The Bard® ConquestTM PTA Balloon Dilatation Catheter is recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

Device Description

The Bard® Conquest™ PTA Balloon Dilatation Catheter is a coaxial lumen catheter with a balloon mounted on its distal tip. One lumen accommodates the insertion guidewire and the second provides a channel for inflation/deflation of the balloon. There are two radiopaque marker bands placed beneath the balloon to indicate its position within the vasculature.

AI/ML Overview

This document describes the Bard® Conquest™ PTA Balloon Dilatation Catheter, a medical device. The information provided is a 510(k) summary for the purpose of demonstrating substantial equivalence to a predicate device, not a study evaluating acceptance criteria for an AI/ML-driven medical device. Therefore, much of the requested information regarding acceptance criteria, study methodologies, and AI-specific performance metrics is not present in the provided text.

Based on the provided text, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria. Instead, it relies on demonstrating "substantial equivalence" to a predicate device through "bench testing."

Acceptance Criteria	Reported Device Performance
Substantially equivalent to predicate device	Bench testing shows that the modified catheter is substantially equivalent to the predicate device, the Opti-Plast Centurion™ 5.5 Fr PTA Catheter.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided. The document mentions "bench testing" but does not detail the sample size or the nature of the test set beyond that.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable and not provided. "Bench testing" typically refers to engineering tests performed in a lab setting, not clinical studies requiring expert ground truth for interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable and not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable and not provided. This is a medical device, not an AI-driven diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable and not provided. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For "bench testing," the "ground truth" would be the established engineering specifications and performance standards for the predicate device. The document does not explicitly state the specific parameters or their "ground truth" values against which the new device's performance was measured, but it implies comparison to the predicate's known characteristics.

8. The sample size for the training set

This information is not applicable and not provided. There is no mention of a training set as this is not an AI/ML-based device.

9. How the ground truth for the training set was established

This information is not applicable and not provided. There is no mention of a training set.

Summary

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Bard Peripheral Technologies C.R. Bard, Inc. 13183 Harland Dr., N.E. Covington, GA 30014

K014212

JAN 1 7 2002

BARD

510(k) SUMMARY OF SAFETY AND EFFECTIVENES INFORMATION

A.. Submitter Information:

Submitter's Name:	C.R. Bard, Inc., Peripheral Technologies Division
Submitter's Address:	13183 Harland Drive, Covington, GA 30014
Contact Person:	Carol Vierling
Contact Person's Telephone Number:	(770) 385-2347
Contact Person's FAX Number:	(770) 385-2340
Date of Preparation:	December 14, 2001

B. Device Name:
Bard® Conquest™ PTA Balloon Dilatation Catheter
C. Predicate Device:
Opti-Plast Centurion™ 5.5 Fir PTA Catheter
D. Device Description: ·
The Bard® Conquest™ PTA Balloon Dilatation Catheter is a coaxial lumen catheter with a balloon mounted on its distal tip. One lumen accommodates the insertion guidewire and the second provides a channel for inflation/deflation of the balloon. There are two radiopaque marker bands placed beneath the balloon to indicate its position within the vasculature.

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E. Intended Use:

The Bard® Conquest™ PTA Balloon Dilatation Catheter is recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

F. Technological Characteristics Summary:
The Bard® Conquest™ PTA Balloon Dilatation Catheter is offered in 6, 7 or 8 Fr shaft diameters and shaft lengths of 50, 75 or 100cm, depending on balloon size. Various balloon diameters and lengths are available.
G. Performance Data:
Bench testing shows that the modified catheter is substantially equivalent to the predicate device, the Opti-Plast Centurion™ 5.5 Fr PTA Catheter.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three wavy lines representing the flow of life. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 7 2002

Ms. Carol Vierling Director, Regulatory Affairs C.R. Bard, Inc. Bard Peripheral Technologies 13183 Harland Drive, N.E. Covington, GA 30014

Re: K014212

Trade Name: Bard® Conquest™ PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: December 14, 2001 Received: December 21, 2001

Dear Ms. Vierling:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Carol Vierling

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Dallas Miller

ram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Device Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ATTACHMENT 5

Indications for Use Statement

DeviceName	Bard® ConquestTM PTA Balloon Dilatation Catheter

Indicationsfor Use	The Bard® ConquestTM PTA Balloon Dilatation Catheteris recommended for use in Percutaneous Transluminal Angioplasty of thefemoral, iliac and renal arteries and for the treatment of obstructive lesionsof native or synthetic arteriovenous dialysis fistulae. This catheter is notfor use in coronary arteries.

PLEASE DO NOT WRITE BELOW THIS LINE--- CONTINUE ON ANOTHER PAGE IF NEEDED. .

Concurrence of CDRH, Office of Device Evaluation (ODE)

N
Division of Cardiovascular & Respiratory Devices
510(k) Number 2617212

Prescription Use
(Per 21 CFR 801.109

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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).