Predicate Device
A predicate device is a term commonly used in the US FDA 510k clearance for medical devices. A predicate device refers to an existing medical device that is already legally marketed and has been 510K cleared by the U.S. Food and Drug Administration (FDA). When a manufacturer seeks 510k clearance for a medical device, they often compare it to a predicate device to demonstrate its safety and effectiveness. This comparison helps the FDA to determine substantial equivalence to the predicate device
In the 510(k) process, the FDA mandates that manufacturers must submit a premarket notification for medical devices, requiring at least 90 days for commercial distribution. The 510(k) is a marketing submission demonstrating a new device’s substantial equivalent to a predicate device, evaluated using statutory criteria and performance data
510(k) Modernization, the FDA is proposing draft guidance to modernize its 510(k) program for predicate devices, focusing on best practices and transparency. The goal is to make cleared devices equivalent to older predicate devices, especially those over ten years old, and encourage safer, more effective medical devices
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Choosing a predicate device for a 510(k) submission
FDA recommends that submitters include a narrative explaining their selection of the predicate device(s) used in support of the 510(k) submission in their draft 510(k) Summary submitted with their original 510(k). Most submitters likely start with basic administrative information to identify valid predicate device(s), including but not limited to the
- Trade names of similar devices.
- Manufacturer(s) of similar devices.
- 510(k) numbers for similar devices.
- Searching of classification information (e.g., product codes, classification regulation) for similar devices.
FDA recommends reviewing 510(k) Summary and Indications for Use documents for legally marketed devices and applying best practices when selecting a predicate device for 510(k) submission.
Predicate Devices with Established Methods
Choose predicate devices that have been cleared using well-established methods, including FDA-recognized voluntary consensus standards, guidance documents, qualified medical device development tools, or widely accepted public domain or scientific literature references
Prioritize Safety and Performance
Select predicate devices that meet or exceed expected safety and performance standards. Take into account any reported adverse events, malfunctions, or deaths related to the predicate device
Mitigate Safety Issues
Ensure that the chosen predicate devices do not have unaddressed use-related or design-related safety concerns. The FDA wants to ensure there are no emerging safety signals or communications associated with the predicate device
Avoid Design-Related Recalls
Predicate devices should not have a history of design-related recalls, indicating potential issues in their design or functionality.
Working with FDA 510k consultants like I3CGLOBAL helps manufacturers prepare and respond to FDA queries more efficiently and effectively, ultimately speeding up the 510k approval process and bringing their medical devices to market faster.
Choosing a predicate device for a 510(k) submission
The 510(k) Summary is a document that provides an adequate summary of any information respecting safety and effectiveness and must include all the elements identified in 21 CFR 807.92. A 510(k) Summary must be in sufficient detail to provide an understanding of the basis for determining substantial equivalence
FDA recommends that submitters include a narrative explaining their selection of the predicate device(s) used in support of the 510(k) submission in their draft 510(k) Summary submitted with their original 510(k)
When a submitter cannot identify a valid predicate device(s) that is consistent with any of the best practices discussed in this guidance, FDA recommends that the submitter include a statement in their 510(k) Summary that a valid predicate that is consistent with the best practices was not available. FDA recommends that the submitter also use the Performance Data Section of the 510(k) Summary to describe how performance testing was conducted to address any known safety or effectiveness concerns with the predicate device used to support the 510(k) submission
Example;
A submitter is preparing a 510(k) submission for a coronary guidewire, Guidewire X. The submitter identified four valid predicate devices, all of which have the same intended use as Guidewire X and any differences in technological characteristics do not raise different questions of safety and effectiveness. The submitter included the following table in their 510(k) submission, along with their rationale for selecting Predicate 4 as the predicate device used to support their 510(k) submission
With this guidance, the FDA intends that the 510(k) premarket review process improve predictability, consistency, and transparency
Frequently Asked Questions
Predicate Devices without an associated design related recall
FDA recommends selecting a valid predicate device that has not been subject to a design-related recall. It is important to search in the Medical Device Recalls Database to assess whether any of the valid predicate devices have an associated recall. If unable to find a suitable predicate statement can be
included in the 510(k) summary. Performance data can address safety and effectiveness concerns.
Predicate devices without unmitigated use related or design related safety issues
The FDA recommends selecting a predicate device that does not have unmitigated use-related or design-related safety issues, considering any emerging safety signals or safety communications announced on relevant FDA web pages. Search about emerging signals and safety issues on:
- Medical Device Safety
CBER Safety & Availability (Biologics) database
Predicate devices meet or exceed expected safety and performance
The FDA recommends considering evidence of safety concerns, any adverse events and post-distribution information while selecting a predicate.
After identification of the predicate device search can be done with useful databases such as:
- Manufacturer and User Facility Device Experience (MAUDE) Database
- Medical Device Reporting (MDR) Database
- MedSun Reports Database
Predicate devices cleared using well established methods
FDA recommends using well-established methods to select a valid predicate:
- The FDA-recognized voluntary consensus standard
- FDA guidance document
- Qualified medical device development tool (MDDT)
- An accepted method published in the public domain or scientific literature for the context of use
After the identification of a valid predicate device, FDA recommends searching for the nonclinical tests submitted, referenced in the 510(k) submission to support a determination of substantial equivalence.