Split predicate

FDA does not accept this approach, because neither device alone shows that the new device is as safe and effective. Multiple predicates are possible in some cases, but each comparison still has to meet the full substantial equivalence standard.

Using one legally marketed device for intended use and a different legally marketed device for technological characteristics to demonstrate substantial equivalence. The use of a “split predicate” is inconsistent with the 510(k) regulatory standard.

FDA guidance: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] (July 2014), Appendix D, Glossary of Significant Terminology