Stealth AXiS Cranial clinical application

The Stealth AXiS Cranial clinical application is surgical navigation software that guides surgeons during open, minimally invasive, and percutaneous neurosurgical procedures by precisely positioning surgical instruments and helping locate anatomical structures relative to patient imaging. It supports cranial procedures including tumor resections, ventricular catheter placement, depth electrode placement, and biopsies by displaying real-time instrument position and trajectory on diagnostic or intraoperative images.

The system demonstrates 3D positional accuracy with mean error ≤2.0 mm and trajectory angle accuracy with mean error ≤2.0 degrees. It supports multiple imaging modalities (X-Ray, MR, Nuclear Medicine) and includes features such as ultrasound overlay, 3D/2D visualization, trajectory guidance, multiple patient registration methods (trace, touch, O-arm), planning tools including model building and tractography with enhanced CSD techniques, and compatibility with various stereotactic frames and microscope/ultrasound systems via optical and electromagnetic tracking technologies.

Not stated in this summary. The document references ISO 13485 (Design controls, Nonconforming product, Corrective and preventative action) and ISO 13484 in the regulatory requirements section, but no specific consensus standards were cited for device testing or performance validation.

The Stealth AXiS Cranial application is substantially equivalent to the StealthStation S8 Cranial Software predicate (K212397) because both devices have identical intended use, indications for use, system accuracy requirements (≤2.0 mm positional error, ≤2.0 degree trajectory error), imaging modalities, and substantially overlapping technological features including visualization, registration, and planning capabilities. Software verification and validation testing and summative usability validation confirmed the subject device performs as intended for the same use environment.