The Advance Micro 14 Ultra Low-Profile PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including internal pudendal, iliac, renal, popliteal, femoral, iliofemoral, anterior tibial, posterior tibial, peroneal, pedal, radial, brachial, and ulnar, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary arteries.

Device Description

The Advance Micro 14 Ultra Low-Profile PTA Balloon Catheter is an over-the-wire catheter available with an inflated balloon diameter of 1.5 mm with balloon lengths of 2 and 4 cm and balloon diameters of 2, 2.5, and 3 mm with balloon lengths of 2, 3, 4, 6, 8, 10, and 12 cm. The catheter is 2.5 French in outer diameter with a length of 50, 90, or 150 cm. The catheter is compatible with a 0.014 inch (0.36 mm) diameter wire guide. It will be supplied sterile, intended for one-time use.

AI/ML Overview

The provided text describes the regulatory submission for the "Advance Micro 14 Ultra Low-Profile PTA Balloon Catheter," a medical device. This type of submission (510(k)) focuses on demonstrating substantial equivalence to a legally marketed predicate device through a series of engineering and performance tests, not clinical studies involving human patients or complex AI algorithms. Therefore, many of the requested fields related to clinical trials, AI, ground truth, and expert evaluation are not applicable or cannot be extracted from this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Predetermined Acceptance Criteria	Reported Device Performance
Balloon Minimum Burst Strength	Balloons burst at or above the minimum rated burst pressure, with linear tears as the failure mode.	"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."
Balloon Preparation and Simulated Use	Materials withstand contact with saline/heparin and contrast medium (1:1 ratio); compatible with recommended introducer and wire guide; perform according to instructions for use.	"All materials withstand contact with saline/heparin and contrast medium (1:1 ratio) during simulated use. Simulated use testing shows the devices are compatible with the recommended introducer and wire guide and perform according to the instructions for use. The predetermined acceptance criteria were met."
Catheter Diameter and Balloon Profile	Device profile is less than 1.016 mm (0.040 inch).	"Measurement of the diameter of catheter shaft. bonds, and folded balloon shows that the device profile is less than 1.016 mm (0.040 inch). The predetermined acceptance criteria were met."
Balloon Compliance	Under simulated body temperature, each balloon meets its labeled diameter within tolerance at nominal pressure.	"Under simulated body temperature conditions, each balloon will meet its labeled diameter within tolerance at the nominal pressure. The predetermined acceptance criteria were met."
Balloon Fatigue	Balloons free from leakage and damage on inflation; withstand 10 cycles of inflation.	"Balloons are free from leakage and damage on inflation, withstanding 10 cycles of inflation. The predetermined acceptance criteria were met."
Bond Strength	Tensile force during proper clinical use should not fracture or rupture balloon catheter bonds (in conformance with ISO 10555-1).	"The tensile force during proper clinical use should not fracture or rupture the balloon catheter bonds. In conformance with the applicable sections of ISO 10555-1, the predetermined acceptance criteria were met."
Inflation / Deflation Time	Balloon inflates to rated burst pressure within 60 seconds; fully deflates within 60 seconds.	"The balloon will inflate to rated burst pressure within 60 seconds and fully deflate within 60 seconds. The predetermined acceptance criteria were met."

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

Sample Size: The document does not specify the exact sample sizes (number of catheters or balloons) used for each physical and mechanical test. It only mentions that "the predetermined acceptance criteria were met" for all tests.
Data Provenance: The tests are described as in vitro or simulated use laboratory tests conducted by the manufacturer, Cook Incorporated. There is no mention of clinical data, human subjects, or country of origin for patient data as this is a device performance evaluation, not a clinical trial. The testing presumably occurred at Cook's facilities.

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

Not Applicable. This document describes engineering and performance tests on a physical medical device. "Ground truth" in the context of expert consensus, pathology, or clinical outcomes is not relevant here. The "ground truth" for these tests is defined by the physical properties of the material and device, as measured by standard laboratory methods against pre-defined engineering specifications.

4. Adjudication method for the test set:

Not Applicable. As these are physical and mechanical tests, there is no "adjudication method" in the sense of reconciling differing expert opinions. The results are objective measurements against defined criteria.

