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 document is a 510(k) Premarket Notification for a medical device, specifically a balloon catheter. However, it does not contain specific acceptance criteria or a detailed study report that would typically describe device performance against such criteria.

Instead, the document primarily focuses on regulatory approval based on demonstrating substantial equivalence to predicate devices, and lists general types of tests performed. It lacks quantitative data, statistical analyses, or detailed methods for establishing ground truth or expert involvement as requested in the prompt.

Therefore, I cannot fulfill most of your request directly from the provided text. I will outline what information is available and explicitly state what is missing.

Summary of Available Information (and Missing Information):

This document is a 510(k) Premarket Notification for the ATB™ All-Terrain Balloon™ PTA Dilatation Catheter. It declares substantial equivalence to predicate devices based on intended use, materials, and technological characteristics. The document lists general types of tests performed but does not provide specific acceptance criteria, quantitative results, or detailed study methodologies.

Here's an breakdown based on your request:

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

Acceptance Criteria: Not explicitly stated. The document mentions "conformance to the requirements for its use as a PTA dilatation balloon catheter" but does not define these requirements quantitatively (e.g., "burst pressure must exceed X psi in Y% of samples").
Reported Device Performance: No specific quantitative performance data is reported. The document lists types of tests performed (Tensile, Balloon deflation, Balloon burst, Balloon compliance, Balloon fatigue, Balloon profile) and states that "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance..." However, no numerical results, ranges, or pass/fail rates are provided.

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

Sample Size for Test Set: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This type of detail is not typically included in a 510(k) summary focused on substantial equivalence.

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 / Not specified. This type of information (expert consensus for ground truth) is relevant for studies involving imaging or diagnostics where subjective interpretation is key. For a physical medical device like a balloon catheter, "ground truth" would typically refer to objective physical properties measured against engineering specifications, not expert interpretation of data. The document does not describe any human-read data or ground truth establishment relevant to expert review.

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

Not applicable / Not specified. Adjudication methods are typically used in clinical trials or studies where human readers or experts are evaluating outcomes, often in cases of disagreement. This is not relevant for the types of physical device tests mentioned (tensile, burst, etc.).

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. This is definitively stated as "No". An MRMC study is relevant for diagnostic or AI-assisted devices that involve human interpretation of cases. This document is for a physical interventional medical device and does not involve AI or diagnostic interpretation in its reported testing.

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

No. This is definitively stated as "No". Similar to point 5, this is not an AI-driven device, so standalone algorithm performance is irrelevant.

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

For the physical tests mentioned (burst, tensile, etc.), the "ground truth" would be established by engineering specifications and validated testing methodologies (e.g., measuring pressure at which a balloon bursts, force required for tensile failure). The document does not specify these in detail, but it's implied that standard physical testing methods were used. It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable / Not specified. This device does not involve AI/machine learning, so there is no training set in the conventional sense.

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

Not applicable / Not specified. As there is no training set, this question is not applicable.

Summary

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

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

Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters and numbers. The sequence begins with the letter 'K', followed by the numbers '031766', and then the number '24' is written below the last two digits of the previous number. The handwriting is in black ink on a white background, and the characters are somewhat stylized.

510(k) Summary

JUN 2 6 2003

Submitted By:

Karen Bradburn, RAC Regulatory 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 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.

{1}------------------------------------------------

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
ന് Balloon burst tests
Balloon compliance ধ .
1. Balloon fatigue tests
1. Balloon profile

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}------------------------------------------------

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 6 2003

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

Re: K031766

ATB™ All-Terrain™ Balloon PTA Dilation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: 74 DQY Dated: June 6, 2003 Received: June 9, 2003

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.

{3}------------------------------------------------

Page 2 - Ms. Karen Bradburn

Please be advised that FDA s issuance of a substantial equivalence determination docs 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 (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), please contact the Office of Compliance at (301) 594-4646. 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,

Dale Hill

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

Enclosure

{4}------------------------------------------------

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

510(k) Number (if known): K031766

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	X (Per 21 CFR 801.109)	OR	Over-the-Counter Use
------------------	------------------------------------------------------------------------	----	----------------------

(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number	K031766
---------------	---------

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).