Arrow GPSCath Balloon Dialation Catheter (150 cm)

K142300 · Hotspur Technologies, Inc., · LIT · Sep 17, 2014 · Cardiovascular

Device Facts

• Record ID: K142300
• Device Name: Arrow GPSCath Balloon Dialation Catheter (150 cm)
• Applicant: Hotspur Technologies, Inc.,
• Product Code: LIT · Cardiovascular
• Decision Date: Sep 17, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arrow GPSCath Balloon Dilatation Catheter (150 cm) is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal 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 (150 cm) is a 0.014" guidewire-compatible PTA balloon catheter. Device features semi-compliant angioplasty balloon at distal tip and integrated valve technology allowing fluid injection through inflation lumen without guidewire removal. Radiopaque markers identify balloon working length and valve position for angiographic placement. Proximal handle includes inflation and guidewire luer lock hubs. Used by physicians in clinical settings for peripheral vascular interventions. Device enables balloon dilation of stenotic lesions while facilitating simultaneous fluid/contrast injection. Benefits include reduced procedure time and simplified workflow by eliminating need to remove guidewire for injections.

Clinical Evidence

Bench testing only. Performance qualification conducted at time zero for balloon compliance, rated burst pressure, and crossing profile. Results support updated compliance chart and introducer sheath compatibility. All other performance data remains consistent with predicate device (K140351).

Technological Characteristics

0.014" guidewire compatible PTA balloon catheter. Features semi-compliant balloon and proximal valve for fluid injection. Includes four radiopaque markers (two for balloon, two for valve). Proximal handle with dual luer lock hubs. No changes to materials, design, or sterilization from predicate.

Indications for Use

Indicated for patients requiring Percutaneous Transluminal Angioplasty (PTA) in peripheral vasculature (iliac, femoral, popliteal, infra-popliteal, renal arteries) or treatment of obstructive lesions in native/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

• Arrow GPSCath™ Balloon Dilatation Catheter (150cm) (K140351)

Submission Summary (Full Text)

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

September 17, 2014

Hotspur Technologies, Inc. Mr. Eric Ankerud Regulatory and Quality Consultant 880 Maude Avenue, Suite A Mountain View, CA 94043

Re: K142300

Trade/Device Name: Arrow GPSCath Balloon Dilatation Catheter (150 cm) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: August 14, 2014 Received: August 18, 2014

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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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/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 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,

Kenneth J. Cavanaugh -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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#### Indications for Use Statement

510(k) Number (if known):_ K142300

Device Name:

# Arrow® GPSCath™ Balloon Dilatation Catheter (150 cm)

Indications for Use:

The Arrow GPSCath Balloon Dilatation Catheter (150 cm) is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal 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.

ア 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)

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# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

# A. Submitter Information

B.

| Submitter's Name: | Hotspur Technologies, Inc.<br>A Subsidiary of Teleflex Medical, Inc. |
|----------------------|-------------------------------------------------------------------------------------------|
| Address: | 880 Maude Avenue, Suite A<br>Mountain View, CA 94043 |
| Telephone: | 978-302-9467 |
| Fax: | 408-608-1597 |
| Contact Person: | Eric Ankerud |
| Date of Preparation: | August 11, 2014 |
| Subject Device | |
| Trade Name: | Arrow® GPSCath™ Balloon Dilatation Catheter<br>(150cm) |
| Common/Usual Name: | Balloon Catheter |
| Classification Name: | 21 CFR 870.1250, Catheter, Angioplasty,<br>Peripheral, Transluminal/Percutaneous Catheter |
| Class: | II |
| Product Code: | LIT |

# C. Predicate Device Name(s):

Arrow GPSCath™ Balloon Dilatation Catheter (150cm), K140351 (Hotspur Technologies)

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# D. Indication for Use:

The Arrow GPSCath Balloon Dilatation Catheter (150cm) is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal 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.

# E. Device Description:

The Arrow GPSCath Balloon Dilatation Catheter (150cm) is an 0.014" guidewire compatible PTA balloon catheter consisting of a semi-compliant angioplasty balloon fixed at the distal tip and a novel valve technology that allows injection of fluids through the inflation lumen without removal of the guidewire. Two radiopaque markers identify the balloon working length and two radiopaque markers indentify the valve to aid in angiographic placement. The proximal portion of the catheter includes an inflation female luer lock hub on the side of the handle and a guidewire female luer lock hub in the proximal end of the handle.

Balloon inflation function is achieved using an angioplasty balloon mounted to the catheter shaft like a typical PTA balloon catheter. The fluid injection function is achieved through a valve at the proximal end of the balloon that is controlled through the device handle.

# F. Predicate Device Reference:

The Arrow GPSCath Balloon Dilatation Catheter (150cm) which is the subject of this Special 510(k) is substantially equivalent in its intended use, principle of operation, and technological characteristics to the Arrow GPSCath Balloon Dilatation Catheter (150cm) that was previously cleared under K140351.

# G. Performance Data:

Additional testing of key performance data, including balloon compliance, balloon rated burst pressure, and crossing profile was conducted at time zero for performance qualification resulting in an update to the Arrow GPSCath Balloon Dilatation Catheter (150cm) Compliance Chart and introducer sheath compatibility, which is the subject of this Special 510(k). All other performance data applicable to the subject device is the same as for the predicate device (K140351) since there has been no change to the device design, materials, manufacturing processes, or sterilization cycle.

# H. Basis for Determination of Substantial Equivalence:

Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation, and overall technological characteristics, Arrow GPSCath Balloon Dilatation Catheter (150cm) is determined to be substantially equivalent to the existing legally marketed Arrow GPSCath Balloon Dilatation Catheter (150cm) device.