CO2 rebreathed by the<br>patient. The design of the mask components is such that<br>the incorporation of these vent holes do not interfere with |

ResMed Ltd 1 Elizabeth MacArthur Drive, Bella Vista NSW 2153 Australia Tel: [phone] ABN 30 003 765 142

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## RESMED

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the intended performance of the masks.

| Both the masks connect to conventional air delivery hose<br>between the mask and the positive airway-pressure<br>source via standard conical connectors (ref: ISO 5356-<br>1:2004) | |
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| Both the masks have provisions for connecting oxygen<br>and pressure sensing tubing via luer ports. | |
| Both the masks are constructed using molded plastic<br>components and fabric headgear. All the components of<br>both the masks are fabricated using materials deemed<br>safe. (ref: ISO 10993-1). | |
| The main differences between Micro Mirage and Ultra<br>Mirage II are in the number of components, their<br>design/geometry and how individual components interface<br>with each other. Both the masks are designed and<br>constructed under ResMed's 21 CFR Part 820 compliant<br>Quality Management System. | |
| The predicate device can be reused by multiple patients<br>in the hospital/institutional environment where as the new<br>device is labeled for single patient reuse. | |
| Clinical Data | Use of vented nasal masks with CPAP or Bilevel therapy<br>is proven technology and is well accepted by the medical<br>community. Bench testing is sufficient to demonstrate<br>safety and efficacy of the Mirage Micro, as was the case<br>with the predicate devices. |
| Performance Data | The CO2 performance the new device and the predicate<br>device are substantially equivalent.<br><i>Comparison with predicate Meridian</i><br>Both the new device and the predicate are designed to<br>operate on the same standard flow generator setting. The<br>pressure-flow characteristics and flow impedance of both<br>the new device and the predicate device are substantially<br>equivalent. |
| Substantial Equivalence<br>Conclusion | Mirage Micro is substantially equivalent to the predicate<br>devices:<br>- it has the same intended use with reduced scope<br>being for single patient reuse;<br>- it has similar technological characteristics to Ultra<br>Mirage II;<br>- it does not raise new questions of safety and<br>effectiveness;<br>- it is at least as safe and effective as the Ultra Mirage II<br>and the Meridian |

ResMed Ltd 1 Elizabeth MacArthur Drive, Bella Vista NSW 2153 Australia Tel: [phone] ABN 30 003 765 142

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OCT 1 0 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ResMed Limited C/O Mr. David D' Cruz Vice President Clinical & Regulatory Affairs ResMed Corporation 14040 Danielson Street Poway California, 92064-6857

Re: K071808

Trade/Device Name: MIRAGE MICROTM Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: September 21, 2007 Received: September 24, 2007

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Sylite H. Michin Dmd

Chiu Lin, Ph.D. 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):

Device Name:

MIRAGE MICRO™

Indication for Use

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

The Mirage Micro is: .

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

Prescription Use

AND/OR

Over-The-Counter Use

× (Part 21 CFR 801 Subpart D) Subpart C)

(Part 21 CFR 807

(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

Misi Jahlal

(Division Sign-Off) Chasion of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K071868