(455 days)
One way Speaking Valve for spontaneous breathing tracheostomy patients. The device connects directly to an ISO 15mm tracheostomy tube. The valve opens upon inhalation and then closes immediation, forcing the expired gasses through the larynx and mouth to produce speech.
One way Speaking Valve
I am sorry, but based on the provided text, the document is a 510(k) premarket notification letter from the FDA regarding a device named "SPIRO Speaking Valve." This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone) related to AI or even general device performance data beyond its indication for use.
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§ 868.5800 Tracheostomy tube and tube cuff.
(a)
Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.(b)
Classification. Class II.