(44 days)
A one-way valve that prevents the escape of inspiratory gases and rebreathing of expired gases while providing a means of egress for expired gases. Fits all 22 male T-pieces and allows the use of a PEEP valve as the gases exit the valve via a 22 mm port. ISO connections: When assembling any connections use a push and twist action to ensure a secure fit. All ports should remain capped when not is use. Recommended Change: every 24 hours or more frequently if visible deterioration is observed. Single patient use. Non-conductive. Non-sterile. Do not autoclave. CAUTIONS: Federal law restricts this device to sale by or on the order of a physician.
A one-way valve that prevents the escape of inspiratory gases and rebreathing of expired gases while providing a means of egress for expired gases. Fits all 22 male T-pieces and allows the use of a PEEP valve as the gases exit the valve via a 22 mm port.
The provided text is a 510(k) clearance letter from the FDA for an "Exhalation Valve - PN 1922". It does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance metrics.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. However, it does not describe any specific performance studies, their results, or the methodology used to establish such results.
Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed scientific study of the device's performance against predefined acceptance criteria.
§ 868.5870 Nonrebreathing valve.
(a)
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.(b)
Classification. Class II (performance standards).