Regulatory Feasibility Analysis

FDA 510(k) Pathway Validation

A technical breakdown proving that a valid 510(k) regulatory pathway exists for Cavia, despite its use of consumer Android hardware.

1. What Does the FDA Demand?

To secure clearance under the 510(k) Pathway (and avoid the costly De Novo route), Cavia must prove "Substantial Equivalence".

The "Substantial Equivalence" Formula:

  • Same Intended Use: The device must diagnose/monitor the same condition as an existing cleared device.
  • Same Technological Characteristics: It must use similar technology OR show that any technological differences (e.g., Android vs Apple Watch) do not raise new safety/efficacy questions.

2. The Regulatory Challenge for Cavia

Cavia introduces two distinct technological differences that could trigger FDA scrutiny. We must prove these are safe.

Challenge A: "The Android Variable"

Most approved predicates (like NeuroRPM) run on the Apple Watch, which has uniform hardware. Cavia runs on Android (BYOD - Bring Your Own Device), where hardware varies by manufacturer.
Risk: FDA defines this as "uncontrolled hardware."

Challenge B: "Passive Collection"

Cavia runs in the background. Traditional tests are active.
Risk: FDA requires proof that continuous background data is as accurate as "snapshot" clinical visits.

3. The Solution: Composite Predicate Strategy

To bridge these gaps, we do not rely on a single device. We use a Composite Strategy citing accepted precedents that have already solved these specific problems.

BRIDGE 1: Proving the Data Type

Predicate: NeuroRPM
Device Details:
View FDA Summary ↗
How this helps Cavia:

NeuroRPM proved that consumer-grade accelerometers (in watches) are valid medical instruments for tracking Parkinson's (tremor/bradykinesia).

Technical Precedent:
The FDA accepted that purely software-based AI processing raw accelerometer data (without new hardware) is Substantially Equivalent to traditional clinical observation (UPDRS).

✔ Solves Challenge B (Passive Collection): It validates that passive meaningful motion data is clinically acceptable.

BRIDGE 2: Proving the Platform (Android)

Reference: Biofourmis
Device Details:
  • Device: Biovitals Analytics
  • 510(k) Number: K183282
  • Cleared: Oct 2019
  • Class: Software-as-a-Medical-Device
View FDA Summary ↗
How this helps Cavia:

Biofourmis (Biovitals) is the "Slam Dunk" precedent for Android. They received clearance for a Software-Only Analytics Engine that is explicitly "Device Agnostic".

Technical Precedent:
The FDA accepted that the software is the medical device, not the phone. As long as Cavia's software includes "Data Integrity Checks" (verifying the phone's sensor sampling rate is sufficient), it can run on any compatible Android device.

✔ Solves Challenge A (Android): It creates the regulatory precedent for software-only clearance independent of the specific phone hardware.

4. Conclusion: Is the Pathway Open?

YES. The regulatory precedent is established.

Cavia does not strictly "invent" a new category. Instead, it combines the Sensor Technology of NeuroRPM with the Software Architecture of Biofourmis.

The Final Equation:

Since the FDA has already cleared (A) Watch-based Motion Tracking AND (B) Device-Agnostic Software, there is no regulatory basis to reject Cavia solely on the grounds of "Technology" or "Platform", provided standard verification testing (bench tests) is performed.

4.5 Which FDA Codes Apply to Cavia?

Beyond just the predicates, these are the specific FDA Product Codes that describe Cavia's functionality. This tells us exactly which regulatory "bucket" we fall into.

Code Classification Name Why is this relevant to Cavia?
GYD Neurological Behavior Monitor
(21 CFR 882.1950) 		The "Tremor" Bucket.
This is the code for apps that measure tremor severity. Since Cavia "aids in the assessment of tremors," this is our Primary Product Code. It defines our core medical claim.
PLB Multivariate Vital Signs Index
(21 CFR 870.2910) 		The "AI Analytics" Bucket.
This code is for software that takes multiple inputs (like Cavia taking Gait + Tremor + Speech) and calculates a single "Score". It validates our "Multi-Sensor" approach.
LXJ Human Motion Measuring System
(21 CFR 888.1500) 		The "Gait" Bucket.
If we emphasize "Gait Analysis" as a separate feature from tremor, this code applies. It covers optical or sensor-based systems that measure human movement/speed.

5. Supporting FDA Documentation

📄 Guidance for Software Med Devices 📋 How to Submit a 510(k)