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.

Device Description

The Advance® 35LP Low Profile PTA Balloon Dilatation Catheter measures a nominal 5.0 French in outside diameter. Catheter lengths of 80 and 135 cm are available. It is used percutaneously over a pre-positioned wire guide. The proximal end includes a Luer connector which provides access to the end hole lumen and a Luer connector which permits access to the balloon inflation lumen. The catheter incorporates radiopaque markers to assist fluoroscopic visualization of the balloon during use.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Advance® 35LP Low Profile PTA Balloon Dilatation Catheter:

Executive Summary:

The provided 510(k) summary for the Advance® 35LP Low Profile PTA Balloon Dilatation Catheter outlines a series of performance and safety tests conducted to demonstrate substantial equivalence to predicate devices. The acceptance criteria are implicitly met by the successful completion of these tests. However, the document does not explicitly state numerical acceptance criteria or provide specific reported performance values in a table format for each test. The studies performed are primarily bench and preclinical tests, not clinical efficacy or comparative effectiveness studies involving human subjects or AI.

Acceptance Criteria and Device Performance Study Analysis

1. Table of Acceptance Criteria and Reported Device Performance

It is important to note that the provided 510(k) summary lists the types of tests performed but does not explicitly state specific numerical acceptance criteria or quantifiable reported device performance values for each test. Instead, it concludes generally that "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."

To create a table, we must infer the acceptance criteria as the successful completion of each test without failure or deviation from expected safety and performance parameters for a PTA balloon catheter. The "Reported Device Performance" is broadly stated as "conformance to the requirements."

Test Name	Acceptance Criteria (Inferred from documentation)	Reported Device Performance (as stated or inferred)
1. Tensile Test	Device components (e.g., catheter shaft, balloon bond) must withstand specified tensile forces without breakage or unacceptable deformation.	Results provide reasonable assurance of conformance to requirements for use.
2. Balloon Inflation/Deflation Test	Balloon must reliably inflate and deflate to specified pressures and durations without rupture, leakage, or permanent deformation.	Results provide reasonable assurance of conformance to requirements for use.
3. Balloon Burst Test	Balloon must withstand a specified pressure beyond its nominal inflation pressure without catastrophic failure, or burst at a predictable pressure.	Results provide reasonable assurance of conformance to requirements for use.
4. Balloon Compliance Test	Balloon diameter and length must conform to specified dimensions at various inflation pressures, exhibiting appropriate compliance characteristics.	Results provide reasonable assurance of conformance to requirements for use.
5. Balloon Fatigue Test	Balloon must withstand repeated inflation/deflation cycles without structural degradation or loss of integrity.	Results provide reasonable assurance of conformance to requirements for use.
6. Bond Strength Test	All bonded components (e.g., balloon to shaft) must maintain integrity under specified stress conditions.	Results provide reasonable assurance of conformance to requirements for use.
7. Animal Test	Device must demonstrate safe and effective performance in an appropriate animal model, including biocompatibility and functional performance.	Results provide reasonable assurance of conformance to requirements for use. (No specific animal species or detailed outcomes are provided in the summary).
8. Shelf Life Test	Device must maintain sterility, functionality, and integrity for its stated shelf life duration.	Results provide reasonable assurance of conformance to requirements for use.
9. Sterility Test	Device must meet established sterility assurance level (SAL) requirements.	Results provide reasonable assurance of conformance to requirements for use.
10. Biocompatibility Test	Device materials must demonstrate acceptable biological response (e.g., non-cytotoxic, non-sensitizing, non-irritating) as per ISO 10993 standards.	Results provide reasonable assurance of conformance to requirements for use.

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

The document does not provide specific sample sizes (number of devices, number of animal subjects, etc.) for each of the listed tests.
The data provenance for the non-animal tests would be in-vitro (bench testing) performed by Cook Incorporated. The animal test provenance is preclinical. There is no indication of human clinical data or retrospective/prospective human studies.

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

This information is not applicable as the tests described are primarily engineering/bench tests and an animal study. They do not involve expert interpretation or ground truth establishment in the context of diagnostic performance or clinical outcomes. The "ground truth" for these tests is based on objective physical measurements, material properties, and biological responses.

4. Adjudication Method for the Test Set

This information is not applicable for the types of tests conducted. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies, especially those involving expert consensus for ground truth determination, which is not the case here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The provided text describes engineering tests and an animal study, not clinical studies involving human readers or assessment of AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This device is a physical medical catheter, not an AI or software-as-a-medical-device (SaMD).

7. The Type of Ground Truth Used

The ground truth for the various tests is based on:

Engineering specifications and standards: For tensile, inflation/deflation, burst, compliance, fatigue, and bond strength tests.
Established biological testing standards (e.g., ISO 10993): For biocompatibility tests.
Sterility assurance level (SAL) requirements: For sterility tests.
Observed physiological and functional outcomes in an animal model: For the animal test.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this device is not an AI/ML algorithm. The "training" for the device's design comes from engineering principles, material science, and prior knowledge from predicate devices.

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

This information is not applicable as there is no training set in the context of AI/ML. The "ground truth" for the device's design and manufacturing processes would be established through industry standards, regulatory requirements, Cook Incorporated's internal quality systems, and experience with similar predicate devices.

Summary

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Special 510(K) Premarket Notification PTA Balloon Catheter: Advance® 35LP Low Profile PTA Balloon Dilatation Catheter Cook Incorporated 22 May 2009

510(k) Summary

Submitted By:

Nathan Simon, M.S. Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, PO Box 489 Bloomington, IN 47402 812-339-2235 April 17, 2009

Device:

Trade Name:

Advance® 35LP Low Profile PTA Balloon Dilatation Catheter

Proposed Classification:

Catheter, Percutaneous (74 DQY)

Indications for Use:

Predicate Devices:

The Advance® 35LP Low Profile 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® 35LP Low Profile PTA Balloon Dilatation Catheter. The identical indications for use and similar technological characteristics of the Advance® 35LP Low Profile PTA Balloon Dilatation Catheter as compared to the predicate devices support a determination of substantial equivalency.

JUN 1 2 2009

K091527 -65-

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K091527 page 2 of 2

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Special 510(K) Premarket Notification PTA Balloon Catheter: Advance® 35LP Low Profile PTA Balloon Dilatation Catheter Cook Incorporated 22 May 2009

Test Data:

The Advance® 35LP Low Profile PTA Balloon Dilatation Catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:

1. . Tensile test
1. Balloon inflation/deflation test
1. Balloon burst test
1. Balloon compliance test
1. Balloon fatigue test
1. Bond strength test
1. Animal test
1. Shelf life test
ੇ. Sterility test
1. 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 PTA dilatation balloon catheter.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three parallel lines that curve and converge. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 2 2009

Cook Incorporated C/O Nathan Simon Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47402

Re: K091527

Trade/Device Name: Advance 35LP Low Profile Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: May 22, 2009 Received: May 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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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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 go to http://www.fda.gov/cdrh/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Dunia R. Kirchner

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

Enclosure

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Special 510(K) Premarket Notification PTA Balloon Catheter: Advance® 35LP Low Profile PTA Balloon Dilatation Catheter Cook Incorporated 22 May 2009

K091527 510(k) Number (if known):

Device Name: Advance® 35LP Low Profile PTA Balloon Dilatation Catheter

Indications for Use:

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

Over-the-Counter Use (21 CFR 807 Subpart C) lot 1

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

unia R. Valassa

ision Sian-C Division of Cardiovascular Device

510(k) Number K091627

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).