| Device |
neurological stereotaxic instrument, real-time intraoperative mri |
| Regulation Description |
Stereotaxic instrument. |
| Definition |
To aid the surgeon in planning and conducting general stereotactic neurosurgery in an MRI suite. |
| Physical State |
Software: aquire MR images, trajectory planning, guidance regarding alignment of targeting frame with planned trajectory, confirmation of final tool position (MR compatible tools only). Hardware: stereotaxic frame and accessories (e.g. various diameter guide tubes, MRI-visible marking grid to facilitate identifying burr hole location on skull). |
| Technical Method |
Device software receives real-time, intraoperative MR images of the brain target and the trajectory of the targeting frame attached to the patient's skull. Software and MRIs are used to plan trajectory, guide alignment of frame with planned trajectory, and confirm final position of surgical tool (MR compatible tools only). |
| Target Area |
skull and brain |
| Regulation Medical Specialty |
Neurology |
| Review Panel |
Neurology |
|---|
| Product Code | ORR |
|---|
| Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices
(DHT5A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
882.4560
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
|
|
