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 COOK PTA balloon 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 vinyl tubing compatible with an 0.035-inch guidewire. It will be supplied sterile, intended for one-time use.

AI/ML Overview

Here's an analysis of the provided text regarding the COOK PTA balloon catheter, focusing on the requested acceptance criteria and study information:

Acceptance Criteria and Device Performance Study for COOK PTA Balloon Catheter (K972800)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test Performed	Reported Device Performance (as described in the document)
Mechanical Performance	Tensile tests	"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."
	Flow rate tests	"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."
	Repeated balloon inflation tests	"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."
	Balloon burst tests	"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."
Biocompatibility	Biocompatibility tests	"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."
In Vivo Performance	Animal tests	"Animal tests to assess in vivo performance characteristics." (No specific results detailed, only that they were performed).

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify the sample sizes used for any of the tests (tensile, flow rate, inflation, burst, biocompatibility, or animal tests).

The data provenance is not explicitly stated beyond being part of a 510(k) submission from COOK INCORPORATED, a US-based company. It can be inferred that the testing was conducted by or for COOK INCORPORATED for regulatory submission. Whether the data is retrospective or prospective is not indicated.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The tests described are largely objective engineering and biological assessments, not typically requiring human expert-established ground truth in the way a diagnostic imaging device would.

4. Adjudication Method for the Test Set

This information is not applicable/provided. The described tests are objective measurements, not subjective assessments requiring adjudication among experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device submission. This type of study is typically relevant for diagnostic devices where human interpretation plays a significant role, not for a PTA balloon catheter which is a therapeutic device with objective performance metrics.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not applicable to a physical medical device like a PTA balloon catheter. There is no "algorithm" in the sense of AI or software that would have a standalone performance. The device's performance is inherently its standalone performance when used as intended.

7. Type of Ground Truth Used

The ground truth for the performance tests would be established by:

Engineering specifications/standards: For tensile strength, burst pressure, flow rates, etc. (e.g., minimum burst pressure, maximum elongation).
Biocompatibility standards: For biocompatibility tests (e.g., ISO 10993).
Physiological/anatomical criteria: For animal tests (e.g., successful dilatation, absence of adverse events like vessel dissection or thrombosis).

The document states that the tests provide "reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use," implying that predefined acceptance criteria (ground truth) were met.

8. Sample Size for the Training Set

This information is not applicable/provided. This device is a physical medical device, not an AI/ML algorithm that requires a "training set" of data. The "training" for such devices typically involves materials science, engineering design, and manufacturing process optimization.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/provided for the reasons stated in point 8.

Summary

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APR 1 6 1998

510(k) Premarket Notification PTA Balloon Catheter COOK INCORPORATED

0 Safety and Effectiveness Information

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 November 26, 1997

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.

OMPANY

1972800

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CONFIDENT

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

Tensile tests I
트 Flow rate tests
그 Repeated balloon inflation tests
트 Balloon burst tests
포 Biocompatibility tests
Animal tests to assess in vivo performance characteristics 내

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 Department of Health & Human Services (HHS) in the United States. The logo features a stylized depiction of an eagle or bird with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 6 1998

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

Re: K972800 PTA Balloon Catheter Trade Name: Regulatory Class: II Product Code: LIT Dated: March 3, 1998 Received: March 3, 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 reqistration, 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with 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 Register. Please note: this

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Page 2 - Ms. 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 requlations.

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 requlation 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. Callehan

Thomas J. Callahan, 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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Balloon Cathe COOK INCORPORAT

12972800 510(k) Number (if known):

Device Name:

PTA Balloon Catheter

Indications for Use:

Ru A Ro

(Division Sign-Off)

stillionn of Cardiovascure 'especatory, no Neurological Devices 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).