(618 days)
The Disposable Cannula Tracheostomy Tubes are designed to provide an adult tracheostomy patient with an effective airway for breathing and/or ventilation.
The PneumoCare Disposable Cannula Tracheostomy Tube is constructed of a soft inner and outer cannula and incorporates a soft flange which is attached to the outer cannula. The tracheostomy tubes are available in both the fenestrated and standard configuration. Both configurations are available in 6.0. 7.0. 8.0 and 9.0mm sizes, where the size of the tube is determined by the inner diameter of the inner cannula. The tracheostomy tubes incorporate a swivel connection and a rotating angled elbow. The features allow for increased chin movement and patient comfort.
This request cannot be fulfilled. The provided document is a 510(k) summary for a medical device (tracheostomy tube) that highlights substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and detailed performance data. Therefore, the information needed to answer the questions about acceptance criteria, study details, ground truth, and sample sizes is not present in 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.