(16 days)
Not Found
No
The device description focuses on mechanical components and operation, with no mention of AI/ML terms or functionalities.
Yes
The device is intended for atherectomy of peripheral vasculature, which is a medical procedure to remove plaque and restore blood flow, thus treating a medical condition.
No
The device is described as a "plaque excision system" designed to remove atherosclerotic lesions from peripheral arteries, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines hardware components including a catheter, cutter driver, and battery-driven unit, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "atherectomy of the peripheral vasculature." This is a surgical procedure performed in vivo (within the living body) to remove plaque from arteries.
- Device Description: The description details a mechanical device designed to physically cut and remove tissue from within the body. It involves a catheter, a cutting assembly, and a power source.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The TurboHawk Peripheral Plaque Excision System is a surgical device used for a therapeutic procedure, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
Treatment of de novo and restenotic atherosclerotic calcified and non-calcified lesions located in native peripheral arteries.
The TurboHawk Peripheral Plaque Excision System is intended for use in atherectomy of the peripheral vasculature. The TurboHawk Catheter is NOT intended for use in the coronary, carotid, iliac, or renal vasculature.
Product codes
MCW
Device Description
The TurboHawk Peripheral Plaque Excision System (TurboHawk Catheter and SilverHawk™ Cutter Driver) is designed for the treatment of de novo and restenotic calcified and non-calcified atherosclerotic lesions located in native peripheral arteries. The TurboHawk Catheter consists of a flexible shaft designed to track over a 0.014" guidewire. At the distal end of the TurboHawk Catheter is a small cutting assembly comprised of a rotating inner cutter contained within a tubular housing. The proximal end of the TurboHawk Catheter contains a connector and cutter positioning lever (thumb switch) designed to fit into the SilverHawk Cutter Driver. The SilverHawk Cutter Driver is a handheld, disposable, battery-driven unit (Catalog No: 02550) which powers the system. The TurboHawk Peripheral Plaque Excision System has two switches: 1) the SilverHawk Cutter Driver main power switch and 2) the TurboHawk Catheter thumb switch. The SilverHawk Cutter Driver main power switch supplies power to the device when turned ON. The TurboHawk Catheter thumb switch activates the drive shaft and engages the cutter when pulled proximally to the ON position. With the cutter engaged, the TurboHawk 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 Catheter thumb switch distally deactivating the drive shaft and disengaging the cutter. The TurboHawk 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
native peripheral arteries, peripheral vasculature. The TurboHawk Catheter is NOT intended for use in the coronary, carotid, iliac, or renal 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SilverHawk™ Peripheral Plaque Excision System (K061188)
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).
0
TurboHawk Peripheral Plaque Excision System
Image /page/0/Picture/1 description: The image shows the logo for EV3, a robotics kit. Above the logo is the number K093301. The EV3 logo consists of the letters "ev3" in a stylized font, with three circles above the letters. The circles are arranged in a triangular pattern.
510(k) Summary
NOV - 6 2009
TurboHawk™ Peripheral Plaque Excision System
| 510(k) Summary | This summary of 510(k) safety and effectiveness information is being
submitted in accordance with the requirements of 21 C.F.R § 807.92. |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | ev3 Inc. |
| Submitter | ev3 Inc.
