(467 days)
The Wilson-Cook® Colonic Z-Stent® is a self-expanding, tubular prosthesis used to maintain patency of malignant colonic strictures in patients having high operative risk and/or advanced disease. The Wilson-Cook® Colonic Z-Stent® Introduction System is used to place the Colonic Z-Stent®. This device and the introduction system are supplied sterile and intended for single use only.
The Wilson-Cook® Colonic Z-Stent® is a self-expanding, tubular prosthesis used to maintain patency of malignant colonic strictures in patients having high operative risk and/or advanced disease. The Wilson-Cook® Colonic Z-Stent® Introduction System is used to place the Colonic Z-Stent®. This device and the introduction system are supplied sterile and intended for single use only.
The provided document is a 510(k) summary for the Wilson-Cook® Colonic Z-Stent®. It outlines the device description, intended use, and claims of substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving that the device meets such criteria.
The 510(k) submission process primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device (one that was on the market before May 28, 1976, or has been reclassified). This typically involves comparing characteristics like:
- Intended Use: The purpose of the device.
- Technological Characteristics: How the device functions and its design.
- Performance Data: Often non-clinical (e.g., bench testing, biocompatibility) or sometimes clinical if necessary to address specific performance questions not adequately covered by predicate device data.
The document states: "The device will be manufactured according to specified process controls and a Quality Assurance Program. The device will undergo packaging procedures similar to devices currently manufactured and marketed by Wilson-Cook® Medical. This device is similar with respect to indications for use and design to predicate devices in terms of section 510(k) substantial equivalency."
This statement indicates that the submission relies on demonstrating similarity to existing predicate devices and adherence to manufacturing quality standards, rather than presenting a novel clinical study with explicit acceptance criteria for device performance in a clinical setting.
Therefore, I cannot extract the requested information (points 1-9) as it is not present in the provided text. The document is a regulatory approval notice based on substantial equivalence, not a clinical study report with performance metrics.
§ 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.”