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 Description

The TurboHawk Peripheral Plaque Excision System (TurboHawk Catheter and SilverHawk™ Cutter Driver) is designed for the treatment of de novo and restenotic calcified and non-calcified atherosclerotic lesions located in native peripheral arteries. The TurboHawk Catheter consists of a flexible shaft designed to track over a 0.014" guidewire. At the distal end of the TurboHawk Catheter is a small cutting assembly comprised of a rotating inner cutter contained within a tubular housing. The proximal end of the TurboHawk Catheter contains a connector and cutter positioning lever (thumb switch) designed to fit into the SilverHawk Cutter Driver. The SilverHawk Cutter Driver is a handheld, disposable, battery-driven unit (Catalog No: 02550) which powers the system. The TurboHawk Peripheral Plaque Excision System has two switches: 1) the SilverHawk Cutter Driver main power switch and 2) the TurboHawk Catheter thumb switch. The SilverHawk Cutter Driver main power switch supplies power to the device when turned ON. The TurboHawk Catheter thumb switch activates the drive shaft and engages the cutter when pulled proximally to the ON position. With 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 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 cutting sequence is repeated as necessary to achieve the desired degree of plaque excision.

AI/ML Overview

The provided document describes the TurboHawk™ Peripheral Plaque Excision System. It is a 510(k) summary for a medical device rather than a study report for an AI/ML device. Therefore, the detailed information about acceptance criteria, study design, expert qualifications, and AI-specific performance metrics (like effect size with AI assistance or standalone algorithm performance) is not applicable or present in this document.

However, based on the information provided, here's what can be extracted and inferred within the context of a medical device submission:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in a table format for specific performance metrics. Instead, it states that "Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence."

The reported device performance is broadly summarized as:

Performance data: "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."
Conclusion regarding substantial equivalence: "Based on the identical indications for use, similar technological characteristics, materials and operating principle, and the results from safety and performance testing, the TurboHawk Peripheral Plaque Excision System is considered substantially equivalent to the SilverHawk Peripheral Plaque Excision System (K061188)."

Without specific individual test results and their predefined acceptance values, a detailed table cannot be created.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document mentions "Bench testing and biocompatibility testing." These types of tests typically do not involve human subject data or clinical trials in the way an AI/ML study would. Therefore, concepts like "test set," "sample size," and "data provenance" related to patient data are not directly applicable here. For bench testing, the "sample size" would refer to the number of devices or components tested, and "provenance" would relate to the manufacturing batch or lot of those samples. This specific information is not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable. The device is a physical medical instrument (an atherectomy catheter system), not an AI/ML diagnostic tool requiring expert-established ground truth on medical images or patient data. Bench testing and biocompatibility testing involve laboratory measurements and assessments against engineering specifications and biological safety standards, not expert medical opinions on patient cases.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as this refers to adjudication of expert opinions, which is not part of the evaluation for this type of device submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical atherectomy system, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable, as the device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For this type of device, the "ground truth" for evaluating its performance would typically involve:

Engineering specifications: The device is designed to meet certain physical and mechanical properties.
Material standards: Biocompatibility is assessed against established standards for material safety.
Functional performance criteria: Bench testing would verify functions like cutting ability, tissue capture, guidewire trackability, and power system operation against predetermined, measurable criteria.
Predicate device performance: Substantial equivalence relies on demonstrating that the new device performs similarly to a legally marketed predicate device (SilverHawk™ Peripheral Plaque Excision System in this case) under comparable test conditions.

The document states that "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." This implies the "ground truth" was compliance with established engineering, material, and functional performance benchmarks rather than expert medical diagnoses.

8. The sample size for the training set

Not applicable. This device does not involve machine learning; therefore, there is no "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

Summary

{0}------------------------------------------------

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 beingsubmitted in accordance with the requirements of 21 C.F.R § 807.92.
Applicant	ev3 Inc.
Submitter	ev3 Inc.3033 Campus DrivePlymouth, MN 55441Tel: 763-398-7000Fax: 763-591-3248
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 Stripper21 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-calcified lesions located in native peripheral arteries.
Device Description	The TurboHawk Peripheral Plaque Excision System (TurboHawkCatheter and SilverHawk™ Cutter Driver) is designed for thetreatment of de novo and restenotic calcified and non-calcifiedatherosclerotic lesions located in native peripheral arteries. TheTurboHawk Catheter consists of a flexible shaft designed to track overa 0.014" guidewire. At the distal end of the TurboHawk Catheter is asmall cutting assembly comprised of a rotating inner cutter containedwithin a tubular housing. The proximal end of the TurboHawkCatheter contains a connector and cutter positioning lever (thumbswitch) designed to fit into the SilverHawk Cutter Driver. TheSilverHawk Cutter Driver is a handheld, disposable, battery-drivenunit (Catalog No: 02550) which powers the system.The TurboHawk Peripheral Plaque Excision System has two switches:1) the SilverHawk Cutter Driver main power switch and 2) theTurboHawk Catheter thumb switch. The SilverHawk Cutter Driver
	main power switch supplies power to the device when turned ON. TheTurboHawk Catheter thumb switch activates the drive shaft andengages the cutter when pulled proximally to the ON position. Withthe 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 thumbswitch 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. Thiscutting sequence is repeated as necessary to achieve the desired degreeof plaque excision.
Performance data	Bench testing and biocompatibility testing were performed to supporta determination of substantial equivalence. Results from this testingprovide assurance that the proposed device has been designed andtested to assure conformance to the requirements for its intended use.
Summary of SubstantialEquivalence	The TurboHawk Peripheral Plaque Excision System has the followingsimilarities 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 technologicalcharacteristics, materials and operating principle, and the results fromsafety and performance testing, the TurboHawk Peripheral PlaqueExcision System is considered substantially equivalent to theSilverHawk Peripheral Plaque Excision System (K061188).

{1}------------------------------------------------

TurboHawk Peripheral Plaque Excision System

{2}------------------------------------------------

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.

{3}------------------------------------------------

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 (800) 638-2041 or (301) 796-7100 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

{4}------------------------------------------------

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:

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

Regulation Number and Section

§ 870.4875 Intraluminal artery stripper.

(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).