(50 days)
The Trajectory Guide is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures within the MRI/CT environment and in conjunction with MR/CT imaging. The Trajectory Guide is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode introduction. The device will provide accurate delivery of devices or instruments to target sites 3mm and larger.
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The provided document is a 510(k) clearance letter from the FDA for a device named "Navigus Trajectory Guide". This letter confirms that the device is substantially equivalent to legally marketed predicate devices. However, it does not contain a detailed study description with specific acceptance criteria and performance metrics for the device. Such information is typically found in the 510(k) submission itself, which is a much larger document than this clearance letter.
Therefore, based solely on the provided text, I cannot provide the requested information about acceptance criteria or a detailed study that proves the device meets those criteria. The document only confirms the regulatory clearance based on substantial equivalence.
§ 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).