BARD MEMOTHERM TRANSHEPATIC BILIARY ENDOPROSTHESIS

K963782 · C.R. Bard, Inc. · FGE · May 2, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K963782
• Device Name: BARD MEMOTHERM TRANSHEPATIC BILIARY ENDOPROSTHESIS
• Applicant: C.R. Bard, Inc.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: May 2, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bard Memotherm Transhepatic Biliary Endoprosthesis is indicated for use in the treatment of biliary strictures resulting from malignant neoplasms.

Device Story

Self-expanding metal mesh stent; nitinol construction; designed to maintain patency of biliary ducts obstructed by malignant neoplasms. Pre-loaded on 7 Fr. delivery system; compatible with 7 Fr. introducer and .035" guidewire. Deployed by physician in clinical setting to treat strictures. Stent resists bile corrosion and compressive forces; elastic properties comparable to predicate. Benefits include maintaining biliary drainage in oncology patients.

Clinical Evidence

Bench testing only. Performance data includes delivery system pull tests (shaft-to-handle >5 lbs; tip-to-shaft >2 lbs), deployment testing in tortuous paths, and assessment of corrosion resistance and compressive strength.

Technological Characteristics

Metal mesh stent; material: nitinol; self-expanding; diameters: 7, 8, 9, 10, 12mm; lengths: 30-110mm; delivery system: 7 Fr. compatible with .035" guidewire.

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

• Schneider Wallstent

Submission Summary (Full Text)

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C.R. Bard, Inc.
8195 Industrial Blvd.
Covington, GA 30209
May - 2 1997
K963782
BAIRD

SECTION VI

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

A. Submitter Information:
Submitter's Name: C. R. Bard, Inc., Radiology Division
Submitter's Address: 13183 Harland Drive., Covington, GA 30209
Contact Person: Donna J. Wilson
Contact Person's Address: 8195 Industrial Blvd.,
Covington, GA 30209
Contact Person's Telephone Number: 770-784-6135
Contact Person's FAX Number 770-784-6419
Date of Preparation: September 16, 1996

B. Device Name:
Bard® Memotherm® Transhepatic Biliary Endoprosthesis

C. Predicate Device Name:
Schneider Wallstent

D. Device Description
The Bard Memotherm Transhepatic Endoprosthesis is a stenting device designed to maintain the patency of biliary ducts obstructed by malignant neoplasms. The device includes the self-expanding Bard Memotherm Transhepatic Biliary Endoprosthesis pre-loaded on a unique delivery system. This 7 Fr. delivery system is compatible with a 7 Fr. introducer and accepts a .035" guidewire. The Bard Memotherm Transhepatic Biliary Endoprosthesis is available in various diameters and lengths.

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## E. Intended Use:

The Bard Memotherm Transhepatic Biliary Endoprosthesis is indicated for use in the treatment of biliary strictures resulting from malignant neoplasms.

## F. Technological Characteristics Summary:

The Bard Memotherm Transhepatic Biliary Endoprosthesis is a metal mesh stent constructed of biocompatible nitinol. It is self-expanding and is packaged pre-mounted on a disposable delivery system. It will be available in expanded diameters of 7, 8, 9, 10 and 12mm and in lengths from 30mm to 110mm.

## G. Performance Data:

The Bard Memotherm Transhepatic Biliary Endoprosthesis deploys easily from the delivery system even in a tortuous path. The delivery system withstands pull test forces in excess of 5 lbs for the shaft-to-handle joint and in excess of 2 lbs for the tip-to-shaft joint. Elastic properties of the Memotherm stent are comparable to those for the predicate device. The stent is resistant to corrosion by bile and to compressive forces expected to be encountered within the biliary system.

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