AUTOVENT MODEL 4000

K070120 · Allied Healthcare Products, Inc. · BTL · May 3, 2007 · Anesthesiology

Device Facts

• Record ID: K070120
• Device Name: AUTOVENT MODEL 4000
• Applicant: Allied Healthcare Products, Inc.
• Product Code: BTL · Anesthesiology
• Decision Date: May 3, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5925
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Autovent 4000 is a powered emergency transport ventilator, which is designed to provide emergency respiratory support by means of a face mask or tube inserted into the patients airway.

Device Story

Autovent 4000 is a powered emergency transport ventilator; provides respiratory support to patients via face mask or endotracheal tube. Device operates in emergency and transport environments; used by trained medical personnel. Provides mechanical ventilation to assist patient breathing; supports clinical decision-making by maintaining airway patency and gas exchange during transport or emergency stabilization. Benefits include reliable respiratory support in pre-hospital or inter-facility transfer scenarios.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and design characteristics.

Technological Characteristics

Powered emergency transport ventilator; pneumatic/mechanical operation; portable form factor for transport use. Class II device (21 CFR 868.5925).

Indications for Use

Indicated for patients requiring emergency respiratory support via face mask or airway tube. Intended for use by trained medical personnel in emergency or transport settings.

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

Mr. Wayne Karcher Regulatory Affairs Coordinator Allied Healthcare Products, Incorporated 1720 Sublette Avenue St. Louis, Missouri 63110

Re: K070120

Trade/Device Name: Autovent 4000 Regulation Number: 21 CFR 868.5925 Regulation Name: Powered Emergency Ventilator Regulatory Class: II Product Code: BTL Dated: April 3, 2007 Received: April 11, 2007

Dear Mr. Karcher:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

MAY 3 2007

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## Page 2 - Mr. Karcher

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Suifte y. Michael DMD.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

## Enclosure

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## Indications for Use

510(k) Number: K070120

Device Name: Autovent 4000

Indications For Use: The Autovent 4000 is a powered emergency transport ventilator, which is designed to provide emergency respiratory support by means of a face mask or tube inserted into the patients airway.

Prescription Use: Yes AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use: No (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chlildo

on of Anesthesiology, General Hospital, aon Control, Dental Devices

3(k) Number: Ks 70 120

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