The Traditional 510k is one of the three types of the 510k in the US FDA. This type of 510k can be used for any circumstances and any kind of medical device for which the premarket notification is applicable for marketing in the USA. Traditional 510k should contain explanations on the intended use, technological characteristics, reports on the performance tests, and demonstration of the substantial equivalence with the predicate device.
The contents of the Traditional 510k contain some common sections. These sections include some forms from the FDA such as FDA 3601, FDA 3514, FDA 3881. Apart from these the contents include the indication of use, 510 k summary, Declaration of Conformity, Device description, Executive summary, Substantial equivalence, Labelling, Biocompatibility testing protocol and reports, sterilization details, Electric Safety reports, Performance Testing protocol and reports.
Are all the above sections to be on the sequence and what if one of the sections is not applicable?
What is a 510k summary generally contain?