(459 days)
The microTargeting™ Electrodes are intended for use in intra-operative recording of single unit neuronal activity in the brain.
The microTargeting™ Electrodes (K991522) are for intra-operative single-unit recording during functional neurosurgery.
microTargeting™ Electrodes Components
- Electrodes
- Protective Tube (Shielded) .
microTargeting™ Electrodes Accessories - . Sterilizable Case (E5-75)
This document is a 510(k) premarket notification for the FHC, Inc. microTargeting™ Electrodes, dated August 4, 2000. It seeks to establish substantial equivalence to legally marketed predicate devices, not primarily to demonstrate performance against acceptance criteria through a study.
Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving device performance against those criteria. The document is a regulatory submission for premarket clearance and focuses on establishing substantial equivalence based on technological characteristics and intended use, rather than presenting a performance study with specific acceptance criteria.
The sections for acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth, and training set information are not applicable to this type of document.
§ 882.1330 Depth electrode.
(a)
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.(b)
Classification. Class II (performance standards).