(52 days)
The Flamingo™ WALLSTENT® Esophageal Endoprosthesis is intended to be used for the - palliative treatment of strictures of the esophagus, - including cardia, due to a malignant process - palliative treatment of tracheo-esophageal fistulae due to a malignant process.
The Flamingo™ WALLSTENT® Esophageal Endoprosthesis is a self expanding prosthesis constructed of biomedical superalloy with an elastomeric polymer covering. The prosthesis is a braided wire structure which is covered with elastomeric polymer over approx. 75 % of it's length. The outward radial force, the conical shape of the stent along with the ends of the device serve to stabilize the placed. The stent's purpose is to increase or maintain the inner lumenal diameter of the esophageal passage or to close tracheo-esophageal fistulae. 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 the sliding of the outer coaxial tube. The prosthesis is packaged constrained on the delivery system ready for placement. The system is sterile and intended for single use only.
This document describes the Flamingo™ WALLSTENT® Esophageal Endoprosthesis, a medical device for treating esophageal strictures and tracheo-esophageal fistulae due to malignant processes. However, it does not contain information about acceptance criteria, device performance studies, or any of the other specific details requested in the prompt related to a comparative effectiveness study, standalone algorithm performance, or ground truth establishment.
The provided text is a 510(k) summary from 1999, which primarily focuses on establishing substantial equivalence to previously marketed devices based on design, materials, manufacturing methods, and indications for use. It's a regulatory document for market clearance, not typically a detailed report of clinical study results or performance metrics as requested by the prompt for AI/diagnostic devices.
Therefore, I cannot fulfill the request using the provided input, as the information is not present in the document.
§ 878.3610 Esophageal prosthesis.
(a)
Identification. An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal 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.”