It is first important to identify the predicate device and its trade name, model number, 510(k) submitter, and 510(k) number. Additionally, the sponsor must provide a detailed comparison between the two devices in terms of:
- Indications for use
- Performance specifications, including any testing
Within the executive summary, it is also necessary to describe both the device in question and the predicate device in appropriate detail. Typically, a table is used to summarize and compare various characteristics of the two devices in appearance and functionality.