ARROW GPSCATH BALLOON DILATATION CATHETER

K130397 · Hotspur Technologies · LIT · Jun 20, 2013 · Cardiovascular

Device Facts

• Record ID: K130397
• Device Name: ARROW GPSCATH BALLOON DILATATION CATHETER
• Applicant: Hotspur Technologies
• Product Code: LIT · Cardiovascular
• Decision Date: Jun 20, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arrow GPSCath Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

Device Story

Arrow GPSCath Balloon Dilatation Catheter is a 0.035" guide-wire compatible PTA balloon catheter featuring a proprietary proximal valve system for fluid injection. Device allows treatment of obstructive lesions in peripheral arteries and arteriovenous dialysis fistulae while maintaining guidewire position. Used by clinicians in clinical settings. Device transforms input (fluid injection) into mechanical dilation of vessels via inflatable balloon. Output is physical dilation of obstructive lesions. Benefits include procedural efficiency by enabling fluid delivery without losing guidewire access.

Clinical Evidence

No clinical data. Evidence consists of bench testing, biocompatibility, and simulated use testing. Bench tests included balloon compliance, burst strength, torque strength, bond strength, tip-pull strength, rated burst pressure, fatigue, inflation/deflation time, and contrast media flow rate. Biocompatibility testing included cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, hemolysis, complement activation, thromboresistance, and partial thromboplastin time. All tests met predetermined acceptance criteria.

Technological Characteristics

0.035" guide-wire compatible PTA balloon catheter. Features proprietary proximal valve system for fluid delivery. Materials evaluated for biocompatibility per ISO standards. Mechanical characteristics include balloon inflation/deflation, high-pressure dilation capability, and bond/burst strength specifications. Sterilization method utilized. Standalone device; no software or electronic components.

Indications for Use

Indicated for percutaneous transluminal angioplasty of femoral, iliac, and renal arteries 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

• GPSCath Balloon Dilatation Catheter (K113769)

Reference Devices

• GPSCath Balloon Dilatation Catheter (cleared as PTA-Duo PTA Balloon Catheter, K101047)

Submission Summary (Full Text)

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Traditional 510(k) Notification Arrow GPSCath™ Balloon Dilatation Catheter

510(k) SUMMARY

## JUN 2 0 2013

| A. | Submitter Information | |
|----|--------------------------|--------------------------------------------------------------------|
| | Submitter's Name: | Hotspur Technologies, Inc.<br>Subsidiary of Teleflex Medical, Inc. |
| | | |
| | Address: | 880 Maude Ave., Suite A |
| | | Mountain View, CA 94043 |
| | Telephone: | 650-969-3150 |
| | Fax: | 408-608-1597 |
| | Contact Person: | Eric Ankerud |
| B. | Subject Device | |
| | Trade Name: | Arrow GPSCath Balloon Dilatation Catheter |
| | Common/Usual Name: | Balloon Catheter |
| | Classification Name: | Catheter, Angioplasty, Peripheral, Transluminal/Percutaneous |
| | | Catheter (21 CFR 870.1250, Product Code LIT) |
| C. | Predicate Device Name(s) | |
| | Trade Name(s): | GPSCath Balloon Dilatation Catheter, #K113769 |
| D. | Reference Device Name(s) | |
| | Trade Name(s): | GPSCath Balloon Dilatation Catheter |
| | | (Cleared under the name PTA-Duo PTA Balloon Catheter), |
| | | #K101047 |

## E. Device Description:

The proposed Arrow GPSCath Balloon Dilatation Catheter is designed for dilation of peripheral vessels in the arterial system and native or synthetic arteriovenous dialysis fistulae in the treatment of obstructive lesions. The Arrow GPSCath Balloon Dilatation Catheter is a 0.035" guide-wire compatible, PTA balloon catheter with a proprietary proximal valve system which allows injection of fluids. By providing an angioplasty balloon with fluid delivery capability, the user is able to treat obstructive lesions within the arterial system and arteriovenous dialysis fistulae without having to lose guidewire position.

