TRAILBLAZER SUPPORT CATHETER

K092299 · Ev3, Inc. · DQY · Aug 7, 2009 · Cardiovascular

Device Facts

• Record ID: K092299
• Device Name: TRAILBLAZER SUPPORT CATHETER
• Applicant: Ev3, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Aug 7, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

TrailBlazer™ Support Catheters are percutaneous, single lumen catheters designed for use in the peripheral vascular system. TrailBlazer™ Support Catheters are intended to guide and support a guide wire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

Device Story

TrailBlazer™ Support Catheter is an over-the-wire (OTW), single-lumen percutaneous catheter used in peripheral vascular procedures. Device features an atraumatic tapered tip and three distal radiopaque markers for positioning; distal 40 cm includes a hydrophilic coating. Available in 0.014", 0.018", and 0.035" guidewire compatibility with lengths of 65-150 cm. Operated by clinicians to navigate vasculature, support guidewire placement, perform wire exchanges, and infuse saline or contrast media. Output is mechanical support and fluid delivery conduit. Benefits include improved access to peripheral vasculature and procedural efficiency during interventional tasks.

Clinical Evidence

Bench testing only.

Technological Characteristics

Over-the-wire (OTW) single-lumen catheter; 5 Fr compatible; hydrophilic coating on distal 40 cm; three radiopaque markers; available in 0.014", 0.018", and 0.035" guidewire diameters; lengths 65-150 cm. Mechanical device; no software or energy source.

Indications for Use

Indicated for use in the peripheral vascular system to guide and support a guidewire during vascular access, facilitate wire exchanges, and deliver saline or diagnostic contrast agents.

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

• Spectranetics Quick-Cross™ Support2 Catheters (K072750)
• Vascular Solutions Minnie™ Support Catheter (K082337)

Submission Summary (Full Text)

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# AUG 0 7 2009

# 510(k) Summary

# TrailBlazer™ Support Catheter

| 510(k) Summary | This summary of 510(k) safety and effectiveness information is<br>being submitted in accordance with the requirements of 21 C.F.R §<br>807.92. |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | ev3 Inc. |
| Submitter | ev3 Inc.<br>9600 54th Ave. N<br>Plymouth, MN 55442<br>Tel: [phone]<br>Fax: [phone] |
| Contact Person | David Robertson<br>Regulatory Affairs Associate |
| Date Prepared | July 16, 2009 |
| Device Trade Name | TrailBlazer™ Support Catheter |
| Device Common<br>Name | Catheter, Support |
| Classification Name | Catheter, Percutaneous (21 CFR 870.1250), Product Code DQY |
| Classification Panel | Cardiovascular |
| Predicate Devices | Spectranetics Quick-Cross™ Support2 Catheters (K072750)<br>Vascular Solutions Minnie™ Support Catheter (K082337) |
| Intended use | TrailBlazer™ Support Catheters are percutaneous, single lumen<br>catheters designed for use in the peripheral vascular system.<br>TrailBlazer™ Support Catheters are intended to guide and support a<br>guide wire during access of the vasculature, allow for wire<br>exchanges and provide a conduit for the delivery of saline solutions<br>or diagnostic contrast agents. |
| Device Description | The TrailBlazer™ Support Catheter is an over-the-wire (OTW)<br>single lumen catheter with an atraumatic tapered tip. The catheter<br>system is offered in 9 models that are 0.014", 0.018", and 0.035"<br>guidewire compatible and have working lengths of 65 cm, 90 cm,<br>135 cm, 150 cm. The distal catheter shaft has three radiopaque<br>markers that aid in positioning the catheter. The distal 40 cm<br>portion of the catheter has a hydrophilic coating. The manifold<br>provides a proximal lumen which transitions to the catheter shaft<br>and terminates at the distal tip. This lumen is used to pass the<br>catheter over a guidewire. All models are 5 Fr compatible. |
| ev3 Corporate World Headquarters / Peripheral Vascular • 9600 54th Avenue North • Plymouth, MN 55442 • PH [phone]<br>ev3 Europe SAS • 106/108 rue La Boétie • 75008 Paris, France • PH [phone]<br>ev3 Neurovascular • 9775 Toledo Way • Irvine, CA 92618 • PH [phone]<br>www.ev3.net | |
| Performance data | Bench testing was performed to support a determination of substantial equivalence. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. |
| Summary of Substantial Equivalence | The TrailBlazerTM Support Catheter has the following similarities to the predicate devices: Similar fundamental scientific technology Similar operating principle Similar flow rate Similar crossing profiles Similar catheter lengths |
| Conclusion | Based on the similar indications for use, technological characteristics, and performance testing, ev3 believes the TrailBlazerTM Support Catheter is substantially equivalent to the Spectranetics Quick-Cross Support Catheter (K072750) and Vascular Solutions Minnie Support Catheter (K082337). |

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

# AUG 0 7 2009

ev3 Inc. c/o Mr. Mark Job Reviewer Regulatory Technology Services 1394 25th Street NW Buffalo, MN 55313

Re: K092299

> Trade/Device Name: Trailblazer Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (Two) Product Code: DQY Dated: July 27, 2009 Received: July 31, 2009

Dear Mr. Job:

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 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 Job

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Dina R. Kirchner

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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## Page 1 of 1

### Indications for Use Statement

510(k) Number (if known):_K 0 9 22 99

Device Name: TrailBlazer™ Support Catheter

Indications for Use:

TrailBlazer™ Support Catheters are percutaneous, single lumen catheters designed for use in the peripheral vascular system. TrailBlazer™ Support Catheters are intended to guide and support a guide wire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

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)

Duna D. V. Auner

ign-Off)
Cardiovascular Devices

510(k) Number K092249