The 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application is a stereotaxic image-guided navigation system that assists surgeons in performing precise cranial surgery. It provides real-time tracking of instruments, image registration with preoperative scans, and step-by-step guidance for biopsies and ventricular catheter placement, improving surgical accuracy and safety.
The 7D Surgical System is a stereotaxic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments used by surgeons. The system is also intended to be used as the primary surgical luminaire during image guided surgery. The device is indicated for cranial surgery where reference to a rigid anatomical structure can be identified.
The system uses structured light imaging, optical tracking of passive marker instruments, image registration to preoperative DICOM scans, and integrates software and hardware including a cart, articulated arm, head with imaging and illumination capabilities, and navigational instruments for cranial procedures.
Nonclinical verification and validation including system and software testing, surgical simulations on phantoms, risk analysis, biocompatibility, sterilization, and product safety standard compliance. Accuracy metrics such as Target Registration Error (1.36 mm mean) and Trajectory Angle Error (1.35 degrees mean) were within acceptable limits. No clinical trial was required due to equivalence with predicate devices.
No predicate devices specified
Submission
10/18/2019
FDA Approval
11/27/2019
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