What does this estimator predict?

It estimates your relative risk of an early RTA setback by scoring the completeness of high-impact submission areas such as administrative documents, predicate rationale, performance testing alignment, labeling consistency, and eSTAR structure quality.

Is this an FDA-approved scoring method?

No. This is an internal planning tool to help teams prioritize quality work before filing. Final acceptance decisions are made by FDA based on the official RTA checklist and submission content.

How should teams use the result?

Use the risk score to decide where to spend remediation effort before submission and to set a go/no-go readiness gate with concrete owners and due dates.

FDA 510(k) RTA Deficiency Risk Estimator

This utility page helps device teams estimate where their 510(k) package is most likely to fail an early administrative acceptance check and how to fix those gaps before filing. It is a planning and prioritization tool, not legal advice and not a substitute for FDA review.

Use Tool 1 to score your current readiness profile and identify top deficiency drivers. Then use Tool 2 to estimate whether your team has enough remediation capacity to close those gaps before your target submit date.

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How To Use This Utility

Step 1: Score Readiness Quality

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Rate each submission domain from 0 to 5 based on objective evidence quality.
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Run the risk estimator to see your weighted score and risk band.
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Use the generated priority list to focus on highest-impact deficiencies first.

Step 2: Pressure-Test Team Capacity

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Estimate unresolved deficiency count and average close-time per item.
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Compare required remediation time vs. available weeks before filing.
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Decide to file, delay, or add resources before go-live.

Utility Tool 1: Weighted RTA Deficiency Risk Score

Score each section from 0 (poor/incomplete) to 5 (strong/complete)

The weights reflect practical impact on early acceptance and review continuity. Lower scores in heavily weighted sections push overall risk up.

Administrative completeness (weight 20) Cover sheet, fee proof, signatures, required forms, section presence.

Predicate rationale quality (weight 18) Clear substantial equivalence argument and difference handling.

Performance evidence mapping (weight 18) Claims-to-test traceability with acceptance criteria and outputs.

Labeling and IFU consistency (weight 14) Consistent intended use, indications, warnings, and instructions.

eSTAR package structure quality (weight 18) Expected sections complete, cross-references coherent, no major gaps.

Response preparedness (weight 12) Owners, templates, and escalation paths ready for fast deficiency closure.

Run the estimator to view your weighted readiness score, risk band, and top remediation priorities.

Utility Tool 2: Remediation Capacity Estimator

Check if your team can close known gaps before filing

This tool estimates remediation load and compares it with available team capacity before your target submit date.

Open deficiencies to resolve

Average hours per deficiency

Active contributors (FTE equivalent)

Available hours per contributor per week

Weeks until target submission

Rework buffer factor Use higher values when cross-functional re-approval is likely.

Run the estimator to compare remediation effort demand vs available team capacity.

Risk Band Interpretation

Low Risk (80-100)

Your package appears broadly coherent. Keep validating cross-references and document version control before filing.

Moderate Risk (60-79)

Targeted deficiencies could still trigger avoidable delay. Run a focused quality sprint on your lowest-scoring weighted domains.

High Risk (<60)

Filing now likely increases probability of acceptance setbacks and avoidable cycle time. Close critical gaps first or adjust timeline/resources.

Pre-Submission Decision Checklist

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Have you scored each domain with objective evidence, not optimistic assumptions?
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Are lowest-scoring weighted domains assigned to named owners with due dates?
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Does your remediation capacity exceed demand by at least 15% buffer?
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Can you defend intended use, predicate rationale, and testing traceability in one pass?

Related 510(k) Pages

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510(k) Submission Services for end-to-end filing support.
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510(k) Checklist Guide for detailed pre-file section checks.
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eSTAR Guide for structured submission workflow quality.
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Fees & Timeline Toolkit to model budget and schedule exposure.

Frequently Asked Questions

What score should trigger a filing delay decision?

Many teams treat any score below 60 as a hold condition until top weighted gaps are closed and re-scored with evidence.

How often should we re-run this estimator?

Re-run at each readiness gate: after core drafting, after test report integration, and before final eSTAR packaging.

What if our score is good but capacity fit is negative?

Your quality profile may be acceptable, but execution bandwidth is still a risk. Add focused resources or extend the submission date to protect quality.

References & Citations

This utility is based on public FDA resources and intended for planning use.