7F SHERPA NX GUIDE CATHETER

K051846 · Medtronic Vascular · DQY · Aug 5, 2005 · Cardiovascular

Device Facts

• Record ID: K051846
• Device Name: 7F SHERPA NX GUIDE CATHETER
• Applicant: Medtronic Vascular
• Product Code: DQY · Cardiovascular
• Decision Date: Aug 5, 2005
• 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

The 7F Sherpa NX Guiding Catheter is a percutaneous catheter used by clinicians to provide a pathway for introducing therapeutic devices into the coronary or peripheral vascular system. The device features a four-layer construction consisting of an inner polyethylene liner, a braid wire layer, an intermediate layer, and an outer jacket. It includes a luer hub, strain relief, a secondary (transition) segment, a primary segment, a tungsten marker band, a segment sleeve, and a soft tip. The catheter is designed to facilitate the delivery of interventional tools during vascular procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Four-layer construction: inner polyethylene liner, braid wire, intermediate layer, outer jacket. Includes luer hub, strain relief, tungsten marker band, and soft tip. 7F diameter. Percutaneous catheter. Class II device (21 CFR 870.1250).

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

• 6F Sherpa NX Guide Catheter (K042489)

Submission Summary (Full Text)

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K651846

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AUG 5 - 2005

## 510(k) Summary

| Submitter: | Medtronic Vascular<br>37A Cherry Hill Drive<br>Danvers, MA 01923<br>USA |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Fred Boucher<br>Director, Regulatory Affairs<br>978.739.3116<br>978.777.0390<br>[e-mail] |
| Date Prepared: | July XX, 2005 |
| Trade Name: | 7F Sherpa NX Guiding Catheter |
| Common Name: | Percutaneous Catheter |
| Classification<br>Name: | Percutaneous Catheter |
| Predicate Device: | 6F Sherpa NX Guide Catheter (K042489) |
| Device<br>Description: | The 7F 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, tungsten marker band, a segment sleeve and a soft<br>tip.<br>The 7F Sherpa NX Guide Catheter design is based on a four<br>layer design with an inner linner 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 |
| Summary of<br>Technological | In addition to being technologically equivalent to the<br>predicate devices, the 7F Sherpa NX Guiding Catheter has |

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- been subjected to performance testing and it has been Characteristics: determined that the 7F Sherpa NX Guiding Catheter is suitable for its intended use.
- The 7F Sherpa NX Guiding Catheter is manufactured under Summary of Nonthe same conditions, using the similar processes and clinical Data: equivalent materials, as the 6F Sherpa NX Guiding Catheter; the legally marketed predicate device. In addition to being technologically equivalent, the indications for use have not changed.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 5 - 2005

Medtronic Vascular c/o Mr. Fred Boucher Director Regulatory Affairs 37A Cherry Hill Drive Danvers, CA 01923

Re: K051846

Medtronic® 7F Sherpa NX Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Percutaneous Regulatory Class: Class II (Two) Product Code: DQY Dated: July 6, 2005 Received: July 7, 2005

Dear Mr. Boucher:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector 310(t) per levice is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations) it itgains and ment date of the Medical Device Amendments, or to Conninered prior to May 20, 2017) in accordance with the provisions of the Federal Food, DINE, de vices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, chereleve, mains of the Act include requirements for annual registration, listing of general obtired provisions 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 If your device is elabilition (osmal controls. Existing major regulations affecting your device can may oe subject to back as a subjections, 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. Fred Boucher

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that I DTT 3 iboastes of our device complies with other requirements of the Act that I DA has made a acterimaliations administered by other Federal agencies. You must of ally it cach statures and regalations and and limited to: registration and listing (21 Comply with an the 11et 6 requirements (1); good manufacturing practice requirements as set CFR Part 807), adoling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro no begin marketing your device as described in your Section 510(k) I mis icher will and w you'll begin finding of substantial equivalence of your device to a legally premarket notification: "The Province of and this, permits 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 If you desire specific at [phone]. Also, please note the regulation entitled, Colliact the Office of Compunations on the time (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionnational 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,

Duna R. Vadines

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): | K051846 |
|---------------------------|---------|
|---------------------------|---------|

Device Name: Device name: Medtronic® 7F Sherpa NX guiding Catheter

Indications For Use: The Medtronic 7F Sherpa NX Guide Catheter is designed to provide a pathway through which therapeutic devices are introduced. The 7F Sherpa NX guiding catheter is intended for used 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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Dwna R. Vachner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_ko5184(c

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