(148 days)
The BEAR Adjustable Pressure Limit Valve is intended to be an accessory for the BEAR 33 Volume Ventilator which provides clinically accepted features for the ventilation management of pediatric patients requiring breath volume delivery of 100 ml to 2200 ml.
In addition to the standard features, the intent of this device is to be utilized during high flow and high tidal volume delivery to those patients with an uncuffed artificial airway or in other patient configurations which ensure an intentional artificial airway leak.
The pressure relief valve is intended to be used with patients that have respiratory failure/insufficiency and require mechanical ventilation.
BEAR® Adjustable Pressure Relief Valve
I am sorry, but the provided document is a letter from the FDA regarding a 510(k) premarket notification for a medical device (BEAR® Adjustable Pressure Limit Valve). It does not contain information about the acceptance criteria and the study that proves the device meets those criteria in the context of an AI-powered medical device.
Therefore, I cannot provide the requested information based on this document.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).