DUTAU-NOVATECH®

The DUTAU-NOVATECH® is a rigid bronchoscope consisting of a bronchoscope head with replaceable, dismantlable tubes made of medical-grade stainless steel. It is inserted into the trachea and bronchi to allow visualization and insertion of diagnostic and treatment instruments during ENT endoscopic procedures in patients over 5 years of age. The device is supplied unsterile and must be cleaned, disinfected, and sterilized before use.

Both the DUTAU-NOVATECH® and predicate device use identical operating principles and basic design. The proposed device has bronchial and tracheal tubes with lengths of 25 or 35 cm and diameters of 8.5–14 mm (inner and outer), compared to the predicate's 20–43 cm lengths and 3.5–13.6 mm diameters. Both feature manually operable stainless steel construction, identical materials (surgical-grade stainless steel with silicone caps), identical sterilization methods (steam reprocessing), and equivalent components including bronchoscope heads, ventilation elements, lateral ports, and injection cannulas.

ISO 10993-1 (biocompatibility), ISO 18562 (biocompatibility for gas pathways), ISO 5356-1 (connector tension and disconnect testing), ASTM F899 and EN 10088 (surgical instrument steel specifications), ISO 14937:2010 and ISO 17665-1:2006 (sterilization validation). Additional internal protocol tests included assembling, compression, tensile, connection stability, torque, atraumaticity, and leakage testing.

The DUTAU-NOVATECH® is substantially equivalent because it shares the identical intended use (rigid bronchoscopy in trachea and bronchi for ENT procedures), the same regulatory classification (Class II, product code EOQ), and fundamentally the same design and operating principle as the predicate Karl Storz device. Both devices are made of identical materials, feature equivalent component designs and dimensions within comparable ranges, and employ identical sterilization and reprocessing methods. Biocompatibility testing and mechanical performance testing (connector stability, compression, tension, torque) demonstrate safety and functionality equivalent to the predicate device.