(85 days)
Transtracheal catheter for patients requiring high flow supplemental oxygen for the treatment of hypoxemia
SCOOP I, Transtracheal Catheter
The provided document is a 510(k) premarket notification approval letter for the SCOOP I Transtracheal Catheter. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria.
The letter from the FDA primarily focuses on the regulatory approval process, stating that the device is substantially equivalent to pre-amendment devices and can proceed to market. It mentions general controls provisions, potential additional controls for Class II/III devices, and compliance with Good Manufacturing Practice.
Therefore, I cannot extract the requested information (acceptance criteria, device performance, study details, expert qualifications, etc.) from the provided text. This information would typically be found in the 510(k) submission itself or a separate clinical/performance study report, neither of which is included in this document.
§ 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.