5F & 6F LAUNCHER GUIDE CATHETER, 5F SHERPA ACTIVE NX GUIDE CATHETER, 6F Z4 GUIDING CATHETER

K132673 · Medtronic, Inc. · DQY · Oct 22, 2013 · Cardiovascular

Device Facts

• Record ID: K132673
• Device Name: 5F & 6F LAUNCHER GUIDE CATHETER, 5F SHERPA ACTIVE NX GUIDE CATHETER, 6F Z4 GUIDING CATHETER
• Applicant: Medtronic, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Oct 22, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Medtronic Guide Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended for used in the coronary or peripheral vascular system.

Device Story

Medtronic Launcher and Sherpa Guide Catheters are percutaneous catheters used to provide a pathway for therapeutic devices in the coronary or peripheral vascular system. The device consists of a luer hub, an outer jacket for stiffness and kink resistance, a wire-braided shaft for torque and crush resistance, and a soft distal tip to minimize vessel trauma. The inner lumen features a lubricious coating (Launcher) or an HDPE liner (Sherpa). The device is operated by a physician in a clinical setting to facilitate the delivery of interventional tools. It does not involve electronic processing or software.

Clinical Evidence

No clinical investigation has been performed on the modified device. Substantial equivalence is supported by non-clinical bench testing.

Technological Characteristics

Percutaneous catheter; materials include stainless steel braid, HDPE liner (Sherpa), and lubricious coating (Launcher). Features luer hub, wire-braided shaft, and soft distal tip. Compliant with ISO 10993 for biocompatibility. No electronic components or software.

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

• 5F Launcher® Guide Catheter (K103386)
• 6F Launcher® Guide Catheter (K021256)
• 5F Sherpa® Guide Catheter (K062420)
• 6F Sherpa® (Z4) Guiding Catheter (K042489)

Submission Summary (Full Text)

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OCT 22 2013

## Special 510(k) Summary

| Submitter: | Medtronic Vascular<br>37A Cherry Hill Drive<br>Danvers, MA 01923-5186 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Heather Morose<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Alternate Contact: | Fred Boucher<br>Director of Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | August 23, 2013 |
| Trade Name: | 5F Launcher® Guide Catheter<br>6F Launcher® Guide Catheter<br>SF Sherpa® Active NX Guide Catheter<br>6F Z4 (Sherpa) Guiding Catheter |
| Common Name: | Guiding Catheter |
| Classification Name: | Catheter, Percutaneous<br>21CFR 870.1250, Product Code DQY |

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| | Device | 510(k) | Clearance Date |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|----------------|
| Predicate Devices: | 5F Launcher®<br>Guide Catheter | K103386 | 02/11/2011 |
| | 6F Launcher®<br>Guide Catheter | K021256 | 05/17/2002 |
| | 5F Sherpa® Guide<br>Catheter | K062420 | 09/08/2006 |
| | 6F Sherpa® (Z4)<br>Guiding Catheter | K042489 | 12/13/2004 |
| Device<br>Description: | The Medtronic Launcher Guide Catheter is<br>constructed with an inner liner, stainless steel braid,<br>outer shaft jacket, sleeve, marker band and a soft<br>distal tip. The inner lumen of the Launcher Guide<br>Catheter has a lubricious coating. The inner lumen of<br>the Sherpa Guide Catheters is an HDPE liner. | | |
| Statement of Intended<br>Use: | The Medtronic Guide Catheter is designed to provide<br>a pathway through which therapeutic devices are<br>introduced. The guiding catheter is intended for used<br>in the coronary or peripheral vascular system. | | |
| Summary of<br>Technological<br>Characteristics: | The technological characteristics of the subject<br>medical devices 5F and 6F Launcher and Sherpa<br>Guide Catheters are identical to the predicate devices. | | |
| | Luer hub: The luer hub allows interfacing of the<br>catheter with other devices. | | |
| | Outer jacket: The outer jacket provides the catheter<br>with its ability to retain its curve, and also provides<br>support and contributes to the shaft stiffness and kink<br>resistance. | | |
| | Wire braided shaft: The wire braided shaft<br>provides the catheter with torque response and crush<br>resistance. | | |

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| | Distal segments: The distal segments allow a<br>transition of catheter stiffness from the proximal<br>catheter shaft to the soft distal tip. | |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | i.<br>Soft tip: The soft tip minimizes the<br>potential for vessel trauma when the<br>catheter is advanced in the vasculature<br>system. | |
| Summary of Non-<br>clinical Data: | No new safety or effectiveness issues were raised<br>during the evaluation and testing. Current testing<br>demonstrates that the 5F and 6F Launcher and Sherpa<br>Guide Catheters are safe, effective and are<br>substantially equivalent to the predicate devices. | |
| Biocompatibility<br>Testing: | The current biocompatibility testing supports the<br>biological safety, as no new materials or processes<br>are being introduced into the design, and no<br>additional biocompatibility tests were deemed<br>necessary. Therefore, the modified 5F and 6F<br>Launcher and Sherpa Guide Catheters remain<br>biocompatible and compliant to ISO 10993 | |
| Summary of<br>Clinical Data: | No clinical investigation has been performed on the modified<br>device. | |
| Conclusion from<br>Data: | Medtronic Vascular has demonstrated that the modified 5F<br>and 6F Launcher and Sherpa Guide Catheters are substantially<br>equivalent to the predicate device. | |

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling a bird or abstract human figure, with three curved lines forming its body and wings. The symbol is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

October 22, 2013

Medtronic Inc. C/O Heather Morose Regulatory Affairs Specialist 37a Cherry Hill Drive Danvers, MA 01923 US

Re: .K 132673

> Trade/Device Name: 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 5F Sherpa Guide Catheter and 6F Sherpa Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: September 20, 2013 Received: September 23, 2013

Dear Ms. Morose:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 (2 l CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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## Page 2 - Heather Morose

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

M.A. Stillemann

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

K132673 510(k) Number (if known): _

Device Name: Medtronic SF and 6F Launcher™ Guide Catheters and Medtronic 5F and 6F Sherpa™ Guide Catheter.

Indications for Use: The Medtronic Guide Catheters are intended to be used in the coronary or the peripheral system; and are designed to provide a pathway through which therapeutic devices are introduced.

ਨਾ Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

M.A. Zillerman

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