The HawkOne Directional Atherectomy System is intended for use in atherectomy of the peripheral vasculature. The HawkOne catheter is indicated for use in conjunction with the SpiderFX Embolic Protection Device in the treatment of severely calcified lesions. The HawkOne catheter is NOT intended for use in the coronary, carotid, iliac or renal vasculature.

Device Description

The HawkOne™ directional atherectomy system (HawkOne catheter and cutter driver) is designed for the treatment of de novo and restenotic atherosclerotic calcified and non-calcified lesions located in native peripheral arteries. When treating complex, hard, calcified lesions, pairing the HawkOne catheter with the SpiderFX™ embolic protection device mitigates risk of distal embolization that can be generated when heavily calcified plaque breaks down. For information about the SpiderFX embolic protection device, reference the Instructions for Use provided with the device.

The HawkOne catheter consists of a flexible shaft designed to track with a 0.36 mm (0.014 in) guidewire. At the distal end of the HawkOne catheter there is a small cutting unit comprised of an inner blade that rotates within a tubular housing. The proximal end of the HawkOne catheter contains a connector and cutter positioning lever (thumb switch) designed to fit into the cutter driver. The cutter driver (catalog number H1-14550) is a battery driven, internally powered device, designed to power the HawkOne directional atherectomy catheter.

The HawkOne directional atherectomy system has two switches: 1) the main power switch on the cutter driver and 2) the cutter positioning lever (thumb switch) on the HawkOne catheter. The main power switch on the cutter driver supplies power to the device when turned On. When the thumb switch is pulled proximally to the On position, the HawkOne catheter activates the drive shaft and the cutter. With the cutter engaged, the HawkOne 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 HawkOne catheter thumb switch distally, deactivating the drive shaft and disengaging the cutter. When the HawkOne catheter thumb switch is fully advanced distally to the Off position, excised tissue is packed into the tip. This cutting sequence is repeated as necessary to achieve the desired degree of plaque excision.

AI/ML Overview

The provided text describes a 510(k) summary for the Medtronic HawkOne Directional Atherectomy System, focusing on demonstrating substantial equivalence to predicate devices, particularly a smaller 6F version compared to the existing 7F version. The document details bench testing performed, but it does not include information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of clinical performance or human reader studies (MRMC or standalone AI performance). The testing mentioned (bench tests) is for the device's physical and functional characteristics, not for diagnostic or therapeutic efficacy in a clinical setting in relation to established criteria.

Therefore, many of the requested items cannot be answered from the provided text.

Here's a breakdown of what can and cannot be answered:

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

The document lists various bench tests but does not provide specific acceptance criteria or reported performance values for these tests. For instance, it mentions "Cutter Height" but not what the acceptable range for cutter height is, or what was measured.

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

This information is not provided. The testing described is bench testing of the device itself, not clinical testing on patient data.

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 is not applicable as the summary describes bench testing of mechanical properties, not clinical studies requiring expert ground truth.

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

Not applicable.

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 is a medical device for atherectomy, not an AI software intended to assist human readers in diagnosis.

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

Not applicable. This is a physical medical device.

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

For the bench testing, the "ground truth" would be engineering specifications and validated test methods. The document does not explicitly state the specific ground truths but implies that the tests were designed to show comparability to predicate devices.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable.

Summary of available information related to acceptance criteria and device performance (from bench testing):

The document lists the following bench tests performed to demonstrate substantial equivalence:

Test Performed	Reported Device Performance (as described)	Acceptance Criteria (as described)
Device Inspections	Demonstrated comparability to predicate and reference devices.	Not specified
Cutter Height	Demonstrated comparability to predicate and reference devices.	Not specified
Tracking Force	Demonstrated comparability to predicate and reference devices.	Not specified
Cycle and Life	Demonstrated comparability to predicate and reference devices.	Not specified
Repeated Cutter Spin Down and Packing	Demonstrated comparability to predicate and reference devices.	Not specified
Carbide Edge Attachment	Demonstrated comparability to predicate and reference devices.	Not specified
Shaft Torque Test	Demonstrated comparability to predicate and reference devices.	Not specified
DFT Torque and Pressure Test	Demonstrated comparability to predicate and reference devices.	Not specified
Device Tensile Tests	Demonstrated comparability to predicate and reference devices.	Not specified
Coating integrity	Demonstrated comparability to predicate and reference devices.	Not specified
Cut depth	Demonstrated comparability to predicate and reference devices.	Not specified
Mass Per Pass (Tissue Removal Rate)	Demonstrated comparability to predicate and reference devices.	Not specified
Embolization	Demonstrated comparability to predicate and reference devices. The text mentions that for severely calcified lesions, pairing with SpiderFX mitigates risk of distal embolization.	Not specified
Simulated Use (trackability, rotational fatigue, cycling and cutting)	Demonstrated comparability to predicate and reference devices.	Not specified
Biocompatibility	Demonstrated comparability to predicate and reference devices.	Not specified

Study Proving Device Meets Acceptance Criteria:

The study described is a bench testing program aimed at demonstrating substantial equivalence of the proposed HawkOne 6F Directional Atherectomy System to its predicate and reference devices (HawkOne 7F and TurboHawk). The purpose was to show that, despite changes like a reduced crossing profile, smaller driveshaft, cutter, and tip, and a material supplier change, the device performs comparably.

