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 ATB Advance PTA Dilatation Catheter 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 illac, 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 guidewire. It will be supplied sterile, intended for one-time use.

AI/ML Overview

The provided text describes a 510(k) submission for the ATB™ Advance PTA Dilatation Catheter. It outlines the device's indications for use, its classification, and a list of tests performed to demonstrate its safety and effectiveness. However, it does not include detailed acceptance criteria or the specific results that prove the device meets these criteria in a structured format as requested. It only broadly states that the test results "provide reasonable assurance that the device has been designed" for its intended purpose.

Therefore, for many of the requested points, the information is not available in the provided text.

Here is an analysis based on the information provided:

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

The document lists several tests performed but does not specify acceptance criteria or quantitative performance results. It generally states that "The results of these tests provide reasonable assurance that the device has been designed."

Test Type	Acceptance Criteria (Not provided in text)	Reported Device Performance (No specific data provided)
Tensile tests	Not specified	General assurance of design adequacy
Balloon inflation/deflation	Not specified	General assurance of design adequacy
Balloon burst tests	Not specified	General assurance of design adequacy
Balloon compliance	Not specified	General assurance of design adequacy
Balloon fatigue tests	Not specified	General assurance of design adequacy
Balloon profile	Not specified	General assurance of design adequacy
Balloon burst within a stent	Not specified	General assurance of design adequacy
Balloon fatigue within a stent	Not specified	General assurance of design adequacy

2. Sample sizes used for the test set and the data provenance

Sample sizes: Not specified in the provided text for any of the listed tests.
Data provenance: Not specified. Based on the nature of a 510(k) submission for a medical device prior to market, these would typically be lab-based engineering and bench tests, not clinical studies with human data. Therefore, country of origin related to patient data is not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The tests described are engineering and bench tests, not studies requiring expert clinical interpretation for ground truth.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1) are relevant for clinical studies or studies involving human assessment of data, not for the engineering tests described.

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

Not applicable. This is a medical device (dilatation catheter) and the tests are for its physical properties, not an AI-based diagnostic tool. No MRMC study was mentioned.

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

Not applicable. This is a medical device, not an algorithm.

7. The type of ground truth used

For the engineering tests listed (tensile, burst, fatigue, etc.), the "ground truth" would be established by physical measurements and engineering specifications, rather than expert consensus, pathology, or outcomes data. For example, a burst test would determine the actual pressure at which a balloon bursts, and this would be compared against a pre-defined engineering specification.

8. The sample size for the training set

Not applicable. This is a medical device, not a machine learning model. There is no concept of a "training set" for the type of tests described.

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

Not applicable, as there is no training set mentioned or implied for this type of medical device submission.

Summary

{0}------------------------------------------------

510(k) Summary

Submitted By:

Karen Bradburn, RAC Senior Requlatory Affairs Specialist Cook Incorporated 750 Daniels Way, PO Box 489 Bloomington, IN 47402 812-339-2235 October 26, 2006

NOV 1 4 2006

K063252

Lot 2

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 devices, this device meets the requirements for section 510(k) substantial equivalence.

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Test Data:

The ATB™ Advance PTA Dilatation Catheter was subjected to the following tests to assure The ATD … Auvance TTA Blatation Outhoter was catholor was cathers. These tests were comprised of:

Tensile tests 1.
Balloon inflation/deflation tests 2.
Balloon burst tests 3.
Balloon compliance 4.
Balloon fatigue tests 5.
Balloon profile റ്.
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 i The results of these tests provide roubonable addrance and a PTA dilatation balloon catheter.

KO63252 p. 20f2

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 4 2006

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

Re: K063252 ATB Advanced PTA Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (Two) Product Code: DQY Dated: October 26, 2006 Received: October 27, 2006

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.

Image /page/2/Picture/9 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

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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 af 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Duma R. balmer

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): K063252

PTA Balloon Catheter Device Name:

Indications for Use:

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

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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)

pring R. Jackner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K 0 63252

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).