BARD TRU-TRAC PERIPHERAL BALLOON DILATATION CATHETER

K960517 · C.R. Bard, Inc. · LIT · Apr 9, 1996 · Cardiovascular

Device Facts

• Record ID: K960517
• Device Name: BARD TRU-TRAC PERIPHERAL BALLOON DILATATION CATHETER
• Applicant: C.R. Bard, Inc.
• Product Code: LIT · Cardiovascular
• Decision Date: Apr 9, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Any use of this product for procedures other than those indicated is not recommended.

Device Story

Multi-lumen balloon dilatation catheter; used for PTA of femoral, iliac, renal arteries and AV dialysis fistulae. Device features distal balloon for dilatation; guidewire lumen for tracking, pressure monitoring, or infusion. Operated by physician in clinical setting. Inserted via introducer over .035" guidewire; advanced to lesion site; balloon inflated with fluid to dilate vessel. Radiopaque markers facilitate positioning. Single-use; sterile; non-pyrogenic.

Clinical Evidence

Bench testing only. Performance data includes balloon inflation characteristics, burst pressure testing (99.9% reliability at 95% confidence level), and balloon growth metrics (less than 15% over working pressure range).

Technological Characteristics

Materials: PEBAX (shaft), PET (balloon), tantalum (marker bands). Multi-lumen design; 5 Fr or 5.8 Fr shaft diameters; balloon diameters 4-10mm; lengths 2-10cm. Fluid-actuated inflation. Sterilized for single use.

Indications for Use

Indicated for patients requiring Percutaneous Transluminal Angioplasty (PTA) of femoral, iliac, or renal arteries, or treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Medi-Tech® Ultra-Thin™ Balloon Dilatation Catheter

Submission Summary (Full Text)

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Bard Radiology Division
13183 Harland Dr., N.E.
Covington, GA 30209
K960517
BARD

# 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: February 2, 1996

B. Device Name:

Bard® Tru-Trac™ Peripheral Balloon Dilatation Catheter

C. Predicate Device Name:

Medi-Tech® Ultra-Thin™ Balloon Dilatation Catheter

D. Device Description

The Bard Tru-Trac Peripheral Balloon Dilatation Catheter is a multi-lumen catheter with a discrete balloon mounted on its distal tip. The clear lumen, labeled "balloon", is for balloon inflation. The green lumen, labeled "distal", allows the catheter to track over a guidewire and can be used for monitoring of pressure or infusion of medication and/or contrast medium.

The catheter shaft gradually tapers beneath the balloon, nominally one french size. The tip is further tapered to provide a smooth interface with a Bard .035" PTFE-coated guidewire. Two radiopaque markers are placed beneath the "working area" of the balloon.

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The balloon is wrapped clockwise (when viewed from the proximal shaft to the distal tip) around the shaft and is protected by a balloon folding tool prior to sterilization. A stylette is inserted in the distal (guidewire) lumen beneath the balloon folding tool.

The Bard Tru-Trac Peripheral Balloon Dilatation Catheter is available in various models incorporating balloon diameters (inflated) of 4mm-10mm; balloon lengths of 2, 3, 4, 8 and 10 cm; shaft lengths ranging from 45 to 125cm (standard lengths of 45, 75, 85 and 125cm); and shaft diameter of 5 Fr. (for balloons with inflated diameters < 10mm) or 5.8 Fr. (for balloons with 10mm inflated diameter).

The device is provided sterile and non-pyrogenic for one time use only and is not intended to be re-used or re-sterilized. Guidewires, guiding catheters or introducers that may be required for a particular procedure are not packaged with the balloon dilatation catheter and must be obtained separately.

## E. Intended Use:

As stated in the device package insert (Directions for Use) the Bard Tru-Trac Peripheral Balloon Dilatation Catheters is:

"Recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Any use of this product for procedures other than those indicated is not recommended."

## F. Technological Characteristics Summary:

The Bard Tru-Trac Peripheral Balloon Dilatation Catheter is constructed of biocompatible materials. The shaft of the device is constructed of PEBAX (elasticized nylon), the balloon is constructed of PET (polyethyleneterephthalate), the marker bands are tantalum. The catheter is generally inserted through an introducer and over a guidewire, advanced within the vessel to the point of lesion and inflated with fluid to perform dilatation of the vessel.

## G. Performance Data:

Each balloon inflates to the stated diameter and length at a specific pressure—typically between 3 and 4 atms. The maximum amount of balloon growth in either diameter or length is less than 15% over the

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working pressure range. All balloons are preinflated to full size. The maximum recommended inflation pressure is the pressure at which 99.9% of balloons, at a 95% confidence level, will not burst at or below this pressure upon a single inflation. The maximum inflation pressure is not to exceed 15 atm for inflated balloon diameters <10mm and not to exceed 13 atm for 10mm inflated balloon diameter.

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