The following steps can be taken to determine whether or not a new 510(k) is necessary for your device:
Is it a change in material type, material formulation, chemical composition, or the material’s processing?
The biocompatibility and physical properties of a finished device depend not only on the materials, but also on the processing of the materials, manufacturing methods (including the sterilization process), and the manufacturing residuals that may be present on the finished device. Changes of this type should be further evaluated for their potential impact on safety and effectiveness. Many material changes result from material supplier changes, including changes made by a material supplier, or changes from one supplier to another. When these types of changes occur, the manufacturer should utilize their quality system process to analyze the material and determine the extent of the change made, as this analysis might impact answers to subsequent questions, even when these changes result in materials that remain within the original material specifications.
Will the changed material directly or indirectly contact body tissues or fluids?
Both direct and indirect patient and user contact should be considered in answering this question. Direct contact is when a material comes into physical contact with a patient or user while the material is still in or on the patient or user. A material with indirect contact is a material through which a fluid or gas passes, prior to the fluid or gas coming into physical contact with body tissue (i.e., the device or device component itself does not physically contact body tissue).
Does a risk assessment identify any new or increased biocompatibility concerns?
Manufacturers should conduct a biocompatibility risk assessment, which may include an assessment of the device’s toxicological and physical properties, of any changed materials that may contact the patient or user to determine if there are any new or increased biocompatibility concerns. A supporting toxicological assessment can be based on an analysis of the chemical formulations or the results of chemical characterization tests if the detailed formulation is not available. If, however, this analysis identifies new chemical entities or other properties that are either novel or have the potential to generate adverse biocompatibility responses, such as genotoxicity, submission of a new 510(k)may be required.
Has the manufacturer used the same material in a similar legally marketed device?
Manufacturers who have identified possible biocompatibility concerns in their risk assessment should consider whether they have used the same material, in its final, finished state, in another one of its own legally marketed devices that has been cleared or approved by the FDA. If the manufacturer has used the same material in a similar device that has been cleared or approved by the FDA and there is no postmarket evidence of biocompatibility issues with the device, that may provide evidence that the material will be biocompatible in its new application in the changed device as well. The material in question should have the same formulation or chemical composition and be subjected to the same processing, including sterilization. Note that the size and geometry of the changed device or component could affect the material properties. Any change in chemical composition, manufacturing process, physical configuration (e.g. size, geometry, surface properties) or intended use of the device should be evaluated with respect to possible changes in biocompatibility and the need for additional biocompatibility assessment. Manufacturers should not compare their changed material to materials in other manufacturers’ legally marketed devices, unless the exact formulation and processing of the device, which may affect the safety and effectiveness of the final finished product, can be verified.
Could the change affect the device’s performance specifications?
Manufacturers should consider whether the material change could affect the performance of the device by affecting its mechanical properties, such as strength, hardness, etc. Manufacturers should also consider whether the new material could be affected by any labeled cleaning, disinfection, and/or sterilization process of the device. If the change could not affect the device’s performance specifications, it is unlikely the change could significantly affect safety or effectiveness, and the manufacturer should document the change.