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.
State whether the materials are identical to the pre-amendment or predicate device. If the materials are not identical, biocompatability test data must be provided. Identify the voluntary standards with which the device materials will conform. Labeling for devices provided non-sterile, package inserts must be supplied that include the recommended sterilization process parameters. For steam, include the cycle, temperature, and exposure time.