The TurboHawk Plus directional atherectomy system is intended for use in atherectomy of the peripheral vasculature. The TurboHawk Plus catheter is indicated for use in conjunction with the SpiderFX embolic protection device in the treatment of severely calcified lesions. The TurboHawk Plus catheter is not intended for use in the coronary, carotid, iliac, or renal vasculature.

Device Description

The TurboHawk Plus Directional Atherectomy System (TurboHawk Plus Catheter and cutter driver) is designed for the treatment of de novo and restenotic atherosclerotic calcified and noncalcified lesions located in native peripheral arteries. When treating complex, hard, calcified lesions, pairing the TurboHawk Plus catheter with the SpiderFX embolic protection device mitigates risk of distal embolization that may be generated when heavily calcified plaque breaks down.

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

The TurboHawk Plus 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 TurboHawk Plus 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 TurboHawk Plus catheter activates the drive shaft and the cutter. With the cutter engaged, the TurboHawk Plus 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 Plus catheter thumb switch distally, deactivating the drive shaft and disengaging the cutter. When the TurboHawk Plus 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

This document describes the FDA's 510(k) premarket notification for the TurboHawk Plus Directional Atherectomy System. The provided text does not contain a study comparing AI performance, but rather outlines the performance testing conducted to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the requested information based on the provided text, focusing on the device performance and acceptance criteria for the TurboHawk Plus Directional Atherectomy System:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the performance tests were conducted using internal Risk Analysis procedures and that "The results from these tests demonstrate that TurboHawk Plus meets the product performance specifications." It does not provide specific numerical acceptance criteria or detailed numerical results for each test. Instead, it broadly asserts that the device meets those specifications.

Performance Test	Acceptance Criteria (Implicit)	Reported Device Performance
Device Inspections	Meets internal quality and design specifications.	Met product performance specifications.
Simulated Use (trackability, rotational fatigue, cycling and cutting)	Meets functional requirements under simulated use conditions.	Met product performance specifications.
Kink resistance	Maintains structural integrity and functionality despite kinking.	Met product performance specifications.
Heat generation	Operates within safe temperature limits.	Met product performance specifications.
Torsional Strength	Maintains structural integrity under torsional stress.	Met product performance specifications.
Tensile Strength	Withstands tensile forces without failure.	Met product performance specifications.
Catheter to cutter driver interaction	Proper and safe functional interaction between components.	Met product performance specifications.
Cut Mass/Pass (Plaque Removal Efficiency)	Achieves effective plaque removal.	Met product performance specifications.
Capture Efficiency (Debris removal and collection)	Effectively captures and collects excised tissue.	Met product performance specifications.
Cycle & Life	Performs reliably over its intended lifespan.	Met product performance specifications.
Cutting embolization analysis	Minimizes the risk of clinically significant embolization.	Met product performance specifications.
Consistency of Tissue Removal	Achieves consistent tissue removal.	Met product performance specifications.
Coating integrity	Maintains integrity of the coating.	Met product performance specifications.
Particulate evaluation	Minimizes particulate generation.	Met product performance specifications.
Biocompatibility (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Haemocompatibility tests)	Meets ISO 10993-1 standards for intended use.	Considered biocompatible for its intended use under ISO 10993-1 category: externally communicating device, circulating blood contact with limited (<24 hour) exposure.

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

The document does not explicitly state the sample sizes used for each performance test. It mentions that "performance tests were performed using internal Risk Analysis procedures," but does not specify the number of devices or components tested. The data provenance is internal testing performed by Medtronic, Inc.

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

This information is not applicable to the provided document. The performance tests described are primarily engineering and biocompatibility evaluations, not clinical studies requiring expert interpretation of ground truth in the context of medical imaging or diagnosis.

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

This information is not applicable. The performance tests are objective engineering and laboratory assessments, not clinical evaluations requiring adjudication of expert opinions.

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

A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was not done. This document pertains to the clearance of a medical device (directional atherectomy system), not an AI algorithm. Therefore, there is no discussion of human reader improvement with or without AI assistance.

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

This information is not applicable. The device is a physical medical instrument, not an algorithm.

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

For the performance tests, the "ground truth" refers to established engineering standards, material science properties, and biological safety limits (e.g., ISO 10993 for biocompatibility). For tests like cut mass/pass and capture efficiency, the ground truth would be quantifiable measurements against defined performance targets. It is not an expert consensus for diagnostic purposes, pathology, or outcomes data in the traditional sense of a clinical trial.

8. The sample size for the training set

This information is not applicable. This device is not an AI algorithm, and therefore does not have a "training set."

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

This information is not applicable.

