The main requirements to be fulfilled in a 510(k) submission can be divide into:
- Identifying the product code and regulation number: Product code is a unique code that matches the actual product name and/or the description of the device given in the invoice. It is used to identify a specific product and normally is combination of 3 letters. Each product code is placed into a generic category based on the classification regulation. The method to identify and classify the device is provided in the regulation.
- Classification of proposed device: Medical devices are classified into Class I, II or III depending on the regulation number and product code associated with it to guarantee its safety and effectiveness.
- Identifying suitable predicate device: A medical device which is legally marketed in the US and can be used as a point of comparison to prove the performance and safety of the proposed medical device that is seeking FDA clearance is known as a predicate device.
- Establishing substantial equivalence: The successful 510(k) submission depends on proving substantial equivalence of the proposed device with respect to a predicate device. Substantial equivalence is used to establish the safety and effectiveness of a new device by comparing it to a predicate device. The product details of predicate device, if proven to be substantially equivalent, can be used to demonstrate that the medical device seeking clearance is as safe and effective as the predicate device.
- Performance testing: The performance tests as suggested in the FDA guidance (if available) and mentioned in the predicate device should be performed and the acceptance criteria should be met to ensure the effectiveness of the proposed device.
- Biocompatibility testing: The biocompatibility tests should be planned if the proposed device comes into direct or indirect contact with human tissue. The biocompatibility tests are conducted as described in the FDA guidance, Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part-1: Evaluation and Testing and according to ISO 10993-1:2018, Biological Evaluation of Medical Devices – Part 1, Evaluation and Testing within a Risk Management Process. The device should be proved to be biocompatible to human tissue.
- Regulatory documents: All documents must be prepared in accordance with the FDA requirements. Any additional details that are to be submitted can be included as annex. Please refer https://www.fda.gov/media/130647/download for the format 510(k).