VASCUTRAK PTA DILATION CATHETER

K063657 · Ymed, Inc. · PNO · Dec 12, 2006 · Cardiovascular

Device Facts

• Record ID: K063657
• Device Name: VASCUTRAK PTA DILATION CATHETER
• Applicant: Ymed, Inc.
• Product Code: PNO · Cardiovascular
• Decision Date: Dec 12, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended 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.

Device Story

VascuTraK™ PTA Dilatation Catheter is a sterile, single-use device for peripheral angioplasty. Device features a flexible shaft with a single through-lumen and a 24 cm distal lumen for 0.014" guidewire compatibility. Distal end contains a semi-compliant balloon inflated via the central lumen. Used by physicians in clinical settings to dilate stenoses in peripheral arteries and arteriovenous dialysis fistulae. Operation involves advancing the catheter over a guidewire to the target lesion, followed by balloon inflation to restore vessel patency. Benefits include improved blood flow in peripheral vasculature and dialysis access sites.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1. Physical testing conducted to verify catheter integrity, including balloon burst pressure.

Technological Characteristics

Sterile, single-use PTA catheter. Features flexible shaft, single through-lumen, 24 cm distal lumen for 0.014" guidewire, and semi-compliant balloon. Materials have established history of use. Sterilization to SAL 10^-6. Mechanical device; no software or energy source.

Indications for Use

Indicated for patients requiring dilatation of stenoses in peripheral arteries (iliac, femoral, popliteal, ilio-femoral, infrapopliteal, renal) and treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae. Contraindicated for use in coronary arteries.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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: [phone] Fax: [phone]

Manufacturer

ThermopeutiX, Inc. 9925B Business Park Avenue San Diego, California 92131 Phone: [phone] Fax: [phone]

#### 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)
- 3) Guidant VIATRAC® 14 Peripheral Dilatation Catheter (K000101)
- 4) 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

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 synthelic 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,

#### 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.