Type of Study: Bench testing (non-clinical, engineering/materials testing).
Purpose: To demonstrate that the technological characteristics and performance criteria of the proposed HawkOne 6F are comparable to the predicate and reference devices.
Methodology: Various tests listed above were performed using "internal Risk Analysis procedures."

Missing Information: The document explicitly states that the "results from these tests demonstrate that the technological characteristics and performance criteria of the proposed HawkOne 6F devices are comparable to the predicate and reference devices," but it does not provide the specific numerical acceptance criteria or the measured performance values for each test. Instead, it offers a general statement of comparability.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 14, 2016

Medtronic Vascular, Inc. Ms. Rupali Gupta Senior Regulatory Affairs Specialist 3033 Campus Drive Plymouth, MN 55441

Re: K161361

Trade/Device Name: HawkOne Directional Atherectomy System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: August 31, 2016 Received: September 1, 2016

Dear Ms. Gupta:

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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

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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

510(k) Number (if known) K161361

Device Name

HawkOne Directional Atherectomy System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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HawkOne Directional Atherectomy System 510(k) Summary

510(k) Summary

HawkOne™ Directional Atherectomy System

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 C.F.R § 807.92.

1. Submitter Information

Applicant	Medtronic Vascular, Inc.4600 Nathan Lane NPlymouth, MN 55441-2651Tel: 763-398-7000Fax: 763-591-3248
Contact Person	Rupali GuptaSenior Regulatory Affairs Specialist
Date Prepared	May 13, 2016

2. Subject Device

Device Trade Name	HawkOne Directional Atherectomy System
Device Common Name	Catheter, Peripheral, Atherectomy
Classification Name	Intraluminal Artery Stripper21 CFR 870.4875, Product Code MCW
Classification Panel	Cardiovascular

3. Predicate Device

Device Trade Name	HawkOne Directional Atherectomy System (H1-LX and H1-LS)
510(k) Number	K141801
510(k) Clearance Date	October 16, 2014

4. Reference Device

Device Trade Name	TurboHawk™ Peripheral Plaque Excision System
510(k) Number	K103618
510(k) Clearance Date	January 5, 2011

5. Device Description

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HawkOne Directional Atherectomy System 510(k) Summary

distal embolization that can be generated when heavily calcified plaque breaks down. For information about the SpiderFX embolic protection device, reference the Instructions for Use provided with the device

6. Indications for Use

7. Comparison of Technological Characteristics

The primary purpose of this traditional 510(k) is to reduce the crossing profile from 2.6mm to 2.2mm by using a smaller driveshaft, cutter, and tip, compared to the HawkOne 7F device, so that the proposed HawkOne 6F device can be tracked through a 6F introducer sheath. There is also a change in the material supplier in this submission. When compared to the TurboHawk reference device, the proposed HawkOne 6F has an increased device RPM, improved torque shaft laminates, and includes a pre-loaded distal flush tool."

The proposed HawkOne 6F catheter will only function with the HawkOne cutter driver (H1-14550) which is currently used for the primary predicate HawkOne 7F catheters. HawkOne 6F catheters will not function and are functionally unable to connect with the previously released cutter driver (FG-02550) which is used with the reference TurboHawk catheters.

The proposed HawkOne 6F is considered to be substantially equivalent to the legally marketed HawkOne Directional Atherectomy System (referred to as HawkOne 7F), cleared by FDA under premarket notification K141801 on October 16, 2014 and TurboHawk Peripheral Plaque Excision

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HawkOne Directional Atherectomy System 510(k) Summary

System, SX-C, SS-C, SS-CL (referred to as TurboHawk) for small vessel, cleared by FDA under premarket notification K103618 on January 05, 2011.

The proposed and predicate devices share the following technological characteristics:

Intended Use
Fundamental scientific technology
Principles of Operation ●
. Conditions of Use
Packaging Materials .
. Sterilization site, method, parameters, and sterility assurance level

Additionally, the indications for use, labeling, device materials, and manufacturing site and methods are similar between the proposed and marketed devices.

8. Performance Testing Summary

To demonstrate substantial equivalence of the proposed HawkOne Directional Atherectomy System (HawkOne 6F) to the predicate devices, bench testing was performed.

Using internal Risk Analysis procedures, the following tests were performed:

Device Inspections ●
Cutter Height ●
Tracking Force
Cycle and Life ●
Repeated Cutter Spin Down and Packing
Carbide Edge Attachment
Shaft Torque Test
DFT Torque and Pressure Test
Device Tensile Tests ●
Coating integrity
Cut depth ●
Mass Per Pass (Tissue Removal Rate)
Embolization
Simulated Use (trackability, rotational fatigue, cycling and cutting)
Biocompatibility

The results from these tests demonstrate that the technological characteristics and performance criteria of the proposed HawkOne 6F devices are comparable to the predicate and reference devices and that the proposed HawkOne 6F device performs in a manner equivalent to the predicate devices currently on the market.

9. Conclusions

Based on the identical intended use, similar technological characteristics, and safety and performance testing included in this submission. Medtronic Vascular. Inc (formerly d.b.a. ev3 Inc./Covidien 11c) considers the proposed HawkOne 6F device to be substantially equivalent to the currently marketed HawkOne 7F, K141801 (primary predicate) and TurboHawk, K103618 (reference) devices.

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).