(88 days)
On/Off control of oxygen flow when using a resuscitator bag. For use with hyperinflation bag (not included) weighing ~3 ounces - 4 pounds (90 - 1814 grams). The use of these sizes of bags typically range from neonatal, pediatric to adult care. The valves are intended to be used with a flowmeter (not included) which controls the flow of oxygen to the valve. On/off oxygen action is controlled by lifting/replacing bag on arm of valve. Immediate oxygen flow is provided when bag is lifted from arm (preventing personnel from having to turn oxygen on). Oxygen flow is stopped when bag is replaced.
Instant Flow Valves
The provided text is a 510(k) clearance letter from the FDA for "Instant Flow Valves" and an "Indication for Use Statement". It does not contain any information about acceptance criteria, device performance, study details (sample size, data provenance, ground truth, expert qualifications, adjudication, MRMC, standalone performance), or training set information for a medical device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document is solely a regulatory clearance for marketing based on 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).