HeroTracker Sense

The HeroTracker Sense is an add-on sensor device that attaches to metered-dose inhalers (MDIs) to electronically record and monitor inhaler usage patterns and technique. It captures data on actuation timing, inhaler shake, orientation, inhalation coordination, and inspiratory strength/duration, then wirelessly transmits this data to a mobile app for review by patients, clinicians, and educators. The device is intended for home use in patients aged 12 and older.

Both HeroTracker Sense and the predicate (Hailie Sensor) attach to the top of an MDI canister, use Bluetooth 4.0 for wireless data transfer, employ a lithium coin cell CR2032 battery with 1-year service life, and include a plastic external enclosure. The key difference is the type of sensors: HeroTracker uses force, acceleration, and airflow sensors, while Hailie uses optical, induction coil, motion, and flow sensors. Both devices support recent iOS and Android versions and provide patient data storage and reporting with no dose-counting function.

ISO 10993-1 (biocompatibility), IEC 60601-1/60601-1-11/60601-1-6 (electrical safety), IEC 60601-1-2 (electromagnetic disturbance), IEC 62304 (software verification and validation), ISO 18562-1 (breathing gas pathway safety), ASTM 4169 (transportation testing), and internal performance specifications for device functionality and MDI compatibility.

HeroTracker Sense and Hailie Sensor share the same intended use—recording MDI actuation and technique data for clinical assessment—and employ the same overall design principle of wireless data capture and mobile app delivery. Although the sensor technologies differ (force/acceleration/airflow versus optical/induction/motion/flow), both achieve the same functional output of monitoring usage and technique. The predicate's non-clinical testing (biocompatibility, electrical safety, EMD, software validation) was replicated for HeroTracker Sense with passing results, and performance testing confirmed compatibility with the specified MDI inhalers. Since the technological differences do not raise new safety or effectiveness concerns and the device meets the same performance standards, substantial equivalence is established.