Provide the magnification, working length, inner and outer cannula diameters, field of view, and direction of view. See Figures 1 and 2 for the definition of field and direction of view. For rigid scopes with outer diameters less than 1.2 mm, provide a complete test report demonstrating its ability to withstand loading for each intended use without fracturing. For deflectable scopes, provide the angle of deflection and a description of the mechanism of deflection. Describe how the device interconnects with other systems, i.e., irrigation, video recording, and light transmission.
Accessories Provide a description of each accessory, including the length and diameter.
For multiple accessories, provide a table listing each accessory, its specific use and its material. Irrigation Systems Provide a complete description of the irrigation system, including control of intra-articular pressure and flow rate. Labeling must include the maximum intra-articular pressure for each joint. If reference is made to information from a previous document, provide the document number, volume, page number, and submission date. Materials Identify the materials in each device component.