(79 days)
The VIATORR® Endoprosthesis is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms.
The VIATORR Endoprosthesis is a self-expanding implantable endoprosthesis that is compressed and secured on the distal end of a catheter delivery system. The catheter delivery system provides a means for implanting the endoprosthesis at a target location within the tracheobronchial tract. The endoprosthesis consists of a fluoropolymeric tube with a nitinol structure located over its external surface and radiopaque markers. The catheter delivery system is configured with radiopaque markers and is designed for use with guidewires.
The provided document is a 510(k) premarket notification for the VIATORR® Endoprosthesis, a tracheal prosthesis. It does not contain information about acceptance criteria or a study demonstrating the device meets such criteria. The letter confirms substantial equivalence to predicate devices based on composition, design, intended use, and performance attributes, but no specific performance metrics, study designs, or ground truth establishment methods are detailed.
Therefore, I cannot provide the requested information from this 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.”