SULLIVAN MIRAGE FULL FACE MASK

K982530 · Resmed, Ltd. · BZD · Oct 16, 1998 · Anesthesiology

Device Facts

• Record ID: K982530
• Device Name: SULLIVAN MIRAGE FULL FACE MASK
• Applicant: Resmed, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Oct 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sullivan® Mirage™ Full Face Mask is a patient interface accessory for use with Constant Positive Airway Pressure (CPAP) and bilevel systems used in the treatment of adult Obstructive Sleep Apnea (OSA) and/or ventilatory support.

Device Story

Sullivan® Mirage™ Full Face Mask is a patient interface accessory designed for use with CPAP and bilevel systems. It functions as a conduit to deliver positive airway pressure to the patient's nose and mouth. Used in clinical or home settings, the mask is worn by the patient to facilitate treatment for Obstructive Sleep Apnea (OSA) or to provide ventilatory support. The device is operated by the patient under the guidance of a healthcare provider. It does not perform automated analysis or processing; it serves as a mechanical interface to maintain a seal for effective pressure delivery, thereby supporting respiratory therapy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Patient interface mask system for CPAP/bilevel therapy. Mechanical design for facial seal. Non-electronic, passive device. No software or algorithm components.

Indications for Use

Indicated for adult patients requiring CPAP or bilevel system therapy for Obstructive Sleep Apnea (OSA) or 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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 16 1998

Mr. Scott Dudevoir ResMed Ltd. c/o ResMed Corp. 10121 Carroll Canyon Road San Diego, CA 92131

Re: K982530 Sullivan® Mirage™ Full Face Mask System Requlatory Class: II (two) Product Code: 73 BZD Dated: July 16, 1998 Received: July 20, 1998

Dear Mr. Dudevoir:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Scott Dudevoir

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. CallaMan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): 1982530

Mirage Full Face Mask Device Name:

The Sullivan® Mirage™ Full Face Mask is a patient interface Indications For Use: accessory for use with Constant Positive Airway Pressure (CPAP) and bilevel systems used in the treatment of adult Obstructive Sleep Apnea (OSA) and/or ventilatory support.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

HPRen

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number

(Optional Format 3-10-98)

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