(98 days)
The Venner PneuxP. Y.TM Tracheostomy Tube (TT) is a tracheostomy tube intended to be inserted into the patient's trachea via a tracheostomy stoma during extended periods (not more than 30 days) of intensive or critical care to facilitate ventiliation and for evacuation or drainage of secretion from the subglottice space.
Venner Pneux P.Y.TM TracheostomyTube
I am sorry, but the provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for a medical device (Venner Pneux P.Y. Tracheostomy Tube). This document primarily focuses on the regulatory approval process and includes information such as the device name, regulation number, regulatory class, and the FDA's determination of substantial equivalence to predicate devices.
It does not contain information about acceptance criteria, specific device performance data from a study, sample sizes, data provenance, expert qualifications, ground truth establishment, or any details about multi-reader multi-case studies or standalone algorithm performance.
Therefore, I cannot fulfill your request for a description of the acceptance criteria and the study that proves the device meets them based on the provided text.
§ 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.