VIKING OPTIMA GUIDING CATHETER

K012002 · Guidant Corp. · DQY · Jul 26, 2001 · Cardiovascular

Device Facts

• Record ID: K012002
• Device Name: VIKING OPTIMA GUIDING CATHETER
• Applicant: Guidant Corp.
• Product Code: DQY · Cardiovascular
• Decision Date: Jul 26, 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 is a percutaneous catheter used to provide a pathway for therapeutic and diagnostic devices. It features a radiopaque shaft with variable stiffness at the distal end, determined by the durometer of polymer segments (Nylon 12 and/or Pebax, 25-72D). The device includes a radiopaque soft tip and is available in various lengths (40-160 cm) and tip shapes, with or without sideholes, to accommodate patient anatomy and physician preference. It is used by physicians in clinical settings to facilitate the delivery of interventional tools. The device is a mechanical conduit; it does not perform automated analysis or processing.

Clinical Evidence

Bench testing only.

Technological Characteristics

Radiopaque shaft; variable stiffness distal end; materials include Nylon 12 and Pebax (25-72D durometer); reinforcement wire; radiopaque soft tip; lengths 40-160 cm; various tip shapes; available with/without sideholes. Mechanical device; no software or energy source.

Indications for Use

Indicated for patients requiring a pathway for the introduction of therapeutic and diagnostic devices during interventional procedures.

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)

{0}------------------------------------------------

. . . . .

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

## APPENDIX A - 510(K) SUMMARY

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

| Submitter | Guidant Corporation<br>Vascular Invention<br>26531 Ynez Road, Temecula CA 92591<br><br>Contact: Stacey Simon<br>Phone: [phone], Fax: [phone] |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date | June 25, 2001 |
| Device name | Device Trade Name: VIKING OPTIMA™ Guiding Catheter<br>Device Common Name: Percutaneous Catheter<br>Device Classification Name: Guiding Catheter<br>Device Classification: Class II<br>Product Code: 74 DQY |
| Summary of<br>substantial<br>equivalence | The design, materials, method of operation, and intended use features<br>of the proposed (6F) 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 (6F) VIKING OPTIMA™ 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.<br><br>The proposed (6F) VIKING OPTIMA™ Guiding Catheter has a<br>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 25 to 72D. The guiding catheter also has a radiopaque soft tip at<br>the most distal section.<br><br>The proposed (6F) VIKING OPTIMA™ 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 (6F) VIKING OPTIMA™ Guiding Catheter incorporates<br>similar design, components, method of operation, and indication of<br>the predicate device, the VIKING OPTIMA™ Guiding Catheter<br>(K001435) with exception of the shape of the reinforcement wire. |
| Performance<br>data | The substantial equivalence of the proposed (6F) VIKING OPTIMA™<br>Guiding Catheter has been demonstrated through data collected from<br>nonclinical bench tests and analyses. |

{1}------------------------------------------------

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 26 2001

Ms. Stacey Simon Regulatory Affairs Coordinator Guidant Corporation Vascular Intervention Group 26531 Ynez Road Temecula, CA 92591

K012002 Re:

> VIKING OPTIMA™ Guiding Catheter Regulation Number: 870.1250 Regulatory Class: II (two) Product Code: DQY Dated: June 25, 2001 Received: June 27, 2001

Dear Ms. Simon:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{3}------------------------------------------------

Page 2 - Ms. Stacey Simon

This letter will allow you to begin marketing your device as described in your 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 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

W. E. Dillah III

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## APPENDIX B - INDICATIONS STATEMENT

| 510(k) number (if known): | The 510(k) number has not been issued yet. |
|---------------------------|------------------------------------------------------------------------------------------------------------------------|
| | K012002 |
| 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 ﮐﮯ (Per 21 CFR 801.109)

OR

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

**Division of Cardiovascular & Respiratory Devices**
510(k) Number K012002

27