The 510(k) premarket notification program is primarily intended for medical devices that are “substantially equivalent” to other medical devices that have previously received market clearance from the FDA. In this context, substantial equivalence refers to factors such as a device’s design, construction, use indications, safety performance, effectiveness and any other applicable characteristics. Accordingly, the scope and depth of information provided with a 510(k) submission must be sufficient to allow FDA reviewers to determine whether the subject medical device is substantially equivalent to an identified predicate device.
Here is a brief summary of the specific information required by the FDA in connection with all 510(k) submissions:
Device description – A 510(k) submission must include a description of the medical device, including all models and accessories or components, as well as device performance specifications. In addition, it is advisable to include information on the materials used in all device components that come in direct contact with patients
Substantial equivalence—The FDA evaluation of 510(k) submissions is based on whether a given medical device is substantially equivalent to a device that has previously received market clearance from the FDA. To facilitate this evaluation, device manufacturers must specifically identify a predicate device (or devices) whose use indications, technological characteristics, and performance are comparable to the device being submitted for review. In cases where a medical device and predicate device differ from each other, a manufacturer must submit data or other rationale that clearly demonstrates that the differences do not affect the intended use or raise new or different questions regarding a device’s safety and effectiveness.[i]
Sterilization and shelf life—For all medical devices labeled as sterile, manufacturers must provide verification and validation data on a device’s sterilization and shelf life. Specific information should include the method of sterilization used (that is, dry heat, moist heat, ethylene oxide (EO), or radiation), and a description of the packaging used to maintain sterility of a device.[ii]
Biocompatibility—Manufacturers of medical devices that come either in direct or indirect contact with patients must submit testing data regarding the biocompatibility of any patient-contacting materials. The exception to this requirement is when the identified predicate device uses identical materials produced using the same manufacturing, processing, packaging, and (if applicable) sterilization methods.
Software—510(k) submissions for medical devices containing or utilizing software must include software documentation, including information on the role of software in causing, controlling and/or mitigating hazards that could result in injury to either a patient or a device operator. The extent of documentation to be provided depends on a manufacturer’s estimate of a device’s “level of concern,” that is, the potential severity of injury that could occur as a result of device failures, design flaws or other causes.[iii]
EMC and electrical safety—For medical devices incorporating electronic components, manufacturers should submit test data providing evidence of compliance with applicable electromagnetic compatibility (EMC) and electrical safety standards.
Performance testing—Performance testing data is required to support a manufacturer’s claim of substantial equivalence with a predicate device. The extent of performance data required in connection with a 510(k) submission depends on the complexity of the device, as well as its intended use. Performance data can be based on a variety of types of testing, including bench testing, animal testing, clinical studies and clinical trials, but should be conducted on all device sizes and models in a manner consistent with actual use. As an alternative to testing, manufacturers can submit previously published data for a predicate device to demonstrate substantial equivalence.
Proposed labeling—A 510(k) submission must include labeling information, including final draft copies of all proposed labels, labeling, user instructions and service manuals, as well as copies of proposed promotional materials and/or advertising. Manufacturers are also encouraged to submit copies of labeling used in conjunction with an identified predicate device.