SULLIVAN VPAP II ST VENTILATORY SUPPORT SYSTEM

K974539 · Resmed, Ltd. · MNT · Aug 6, 1998 · Anesthesiology

Device Facts

• Record ID: K974539
• Device Name: SULLIVAN VPAP II ST VENTILATORY SUPPORT SYSTEM
• Applicant: Resmed, Ltd.
• Product Code: MNT · Anesthesiology
• Decision Date: Aug 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SULLIVAN® VPAP™ II ST Ventilatory Support System is intended to assist the ventilation of adult patients with respiratory insufficiency, respiratory failure, and/or obstructive sleep apnea. When used for respiratory insufficiency and/or respiratory failure an external alarms monitor must be connected. The system is intended for use in a hospital or health care facility, such as a nursing facility, ambulatory surgical facility or hospice.

Device Story

Sullivan VPAP II ST is a ventilatory support system providing non-invasive positive pressure ventilation; assists adult patients with respiratory insufficiency, failure, or obstructive sleep apnea. Device operates in hospital or healthcare facility settings; requires external alarm monitor for respiratory failure/insufficiency applications. System delivers prescribed pressure support to aid patient breathing; clinician-operated. Output assists ventilation; helps manage respiratory conditions; improves patient outcomes by supporting gas exchange.

Clinical Evidence

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

Technological Characteristics

Ventilatory support system; non-invasive positive pressure delivery. Designed for hospital/healthcare facility use. Requires external alarm monitoring for specific indications.

Indications for Use

Indicated for adult patients with respiratory insufficiency, respiratory failure, or obstructive sleep apnea. Requires external alarm monitor for respiratory insufficiency/failure cases. Intended for hospital or healthcare facility use.

Regulatory Classification

Identification

A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

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

AUG 6 1998

Mr. Scott Dudevoir
Resmed Ltd.
C/O Resmed Corp.
5744 Pacific Centre Blvd.
San Diego, CA 92131

Re: K974539
Sullivan® VPAP II ST Ventilatory Support System
Regulatory Class: II (two)
Product Code: 73 MNt
Dated: August 3, 1998
Received: August 4, 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, 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): K974539

Device Name: SULLIVAN® VPAP™ II ST Ventilatory Support System

Indications For Use: The SULLIVAN® VPAP™ II ST Ventilatory Support System is intended to assist the ventilation of adult patients with respiratory insufficiency, respiratory failure, and/or obstructive sleep apnea. When used for respiratory insufficiency and/or respiratory failure an external alarms monitor must be connected. The system is intended for use in a hospital or health care facility, such as a nursing facility, ambulatory surgical facility or hospice.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Mark Wame

☑ For Prescription Use

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