Stealth AXiS™ ENT clinical application

The Stealth AXiS ENT Clinical Application is surgical navigation software that guides surgeons during ear, nose, and throat (ENT) procedures by tracking surgical instrument position and displaying it on preoperative or intraoperative medical images. It is intended for functional endoscopic sinus surgery (FESS), endoscopic skull base procedures, and lateral skull base procedures where stereotactic navigation is appropriate.

The device maintains identical core features to the predicate: 3D positional accuracy within 2.0 mm mean error and trajectory angle accuracy within 2.0 degrees; support for X-ray, MR, and nuclear medicine imaging; 3D/2D anatomic display with orthogonal views; trace and touch patient registration; and network connectivity with DICOM import/export. One feature (PointMerge registration) was removed from the predicate version.

The document cites ISO 13485 for quality management system requirements (design controls, nonconforming product, corrective and preventative actions) but does not reference specific consensus standards for device performance testing.

The subject device is substantially equivalent because it shares the same intended use, indications for use, product code (PGW), and regulatory classification (Class II, 21 CFR 882.4560) as the predicate StealthStation S8 ENT Software v1.3. All core navigation, imaging, planning, and display features are identical or equivalent; the addition of minimally invasive procedures reflects current clinical practice without changing the fundamental application, and removal of one registration feature does not impact device function or safety.