(105 days)
Not Found
No
The device description and performance studies focus on mechanical aspects of atherectomy and do not mention any AI/ML components or functionalities.
Yes
The HawkOne Directional Atherectomy System is intended for atherectomy, which is the removal of plaque from arteries to restore blood flow. This direct treatment of a disease or condition makes it a therapeutic device.
No
Explanation: The device is an atherectomy system designed for the treatment of plaque in peripheral arteries, which is a therapeutic (treatment) function, not a diagnostic one.
No
The device description clearly outlines physical hardware components including a catheter, cutter driver, and a battery-driven power source.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "atherectomy of the peripheral vasculature." This is a surgical procedure performed in vivo (within the body) to remove plaque from blood vessels.
- Device Description: The device is a "directional atherectomy system" consisting of a catheter and a cutter driver. This is a mechanical device used for a physical intervention.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or treatment. This device does not perform any such analysis of biological samples.
The device is clearly designed for a therapeutic intervention within the patient's body, not for diagnostic testing of samples outside the body.
N/A
Intended Use / 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.
Product codes
MCW
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Bench testing was performed. Tests included: Device Inspections, Urge Force, Cycle and Life, Cutter Height, Tracking Force, Repeated Cutter Spin Down and Packing, 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 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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
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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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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 llc
4600 Nathan Lane N
Plymouth, MN 55441-2651
Tel: 763-398-7000
Fax: 763-591-3248 |
|----------------|---------------------------------------------------------------------------------------------------------|
| Contact Person | Julie Underdahl
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 |
| 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
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
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).