SULLIVAN AUTOSET NASAL CPAP SYSTEM

K984428 · Resmed, Ltd. · BZD · Jul 26, 1999 · Anesthesiology

Device Facts

• Record ID: K984428
• Device Name: SULLIVAN AUTOSET NASAL CPAP SYSTEM
• Applicant: Resmed, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Jul 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sullivan Mirage Mask System is indicated for use with nasal Continuous Positive Airway Pressure (CPAP) and Variable Positive Airway Pressure (VPAP) systems for the indications specified in the relevant system's labeling; and with other CPAP and bilevel systems recommended by a physician or respiratory therapist.

Device Story

Sullivan Mirage Mask System is a patient interface for CPAP and VPAP therapy. It delivers prescribed positive airway pressure from a flow generator to the patient's airway via a nasal mask. Used in home or clinical settings; operated by the patient under physician or respiratory therapist guidance. The mask maintains a seal to ensure effective pressure delivery, facilitating treatment for conditions requiring airway pressure support. It serves as the delivery conduit between the therapy device and the patient.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on device design and intended use.

Technological Characteristics

Nasal mask system for CPAP/VPAP therapy. Mechanical interface design; no electronic components, sensors, or software. Materials and dimensions are consistent with standard nasal mask interfaces for respiratory therapy.

Indications for Use

Indicated for use with CPAP and VPAP systems for patients requiring positive airway pressure therapy as prescribed by a physician or respiratory therapist.

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

JUL 26 1999

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

K984428 Re: Sullivan Autoset Nasal CPAP System Requlatory Class: II (two) Product Code: 73 BZD Dated: April 23, 1999 Received: April 26, 1999

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 requlation 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 requlation (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 requlation 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,

sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, 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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Page

4428 510(k) Number (if known): _ K98

Sullivan MIRAGE MASK SYSTEM Device Name:

Indications For Use: The Sullivan Mirage Mask System is indicated for use with nasal Continuous Positive Airway Pressure (CPAP) and Variable Positive Airway Pressure (VPAP) systems for the indications specified in the relevant system's labeling; and with other CPAP and bilevel systems recommended by a physician or respiratory therapist.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

M.
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Cardiovascular, Respiratory,
ical Devices
K984428

(Optional Format 3-10-98)

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