Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT

The Alignment System Cranial is an image-guided surgery system that uses optical tracking technology to help surgeons plan and achieve precise instrument trajectories during cranial stereotactic procedures. It is intended for biopsy of intracranial lesions, placement of stereoelectroencephalography (SEEG) electrodes, and placement of anchor bolts for laser interstitial thermal therapy (LITT).

The device uses infrared tracking cameras to recognize passive markers on instruments and track their position relative to patient anatomy, displayed on pre- or intraoperative images. It supports both active positioning devices (Surgical Base System and Cirq Arm System) and passive positioning device (VarioGuide), achieving mean navigation accuracy of ±2 mm positional error and ±2° angular displacement. The software includes automatic registration with AI/ML-based landmark detection and runs on IGS platforms (Curve, Curve Navigation 17700, Kick 2, or Buzz Navigation).

IEC 62366-1 (usability engineering), IEC 60601-1 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility), ISO 10993-1 (biocompatibility), and FDA guidance on software verification and validation, device reprocessing, and medical device reporting.

The subject device demonstrates equivalent intended use and technological characteristics to both predicates: it employs the same optical tracking localization technique and achieves identical system accuracy (±2 mm, ±2°). The biopsy and SEEG indications are covered by both predicates; LITT is covered by the primary predicate K191597. Usability testing confirmed the LITT workflow is comparable to existing biopsy/SEEG workflows. The instrumentation supports the same three indications with similar mechanical fixation methods, and performance testing confirms equivalent accuracy specifications, making the device substantially equivalent despite the new LITT indication and new platform model.