Summary

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August 24, 2021

Medtronic, Inc Jenny Andersen Senior Director of Regulatory Affairs 4600 Nathan Lane North Plymouth, Minnesota 55442

Re: K212027

Trade/Device Name: TurboHawk Plus Directional Atherectomy System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: June 29, 2021 Received: June 30, 2021

Dear Jenny Andersen:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212027

Device Name

TurboHawk Plus 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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K212027

TurboHawk Plus Directional Atherectomy System 510(k) Summary

510(k) Summary TurboHawk Plus™ 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, Inc710 Medtronic ParkwayMinneapolis, MN 55432Tel: 763-514-4000
Contact Person	Angela HuberRegulatory Affairs Manager612-704-2418angela.huber@medtronic.com
Date Prepared	June 24, 2021

2. Subject Device

Device Trade Name	TurboHawk Plus 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	TurboHawk™ Peripheral Plaque Excision System
510(k) Number	K1701911
Clearance Date	June 16, 2017

4. Reference Device

Device Trade Name	HawkOne Directional Atherectomy System
510(k) Number	K161361	K141801
510(k) Clearance Date	October 14, 2016	October 16, 2014

1 Medtronic considers the TurboHawk Plus Directional Atherectomy System to be substantially equivalent to the currently marketed TurboHawk Peripheral Plaque Excision Systems, K170191. Previous 510k clearances include; K111723, K103618, K093301.

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K212027

TurboHawk Plus Directional Atherectomy System 510(k) Summary

5. Device Description

6. Intended Use

The TurboHawk Plus is intended for treatment of de novo and restenotic atherosclerotic calcified and non-calcified lesions located in native peripheral arteries.

7. Indications for Use

8. Comparison of Technological Characteristics

The TurboHawk Plus is comprised of HawkOne catheter (reference) combined with the TurboHawk cutter driver (predicate). The TurboHawk Plus device uses similar design and

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K212027 TurboHawk Plus Directional Atherectomy System 510(k) Summary

materials as the predicate devices. Modifications have been made to the TurboHawk Plus device design, so the proposed device catheter can function with the predicate cutter driver. Additionally, modifications are made to allow for improved tracking, crossing, torqueability, radiopacity, as well as improved procedural efficiency with the pre-loaded distal flush tool when compared to the predicate.

TurboHawk Plus shares the following similarities to the predicate device and reference devices.

Same intended use ●
Similar indications for use ●
Same fundamental scientific technology ●
Same principle of operation
Similar catheter and cutter driver materials ●
Similar device dimensions and diameter of vessels
Same lubricious coating
Same sterility assurance level and method of sterilization
Same packaging material and configuration .

In addition, device materials, and manufacturing site and methods and labeling are similar between the proposed and legally marketed predicate device and reference devices.

9. Performance Testing Summary

To demonstrate substantial equivalence of the proposed TurboHawk Plus to the predicate device. the following performance tests were performed using internal Risk Analysis procedures:

Device Inspections ●
Simulated use (trackability, rotational fatigue, cycling and cutting) ●
Kink resistance ●
Heat generation ●
Torsional Strength
Tensile Strength
Catheter to cutter driver interaction
Cut Mass/Pass (Plaque Removal Efficiency) ●
Capture Efficiency (Debris removal and collection)
Cycle & Life
Cutting embolization analysis
Consistency of Tissue Removal ●
Coating integrity ●
Particulate evaluation ●

The results from these tests demonstrate that TurboHawk Plus meets the product performance specifications. The technological characteristics and performance criteria of the TurboHawk Plus

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TurboHawk Plus Directional Atherectomy System 510(k) Summary K212027

devices are comparable to the predicate device and the proposed TurboHawk Plus device performs in a manner equivalent to the predicate device currently on the market.

10. Biocompatibility Testing

The biocompatibility evaluation for the TurboHawk Plus was conducted in accordance with the principles of the ISO 10993:2018 Part 1, "Evaluation and Testing within a risk management process ".

The biocompatibility testing included the following tests:

Cytotoxicity
Sensitization ●
Irritation
Acute Systemic Toxicity ●
Pyrogenicity
Haemocompatibility -Hemolysis ●
Haemocompatibility -Complement Activation
Haemocompatibility -Partial Thromboplastin Time (PTT)
Haemocompatibility Thromboresistance ●
Hemocompatibility Platelet and Leukocyte Count ●

The TurboHawk Plus is considered biocompatible for its intended use under ISO 10993-1 category: externally communicating device, circulating blood contact with limited (<24 hour) exposure.

11.Conclusions

Based on the same intended use and indications for use, similar technological characteristics, and safety and performance testing included in this submission, Medtronic considers the TurboHawk Plus Directional Atherectomy System to be substantially equivalent to the currently marketed TurboHawk Peripheral Plaque Excision Systems, K170191.

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).