(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.
§ 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).