(84 days)
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.
The microTargeting® Drive System with maTrix drive mount permits the accurate positioning of microelectrodes, stimulating electrodes, DBS electrodes, lesion 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
- verification probe
- 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
- lesion insertion tube kit and depth stops
- custom microelectrode depth stops
I am sorry, but the provided text does not contain the information needed to answer the question about acceptance criteria and study details for the microTargeting® Drive System. The document is primarily a 510(k) summary for regulatory clearance, focusing on general device information, legal marketing, description, intended use, and substantial equivalence to predicate devices. It does not include specific performance data, study designs, or acceptance criteria.
§ 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).