8F SHERPA NX GUIDE CATHETER

K060418 · Medtronic Vascular · DQY · Mar 15, 2006 · Cardiovascular

Device Facts

• Record ID: K060418
• Device Name: 8F SHERPA NX GUIDE CATHETER
• Applicant: Medtronic Vascular
• Product Code: DQY · Cardiovascular
• Decision Date: Mar 15, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

Provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system

Device Story

8F Sherpa NX Guiding Catheter functions as a conduit for delivering therapeutic devices into coronary or peripheral vasculature. Device construction includes luer hub, strain relief, and multi-layer shaft (outer jacket, braid wire, intermediate layer, inner polyethylene liner), plus secondary/primary segments, tungsten marker band, segment sleeve, and soft tip. Used by clinicians in clinical settings to facilitate interventional procedures. Provides stable pathway for device navigation; enables therapeutic intervention access. Benefits patient by allowing precise delivery of interventional tools to target vascular sites.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Four-layer shaft design: outer jacket, braid wire, intermediate layer, and inner polyethylene liner. Includes luer hub, strain relief, tungsten marker band, and soft tip. 8F diameter. Non-active, mechanical device.

Indications for Use

Indicated for use in the coronary or peripheral vascular system to provide a pathway for the introduction of therapeutic devices.

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

• 7F Sherpa NX Guide Catheter (K042489)
• 8F Launcher Guide Catheter (K023402)

Submission Summary (Full Text)

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Medironic Vascular 37 A Cherry Hitl Dave Danvers, MA 01924 www.medironices.o

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K060418

## 510(k) Summary

| Submitter: | Medtronic Vascular<br>37A Cherry Hill Drive<br>Danvers, MA 01923<br>USA |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mark Puopolo<br>Sr. Regulatory Affairs Specialist<br>978.739.3108<br>978.777.0390<br>[e-mail] |
| Date Prepared: | February 8, 2006 |
| Trade Name: | 8F Sherpa NX Guiding Catheter |
| Common Name: | Percutaneous Catheter |
| Classification<br>Name: | Percutaneous Catheter |
| Predicate Device: | 7F Sherpa NX Guide Catheter (K042489)<br>8F Launcher Guide Catheter (K023402) |
| Device<br>Description: | The 8F Sherpa NX guide catheter consists of a luer hub, strain<br>relief, a shaft (outer jacket, braid wire, an intermediate layer,<br>and inner liner), a secondary (transition) segment, a primary<br>segment, primary (transition) segment, tungsten marker band.<br>a segment sleeve and a soft tip.<br>The 8F Sherpa NX Guide Catheter design is based on a four<br>layer design with an inner liner of polyethylene. |
| Statement of<br>Intended Use: | Provide a pathway through which therapeutic devices are<br>introduced. The guiding catheter is intended to be used in the<br>coronary or peripheral vascular system |

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## K060418

In addition to being technologically equivalent to the Summary of Technological predicate devices, the 8F Sherpa NX Guiding Catheter has been subjected to performance testing and it has been Characteristics: determined that the 8F Sherpa NX Guiding Catheter is suitable for its intended use. Summary of Non-The 8F Sherpa NX Guiding Catheter is manufactured under clinical Data: the same conditions, using the similar processes and equivalent materials, as the 7F Sherpa NX Guiding Catheter; and 8F Launcher Guiding Catheter, the legally marketed predicate devices. In addition to being technologically equivalent, the indications for use have not changed.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 2006

Medtronic Vascular c/o Mr. Mark Puopolo Sr. Regulatory Affairs Specialist 37A Cherry Hill Drive Danvers, MA 01923

Re: K060418 8F Sherpa NX Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: DQY Dated: February 15, 2006 Received: February 17, 2006

Dear Mr. Puopolo:

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 Found, Trug, 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 - Mr. Mark Puopolo

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,

Abimmerman 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

510(k) Number (if known):

K060418

Device Name: Medtronic® 8F Sherpa NX guiding Catheter

Indications For Use: The Medtronic 8F Sherpa NX Guide Catheter is designed to provide a pathway through which therapeutic devices are introduced. The 8F Sherpa NX guiding catheter is intended for use in the coronary or peripheral vascular system.

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)

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