BARD A-TRAC UROLOGICAL BALLOON DILATION CATHETER

K962921 · C.R. Bard, Inc. · EZN · Oct 9, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K962921
• Device Name: BARD A-TRAC UROLOGICAL BALLOON DILATION CATHETER
• Applicant: C.R. Bard, Inc.
• Product Code: EZN · Gastroenterology, Urology
• Decision Date: Oct 9, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indicated for use in dilation of the ureter or urethra through the working channel of an endoscope.

Device Story

Multi-lumen balloon dilation catheter; distal balloon mounted on tapered shaft; guidewire-compatible; radiopaque markers for visualization. Used by urologists during endoscopic procedures; inserted through endoscope working channel over guidewire to stricture or stone site. Balloon inflated with fluid to dilate ureter or urethra; facilitates stone removal or stricture treatment. Single-use; sterile.

Clinical Evidence

Bench testing only. Performance data includes balloon inflation diameter/length verification at 3-4 atm, balloon growth <15% over working pressure range, and burst pressure testing (max 13-15 atm) to ensure 99.9% reliability at 95% confidence level.

Technological Characteristics

Materials: Nylon shaft, PET balloon, tantalum marker bands. Multi-lumen design; 5 Fr or 5.8 Fr shaft diameter; 4-10mm balloon diameter; 2-10cm balloon length. Guidewire compatible (0.035"). Sterile, single-use.

Indications for Use

Indicated for dilation of ureter or urethra in patients requiring treatment of strictures or stone/calculi removal via endoscopic access.

Regulatory Classification

Identification

A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.

Predicate Devices

• Bard® Tru-Trac™ Peripheral Balloon Dilatation Catheters
• Microvasive (Boston Scientific) Uro Max™ II High Pressure Ureteral Balloon Dilatation Catheter
• Microvasive (Boston Scientific) Phantom 5™ Plus ST (Short Tip) Ureteral Balloon Dilatation Catheter

Submission Summary (Full Text)

{0}

BARD Urological Division
C. R. Bard, Inc.
8195 Industrial Blvd.
Covington, GA 30209-2695
K962921 p 173
OCT - 9 1996
BARD

# SECTION VI

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

### A. Submitter Information:

Submitter's Name: C. R. Bard, Inc., Urological Division
Submitter's Address: 8195 Industrial Blvd., 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: July 23, 1996

### B. Device Name:

Bard® A-Trac™ Urological Balloon Dilation Catheter

### C. Predicate Device Name:

Bard® Tru-Trac™ Peripheral Balloon Dilatation Catheters and Microvasive's (Boston Scientific Corporation) Uro Max™ II High Pressure Ureteral Balloon Dilatation Catheter and Phantom 5™ Plus ST (Short Tip) Ureteral Balloon Dilatation Catheter.

### D. Device Description:

The Bard® A-Trac™ Urological Balloon Dilation 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 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.

-6.1-
480-06

{1}

K962921 p293

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 0.035" PTFE-coated guidewire. Two radiopaque markers are placed beneath the "working area" of the balloon.

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® A-Trac™ Urological Balloon Dilation 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 &lt; 10mm) or 5.8 Fr. (for balloons with 10mm inflated diameter).

The device is provided sterile for one time use only and is not intended to be re-used or re-sterilized. Guidewires 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 (Information for Use) the Bard® A-Trac™ Urological Balloon Dilation Catheter is:

"Indicated for use in dilation of the ureter or urethra through the working channel of an endoscope."

## F. Technological Characteristics Summary:

The Bard® A-Trac™ Urological Balloon Dilation Catheter is constructed of biocompatible materials. The shaft of the device is constructed of nylon, the balloon is constructed of PET (polyethylene terephthalate), the marker bands are tantalum. The catheter is generally inserted through the working channel of an endoscope and over a guidewire, advanced within the urethra or ureter to the stone or calculi location or point of stricture and inflated with fluid to perform dilation of the urethra or ureter to allow stone removal or treatment of stricture.

-6.2-

{2}

K962921 P393

## 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 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 &lt;10mm and not to exceed 13 atm for 10mm inflated balloon diameter.