WALLSTENT ENTERAL ENDOPROSTHESIS

K980113 · Boston Scientific Scimed, Inc. · MUM · Apr 3, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K980113
• Device Name: WALLSTENT ENTERAL ENDOPROSTHESIS
• Applicant: Boston Scientific Scimed, Inc.
• Product Code: MUM · General, Plastic Surgery
• Decision Date: Apr 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3610
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended as a for the palliative treatment of duodenal strictures caused by malignant neoplasms. This device is intended as a non-surgical permanent implant as a safe and effective procedure to eliminate gastric outlet obstruction.

Device Story

WALLSTENT Enteral Endoprosthesis consists of a self-expanding metallic stent and delivery system. Stent is composed of implant-grade cobalt-base superalloy wire in a braided tubular mesh configuration. Device is used by physicians to open restricted lumens in the duodenum. Deployment utilizes dynamic radial force to expand the lumen diameter, decompressing strictures and relieving gastric outlet obstruction. Procedure allows for oral nutrient intake within hours to days, eliminating need for surgical bypass. Device is a permanent, non-surgical implant.

Clinical Evidence

No new clinical data provided. Evidence relies on clinical literature demonstrating successful in vivo use of metal stents for duodenal stricture decompression, resulting in relief of gastric outlet obstruction and restoration of oral intake.

Technological Characteristics

Implant-grade cobalt-base superalloy wire; braided tubular mesh configuration; self-expanding; dynamic radial force deployment; multiple sizes available.

Indications for Use

Indicated for palliative treatment of duodenal strictures caused by malignant neoplasms in patients requiring relief of gastric outlet obstruction.

Regulatory Classification

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.

Special Controls

The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”

Predicate Devices

• WALLSTENT® Enteral Endoprosthesis (K980113)

Submission Summary (Full Text)

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## 510(k) Summary for The WALLSTENT® Enteral Endoprosthesis

APR - 3 1998

| Date Prepared: | January 12, 1998 |
|----------------|---------------------------------------------------------------------------------------|
| Sponsor: | Schneider (USA) Inc<br>5905 Nathan Lane<br>Plymouth, MN 55442<br>Phone: [phone] |
| Contact: | Kathy Jo Fahey<br>Sr. Regulatory Affairs Specialist |

Device Proprietary Name: WALLSTENT® Enteral Endoprosthesis

Class III Classification:

Equivalent Devices: WALLSTENT® Enteral Endoprosthesis

[phone]

## Device Description:

The WALLSTENT® Enteral Endoprosthesis is comprised of two components: the temporary (short-term) implantable metallic stent and the delivery device. The stent is composed of implant-grade cobalt-base superalloy wire braided in a tubular mesh configuration. The design configuration results in a stent that is flexible, compliant and The stent is available in multiple sizes. Physician preference and self-expanding. individual patient condition and/or anatomy will determine the appropriate size chosen.

## Intended Use:

This device is intended as a for the palliative treatment of duodenal strictures caused by malignant neoplasms. This device is intended as a non-surgical permanent implant as a safe and effective procedure to eliminate gastric outlet obstruction.

## Technological Characteristics:

Enteral Endoprosthesis has identical technological (materials, The WALLSTENT construction, processing) characteristics as the predicate device the WALLSTENT® devices. These devices allow for self expanding deployment using dynamic radial force to gently and firmly expand the lumen diameter. The WALLSTENT® Enteral Endoprosthesis will be used to open a pathway through a restricted lumen. The other predicate devices ultimately achieve the same end result.

A search of clinical literature has found that the clinical in vivo experience of a stent within the clinical indication that we are requesting has been successful. In brief a metal stent placement within the duodenal area has been successful in the decompression of a stricture, allowing for immediate relief of gastric outlet obstruction and permitting the patient oral intake of nutrients within several hours to days of the procedure. This procedure eliminates the need for surgical bypass.

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Performance testing was done on the predicate device. Tests included fatigue, corrosion resistance, relative radial force, and stent deformation testing to assure mechanical strength of the wire. The results were all within the expected ranges. Because this is a request for an additional indication and introduces no new materials, design or processes these tests were not repeated.

The results of these tests demonstrate that the Schneider WALLSTENT® Enteral Endoprosthesis is equivalent to the predicate device and is therefore safe for its intended use.

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Image /page/2/Picture/0 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 3 1998

Ms. Kathy Jo Fahey Senior Regulatory Affairs Specialist Schneider, (USA), Inc. 5905 Nathan Lane Minneapolis, MN 55442

Re: K980113

WALLSTENT® Enteral Endoprosthesis and UNISTEPTM Delivery System Dated: January 12, 1998 Received: January 13, 1998 Regulatory Class: III 21 CFR 878.3610/Procode: 78 MUM

Dear Ms. Fahev:

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 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 Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (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 equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (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 542 of the Act for devices under the Electronic Product 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 predicate device results in a classification 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely yours.

Lillian Yin, Ph.D.

Director, Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1480113

Page 1 of 1

510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name: Schneider WALLSTENT® Enteral Endoprosthesis

Indication for Use:

The Schneider (USA) Inc Enteral Endoprosthesis is indicated for palliation of duodenal strictures caused by malignant neoplasms.

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEFDED NEEDED ==============================================================================================================================================================================

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Robert S. Stling/

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K980113

**Prescription Use**
or
(Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________