MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)

The MiiS Horus Arthroscope is a sterile, single-use endoscopic device designed for diagnostic and operative arthroscopic procedures to visualize interior body cavities through surgical openings in adults. It operates with two reusable compatible display systems: a Tablet (EDS 500) or Video Box (EVS 700) that receive and display live images or video from the arthroscope.

The device shares a 120° field of view and 125 mm working length with the predicate. Key differences include a slightly larger outer diameter (2.2–3.4 mm vs. 1.9 mm) and a 30° direction-of-view option; depth of field ranges 3–50 mm versus 3×100 mm in the predicate. Resolution is 720×720 pixels versus 400×400, with >100 Lux illuminance versus 49 Lux. Both use EO sterilization and meet the same electrical safety and biocompatibility standards.

Testing per IEC/EN 60601-1 (electrical safety), IEC/EN 60601-1-2 (EMC), ISO 11135 (sterilization validation), ISO 11607-1 (package integrity), ASTM D4169 (transportation), ASTM F1980 (aging), ISO 10993 series (biocompatibility), ISO 8600 (endoscopic performance), and IEC 62471 (photobiological safety).

The MiiS Horus is substantially equivalent because it has the same intended use in arthroscopic diagnostics and procedures, shares key mechanical specifications and field of view with the Arthrex NanoScope predicate, passed identical testing protocols, and uses the same sterilization method. Minor differences in scope diameter and optional 30° viewing angle do not introduce new safety or effectiveness risks and remain within established arthroscope specifications.