What key information is typically required in a 510(k) submission?

The key information required in a 510(k) submission is critical for demonstrating that a new device is substantially equivalent to a device already cleared for market, referred to as the predicate device. This submission typically includes a thorough device description, which outlines the device's features and specifications. The intended use conveys how the device is meant to be used, which is vital for regulatory assessment.

Additionally, detailing the technological characteristics provides insight into how the device functions and is designed, fostering an understanding of its safety and effectiveness in comparison to the predicate. Furthermore, a comparative analysis with predicate devices is essential, as it shows how the new device aligns with existing, previously cleared products, ensuring that it meets the regulatory requirements for safety and efficacy.

The other choices lack the comprehensive nature and relevant details necessary for a complete 510(k) submission. Simply including market strategy or product pricing would not satisfy the regulatory requirements, as the focus is on safety and technological equivalence rather than commercial aspects. Likewise, relying solely on clinical trial results without contextual information about the device or its relation to predicate devices would not fulfill the requirements, and customer testimonials or warranty details do not provide the regulatory information needed for assessment.