KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612)

The KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) is a sterile single-use flexible video endoscope intended for physicians to perform endotracheal intubation and diagnostic/therapeutic bronchoscopy procedures. It provides visualization via a video monitor and includes an E-Box adaptor for operating on compatible camera control units.

The subject device has a maximal outer diameter of 6.2 mm (versus 5.3 mm predicate), insertion tube diameter of 6.5 mm, working channel inner diameter of 3.0 mm (versus 2.2 mm predicate), and tip deflection of 180°/140° (versus 180°/180° predicate). Both devices use CMOS imaging sensors distally, LED illumination, and are compatible with C-MAC, Image1 S, and Tele Pack CCUs. Resolution, field of view, and sterilization methods are identical.

The device follows FDA-recognized consensus standards including IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18 (electrical safety and EMC), IEC 62471, ISO 10993 (biocompatibility), and ISO 8600. Additional bench testing verified design specifications.

The subject device is substantially equivalent to the predicate (K212656) because non-clinical bench testing demonstrates it performs as well as the predicate with only minor dimensional and deflection parameter variations. Both devices share the same fundamental design, imaging technology, sterilization method, and intended use, with the modifications being well-characterized and not introducing new risks or altering the basic function.