Build the 510(k) Comparison
Explain substantial equivalence using intended use, technological characteristics, and performance evidence.
A team wants to use one cleared wired accessory as the predicate for a wireless home-use accessory. A 510(k) substantial-equivalence comparison asks: same intended use, same technological characteristics or no new safety/effectiveness questions, and performance data that supports the differences. The common shortcut is saying the sensor is the same while ignoring wireless transfer, user population, use environment, app display, and failure modes. Lock the intended use Write the proposed intended use beside the predicate intended use and highlight any change in user, patient, condition, or environment. Intended-use differences are gating because they can move the device out of the…
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