FDA 510(k) Premarket Notification — Substantial Equivalence Summary

Overview

Draft and validate 510(k) premarket notification submissions for Class II medical devices. Structures the document per FDA guidance (Refuse to Accept checklist, 21 CFR 807.87) with device description, predicate comparison, performance data summary, and labelling.

Example Conversation

You: We need to prepare the 510(k) summary and substantial equivalence section for our Class II patient monitor. We have a predicate (K123456) and bench data. Can you draft the document and run the RTA check?

Agent: I’ll draft the 510(k) summary with device description, predicate comparison table (technological and performance characteristics), performance data summary, and labelling review, then run rta_checklist_validator on it.

Agent: Created 510k-summary-draft.md. Running rta_checklist_validator…

Agent: Check PASS — all mandatory sections are present, predicate K-number is cited, and the SE table includes technological and performance comparison. Ready for your review before submission.

You: Add a row for software level of concern in the SE table.

Agent: Updated the substantial equivalence table with a software level of concern row. Re-ran rta_checklist_validator: still PASS.

What the Tools Validate

The skill includes one extension tool:

rta_checklist_validator checks the 510(k) document against the FDA Refuse to Accept (RTA) checklist:

• Mandatory sections — Device description, predicate comparison, substantial equivalence argument, performance data summary, labelling must all be present.
• Predicate K-number — Predicate device(s) must reference a valid K-number (e.g. K123456).
• Substantial equivalence table — Must include technological and/or performance comparison columns.

Output: PASS if all checks are satisfied; otherwise FAIL with a short line per missing element. Run on the draft before submission; fix gaps and re-run until the audit passes.

Output Excerpt

Excerpt from a generated 510(k) summary and sample validator report.

510(k) summary (excerpt):

## Device Description
[Product name], Class II patient monitoring system. Intended use: continuous non-invasive monitoring of vital signs in hospital and home care settings.

## Predicate Device
Predicate: [Device name], K123456. Indications for use align with subject device.

## Substantial Equivalence Comparison
| Characteristic    | Subject device | Predicate (K123456) |
|------------------|----------------|---------------------|
| Technological    | [Description]  | [Description]       |
| Performance      | [Description]  | [Description]       |

## Performance Data Summary
Bench testing: [criteria and results]. Clinical data: [summary].

rta_checklist_validator report (excerpt):

=== FDA 510(k) RTA CHECKLIST VALIDATOR ===
Result: PASS

Document: 510k-summary-draft.md
Section 'device description' is present.
Section 'predicate comparison' is present.
...
Document meets FDA RTA checklist expectations for 510(k) summary.

Getting Started

Add your source materials to the project workspace (device details, predicate information, performance data), then activate the FDA 510(k) Premarket Notification — Substantial Equivalence Summary skill. The agent will guide you through device identification, predicate comparison, performance data summary, labelling review, and running rta_checklist_validator before submission.