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.

Device Description

AI/ML Overview

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.

Summary

{0}------------------------------------------------

510(k) Response to Request for Additional Information Wilson-Cook® Colonic Z-Stent® D.C. #K990034

K 990034
1.2
page 1 of 1

APR 1 7 2000

510(k) Summary:

Submitted By:

Neal E. Fearnot, Ph.D. MED Institute, Incorporated 1400 Cumberland Avenue West Lafayette, Indiana 47906 (765) 463-7537 October 1, 1999

Device:

Trade Name:	Wilson-Cook® Colonic Z-Stent®
Common/Usual Name:	Self-Expandable Stent, Z-Stent®
Proposed Classification:	Self-expanding colonic stent

Predicate Devices:

The Wilson-Cook® Colonic Z-Stent® is similar to predicate self-expandable Z-Stents® manufactured by Wilson-Cook® Medical, Incorporated and Schneider (USA) which are used in the digestive tract to maintain patency.

Device Description:

Substantial Equivalence:

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.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird-like shape.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 7 2000

Neal E. Fearnot, Ph.D. President MED Institute. Incorporated 1400 Cumberland Avenue West Lafayette, IN 47906

Re: K990034 Wilson-Cook® Colonic Z-Stent® Dated: February 29, 2000 Received: March 1, 2000

Requiatory Class: II 21 CFR §878.3610/Procode: 78 MQR

Dear Dr. Fearnot:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmelic Act (Act). You may, therefore, market the device, subject to the general controls of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalion assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requiration entititled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-5597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

{2}------------------------------------------------

510(k) Number (if known):

Device Name: _ Wilson-Cook® Colonic Z-Stent®

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Lynn

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number.

Prescription Use_ (Per 21 CFR 801.109)

Over-The-Counter Use_

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.”