MODIFICATION TO VIKING OPTIMA GUIDING CATHETER

K013638 · Guidant Corp. · DQY · Dec 4, 2001 · Cardiovascular

Device Facts

• Record ID: K013638
• Device Name: MODIFICATION TO VIKING OPTIMA GUIDING CATHETER
• Applicant: Guidant Corp.
• Product Code: DQY · Cardiovascular
• Decision Date: Dec 4, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The guiding catheter is designed to provide a pathway through which therapeutic and diagnostic devices are introduced.

Device Story

VIKING OPTIMA™ Guiding Catheter; percutaneous catheter used to provide pathway for therapeutic/diagnostic devices. Features radiopaque shaft with variable stiffness (25D-72D Pebax/Nylon 12 polymers) and radiopaque soft tip. Available in 7F/8F sizes; lengths 40-160 cm; various tip shapes; optional sideholes. Used by physicians in clinical settings to facilitate device delivery. Benefits patient by enabling access for interventional procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Radiopaque shaft; variable stiffness via polymer durometer (25D-72D Pebax/Nylon 12); radiopaque soft tip; reinforcement wire; 7F/8F diameters; 40-160 cm lengths. Mechanical device; no software or energy source.

Indications for Use

Indicated for providing a pathway for the introduction of therapeutic and diagnostic devices into the vasculature.

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

• VIKING OPTIMA™ Guiding Catheter (K001435)

Submission Summary (Full Text)

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K013638

| Submitter | Guidant Corporation<br>Vascular Invention<br>26531 Ynez Road, Temecula CA 92591<br>Contact: Nancy E. Ralston | |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| | Phone: [phone], Fax: [phone] | |
| Date | November 1, 2001 | |
| Device name | Device Trade Name:<br>Device Common Name:<br>Device Classification Name:<br>Device Classification:<br>Product Code: | VIKING OPTIMA™ Guiding Catheter<br>Percutaneous Catheter<br>Guiding Catheter<br>Class II<br>74 DQY |
| Summary of<br>substantial<br>equivalence | The design, materials, method of operation, and intended use features<br>of the proposed (7F, 8F) VIKING OPTIMA™ Guiding Catheter are<br>substantially equivalent with regard to these features in the predicate<br>device, the VIKING OPTIMA™ Guiding Catheter, K001435. | |
| Device<br>description | The proposed (7F, 8F) VIKING OPTIMATM Guiding Catheter has a<br>standard working length of 100 cm and a standard overall length of<br>107 cm, but can be produced in lengths from 40 to 160 cm depending<br>upon physician preference and patient size. | |
| | The proposed (7F, 8F) VIKING OPTIMATM Guiding Catheter has<br>a radiopaque shaft, which varies in stiffness at the distal end to<br>accommodate customer preference and give optimal support in each tip<br>shape. The stiffness of the shaft is determined by the durometer of the<br>segment of polymer along the axial length. The lower the durometer<br>of polymer (or polymer blend of Nylon 12 and/or Pebax), the more<br>flexible the guiding catheter. The Pebax raw material durometers vary<br>from 25D to 72D. The guiding catheter also has a radiopaque soft tip at<br>the most distal section. | |
| | The proposed (7F, 8F) VIKING OPTIMATM Guiding Catheter is<br>manufactured in varying tip shapes. Each shape is specific for patient<br>anatomy and physician preference, and therefore a wide range of<br>shapes is available with and without sideholes. | |
| Indications | The guiding catheter is designed to provide a pathway through which<br>therapeutic and diagnostic devices are introduced. | |
| Technological<br>characteristics | The proposed (7F, 8F) VIKING OPTIMATM Guiding Catheter incorporates similar design, components, method of operation, and indication of the predicate device, the VIKING OPTIMATM Guiding Catheter (K001435) with exception of the shape of the reinforcement wire. | |
| Performance<br>data | The substantial equivalence of the proposed (7F, 8F) VIKING<br>OPTIMATM Guiding Catheter has been demonstrated through data collected from non-clinical bench tests and analyses. | |

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Image /page/2/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter of the circle. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## DEC 0 4 2001

Ms. Nancy E. Ralston Regulatory Affairs Coordinator Guidant Corporation 26531 Ynez Road Temecula, CA 92591-4628

Re: K013638 VIKING OPTIMA™ Guiding Catheter Regulation Number: 870.1250 Regulation Name: Percutaneous catheter. Regulatory Class: Class II Product Code: DQY Dated: November 1, 2001 Received: November 5, 2001

## Dear Ms. Ralston:

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.

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.

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Page 2 - Ms. Nancy E. Ralston

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

N. Sadler Tella

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

Enclosure

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## APPENDIX B - INDICATIONS STATEMENT

| 510(k) number<br>(if known): | K013638 |
|------------------------------|---------|
|------------------------------|---------|

The 510(k) number has not been issued yet.

| Device name | VIKING OPTIMA™ Guiding Catheter |
|-------------|------------------------------------------------------------------------------------------------------------------------|
| Indications | The guiding catheter is designed to provide a pathway through which therapeutic and diagnostic devices are introduced. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

Division of C 510(k) Number OR

Over-The-Counter (Optional Format 1-1-96)

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