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 Description

The Bard Tru-Trac Peripheral Balloon Dilatation Catheter is a multilumen 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.

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.

AI/ML Overview

The provided text describes a medical device, the Bard® Tru-Trac™ Peripheral Balloon Dilatation Catheter, and its performance characteristics. However, it does not contain information about acceptance criteria and a study proving a device meets them in the context of an AI/machine learning diagnostic device. The text is a regulatory submission (510(k) summary) for a physical medical device, primarily focusing on its design, intended use, and manufacturing specifications.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, etc.) because the document does not relate to an AI-driven diagnostic.

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Summary

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

K960517

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 multilumen 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.

480-06

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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.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
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.(b)
Classification. Class II (performance standards).