MIRAGE MICRO

K072940 · Resmed, Ltd. · BZD · Dec 13, 2007 · Anesthesiology

Device Facts

• Record ID: K072940
• Device Name: MIRAGE MICRO
• Applicant: Resmed, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Dec 13, 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 environment and multi-patient re-use in 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 conical connectors and includes luer ports for oxygen or pressure sensing. Integrated vent holes flush CO2 to minimize rebreathing. Used in home or hospital settings; operated by patients or clinicians. Device provides a seal to direct airflow to the nose, facilitating prescribed therapy. Safety and efficacy established via bench testing comparing pressure-flow characteristics, impedance, and CO2 performance against predicate masks.

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

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. Biocompatible materials (ISO 10993-1). Non-sterile, reusable.

Indications for Use

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

• Mirage Micro Mask (K071808)
• Mirage Quattro Mask (K063122)

Submission Summary (Full Text)

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## RESMED

K072940

Mirage Micro Traditional 510k

| 510(k) SUMMARY<br>[As required by 21 CFR 807.92(c)] | | |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Date Prepared | October 15, 2007 | |
| Official Contact | Mr. David Thomson,<br>Senior Regulatory Affairs Manager | DEC 1 3 2007 |
| Device Trade Name | Mirage Micro™ | |
| 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 Mask (K071808)<br>Mirage Quattro Mask (K063122) | |
| 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><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><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><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<br>environment and multi-patient re-use in the<br>hospital/institutional environment. | |
| Technological<br>Characteristics<br>comparison | Comparison with predicate Mirage Micro<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><br>Both the masks incorporate vent holes to provide<br>continuous air leak to flush out the dead space within the | |
| | 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<br>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) | |
| | 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). | |
| | Comparison with predicate Mirage Quattro<br>Both the new device and the predicate device can be<br>reused in the hospital / institution environment. | |
| 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 | Comparison with predicate Mirage Micro | |
| | The CO2 performance of the new device and the<br>predicate device are substantially equivalent. | |
| | 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 | New Mirage Micro is substantially equivalent to the<br>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:<br>- it is at least as safe and effective as the predicate<br>devices Mirage Micro and Mirage Quattro. | |

October 15, 2007

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The seal is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.

DEC 1 3 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: K072940

Trade/Device Name: Mirage MicroTM Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: October 15, 2007 Received: October 17, 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.

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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RESMED

Mirage Micro Traditional 510k

## Indication for Use

| 510(k) Number (if known): | | |
|---------------------------|----------------|--|
| Device Name: | MIRAGE MICROTM | |
| 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 multi-patient reuse in the ﯿ hospital/institutional environment.

| Prescription Use | <b>X</b> | AND/OR | Over-The-Counter Use | |
|-----------------------------|----------|--------|-----------------------------|--|
| (Part 21 CFR 801 Subpart D) | | | (Part 21 CFR 807 Subpart C) | |

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Concurrence of CDRH; Office of Device Evaluation (ODE)
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K072940October 15, 2007