(282 days)
This device is used to provide annartificial airway inforder torassist in commen the treatment of a variety of respiratory diseases and airway management for adult patients.
The device is to be used by the order of a nhysician.
The device is primarily intended for use in conjunction with Percutaneous Dilational (or Dilatational) Tracheotomy and is inserted into the natient using the Introducer provided with the Percutaneous Dilational Kit.
The device is intended to be used as the initial artificial airway immediately post tracheotomy.
There is no "new" intended theraneutic use of this device to existing devices marketed.
The device includes an Outer Cannula with a Cuff. The Cuff is deflated or inflated via an Inflation System comprised of tubing communicating between the Cuff and a Luer Valve to which a syringe can be attached. A Pilot Balloon is adjacent to the Luer Valve to indicate the inflation status of the Cuff. A Neck Plate is attached to the Outer Cannula. An Inner Cannula is included with an integral 15mm male conical connector. The Inner and Outer Cannula are attached together by a snap-lock mechanism. The Outer Cannula distal end is designed to have smooth transitions in outer diameter in order to minimize the amount of resistance that would occur with abrupt transitions.
The provided document describes the K963732 submission for the Shiley Percutaneous Dual Cannula Tracheostomy Tube. It details the device, its intended use, and its similarities and differences to predicate devices, but it does not contain a study with detailed acceptance criteria and reported device performance as requested.
Instead, the submission states:
- Non-Clinical Tests: "Physical integrity of the Cuff-to-Cannula bond strength of the new PERC device will be demonstrated to be equivalent to the predicate DCT device. Insertion force of the new PERC device will be less than that of the predicate DCT device. This data will be available from the manufacturer upon request." This indicates that these tests were planned or conducted, but the results and specific acceptance criteria are not included in the provided text.
- Clinical Tests: "It is not required to conduct clinical tests on the new PERC product due to its similarity to the predicate DCT product and other competitor's predicate products."
Therefore, based only on the provided text, I cannot complete the requested tables and sections with the specific details about acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, or multi-reader multi-case studies because this information is not present in the given document.
The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study report for the new device.
§ 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.