(28 days)
Stereotactic spatial positioning and orientation of an instrument holder or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments.
neuromate Gen III has been validated with the following stereotactic frames:
- 1 the Leksell Type G comprising of head frame and CT Localizer,
- 2 the CRW HRAIM with the BRWLF localizer.
- 3 the CRW UCHRA with the Luminant and BRWLF localizers
Not Found
This document is a 510(k) clearance letter for the neuromate Gen III device, a stereotaxic instrument. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The document primarily covers:
- The FDA's determination of substantial equivalence.
- Regulatory information regarding the device's classification, general controls, and compliance requirements.
- Instructions for reporting adverse events and seeking regulatory guidance.
- The device's Indications for Use, which describes its purpose (stereotactic spatial positioning and orientation of an instrument holder or tool guide for neurosurgical instruments) and the stereotactic frames it has been validated with.
Therefore, I cannot provide the requested information based on this document. The document confirms market clearance but does not detail the specific performance studies or acceptance criteria that led to that clearance.
§ 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).