SULLIVAN AUTOSET PORTABLE II NASAL CPAP SYSTEM

K970771 · Resmed, Ltd. · BZD · Jun 20, 1997 · Anesthesiology

Device Facts

• Record ID: K970771
• Device Name: SULLIVAN AUTOSET PORTABLE II NASAL CPAP SYSTEM
• Applicant: Resmed, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Jun 20, 1997
• 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

SULLIVAN AutoSet Portable II is a nasal continuous positive airway pressure (CPAP) system. Device monitors patient breathing patterns to automatically adjust pressure levels in response to obstructive sleep apnea events. Used in home or clinical settings by adult patients under physician prescription. System delivers pressurized air via nasal interface to maintain airway patency during sleep. Output consists of automated pressure regulation based on detected respiratory flow limitations. Benefits include improved sleep quality and reduction of apnea-related symptoms.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Nasal CPAP system; automated pressure adjustment mechanism; portable form factor; prescription-only device.

Indications for Use

Indicated for 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Dr. Michael D. Hallett
ResMed Corp.
5744 Pacific Center Blvd., Suite 311
San Diego, California 92121

Re: K970771
SULLIVAN® AutoSet Portable II Nasal CPAP System
Regulatory Class: II (two)
Product Code: 73 BZD
Dated: May 29, 1997
Received: June 2, 1997

Dear Dr. Hallett:

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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 2 - 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.

JUN 20 1997

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Page 2 - Dr. Michael D. Hallett

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/dsmamain.html".

Sincerely yours,


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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ResMed Ltd
SULLIVAN® AutoSet™ Portable II Nasal CPAP System 510(k) Premarket Notification

## 2.3 Indications for Use

510(k) Number (if known):

Device Name: SULLIVAN® AutoSet™ Portable II Nasal CPAP System

Indications For Use: TREATMENT OF OBSTRUCTIVE SLEEP APNEA IN ADULT PATIENTS

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Christy Fournier
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K976771

Prescription Use ☑ (Per 21 CFR 801.109)
OR
Over-The-Counter Use ☐

(Optional Format 1-2-96)

February 1997
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