NAVARRE PERCUTANEOUS BILIARY DRAINAGE

K955110 · Navarre Biomedical , Ltd. · FGE · Nov 7, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K955110
• Device Name: NAVARRE PERCUTANEOUS BILIARY DRAINAGE
• Applicant: Navarre Biomedical , Ltd.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Nov 7, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Percutaneous Biliary Drainage Catheter is to treat patients with obstructive jaundice, sepsis, and hepatic decompensation and pre-operative decompression.

Device Story

Percutaneous Biliary Drainage Catheter used for biliary duct drainage; treats obstructive jaundice, sepsis, hepatic decompensation, and pre-operative decompression. Device features tip-locking mechanism, flexible cannula, and biliary septum for fluid injection into bile duct. Used by clinicians in interventional radiology or surgical settings to provide drainage from bile duct to duodenum. Benefits patient by relieving biliary obstruction and associated complications. Design modifications from predicates include altered distal ported section length, catheter length, and addition of biliary septum.

Clinical Evidence

Bench testing only. Laboratory cytotoxicity testing confirmed non-cytotoxic status. Qualification tests demonstrated physical characteristics equivalent to predicate devices.

Technological Characteristics

Biliary drainage catheter with tip-locking mechanism, flexible cannula, and biliary septum. Features modified metallic reinforcement. Materials and physical characteristics verified as substantially equivalent to predicate drainage catheters.

Indications for Use

Indicated for patients with obstructive jaundice, sepsis, hepatic decompensation, and those requiring pre-operative decompression.

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

• Navarre Locking Pigtail Universal Drainage Catheter (K955110)
• Navarre Universal Drainage Catheter (K955110)
• Cook Ultrathane™ Biliary Drainage Catheter (K955110)
• Meditech VTCB Biliary System™ (K955110)

Submission Summary (Full Text)

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NOV - 7 1996
K955110
P194

# 510(k) SUMMARY

## A. Submitter Information

Submitter’s Name: Navarre Biomedical Ltd.

Address: 2545 Fernbrook Lane North
Plymouth, MN 55447

Telephone Number: 612/449-6131

Fax Number: 612/449-6101

Contact Person: Kelly Behrendt

Submission Preparation Date: November 2, 1995

## B. Device Information

Trade Name: Navarre Percutaneous Biliary Drainage Catheter

Common Name: Biliary Drainage Catheter

Classification Name: Biliary Catheter (21 CFR 876.5010)

## Predicate Device

This 510(k) summary identifies the Navarre Locking Pigtail Universal Drainage Catheter and the Navarre Universal Drainage Catheter, as substantially equivalent to the proposed Navarre Percutaneous Biliary Drainage Catheter. The Biliary Catheter is also substantially equivalent to the predicate Cook Ultrathane™ Biliary Drainage Catheter and the Meditech VTCB Biliary System™ designs.

## Device Description

The proposed Percutaneous Biliary Drainage Catheter is identical to the predicate Navarre Locking Pigtail Universal Drainage Catheter in that they have identical

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K955110
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tip-locking mechanisms. They differ only in the length of the distal ported section, catheter length, addition of a flexible cannula, number of drain holes, and the addition of a biliary septum to inject fluids into the bile duct.

Intended Use: The intended use of the Percutaneous Biliary Drainage Catheter is to treat patients with obstructive jaundice, sepsis, and hepatic decompensation and pre-operative decompression.

C. Comparison of Required Technological Characteristics

The Percutaneous Biliary Drainage Catheter is substantially equivalent to the commercially-available Locking Pigtail Universal Drainage, Navarre Universal Drainage, Cook Ultrathane™ Biliary Drainage Catheter, and the Medi-tech VTCB Biliary System™. The Biliary Catheter differs technologically from Navarre predicates only in that it has a modified metallic reinforcement, a more flexible cannula, and a biliary septum. Testing showed that the Percutaneous Biliary Drainage Catheter does not raise any new questions of safety and effectiveness.

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Comparison of Required Characteristics

| Characteristics | Proposed Navarre Percutaneous Biliary Drainage Catheter | Predicate Navarre hydrophilic Universal Drainage Catheter | Predicate Navarre Locking Pigtail Universal Drainage Catheter | Predicate Cook Ultrathane Biliary Catheter | Predicate Medi-tech VTCB Biliary System |
| --- | --- | --- | --- | --- | --- |
| a. Product Labeling | Substantially equivalent | Substantially equivalent | Substantially equivalent | Substantially equivalent | Substantially equivalent |
| b. Intended Use | Obstructive jaundice, sepsis, hepatic decompensation and pre-operative decompression | Nephrostomy, abscess and general drainage | Abscess, cyst, and general purpose drainage | Identical to proposed catheter | Identical to proposed catheter |
| c. Physical Characteristics | Substantially equivalent | Substantially equivalent | Substantially equivalent | Substantially equivalent | Substantially equivalent |
| d. Anatomical Sites | Bile duct and duodenum | Kidney and general drainage sites | Abscessed sites | Identical to proposed catheter | Identical to proposed catheter |
| e. Target Population | Patients with obstructive jaundice, sepsis and hepatic decompensation and pre-operative decompression | Patients requiring kidney, abscess, or other general drainage applications | Patients with abscess and general drainage needs | Identical to proposed catheter | Identical to proposed catheter |
| f. Performance Testing | Substantially equivalent | Substantially equivalent | Substantially equivalent | Substantially equivalent | Substantially equivalent |
| g. Safety Characteristics | Identical | Identical | Identical | Substantially equivalent | Substantially equivalent |

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p4014

# D. Summary of Nonclinical Tests

Laboratory tests for cytotoxicity showed that the Percutaneous Biliary Drainage Catheter is non-cytotoxic. Qualification tests demonstrate that the physical characteristics of the catheter are equivalent to predicate devices. In conclusion, the laboratory results show that the Percutaneous Biliary Drainage Catheter design does not raise any new questions of safety and efficacy and that the Biliary Catheter is substantially equivalent to the current Locking Pigtail Universal Drainage, Navarre Universal Drainage, Cook Ultrathane™ Biliary Drainage Catheter, and the Medi-tech VTCB Biliary System.™