ClearPoint System (Software Version 2.2)
ClearPoint Neuro Inc.ClearPoint System (Software Version 2.2) is a medical software device designed to assist clinicians during neurological procedures by providing MRI-guided stereotactic guidance for the placement and operation of instruments like biopsy needles or deep brain stimulation leads. It integrates advanced automatic segmentation and visualization of brain structures from MRI scans, enhancing planning and intraoperative navigation. This helps improve surgical accuracy and patient outcomes in brain interventions.
Intended Use
The ClearPoint System is intended to provide stereotactic guidance for neurological procedures within the MRI environment, including automatic identification, labeling, visualization, and quantification of brain structures from MRI images, used during biopsies and deep brain stimulation lead placement.
Technology
ClearPoint System Software Version 2.2 integrates ClearPoint Neuro Maestro Brain Model software to enable automatic segmentation and visualization of brain structures. It includes a workstation laptop, SMARTGrid MRI-Guided Planning Grid, SMARTFrame MRI-Guided Trajectory Frame, and accessories for neurosurgical guidance. It operates with 1.5 and 3.0 Tesla MRI scanners, supports Windows 10/11 OS, and features image registration, 3D visualization, and measurement tools.
Performance
Software verification testing included automated verification, integrated system verification, localization verification, regression test verification, and manual testing, all meeting acceptance criteria. Accuracy testing confirmed that software modifications did not adversely affect system accuracy, with positional errors under 1.5 mm and angular errors below 0.5 degrees.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/28/2023
2 months - 2
FDA Approval
11/27/2023
Other devices from ClearPoint Neuro Inc.
- ClearPoint Maestro Brain Model2022 • 510K
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