(97 days)
The WALLSTENT® Tracheobronchial Endoprosthesis is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
The WALLSTENT® Tracheobronchial Endoprosthesis is a self-expanding prosthesis constructed of biomedical superalloy and an elastomeric polymer. Smaller diameter models may utilize a radiopaque core. The prosthesis is a braided wire structure which may be covered with an elastomeric polymer in selected models. The outward radial force along with the ends of the device serve to stabilize the prosthesis after implanted. The prosthesis is offered in covered and uncovered versions to allow physicians to select the most appropriate model based on their preference and individual patient condition. The stent's purpose is to increase or maintain the inner luminal diameter of the tracheobronchial passage. The stent is placed by means of a delivery system. The delivery system is a coaxial tubing assembly which constrains the prosthesis until it is released in a controlled manner. The release of the stent is accomplished by retracting the outer sheath. The prosthesis is packaged constrained on the delivery system ready for placement. The system is sterile and intended for single use only.
The provided text describes a 510(k) premarket notification for the WALLSTENT® Tracheobronchial Endoprosthesis, which is a medical device. This document is a regulatory submission for market clearance and does not contain acceptance criteria or a study that proves the device meets specific performance criteria in the way an AI/ML device submission would.
The document details the device's description, indications for use, and a comparison to predicate devices to demonstrate substantial equivalence, a key concept in 510(k) submissions. It mentions modifications to existing stents (increasing wire diameter and/or number of wires to standardize relative radial force), suggesting that some testing or design changes occurred, but it doesn't provide performance metrics or the details of a study with acceptance criteria.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance because it is not present in the provided text. The submission is focused on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study against predefined acceptance criteria.
§ 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.”