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. Intended to treat because is also intended for post-dilatation of balloonexpandable peripheral vascular stents.

Device Description

The ATB™ Advance 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 or 6.0 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) Pre-market Notification for the ATB™ Advance PTA Dilatation Catheter. It outlines the device, its intended use, and substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a specific study proving the device meets those criteria from an AI/ML perspective.

The "Test Data" section lists various in-vitro tests conducted on the device, inherently mechanical in nature. These are standard engineering tests for medical devices, not studies of an AI's performance.

Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria, statistical performance metrics, sample sizes for AI training/testing, expert qualifications, adjudication methods, or MRMC studies, as these concepts are not present in the provided document.

The document describes a traditional medical device submission for a physical catheter, not an AI or software as a medical device.

What the document does provide in relation to "tests":

The ATB™ Advance PTA Dilatation Catheter was subjected to the following physical/mechanical tests to assure reliable design and performance:

Tensile tests
Balloon inflation/deflation tests
Balloon burst tests
Balloon compliance
Balloon fatigue tests
Balloon profile
Balloon burst within a stent
Balloon fatigue within a stent

The document states: "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 for each of these tests and their corresponding reported performance values are not detailed in the provided text.

Summary

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AUG 2 5 2005

K052036
p. 1 of 2

510(k) Summary

Submitted By:

Karen Bradburn, RAC Senior Regulatory Affairs Specialist Cook Incorporated 750 Daniels Wav. PO Box 489 Bloomington, IN 47402 812-339-2235 July 27, 2005

Device:

Trade Name: Proposed Classification: ATB™ Advance PTA Dilatation Catheter Catheter, Angioplasty, Peripheral, Transluminal (74 DQY)

Predicate Devices:

The ATB™ Advance PTA Dilatation Catheter is similar in terms of intended use, materials of construction 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 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™ Advance 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:

Tensile tests 1 -
Balloon inflation/deflation tests 2.
Balloon burst tests 3.
1. Balloon compliance
Balloon fatigue tests 5.
1. Balloon profile
Balloon burst within a stent 7.
Balloon fatigue within a stent 8.

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.

KOS2036 0. 2042

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Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three horizontal lines representing its wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

AUG 25 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

K052036 Re:

ATB-All terrain Balloon PTA Dilation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: II Product Code: DQY Dated: July 27, 2005 Received: July 28, 2005

Dear Ms. Bradburn:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaller of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) is registly the enactment date of the Medical Device Amendments, or to commerce proof to May 20, 1970, are excerdance with the provisions of the Federal Food, Drug, de necs that have occh recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mercere, manies of the Act include requirements for annual registration, listing of general oonlively provisiveing 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 rr your device to such additional controls. Existing major regulations affecting your device can may or babyer to been it 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

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 (240) 276-0120. 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/industry/support/index.html.

Sincerely vours.

Donner R. bochner

(A 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

510(k) Number (if known): _ Kos2036

PTA Balloon Catheter Device Name:

Indications for Use:

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. Intended to trout because is also intended for post-dilatation of balloonexpandable peripheral vascular stents.

Prescription Use × (Per 21 CFR 801 Subpart D) OR

Over-the-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dina P. Jackson

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number Ko 5 30 3 6

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).