GOPHER 2F SUPPORT CATHETER, MODEL 5600 AND GOPHER 3F SUPPORT CATHETER, MODEL 5610

K070372 · Vascular Solutions, Inc. · DQY · Jun 1, 2007 · Cardiovascular

Device Facts

• Record ID: K070372
• Device Name: GOPHER 2F SUPPORT CATHETER, MODEL 5600 AND GOPHER 3F SUPPORT CATHETER, MODEL 5610
• Applicant: Vascular Solutions, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Jun 1, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Gopher Support Catheter is intended to be used in conjunction with steerable guidewires in order to access discreet regions of the arterial and/or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic or therapeutic agents.

Device Story

Gopher Support Catheter is a percutaneous catheter used in arterial/coronary vasculature. It functions as a conduit for steerable guidewires, facilitating placement/exchange of interventional devices and subselective delivery of diagnostic/therapeutic agents. Operated by physicians in clinical settings, the device is compatible with ≥6F guide catheters and ≤0.014" guidewires. It features a polymeric outer layer, laser-cut Nitinol middle layer, and PTFE/polyimide inner liner. Radiographic visualization is provided by a markerband (2F) or threaded stainless steel distal tip (3F). The device includes a luer hub, strain relief, and adjustable torque device. By providing structural support and trackability, it assists clinicians in navigating complex vascular anatomy, potentially improving procedural success in interventional cardiology.

Clinical Evidence

No clinical data. Bench testing only. Testing included visual inspection, torque strength, kink resistance, guide catheter/guidewire interface, fluid/air leak, flow rate, and bond strength. Biocompatibility testing performed per ISO 10993 (cytotoxicity, sensitization, reactivity, systemic toxicity, hemocompatibility).

Technological Characteristics

Materials: Polymeric outer layer, laser-cut Nitinol middle layer, PTFE/polyimide inner liner, stainless steel distal tip (3F). Dimensions: 2F and 3F sizes, ~135cm working length. Features: Radiopaque markerband/tip, luer hub, strain relief, adjustable torque device. Sterilization: Sterile, single-use. Connectivity: None.

Indications for Use

Indicated for patients requiring access to discrete regions of arterial and/or coronary vasculature for guidewire/device placement, exchange, or subselective infusion of diagnostic/therapeutic agents.

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

• Skyway™ Support Catheter (K052258 and K060327)
• Tornus Support Catheter (K051772)

Submission Summary (Full Text)

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## 510(k) Summary (As required by 21 CFR 807.92(c))

JUN - 1 2007

K070372 510(k) Number: ____

Date Prepared

May 29, 2007

#### Submitter Information

| Submitter's Name: | Vascular Solutions, Inc. |
|-------------------|----------------------------------------------|
| Address: | 6464 Sycamore Court<br>Minneapolis, MN 55369 |

Julie Tapper Contact Person: Senior Regulatory Affairs Associate Phone [phone] Fax [phone]

#### Device Information

| Trade Name: | Gopher™ Support Catheter |
|----------------------|--------------------------------------------------------------|
| Common Name: | Percutaneous catheter |
| Class: | II |
| Classification Name: | Percutaneous catheter<br>(21 CFR 870.1250, Product Code DQY) |

#### Predicate Devices

Skyway™ Support Catheter (K052258 and K060327), manufactured by Vascular Solutions, Inc.

Tornus Support Catheter (K051772), manufactured by Asahi Intecc Co., Ltd.

#### Device Description

The Gopher catheter is available in two sizes-2F and 3F. Each catheter assembly has a polymeric outer layer and Nitinol middle layer that extend the length of the catheter. a porfilerie oud, the Nitinol tubing is laser cut and is lined with a PTFE/polyimide inner layer. To provide a radiographic means of locating the tip, the 2F size has a radiopaque markerband near the distal tip and the 3F distal tip is a segment of threaded, radiopaque stainless steel.

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Each catheter has printed positioning marks at 95cm and 105cm from the catheter's distal tip, a luer hub and strain relief on the proximal end, and an adjustable torque device near the proximal end. Each Gopher catheter model is compatible with ≥6F guide catheters and ≤0.014" guidewires and has a working length of approximately 135cm.

The Gopher catheter is provided sterile and intended for a single use.

#### Intended Use/Indications for Use

The Gopher Support Catheter is intended to be used in conjunction with steerable guidewires in order to access discreet regions of the arterial and/or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic or therapeutic agents.

#### Summary of Non-clinical Testing

Bench testing was conducted on the Gopher catheter, including the packaging, and included an assessment of the physical properties of the device and its ability to achieve its intended use. The results of the tests confirmed the suitability of the device for its intended use. Each bench test that was conducted is listed, below.

| Visual Inspection | Torque Device-to-shaft Interface |
|-----------------------------------|----------------------------------------------------------------|
| Guidewire Interface | Hub-to-proximal shaft Bond Strength |
| Tortuosity | Distal Shaft Bond Strength |
| Catheter Kink Resistance | Markerband Visibility (2F) |
| Guide Catheter Interface | Radiopaque Distal Tip (3F) |
| Fluid Leak Under Pressure | Packaging-Pouch Visual Appearance after Distribution Testing |
| Air Leak During Aspiration | Packaging-Product Containment after Distribution Testing |
| Flow Rate | Packaging-Product Visual Appearance after Distribution Testing |
| Catheter Integrity After Torquing | Packaging-Label Legibility after Distribution Testing |
| Torque Strength | |

In addition, the biocompatibility of the Gopher catheter was assessed in accordance with ISO 10993, "Biological Evaluation of Medical Devices." The testing confirmed that the materials and processes used in the manufacture of the Gopher catheters are biocompatible. The tests that were conducted are listed, below.

| Cytotoxicity | Hemocompatibility, hemolysis |
|---------------------------|----------------------------------------------------------|
| Sensitization | Hemocompatibility, Prothrombin Time |
| Intracutaneous Reactivity | Hemocompatibility, Lee White Coagulation Test |
| Acute Systemic Toxicity | Hemocompatibility, In vitro Hemocompatibility Assessment |
| Material Mediated Pyrogen | |

#### Summary of Clinical Testing

Clinical evaluations were not required for this device.

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K070372 p. 30f 3

#### Statement of Equivalence

The Gopher catheter is substantially equivalent to the currently marketed Skyway and Tornus catheters, based on comparisons of the device classifications, indications for use, technological characteristics, and sterilization methods.

#### Conclusion

The Gopher catheter is substantially equivalent to the currently marketed Skyway and Tornus catheters, based on comparisons of the device classifications, indications for use, technological characteristics, and sterilization methods. Bench tests confirmed the suitability of the device for its intended use.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 1 2007

Vascular Solutions, Inc. c/o Ms. Julie Tapper Senior Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, MN 55369

Re: K070372

Gopher™ Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II (two) Product Code: DOY Dated: May 16, 2007 Received: May 21, 2007

Dear Ms. Tapper:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Ms. Julie Tapper

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

C.S.N.

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: ___ K070372

Device Name:

Gopher™ Support Catheter

#### Indications for Use:

The Gopher Support Catheter is intended to be used in conjunction with steerable guidewires in order to access discreet regions of the arterial and/or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic or therapeutic agents.

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)

QSSM

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K070372