For percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and ilio femoral and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Description

The ATB™ All-Terrain Balloon™ PTA Dilatation Catheter is an over-the wire balloon catheter indicated for percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and illo femoral and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device will be made with 5.0 French nylon tubing compatible with an 0.035-inch guidewire. It will be supplied sterile, intended for one-time use.

AI/ML Overview

The provided text describes a Special 510(k) Premarket Notification for the ATB™ All-Terrain Balloon™ PTA Dilatation Catheter. This document is a regulatory submission to the FDA, not a study report demonstrating the device's performance against specific acceptance criteria in a clinical or analytical setting.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in this document. The document focuses on demonstrating substantial equivalence to predicate devices through in-vitro testing and manufacturing controls, rather than a standalone clinical study with detailed performance outcomes.

Here's a breakdown of what can be extracted and what is not available based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in a table format with specific quantitative acceptance criteria or reported numerical performance data. The document states that the device was "subjected to the following tests to assure reliable design and performance under the specified testing parameters," but it does not list the specific acceptance thresholds for these tests or the exact results obtained.

Acceptance Criterion (Not explicitly stated)	Reported Device Performance (Summary statement only)
(e.g., Tensile Strength > X N)	"The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a PTA dilatation balloon catheter."
(e.g., Inflation/Deflation Time < Y seconds)	"The ATB™ All-Terrain Balloon™ PTA Dilatation Catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of: 1. Tensile tests, 2. Balloon deflation tests, 3. Balloon burst tests, 4. Balloon compliance, 5. Balloon fatigue tests, 6. Balloon profile"
(e.g., Burst Pressure > Z atm)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified. The document mentions various "tests" (Tensile, Balloon deflation, Balloon burst, Balloon compliance, Balloon fatigue, Balloon profile) but does not provide any details about the number of devices or samples tested for each.
Data Provenance: The tests are described as being conducted "to assure reliable design and performance." This implies in-vitro (laboratory) testing performed by the manufacturer, Cook Incorporated, likely in the USA, as Cook Incorporated is an American company. The data is retrospective in the sense that these tests were performed prior to the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. This type of information is relevant for studies involving human interpretation (e.g., imaging studies where experts establish a diagnostic ground truth). The tests described are benchtop/in-vitro performance tests, not clinical studies requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

Not applicable. See point 3. Benchtop tests typically have objective, measurable outcomes, not subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document does not describe any clinical study, let alone an MRMC comparative effectiveness study. The submission focuses on substantial equivalence based on materials, intended use, and in-vitro performance testing.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Not applicable. This device is a physical medical device (a balloon catheter), not a software algorithm or AI component.

7. Type of Ground Truth Used

For the in-vitro tests mentioned (Tensile, Balloon deflation, Balloon burst, etc.), the "ground truth" would be established by objective engineering specifications and measurements. For example, a burst test's ground truth is the pressure at which the balloon ruptures, measured by calibrated equipment, and then compared against a pre-defined performance specification. It's not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is a physical device, not an AI/ML model being developed. The document refers to manufacturing processes and quality assurance, which fall under good manufacturing practices rather than machine learning training.

9. How the Ground Truth for the Training Set Was Established

Not applicable. See point 8.

Summary

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OCT 2 2 2003

K032931

Special 510(k) Premarket Notification PTA Balloon Catheter COOK INCORPORATED

510(k) Summary

Submitted Bv:

Karen Bradburn, RAC Regulatory Affairs Coordinator Cook Incorporated 750 Daniels Wav, PO Box 489 Bloomington, IN 47402 812-339-2235 September 19, 2003

Device:

Trade Name:
Proposed Classification:

ATB™ All-Terrain Balloon™ PTA Dilatation Catheter Catheter, Angioplasty, Peripheral, Transluminal (74 DQY)

Predicate Devices:

The ATB™ All-Terrain Balloon™ PTA Dilatation Catheter is similar in terms of intended use, materials of constructions and technological characteristics to predicate devices reviewed as devices for transluminal percutaneous angioplasty of vessel lumens which are narrowed or obstructed.

Device Description:

Substantial Equivalence:

This device will be manufactured according to specified process controls and a Quality Assurance Program. This device will undergo packaging similar to the devices currently marketed and distributed by Cook Incorporated. This device will undergo sterilization similar to the devices currently marketed and distributed. Being similar with respect to indications for use, materials and physical construction to predicate devices, this device meets the requirements for section 510(k) substantial equivalence.

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Special 510(k) Premarket Notification PTA Balloon Catheter COOK INCORPORATED

Test Data:

The ATB™ All-Terrain Balloon™ PTA Dilatation Catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:

1 -Tensile tests
1. Balloon deflation tests
1. Balloon burst tests
1. Balloon compliance
1. Balloon fatigue tests
1. Balloon profile

The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a PTA dilatation balloon catheter.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

OCT 2 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cook, Incorporated c/o Ms. Karen Bradburn, RAC Regulatory Affairs Coordinator 750 Daniels Way P.O. Box 489 Bloomington, Indiana 47402

Re: K032931

Trade Name: ATB™ All-Terrain Balloon™ PTA Dilatation Catheter Regulation Number: 21 CFR §870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: September 19, 2003 Received: September 22, 2003

Dear Ms. Bradburn:

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. Karen Bradburn, RAC

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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.

Ashley B. Bairn

for

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

Enclosure

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Special 510(k) Premarket Notification PTA Balloon Catheter COOK INCORPORATED

4032331 510(k) Number (if known):

Device Name: PTA Balloon Catheter

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Prescription Use
(Per 21 CFR 801.109)

Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________

Elias Mallis

on Sigif-Only Devices

KO32931 510(k) Number_

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).