Evolution Esophageal Stent System – Partially Covered

• K Number: K162717
• Device Name: Evolution Esophageal Stent System – Partially Covered
• Manufacturer: Cook Ireland Ltd.
• Date Cleared: 2016-12-21 ( 83 days)
• Product Code: ESW
• Regulation Number: 878.3610
• Type: Traditional
• Panel: GU
• Reference & Predicate Devices: K080359 , K093619

Intended Use

This device is used to maintain patency of malignant esophageal strictures and / or to seal tracheoesophageal fistulas.

Device Description

The Evolution® Esophageal Stent System - Partially Covered consists of a self-expanding metal stent and a stent introduction system. The stent is provided pre-loaded in the introduction system. The handle allows for desheathing to deploy the stent and resheathing recapturing the stent during stent deployment. The stent is woven from nitinol wire. The stent is formed with a flange at either end. The increased diameter of the stent at the stent ends helps provide resistance to migration. A silicone membrane applied to the stent covers the complete body of the stent along with part of both flanges. The covering is intended to reduce the risk of tissue ingrowth and provides a seal for tracheoesophageal fistulas. To aid in visibility under fluoroscopy there are four bands at either end of the stent. The stent has a lasso loop which can be used to reposition the stent during the initial placement procedure if desired. The device is supplied sterile, intended for single use only and is available for prescription use only.

AI/ML Overview

This document describes the Cook Ireland Ltd. Evolution® Esophageal Stent System - Partially Covered and its substantial equivalence to predicate devices, but does not contain any information about acceptance criteria, device performance metrics, or study results related to an AI/Machine Learning device or software.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The provided text pertains to a traditional medical device (an esophageal stent) and focuses on its physical characteristics, materials, and non-clinical performance testing (biocompatibility, simulated use, corrosion, etc.) to demonstrate substantial equivalence for regulatory clearance. It does not involve any AI/ML components or studies that would involve performance metrics like sensitivity, specificity, or reader studies with AI assistance.

Regulation Number and Section

§ 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.”