510(k) eSTAR Submission demo
The eSTAR built section by section from the design file, with a technical screening preflight before it goes to FDA. 1:15
What the demo shows
A 510(k) submission solution that assembles and checks FDA eSTAR files for medical devices.
Agents draft each eSTAR section from the design file and test reports, lay the device beside its predicate with the report that answers each difference, match standards to FDA's recognized editions and run a 31-check technical screening preflight; a regulatory director approves and signs.
Transcript
- 510(k) eSTAR Submission assembles and checks FDA eSTAR files for device regulatory teams.
- One wrong answer at FDA screening can hold a 510-k for 180 days.
- Viltara's VLT Flow & Fusion set sits beside its predicate, row by row.
- Each difference carries the test report that answers it.
- Now the pre-flight.
- 31 checks. The way FDA screens an S-Star.
- 30 go green. Line 22 stays red.
- Sterility cites a 2007 standard FDA no longer recognizes.
- The lab used 2014.
- One click swaps the citation, and the ready light turns green.
- Marcus signs. Their last nine submissions cleared screening first time.
- Built on Botminds: agents, data, screens, and governance on one platform.
Transcribed from the film’s narration. Captions are on the player.