ADDNOX (BPSPM1)

The ADDNOX is a transcutaneous electrical nerve stimulator that delivers non-invasive electrical stimulation to the trigeminal nerve via electrodes placed on the forehead. It is intended for treating pediatric ADHD (ages 7-12) as a monotherapy in patients not currently taking prescription ADHD medications, administered nightly during sleep under caregiver supervision.

The ADDNOX uses a symmetrical square wave at 120 Hz with 250 μS pulse duration and 10 mA maximum output current (same as predicate). Key differences include: improved battery service life (500 vs 300 charge cycles), redesigned charging method (cradle vs USB), smaller form factor (45×44×18.8 mm vs 60×44×17.6 mm), refined electrodes (78×32.86 mm vs 90×31.90 mm), addition of mobile app and wireless communication capabilities, and extended device lifespan (3 vs 1.5 years).

IEC 60601-1:2005/A2:2020 (electrical safety), IEC 60601-1-2:2014/A1:2020 (EMC), IEC 60601-1-11:2015/A1:2020 (home use safety), IEC 60601-2-10:2012/A1:2016 (nerve stimulator safety), ISO 10993 series (biocompatibility: cytotoxicity, sensitization, intracutaneous reactivity), IEC 62304:2006/A1:2015 (software validation), and manufacturer's own standards for performance and wireless communication testing.

The device is substantially equivalent because it applies identical electrical stimulation parameters (waveform, frequency, pulse duration, current) to the same anatomical target (trigeminal nerve) for the same indication (pediatric ADHD monotherapy ages 7-12). Although differences exist in appearance, charging method, battery cycles, electrode dimensions, device lifespan, and new wireless/app features, safety and performance testing per IEC and ISO standards demonstrated these differences do not affect safety or effectiveness. The predicate device (SMILE) established the safety and efficacy framework for this device class; the subject device maintains biocompatibility, electrical safety, and performance within established parameters while offering incremental improvements.