(84 days)
Not Found
No
The document describes a mechanical drive system for positioning electrodes and instruments during neurosurgery. There is no mention of AI, ML, image processing, or any data-driven algorithms. The focus is on the mechanical components and their compatibility with existing stereotactic systems.
No
The device is described as a system for accurate positioning of instruments like microelectrodes and stimulating electrodes in neurosurgical procedures, but it does not directly perform a therapeutic function on its own. It is a tool used for facilitating therapeutic procedures.
No
The device is described as an instrument for accurate positioning of electrodes and other instruments in the brain or nervous system during neurosurgical procedures, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly lists multiple hardware components and accessories, indicating it is a physical medical device system, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Intended Use: The FHC microTargeting® Drive System is intended for the accurate positioning of electrodes and other instruments directly within the brain or nervous system during neurosurgical procedures. This is an in vivo application (within a living organism), not an in vitro application (outside of a living organism, typically in a lab setting).
- Device Description: The description details components used for physical manipulation and positioning within the body, not for analyzing biological specimens.
- Anatomical Site: The anatomical site is the "brain or nervous system," which is a living part of the body.
Therefore, based on the provided information, the FHC microTargeting® Drive System is a surgical device used for positioning instruments during neurosurgery, not an IVD.
N/A
Intended Use / Indications for Use
The FHC microTargeting® Drive System is intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, DBS™ electrodes or other instruments in the brain or nervous system.
Product codes
HAW
Device Description
The microTargeting® Drive System with maTrix drive mount permits the accurate t positioning of microelectrodes, stimulating electrodes, DBS " electrodes, leston positioning on thereficeroded, climataling aerous in the brain and nervous system and is adaptable to all major stereotactic systems.
microTargeting™ Drive System Components
- microTargeting™ drive
- maTrix™ drive mount and lower guide
- maTrix™ guide bushings
- DBS™ holder with DBS/lesion stop t
- verification probe e
- sterilization case #
- cleaning brushes
- hex wrench
microTargeting™ Drive System Accessories
- Radionics adaptor . #
- Leksell adaptor
- BrainLab adaptor
- Leibinger RM adaptor
- Leibinger ZD adaptor
- Leibinger Ost-Reg™ (STarFix™) adaptor
- NeuroMate™ adaptor
- single electrode insertion tube set
- array electrode insertion tube set ti
- lesion insertion tube kit and depth stops G
- custom microelectrode depth stops
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain or nervous system
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K003776, K99068, K992721, K991077
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
0
AUG 3 0 2001
510(k) SUMMARY ರ್ಧ SAFETY and EFFECTIVENESS
| A. General Information | |
|---|---|
| -- | ------------------------ |
FHC. Inc. 1. Submitter's Name: 9 Main Street 2. Address: Bowdoinham, ME 04008 207-666-8190 3. Telephone Number: Frederick Haer 4. Contact Person: May 30, 2001 5. Date Prepared: 6. Registration Number: 1226598 B. Device microTargeting® Drive System 1. Name: microTargeting® Drive System 2. Trade Name: Stereotactic Microdrive System 3. Common Name: 4. Classification Name: Stereotactic Instrument HAW 5. Product Code: 6. Class: } { 7. Regulation Number: 882.4560
1
C. Identification of Legally Marketed Devices
| Name | K Number | Date Cleared |
|---|---|---|
| 1. FHC microTargeting® Drive System | K003776 | Feb. 23, 2001 |
| 2. Axon Instruments MP-1 Micropositioner | K99068 | Nov. 3, 1999 |
| 3. Radionics CRW-FMD | K992721 | Sept. 10, 1999 |
| 4. MSC μEEG uDrive Model 25/50 | K991077 | June 9, 1999 |
D. Description of Device
The microTargeting® Drive System with maTrix drive mount permits the accurate t positioning of microelectrodes, stimulating electrodes, DBS " electrodes, leston positioning on thereficeroded, climataling aerous in the brain and nervous system and is adaptable to all major stereotactic systems.
microTargeting™ Drive System Components
- microTargeting™ drive �
- maTrix™ drive mount and lower guide 委
- maTrix™ guide bushings �
- DBS™ holder with DBS/lesion stop t
- verification probe e
- sterilization case #
- cleaning brushes �
- hex wrench �
microTargeting™ Drive System Accessories
- Radionics adaptor . #
- Leksell adaptor �
- BrainLab adaptor �
- Leibinger RM adaptor �
- Leibinger ZD adaptor ◆
- Leibinger Ost-Reg™ (STarFix™) adaptor �
- NeuroMate™ adaptor �
- single electrode insertion tube set �
- array electrode insertion tube set ti
- lesion insertion tube kit and depth stops G
- custom microelectrode depth stops �
2
E. Intended Use Statement
The FHC microTargeting® Drive System is intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, DBS™ electrodes or other instruments in the brain or nervous system.
F. Technological Characteristics Summary
The FHC microTargeting® Drive System is substantially equivalent to the FHC, Inc. microTargeting® Drive System (K003776), Axon Instruments Guideline System 3000 MP-1 Micropositioner (K990683), the Radionics Cosman Robert Wells Functional Probe Microdrive (CRW-FMD) (K992721) and the Microrecording System Consultants uEEG™ Pro System 5000 µDrive Model 25/50 (K991077).
Differences that exist between these devices, relating to technical specifications, physical appearance, and design do not affect the relative safety and effectiveness of the microTargeting® Drive System.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is written in all capital letters and is evenly spaced around the caduceus symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 0 2001
Mr. Frederick Haer President/CEO FHC, Inc. 9 Main Street Bowdoinham, Maine 04008
Re: K011775
Trade/Device Name: microTargeting® Drive System Regulation Number: 882.4560 Regulatory Class: II Product Code: HAW Dated: May 30, 2001 Received: June 7, 2001
Dear Mr. Haer:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2 - Mr. Frederick Haer
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nredicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Susan Wall, M.D.
RN
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of_1_
K011775 510(k) Number (if known):_
Device Name: microTargeting@ Drive System
Indications For Use: The FHC microTargeting® Drive System is intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate neurosuryical procedures which required the works over on positioning of mioroelowoods in the brain or nervous system.
(Please do not write below This Line-continue on another Page if NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Division Sign Off
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K011775