A 510(k) eSTAR built to clear FDA's technical screening the first time, every check green
An eSTAR that clears FDA's technical screening the first time, every check green.
See one case, screen by screen ↓eSTAR is FDA's electronic submission template, and every 510(k) must now be sent as one unless it is exempt. It runs to some 20 sections, from device description and the predicate comparison to sterility, biocompatibility, labeling and performance testing. 510(k) eSTAR Submission drafts those sections from your design history file, test reports and labeling and checks the result before it goes.
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Every 510(k) now goes to FDA as an eSTAR: some 20 sections, from device description and the predicate comparison to sterility, biocompatibility, labeling and performance testing. The regulatory specialist assembles it by hand from three sources that never agree perfectly — the design history file, a dozen test reports and the labeling. The same model number, shelf life or standard edition appears in five places, and each is copied across by hand.
Checking is reading. The template's own checks only test that a field is filled, not that the answer is right, that an attachment answers its question, or that the standard cited is the edition FDA recognises today. FDA screens each eSTAR within 15 days; an answer that contradicts the device, an unexplained “N/A” or an attachment that misses its question puts the submission on hold for up to 180 days until a complete replacement arrives. A weak predicate comparison costs an Additional Information request and another cycle.
Estimated split for a Traditional 510(k) from the start of drafting to a ready eSTAR — about 10 weeks by hand, 3 with the solution.
Five specialist agents draft, compare, match and check every section; a regulatory director approves and signs.
Veltara Medical is filing a Traditional 510(k) for the VLT-Flow 80 Subcutaneous Infusion Set — six models, product code FPA, 21 CFR 880.5440, Class II — against the Halvern SoftPort 90, K231592. Target submission: 20 Oct. Here is what happens next, screen by screen, in the working solution.
Nadia owns the VLT-Flow 80 eSTAR v6.1: 22 of 22 sections drafted, 46 attachments, target 20 Oct. The preflight last ran on 12 Oct and the draft has had 14 edits since, so its 31 checks sit grey in eight groups — from submission and administration to declarations — with one light at the end: Ready to submit.
On the submission strip: “FDA screens it within 15 days · if it fails, up to 180 days on hold.”
The comparer read the predicate's 510(k) Summary and the design history file and laid out 17 rows: 11 the same, 6 different. Each difference carries the report that answers it. The FEP cannula against the predicate's PTFE is answered by biocompatibility testing of the finished device (TR-0412) and kink and joint-strength testing (TR-0418), and the sentence for Section 8 is already drafted.
TR-0418: “0 of 60 FEP cannulae occluded after 72 h bent at 90°; acceptance: 0 of 60.”
The draft claimed 36 months, like the predicate. On 6 Oct the comparer flagged that 36 months had no report behind it: packaging integrity and accelerated aging report TR-0433 supports 24. Nadia chose to claim 24 months rather than wait for real-time data, and on 9 Oct the drafter changed it in the description, the labels, Section 12 and the Summary. The gap is closed.
TR-0433: “Accelerated aging to ASTM F1980-21 supports a labeled shelf life of 24 months.”
Each of the 22 sections was drafted from the design history file, 9 test reports and the labeling; 17 of 22 are approved. Section 11, Sterility, states the method — ethylene oxide, SAL 10⁻⁶, at Lakeview Sterilization Services — and the residuals and endotoxin results, each with its citation. Its validation sentence cites ISO 11135-1:2007.
The drafter never writes a claim without a source and never answers “N/A” without the reason.
The agents read 22 sections and 46 attachments in 1.4 s, cross-checked the facts that repeat — 6 model numbers, the product code, shelf life and indications across 31 documents — in 2.2 s, tied the 6 differences to their reports and matched 14 standards to FDA's recognised list. Each line turns green as it is checked.
“Matched 14 standards to FDA's recognised list — ISO 11135 cited at a withdrawn edition.”
Sterilization cites a withdrawn edition of ISO 11135: ISO 11135-1:2007 appears in Section 11, para 2 and Section 4, row 7, while FDA recognises ISO 11135:2014 + Amd 1:2018. The wrong edition came from the 2019 eSTAR of the VLT-Flow 60, reused as a starting point. The ready light reads “Not ready yet”.
