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 18LP Low Profile PTA Balloon Dilatation Catheter is an over-the-wire catheter. The 4 Fr balloon catheter will be compatible with a 0.018 inch wire guide. The balloon catheter will be supplied sterile, intended for one-time use.

AI/ML Overview

The provided document describes the acceptance criteria and performance study for a medical device, specifically the Advance® 18LP Low Profile PTA Balloon Dilatation Catheter, not an AI or software device. Therefore, many of the typical criteria for evaluating AI/software performance, such as MRMC studies, training set details, or expert ground truth adjudication, are not applicable here.

The study focuses on the physical and functional performance of the balloon catheter to demonstrate its substantial equivalence to a predicate device for a 510(k) submission.

Here's an analysis of the provided information, framed within the requested categories where applicable, with an emphasis on what is present and what is not for a medical device (as opposed to an AI/software device):

Acceptance Criteria and Device Performance for the Advance® 18LP Low Profile PTA Balloon Dilatation Catheter

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
1. Balloon Minimum Burst Strength (Balloon must burst at or above minimum rated burst pressure, with linear tears.)	Testing shows the balloons will burst at or above the minimum rated burst pressure, with all failure modes being linear tears. The predetermined acceptance criteria were met.
2. Balloon Compliance (Balloon must meet labeled diameter within tolerance at nominal pressure under simulated body temperature.)	Testing shows that, under simulated body temperature conditions, each balloon will meet its labeled diameter within tolerance at the nominal pressure. The predetermined acceptance criteria were met.
3. Balloon Profile (Catheter shaft, bonds, and folded balloon must be compatible with 4, 5, 6, or 7 Fr sheath profiles (< 0.062, 0.074, 0.087 or 0.100 inch Profile).)	Measurement of the diameter of catheter shaft, bonds, and folded balloon shows that the device is compatible with a 4, 5, 6, or 7 Fr sheath (< 0.062, 0.074, 0.087 or 0.100 inch profile). The predetermined acceptance criteria were met.
4. Balloon Fatigue (Balloons must be free from leakage and damage after 10 cycles of inflation/deflation to rated burst pressure.)	Testing shows that balloons are free from leakage and damage on inflation, withstanding 10 cycles of inflation/deflation (inflating to rated burst pressure, holding for 30 seconds and deflating). The predetermined acceptance criteria were met.
5. Inflation/Deflation (Balloon must inflate to rated burst pressure within 60 seconds and fully deflate within 60 seconds.)	Testing shows that the balloon will inflate to rated burst pressure within 60 seconds and fully deflate within 60 seconds. The predetermined acceptance criteria were met.
6. Sheath Compatibility (Balloon catheters must be compatible with 4, 5, 6, or 7 Fr sheath.)	Testing shows that the balloon catheters are compatible with a 4, 5, 6, or 7 Fr sheath. The predetermined acceptance criteria were met.
7. Balloon and Catheter Bond Strength (Tensile force during proper clinical use should not fracture or rupture the balloon catheter bond, per ISO 10555-1.)	Testing shows the tensile force during proper clinical use should not fracture or rupture the balloon catheter bond. In conformance with the applicable sections of ISO 10555-1, the predetermined acceptance criteria were met.
8. Shaft Selection Burst Strength (Shaft must not burst before the balloon.)	Testing shows the shaft will not burst before the balloon. The predetermined acceptance criteria were met.
9. Kink Radius (Catheter kinked at a radius less than 13 millimeters.)	Testing shows that the catheters kinked at a radius less than 13 millimeters. The predetermined acceptance criteria were met.
10. Torque Strength (Catheters must withstand no less than two rotations before failure.)	Testing shows that the catheters withstood no less than two rotations before failure. The predetermined acceptance criteria were met.
11. Biocompatibility (Device must be biocompatible based on cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility, per ISO 10993-1.)	Testing (i.e., cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility) shows the device is biocompatible. In conformance with the applicable sections of ISO 10993-1, the predetermined acceptance criteria were met.
12. Sterilization (Sterility, bioburden, and residuals testing results must meet predetermined acceptance criteria.)	Sterility, bioburden, and residuals testing results met the predetermined acceptance criteria.

Regarding AI/Software-Specific Evaluation Criteria (Not Applicable for this Device):

The provided document describes a physical medical device (PTA Balloon Catheter) and its engineering performance testing for a 510(k) submission, not an AI or software algorithm. Therefore, the following requested items, which are standard for AI/software evaluation, are not present or applicable in this context:

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

This refers to physical testing of components and device function, not a "data test set" in the AI sense. The number of physical units tested for each criterion is implied to be sufficient for regulatory purposes, but specific sample sizes (e.g., how many balloons were burst, or how many catheters were fatigued) are not explicitly stated in this summary.
Data provenance (country of origin, retrospective/prospective) is not applicable; these are laboratory and bench tests of manufactured devices.

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

Ground truth here is established by engineering specifications, physical measurements, and industry standards (e.g., ISO 10555-1, ISO 10993-1), not by expert human interpretation of data (like radiologists marking images). The "experts" would be the engineers and technicians conducting the tests and verifying compliance with the standards.

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

Not applicable. This is for human review or labeling disagreement in data sets, not physical device testing.

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 physical catheter, not an AI system assisting human readers.

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

Not applicable. There is no algorithm. The performance tested is the physical device itself.

