Which of the following devices would not typically require a 510(k) submission?

A device intended solely for a specific patient would likely not require a 510(k) submission because it falls under the category of "custom devices." Custom devices are designed for the sole use of an individual patient, typically based on a physician’s order, and therefore are exempt from the premarket notification process. The regulatory framework acknowledges that such devices are tailored specifically to meet the needs of an individual, which distinguishes them from mass-produced items that require a 510(k) for market entry.

The other choices involve scenarios that typically do require a 510(k) submission. For instance, a device that is identical to a previously marketed device may still require a 510(k) submission to demonstrate substantial equivalence. A significantly modified device that alters its technology would certainly necessitate a 510(k) to ensure safety and efficacy in light of the changes made. Lastly, devices that are not intended for human use may have different regulatory requirements, but if they are intended to be used in a clinical setting, they could still fall under the 510(k) requirement depending on their classification.