3033 Campus Drive
Plymouth, MN 55441
Tel: 763-398-7000
Fax: 763-591-3248 |
| Contact Person | Brenda Johnson |
| Date Prepared | October 8, 2009 |
| Device Trade Name | TurboHawk™ Peripheral Plaque Excision System |
| Device Common Name | Catheter, Peripheral, Atherectomy |
| Classification Name | Intraluminal Artery Stripper
21 CFR 870.4875, Product Code MCW |
| Classification Panel | Cardiovascular |
| Predicate Devices | SilverHawk™ Peripheral Plaque Excision System (K061188) |
| Intended use | Treatment of de novo and restenotic atherosclerotic calcified and non-
calcified lesions located in native peripheral arteries. |
| Device Description | The TurboHawk Peripheral Plaque Excision System (TurboHawk
Catheter and SilverHawk™ Cutter Driver) is designed for the
treatment of de novo and restenotic calcified and non-calcified
atherosclerotic lesions located in native peripheral arteries. The
TurboHawk Catheter consists of a flexible shaft designed to track over
a 0.014" guidewire. At the distal end of the TurboHawk Catheter is a
small cutting assembly comprised of a rotating inner cutter contained
within a tubular housing. The proximal end of the TurboHawk
Catheter contains a connector and cutter positioning lever (thumb
switch) designed to fit into the SilverHawk Cutter Driver. The
SilverHawk Cutter Driver is a handheld, disposable, battery-driven
unit (Catalog No: 02550) which powers the system.
The TurboHawk Peripheral Plaque Excision System has two switches:
- the SilverHawk Cutter Driver main power switch and 2) the
TurboHawk Catheter thumb switch. The SilverHawk Cutter Driver |
| | main power switch supplies power to the device when turned ON. The
TurboHawk Catheter thumb switch activates the drive shaft and
engages the cutter when pulled proximally to the ON position. With
the cutter engaged, the TurboHawk 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 Catheter thumb
switch distally deactivating the drive shaft and disengaging the cutter. |
| | The TurboHawk 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. |
| Performance data | Bench testing and biocompatibility testing were performed to support
a determination of substantial equivalence. Results from this testing
provide assurance that the proposed device has been designed and
tested to assure conformance to the requirements for its intended use. |
| Summary of Substantial
Equivalence | The TurboHawk Peripheral Plaque Excision System has the following
similarities to the predicate device: |
| | ● Identical indications for use |
| | ● Similar intended use |
| | ● Similar materials |
| | ● Similar fundamental scientific technology |
| | ● Similar operating principle |
| Conclusion | Based on the identical indications for use, similar technological
characteristics, materials and operating principle, and the results from
safety and performance testing, the TurboHawk Peripheral Plaque
Excision System is considered substantially equivalent to the
SilverHawk Peripheral Plaque Excision System (K061188). |
1
TurboHawk Peripheral Plaque Excision System
.
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", indicating the department's name and national affiliation.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
ev3, Inc. c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 2510 Street NW Buffalo, MN 55313
NOV - 6 2009
Re: K093301
Trade/Device Name: TurboHawk Peripheral Plaque Excision System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: October 20, 2009 Received: October 21, 2009
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device w 6 nave reviewed your because in in in in in in the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the onoroome) to regary and entirent date of the Medical Device Amendments, or to commerce pror to May 20, 1978, in the provisions of the Federal Food, Drug, de rices mat have been rouire approval of a premarket approval approval application (PMA). and Costinetto (110) that to nov requesable to the general controls provisions of the Act. The r ou may, mercere, market the Act include requirements for annual registration, listing of general obnition proficturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is bluestined (000 acres) Existing major regulations affecting your device can be finay of subjoct to additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Mark Job
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please the Somer velation 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 of Surveillance and Biometrics/Division of Postmarket Surveillance.
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.
Sincerely yours,
Dura R. buhner
Image /page/3/Picture/7 description: The image shows a black and white drawing of a cursive letter. The letter appears to be an 'f' or a similar character with a loop at the top and a curved line extending to the right. The drawing is simple and lacks detail, focusing on the basic shape of the letter.
Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1_of_1
Indications for Use Statement
1/093301 510(k) Number (if known) :_
Device Name: TurboHawk Peripheral Plaque Excision System Indications for Use:
The TurboHawk Peripheral Plaque Excision System is intended for use in atherectomy of the peripheral vasculature. The TurboHawk Catheter is NOT intended for use in the coronary, carotid, iliac, or renal vasculature.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anna R. Lanier
ivision Sign-Off) Division Sign-On)
Division of Cardiovascular Devices
510(k) Number K093301