WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS/WALLSTENT ENDOSCOPIC BILIARY ENDOPROSTHESIS

K961262 · Boston Scientific Scimed, Inc. · FGE · May 10, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K961262
• Device Name: WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS/WALLSTENT ENDOSCOPIC BILIARY ENDOPROSTHESIS
• Applicant: Boston Scientific Scimed, Inc.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: May 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

for treatment of biliary strictures produced by malignant neoplasms.

Device Story

Self-expanding biliary stent; braided biomedical superalloy wire with radiopaque core; constrained on coaxial delivery system. Physician deploys stent by retracting outer tube; stent expands to maintain patency in malignant biliary strictures. Modification increases radial force in 12 mm diameter models via increased wire diameter and wire count. Single-use; sterile; intended for clinical use in biliary tract.

Clinical Evidence

Bench testing only. Performance validated via axial fatigue and relative radial force testing comparing modified 12 mm stent to predicate devices.

Technological Characteristics

Self-expanding braided wire stent; biomedical superalloy with radiopaque core. Coaxial delivery system. Modification: increased wire diameter and wire count to standardize radial force. Sterile; single-use.

Indications for Use

Indicated for patients with biliary strictures caused by malignant neoplasms.

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 (K914277, K923993)

Submission Summary (Full Text)

{0}

10-1-88 THU 12:11 PM SCHNEIDER, USA
FAX NO. 18125505808
P. 3
K961262
MAY 10 1996

# 510(k) SUMMARY

## General Information

| Date Prepared | March 29, 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, K914277, K923993 |

{1}

IL - L-83 THU 12:11 PM SCHNEIDER, USA
FAX NO. 15125505806
P. 4
K961262

## Device Description

The WALLSTENT® Biliary Endoprosthesis is a self-expanding prosthesis constructed of biomedical superalloy with a radiopaque core. The prosthesis is a braided wire structure allows for self expansion. This premarket notification deals with the modification of the 12 mm diameter prosthesis to increase the radial force.

The delivery system is a coaxial tubing assembly which constrains the prosthesis until it is released in a controlled manner. The release of the prosthesis is accomplished by pulling the outer tube back, thus exposing the stent and allowing gradual release and expansion of the prosthesis. The prosthesis is packaged constrained on the delivery system ready for placement. The system is sterile and intended for single use only. The fully expanded stents are offered in sizes from 3 to 12 mm.

## Intended Use

The indication for the use of the WALLSTENT® Endoprosthesis is "for treatment of biliary strictures produced by malignant neoplasms."

## Technological Changes

This premarket notification deals with the modification of the 12 mm diameter prosthesis to standardize the relative radial force. This is accomplished by increased wire diameter and the number of wires used to fabricate the stent.

The modified 12 mm diameter stent can be found substantially equivalent based on the results of axial fatigue and relative radial force testing which demonstrate that the fatigue life and relative radial force are comparable to the predicate device.

## Summary

In summary Schneider (USA) Inc believes the modified device is substantially equivalent based design, materials, methods of fabrication and indications for use.