ULTRA MIRAGE II MASK

K050359 · Resmed, Ltd. · BZD · Mar 16, 2005 · Anesthesiology

Device Facts

• Record ID: K050359
• Device Name: ULTRA MIRAGE II MASK
• Applicant: Resmed, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Mar 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ultra Mirage II Mask is intended for multipatient re-use for adult patients prescribed continuous positive airway pressure (CPAP) or bilevel therapy in hospitals, clinic and home environments.

Device Story

Ultra Mirage II Mask is a nasal mask with headgear; provides seal for delivery of non-invasive ventilatory support via CPAP or bi-level therapy. Device connects to flow generator via tubing; delivers air pressure to patient lungs. Designed for multi-patient re-use in hospitals, clinics, and home environments. Available in one frame size with four cushion variants (standard, large, shallow, shallow-wide). Healthcare providers or patients use the mask to facilitate therapy; proper seal improves comfort and ease-of-use. Benefits include effective non-invasive ventilation for patients requiring respiratory support.

Clinical Evidence

Bench testing only. Performance testing verified safety and effectiveness; materials tested for biocompatibility per ISO 10993 standards.

Technological Characteristics

Nasal mask with headgear; four cushion variants (standard, large, shallow, shallow-wide). Materials tested per ISO 10993. Non-invasive interface for CPAP/bi-level therapy. No electronic components or software.

Indications for Use

Indicated for adult patients prescribed CPAP or bilevel therapy for non-invasive ventilatory support.

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 Mask (K961783)
• Mirage Activa (K032916)

Reference Devices

• Autoset Spirit (K013843)
• S7 Elite (K013909)

Submission Summary (Full Text)

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MAR 16 2005

Sponsor:
ResMed Ltd

#### 510(K) SUMMARY ﺑﻴﺮ

# 510(k) SUMMARY—Ultra Mirage II 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: | February 11, 2005 |
| Device Trade Name: | Ultra Mirage II Mask |
| Device Common Namel<br>Classification Name: | Ultra Mirage II Mask |
| Predicate Devices: | K961783 Modular Mask<br>K032916 Mirage Activa |

## Device Description:

The Ultra Mirage II Mask is designed for adult patients for the delivery of non-invasive ventilatory support using continuous positive airway pressure or bi-level therapy. It is intended for multiplepatient re-use and is minimally obtrusive to the user, providing a high level of comfort, ease-of-use and seal.

#### Intended Use:

The Ultra Mirage II Mask is intended for multipatient re-use for adult patients prescribed continuous positive airway pressure (CPAP) or bilevel therapy in hospitals, clinic and home environments.

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

#### Overview:

Overview :
The Ultra Mirage II Mask is a nasal mask supported by headgear to allow a seal with the patients The Ottra Mirage II Mask may then be connected via tubing to a CPAP or bi-level flow lace. The Olira Mirage in Made mayentilation is applied to the lungs in a non-invasive manner.

The Ultra Mirage II Mask comes in one frame size with four cushion variants (standard, large, shallow, shallow-wide).

The Ultra Mirage II Mask design is substantially equivalent to predicate devices. The Ultra Mirage I he Otta Mirage in mask dolgh to educal and has the same fundamental scientific technology as its predicates.

#### Performance Data:

r efformance testing has been carried out to verify the safety and effectiveness of the Ultra Mirage r enominer tooling noo boon carnoe is equivalent to ResMed's Ultra Mirage Mask as ir Mask. THO Olira Mirago It fitten Autoset Spirit (K013843) and S7 Elite (K013909) submissions. The results of the performance data show that the Ultra Mirage II mask is substantially equivalent to the Modular (K961783) and Mirage Activa (K032916) predicate masks (refer section 5.2.1)

### Materials Biocompatibility

Materials have been carefully selected to ensure patient safety and efficacy of the product. Those materials used to create components of the Ultra Mirage II Mask, which contact the skin and/or the air-path, have been tested to the ISO 10993 standards by an independent certified laboratory. The details are referenced in section 5.4.

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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 depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

MAR 16 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K050359

Trade/Device Name: Ultra Mirage II Mask Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: February 11, 2005 Received: February 14, 2005

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 micrsate comments, or to devices that have been reclassified in accordance with the provisions of Amendinens, or to do roses ken metic Act (Act) that do not require approval of a premarket the Federal F USA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of a 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 (1 MA), it may be subject to fact of Federal Regulations, Title 21, Parts 800 to 898. In your device ear oe founcements 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 I Trase oc advisour that 122 a determination that your device complies with other requirements mean that I Dr may Federal statutes and regulations administered by other Federal agencies. of the Act of any t oderal banks and surfection to be not limited to: registration r ou must comply with a 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CF ref art 087), abouting systems (QS) regulation (21 CFR Part 820); and if requirements us bet form in are quadiation 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) This letter will around Jo The FDA finding of substantial equivalence of your device to a premaired predicated. - I 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), 11 you desire specific acroof 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 may ovent 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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#### INDICATIONS FOR USE র্ব

510(k) Number (if known): KoSO359

Ultra Mirage II Mask Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Ultra Mirage II Mask is intended for multipatient re-use for adult patients prescribed The other winess in Mast pressure (CPAP) or bilevel therapy in hospitals, 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)

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