GPSCATH BALLON DILATATION CATHETER

K113769 · Hotspur Technologies · LIT · Jan 20, 2012 · Cardiovascular

Device Facts

• Record ID: K113769
• Device Name: GPSCATH BALLON DILATATION CATHETER
• Applicant: Hotspur Technologies
• Product Code: LIT · Cardiovascular
• Decision Date: Jan 20, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 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

GPSCath Balloon Dilatation Catheter is a 0.035" guide-wire compatible PTA balloon catheter; features proprietary proximal valve system allowing fluid injection. Device used by physicians in clinical settings to treat obstructive lesions in peripheral arteries and arteriovenous dialysis fistulae. Operator maintains guidewire position while performing angioplasty via balloon inflation. Output is mechanical dilation of vessel/fistula. Benefits include treatment of obstructive lesions without loss of guidewire access. Modification involves updated balloon rated burst pressure and compliance specifications.

Clinical Evidence

Bench testing only. Evaluated via in vitro testing including balloon compliance, catheter body burst strength, balloon rated burst pressure, balloon fatigue, and inflation/deflation time to confirm performance against established specifications.

Technological Characteristics

0.035" guide-wire compatible PTA balloon catheter; includes proprietary proximal valve system for fluid delivery. Usable length 55 cm. Mechanical dilation principle. Sterilization method not specified.

Indications for Use

Indicated for patients requiring Percutaneous Transluminal Angioplasty of femoral, iliac, or renal arteries, or 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 (previously cleared as PTA-Duo PTA Balloon Catheter, K101047)

Submission Summary (Full Text)

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Special 510(k) Notification: GPSCath™ Balloon Dilatation Catheter Increased Rated Burst Pressure

CONFIDENTIAL

#### 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

## A. Submitter Information

Submitter's Name: Address:

Telephone: Fax: Contact Person: Hotspur Technologies, Inc. 880 Maude Ave., Suite A Mountain View, CA 94043 650-969-3150 408-608-1597 Eric Ankerud, Executive Vice President Clinical, Regulatory, Quality

JAN 2 0 2012

#### B. Subject Device

Trade Name: Common/Usual Name: Classification Name:

GPSCath Balloon Dilatation Catheter Balloon Catheter 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 (previously cleared under the name of PTA-Duo PTA Balloon Catheter, 510(k) #K101047)

#### D. Device Description:

The GPSCath Balloon Dilatation Catheter is designed for dilation of peripheral vessels in the arterial svstem and native or synthetic arteriovenous dialysis fistulae in the treatment of obstructive lesions. The 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.

#### E. Intended Use:

The 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 lessions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

#### F. Reason for Modification:

The purpose of this Special 510(k) is to revise the GPSCath Balloon Dilatation Catheter Instructions for Use (IFU) to illustrate a new balloon rated burst pressure and compliance table based on the following bench top testing: Balloon Compliance, Catheter Body Burst Strength, Balloon Rated Burst Pressure, Balloon Fatigue and Balloon Inflation/ Deflation Time Testing. Hotspur also wishes to notify FDA of a new commercial trade name for the PTA-Duo PTA Balloon Catheter which was originally cleared under 510(k) #K101047. Hotspur has replaced the PTA-Duo PTA Balloon Catheter name with the new commercial trade name of GPSCath Balloon Dilatation Catheter. Additionally, this Special 510(k) includes minor revisions to the IFU for consistency and clarification.

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Image /page/1/Picture/2 description: The image contains the logo for Hotspur Technologies. The logo consists of a stylized, circular graphic on the left, resembling a series of concentric arcs or waves. To the right of the graphic, the word "Hotspur" is written in a slightly bold, sans-serif font. Below "Hotspur," the word "Technologies" is written in a smaller, lighter font, also sans-serif. The overall design is simple and modern.

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

The modified GPSCath Balloon Dilatation Catheter and the predicate PTA-Duo PTA Balloon Catheter are both indicated for treatment of obstructive lesions by high pressure dilation in the arterial system and of native or synthetic arteriovenous dialysis fistulae.

The GPSCath Balloon Dilatation Catheter contains an inflatable balloon for dilation of obstructive lesions. The usable length of both devices is 55 cm. The modified GPSCath Balloon Dilatation Catheter and predicate device are substantially equivalent in terms of intended use, fundamental scientific technology, target population, operating principles, and method of sterilization.

## H. Performance Data:

The modified GPSCath Balloon Dilatation Catheter was evaluated using in vitro test data to confirm the performance characteristics as compared to the cleared device, the GPSCath Balloon Dilatation Catheter which was originally cleared as the PTA-Duo PTA Balloon Catheter under 510(k) #K101047 device.

Bench top tests, specifically Balloon Compliance, Catheter Body Burst Strength, Balloon Rated Burst Pressure, Balloon Fatigue and Balloon Inflation/ Deflation Time Testing, were completed to demonstrate that the modified GPSCath Balloon Dilatation Catheter met the established specifications necessary for consistent performance during its intended use.

## I. Conclusions:

The modified 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 modified GPSCath Balloon Dilatation is substantially equivalent to the legally marketed predicate device and does not raise any new safety or effectiveness questions. Device modifications 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JAN 2 0 2012

Hotspur Technologies, Inc. c/o Eric Ankerud Executive VP Clinical, Regulatory, and Quality 880 Maude Ave., Suite A Mountain View, CA 94043

Re: K113769

Trade/Device Name: GPSCath Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: December 20, 2011 Received: December 22, 2011

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. 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.

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Page 2 - Mr. Eric Ankerud

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 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/ReportalProblem/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.

M.A. Hilbebun

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

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for Hotspur Technologies. The logo consists of a stylized symbol on the left and the company name on the right. The symbol is made up of curved lines that resemble a stylized letter C. The company name is written in a simple, sans-serif font, with the word "Hotspur" in a larger font size than the word "Technologies".

CONFIDENTIAL

#### STATEMENT OF INDICATIONS FOR USE

510(k) Number: Device Name: Indication For Use:

K113769

GPSCath™ Balloon Dilatation Catheter The 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)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

M. L. Kleham

Division Sign-Off) Division of Cardiovascular Devices

12113769 510(k) Number_