PORTABLE VENTILATOR, MODEL EPV-100

K072214 · Allied Healthcare Products, Inc. · BTL · Mar 6, 2008 · Anesthesiology

Device Facts

• Record ID: K072214
• Device Name: PORTABLE VENTILATOR, MODEL EPV-100
• Applicant: Allied Healthcare Products, Inc.
• Product Code: BTL · Anesthesiology
• Decision Date: Mar 6, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5925
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The EPV100 is intended to be used as an electronically controlled gas powered emergency ventilator, which is designed to provide emergency respiratory support by means of a face mask or tube inserted into the patient's airway. The ventilator is intended for use on patients weighing greater than 20kg (44 lbs). This ventilator is intended to be used in the environments associated with emergency medical services (EMS), interhospital transport and hospital facility usage.

Device Story

EPV-100 is an electronically controlled, gas-powered portable ventilator; provides emergency respiratory support via face mask or airway tube. Designed for patients >20kg; used in EMS, interhospital transport, and hospital environments. Operated by trained medical personnel. Device delivers gas-based ventilation to assist patient breathing; supports clinical decision-making during emergency resuscitation or transport. Benefits include portable, reliable respiratory assistance in acute care settings.

Clinical Evidence

Bench testing only.

Technological Characteristics

Electronically controlled, gas-powered portable ventilator. Designed for use with face mask or airway tube. Class II device (Product Code BTL).

Indications for Use

Indicated for emergency respiratory support in patients weighing >20kg (44 lbs) via face mask or airway tube. Intended for use in EMS, interhospital transport, and hospital 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

MAR - 6 2008

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

Re: K072214

Trade/Device Name: EPV-100, Portable Ventilator Regulation Number: 21CFR 868.5925 Regulation Name: Powered Emergency Ventilator Regulatory Class: II Product Code: BTL Dated: February 28, 2008 Received: February 29, 2008

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.

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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 yours,

Sutia Y. Michael Davis.

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 K072214

Device Name: EPV-100, Portable Ventilator

Indications for Use: The EPV100 is intended to be used as an electronically controlled gas powered emergency ventilator, which is designed to provide emergency respiratory support by means of a face mask or tube inserted into the patient's airway. The ventilator is intended for use on patients weighing greater than 20kg (44 lbs). This ventilator is intended to be used in the environments associated with emergency medical services (EMS), interhospital transport and hospital facility usage.

Prescription Use: Yes (Part 21CFR 801 Subpart D) AND/OR Over-the Counter Use: No (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Minh Thanh

(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K072214