Get Guidance For The Content Of Premarket Notifications (510(k)s) For Extracorporeal Shock Wave

This guide provides a clear and supportive approach to completing the Guidance For The Content Of Premarket Notifications (510(k)s) for extracorporeal shock wave lithotripters. By following these detailed instructions, users can confidently navigate the online form.

Follow the steps to effectively complete your 510(k) submission.

1. Click ‘Get Form’ button to begin the process of obtaining the form. This action will allow you to access the document needed for submission.
2. Identify and provide the required Sponsor and Device Identification information, including the sponsor's contact details, the proposed device name, and the predicate device information to establish substantial equivalence.
3. Fill in the Classification/Product Code section accurately by referencing the applicable CFR number, regulatory class, and product code specifically associated with extracorporeal shock wave lithotripters.
4. Complete the Device Description section by clearly stating the intended use, technical characteristics, and a summary of all safety features along with any required diagrams.
5. Document the Claim of Substantial Equivalence, ensuring comparisons include intended uses and technological characteristics with adequately detailed tabular presentations.
6. Provide evidence of Conformance to Standards, including relevant consensus standards and accompanying declarations of conformity for regulatory compliance.
7. Submit the results of Performance Testing, detailing shock wave characterization measurements and localization accuracy among other required evaluations to validate the device's efficacy.
8. Accurately prepare Labeling materials in accordance with FDA guidelines, ensuring that all contraindications, warnings, and usage information are thoroughly covered.
9. Include a description of the Training Program for users needing instructions on safe operation of the proposed SWL system.
10. After thoroughly filling out all sections, review the entire submission for completeness, then save changes, download, print, or share the completed form for your records.

Complete your 510(k) submission online to streamline the approval process for your device.