MIRAGE VISTA MASK

K031047 · Resmed, Ltd. · BZD · Aug 19, 2003 · Anesthesiology

Device Facts

• Record ID: K031047
• Device Name: MIRAGE VISTA MASK
• Applicant: Resmed, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Aug 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Mirage Vista™ Mask is a nasal mask accessory for non-continuous ventilators (CPAP/bi-level flow generators). Device straps to patient face, covering nose; connects via tubing to flow generator to deliver positive pressure ventilation. Designed for adult patients in hospital, clinical, or home environments. Features unobtrusive frame allowing field of vision and use of glasses. One frame size with two cushion options (standard/deep). Multiple-patient use design. Healthcare providers use device to facilitate prescribed respiratory therapy; patient benefits from non-invasive pressure delivery.

Clinical Evidence

Bench testing only. Evaluated pressure-flow characteristics, functional dead space (CO2 re-breathing), and flow impedance. Device validated for multiple-patient use. Materials are either predicate-cleared or compliant with ISO 10993 standards.

Technological Characteristics

Nasal mask with frame and cushion. Materials compliant with ISO 10993 or predicate-cleared. Non-invasive interface for positive pressure ventilation. Single frame size, two cushion sizes (standard/deep).

Indications for Use

Indicated for adult patients prescribed CPAP or bi-level therapy requiring non-continuous ventilation via a nasal mask in hospital, clinical, 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

• Modular Nasal Mask (K961783)

Submission Summary (Full Text)

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#### 510(K) SUMMARY 3

# 510(k) SUMMARY-Mirage Vista™ Mask

| Submitter Name: | ResMed Corp. |
|---------------------------------------------|----------------------------------------------------|
| Submitter Address: | 14040 Danielson Street, Poway CA 92064-6857<br>USA |
| Contact Person: | Roger Kotter, QA&RA Director |
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| Date Prepared: | March 28, 2003 |
| Device Trade Name: | Mirage Vista™ Mask |
| Device Common Name/<br>Classification Name: | Nasal Mask |
| Predicate Devices: | Modular Nasal Mask K961783 |

## Device Description:

The Mirage Vista™ mask has an unobtrusive design, which increases the patient's field of vision and allows wearing of glasses whilst the mask is in use. The new design reduces the perceived size and weight of the mask when compared to the predicate mask.

### Intended Use:

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

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

The Mirage Vista™ 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 manner.

Mirage Vista™ mask comes in one frame size and two cushion sizes (standard and deep).

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| Sponsor: | Mirage Vista™ Mask |
|------------|-------------------------------------------|
| ResMed Ltd | Traditional 510(k) Premarket Notification |

The Mirage Vista™ mask is substantially equivalent to the Modular mask. The two masks have the same intended use except reuse (the Mirage Vista™ mask is a multiple-patient use mask, whereas the Modular mask is a single-patient use mask); the same operating principle; the same technological characteristics; and the same type of manufacturing process.

## Performance Data:

The Mirage Vista™ mask was tested to determine the pressure-flow characteristic, functional dead space (CO2 re-breathing) and flow impedance. The results of the performance data show that the mask is substantially equivalent to the predicate mask. In addition, the Mirage Vista mask was validated for multiple-patient use.

The materials used for the mask components, which contact the skin and/or the air-path, are either predicate materials (i.e., cleared previously for the same intended use), or are compliant with the ISO 10993 standards.

## Conclusion:

The Mirage Vista™ mask is substantially equivalent to the Modular mask.

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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 of America. The seal is circular and features the department's name around the perimeter. In the center of the seal is an emblem that resembles a stylized caduceus or a symbol representing health and medicine.

Public Health Service

AUG 1 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ResMed Limited C/O Mr. Roger Kotter Quality Assurance & Regulatory Affairs Director ResMed Corporation 14040 Danielson Street Poway, CA 92064-6857

Re: K031047

Trade/Device Name: Mirage Vista™ Mask Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: March 28, 2003 Received: April 2, 2003

Dear Mr. Kotter:

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. Kotter

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 (OS) 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 Russe

Susan Runner, DDS, MA Interim 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 4

510(k) Number (if known):

KO31047

Device Name:

Mirage Vista™ Mask

Indications for Use:

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

signature

ion Sign-Off) on of Anesthesiology, General Hospital, fection Control Der

510(k) Number

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Concurrence of CDRH; Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)