HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM

K141801 · Covidien, LLC · MCW · Oct 16, 2014 · Cardiovascular

Device Facts

• Record ID: K141801
• Device Name: HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM
• Applicant: Covidien, LLC
• Product Code: MCW · Cardiovascular
• Decision Date: Oct 16, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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 Story

HawkOne Directional Atherectomy System treats peripheral artery disease by removing atherosclerotic plaque. System comprises flexible catheter with distal rotating cutting assembly and battery-powered cutter driver. Physician advances catheter over 0.014" guidewire to lesion site; activates thumb switch to engage rotating blade; shaves occlusive material; captures excised tissue in catheter tip. Process repeated as needed. Used in clinical setting; requires SpiderFX Embolic Protection Device for severely calcified lesions to mitigate distal embolization. Output is physical removal of plaque, improving vessel patency.

Clinical Evidence

Bench testing only. Performance evaluated via device inspections, urge force, cycle/life testing, cutter height, tracking force, shaft torque, carbide edge attachment, tensile tests, catheter/driver interaction, embolization, cut mass per pass, tissue removal cycles, package integrity, and biocompatibility.

Technological Characteristics

Directional atherectomy catheter with rotating inner blade in tubular housing; battery-powered cutter driver; 0.014" guidewire compatible. Mechanical cutting principle. Sterilized via validated method. Standalone operation.

Indications for Use

Indicated for atherectomy of peripheral vasculature in patients with de novo and restenotic atherosclerotic calcified and non-calcified lesions. Use with SpiderFX Embolic Protection Device required for severely calcified lesions. Contraindicated for use in coronary, carotid, iliac, or renal vasculature.

Regulatory Classification

Identification

An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)

Predicate Devices

• TurboHawk Peripheral Plaque Excision System (K111723)
• TurboHawk Peripheral Plaque Excision System (K103618)

Reference Devices

• SpiderFX Embolic Protection Device

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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## Indications for Use

510(k) Number (if known)

Device Name

HawkOne Directional Atherectomy System

K141801

Indications for Use (Describe)

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.

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)

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# 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 llc<br>4600 Nathan Lane N<br>Plymouth, MN 55441-2651<br>Tel: [phone]<br>Fax: [phone] |
|----------------|---------------------------------------------------------------------------------------------------------|
| Contact Person | Julie Underdahl<br>Senior 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 Stripper<br>21 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

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

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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

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.

#### 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

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- 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).