Submitted by kBLASTER Team on
Final guidance was published by FDA on July 28, 2014 titled The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notification [510(k)]. This guidance recommends the identification of a single primary predicate in all 510(k) submissions and has ruled that the use of "split predicates as inconsistent with the 510(k) regulatory standard". Multiple predicates are still allowed, but each predicate used must have identical intended use if multiple predicate approach is utilized. The following excerpts were taken from this final guidance which further clarify the need to specify a single primary predicate in all 510(k) submissions, as well as commentary on multiple predicate usage and split predicates being inconsistent with 510(k) standard:
..."FDA encourages manufacturers to identify a single predicate device to simplify and facilitate the decision-making process. When a manufacturer does identify multiple predicates, the primary predicate refers to the one with indications for use and technological characteristics most similar to the device under review. Although using a single predicate is optimal, when multiple predicates are appropriate (as described in the examples below), FDA recommends identifying a primary predicate in the submission to facilitate a timely, well-supported decision."
..."Section 513(i) of the FD&C Act and 21 CFR 807.100(b) state that, for a new device to be considered substantially equivalent to a predicate device, the new device must have the same intended use as the predicate device and the same technological characteristics or different technological characteristics that do not raise different questions of safety and effectiveness than the predicate device. Therefore, the use of a “split predicate” is inconsistent with the 510(k) regulatory standard. “Split predicate” refers to a situation in which a manufacturer is attempting to “split” the 510(k) decision making process by demonstrating that a new device has the same intended use as one marketed device while comparing the new device’s technological characteristics with a second marketed device that has a different intended use. As a general matter, to find a device substantially equivalent, FDA must be able to address Decision Points 1 through 4 in the Flowchart using one predicate device identified by the manufacturer."
..."Although manufacturers may cite more than one predicate device in a 510(k), FDA recommends that the manufacturer clearly identify the primary predicate device to which substantial equivalence is being claimed.19 Further, as part of the decision-making process, FDA should clearly cite the predicate device relied upon in determining substantial equivalence for the new device in its review documentation. If multiple predicates or reference devices are used in accordance with this guidance, the manufacturer should identify each device and explain why more than one predicate or a reference device is necessary and appropriate to support substantial equivalence. Manufacturers should choose the most appropriate single or primary predicate for their new device, and should limit the multiple predicates to those most helpful in facilitating review of the new device and to the minimum number necessary to support substantial equivalence. Predicate device(s) relied upon for SE must be accurately cited in the 510(k) Summary (see Appendix B) according to 21 CFR 807.92 (a)(3).
..."Appendix D. Glossary of significant terminology. The following terms are defined for purposes of this guidance: