(158 days)
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.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA to OEMedic International, Incorporated regarding their Besmed® Silicone Manual Resuscitator. This document is a regulatory approval letter and does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications for an AI/ML medical device.
Therefore, I cannot extract the requested information from the provided text. The questions posed relate to the development and validation of an AI/ML-based medical device, which is not what this document describes. This document is for a traditional medical device (manual resuscitator) and confirms its substantial equivalence to a predicate device.
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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 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.
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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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
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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)
§ 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).