VASCUTRAK II PTA DILATATION CATHETER

K073025 · Thermopeutix, Inc. Dba Ymed, Inc. · PNO · Nov 9, 2007 · Cardiovascular

Device Facts

• Record ID: K073025
• Device Name: VASCUTRAK II PTA DILATATION CATHETER
• Applicant: Thermopeutix, Inc. Dba Ymed, Inc.
• Product Code: PNO · Cardiovascular
• Decision Date: Nov 9, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

VascuTraK™ II PTA Dilatation Catheter is a sterile, single-use peripheral angioplasty device. It features a flexible shaft with a semi-compliant balloon and a dual-lumen configuration (24 cm proximal, 18 mm distal) to accommodate a 0.014" guidewire, facilitating catheter exchange. Operated by physicians in clinical settings, the device is inserted into the vasculature to dilate stenoses or obstructive lesions. The balloon is inflated via a proximal luer fitting. The device restores blood flow by mechanically expanding narrowed vessels. This modification introduces a short guidewire lumen at the distal tip compared to the predicate.

Clinical Evidence

Bench testing only. Performance testing included balloon performance and tip tensile testing. Results were consistent with the original device. Biocompatibility was previously demonstrated per ISO 10993-1.

Technological Characteristics

Sterile, single-use PTA catheter. Features a flexible shaft with a semi-compliant balloon. Dual-lumen design (24 cm proximal, 18 mm distal) for 0.014" guidewire. Materials are identical to the predicate device. Sterilization provides a Sterility Assurance Level (SAL) of 10^-6.

Indications for Use

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

• VascuTraK™ PTA Dilatation Catheter (K063657)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and features the department's name around the perimeter. In the center of the seal is a stylized image of a bird with its wings spread.

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

June 15, 2016

ThermopeutiX, Inc. c/o Mr. Thomas P. Schroeder Director, RA/QA 9925B Business Park Avenue San Diego, CA 92131

Re: K073025

Trade/Device Name: Vascutrak™ II PTA Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Transluminal Peripheral Angioplasty Catheter Regulatory Class: Class II (Two) Product Code: PNO Dated: October 23, 2007 Received: October 26, 2007

Dear Mr. Schroeder:

This letter corrects our substantially equivalent letter of November 9, 2007.

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

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Page 2 - Mr. Thomas Schroeder

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 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 [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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YMed, Inc. Special 510(k) Device Modification October 19, 2007

## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K073025

Device Name: VascuTraK™ II PTA Dilatation Catheter

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

Prescription Use: X (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)

prima R. Wilsonel (Division Sign-Off) Division of Cardiovascular Devices

510(k) Number 长۵23025

Page 17 of 50

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# 073025 Med Inc. Special 510(k) Device Modification October 19, 2007

## 510 (k) SUMMARY

#### Applicant

NOV 0 9 2007

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 ^™ II PTA Dilatation Catheter |

#### Unmodified Device

The YMed VascuTraK™ II PTA Dilalation Catheter is modification to the VascuTraK™ PTA Dilatation Catheter cleared under K063657.

The distal tip configuration is being modified from a short lumen tip to permit use of an external guidewire to facilitate catheter exchange.

#### Indications for Use

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

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K073025 p.20f2 YMed, Inc. Special 510(k) Device Modification October 19, 2007

#### Device Description

The VascuTraK™ II Catheter is a sterile single use device that consists of a flexible shaft with a single through lumen terminating in a semi-compliant balloon. The catheter has a 24 cm lumen proximal to the balloon that accepts a 0.014" guidewire and an 18 mm lumen distal to the balloon that accepts a 0.014" guidewire. The distal balloon is inflated via a central lumen terminated in a luer fitting at the proximal end. The balloon is available in various diameters and lengths,

#### Technological Characteristics Comparison

The VascuTraK II PTA Dilatation Catheter is identical in design and construction to the currently marketed VascuTraK™ PTA Dilatation Catheter. This version of the catheter utilizes a short guidewire lumen rather than a short guidewire at the distal tip.

#### Performance and Safety

No new materials were used and the biological safety of the device was previously demonstrated through biocompatibility studies of patient contact materials in accordance with the requirements outlined in ISO 10993-1.

The modification does not affect the ability to sterilize the device; thus, the prior sterilization testing is valid. The device conforms to a Sterility Assurance Level (SAL) of 10°.

Testing of the modified catheter was performed and included balloon performance and tip tensile testing. Results for the modified device were consistent with those of the original device.

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.