MIRAGE ACTIVA MASK

K032916 · Resmed, Ltd. · BZD · Dec 4, 2003 · Anesthesiology

Device Facts

• Record ID: K032916
• Device Name: MIRAGE ACTIVA MASK
• Applicant: Resmed, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Dec 4, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mirage Activa™ mask is an accessory to a non-continuous ventilator (respirator), intended for multiple-patient use for adult patients prescribed continuous positive airway pressure (CPAP) or bi-level therapy in hospital, clinic, and home environments.

Device Story

Mirage Activa™ is a nasal mask interface for CPAP or bi-level ventilators; features dual cushion design with built-in bellows. Device straps to patient face, covering nose; connects via tubing to flow generator to deliver non-invasive positive pressure ventilation. Designed for multiple-patient, multiple-use in clinical and home environments. Healthcare providers use the mask to facilitate respiratory therapy; infection control protocols (disinfection guide) enable safe multi-patient reuse. Benefits include effective delivery of prescribed airway pressure therapy.

Clinical Evidence

No clinical data. Bench testing only. Validation of multiple-patient use protocols performed following AAMI TIR No. 12-1994 guidance, comparing infection control procedures against predicate Full Face Mask Series 2 devices.

Technological Characteristics

Nasal mask with dual cushion design and built-in bellows. Available in one frame size and three cushion sizes (standard, large, shallow). Connects to CPAP/bi-level flow generators. Multiple-patient use enabled via validated disinfection procedures.

Indications for Use

Indicated for adult patients prescribed CPAP or bi-level therapy requiring non-invasive positive pressure ventilation via a nasal mask in hospital, clinic, or home settings.

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 ACTIVA™ MASK (K030798)
• MIRAGE FULL FACE SERIES 2 (K023244)
• MIRAGE FULL FACE SERIES 2 (K023306)

Reference Devices

• MIRAGE FULL FACE SERIES 2 (K023284)
• MODULAR Mask (K961783)

Submission Summary (Full Text)

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#### Sponsor: ResMed Ltd

#### 510(K) SUMMARY 3

# 510(k) SUMMARY-Mirage Activa™ Mask

| Submitter Name: | ResMed Corp. |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 14040 Danielson Street, Poway CA 92064-6857<br>USA |
| Contact Person: | David D'Cruz, VP US Clinical & Regulatory Affairs |
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| Date Prepared: | September 15, 2003 |
| Device Trade Name: | Mirage Activa™ Mask |
| Device Common Name/<br>Classification Name: | Nasal Mask |
| Predicate Devices: | K030798 MIRAGE ACTIVA™ MASK (single-patient multiple use)<br>K023244 MIRAGE FULL FACE SERIES 2 (Cidex Plus, Cidex OPA)<br>K023306 MIRAGE FULL FACE SERIES 2 (Sterrad) |

## Device Description:

Mirage Activa™ is a respiratory nasal mask using a dual cushion design with built-in bellows. It is a multiple-patient, multiple-use interface accessory for use with CPAP or bi-level devices.

K023284 MIRAGE FULL FACE SERIES 2 (High Level Thermal) K961783 MODULAR Mask (cleared as part of the VPAP 2 system)

## Intended Use:

The Mirage Activa™ mask is an accessory to a non-continuous ventilator (respirator), intended for multiple-patient use for adult patients prescribed continuous positive airway pressure (CPAP) or bi-level therapy in hospital, clinic, and home environments.

# Device Technological Characteristics and Comparison to Predicate Device(s):

The Mirage Activa™ mask is strapped to the patient's face covering the nose, and connected via tubing to a CPAP or bi-level flow generator. Positive pressure ventilation is thus applied to the lungs in a non-invasive way.

The Mirage Activa™ mask comes in one frame size and three cushion sizes (standard, large and shallow).

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FDA cleared the Mirage Activa™ mask as a single-patient, multiple-use device in K030798 IFDA Gleated the Mirage Alontal "Thank as a predicate device. Resmed is seeking for the Mirage Activa™ mask to be cleared as a multiple patient, multiple use device

#### Performance Data:

Specific protocols for validating multiple-patient use have been developed by Resmed (following the guidance of AAMI TIF No. 12-1994). These protocols have been reviewed and (rollowing the Guldated of 7 the Full Face Mask Series 2 (K023244, K023284 and K023306) and represent current state-of-the-art infection control procedures. Resmed has adopted the represent current state of the art intends to include the Disinfection Guide provided in Appendix A with the sale of Mirage Activa™ masks.

#### Conclusion:

The Mirage Activa™ mask is substantially equivalent to the previously cleared predicate masks and can be relabeled for multiple-patient, multiple-use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and two wavy lines representing its legs. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC = 4 2003

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

Re: K032916

Trade/Device Name: Mirage Activa Mask Regulation Number: 868.5905 Regulation Name: Non-continuous Ventilator Regulatory Class: II Product Code: BZD Dated: September 15, 2003 Received: September 22, 2003

Dear Mr. D'Cruz

We have reviewed your Section 510(k) premarket notification of intent to market the device
ty the state of the substantial the device is substantially equivalent (for the We have reviewed your Section 310(x) persualite is substantially equivalent (for the referenced above and have detembled the development of edicate devices marketed in
indications for use stated in the enclosure) to hegally marketed in indications for use stated in the enclosure to tegans the of the Medical Device interstate commerce prior to May 20, 1970, the cities and reservance with the provisions of
Amendments, or to devices that have been receives anoroval of a remarks Amendments, or to devices that have been results approval of approval of a prematket
the Federal Food, Drug, and Cosmetic Act (Act) that do not require subject to the eeneral the Federal Food, Drug, and Cosment Act (rec) market the device, subject to the general
approval application (PMA). You may, therefore, market the device, subject to the gen approval application (PMA). Tou may, increases provisions of the Act include
controls provisions of the Act. The general controls grovisions of the Act include controls provisions of the Act. The gential of devices, good manufacturing practice,
requirements for annual registration, listing of devices on requirements for annual rogistins misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III
ns affect of the started that the charges the Fivisting major regulations affect If your device is classified (see above) into class (spe major regulations affecting (PMA), it may be subject to such additions. Title 21, Parts 800 to 898. In the Federal your device can be found in the Code of I cachar regarations, wour 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. or the recess 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/dsma/dsmamain.html

Sincerely yours,

Susan Runore

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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# Indications for Use

510(k) Number (if known):_K032916

Device Name:_ Mirage Activa™ Mask

Indications For Use:

The Mirage Activa™ mask is an accessory to a non-continuous ventilator (respirator), intended for multiple-patient use for adult patients prescribed continuous positive airway pressure (CPAP) or bi-level therapy in hospital, clinic and home environments.

Prescription Use ___ × (Part 21 CFR 801 Subpart D)

・・

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ettutuderson

sion Sinn-Off n of Anesthesiology, General Hospital.

510(k) Number: K032916