SIRIUS Endoscope System (PR-SI-1230)

The SIRIUS Endoscope System is a robotic 3D laparoscopic camera with an articulated tip for minimally invasive endoscopic surgery. It features a 10mm diameter insertion section with 342mm working length, stereo 1080p HD resolution, and flexible tip capable of C and S-shaped bending with ±90° up-down and ±45° left-right articulation. It is intended for endoscopy and endoscopic surgery within thoracic and abdominal cavities including female reproductive organs, but is not suitable for cardiac procedures.

The subject device shares identical operating principles, anatomical access routes, shaft diameter (10mm), tip articulation angles, camera resolution (1920×1080), optics type, single-use design, EO sterilization, and biocompatibility standards with the predicate. Minor differences include a 2mm longer working length (342mm vs 340mm), a customized joystick (vs off-the-shelf), and a new locking mechanism for the laparoscope handle. These mechanical and electronic differences were verified by electrical safety, EMC, and usability testing to have no impact on effectiveness or safety.

ISO 10993 series (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogen); ISO 11135:2014 (EO sterilization validation); ISO 10993-7:2008 (residual gas limits); IEC 60601-1, IEC 60601-2-18, IEC 60601-1-2 (electrical safety and EMC); IEC 62471:2006 (light source safety); ISO 8600 series (endoscope performance and field of view); ANSI AAMI IEC 62366-1:2015+AMD1:2020 (usability engineering).

The subject device (PR-SI-1230) and predicate device (K221642) share identical intended use, manufacturing principles, and core technical specifications. The minor differences—working length tolerance, joystick customization, and addition of a locking mechanism—were validated through bench testing, electrical safety/EMC testing, and usability engineering to produce equivalent performance without affecting safety or effectiveness. Because the devices are from the same manufacturer with the same design approach and the differences do not alter the fundamental function, risk profile, or clinical performance, substantial equivalence is established.