Submitted by kBLASTER Team on
Draft Guidance published by FDA on December 27, 2011. This guidance document is being distributed for comment purposes only. This guidance introduced the concept of primary predicate usage and excerpts from guidance document related to primary predicates are shown below:
...Section 513(i) of the FD&C Act states 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 (primary) predicate device and the same technological characteristics or different technological characteristics that do not raise different questions of safety and effectiveness than the (primary) predicate device. Thus, 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 (primary) predicate device identified by the manufacturer. FDA may use one or more additional devices proposed by the manufacturer in certain instances to help support substantial equivalence, as described below.
...In certain circumstances, where appropriate, a manufacturer may refer to legally marketed devices that have a different intended use or different technological characteristics that raise different questions of safety and effectiveness, to address specific scientific questions for a new device. If a manufacturer successfully navigates through Decision Point 4 on the Flowchart using a primary predicate device, other legally marketed devices, which FDA calls "reference devices," may be used to address certain performance characteristics of the new device. If a manufacturer intends to use a reference device, the manufacturer should provide a scientific rationale that justifies its use. A reference device is not considered to be a predicate device. This concept is illustrated in the Reference Device Scenario below. We recommend that you read this Scenario side-by-side with the Flowchart in Appendix A so that you can follow the decision-making process.
...Although manufacturers may cite more than one predicate device in a 510(k), FDA recommends that the manufacturer identify the primary predicate device to which a substantial equivalence claim is being made.20Further, 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 predicate for their new device. This information also should be accurately cited in the 510(k) Summary (see Appendix B).
This guidance also introduced the concept of reference device usage for technological predicates and excerpts from this guidance document related to reference device are shown below:
...In certain circumstances, where appropriate, a manufacturer may refer to legally marketed devices that have a different intended use or different technological characteristics that raise different questions of safety and effectiveness, to address specific scientific questions for a new device. If a manufacturer successfully navigates through Decision Point 4 on the Flowchart using a primary predicate device, other legally marketed devices, which FDA calls "reference devices," may be used to address certain performance characteristics of the new device. If a manufacturer intends to use a reference device, the manufacturer should provide a scientific rationale that justifies its use. A reference device is not considered to be a predicate device. This concept is illustrated in the Reference Device Scenario below. We recommend that you read this Scenario side-by-side with the Flowchart in Appendix A so that you can follow the decision-making process.
Reference Device Scenario: In this scenario, the scientific methods used to evaluate a legally marketed device with an intended use that differs from that of the new device are used to support the evaluation of certain characteristics of the new device. This scenario is very complicated; accordingly, FDA will need to rely on its scientific and regulatory expertise to determine when this scenario may be applied. Nevertheless, FDA believes that, in select cases, it is appropriate to use reference devices to support an SE determination.
Illustrative Example: A manufacturer submits a 510(k) for a total knee implant with coating X (the new device). Other coated knee implants with the same intended use with coatings A, B, and C are legally marketed. In addition, a total hip implant with coating X is legally marketed. The manufacturer cites the legally marketed knee implant with coating A as the predicate device. FDA determines that the new device has an appropriate predicate device (thus, answering "yes" at Decision Point 1) and the new device has the same intended use as the predicate device (thus, answering "yes" at Decision Point 2 in the Flowchart).18 However, FDA determines that the new device does not have the same technological characteristics as the predicate device (thus, answering "no" at Decision Point 3 in the Flowchart), because the new device (knee implant with coating X) has a chemical profile different from the chemical profile of the cited predicate device (knee implant with coating A). There are no other technological differences between the new device and the cited predicate device (knee implant with coating A). FDA determines that the new device does not raise different questions of safety and effectiveness. In this case, FDA determines that the safety and effectiveness questions regarding the coating material are whether it is biocompatible and whether it impacts the fixation of the implant and these questions apply to both the new device and predicate device (thus, answering "no" at Decision Point 4 in the Flowchart).
After Decision Point 4 in the Flowchart, if appropriate, the manufacturer may refer to the reference device (the hip implant with coating X in this situation) to support the appropriate scientific methods for the characterization of coating X on the new knee implant device. In this particular example, the manufacturer provided an adequate scientific rationale to support that the methods used to characterize the biocompatibility and characteristics of the coating (e.g., strength, abrasion, etc.) on the hip implant are applicable to the knee implant.19 The reference device (hip implant with coating X) is used in this case solely to assist with the characterization of the coating on the new device (knee implant with coating X).
3. Identification and Documentation of the Predicate(s)
Although manufacturers may cite more than one predicate device in a 510(k), FDA recommends that the manufacturer identify the primary predicate device to which a substantial equivalence claim is being made.20Further, 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 predicate for their new device. This information also should be accurately cited in the 510(k) Summary (see Appendix B).