Identification of predicate creep under the 510(k) process: A case study of a robotic surgical device

Abstract

The FDA's 510(k) process for medical devices is based on “substantial equivalence” to devices clearedpre-1976 or legally marketed thereafter, known as predicate devices. In the last decade, several high-profile device recalls have drawn attention to this regulatory clearance process and researchers have raised questions about the validity of the 510(k) process as a broad clearance mechanism. One of the issues raised is the risk of predicate creep, a cycle of technology change through repeated clearance of devices based on predicates with slightly different technological characteristics, such as materials and power sources, or have indications for different anatomical sites. This paper proposes a new way to identify potential “predicate creep” through the use of product codes and regulatory classifications. We test this method by applying it to a case study of a Robotic Assisted Surgery (RAS) device, the Intuitive Surgical Da Vinci Si Surgical System. We find that there is evidence of predicate creep using our method, and discuss implications of this method for research and policy.