(151 days)
No
The description details a mechanical atherectomy system with a rotating blade and a battery-powered driver. There is no mention of any computational or algorithmic components that would suggest the use of AI or ML. The device's operation is based on physical mechanisms controlled by switches.
Yes
The device is described as an "atherectomy system" intended for "atherectomy of the peripheral vasculature," which is a medical procedure to remove plaque from arteries to restore blood flow, thereby treating a health condition.
No.
The device description clearly states its purpose is for "treatment of de novo and restenotic atherosclerotic calcified and non-calcified lesions" by "shaving occlusive material from the artery," indicating a therapeutic function rather than diagnosis.
No
The device description clearly outlines physical components like a catheter, cutter driver, flexible shaft, cutting unit, and switches, indicating it is a hardware-based medical device.
Based on the provided text, the HawkOne Directional Atherectomy System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- The HawkOne system is a surgical device used in vivo (inside the body) to physically remove plaque from peripheral arteries. It is a therapeutic device, not a diagnostic one.
- The description clearly outlines a mechanical process of cutting and removing tissue from within the patient's blood vessels.
Therefore, the HawkOne Directional Atherectomy System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
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 treating complex, hard, calcified lesions, pairing the HawkOne catheter with the SpiderFX™ embolic protection device mitigates risk of distal embolization that can be generated when heavily calcified plaque breaks down. For information about the SpiderFX embolic protection device, reference the Instructions for Use provided with the device
The HawkOne catheter consists of a flexible shaft designed to track with a 0.36 mm (0.014 in) guidewire. At the distal end of the HawkOne catheter there is a small cutting unit comprised of an inner blade that rotates 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.
The HawkOne 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 HawkOne 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 HawkOne catheter activates the drive shaft and the cutter. 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. When the HawkOne 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.
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 performed included: Device Inspections, Cutter Height, Tracking Force, Cycle and Life, Repeated Cutter Spin Down and Packing, Carbide Edge Attachment, Shaft Torque Test, DFT Torque and Pressure Test, Device Tensile Tests, Coating integrity, Cut depth, Mass Per Pass (Tissue Removal Rate), Embolization, Simulated Use (trackability, rotational fatigue, cycling and cutting), and Biocompatibility. The results demonstrated that the technological characteristics and performance criteria of the proposed HawkOne 6F devices are comparable to the predicate and reference devices.
Key Metrics
Mass Per Pass (Tissue Removal Rate)
Predicate Device(s)
Reference Device(s)
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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, layered on top of each other to create a sense of depth. The profiles are connected to a symbol that resembles a bird's wing or a flowing ribbon. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 14, 2016
Medtronic Vascular, Inc. Ms. Rupali Gupta Senior Regulatory Affairs Specialist 3033 Campus Drive Plymouth, MN 55441
Re: K161361
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: August 31, 2016 Received: September 1, 2016
Dear Ms. Gupta:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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.
Sincerely yours,
Image /page/1/Picture/7 description: The image shows the name "Brian D. Pullin -S" in a clear, sans-serif font. The text is horizontally aligned and appears to be part of a larger document or label. The letters are uniformly sized and spaced, contributing to the legibility of the name.
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) K161361
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)
| 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. 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/0 description: The image shows the word "Medtronic" in a bold, sans-serif font. The color of the text is a dark blue. The text is the only element in the image, and it is centered.
HawkOne Directional Atherectomy System 510(k) Summary
510(k) Summary
HawkOne™ 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 Vascular, Inc.
4600 Nathan Lane N
Plymouth, MN 55441-2651
Tel: 763-398-7000
Fax: 763-591-3248 |
|----------------|---------------------------------------------------------------------------------------------------------------------|
| Contact Person | Rupali Gupta
Senior Regulatory Affairs Specialist |
| Date Prepared | May 13, 2016 |
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 Device
| Device Trade Name | HawkOne Directional Atherectomy System (H1-LX and H1-LS) |
|---|---|
| 510(k) Number | K141801 |
| 510(k) Clearance Date | October 16, 2014 |
4. Reference Device
| Device Trade Name | TurboHawk™ Peripheral Plaque Excision System |
|---|---|
| 510(k) Number | K103618 |
| 510(k) Clearance Date | January 5, 2011 |
5. 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 treating complex, hard, calcified lesions, pairing the HawkOne catheter with the SpiderFX™ embolic protection device mitigates risk of
4
HawkOne Directional Atherectomy System 510(k) Summary
distal embolization that can be generated when heavily calcified plaque breaks down. For information about the SpiderFX embolic protection device, reference the Instructions for Use provided with the device
The HawkOne catheter consists of a flexible shaft designed to track with a 0.36 mm (0.014 in) guidewire. At the distal end of the HawkOne catheter there is a small cutting unit comprised of an inner blade that rotates 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.
The HawkOne 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 HawkOne 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 HawkOne catheter activates the drive shaft and the cutter. 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. When the HawkOne 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. 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.
7. Comparison of Technological Characteristics
The primary purpose of this traditional 510(k) is to reduce the crossing profile from 2.6mm to 2.2mm by using a smaller driveshaft, cutter, and tip, compared to the HawkOne 7F device, so that the proposed HawkOne 6F device can be tracked through a 6F introducer sheath. There is also a change in the material supplier in this submission. When compared to the TurboHawk reference device, the proposed HawkOne 6F has an increased device RPM, improved torque shaft laminates, and includes a pre-loaded distal flush tool."
The proposed HawkOne 6F catheter will only function with the HawkOne cutter driver (H1-14550) which is currently used for the primary predicate HawkOne 7F catheters. HawkOne 6F catheters will not function and are functionally unable to connect with the previously released cutter driver (FG-02550) which is used with the reference TurboHawk catheters.
The proposed HawkOne 6F is considered to be substantially equivalent to the legally marketed HawkOne Directional Atherectomy System (referred to as HawkOne 7F), cleared by FDA under premarket notification K141801 on October 16, 2014 and TurboHawk Peripheral Plaque Excision
5
HawkOne Directional Atherectomy System 510(k) Summary
System, SX-C, SS-C, SS-CL (referred to as TurboHawk) for small vessel, cleared by FDA under premarket notification K103618 on January 05, 2011.
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.
8. Performance Testing Summary
To demonstrate substantial equivalence of the proposed HawkOne Directional Atherectomy System (HawkOne 6F) to the predicate devices, bench testing was performed.
Using internal Risk Analysis procedures, the following tests were performed:
- Device Inspections ●
- Cutter Height ●
- Tracking Force
- Cycle and Life ●
- Repeated Cutter Spin Down and Packing
- Carbide Edge Attachment
- Shaft Torque Test
- DFT Torque and Pressure Test
- Device Tensile Tests ●
- Coating integrity
- Cut depth ●
- Mass Per Pass (Tissue Removal Rate)
- Embolization
- Simulated Use (trackability, rotational fatigue, cycling and cutting)
- Biocompatibility
The results from these tests demonstrate that the technological characteristics and performance criteria of the proposed HawkOne 6F devices are comparable to the predicate and reference devices and that the proposed HawkOne 6F device performs in a manner equivalent to the predicate devices currently on the market.
9. Conclusions
Based on the identical intended use, similar technological characteristics, and safety and performance testing included in this submission. Medtronic Vascular. Inc (formerly d.b.a. ev3 Inc./Covidien 11c) considers the proposed HawkOne 6F device to be substantially equivalent to the currently marketed HawkOne 7F, K141801 (primary predicate) and TurboHawk, K103618 (reference) devices.