## F. Intended Use:

The Arrow GPSCath Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

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Image /page/1/Picture/0 description: The image shows the logo for Hotspur Technologies. The logo consists of a circular graphic on the left and the words "Hotspur Technologies" on the right. The circular graphic is made up of three curved lines that resemble waves or arcs. The word "Hotspur" is in a larger font than the word "Technologies".

## Traditional 510(k) Notification Arrow GPSCath™ Balloon Dilatation Catheter

## G. Reason for Modification:

The purpose of this Traditional 510(k) is to include additional product sizes to the GPSCath Balloon Dilatation Catheter size matrix. As a result of this change, new product codes have been established. Additionally, this Traditional 510(k) includes a dimensional change in the catheter working leneth and packaging, product trade name change, balloon material change, and balloon bonding process change,

## H. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use:

The proposed Arrow GPSCath Balloon Dilatation Catheter and the predicate GPSCath Balloon Dilatation Catheter have the same intended use. Both are indicated for treatment of obstructive lessions by high pressure dilation in the arterial system and of native or synthetic arteriovenous dialysis fistulae.

The proposed Arrow GPSCath Balloon Dilatation Catheter and the GPSCath Balloon Dilatation Catheter contain an inflatable balloon for dilation of obstructive lesions. The proposed device and predicate device are substantially equivalent in terms of intended use, fundamental scientific technology, target population, operating principles, and method of sterilization.

#### I. Performance Data:

The proposed Arrow GPSCath Balloon Dilatation Catheter was evaluated using bench, biocompatibility, package and simulated use test data to confirm the performance characteristics as compared to the predicate device, the GPSCath Balloon Dilatation Catheter (#K113769). Biocompatibility testing included cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, systemic toxicity, hemolysis, complement activation, thromboresistence, partial thromboplastin time, and MEM elution. Bench top tests, specifically balloon compliance, catheter body burst strength, catheter torque strength, catheter balloon bond strength, catheter tip-pull strength, simulated use, balloon rated burst pressure, balloon fatigue, and balloon inflation/deflation time, contrast media flow rate, and catheter visual inspections were completed. All test results demonstrate that the Arrow GPSCath Balloon Dilatation Catheter met the established specifications necessary for consistent performance during its intended use.

### J. Conclusions:

The Arrow GPSCath Balloon Dilatation Catheter met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, test protocols, and/or customer inputs. The Arrow GPSCath Balloon Dilatation is substantially equivalent to the legally marketed predicate device and does not raise any new safety or effectiveness questions. Minor enhancements do not affect safety or effectiveness of the device nor do they affect the functionality or indications for use of the Arrow GPSCath Balloon Dilatation Catheter. The modifications identified in this submission are documented in Hotspur's Design History File in accordance with design controls, 21 CFR 820.30, and Hotspur's internal quality system procedures.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

## June 20, 2013

Hotspur Technologies, Inc.

c/o Eric P. Ankerud, J.D. Regulatory and Quality Consultant 880 Maude Avenue, Suite A Mountain View, CA 94043

Re: K130397

Trade/Device Name: Arrow GPSCath Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: LIT Dated: May 10, 2013 Received: May 13, 2013

Dear Mr. Ankerud:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Eric P. Ankerud

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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Bram D. Zuckerman -S

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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Image /page/4/Picture/1 description: The image contains a logo with a circular design on the left and the word "Hotspur" in bold font on the right. Below "Hotspur" is the word "Technologies" in a smaller, less bold font. The circular design consists of three curved lines that resemble waves or orbits, with a pattern of small triangles at the bottom.

Traditional 510(k) Notification Arrow GPSCath™ Balloon Dilatation Catheter

## STATEMENT OF INDICATIONS FOR USE

510(k) Number:

Device Name:

Arrow GPSCath™ Balloon Dilatation Catheter

Indication For Use:

The Arrow GPSCath Balloon Dilatation Catheter is indicated for use in percutaneous transluminal angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)