A predicate device can be any of any of the following, but most commonly,
- A device substantial equivalence claimed through the 510(k) route.
- Marketed before May 28, 1976, legally
- Class III to Class II or I devices
- Granted marketing authorization via the De Novo.
510k applicants must identify differences and highlight them in the comparison table which can be used to provide a scientific or clinical justification for why these differences do not raise new questions of safety or performance. While ensuring that your device matches the predicate in the important features with a predicate, it’s also important to maintain a balance that allows for differentiation and state-of-the-art. Using good judgment is crucial to demonstrate equivalence without sacrificing the uniqueness of the device in the 510k submission.
Criteria should be used for choosing a predicate device
The predicate and new device should have a common Product Code. Database List of legally marketed devices Look for the same Intended Use. Valid Predicate device(s) will either have the same technological characteristics or no significant change in the materials, design, energy source, or other features of the device or different technological characteristics. Predicate chosen after considering Best Practice Principles
Predicate devices cleared using well-established methods
FDA advises manufacturers to choose a valid predicate device that was cleared using well-established methods. Specifically, these methods include current FDA-recognized voluntary consensus standards, guidance documents, qualified medical device development tools, widely available or accepted methods published in the public domain or scientific literature to support the context of use, and methods deemed acceptable through the submitter’s previous premarket submission.
When a manufacturer is choosing between two valid predicate devices, one that complies with current FDA consensus standards and the other that does not, it is expected that the predicate device that adheres to current guidance and/or standards should be selected
Predicate devices that meet or exceed expected safety and performance
The 510k applicant must choose a valid predicate device that continues to perform as intended and safely during use. This can be determined by using the MAUDE Database, Medical Device Reporting (MDR) Database, and Medical Product Safety Network (MedSun) Database to search for any reports of unexpected malfunctions, injuries, or deaths associated with any of the valid predicate devices.
Unmitigated use-related or design-related safety issues with predicate
The next best practice based on the FDA guidance is to choose a valid predicate device that does not have unmitigated design-related or use-related safety issues, including safety communications or emerging signals. The FDA defines emerging signals as new information that suggests a causal association between an adverse event and a device that has the potential to change the device’s benefit-risk profile.
Manufacturers can determine potential safety issues by using CDRH’s Medical Device Safety website and CBER’s Safety & Availability (Biologics) portal to find out if there are design-related or use-related safety issues with any of the valid predicate devices.
Predicate devices without an associated design-related recall
The last best practice that the FDA recommends is to choose a valid predicate device that has not had a design-related recall. Although recalls can be for several reasons, including labelling or manufacturing defects, design-related recalls can indicate a fundamental issue with the design of the potential predicate device.
By following these steps and best practices as defined in the FDA guidance, manufacturers can improve their processes when selecting a predicate device and achieve the objective of a more transparent and consistent 510(k) premarket review process.
Predicate devices cleared using well-established methods:
- Well-established methods include,
- FDA recognized voluntary consensus standard.
- FDA guidance document,
- Qualified medical device development tool (MDDT),
- Accepted method published in the public domain or
- Scientific literature for the context of use.
Predicate devices meeting safety and performance:
- Search the following databases for any reports of unexpected injury, deaths, or malfunctions associated with the predicate devices.
- Manufacturer and User Facility Device Experience (MAUDE) Database.
- Medical Device Reporting (MDR) Database.
- MedSun Reports Database
Conclusion
If you are unable to find a suitable predicate statement, it can be included in the 510(k) summary. If you are a manufacturer or specification developer seeking approval for a new medical device, you will need to submit a 510(k) application to the FDA. Working with FDA 510(k) consultants like I3CGLOBAL helps manufacturers prepare and respond to FDA queries more efficiently and effectively, ultimately speeding up the 510(k)-approval process and bringing their medical devices to market faster.
The I3CGLOBAL 510k Consultants specializes in assisting medical device manufacturers and specification developers in efficiently preparing and submitting their 510(k) files to the FDA, reducing the likelihood of receiving an initial “Refuse to Accept” (RTA) decision.
By London Reads
