AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)

The AURORA Surgiscope System is a neurological endoscope consisting of a sterile, single-use sheath with integrated illumination LEDs and camera, plus a reusable control unit (Image Control Box). It is intended for neurosurgical visualization and therapeutic procedures including ventriculostomies, biopsies, and removal of cysts, tumors, and obstructions.

The subject device and predicate device (K201840) have identical technological characteristics. The only difference is a modification to the obturator handle design, which adds two bridge features over the post channel to improve the strength of the connection between the handle and post.

Not stated in this summary.

The device is substantially equivalent because it has the same intended use, indications for use, and technological characteristics as the predicate device K201840. The sole design modification to the obturator handle (addition of bridge features for structural strength) is a minor enhancement that does not alter the fundamental function or safety profile. Non-clinical testing confirmed the device meets functional requirements following sterilization and environmental conditioning, supporting equivalence to the predicate.