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 All-Terrain Balloon PTA Dilatation Catheter is also intended for post-dilatation of balloon-expandable peripheral vascular stents.

Device Description

The ATB All-Terrain™ Balloon Dilatation Catheter is comprised of a nylon balloon and a nylon shaft. It is used percutaneously over a pre-positioned wire guide. The and a nylen bhat. Tela connector which provides access to the end hole proximal ona mer connector which permits access to the balloon inflation lumen.

The catheter component of this device measures a nominal 5.0 French in outside diameter. The overall catheter lengths of 40, 80 and 120 cm are available. The catheter is offered with inflated balloon diameters of 4, 5, 6, 7, 8, 9 and 10 mm and in lengths of 2, 3, 4, 6 and 8 cm. The catheter incorporates radiopaque markers to assist fluoroscopic visualization of the balloon during use.

AI/ML Overview

The provided document describes the "ATB All-Terrain™ Balloon PTA Dilatation Catheter" and its equivalence to predicate devices, but does not contain the detailed information requested regarding specific acceptance criteria, a comprehensive study for performance validation, or specifics on ground truth establishment from expert opinions.

This document is a 510(k) premarket notification summary, which primarily aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than providing a detailed performance study with quantitative acceptance criteria and ground truth analysis as typically found in clinical trials or AI/software validation studies.

However, based on the information provided, here's what can be extracted and what is explicitly missing:

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

Acceptance Criteria	Reported Device Performance
Functional Performance (Implied)	Meets requirements for its use for peripheral angioplasty and post-dilatation of peripheral vascular stents.
Balloon Minimum Burst Strength	Tests performed, results "provide reasonable assurance that the device has been designed and tested to assure conformance." (Specific values not provided)
Balloon Compliance	Tests performed, results "provide reasonable assurance that the device has been designed and tested to assure conformance." (Specific values not provided)
Balloon Inflation/Deflation Performance	Tests performed, results "provide reasonable assurance that the device has been designed and tested to assure conformance." (Specific values not provided)
Balloon Fatigue	Tests performed, results "provide reasonable assurance that the device has been designed and tested to assure conformance." (Specific values not provided)
Bond Strength	Tests performed, results "provide reasonable assurance that the device has been designed and tested to assure conformance." (Specific values not provided)
Catheter Hub Tensile Strength	Tests performed, results "provide reasonable assurance that the device has been designed and tested to assure conformance." (Specific values not provided)
Diameter and Profile	Tests performed, results "provide reasonable assurance that the device has been designed and tested to assure conformance." (Specific values not provided)
Balloon Minimum Burst Strength within a Stent	Tests performed, results "provide reasonable assurance that the device has been designed and tested to assure conformance." (Specific values not provided)
Balloon Fatigue within a Stent	Tests performed, results "provide reasonable assurance that the device has been designed and tested to assure conformance." (Specific values not provided)

Missing Information/Cannot Answer based on provided text:

While the document states that tests were performed to evaluate the ATB All-Terrain™ Balloon PTA Dilatation Catheter and provide "reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use," it does not provide the specific quantitative acceptance criteria or the actual performance results (e.g., minimum burst pressure values, fatigue cycles passed, tensile strength in Newtons, etc.) for each test mentioned.

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

The document does not specify sample sizes for any of the tests mentioned.
Data Provenance: Not applicable in the context of this document, as the "performance data" refers to in-vitro engineering tests (e.g., burst strength, fatigue) rather than clinical data or patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The "performance data" described are engineering tests. There is no mention of experts establishing a "ground truth" for a test set in the clinical or diagnostic sense within this document.

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

Not applicable. There is no mention of adjudication methods as this document does not describe a study involving expert review or diagnostic assessment.

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

No MRMC comparative effectiveness study was done. This document pertains to a medical device (dilatation catheter), not an AI or diagnostic imaging system that would typically involve human readers.

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, not a standalone algorithm.

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

Not applicable. The "ground truth" for the engineering tests would be established by physical measurement standards and established engineering principles (e.g., material properties, pressure sensors, force gauges).

8. The sample size for the training set

Not applicable. This document describes a physical medical device, not a machine learning model that requires a training set.

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

Not applicable. As above, a training set and its ground truth are not relevant to this device and its documentation.

Summary

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Safety and Effectiveness Information

Submitted By:	Karen Bradburn, RACRegulatory Affairs CoordinatorCook Incorporated750 Daniels WayP.O. Box 489Bloomington, IN 47402(812) 339-2235
Device:	ATB All-Terrain™ Balloon PTA Dilatation CatheterPercutaneous Catheter (DQY)21 CFR §870.1250

Predicate Devices:

The ATB All-Terrain™ Balloon PTA Dilatation Catheter is similar in terms of intended rne ATB Air Tonain Studions and technological characteristics to the predicate devices reviewed.

Device Description

Substantial Equivalence

The ATB All-Terrain™ Balloon PTA Dilatation Catheter is similar to many devices in commercial distribution for dilatation and stent deployment. These devices include oommordial diethbut.on Catheter, D.C.#K022552, K023504, K031766 and K032931 and the RX Viatrac 14 Peripheral Dilatation Catheter, D.C.#K983055.

The similar indications for use and technological characteristics of the ATB All-Terrain™ Balloon PTA Dilatation Catheter as compared to the predicate devices supports a determination of substantial equivalency.

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Performance Data

The following tests have been performed to evaluate the ability of the ATB All-The follow Balloon PTA Dilatation Catheter to perform in accordance with the requirements of the design plan.

Balloon Minimum Burst Strength Testing ם
Balloon Compliance Testing ਹ
Balloon Inflation/Deflation Performance Testing ם
Balloon Fatigue Testing σ
Bond Strength Testing a
Catheter Hub Tensile Strength Testing ପ
Diameter and Profile Testing ロ
Balloon Minimum Burst Strength within a Stent ם
Balloon Fatigue within a Stent σ

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 for peripheral angioplasty and post-dilatation of peripheral vascular stents.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 2 2004

Cook Incorporated Ms. Karen Bradbum Regulatory Affairs P.O. Box 489 Bloomington, IN 47402-0489

Re: K033875

ATB All-Terrain PTA Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Percutaneous Regulatory Class: Class II (two) Product Code: DQY Dated: March 25, 2004 Received: March 26, 2004

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

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) 594-4648. 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.

Duna R. Vochmel

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

Enclosure

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Indications for Use

510(k) Number (if known): K033875

Device Name: ATB All-Terrain Balloon PTA Dilatation Catheter

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/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)

Duna R. Vachner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K033875

Page 1 of

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).