WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS

K964119 · Boston Scientific Scimed, Inc. · FGE · Apr 28, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K964119
• Device Name: WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS
• Applicant: Boston Scientific Scimed, Inc.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Apr 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The WALLSTENT® Biliary Endoprosthesis is intended for use in the treatment of biliary strictures produced by malignant neoplasms.

Device Story

Self-expanding braided wire stent; constructed of biomedical superalloy and elastomeric polymer; used to maintain biliary duct lumen diameter. Delivered via coaxial tubing assembly; outer sheath retraction allows controlled release. New delivery system enables partial deployment and re-constraint for precise placement. Used by clinicians in endoscopic or transhepatic procedures. Stent provides radial force for stabilization; benefits patient by relieving biliary obstruction caused by malignant neoplasms.

Clinical Evidence

Bench testing only; in vitro and in vivo deployment testing performed to compare handling characteristics and deployment forces of the alternate delivery system against the predicate system.

Technological Characteristics

Self-expanding braided wire stent; materials: biomedical superalloy and elastomeric polymer. Delivery system: coaxial tubing assembly. Sterile, single-use. Feature: partial deployment and re-constraint capability.

Indications for Use

Indicated for treatment of biliary strictures caused by malignant neoplasms in patients requiring biliary duct lumen maintenance.

Regulatory Classification

Identification

A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.

Special Controls

*Classification.* Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Predicate Devices

• WALLSTENT® Biliary Transhepatic Endoprosthesis (K911292)
• WALLSTENT® Biliary Endoscopic Endoprosthesis (K914227)
• WALLSTENT® Biliary Transhepatic Endoprosthesis (K923993)
• WALLSTENT® Biliary Endoscopic Endoprosthesis (K961262)

Reference Devices

• Esophageal delivery system (K940396)

Submission Summary (Full Text)

{0}

*APR 28 1997*

Premarket Notification for the

WALLSTENT® Biliary

Endoprosthesis

K964119

16. **510(k) SUMMARY**

## General Information

| Date Prepared | September 26, 1996 |
| --- | --- |
| Classification | Class II |
| Trade Name | WALLSTENT® Biliary Transhepatic Endoprosthesis
WALLSTENT® Biliary Endoscopic Endoprosthesis |
| Common Name | Biliary Stent |
| Submitter | Schneider (USA) Inc
5905 Nathan Lane
Minneapolis, MN 55442
[phone] |
| Contact | Cathy Yohnk
Senior Regulatory Affairs Associate |
| Predicate Device | WALLSTENT® Biliary Transhepatic Endoprosthesis
WALLSTENT® Biliary Endoscopic Endoprosthesis
K911292, K914227, K923993, K961262 |

## Device Description

The WALLSTENT® Biliary Endoprosthesis is a self-expanding prosthesis constructed of biomedical superalloy and an elastomeric polymer. The prosthesis is a braided wire structure. The outward radial force along with the ends of the device serve to stabilize the prosthesis after implanted. The stent’s purpose is to increase or maintain the inner lumenal diameter of the biliary duct.

20

{1}

Premarket Notification for the WALLSTENT® Biliary Endoprosthesis

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 retracting the outer sheath. The prosthesis is packaged constrained on the delivery system ready for placement. The system is sterile and intended for single use only.

## Indication

The WALLSTENT® Biliary Endoprosthesis is intended for use in the treatment of biliary strictures produced by malignant neoplasms.

## Technological Characteristics

The purpose of this 510(k) is to allow an alternate delivery system which allows the user to partially deploy and then reconstrain the stent to facilitate placement. This feature is presently available in the Esophageal delivery system (K940396).

The alternate delivery system can be found substantially equivalent based on the results of *in vitro* and *in vivo* deployment testing which demonstrate that deployment forces and handling characteristics are comparable to the current delivery system.

## Summary

In summary Schneider (USA) Inc believes the alternate delivery system is substantially equivalent based on design, test results, and indications for use.

21