(126 days)
The Trajectory Guide is intended to provide stereotactic guidance for the placement and operation of neurological instruments or devices during planning and operation of neurological procedures within the MRI environment and in conjunction with MRI imaging. The Trajectory Guide is intended as an aid in procedures that have traditionally used stereotactic methodology. These procedures include catheter placement and electrode implant. The device will provide accurate delivery of devices or instruments to target sites 3mm and larger.
Not Found
I am sorry, but the provided text from the FDA Pre-Market Notification does not contain information on the acceptance criteria, device performance, or any studies proving the device meets acceptance criteria. The document is an approval letter for the Trajectory Guide (K983539), indicating that the FDA found it substantially equivalent to previously marketed devices. It outlines the regulatory classification and general controls applicable to the device but does not detail the technical performance or supporting studies.
§ 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).