Neu Platform

The Neu Platform is a smartphone application with cloud-based clinician dashboard designed to measure tremor in adults aged 45 and older with mild to moderate Parkinson's disease. Patients use the app to perform tremor measurement tasks via their phone's accelerometer, and clinicians review the captured data through a web portal.

Both the subject device and predicate use accelerometers in commercial off-the-shelf mobile devices (smartphones/watches) to measure tremor. The Neu Platform uses Apple and Android OS with minimum iOS 14.1 and Android 7, stores data in AWS cloud infrastructure, and implements TLS-1.2+ encryption with AES-256 and multi-factor authentication. The subject device does not measure dyskinesia, unlike the predicate.

Software validation conducted per FDA Guidance 'Content of Premarket Submissions for Device Software Functions' (May 11, 2005). Risk management per IEC 14971. Software development per IEC 62304. Cybersecurity per FDA Guidance 'Content of Premarket Submissions for Management of Cybersecurity in Medical Devices'.

The subject device measures tremor using the same accelerometer-based principle and targets the same patient population (45+ with mild to moderate Parkinson's disease) as the predicate Parky App (K220820). Bench testing shows strong correlations (0.92 and 0.85) with the clinical standard (UPDRS-III), meeting or exceeding the predicate's performance (r=0.72). Both devices provide tremor quantification without diagnosis or treatment recommendations, use similar software development and cybersecurity standards, and function as stand-alone apps on commercial mobile devices with cloud-based clinician dashboards. The removal of dyskinesia detection does not increase risk compared to the predicate.