CORDIS BILIARY STENT

K955728 · Cordis Corp. · FGE · May 8, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K955728
• Device Name: CORDIS BILIARY STENT
• Applicant: Cordis Corp.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: May 8, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cordis Biliary Stent intended use is to maintain patency of a bile duct which is obstructed from malignant neoplasms.

Device Story

Helical coil stent; flexible radiopaque 5400 Grade Tantalum; 7.0 mm diameter; 1.5 cm and 3.0 cm lengths. Supplied mounted/crimped on balloon catheter delivery system. Used by physicians in clinical settings to maintain bile duct patency in malignant obstruction cases. Stent expands upon balloon inflation to support ductal walls; prevents occlusion; improves biliary drainage.

Clinical Evidence

In-vitro and in-vivo testing conducted. Biocompatibility testing performed per ISO 10993 Part 1.

Technological Characteristics

Material: 5400 Grade Tantalum (Ta). Form factor: Helical coil stent, 7.0 mm diameter, 1.5/3.0 cm lengths. Delivery: Balloon catheter system. Radiopaque.

Indications for Use

Indicated for patients with bile duct obstruction 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

• Johnson & Johnson Interventional Systems Palmaz™ Balloon Expandable Stent (K905720, K911581)
• Schneider Wallstent® Transhepatic Biliary Endoprosthesis (K885180, K896163, K911292, K914277)
• Cook Incorporated Gianturco-Rosch Biliary Z Stents™ (K921191, K903858, K882610)

Submission Summary (Full Text)

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K955728 0-000047

# SUMMARY OF SAFETY AND EFFECTIVENESS

MAY - 8 1996

## I. General Provisions

Common or Usual Name: Biliary Stents

Proprietary Name: Cordis Biliary Stent

## II. Name of Predicate Devices

1. Johnson & Johnson Interventional Systems Palmaz™ Balloon Expandable Stent (K905720 and K911581) for design and intended use.

2. Schneider Wallstent® Transhepatic Biliary Endoprosthesis (K885180, K896163, K911292, K914277) for intended use and design.

3. Cook Incorporated Gianturco-Rosch Biliary Z Stents™ (K921191, K903858, K882610) for intended use and design.

## III. Classification

Class II, 21CFR 876.5010, Biliary Catheters and Accessories.

## IV. Performance Standards

Performance standards have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act.

## V. Intended Use and Device Description

The Cordis Biliary Stent intended use is to maintain patency of a bile duct which is obstructed from malignant neoplasms.

The Cordis Biliary Stent is a helical coil made of flexible radiopaque 5400 Grade Tantalum (Ta). The stent is available in 7.0 mm diameter size. The nominal expanded length of the stent is 1.5 cm and 3.0 cm. The stent is supplied mounted and crimped onto a balloon catheter delivery system, the size of which determines the delivered diameter of the stent.

## VI. Biocompatibility

All appropriate biocompatibility tests as specified by ISO 10993 Part 1 - Biological Evaluation of Medical Devices, were successfully performed on the Cordis Biliary Stent.

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## VII. Summary of Substantial Equivalence

The Cordis Biliary Stent is similar in its basic design, construction, indication for use and performance characteristics to other commercially available biliary stents. *In-vitro* and *in-vivo* testing was conducted to support substantial equivalence to the predicate devices.

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