Intended Use

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.

Technology

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.

Performance

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.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    10/18/2019

    1 month
  • 2

    FDA Approval

    11/27/2019

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