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 ilio 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 quidewire. It will be supplied sterile. intended for one-time use.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the ATB™ All-Terrain Balloon™ PTA Dilatation Catheter. It outlines the device's intended use, its similarity to predicate devices, and the tests performed to ensure its safety and performance. However, it does not contain a specific table of acceptance criteria with corresponding performance statistics. The document confirms that the device was deemed substantially equivalent to predicate devices based on these tests.

Given the information provided, here's a breakdown of the requested points, focusing on what can be extracted and noting what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Tensile strength	"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." (Specific quantitative criteria and results are not provided in this document.)
Balloon deflation	"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." (Specific quantitative criteria and results are not provided in this document.)
Balloon burst pressure	"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." (Specific quantitative criteria and results are not provided in this document.)
Balloon compliance	"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." (Specific quantitative criteria and results are not provided in this document.)
Balloon fatigue	"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." (Specific quantitative criteria and results are not provided in this document.)
Accelerated aging	"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." (Specific quantitative criteria and results are not provided in this document.)
Biocompatibility	"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." (Specific quantitative criteria and results are not provided in this document.)

Explanation: The document lists several types of tests performed. For each, it states that "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." However, specific numerical acceptance criteria (e.g., minimum tensile strength in Newtons, maximum burst pressure variation) and the exact quantitative results achieved by the device are not detailed in this summary.

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

Sample Size for Test Set: Not specified. The document lists the types of tests performed but does not state the number of units or samples tested for each.
Data Provenance: The tests were conducted by Cook Incorporated (the manufacturer). The country of origin and whether the data was retrospective or prospective are not explicitly stated, but it can be inferred that these were controlled, prospective engineering and laboratory tests conducted to support regulatory submission.

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

Not applicable. The tests described (tensile, burst, fatigue, etc.) are engineering and material science tests for device performance, not clinical studies requiring expert ground truth establishment in the traditional sense (e.g., diagnosis of medical conditions). The "ground truth" here would be established by the performance metrics defined by engineering standards and internal specifications. The document does not mention any medical experts involved in validating the results of these specific performance tests.

4. Adjudication Method for the Test Set

Not applicable. This concept typically applies to clinical studies where multiple reviewers assess a medical outcome or image. For in-vitro device performance tests like those listed, an adjudication method for establishing ground truth is not relevant. The results are typically objectively measured against predefined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document describes laboratory and engineering tests for device performance and safety (e.g., tensile strength, balloon burst). It does not mention any clinical studies, MRMC studies, or human reader performance evaluations, with or without AI assistance. The device in question is a medical catheter, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical medical instrument (a balloon catheter), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

Engineering Specifications and Industry Standards: For the device performance tests (tensile, burst, fatigue, etc.), the "ground truth" would be the predefined engineering specifications and relevant industry standards that the device must meet to be considered safe and effective for its intended use. This is implicitly what "conformance to the requirements for its use" refers to.

8. The Sample Size for the Training Set

Not applicable. The document describes a physical medical device submitted for 510(k) clearance based on substantial equivalence to predicate devices and performance testing. There is no mention of an algorithm or AI system requiring a "training set" in this context.

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

Not applicable. As there is no "training set" for an algorithm, there is no ground truth to be established for it.

Summary

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Special 510(k) Premarket Notification Balloon Catheter OOK INCORPORATED

SEP 2 7 2002

510(k) Summary

Submitted By:

Karen Bradburn. RAC Requlatory Affairs Coordinator Cook Incorporated 750 Daniels Way, PO Box 489 Bloominaton. IN 47402 812-339-2235 August 1. 2002

Device:

Trade Name:

ATB™ All-Terrain Balloon™ PTA Dilatation Catheter Proposed Classification: Catheter, Angioplasty, Peripheral, Transluminal (74 LIT)

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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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
Balloon fatigue tests ട.
1. Accelerated aging tests
1. Biocompatibility tests

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 shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing. The image is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 7 2002

Cook Incorporated c/o Ms. Karen Bradburn P.O. Box 489 Bloomington, IN 47402-0489

Re: K022552 PTA Balloon Catheter Regulation Number: 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: September 13, 2002 Received: September 16, 2002

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.

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

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Page 2 - Ms. Karen Bradburn

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 vours.

Юлятин

am 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 Notlfication PTA Balloon Catheter COOK INCORPORATED

510(k) Number (if known):

PTA Balloon Catheter Device Name:

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) OR

Over-the-Counter Use_

Division Of Cardiovascular & Respiratory Devices
510(k) Number 5023552

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).