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

The "ground truth" for this device's performance is derived from pre-defined engineering specifications, international standards (e.g., ISO), and physical measurements/observations during bench testing.

8. The sample size for the training set:

Not applicable. This is not an AI model, so there is no "training set."

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

Not applicable, as there is no training set for this physical device.

Summary

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Special 510(k) Premarket Notification PTA Balloon Catheter: Advance® 18LP Low Profile PTA Balloon Dilatation Catheter Cook Incomorated May 22, 2013

510(k) Summary

Submitted By:

MAY 3 1 2013

David E. Chadwick, Ph.D., RAC, FRAPS Director, Regulatory Affairs/Regulatory Science Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 812-339-2235 Fax: 812-332-0281

Device:

Trade Name: Common Name: Proposed Classification: Advance® 18LP Low Profile PTA Balloon Dilatation Catheter PTA Balloon Catheter Catheter, Angioplasty, Peripheral, Transluminal (LIT)

Indications for Use:

Predicate Devices:

Advance® 18LP Low Profile PTA Balloon Dilatation Catheter, K073378, December 28, 2007

Device Description:

Substantial Equivalence:

Cook currently markets the PTA Balloon Catheter which is considered substantially equivalent to the Advance 18LP Low Profile PTA Balloon Dilatation Catheter. The identical indications for use and technological characteristics of the Advance® 18LP Low Profile PTA Balloon Dilatation Catheter as compared to the predicate device support a determination of substantial equivalence.

Comparison to Predicate Device:

The Advance® 18LP Low Profile PTA Balloon Dilatation Catheter has been modified from the predicate Advance® 18LP Low Profile PTA Balloon Dilatation Catheter to include additional balloon diameters of 2, 9, and 10 mm, additional balloon lengths of 1.5, 2.5, 12, 15, 17, and 20 cm, a catheter length of 150 cm for the over-the-wire type, a peripheral exchange delivery system with single-to-dual lumen configuration and a stainless steel proximal catheter shaft, and usable catheter lengths of 110 and 170 cm for the peripheral exchange type. It has been demonstrated that the Advance® 18LP Low Profile PTA Balloon Dilatation Catheter is comparable to the predicate device in terms of design, intended use, materials, fundamental technology, and principle of operation.

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Test Data:

The Advance® 18LP 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. Balloon Minimum Burst Strength - Testing shows the balloons will burst at or above the minimum rated burst pressure, with all failure modes being linear tears. The predetermined acceptance criteria were met.
1. Balloon Compliance - Testing shows that, under simulated body temperature conditions, each balloon will meet its labeled diameter within tolerance at the nominal pressure. The predetermined acceptance criteria were met.
1. Balloon Profile - Measurement of the diameter of catheter shaft, bonds, and folded balloon shows that the device is compatible with a 4, 5, 6, or 7 Fr sheath (< 0.062, 0.074, 0.087 or 0.100 inch profile). The predetermined acceptance criteria were met.
Balloon Fatigue Testing shows that balloons are free from leakage and damage on 4. inflation, withstanding 10 cycles of inflation/deflation (inflating to rated burst pressure, holding for 30 seconds and deflating). The predetermined acceptance criteria were met.
1. Inflation/Deflation - Testing shows that the balloon will inflate to rated burst pressure within 60 seconds and fully deflate within 60 seconds. The predetermined acceptance criteria were met.
Q. Sheath Compatibility - Testing shows that the balloon catheters are compatible with a 4. 5. 6, or 7 Fr sheath. The predetermined acceptance criteria were met.
1. Balloon and Catheter Bond Strength - Testing shows the tensile force during proper clinical use should not fracture or rupture the balloon catheter bond. In conformance with the applicable sections of ISO 10555-1, the predetermined acceptance criteria were met.
1. Shaft Selection Burst Strength - Testing shows the shaft will not burst before the balloon. The predetermined acceptance criteria were met.
ರು. Kink Radius - Testing shows that the catheters kinked at a radius less than 13 millimeters. The predetermined acceptance criteria were met.
1. Torque Strength - Testing shows that the catheters withstood no less than two rotations before failure. The predetermined acceptance criteria were met.
l l . Biocompatibility - Testing (i.e., cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility) shows the device is biocompatible. In conformance with the applicable sections of ISO 10993-1, the predetermined acceptance criteria were met.

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1. Sterilization - Sterility, bioburden, and residuals testing results met the predetermined acceptance criteria.
  In conclusion, the results of these tests support a conclusion that the proposed Advance® 18LP Low Profile PTA Balloon Dilatation Catheter and the predicate device are substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 31, 2013

Cook, Inc. c/o David E. Chadwick, Ph.D., RAC, FRAPS Director, Regulatory Affairs/Regulatory Science 750 Daniels Way Bloomington, IN 47404

Re: K130293

Trade/Device Name: Advance® 18LP Low Profile PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: LIT Dated: May 2, 2013 Received: May 3, 2013

Dear Dr. Chadwick:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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

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Page 2 - Dr. David Chadwick

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 Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Bram D. Zijickerman -S

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® 18LP Low Profile PTA Balloon Dilatation Catheter Cook Incorporated February 5, 2013

510(k) Number (if known):

Device Name: Advance® 18LP Low Profile PTA Balloon Dilatation Catheter

Indications for Use:

Prescription Use X (Per 21 CFR 801 Subpart D)

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)

Bram D. Zuckerman -S 2013.06.04 15:16:01 -04'00'

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).