FDA Submission Wizard

Overview

Draft and validate FDA medical device submissions. Supports 510(k) Premarket Notifications (eSTAR format) with predicate comparison and substantial equivalence arguments, and PMA (Premarket Approval) dossiers with clinical and non-clinical data sections.

The skill covers the two primary FDA premarket pathways for medical devices:

• 510(k) Premarket Notification — For Class I/II devices with a legally marketed predicate. Follows the mandatory eSTAR electronic template format.
• PMA (Premarket Approval) — For Class III devices requiring clinical evidence of safety and effectiveness. Structured as a multi-volume dossier per 21 CFR 814.20.

Getting Started

Add your source materials to the project workspace — device specifications, test reports, predicate device information, clinical data — then activate the FDA Submission Wizard skill. The agent will guide you through pathway selection, outline generation, and validation.

Example Conversation

Below is an example of how a typical 510(k) session unfolds. The agent asks targeted questions to determine the pathway and device context, then generates the submission outline.

You: I need to prepare a 510(k) submission for our new wrist-worn pulse oximeter, the VitalBand Pro.

Agent: I’ll help you draft a 510(k) submission. Let me gather some initial information:

1. What is the predicate device? Please provide the device name, manufacturer, and 510(k) number if you have it.
2. What is the FDA product code for this device? (For pulse oximeters it’s typically DQA)
3. Does the device include software? If so, what functions does it perform?
4. Is the device intended for prescription use, OTC, or both?

You: The predicate is the Masimo MightySat Rx, K201754. Product code DQA. Yes, it has firmware that processes SpO2 and pulse rate from the optical sensor. Prescription use only.

Agent: I’ve created your 510(k) submission outline at output/vitalband-pro-510k.md. Here’s what I’ve filled in so far:

• Section 1 — Applicant info placeholders ready for your company details
• Section 2 — Device identification set to product code DQA, regulation 21 CFR 870.2710, Class II. Device description has placeholders for materials, dimensions, and operating principles
• Section 3 — Predicate comparison table started with Masimo MightySat Rx (K201754). I’ve pre-filled the intended use row as “Same” since both are prescription SpO2 monitors
• Section 5c — Software documentation section flagged, since firmware processing SpO2 signals is typically Moderate level of concern

I’d recommend we work on the device description and comparison table next. Can you provide the sensor wavelengths, materials in skin contact, and battery specifications?

You: 660nm red and 940nm infrared LEDs, medical-grade silicone wristband, lithium polymer battery 3.7V 250mAh. Weight is 38g.

Agent: Updated the device description and comparison table. I also ran the validation script — there are 2 errors and 3 warnings remaining. The main gaps are the biocompatibility section and the SE discussion for the differences I flagged in materials. Want to work on those next?

Sample Output Excerpt

Below is a representative excerpt from a generated 510(k) outline, showing the predicate comparison and substantial equivalence discussion — the most critical sections of any 510(k) submission.

Section 3: Substantial Equivalence Comparison

3a. Predicate Device(s)

Predicate Selection Rationale: The MightySat Rx is a wrist-worn prescription pulse oximeter cleared under product code DQA (21 CFR 870.2710) with the same intended use of noninvasive SpO2 and pulse rate monitoring. It represents the closest technological match to the VitalBand Pro.

3b. Comparison Table

3c. Substantial Equivalence Discussion

Difference 1: Indications for Use — Continuous monitoring addition. The VitalBand Pro adds continuous monitoring to the spot-check indication of the predicate. This does not alter the fundamental measurement or clinical decision-making. Bench testing (Section 5a, Test #3) demonstrates SpO2 accuracy of ±2% Arms over 8-hour continuous sessions, meeting the same accuracy standard as the predicate’s spot-check mode.

Difference 2: Dimensions. The VitalBand Pro is smaller and lighter (38g vs. 56.7g). Mechanical integrity testing (Section 5a, Test #7) confirms the device withstands IEC 60601-1 drop and vibration requirements. The reduced size does not affect optical path length or sensor performance.

Difference 3: Software. The VitalBand Pro uses proprietary SpO2/PR algorithms rather than the predicate’s algorithms, and omits the RRp (respiration rate) feature. Software V&V (Section 5c) demonstrates algorithm accuracy equivalent to the predicate. Hazard analysis identifies no new risks from the firmware differences. Cybersecurity documentation per FDA premarket guidance is provided.

Conclusion: The VitalBand Pro has the same intended use as the MightySat Rx. Technological differences in dimensions, continuous monitoring mode, and software do not raise new questions of safety or effectiveness, as demonstrated by the supporting bench and software test data. The VitalBand Pro is substantially equivalent to the predicate.

Built-in Validation

The skill includes two validation scripts that automatically check your draft against FDA structural requirements. After each editing pass, the agent runs the appropriate validator and reports findings so you can address gaps iteratively.

What the validators check

Severity levels

• ERROR — A required element is missing. Must be resolved before the submission is structurally complete.
• WARNING — A recommended element is absent or may need attention depending on device type (e.g., software documentation for a non-software device).
• INFO — Unfilled placeholders that still need user-provided content.

Example validation output

============================================================
510(k) SUBMISSION VALIDATION REPORT
============================================================
File: output/vitalband-pro-510k.md
Size: 12,847 characters, 389 lines

--- SECTION COMPLETENESS ---
  All required eSTAR sections found.

--- KEY CONTENT CHECKS ---
  All key content elements found.

--- UNFILLED PLACEHOLDERS ---
  Found 14 unfilled placeholders.
  [INFO] line 13: Unfilled placeholder: [COMPANY LEGAL NAME]
  [INFO] line 14: Unfilled placeholder: [STREET, CITY, STATE, ZIP]
  [INFO] line 18: Unfilled placeholder: [NUMBER]
  [INFO] line 19: Unfilled placeholder: [NUMBER]
  ... and 10 more.

--- SUMMARY ---
  Errors:   0
  Warnings: 0
  Info:     14

RESULT: PASS — submission structure appears complete.

The agent runs validation automatically after significant edits and surfaces the findings inline, so you always know exactly what remains before your submission is structurally complete.