Last synced on 20 January 2023 at 11:05 pm

Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.4560
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.4560 Stereotaxic instrument

§ 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).

Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.4560
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.4560 Stereotaxic instrument

§ 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).