What key factor must be demonstrated in a 510(k) submission?

In a 510(k) submission, the primary requirement is to demonstrate substantial equivalence to a legally marketed device, commonly referred to as a predicate device. This means that the new device must either be as safe and effective as the predicate or have similar technological characteristics and intended uses. The substantial equivalence criterion allows the FDA to ensure that the new device is not introducing new safety or effectiveness concerns compared to existing devices on the market.

The focus on demonstrating substantial equivalence is essential because it provides a basis for the FDA's regulatory decision-making without necessitating a lengthy premarket approval process, which is more extensive and applied for higher-risk devices. By relying on the predicate device, manufacturers can streamline the process, promoting innovation while maintaining patient safety.

Other options, while relevant in different contexts, do not pertain directly to the 510(k) submission process. Financial projections or expert endorsements are not criteria for demonstrating safety or effectiveness and do not replace the need for establishing substantial equivalence. Originality of the device concept is also not a requirement for 510(k) submissions, as many devices can be considered substantially equivalent even if they are not original concepts.