The first thing I would do is slow down and identify the actual regulatory question. Write your proposed intended use. Search FDA 510(k) summaries and the classification database. Shortlist legally marketed devices, compare intended use and technology, and identify differences that may raise new safety or effectiveness questions. That gives you something you can check, discuss, and defend rather than an answer based on memory.
Here is a simple example. Two devices can have similar shapes but different clinical purposes. Conversely, differences in technology may be acceptable if they do not raise different questions of safety and effectiveness and are supported by data. That is why I would always ask for the intended use, the device description, and the relevant evidence before making a recommendation.
What does someone in RA actually do here? Often the junior person does not make the final decision. They research the official sources, compare possible routes, gather the right documents, flag gaps, and write a short rationale that a senior colleague can review. That is valuable work, even if you are not the final signatory.
Try this exercise: Build a predicate comparison matrix with intended use, indications, technology, performance tests, and open gaps. Keep it to one page. Add the source, date checked, assumptions, and unanswered questions. If your reasoning changes after checking the official material, that is learning—not failure.
One important limitation: A database match is a starting point, not an FDA determination that your predicate is acceptable. These decisions are specific to the product and market. A short internet post is a starting point, not a regulatory determination.
For people working in device RA: what is the first question you ask when someone brings you a new product or a proposed change? I think those practical questions are what newcomers most need to hear.