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 used in complex, hard, calcified lesions, the HawkOne catheter should be paired with the SpiderFX™ embolic protection device to mitigate risk of distal embolization that may be generated by the breakdown of heavily calcified plaque. The HawkOne catheter consists of a flexible shaft designed to track over a 0.014" guidewire. At the distal end of the HawkOne catheter is a small cutting assembly comprised of a rotating inner blade contained 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the HawkOne Directional Atherectomy System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list acceptance criteria in a quantifiable manner for the HawkOne Directional Atherectomy System. Instead, it states that "bench testing was performed" and the "results from these tests demonstrate that the technological characteristics and performance criteria of the HawkOne Directional Atherectomy System are comparable to the predicate device and that the HawkOne Directional Atherectomy System performs in a manner equivalent to the predicate device currently on the market."

The document lists the types of performance tests conducted, implying these tests were used to assess equivalence to the predicate. Therefore, the "acceptance criteria" can be inferred as meeting or being comparable to the performance of the predicate device (TurboHawk Peripheral Plaque Excision Systems K111723 and K103618) across the following aspects:

Acceptance Criterion (Inferred from tests performed)	Reported Device Performance (as stated in document)
Device Inspections	Comparable to predicate device
Urge Force	Comparable to predicate device
Cycle and Life	Comparable to predicate device
Cutter Height	Comparable to predicate device
Tracking Force	Comparable to predicate device
Repeated Cutter Spin Down and Packing	Comparable to predicate device
Shaft Torque Tests	Comparable to predicate device
Carbide Edge Attachment	Comparable to predicate device
DFT Torque and Pressure Tests	Comparable to predicate device
Device Tensile Tests	Comparable to predicate device
Catheter and Cutter Driver Interaction	Comparable to predicate device
Embolization	Comparable to predicate device
Cut Mass Per Pass (Tissue Removal Rate)	Comparable to predicate device
Tissue Removal Cycles	Comparable to predicate device
Package Integrity	Comparable to predicate device
Biocompatibility	Comparable to predicate device

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample sizes used for the individual performance tests. It only mentions that "bench testing was performed."

The data provenance is internal and refers to "internal Risk Analysis procedures" and "bench testing." No information is provided about the country of origin of the data or whether it was retrospective or prospective. Given it's bench testing, it's generally a controlled laboratory environment rather than patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not provided in the document. As the testing appears to be primarily bench/mechanical testing comparing to a predicate, it's unlikely that traditional "ground truth" established by clinical experts (like radiologists for image analysis) was required in the same way. The "ground truth" here would likely be the established performance characteristics of the predicate device.

4. Adjudication Method for the Test Set

This information is not provided.

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

No such study was mentioned or performed. The device described is a physical atherectomy system, not an AI or imaging diagnostic tool that would involve human readers.

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

This question is not applicable. The HawkOne Directional Atherectomy System is a medical device, not an algorithm, so the concept of "standalone performance" in the context of AI does not fit. Its performance evaluation would be through its mechanical and functional capabilities.

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

The document implies that the ground truth for the performance tests was the established performance characteristics of the predicate device (TurboHawk Peripheral Plaque Excision Systems). The goal was to demonstrate "comparable" and "equivalent" performance to these existing devices. Clinical outcomes data, pathology, or expert consensus on features are not mentioned as direct ground truth for these bench tests.

8. The sample size for the training set

This information is not applicable. This device is not an AI/ML algorithm that requires a training set.

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

This information is not applicable, as it's not an AI/ML device requiring a training set with established ground truth.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with flowing lines extending from the faces.

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

October 16, 2014

Covidien, LLC c/o Julie Underdahl Senior Regulatory Affairs Specialist 3033 Campus Drive Plymouth, MN 55441-2651

Re: K141801

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: September 15, 2014 Received: September 16, 2014

Dear Ms. Underdahl:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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

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 (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" (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

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.

of Surveillance and Biometrics/Division of Postmarket Surveillance.

Sincerely yours,

Kenneth J. Cavanaugh -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known)

Device Name

HawkOne Directional Atherectomy System

K141801

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

Image /page/3/Picture/1 description: The image contains the word "COVIDIEN" in a sans-serif font. To the left of the word is a blue square with a white rectangle in the center and a vertical blue line running through the middle of the square. The word "COVIDIEN" is in a dark blue color.

510(k) Summary

HawkOne™ Directional Atherectomy System

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

1. Submitter Information

Applicant	Covidien llc4600 Nathan Lane NPlymouth, MN 55441-2651Tel: 763-398-7000Fax: 763-591-3248
Contact Person	Julie UnderdahlSenior Regulatory Affairs Specialist
Date Prepared	July 2, 2014

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 Devices

Device Trade Name	TurboHawk™ Peripheral Plaque Excision System
510(k) Number	K111723
510(k) Clearance Date	October 27, 2011
Device Trade Name	TurboHawk™ Peripheral Plaque Excision System
510(k) Number	K103618
510(k) Clearance Date	January 5, 2011

4. Device Description

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

Image /page/4/Picture/1 description: The image shows the logo for Covidien. The logo consists of a blue square with a white rectangle inside, and a vertical blue line running through the center. To the right of the square is the word "COVIDIEN" in bold, dark blue letters. The logo is simple and modern, and the colors are clean and professional.

blade contained 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. For information about the SpiderFX embolic protection device, reference the Instructions for Use provided with the device.

The HawkOne directional atherectomy system has two switches: 1) the cutter driver main power switch and 2) the HawkOne catheter thumb switch. The cutter driver main power switch supplies power to the device when turned On. The HawkOne catheter thumb switch activates the drive shaft and engages the cutter when pulled proximally to the On position. 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. The HawkOne 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.

5. Indications for Use

6. Comparison of Technological Characteristics

The proposed HawkOne Directional Atherectomy System is substantially equivalent to the currently marketed TurboHawk Peripheral Plaque Excision Systems (K111723 and K103618). 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.

7. Performance Testing Summary

To demonstrate substantial equivalence of the proposed HawkOne Directional Atherectomy System to the predicate device, bench testing was performed.

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

. Device Inspections
Urge Force ●
Cycle and Life
Cutter Height
Tracking Force ●
. Repeated Cutter Spin Down and Packing

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image contains the word "COVIDIEN" in a sans-serif font. To the left of the word is a blue square with a white rectangle in the center and a light blue vertical line running through the center of the square. The word "COVIDIEN" is in a dark blue color. The logo is simple and modern.

Shaft Torque Tests ●
Carbide Edge Attachment
DFT Torque and Pressure Tests
Device Tensile Tests ●
. Catheter and Cutter Driver Interaction
. Embolization
. Cut Mass Per Pass (Tissue Removal Rate)
Tissue Removal Cycles
Package Integrity
. Biocompatibility

The results from these tests demonstrate that the technological characteristics and performance criteria of the HawkOne Directional Atherectomy System are comparable to the predicate device and that the HawkOne Directional Atherectomy System performs in a manner equivalent to the predicate device currently on the market.

8. Conclusions

Based on the intended use, technological characteristics, safety and performance testing included in this submission, Covidien considers the proposed HawkOne Directional Atherectomy System to be substantially equivalent to the currently marketed TurboHawk Peripheral Plaque Excision Systems (K11723 and K103618).

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).