EMT-CPAP

K021520 · Emergency Medical Techology · BTL · Jul 15, 2002 · Anesthesiology

Device Facts

• Record ID: K021520
• Device Name: EMT-CPAP
• Applicant: Emergency Medical Techology
• Product Code: BTL · Anesthesiology
• Decision Date: Jul 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5925
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To provide CPAP to spontaneously breathing patients in the hospital and pre-hospital (EMS) environments.

Device Story

EMT-CPAP is a positive end expiratory pressure breathing apparatus; provides continuous positive airway pressure (CPAP) to spontaneously breathing patients. Used in hospital and pre-hospital (EMS) environments. Device delivers pressurized gas to patient airway to assist ventilation; supports respiratory function. Operated by trained medical personnel. Benefits include non-invasive respiratory support for patients in acute distress.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Positive end expiratory pressure breathing apparatus; powered emergency ventilator. Class II device. Product codes BTL and BYE. Regulation numbers 868.5925 and 868.5965.

Indications for Use

Indicated for spontaneously breathing patients requiring CPAP in hospital and pre-hospital (EMS) 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus-like symbol with three wavy lines, resembling a stylized human profile.

Public Health Service

'JUL 1 5 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Emergency Medical Techology C/O Mr. Greg Holland Regulatory Specialist, Incorporated 3722 Avenue Sausalito Irvine, California 92606

Re: K021520

Trade/Device Name: EMT-CPAP Regulation Number: 868.5925 and 868.5965 Regulation Name: Powered Emergency Ventilator and Positive End Expiratory Pressure Breathing Apparatus Regulatory Class: II Product Code: BTL and BYE Dated: June 27, 2002 Received: July 2. 2002

Dear Mr. Holland:

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.

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.

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Page 2 - Mr. Holland

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 (OS) 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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Ri Walmist

Timoth 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 Statement | |
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510(k) Number (if known):__KO21520

EMT-CPAP Device Name:_____________________

Indications For Use:

To provide CPAP to spontaneously breathing patients in the hospital and pre-hospital (EMS) environments.

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Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Dental, Infection Control and General Hospital Devices 510(k) Number _