For percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Description

The Advance® 14Rx Rapid Exchange PTA Balloon Dilatation Catheter is a rapid exchange catheter indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device with 4.0 French nylon tubing compatible with a 0.014-inch guidewire. It will be supplied sterile, intended for one-time use.

AI/ML Overview

The provided document describes the Advance® 14Rx Rapid Exchange PTA Balloon Dilatation Catheter, a medical device used for percutaneous transluminal angioplasty (PTA). This submission is a 510(k) Premarket Notification, which aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.

The document does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of AI/machine learning performance. Instead, it details the safety and performance testing of a physical medical device. Therefore, many of the requested bullet points, which are relevant to AI/ML device studies, cannot be answered from the provided text.

Here's a breakdown of what can and cannot be answered:

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

Acceptance Criteria	Reported Device Performance
Physical Performance Tests	The device was subjected to the following tests:
Tensile strength	Results provide reasonable assurance of conformance for use as a PTA dilatation balloon catheter.
Balloon inflation/deflation reliability	Results provide reasonable assurance of conformance for use as a PTA dilatation balloon catheter.
Balloon burst pressure	Results provide reasonable assurance of conformance for use as a PTA dilatation balloon catheter.
Balloon compliance	Results provide reasonable assurance of conformance for use as a PTA dilatation balloon catheter.
Balloon fatigue resistance	Results provide reasonable assurance of conformance for use as a PTA dilatation balloon catheter.
Bond strength	Results provide reasonable assurance of conformance for use as a PTA dilatation balloon catheter.
Biological/Sterility Tests
Biocompatibility	Results provide reasonable assurance of conformance for use as a PTA dilatation balloon catheter.
Sterility	Results provide reasonable assurance of conformance for use as a PTA dilatation balloon catheter.
Durability/Stability Tests
Shelf life	Results provide reasonable assurance of conformance for use as a PTA dilatation balloon catheter.
In Vivo Testing
Animal test (performance in biological system)	Results provide reasonable assurance of conformance for use as a PTA dilatation balloon catheter.

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

This information is not provided in the document. The tests performed are engineering, material, and biological tests for a physical device, not an AI model.

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)

This information is not applicable as the document describes the testing of a physical medical device, not an AI/ML diagnostic or prognostic system requiring expert-established ground truth from medical images or clinical data.

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

This information is not applicable for the same reasons as point 3.

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

This information is not applicable as the document describes the testing of a physical medical device, not an AI assistance system.

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

This information is not applicable as the document describes the testing of a physical medical device, not a standalone algorithm.

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

For the physical device, the "ground truth" would be the engineering specifications and performance standards established for such devices (e.g., specific tensile strength values, burst pressures, biocompatibility standards). 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 as a PTA dilatation balloon catheter," implying compliance with these established standards. However, the specific quantitative "ground truth" values are not explicitly listed.

8. The sample size for the training set

This information is not applicable as there is no mention of an AI/ML training set.

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

This information is not applicable for the same reasons as point 8.

Summary

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K090822

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Special 510(K) Premarket Notification PTA Balloon Catheter: Advance® 14Rx Rapid Exchange Balloon Catheter Cook Incorporated 24 March 2009

510(k) Summary

Submitted By:

APR 2 7 2009

Nathan Simon, M.S. Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, PO Box 489 Bloomington, IN 47402 812-339-2235

Device:

Trade Name:

Advance® 14Rx Rapid Exchange PTA Balloon Dilatation Catheter

Proposed Classification:

Catheter, Percutaneous (74 DQY)

Indications for Use:

Predicate Devices:

The Advance® 14Rx Rapid Exchange PTA Balloon Dilatation 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:

Cook currently markets the PTA Balloon Catheter which is considered substantially equivalent to the Advance 14Rx Rapid Exchange PTA Balloon Dilatation Catheter. The similar indications for use and technological characteristics of the Advance® 14Rx Rapid Exchange PTA Balloon Dilatation Catheter as compared to the predicate devices support a determination of substantial equivalency.

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Special 510(K) Premarket Notification PTA Balloon Catheter: Advance® 14Rx Rapid Exchange Balloon Catheter Cook Incorporated 24 March 2009

Test Data:

The Advance® 14Rx Rapid Exchange PTA Balloon Dilatation Catheter was subjected to the following The Auvance reliable design and performance under the specified testing parameters. These tests go were comprised of:

1. Tensile test
Balloon inflation/deflation test 2.
Balloon burst test 3.
1. Balloon compliance test
1. Balloon fatigue test
Bond strength test 6.
Animal test 7.
1. Shelf life test
Sterility test 9.
Biocompatibility test 10.

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.

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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, rendered in a simple, stylized manner.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 7 2009

Cook, Incorporated c/o Nathan Simon Regulatory Affairs Specialist 750 Daniels Way, PO Box 489 Bloomington, IN 47402

Re: K090822

Trade/Device Name: Advance 14Rx Rapid Exchange PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: March 24, 2009 Received: March 26, 2009

Dear Mr. Simon:

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 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.

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

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Page - 2 - Mr. Simon

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

buna R. V. humn

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

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Special 510(K) Premarket Notification PTA Balloon Catheter: Advance® 14Rx Rapid Exchange Balloon Catheter Cook Incorporated 24 March 2009

510(k) Number (if known):

K090822

Device Name: Advance® 14Rx Rapid Exchange PTA Balloon Dilatation Catheter

Indications for Use:

For percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Prescription Use X (Per 21 CFR 801 Subpart D) 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)

Duma R. Vc lme
(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number_ko9_0822

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).