AHP 300, EMERGENCY PORTABLE VENTILATOR

K132021 · Allied Healthcare Products, Inc. · BTL · Apr 2, 2014 · Anesthesiology

Device Facts

• Record ID: K132021
• Device Name: AHP 300, EMERGENCY PORTABLE VENTILATOR
• Applicant: Allied Healthcare Products, Inc.
• Product Code: BTL · Anesthesiology
• Decision Date: Apr 2, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5925
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The AHP300 (with internal compressor) is intended to be used as an electrically controlled emergency ventilator. This ventilator 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 5kg (11 1bs). The ventilator is intended to be used in the environments associated with emergency medical services (EMS), inter-hospital transport and hospital facilities usage by qualified, trained personnel under the direction of a physician. The ventilator is intended to be used in temperatures of -18 C to 50 C (0 F to 122 F) and 5% to 95% relative humidity non-condensing.

Device Story

AHP300 is an electrically controlled emergency ventilator with an internal compressor; provides respiratory support via face mask or airway tube. Designed for use in EMS, inter-hospital transport, and hospital environments; operated by qualified, trained personnel under physician direction. Device supports patients weighing >5kg. Provides mechanical ventilation in varied environmental conditions (-18°C to 50°C). Clinicians use device output to manage patient airway and breathing; facilitates life-sustaining respiratory support during transport or emergency care.

Technological Characteristics

Electrically controlled emergency ventilator; includes internal compressor. Operates in temperatures -18°C to 50°C and 5-95% relative humidity. Designed for use with face mask or airway tube.

Indications for Use

Indicated for emergency respiratory support in patients weighing >5kg (11 lbs). Used in EMS, inter-hospital transport, and hospital settings by qualified personnel under physician direction.

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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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

# April 2, 2014

Allied Healthcare C/O Mr. John Smith Partner 555 Thirteenth Street NW WASHINGTON D.C. 20004

Re: K132021

Trade/Device Name: AHP300 Emergency Portable Ventilator Regulation Number: 21 CFR 868.5925 Regulation Name: Powered Emergency Ventilator Regulatory Class: II Product Code: BTL Dated: March 5, 2014 Received: March 5, 2014

Dear Mr. Smith:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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,

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 that I DA has made a doloriniations administered by other Federal agencies. You must of any I edelal statutes and regulations anchuding, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Cr K rat 607), acceing (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Smith

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda,gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/Reportal":gblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Digitally signed by Richard C. Chapman : 上一 Date: 2014.04.02 16:46:56 -04 00

for

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K132021

#### Device Name

AHP300 Emergency Portable Ventilator

#### Indications for Use (Describe)

The AHP300 (with internal compressor) is intended to be used as an electrically controlled emergency ventilator. This ventilator 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 5kg (11 1bs). The ventilator is intended to be used in the environments associated with emergency medical services (EMS), inter-hospital transport and hospital facilities usage by qualified, trained personnel under the direction of a physician. The ventilator is intended to be used in temperatures of -18 C to 50 C (0 F to 122 F) and 5% to 95% relative humidity non-condensing.

#### Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

CONTRACT FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR F Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Digitally signed by Richard C. Chapman Date: 2014.04.02 16:35:09 -04'00

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