The fix: “Swap the citation in both places. The validation report does not change — only what the submission says about it.”
One click opens TR-0430, the EO sterilization validation from Lakeview Sterilization Services, dated 21 Jul 2026 and signed, at the passage on page 3. The work was done to the current edition; only the submission's citation was wrong. The report names the sections that cite it and points back to line 22.
TR-0430, p. 3: “This validation was performed in accordance with ISO 11135:2014 + A1:2018 … using the overkill half-cycle approach.”
Fourteen standards cited, checked against FDA's recognised list refreshed on 12 Oct 2026: one at a withdrawn edition, ISO 11135, and one in a transition period — ISO 10993-1:2018, accepted until 1 Jul 2029 now that FDA partially recognises the 2025 edition. The VLT-Flow 80 can go with 2018; the next biological evaluation should plan for 2025.
The matcher never changes which standard a lab tested to — only the citation.
Nadia presses “Swap the citation in 2 places”. Section 11, para 2 is swapped and checked again; Section 4, row 7 is swapped and its declaration re-attached; line 22 passes. 31 of 31 checks passed, and 5 sections wait for Marcus Feld's approval and signature.
On the record: “Applied by Nadia Brennan · 13 Oct.”
Nadia sends Sections 4, 8, 9, 11 and 22 to Marcus with a note: preflight green, line 22 fixed, target 20 Oct. Marcus approves the five sections and signs the truthful and accurate statement. The eSTAR PDF is ready to download with its 46 attachments, and Nadia submits it herself through the CDRH Portal.
“Ready to submit · 31 of 31 checks · 22 sections approved · statement signed by Marcus Feld, 13 Oct 14:12. Nadia submits through the CDRH Portal.”
The same submission, seen by the four people who carry it — what their weeks looked like, and what they look like now.
Five specialist agents draft, compare, match and check every section; a regulatory director approves and signs.
Drafts each eSTAR section in plain regulatory English from the design history file, the test reports and the labeling, citing the DHF, a test report or the labeling by page for every factual sentence, and using one model-number list throughout.
Builds the substantial equivalence table from the predicate's 510(k) Summary and the design history file — indications, users, technology, materials, performance, sterility, shelf life — and ties each difference to the report that answers it, or opens a gap.
Compares every standard cited — edition and amendments — with FDA's recognised consensus standards, full or partial, refreshed weekly, and flags withdrawn editions and transition dates.
Runs 31 checks modelled on FDA's technical screening: facts that repeat across sections, attachments that answer their questions, no unexplained “N/A”, fee and forms, standard editions and predicate differences — each with its evidence, and a fix when one exists.
Drafts the cover letter and the 510(k) Summary from the approved sections.
Approves every section and signs. The agents propose; a named person decides.
Ask about any section, check, standard or difference from the predicate — or say what to change. Every answer points to its source.
Why is line 22 red?
Sections 11 and 4 cite ISO 11135-1:2007 for the sterilization validation. That edition is withdrawn; FDA recognises ISO 11135:2014 + Amd 1:2018. The lab did the work to the right edition — TR-0430 says so on page 3 — so only the citation is wrong. It came from the 2019 eSTAR of the VLT-Flow 60. The fix is ready on line 22.
Show only the differences from the predicate
Six rows differ from the Halvern SoftPort 90 (K231592): cannula material, tubing length, inserter, adhesive, hub material and shelf life. Five are answered by a test report — for example the FEP cannula by TR-0418 — and shelf life was closed on 9 Oct by claiming 24 months, which TR-0433 supports. None is open.
Which standards must change edition before 2029?
Two. ISO 11135 now: the submission cites the withdrawn 2007 edition. And ISO 10993-1: FDA partially recognised the 2025 edition on 25 May 2026 and accepts declarations to the 2018 edition only until 1 Jul 2029. VLT-Flow 80 can go with 2018; the next biological evaluation should plan for 2025.
