G0 Blood Pressure Monitoring System (G0)

The Aktiia G0 Blood Pressure Monitoring System is a wrist-worn device that measures blood pressure and pulse rate using photoplethysmography (PPG) technology. It consists of a bracelet with optical sensors, a charger, an oscillometric cuff (Aktiia Init I1) for calibration, a mobile app, and cloud-based software. The system is intended for spot-checking blood pressure in adults aged 22–59 years at home after an initial calibration every 24 hours using the oscillometric cuff.

Both the G0 device and predicate (BB-613WP) use PPG optical sensing and Bluetooth wireless technology for data transmission. The key difference is that G0 uses a green LED for PPG signal acquisition while the predicate uses red and infrared LEDs; both employ similar pulse-wave-based algorithms for blood pressure estimation. The G0 algorithm and data storage reside on a cloud server rather than embedded on the device itself, whereas the predicate stores data locally, but both achieve equivalent blood pressure and pulse rate accuracy per ISO 81060-2.

ISO 81060-2 (Non-invasive sphygmomanometers clinical validation); IEC 60601-1 and IEC 60601-1-2 (electrical safety and electromagnetic compatibility); IEC 60601-2-30 (automated non-invasive sphygmomanometers); IEC 62471 (photobiological safety); IEC 62366 and AMD1:2020 (usability); ISO 10993-1 (biocompatibility); IEC 62304 (software lifecycle); IEC 60601-1-11 (home healthcare environment); ISED 300238 (radio emissions).

The G0 and predicate devices have substantially similar indications for use (spot-check blood pressure and pulse rate measurement for home use in adults), employ the same core sensing principle (optical PPG technology), and use comparable pulse-wave-based algorithms to convert optical signals to blood pressure data. Clinical testing per ISO 81060-2 demonstrated that G0 achieves equivalent accuracy and precision to the predicate. Although G0 uses green rather than red/infrared LEDs and processes data on a cloud server rather than locally, these differences do not raise new safety or effectiveness questions, and safety testing confirmed equivalence. The minor technological differences do not alter the fundamental intended use or clinical performance.