SULLIVAN AUTOSET

K980721 · Resmed, Ltd. · BZD · Sep 1, 1998 · Anesthesiology

Device Facts

• Record ID: K980721
• Device Name: SULLIVAN AUTOSET
• Applicant: Resmed, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Sep 1, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Treatment of obstructive sleep apnea in adult patients.

Device Story

The Sullivan AutoSet Nasal CPAP System is a nasal continuous positive airway pressure (CPAP) device used for the treatment of obstructive sleep apnea in adults. It delivers pressurized air to the patient's airway to maintain patency during sleep. The device is intended for prescription use. It functions by monitoring respiratory parameters and automatically adjusting pressure levels to meet the patient's therapeutic needs. The system is designed for use in a home or clinical setting to improve patient breathing and reduce apnea events.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review of the 510(k) submission.

Technological Characteristics

Nasal CPAP system; provides positive airway pressure; includes automated pressure adjustment functionality.

Indications for Use

Indicated for the treatment of obstructive sleep apnea in adult patients.

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

1 1998 SEP

Mr. Scott Dudevoir ResMed Ltd. c/o ResMed Corp. 10121 Carroll Canyon Road San Diego, CA 92131-1109

Re: K980721 Sullivan AutoSet Nasal CPAP System Regulatory Class: II (two) Product Code: 73 BZD Dated: June 2, 1998 Received: June 3, 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 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,

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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## Indications for Use 3.3.

510(k) Number (if known):

298072|

SULLIVAN® AUTOSET® Nasal CPAP System Device Name:

Treatment of obstructive sleep apnea in adult patients. Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark Kramer

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
are Neurological Devices
510(k) Number K980721

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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