TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM

K093301 · Ev3, Inc. · MCW · Nov 6, 2009 · Cardiovascular

Device Facts

• Record ID: K093301
• Device Name: TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
• Applicant: Ev3, Inc.
• Product Code: MCW · Cardiovascular
• Decision Date: Nov 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

Treatment of de novo and restenotic atherosclerotic calcified and non-calcified lesions located in native peripheral arteries. The TurboHawk Peripheral Plaque Excision System is intended for use in atherectomy of the peripheral vasculature. The TurboHawk Catheter is NOT intended for use in the coronary, carotid, iliac, or renal vasculature.

Device Story

TurboHawk Peripheral Plaque Excision System performs atherectomy in peripheral arteries; tracks over 0.014" guidewire. System comprises flexible catheter with distal rotating cutter assembly and handheld, battery-driven SilverHawk Cutter Driver. Physician operates thumb switch on catheter to engage drive shaft and cutter; device shaves occlusive material from artery wall; excised tissue captured in device tip. Thumb switch deactivates cutter and packs tissue. Process repeated to achieve desired plaque excision. Used in clinical setting by physicians to treat atherosclerotic lesions; benefits patient by removing obstructive plaque to restore vessel patency.

Clinical Evidence

Bench testing and biocompatibility testing only. No clinical data provided.

Technological Characteristics

Catheter-based atherectomy system; 0.014" guidewire compatible. Features rotating inner cutter within tubular housing. Powered by handheld, battery-driven disposable driver unit. Mechanical plaque excision principle. Materials similar to predicate.

Indications for Use

Indicated for atherectomy of de novo and restenotic atherosclerotic calcified and non-calcified lesions in native peripheral arteries. Contraindicated for use in coronary, carotid, iliac, or renal vasculature.

Regulatory Classification

Identification

An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)

Predicate Devices

• SilverHawk™ Peripheral Plaque Excision System (K061188)

Submission Summary (Full Text)

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TurboHawk Peripheral Plaque Excision System

Image /page/0/Picture/1 description: The image shows the logo for EV3, a robotics kit. Above the logo is the number K093301. The EV3 logo consists of the letters "ev3" in a stylized font, with three circles above the letters. The circles are arranged in a triangular pattern.

# 510(k) Summary

NOV - 6 2009

# TurboHawk™ Peripheral Plaque Excision System

| 510(k) Summary | This summary of 510(k) safety and effectiveness information is being<br>submitted in accordance with the requirements of 21 C.F.R § 807.92. |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | ev3 Inc. |
| Submitter | ev3 Inc.<br>3033 Campus Drive<br>Plymouth, MN 55441<br>Tel: [phone]<br>Fax: [phone] |
| Contact Person | Brenda Johnson |
| Date Prepared | October 8, 2009 |
| Device Trade Name | TurboHawk™ Peripheral Plaque Excision System |
| Device Common Name | Catheter, Peripheral, Atherectomy |
| Classification Name | Intraluminal Artery Stripper<br>21 CFR 870.4875, Product Code MCW |
| Classification Panel | Cardiovascular |
| Predicate Devices | SilverHawk™ Peripheral Plaque Excision System (K061188) |
| Intended use | Treatment of de novo and restenotic atherosclerotic calcified and non-<br>calcified lesions located in native peripheral arteries. |
| Device Description | The TurboHawk Peripheral Plaque Excision System (TurboHawk<br>Catheter and SilverHawk™ Cutter Driver) is designed for the<br>treatment of de novo and restenotic calcified and non-calcified<br>atherosclerotic lesions located in native peripheral arteries. The<br>TurboHawk Catheter consists of a flexible shaft designed to track over<br>a 0.014" guidewire. At the distal end of the TurboHawk Catheter is a<br>small cutting assembly comprised of a rotating inner cutter contained<br>within a tubular housing. The proximal end of the TurboHawk<br>Catheter contains a connector and cutter positioning lever (thumb<br>switch) designed to fit into the SilverHawk Cutter Driver. The<br>SilverHawk Cutter Driver is a handheld, disposable, battery-driven<br>unit (Catalog No: 02550) which powers the system.<br>The TurboHawk Peripheral Plaque Excision System has two switches:<br>1) the SilverHawk Cutter Driver main power switch and 2) the<br>TurboHawk Catheter thumb switch. The SilverHawk Cutter Driver |
| | main power switch supplies power to the device when turned ON. The<br>TurboHawk Catheter thumb switch activates the drive shaft and<br>engages the cutter when pulled proximally to the ON position. With<br>the cutter engaged, the TurboHawk Catheter is slowly advanced across |
| | the lesion, shaving occlusive material from the artery. The excised |
| | tissue is captured and stored in the tip of the device. The cutting |
| | process is completed by advancing the TurboHawk Catheter thumb<br>switch distally deactivating the drive shaft and disengaging the cutter. |
| | The TurboHawk Catheter thumb switch is fully advanced distally to |
| | the OFF position in order to pack the excised plaque into the tip. This<br>cutting sequence is repeated as necessary to achieve the desired degree<br>of plaque excision. |
| Performance data | Bench testing and biocompatibility testing were performed to support<br>a determination of substantial equivalence. Results from this testing<br>provide assurance that the proposed device has been designed and<br>tested to assure conformance to the requirements for its intended use. |
| Summary of Substantial<br>Equivalence | The TurboHawk Peripheral Plaque Excision System has the following<br>similarities to the predicate device: |
| | ● Identical indications for use |
| | ● Similar intended use |
| | ● Similar materials |
| | ● Similar fundamental scientific technology |
| | ● Similar operating principle |
| Conclusion | Based on the identical indications for use, similar technological<br>characteristics, materials and operating principle, and the results from<br>safety and performance testing, the TurboHawk Peripheral Plaque<br>Excision System is considered substantially equivalent to the<br>SilverHawk Peripheral Plaque Excision System (K061188). |

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## TurboHawk Peripheral Plaque Excision System

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", indicating the department's name and national affiliation.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

ev3, Inc. c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 2510 Street NW Buffalo, MN 55313

NOV - 6 2009

Re: K093301

Trade/Device Name: TurboHawk Peripheral Plaque Excision System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: October 20, 2009 Received: October 21, 2009

#### Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device w 6 nave reviewed your because in in in in in in the device 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 onoroome) to regary and entirent date of the Medical Device Amendments, or to commerce pror to May 20, 1978, in the provisions of the Federal Food, Drug, de rices mat have been rouire approval of a premarket approval approval application (PMA). and Costinetto (110) that to nov requesable to the general controls provisions of the Act. The r ou may, mercere, market the Act include requirements for annual registration, listing of general obnition proficturing 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 bluestined (000 acres) Existing major regulations affecting your device can be finay of subjoct to additions, 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 (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 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 the Somer velation 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Dura R. buhner

Image /page/3/Picture/7 description: The image shows a black and white drawing of a cursive letter. The letter appears to be an 'f' or a similar character with a loop at the top and a curved line extending to the right. The drawing is simple and lacks detail, focusing on the basic shape of the letter.

Bram 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

1/093301 510(k) Number (if known) :_

Device Name: TurboHawk Peripheral Plaque Excision System Indications for Use:

The TurboHawk Peripheral Plaque Excision System is intended for use in atherectomy of the peripheral vasculature. The TurboHawk Catheter is NOT intended for use in the coronary, carotid, iliac, or renal vasculature.

Prescription Use (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)

Anna R. Lanier

ivision Sign-Off) Division Sign-On)
Division of Cardiovascular Devices

510(k) Number K093301