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 guidewire. It will be supplied sterile, intended for one-time use.

AI/ML Overview

The provided submission K023504 describes a Special 510(k) Premarket Notification for a PTA Balloon Catheter, the ATB™ All-Terrain Balloon™ PTA Dilatation Catheter. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through performance testing rather than clinical study.

Here's an analysis based on the provided text, addressing the requested information:

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

The submission lists the tests performed but does not explicitly state the acceptance criteria for each test or the detailed numerical results (performance data) in the provided text. It generally 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."

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document (e.g., "Balloon burst pressure shall be X psi ± Y%").	"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."

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

The submission does not specify the sample sizes used for each of the listed tests (Tensile, Balloon deflation, Balloon burst, Balloon compliance, Balloon fatigue, Balloon profile).
The data provenance is not explicitly stated, but it would be from internal laboratory testing conducted by Cook Incorporated, likely in the USA where the company is based. This is prospective testing, as it's performed specifically to demonstrate device performance prior to marketing.

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

This question is not applicable to this type of device submission. The "ground truth" for evaluating a PTA balloon catheter's physical performance is established through established engineering and materials science testing standards, not by expert medical consensus. The tests are objective measurements of the device's physical properties.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image-based diagnostic studies where human interpretation of data is involved and discrepancies need to be resolved. This submission details engineering and performance testing.

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 device is a medical instrument (PTA balloon catheter), not an AI-powered diagnostic tool or system that would involve human readers or AI assistance.

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

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

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

For the performance testing mentioned, the "ground truth" is defined by established engineering specifications and physical measurement standards. For example, balloon burst pressure would be compared against a pre-defined minimum pressure specification derived from clinical needs and recognized standards for such devices.

8. The sample size for the training set

Not applicable. This is a physical device, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for this device.

Summary

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K023504
25

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

510(k) Summary

Submitted By:

NOV 1 3 2002

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

Device:

Trade Name: Proposed Classification:

ATB™ All-Terrain Balloon™ PTA Dilatation Catheter 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 anqioplasty 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:

Tensile tests 1.
1. Balloon deflation tests
Balloon burst tests 3.
Balloon compliance 4.
1. Balloon fatigue tests
Balloon profile 6.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines representing its feathers.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 2002

Cook Incorporated Ms. Karen Bradburn, RAC Regulatory Affairs Coordinator 750 Daniels Way, PO Box 489 Bloomington, IN 47402

Re: K023504

Trade/Device Name: ATB™ All-Terrain Balloon™ PTA Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: 74 LIT Dated: October 15, 2002 Received: October 18, 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 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

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Page 2 – Ms. Karen Bradburn

forth in the quality systems (OS) 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) 594-4586. 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.

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): ___________________________________________________________________________________________________________________________________________________

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
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Division of Cardiovascular & Respiratory Devices
mber
2023504

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).