For percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and ilio femoral and is also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Description

The PTA Balloon Catheter is a double lumen catheter with a balloon near the distal tip. The catheter features a minimally compliant balloon constructed from high density polyethylene material. The balloon is designed to expand to a specified diameter and length at a specific pressure as labeled. The balloon catheter is provided in an overall length of 135cm. The catheter will be made in four balloon diameters of 2.5mm, 3.0mm, 3.5mm and 4.0mm. Balloon lengths will be 1.5cm, 2.0cm, 3.0cm and 4.5cm. The catheter is compatible with 0.014-inch standard PTA wire guides. Two radiopaque marker bands located at the proximal and distal ends of the balloon segment facilitate fluoroscopic visualization of the balloon during use.

AI/ML Overview

The provided text describes a 510(k) Premarket Notification for a PTA Balloon Catheter. This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies in the way a novel AI or diagnostic device would.

Therefore, many of the requested categories in your prompt are not applicable to this type of regulatory submission. Specifically, this document does not contain:

A table of acceptance criteria and reported device performance in a clinical context for AI/diagnostic devices.
Information on sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, or AI-related comparative effectiveness studies (MRMC or standalone performance).
Details about training sets or how ground truth for training sets was established.

Here's a breakdown of what can be extracted and what is not applicable, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes engineering and material performance tests rather than clinical performance or diagnostic accuracy. The "acceptance criteria" for these tests are not explicitly quantified in this document beyond the statement "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 vascular PTA balloon."

Acceptance Criteria (Implied)	Reported Device Performance
Reliable design and performance under specified testing parameters for vascular PTA balloon use	The balloon catheter was subjected to and passed the following tests:
Balloon Minimum Burst Strength Test	(Results indicate compliance, but specific values are not provided)
Balloon Distensibility Test	(Results indicate compliance, but specific values are not provided)
Balloon Inflation/Deflation Test	(Results indicate compliance, but specific values are not provided)
Balloon Fatigue Test	(Results indicate compliance, but specific values are not provided)
Bond Strength Test	(Results indicate compliance, but specific values are not provided)
Diameter and Profile Test	(Results indicate compliance, but specific values are not provided)
Biocompatibility Test	(Results indicate compliance, but specific values are not provided)

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

Test Set Sample Size: Not specified. The document mentions "the balloon catheter was subjected to the following tests," implying laboratory testing on device prototypes/samples, not a clinical test set with patient data.
Data Provenance: Not applicable. These are laboratory engineering tests, not clinical data from patients.

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

Not applicable. Ground truth for clinical data is not relevant to these engineering performance tests.

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

Not applicable. This concept is for clinical data review, not engineering tests.

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 for angioplasty, not an AI or diagnostic imaging device that involves human readers.

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

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

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

Type of Ground Truth: For the engineering tests, the "ground truth" would be the established engineering specifications, standards, and performance limits for each parameter (e.g., minimum burst pressure, maximum distensibility, cycle endurance). The device's performance is compared against these predetermined specifications.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model that requires a training set.

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

Not applicable. No training set is involved.

Summary

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AUG 20 1998

510(k) Premarket Notification PTA Balloon Catheter COOK INCORPORATED

Safety and Effectiveness Information

April Lavender, RAC Submitted By: Vice President, Regulatory Affairs COOK INCORPORATED 925 South Curry Pike P.O. Box 489 Bloomington, In 47402 (812) 339-2235 January 30, 1998

Device: Trade Name: Proposed Classification Name: None Catheter, Cardiovascular Balloon Type (79GBR)

Predicate Devices:

The PTA balloon catheter is similar in terms of intended use, materials of construction, and technological characteristics to predicate devices reviewed as devices for dilation of lesions in peripheral arteries (iliac, renal popliteal, infra popliteal, femoral and ilio femoral).

Device Description

Substantial Equivalence

The PTA Balloon Catheter is similar to many devices already in commercial distribution for percutaneous transluminal angioplasty (PTA). The similar indications for use and technological characteristics of the PTA Balloon Catheter as compared to the predicate devices supports a

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510(k) Premarket Notification PTA Balloon Catheter COOK INCORPORATED

determination of substantial equivalency. Other companies with similar balloon catheters for PTA are Medi-Tech Corporation of Watertown, Massachusetts, United States Catheter and Instrument of C.R. Bard, as well as COOK INCORPORATED.

Test Data

The balloon catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:

Balloon Minimum Burst Strength Test જુન
જુન Balloon Distensibility Test
જુન Balloon Inflation/Deflation Test
な Balloon Fatigue Test
ન્દ્ર Bond Strength Test
中 Diameter and Profile Test
નું Biocompatibility Test

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 vascular PTA balloon.

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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 20 1998

Ms. April Lavender, RAC Vice President, Regulatory Affairs COOK Inc. 925 South Curry Pike P.O. Box 489 Bloomington, IN 47402

K980390 Re : PTA Balloon Catheter Trade Name: Regulatory Class: II Product Code: LIT Dated: May 21, 1998 Received: May 22, 1998

Dear Ms. Lavender:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. . In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this

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Paqe 2 - Ms. April Lavender

response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respirator and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Premarket Notification PTA Balloon Catheter COOK INCORPORATED

K980390 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)

Over-the-Counter Use

. Rughi

(Division Sign-Off) Division of Cardiovascular. Respiratory, and Neurological Devices

510(k) Number_

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).