Orthoscan TAU MVP Mini C-Arm System

The Orthoscan TAU MVP Mini C-Arm System is a mobile fluoroscopic imaging device that provides real-time visualization during diagnostic, surgical, and emergency procedures on patients of all ages. It combines fluoroscopic X-ray imaging with arthroscopic imaging capability to visualize extremities, limbs, shoulders, and joints in hospitals, ambulatory surgery centers, and physician offices.

The device integrates the Orthoscan TAU Mini C-Arm fluoroscopic system with hardware and software from the MIDASVu arthroscopic imaging system, including a video processing unit, imaging control board, and sterile single-use scopes with LED illumination in three lengths (60mm, 90mm, 120mm). Key unchanged elements include identical C-arm mechanics, workstation platform, monitor display, touch screen interface, DICOM connectivity, and image acquisition and storage capabilities.

The device was tested and certified compliant with IEC 60601-1 ED 3.2 series standards, including IEC 60601-2-54 and IEC 60601-2-28 for electrical safety and electromagnetic compatibility. All applicable sections of 21 CFR Subchapter J performance standards were met. Human factors validation followed IEC 62366-1 and FDA guidance, and image latency testing used industry-standard scientific literature criteria.

The proposed device is substantially equivalent because it does not change the control mechanism, operating principle, energy type, or intended use of the predicate devices (Orthoscan TAU Mini C-Arm K250587 and MIDASVu K243020). Testing demonstrated equivalent or superior arthroscopic image quality, safe dual-mode operation without introducing unacceptable risk, and adequate hazard mitigation through design, labeling, and training.