GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582

K073200 · Vascular Solutions, Inc. · DQO · Feb 1, 2008 · Cardiovascular

Device Facts

• Record ID: K073200
• Device Name: GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582
• Applicant: Vascular Solutions, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: Feb 1, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The Gandras catheter is designed to be used for delivering embolic materials and radiopaque media to selected sites in the vascular system. Diagnostic, embolic, or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer.

Device Story

Gandras Intravascular Catheter is a single-lumen angiographic catheter; 80cm working length; available in 2cm, 4cm, or 6cm tip lengths. Construction includes nylon, 40 durometer Pebax, and pellethane; radiopacity provided by bismuth subcarbonate and tungsten loading. Distal 10-15cm features hydrophilic coating. Device includes press-fit luer hub, strain relief, and peelable tip straightener. Compatible with ≥5F introducer sheaths and <0.035" guidewires. Used by clinicians to deliver diagnostic, embolic, or therapeutic agents to vascular sites. Sterile, single-use device.

Clinical Evidence

No clinical data. Bench testing only, including lubricity, pressure testing, leak testing, kink resistance, bond strength, radiopacity, and distribution testing.

Technological Characteristics

Single-lumen catheter; materials: nylon, 40 durometer Pebax, pellethane, Texin outer layer. Radiopaque via bismuth subcarbonate (nylon) and tungsten (Pebax/pellethane). Hydrophilic coating on distal 10-15cm. Dimensions: 80cm working length; compatible with ≥5F sheaths and <0.035" guidewires. Sterile, single-use.

Indications for Use

Indicated for delivery of embolic materials and radiopaque media to selected sites in the vascular system.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• Renegade STC™ 18 Microcatheter (K023681, K020012)
• AngioDynamics Soft-Vu and AngioDynamics Mariner Hydrophilic Coated Catheters (K061733)

Submission Summary (Full Text)

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

#### 510(k) Number: K073200

#### Date Prepared

January 16, 2008

#### Submitter Information

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

| Contact Person: | Julie Tapper |
|-----------------|-------------------------------------|
| | Senior Regulatory Affairs Associate |
| | Phone [phone], x228 |
| | Fax [phone] |

#### Device Information

| Trade Name: | Gandras™ Intravascular Catheter |
|----------------------|--------------------------------------------------------------------------|
| Common Name: | Diagnostic intravascular catheter |
| Class: | II |
| Classification Name: | Diagnostic intravascular catheter<br>(21 CFR 870.1200, Product Code DQO) |

#### Predicate Devices

Renegade STC™ 18 Microcatheter (K023681, K020012), manufactured by Boston Scientific Corporation.

AngioDynamics Soft-Vu and AngioDynamics Mariner Hydrophilic Coated Catheters (K061733), manufactured by AngioDynamics, Inc.

#### Device Description

The Gandras catheter is an angiographic intravascular catheter that has a working length of approximately 80cm, not including the tip length. The Gandras catheter is offered in three tip lengths-2cm (model 5580), 4cm (model 5581), or 6cm (model 5582). Each catheter assembly has a single lumen that is formed by a segment of nylon that extends distally from the hub, a segment of 40 durometer Pebax that extends distally from the nylon, and pellethane that forms the distal tip. Each catheter also has a Texin outer layer that overlays the nylon and pebax tubing in the mid-shaft. The distal 10-15cm of the catheter is hydrophilically coated to provide a lubricious outer surface. The catheter's radiopacity is provided by 40% bismuth subcarbonate loading in the nylon, 60% tungsten loading in the Pebax, and 65% tungsten loading in the pellethane tubing components.

FEB - 1 2003

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Each catheter has a press-fit luer hub and strain relief on the proximal end, and a peelable tip straightener. Each Gandras catheter is compatible with ≥5F introducer sheaths and <0.035" guidewires.

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

#### Intended Use/Indications for Use

The Gandras catheter is designed to be used for delivering embolic materials and radiopaque media to selected sites in the vascular system. Diagnostic, embolic, or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer.

#### Summary of Non-clinical Testing

Bench testing was conducted on the Gandras 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.

| Hydrophilic coating lubricity | Dynamic pressure |
|--------------------------------|----------------------------------------------------------------|
| Visual inspection | Liquid leak under pressure |
| Packaging stylet removal force | Static pressure |
| Corrosion resistance | Leak During Aspiration |
| Catheter Radiopacity | Kink resistance |
| Curve retention | Hub bond strength |
| Guidewire passage | Proximal to mid shaft strength |
| Introducer sheath passage | Mid to distal shaft strength |
| Tortuosity | Tip straightener peel test |
| Embolic material passage | Packaging-Product Visual Appearance after Distribution Testing |
| Flow rate with contrast | Packaging-Label Legibility after Distribution Testing |

#### Summary of Clinical Testing

Clinical evaluations were not required for this device.

#### Statement of Equivalence

The Gandras catheter is substantially equivalent to the currently marketed Renegade STC. Soft Vu, and Mariner catheters, based on comparisons of the device classifications, indications for use, technological characteristics, and sterilization methods.

#### Conclusion

The Gandras catheter is substantially equivalent to the currently marketed Renegade STC. Soft Vu. and Mariner 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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FEB - 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K073200

> Trade Name: Gandras 110 Intravascular Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: January 16, 2008 Received: January 17, 2008

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. Iisting 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.

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

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Page 2 - Ms. Julie Tapper

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Mcdical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

buna R. V. de Auner

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: K073200

#### Device Name:

Gandras™ Intravascular Catheter

#### Indications for Use:

The Gandras catheter is designed to be used for delivering embolic materials and radiopaque media to selected sites in the vascular system. Diagnostic, embolic, or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer.

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)

Duma R. Jachner

(Division Sign-Off) Division of Cardrovascular Devices

510(k) Number_K073260