The Advance® 14LP Low Profile PTA Balloon Dilatation Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, renal, popliteal, femoral and iliofemoral, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Description

The Advance® 14LP Low Profile PTA Balloon Dilatation Catheters are peripheral (rapid) exchange balloon dilatation catheters that are available with inflated balloon diameters of 2, 2.5, 3, and 4 millimeters and balloon lengths of 20, 40, 60, 80, 120, 160, 200 millimeters. The catheters are supplied sterile and are intended for one-time use.

AI/ML Overview

This is a 510(k) summary for a medical device called the "Advance 14LP Low Profile PTA Balloon Dilatation Catheter." This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the provided text in relation to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Dimensional Verification	Catheter length within acceptable tolerance limits	Met
Balloon Burst Testing	Statistically, balloons burst at or above the minimum rated burst pressure	Met
Balloon Fatigue Testing	Balloons withstand ten inflation and deflation cycles to the rated burst pressure of 16 atm	Met

Important Note: The provided text does not include specific numeric values for the "acceptable tolerance limits" for dimensional verification or the "minimum rated burst pressure" for balloon burst testing. It only states that the acceptance criteria were met.

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

The document does not explicitly state the sample sizes for the dimensional verification, balloon burst, or balloon fatigue tests. It also does not mention the country of origin of the data or whether the data was retrospective or prospective. These tests are typically benchtop engineering tests conducted during device development/validation.

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

This information is not applicable to the type of testing described. The "ground truth" for these engineering performance tests is established by specifications and engineering standards, not by expert medical interpretation.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or complex clinical outcomes. These are engineering performance tests.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes engineering performance tests (dimensional, burst, fatigue) designed to demonstrate the device's physical properties, not its clinical efficacy or human reader performance. This premarket notification relies on "substantial equivalence" to a predicate device, meaning it is similar enough that new clinical trials are not required.

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

This question is not applicable to this device. This is a physical medical device (a catheter), not a software algorithm or AI. Therefore, there is no "standalone algorithm" performance to report.

7. The Type of Ground Truth Used

The ground truth for these tests is based on engineering specifications and performance requirements. For example:

Dimensional Verification: The design specifications for the catheter's length.
Balloon Burst Testing: The specified rated burst pressure for the balloon.
Balloon Fatigue Testing: The specified number of inflation/deflation cycles and rated burst pressure.

8. The Sample Size for the Training Set

This information is not applicable. A "training set" refers to data used to train an AI algorithm. As this device is a physical catheter, not an AI, there is no training set in this context.

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

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

Summary

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Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

February 13, 2017

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

Cook Incorporated Mr. Daniel J. Corbin Regulatory Affairs Specialist 750 Daniels Wav Bloomington, IN 47404

Re: K170193

Trade/Device Name: Advance 14LP Low Profile PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: January 20, 2017 Received: January 23, 2017

Dear Mr. Corbin:

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 of medical device

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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 Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Fernando Aguel-S

for 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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Indications for Use

510(k) Number (if known) K170193

Device Name

Advance 14LP Low Profile PTA Balloon Dilatation Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

Submitted By:	Daniel J. CorbinCook Incorporated750 Daniels WayP.O. Box 489Bloomington, IN 47402Phone: (812) 335-3575 x104018Fax: (812) 332-0281Date Prepared: January 20, 2017
Device:
Trade Name:	Advance® 14LP Low Profile PTA Balloon DilatationCatheter
Common Name:	Percutaneous Transluminal Angioplasty Balloon Catheter
Classification Name:	Catheter, Angioplasty, Peripheral, TransluminalLIT (21 CFR §870.1250)

Indications for Use:

The Advance® 14LP Low Profile PTA Balloon Dilatation Catheter is intended 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.

Predicate Device:

The device, subject of this submission, is substantially equivalent to the predicate device, the Advance 14Rx Rapid Exchange Balloon Catheter, cleared under 510(k) number K090822. The reference device, K130293, the Advance® 18LP Low Profile PTA Balloon Dilatation Catheter has been included in this submission to support the shorter device length.

Comparison to Predicate Device:

It has been demonstrated that the Advance® 14LP Low Profile PTA Balloon Dilatation Catheter is comparable to the predicate device. The Advance® 14LP Low Profile PTA Balloon Dilatation Catheters are identical in terms of intended use, principles of operation, materials of construction, and basic technological characteristics to the predicate device. The predicate device, K090822, was only available with a catheter length of 165 centimeters and the proposed device, the Advance® 14LP Low Profile PTA Balloon Dilatation Catheter, is available with

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catheter lengths of 110 and 165 centimeters. The rated burst pressure will increase from 12 atm to 16 atm.

Device Description:

Test Data:

The following tests were performed to demonstrate that the Advance® 14LP Low Profile PTA Balloon Dilatation Catheters met applicable design and performance requirements and support a determination of substantial equivalence.

. Dimensional Verification - Testing showed that the catheter length was within acceptable tolerance limits. The acceptance criterion was met.
. Balloon Burst Testing - Testing showed that statistically the balloons will burst at or above the minimum rated burst pressure. The acceptance criteria were met.
. Balloon Fatigue Testing - Testing showed that the balloons can withstand ten inflation and deflation cycles to the rated burst pressure of 16 atm. The acceptance criteria were met.

In conclusion, the results of these tests support a determination of substantial equivalence to the predicate device.

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).