(188 days)
We Sense Navigation Probes electrodes are intended to be used in operation room during neurosurgery for temporary (less than two hours) recording and stimulation of defined small area in the brain, and for recording electrical signals from target brain cells. These electrodes can be used only by professional staff and not sell over the counter
NavigationProbes are equipped with a Micro tip and a Macro tip. The micro tip is used to for recording cell potentials of single cells or of cell clusters and for MicroStimulation. The Macro tip is used for stimulation and recording of local field potentials.
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the "Navigation Probes" device. The document is a 510(k) summary for the device, focusing on its substantial equivalence to a predicate device rather than presenting performance study results.
Therefore, I cannot provide the requested information.
§ 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).