21 CFR 870.2380 — Cardiovascular Machine Learning-Based Notification Software
Cardiovascular (CV) · Part 870 Subpart C—Cardiovascular Monitoring Devices · § 870.2380
Identification
Viz HCM is a cardiovascular machine learning-based notification software intended to be used in parallel to the standard of care to analyze 12-lead ECG recordings from patients 18 years of age or older. It detects signs associated with hypertrophic cardiomyopathy (HCM) and allows the user to view the ECG and analysis results. It is not intended for use on patients with implanted pacemakers, does not replace standard diagnostic methods, and is not intended to rule out HCM or be used in lieu of a full patient evaluation.
Classification Rationale
Class II (special controls). The device is a cardiovascular machine learning-based notification software, regulated under 21 CFR 870.2380.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QXO | Cardiovascular Machine Learning-Based Notification Software | 2 | 1 | |
| QXX | Coronary Artery Disease Machine Learning-Based Notification Software | 2 | 1 | |
| QYE | Reduced Ejection Fraction Machine Learning-Based Notification Software | 2 | 5 | |
| SAT | Pulmonary Hypertension Machine Learning-Based Notification Software | 2 | 2 | |
| SBQ | Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software | 2 | 1 | |
| SFR | Hypertension Machine Learning-Based Notification Software | 2 | 1 | |
| SHP | Cardiac Amyloidosis Machine Learning-Based Notification Software | 2 | 1 |
Special Controls
QXO — Cardiovascular Machine Learning-Based Notification Software
In combination with the general controls of the FD&C Act, cardiovascular machine learningbased notification software is subject to the following special controls:
De Novo Order DEN230003
