(130 days)
Airway complications such as anastomosis ans stenosis, Trachea-esophageal fistula, Stenosis of the central airways(such as the trachea and main bronchus), and Compression or strictures due to tumors (Trachea and main bronchus) .
The Rüsch Polyflex Stent Kit consists of a medical silicone supported by a polyester core along with the components required to insert the device into the human body. These components consist of the Introducer Sleeve, the Stent Loader, Soft Positioner, and Blue Stopper.
This document is a 510(k) summary for the Rusch Polyflex Stent Kit. It details the device's description, intended use, and claims of substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) process is a premarket notification to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (predicate device). It typically does not involve new clinical studies to establish acceptance criteria or device performance against those criteria in the way a PMA submission might.
Therefore, I cannot provide the requested information from the given text.
If this were a PMA or a different type of submission that included performance data, I would look for sections detailing:
- Acceptance Criteria: Often expressed as performance targets (e.g., sensitivity, specificity, accuracy, or specific clinical outcomes).
- Study Design: Information on clinical trials, their methodology, endpoints, and statistical analysis.
- Results: The reported performance of the device against the defined criteria.
Since this information is not present in the provided 510(k) summary, I can only state that it is not available here.
§ 878.3720 Tracheal prosthesis.
(a)
Identification. The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal tracheal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”