RESPIRTECHPRO

K973975 · Vortran Medical Technology 1, Inc. · BTL · Jun 12, 1998 · Anesthesiology

Device Facts

• Record ID: K973975
• Device Name: RESPIRTECHPRO
• Applicant: Vortran Medical Technology 1, Inc.
• Product Code: BTL · Anesthesiology
• Decision Date: Jun 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5925
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is to be used by properly trained personnel to deliver emergency, short term, constant flow - pressure cycled ventilatory support.

Device Story

RespirTech PRO™ is an automatic resuscitator designed for emergency, short-term ventilatory support. It provides constant flow, pressure-cycled ventilation. The device is intended for use by trained personnel in clinical or emergency settings to assist patients requiring respiratory support. It functions as a mechanical ventilator to deliver controlled breaths, aiding in patient stabilization. The device is operated by healthcare professionals to manage airway pressure and flow, directly influencing patient ventilation and oxygenation during acute respiratory distress.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Automatic resuscitator; constant flow, pressure-cycled mechanism. Device is a mechanical system for ventilatory support. No software or electronic algorithm described.

Indications for Use

Indicated for emergency, short-term, constant flow, pressure-cycled ventilatory support in patients requiring respiratory assistance, administered by trained personnel.

Regulatory Classification

Identification

A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 12 1998

Gordon A. Wong, M.D. VORTRAN Medical Technology, Inc. 3941 J Street, Suite 354 Sacramento, CA 95819-3633

Re: K973975 RespirTech PRO™ - Automatic Resuscitator Regulatory Class: II (two) Product Code: 73 BTL March 10, 1998 Dated: Received: March 17, 1998

Dear Dr. Wong:

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 requlations 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 - Gordon A. Wong, M.D.

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 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

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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VORTRAN Medical Technology, Inc.

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510(k) Number (if known):

Device Name: RespirTech PRO™ 2000 Indication for Use:

> The device is to be used by properly trained personnel to deliver emergency, short term, constant flow - pressure cycled ventilatory support.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <div>(Division Sign-Off)</div> <div>Division of Cardiovascular, Respiratory,</div> <div>and Neurological Devices</div> |
|---------------|------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K973975 |

| Prescription Use : | <div>OR</div> | Over-The-Counter Use |
|----------------------|---------------|----------------------|
| (Per 21 CFR 810.109) | | |

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