Add a check: IFU revision matches the labeling section
Added as check 32: the IFU revision attached in Section 9 must be the one named in the device description and the 510(k) Summary. On today's draft it passes — IFU rev C everywhere. It runs on every submission from now on and is on the audit trail.
13 screens from the working solution, on its sample data. Pick one to see it large.
What the preflight checks, who approves and how standards are watched are settings for every submission.
| Setting | Default | Choose from |
|---|---|---|
| Preflight checks | 31 on | Each check on or off · add your own check in plain words |
| Every section approved by | Marcus Feld · RA director | Any named approver, by name, time and meaning |
| Sterility, biocompatibility, performance co-approved by | Dr. Aisha Okonkwo · test lab lead | A named co-approver, or not required |
| Truthful and accurate statement | Signed by Marcus Feld | Signed by a person; agents cannot sign |
| Who submits to FDA | Nadia Brennan | A person, through the CDRH Portal |
| Refresh FDA's recognised standards | Weekly · last 12 Oct 2026 | Daily, weekly or monthly |
| Warn before a transition ends | 24 months | 6 to 48 months, in steps of 6 |
| Cite every claim · one model-number list | On · VF-0660 to VF-0910 | On or off |
Every figure is labelled: a target the solution is built to, an estimate, a typical published result, or a proven one.
“demo” = seen in the working solution, on its sample submission · “target” = the design goal, measured in the live solution · “estimated” = our estimate · “typical” = published figures (FDA eSTAR program and 510(k) electronic submission guidance — technical screening within 15 days, hold up to 180 days; FDA MDUFA V performance report — Additional Information requests on the first cycle for 63–68% of 510(k)s, FY2018–FY2022). People, companies, devices, K numbers and submission numbers named on this page are fictional — characters and sample data in the working solution.
eSTAR is FDA's electronic submission template, and every 510(k) must now be sent as one unless it is exempt. It runs to some 20 sections, from device description and the predicate comparison to sterility, biocompatibility, labeling and performance testing. 510(k) eSTAR Submission drafts those sections from your design history file, test reports and labeling and checks the result before it goes.
FDA screens each eSTAR within 15 days, and a failed screen puts it on hold for up to 180 days until a complete replacement arrives. The preflight runs 31 checks modelled on that screening — answers that contradict each other, attachments that don't answer their question, “N/A” where a question applies, standards at an edition FDA no longer recognises, and every predicate difference tied to a test report.
eSTAR submissions are not reviewed under the Refuse to Accept checklist; FDA screens them technically instead. The preflight is built for that technical screening, and you can add your own checks in plain words.
The predicate comparer reads the predicate's 510(k) Summary and your design history file and lays the device beside it row by row. Each difference is tied to the test report that answers it, or opened as a gap. A person chooses the predicate; the comparer never does.
Yes. The standards matcher compares every citation — edition and amendments — with FDA's recognised consensus standards, refreshed weekly, and flags withdrawn editions and transitions such as ISO 10993-1:2018, accepted until 1 Jul 2029. It changes only the citation, never what the lab tested to, and a person applies the fix.
Yes. The agents draft, compare and check. The regulatory affairs director approves every section by name, time and meaning, the test lab lead co-approves test sections, a person signs the truthful and accurate statement and a person submits through the CDRH Portal. Agents never sign, submit or change a test report.
Yes. Each of the 31 preflight checks can be switched on or off, new checks are added in plain words, and the approver for every section, the co-approver for test sections, who signs, who submits, the standards refresh and the transition warning are all settings.
The Agentic Solution Engine builds and deploys it from your requirements and documents — your SOPs, a design history file, test reports and a past eSTAR — and it goes live once every quality gate has passed. We will walk you through it on one of your own devices first.
Every agency change reaches the right team within hours, with what changed marked.
1-min demoCTD Module 2 AuthoringModule 2 summaries drafted in weeks, every statement cited to its source.
1-min demoHealth Authority Query ResponseCited first drafts within hours, consistent with every past answer to every agency.
1-min demoWe'll run 510(k) eSTAR Submission on the design file, test reports and labeling of one of your own devices.