KARL STORZ Mediastinoscopes and Instruments

The KARL STORZ Mediastinoscopes and Instruments are surgical devices intended to aid surgeons in viewing the mediastinum and facilitate introduction and removal of surgical instruments during endoscopic procedures in adults and pediatric patients ≥12 years of age. The instruments are also used for lymph node biopsy, removal of lymphatic nodes and tumors, and grasping and dissecting tissue for diagnosis and treatment of pleural, parenchymal, and mediastinal disease.

The subject mediastinoscopes (10970A, 10970B) are non-powered, reusable surgical instruments with a beveled oval insertion shaft (22mm width, 17mm height) and working channel for two 5mm instruments. The HD Mediastinoscope (10973HD) is identical in design, materials, and dimensions to the predicate K213194, with only an expansion of the indicated patient population to include adolescents ≥12 years. Associated instruments include forceps and sheaths with similar technological features to predicate devices, with minor dimensional variations.

Risk (ISO 14971:2019), Software (IEC 62304 for 10973HD), Usability (IEC 62366-1:2015), Biocompatibility (ISO 10993 series), Electrical Safety and EMC (IEC 60601 series for 10973HD), Endoscope optics (ISO 8600-1 for 10973HD), Photobiological safety (IEC 62471:2006), and Reprocessing (AAMI and ISO standards for cleaning and sterilization).

The HD Mediastinoscope (10973HD) is identical to the predicate K213194 in design, materials, dimensions, optical characteristics, and illumination performance, with only a patient population expansion to include adolescents ≥12 years. The mediastinoscopes and instruments have similar technological and physical characteristics to predicates K954910 and K971166 with only minor dimensional variations. Comparative bench testing demonstrated that all design specifications were met and the subject devices are substantially equivalent to the predicate devices.