Arthrex NanoScope System

The Arthrex NanoScope System is an endoscopic video camera that provides real-time visible light imaging for diagnostic and surgical procedures including laparoscopy, orthopedic, plastic, sinus, spine, and urological surgery. It can also be used as an accessory for microscopic surgery, with specific pediatric indications for laparoscopy and orthopedic procedures.

The system integrates high-definition camera technology, LED lighting, and an imaging management system into a single console with touchscreen interface. It includes a non-sterile reusable camera control unit (CCU) and sterile disposable camera handpieces. The device shares the same principle of operation, accessories, system components, basic software design, cleaning/reprocessing requirements, wireless technology, electrical/thermal safety, and electromagnetic compatibility as the predicate devices.

ISO 10993 series (biocompatibility parts 1, 5, 10, 11, 12, 17, 23, and 7); IEC 60601 series (medical electrical equipment parts 1, 2-18, 1-6, 1-2); ANSI/AAMI ES60601-1; IEC 62304 (medical device software lifecycle); ISO 11737-1 (sterilization microbiological methods); IEC TR 60601-4-2 (electromagnetic immunity guidance).

The Arthrex NanoScope System has the same intended use and substantially similar indications for use as the predicate devices (K201134 and K210088). Non-clinical bench testing including biocompatibility, design verification, EMT/EMC safety, and software testing demonstrated the subject device meets product requirements comparable to predicates. No animal or clinical testing was needed because the technological characteristics are the same or similar, and all verification testing confirmed safety and effectiveness equivalent to legally marketed predicates.