The Bawmed E-Z Bag Resuscitators are manual resuscitators incorporating a bag and valve, intended to provide respiratory support to patients suffering from respiratory distress. The infant model is intended for patients weighing between 5 to 12 kgs, the child model is intended for patients weighing between 10 to 30 kgs, and the adult model is intended for patients weighing more than 30 kgs approximate weight. The Bawmed E-Z Bag Resuscitator provided in reusable models and in the disposable models.

Device Description

manual resuscitators incorporating a bag and valve

AI/ML Overview

This document is a 510(k) clearance letter for the Bawmed E-Z Bag Resuscitator, an emergency manual ventilator. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is a regulatory clearance document, not a scientific study report.

Therefore, I cannot provide the requested information based on the provided text. The document confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. This determination is based on the information submitted by the manufacturer in their 510(k) premarket notification, which would have included performance data, but that specific data and acceptance criteria are not detailed in this clearance letter.

Summary

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 6 2004

Ms. Barbara Woods Director Bawmed UK 6 Great House Meadows Llantwit Major United Kingdon, CF61 1SU

Re: K031434

Trade/Device Name: Bawmed E-Z Bag Resuscitator Regulation Number: 868.5915 Regulation Name: Emergency Manual Ventilator (Resuscitator) Regulatory Class: II Product Code: BTM Dated: January 13, 2004 Received: January 22, 2004

Dear Ms. Woods:

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 approvisions 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 (1 wrl), it may to budgess in the Code of Federal Regulations. Title 21, Parts 800 to 898. In your device ear roublish further announcements concerning your device in the Eederal Register.

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Page 2 - Ms. Barabara Woods

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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Cus

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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Indication for Use

510(k) Number (if known): K031434

Device Name: Bawmed E-Z Bag Resuscitator

Indication for use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

th L

Division of Anesthesio Infection Control, Den

510(k) Number:

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Regulation Number and Section

§ 868.5915 Manual emergency ventilator.

(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).