TurboHawk Plus Directional Atherectomy System

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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). 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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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K212027 Device Name TurboHawk Plus Directional Atherectomy System Indications for Use (Describe) 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. Type of Use (Select one or both, as applicable) | <span style="font-size:12pt;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | |-------------------------------------------------------------------------------------| | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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. 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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, Inc<br>710 Medtronic Parkway<br>Minneapolis, MN 55432<br>Tel: 763-514-4000 | |----------------|------------------------------------------------------------------------------------------| | Contact Person | Angela Huber<br>Regulatory Affairs Manager<br>612-704-2418<br>angela.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 Stripper<br>21 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. {4}------------------------------------------------ K212027 TurboHawk Plus Directional Atherectomy System 510(k) Summary # 5. 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. ### 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 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. # 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 {5}------------------------------------------------ #### 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 {6}------------------------------------------------ #### 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.