SULLIVAN VPAP II ST-A NASAL VPAP SYSTEM

K974417 · Resmed Corp · MNS · Jun 24, 1998 · Anesthesiology

Device Facts

• Record ID: K974417
• Device Name: SULLIVAN VPAP II ST-A NASAL VPAP SYSTEM
• Applicant: Resmed Corp
• Product Code: MNS · Anesthesiology
• Decision Date: Jun 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SULLIVAN VPAP II ST-A System is intended to assist the ventilation of spontaneously breathing adult patients with respiratory insufficiency and/or obstructive sleep apnea. The patient is expected to have no more than minor and transient adverse effects if ventilation is not provided for extensive periods, for example overnight. The System is intended for patients who have adequate mental and physical capabilities, allowing them to quickly remove the mask in the case of system failure. The system is intended for use in the hospital or home.

Device Story

SULLIVAN VPAP II ST-A is a nasal ventilation system providing positive airway pressure to assist breathing. Used in hospital or home settings by adult patients. Device delivers air pressure to support ventilation; intended for patients capable of self-removing mask during failure. Provides respiratory support for obstructive sleep apnea and respiratory insufficiency. Clinicians prescribe and set parameters; patients operate device for overnight or intermittent use. Benefits include non-invasive respiratory assistance.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nasal VPAP (Variable Positive Airway Pressure) system. Electromechanical device for respiratory support. Form factor designed for home or hospital bedside use. Connectivity and specific software architecture not detailed in provided text.

Indications for Use

Indicated for spontaneously breathing adult patients with respiratory insufficiency and/or obstructive sleep apnea. Patients must possess adequate mental and physical capability to remove the mask independently in case of system failure.

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

JUN 24 1998

Mr. Scott Dudevoir
Director Technology Development
ResMed Corporation
10121 Carroll Canyon Road
San Diego, CA 92131-1109

Re: K974417
SULLIVAN® VPAP II ST-A Nasal VPAP System
Regulatory Class: II (two)
Product Code: 73 MNS
Dated: March 24, 1998
Received: March 26, 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 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. David D'Cruz

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® VPAP II ST-A System
510(k) Premarket Notification

## 3.3. Indications for Use

510(k) Number (if known):

Device Name: SULLIVAN® VPAP II ST-A Nasal VPAP System

Indications For Use: The SULLIVAN VPAP II ST-A System is intended to assist the ventilation of spontaneously breathing adult patients with respiratory insufficiency and/or obstructive sleep apnea. The patient is expected to have no more than minor and transient adverse effects if ventilation is not provided for extensive periods, for example overnight. The System is intended for patients who have adequate mental and physical capabilities, allowing them to quickly remove the mask in the case of system failure. The system is intended for use in the hospital or home.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark Krause
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K974417

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

(Optional Format 1-2-96)

November, 97
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