MIRAGE FULL FACE MASK SERIES 2

K023284 · Resmed, Ltd. · BZD · Nov 27, 2002 · Anesthesiology

Device Facts

• Record ID: K023284
• Device Name: MIRAGE FULL FACE MASK SERIES 2
• Applicant: Resmed, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Nov 27, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Mirage Full Face Mask (FFM) Series 2 is intended for multiple-patient use for adult patients prescribed continuous positive airway pressure (CPAP) and bi-level therapy in hospital, clinic, and home environments.

Device Story

Mirage FFM Series 2 is a patient interface accessory for CPAP and bi-level flow generators; covers nose and mouth to deliver non-invasive positive pressure ventilation. Used in hospital, clinic, and home settings. Features three frame sizes with two cushion options (standard/shallow) per frame; 5-point headgear connection for stability; polyurethane-based fabric headgear; luer-lock pressure ports. Designed for multiple-patient use; validated for high-level disinfection via 3.4% glutaraldehyde, 0.08% peroxyacetic acid/1% hydrogen peroxide, or thermal pasteurization (hot water). Valve membrane and air tubing are single-patient use and must be replaced between patients. Healthcare providers assemble/disassemble mask for cleaning/disinfection; patients wear mask during therapy to treat respiratory conditions requiring positive pressure.

Clinical Evidence

Bench testing only. Validation performed for multiple-patient use across 15 cycles of high-level disinfection using three methods: 3.4% glutaraldehyde, 0.08% peroxyacetic acid/1% hydrogen peroxide, and thermal pasteurization (hot water).

Technological Characteristics

Respiratory mask; frame sizes (S, M, L); cushion sizes (standard, shallow). Materials: polyurethane-based fabric headgear; air-path materials identical to predicate. Connectivity: connects via tubing to CPAP/bi-level flow generators. Disinfection: chemical (glutaraldehyde, peroxyacetic acid/hydrogen peroxide) and thermal (hot water pasteurization).

Indications for Use

Indicated for adult patients prescribed CPAP or bi-level therapy requiring a respiratory mask covering the nose and mouth for non-invasive positive pressure ventilation.

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 Full Face Mask (FFM) (K982530)
• Mirage Nasal Mask System (K984428)

Submission Summary (Full Text)

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K023284

### PREMARKET NOTIFICATION

## 510(k) SUMMARY

## [As required by 21 CFR 807.92(c)]

| Submitter Name: | ResMed Ltd |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 97 Waterloo Road, North Ryde NSW 2113, Australia |
| Contact Person: | Roger Kotter |
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| Date Prepared: | September 2002 |
| Device Trade Name: | Mirage Full Face Mask (FFM) Series 2 |
| Device Common Name/<br>Classification Name: | Face mask |
| Predicate devices: | Mirage Full Face Mask (FFM) K982530<br>Mirage Nasal Mask System K984428 |
| Device Description: | Mirage FFM Series 2 is a respiratory mask covering the nose<br>and the mouth. It is a patient interface accessory for use with<br>CPAP and bi-level devices. |
| Intended Use: | Mirage Full Face Mask (FFM) Series 2 is intended for multiple-<br>patient use for adult patients prescribed continuous positive<br>airway pressure (CPAP) and bi-level therapy in hospital, clinic,<br>and home environments. |

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

The Mirage FFM Series 2 is strapped to the patient's face covering the nose and the mouth, 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 FFM Series 2 comes in three frame sizes (small, medium, large), and two cushion sizes (standard and shallow) for each frame size.

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The Mirage FFM Series 2 is substantially equivalent to the Mirage FFM. The two masks have the same intended use. Below is a summary of the similarities and differences in design between the Mirage FFM Series 2 and Mirage FFM:

- The components of Mirage FFM Series 2 are made of the same materials as those of ● Mirage FFM, with the exception of the headgear and the ports caps.
- The headgear of Mirage FFM Series 2 is made of a Polyurethane-based fabric. The . Polyurethane-based fabric is more comfortable, allowing the skin to breathe whilst the headgear is worn.
- . Mirage FFM Series 2 has a 5-points headgear connection, whereas Mirage FFM has a 4-points connection headgear. The additional attachment point for the head strap provides enhanced stability.
- Mirage FFM Series 2 has pressure port luer-lock fittings, whereas Miraqe FFM has . pressure port plugs. The luer-lock fittings provide improved connection. The ports caps material has been changed.
- . Mirage FFM Series 2 has two cushion sizes per frame size (standard and shallow). whereas Mirage FFM has only one cushion size per frame size (standard).
- The shape of the elbow retainer was slightly changed in Mirage FFM Series 2 to . enable a more user-friendly assembly and disassembly.
- Mirage FFM has been validated for high-level disinfection using the following liquid . chemical disinfectants: 3.4% glutaraldehyde solution (e.g. Cidex Plus made by ASP); and 0.08% peroxyacetic acid and 1% hvdrogen peroxide (e.g. Cidex PA made by ASP). Mirage FFM Series 2 has been validated for these two liquid chemicals, and in addition, for high-level thermal disinfection (hot water pasteurisation).

#### Performance Data:

The Miraqe FFM Series 2 was validated for multiple-patient use, with the following high-level disinfection methods:

- . Liquid chemical 3.4% glutaraldehyde solution (e.g. Cidex Plus made by ASP),
- Liquid chemical 0.08% peroxyacetic acid and 1% hydrogen peroxide (e.g. Cidex PA . made by ASP), and
- High-level thermal disinfection (hot water pasteurisation). .

The semi-critical mask components can withstand 15 cycles of high-level disinfection. One conditioning cycle consists of: disassembly, cleaning, disinfecting, and re-assembly. As an exception, the valve membrane and air tubing cannot be disinfected and therefore must be replaced before reusing on another patient. This is highlighted in the user instructions.

The headgear is a non-critical item, i.e., it comes into contact only with intact skin, and as such it does not require high-level disinfection.

Materials used for the mask components in air-path are identical with materials used in predicate mask Mirage FFM.

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# Conclusion:

The Mirage FFM Series 2 is substantially equivalent to the Mirage FFM. The addition of the highlevel thermal disinfection method (hot water pasteurisation) does not affect safety and effectiveness of the Mirage FFM Series 2.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the caduceus symbol. The logo is black and white.

#### Public Health Service

Food and Drug Administrati 9200 Corporate Boulevard Rockville MD 20850

ResMed Limited. C/O Mr. Roger Kotter Senior Director, QA & RA ResMed Corporation 14040 Danielson Street Poway, California 92064-6857

K023284 Re:

> Trade Name: Mirage Full Face Mask Series 2 Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II Product Code: 73 BZD Dated: September 30, 2002 Received: October 2, 2002

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. Roger 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 (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]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Timothy A. Ulatowski

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 Full Face Mask Series 2, High Level Thermal Disinfection Special 510(k) Premarket Notification

Applicant:

ResMed Ltd

Device Name:

Mirage Full Face Mask (FFM) Series 2

510(k) Number (if known):

- K023284

INDICATIONS FOR USE:

The Mirage Full Face Mask (FFM) Series 2 is intended for multiple-patient use for adult patients prescribed continuous positive airway pressure (CPAP) and bi-level therapy in hospital, clinic, and home environments.

S. Awender

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

510(k) Number. K023784

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-896)