(36 days)
The iCAST Covered Stent is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms.
Not Found
The provided FDA 510(k) summary only includes the regulatory approval status and indications for use of the Atrium iCAST Covered Stent. It does not contain information about acceptance criteria, device performance studies, or details relevant to artificial intelligence/machine learning device evaluation (such as sample sizes, ground truth establishment, or expert qualifications).
Therefore, I cannot provide the requested information based on the given document.
§ 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.”