OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK AND RESERVOIR

K021446 · Oemedic International, Inc. · BTM · Oct 11, 2002 · Anesthesiology

Device Facts

• Record ID: K021446
• Device Name: OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK AND RESERVOIR
• Applicant: Oemedic International, Inc.
• Product Code: BTM · Anesthesiology
• Decision Date: Oct 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5915
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The OEMedic International Inc. Besmed® Silicone Manual Resuscitators are intended to provide emergency ventilation or ventilation during patient transport, with air or air enriched with oxygen. The infant model is intended for patients weighing up to 10 kg, the child model is intended for patients weighing between 10 and 30 kg, and the adult model is intended for patients weighing more than 30 kg.

Device Story

Besmed® Silicone Manual Resuscitator is a hand-operated device used to provide positive pressure ventilation to patients during emergencies or transport. It delivers ambient air or supplemental oxygen to the patient's airway via a mask. The device is operated by healthcare professionals in clinical or emergency settings. By manually compressing the silicone bag, the operator forces air into the patient's lungs, assisting or controlling respiration. This provides immediate life-support capability for patients experiencing respiratory failure or arrest. The device is designed for use across three weight-based categories (infant, child, adult) to ensure appropriate tidal volume delivery.

Clinical Evidence

Bench testing only.

Technological Characteristics

Constructed of silicone. Manual operation via bag compression. Includes mask and reservoir. Available in three sizes (infant, child, adult) based on patient weight. No electronic components, software, or external power source.

Indications for Use

Indicated for emergency ventilation or transport ventilation in patients requiring respiratory support. Infant model: patients ≤ 10 kg. Child model: patients 10–30 kg. Adult model: patients > 30 kg.

Regulatory Classification

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.

Submission Summary (Full Text)

{0}------------------------------------------------

## 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 stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 1 2002

OEMedic International, Incorporated C/O Mr. Kevin Walls. RAC Regulatory Insight Incorporated 13 Red Fox Lane Littleton, Colorado 80127

Re: K021446

Trade/Device: Besmed® Silicone Manual Resuscitator Regulation Number: 21 CFR 868.5915 Regulation Name: Manual Emergency Ventilator Regulatory Class: II Product Code: 73 BTM Dated: September 23, 2002 Received: September 24, 2002

Dear Mr. Walls:

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 cither 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.

{1}------------------------------------------------

## Page 2 - Mr. Kevin Walls, RAC

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 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.gov/cdrh/dsma/dsmamain.html

Sincerely,

Patricia Ciacci/for

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

{2}------------------------------------------------

Page 1 of 1

510(k) Number (if known): K021446

Device Names:

OEMedic International Inc. Besmed® Silicone Adult Manual Resuscitator with Mask and Reservoir OEMedic International Inc. Besmed® Silicone Child Manual Resuscitator with Mask and Reservoir OEMedic International Inc. Besmed® Silicone Infant Manual Resuscitator with Mask and Reservoir

Indications for Use: The OEMedic International Inc. Besmed® Silicone Manual Resuscitators are intended to provide emergency ventilation or ventilation during patient transport, with air or air enriched with oxygen. The infant model is intended for patients weighing up to 10 kg, the child model is intended for patients weighing between 10 and 30 kg, and the adult model is intended for patients weighing more than 30 kg.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Alvaro Quesada Soto. J.K.

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

510(k) Number: *KC21446*

Prescription Use × (Per 21 CFR 801.109)

OR

(Division Sign-Off)
Division of Cardiovascular, Respiratory and
Neurological Devices
510(k) Number

Over-The-Counter Use (Optional Format 1-2-96)