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 PTA Balloon Catheter, not an AI-powered diagnostic or imaging device. Therefore, no MRMC study or AI-related effectiveness study was conducted or is relevant to this submission.

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

Not Applicable. This device is a physical medical instrument, not an algorithm or software.

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

The "ground truth" for these tests is established by engineering specifications and industry standards (e.g., ISO 10555-1 mentioned for bond strength) for device performance. It is based on objective physical and mechanical measurements conducted in a laboratory setting.

8. The sample size for the training set:

Not Applicable. This is not an AI/machine learning study. There is no concept of a "training set" in the context of this device's performance evaluation.

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

Not Applicable. As there is no training set, this question is not relevant.

Summary

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Advance Micro 14 Ultra Low-Profile PTA Balloon Catheter Traditional 510(k)

5. 510(k) Summary

MAR 1 9 2013

< 122940

Advance Micro 14 Ultra Low-Profile PTA Balloon Catheter 510(k) Summary 21 CFR 807.92 Date Prepared: March 19, 2013

Submitted By:

Applicant: Address:

Phone Number: Fax Number:

Contact: Contact Address:

Contact Phone Number: Contact Fax Number:

Device Information:

Trade name:

Common name: Classification: Regulation: Product Code:

750 Daniels Way P.O. Box 489 Bloomington, IN 47402 1 (800) 468-1379 (812) 332-0281

Cook Incorporated

Elysia Easton Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 800-346-2686 or 812-355-2525(ext. 2515) 812-332-0281

Advance Micro 14 Ultra Low-Profile PTA Balloon Catheter PTA Balloon Catheter Class II 21 CFR §870.1250 DOY, LIT

Predicate Device:

Advance 14LP Low Profile PTA Balloon Dilatation Catheter

D.C. #K090822, April 27, 2009

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Advance Micro 14 Ultra Low-Profile PTA Balloon Catheter Traditional 510(k)

Device Description:

Intended Use:

The Advance Micro 14 Ultra Low-Profile PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including internal pudendal, iliac, renal, popliteal, femoral, anterior tibial, posterior tibial, peroneal, pedal, radial, brachial, and ulnar, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary arteries.

Discussion of Tests and Test Results:

The Advance Micro 14 Ultra Low-Profile PTA Balloon 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 Preparation and Simulated Use All materials withstand contact with saline/heparin and contrast medium (1:1 ratio) during simulated use. Simulated use testing shows the devices are compatible with the recommended introducer and wire guide and perform according to the instructions for use. The predetermined acceptance criteria were met.
1. Catheter Diameter and Balloon Profile Measurement of the diameter of catheter shaft. bonds, and folded balloon shows that the device profile is less than 1.016 mm (0.040 inch). The predetermined acceptance criteria were met.

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Advance Micro 14 Ultra Low-Profile PTA Balloon Catheter Traditional 510(k)

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 Fatigue Testing shows that balloons are free from leakage and damage on inflation, withstanding 10 cycles of inflation. The predetermined acceptance criteria were met.
- 1. Bond Strength Testing shows the tensile force during proper clinical use should not fracture or rupture the balloon catheter bonds. In conformance with the applicable sections of ISO 10555-1, the predetermined acceptance criteria were met.
- 1. Inflation / Deflation Time 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.

Conclusions Draw from the Tests:

The results of these tests provide reasonable assurance that the device is as safe and effective as the predicate device and support a determination of substantial equivalence.

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

Public Health Service

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

March 19, 2013

Cook Incorporated c/o Ms. Elvsia Easton Regulatory Affairs Specialist 750 Daniels Way. PO Box 489 Bloomington, IN 47402-0489

Re: K122940

Trade/Device Name: Advance Micro 14 Ultra Low-Profile PTA Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, LIT Dated: February 13, 2013 Received: February 14, 2013

Dear Ms. Easton:

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. However, we remind you 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

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Page 2 - Ms. Elysia Easton

Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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/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,

Matthew Gillebrenner

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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Advance Micro 14 Ultra Low-Profile PTA Balloon Catheter Traditional 510(k)

4. Indications for Use Statement

K122940 510(k) Number (if known):

Device Name: Advance Micro 14 Ultra Low-Profile PTA Balloon Catheter

Indications for Use:

Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Matthew G퀘咖lebrenner

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).