The VascuTraK™ PTA Dilatation Catheter is intended for dilatation of stenoses in the peripheral arteries including the iliac, femoral, popliteal, ilio-femoral, infrapopliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Description

The VascuTraK™ Catheter is a sterile single use device that consists of a flexible shaft with a single through lumen and a 24 cm distal lumen that accepts a 0.014" guidewire. The distal end of the catheter contains a semi-compliant balloon that is inflated via the central lumen. The balloon is available in various diameters and lengths,

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the VascuTraK™ PTA Dilatation Catheter. This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study details, and ground truth establishment is not available in this document.

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

1. Table of Acceptance Criteria and Reported Device Performance
This document does not provide a table of acceptance criteria and reported device performance in the way typically found in a clinical study report for an AI/ML medical device. The 510(k) submission relies on demonstrating substantial equivalence to predicate devices based on design, materials, and established safety/performance characteristics, not specific performance metrics against pre-defined acceptance criteria for a novel algorithm.

2. Sample size used for the test set and the data provenance
Not applicable/Not provided. This document does not describe a test set or data provenance for an AI/ML algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. This document does not describe the establishment of a ground truth for a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable/Not provided. This document does not describe an adjudication method for a test set.

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/Not provided. This document is for a medical device (a catheter) and does not involve AI or human readers for diagnostic interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not provided. This device is a physical medical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided.

8. The sample size for the training set
Not applicable/Not provided.

9. How the ground truth for the training set was established
Not applicable/Not provided.

Summary of what can be extracted from the document:

The 510(k) summary focuses on demonstrating that the VascuTraK™ PTA Dilatation Catheter is substantially equivalent to existing, legally marketed predicate devices. The "Performance and Safety" section mentions:

Biological safety: Demonstrated through biocompatibility studies of patient contact materials in accordance with ISO 10993-1.
Physical testing: Performed to assure catheter integrity, including verification of balloon burst pressure.
Sterility: Supplied sterile to a Sterility Assurance Level (SAL) of 10⁻⁶.

These points indicate the types of tests done for a physical device, but they are not presented as "acceptance criteria" against specific numerical performance targets in the context of an AI/ML study. The 510(k) process is about establishing equivalence through comparison to predicates and meeting general safety and performance standards for its device type.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle.

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

June 15, 2016

TUV America, Inc. c/o Ms. Laura Danielson 1775 Old Highway 8 New Brighton, MN 55112-1891

Re: K063657

Trade/Device Name: Vascutrak™ PTA Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, angioplasty, peripheral, transluminal Regulatory Class: Class II Product Code: PNO Dated: December 7, 2006 Received: December 8, 2006

Dear Ms. Danielson:

This letter corrects our substantially equivalent letter of December 12, 2006.

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 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

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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" (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 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 yours,

Misti L. Malone -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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ThermopeutiX, Inc. (YMed) 510(k) Premarket Notification September 29. 2005

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): _ K-063657 _________________________________________________________________________________________________________________________________________

Device Name: VascuTraK™ PTA Dilatation Catheter

Indications for use: The VascuTraK™ PTA Dilatation Catheter is intended for dilatation of stenoses in the peripheral arteries including the iliac, femoral, popliteal, ilio-femoral, infrapopliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Prescription Use: × (Part 21 CFR 801 Subpart D) AND/OR

Over-the-counter Use: (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R-salines

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number 3063657

Page 8 of 94

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ThermopeutiX, Inc. (YMed) 510(k) Premarket Notification November 16, 2006

510 (k) SUMMARY

KO63657 ್

Applicant

YMed, Inc. 9925B Business Park Avenue San Diego, California 92131 Phone: (858) 542-1760 Fax: (858) 542-1717

Manufacturer

ThermopeutiX, Inc. 9925B Business Park Avenue San Diego, California 92131 Phone: (858) 542-1760 Fax: (858) 542-1717

Contact Person

Thomas Schroeder, Director, RA/QA

Common Name:	PTA Catheter
Classification Name:	Catheter, Angioplasty, Peripheral, Transluminal
Proprietary name:	VascuTrak™ PTA Dilatation Catheter

Predicate Devices

The YMed VascuTraK™ Catheter is substantially equivalent in general design and use fealures to many currently marketed balloon dilatation catheters used for peripheral angioplasty procedures; these predicate catheters are:

Invatec Amphirion™ Deep PTA Catheter (K042624) 1)
Cordis SAVVY® PTA Dilatalion Catheter (K971010) 2)
1. Guidant VIATRAC® 14 Peripheral Dilatation Catheter (K000101)
1. Boston Scientific Gazelle™ Balloon Dilatation Catheter (K001134)

DEC 1 2 2008

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ThermopeutiX, Inc. (YMed) 510(k) Premarket Notification November 16, 2006

Indications for Use

K063657 2. 20t2

Device Description

Technological Characteristics Comparison

The catheter is equivalent in design and construction to currently marketed PTA catheters. The construction materials used have an established history of safe use in similar medical devices.

Performance and Safety

The biological safety of the device has been demonstrated through biocompatibility studies of patient contact materials in accordance with the requirements outlined in ISO 10993-1. Physical testing was performed to assure catheter integrity including verification of balloon burst pressure.

The device is supplied sterily will conform to a Sterility Assurance Level (SAL) of 108. The supplied instructions for use provide the user with the applicable warnings and cautions during use. The device is contraindicated for the coronary arteries. There are no new safety or effectiveness issues related to this 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).