Vektor Computational ECG Mapping System (vMap®)

The vMap is a software-based medical device that analyzes non-invasive electrocardiogram (ECG) data acquired from a patient's body surface and uses proprietary algorithms to generate 2D and 3D cardiac electrical maps for physician analysis. It is intended for analysis, display, and storage of cardiac electrophysiological data in clinical and electrophysiology laboratory settings to help identify potential arrhythmia sources.

The device maintains fundamentally similar mapping approaches and analysis methodologies to its predicate. Key changes include hardware decoupling, 3D model manipulation, secure sandboxing, and automated cybersecurity features. The device does not require patient-specific CT imaging, eliminating radiation exposure risks present in some competitors.

The device was evaluated in accordance with FDA's Guidance Document 'Applying Human Factors and Usability Engineering to Medical Devices' (February 3, 2016) and IEC 62366-1:2015+AMD1:2020 (Medical devices—Part 1: Application of usability engineering to medical devices). A summative usability study was conducted to evaluate safe and effective use.

The proposed vMap is substantially equivalent to the primary predicate device (K211546, also vMap) because both share identical intended use and indications for use, analyze the same type of non-invasive ECG input data, use similar computational mapping methodologies, and serve identical patient populations. Testing demonstrates that technological differences do not raise different questions of safety or effectiveness.