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

Device Description

The COOK PTA balloon catheter is an over-the-wire balloon catheter indicated for percutaneous transluminal angioplasty of lesions in peripheral arteries including ilias, renal, popliteal, infrapopliteal, femoral and illio femoral and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device will be made with 5.0(6.0) French vinyl 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) premarket notification for a PTA Balloon Catheter. This type of submission is focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study with detailed performance metrics. Therefore, much of the requested information (such as specific performance metrics, sample sizes for test and training sets, ground truth establishment, expert qualifications, and MRMC studies) is not typically included in a 510(k) submission and is absent from this document.

However, based on the information available, here's a breakdown of what can be inferred:

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

The document does not provide a table of quantitative acceptance criteria with corresponding performance metrics. Instead, it lists general types of tests conducted to assure "reliable design and testing parameters" and "conformance to the requirements for its use as a vascular PTA balloon."

Acceptance Criteria (Implied by Test Type)	Reported Device Performance
Tensile Strength: Adequate to withstand operational forces.	"The results of these tests provide reasonable assurance that the device has been tested to assure conformance to the requirements for its use as a vascular PTA balloon."
Flow Rate: Suitable for intended clinical use.	"The results of these tests provide reasonable assurance that the device has been tested to assure conformance to the requirements for its use as a vascular PTA balloon."
Repeated Balloon Inflation: Durability and performance over multiple inflations.	"The results of these tests provide reasonable assurance that the device has been tested to assure conformance to the requirements for its use as a vascular PTA balloon."
Balloon Burst Pressure: Withstands expected pressures without premature failure.	"The results of these tests provide reasonable assurance that the device has been tested to assure conformance to the requirements for its use as a vascular PTA balloon."
Biocompatibility: Safe for use in the human body.	"The results of these tests provide reasonable assurance that the device has been tested to assure conformance to the requirements for its use as a vascular PTA balloon."
In Vivo Performance: Functional and safe in a live biological system.	"The results of these tests provide reasonable assurance that the device has been tested to assure conformance to the requirements for its use as a vascular PTA balloon."

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

Sample size: Not specified. The document states "The balloon catheter was subjected to the following tests," but provides no numbers for samples tested for each type.
Data provenance: The tests are described as being conducted on the device itself ("balloon catheter was sabled testing parameters"), suggesting laboratory testing and potentially animal testing. The focus is on the physical and biological characteristics of the device, not clinical data from a human population study. Therefore, specific country of origin or retrospective/prospective clinical data are not applicable here.

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

This information is not applicable to a 510(k) submission of this nature. "Ground truth" in the context of device performance testing typically refers to objective measurements or established standards (e.g., a known tensile strength, a specified burst pressure, or a demonstrated biocompatibility according to ISO standards). It does not involve expert consensus in the way AI or diagnostic imaging studies would.

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

Not applicable. This concept is relevant for studies involving human interpretation or clinical outcomes where discrepancies need to be resolved. For engineering and biological testing of a medical device, adjudication methods as described are not used. The focus is on meeting predetermined test specifications.

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 PTA Balloon Catheter, a physical medical device, not an AI-powered diagnostic tool or image analysis software. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this submission.

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

Not applicable, as this is a physical medical device and not an algorithm or AI system.

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

The "ground truth" for the tests performed would be derived from:

Engineering specifications and validated testing methods (e.g., tensile strength determined by a load cell, flow rate measured by a flow meter, burst pressure via a pressure transducer).
Standardized biocompatibility tests (e.g., ISO 10993 series for biological evaluation of medical devices).
Animal study observations for in vivo performance, likely assessed against pre-defined animal welfare and physiological endpoints.

8. The sample size for the training set:

Not applicable. The concept of a "training set" is relevant for machine learning algorithms. This document describes the testing of a physical medical device, not the development of an AI model.

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

Not applicable, as there is no "training set" in the context of this device's testing.

Summary

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JUN 2 9 1998

K981906

Special 510(k) Premarket Notification PTA Balloon Catheter, D.C.#K981906 COOK INCORPORATED

Safety and Effectiveness Information 0

Submitted By:

April Lavender, RAC Vice President Regulatory Affairs COOK INCORPORATED 925 South Curry Pike P.O. Box 489 Bloomington, IN 47402 (812) 339-2235 June 25, 1998

Device:

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

Predicate Devices:

The COOK PTA balloon 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 balloon catheter was subjected to the following tests to assure reliable design and The balloon cannoter was sabled testing parameters. These tests were comprised of:

l Tensile tests
Flow rate tests 트
Repeated balloon inflation tests E
Balloon burst tests 트
I Biocompatibility tests
Animal tests to assess in vivo performance characteristics I

The results of these tests provide reasonable assurance that the device has been I we readler of ested 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 and 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 a bird or eagle with three human profiles incorporated into its design, creating a symbolic representation of health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 9 1998

Ms. April Lavender Cook, Inc. 925 South Curry Pike P.O. Box 489 Bloomington, IN 47402

K981906 Re: PTA Balloon Catheter Requlatory Class: II (two) Product Code: 74 LIT Dated: May 29, 1998 Received: June 1, 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this 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.

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Page 2 - Ms. April Lavender

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) 594-4648. 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" (21 CFR 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. Ca llahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Special 510(k) Premarket Notification PTA Balloon Catheter, D.C.#K972800 COOK INCORPORATED

×981906 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

PTA Balloon Catheter

Indications for Use:

For percutaneous transluminal angioplasty of lesions in peripheral arteries i or porcellinoode transmit infrapopliteal, femoral and ilio femoral and are interating may ronal populaudive lesions of native or synthetic arteriovenous dialysis fistulae.

Taia f R

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 1981906 510(k) Number _

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

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).