DCM (PW-DCM)

The DCM (PW-DCM) is a wrist-worn activity monitor that continuously records physical movement data using a triaxial accelerometer. It is designed for physiological monitoring applications including sleep activity tracking, circadian rhythm analysis, and general quantifiable motion assessment in adult patients only. The device transmits data via a mobile app to a cloud platform where healthcare professionals access results through a web-based dashboard.

The DCM uses a triaxial MEMS accelerometer with 0.061 mg/LSB sensitivity and ±2g dynamic range operating at 12.5 Hz, powered by a lithium coin-cell battery. The biosensor mounts on an EKG electrode or wrist strap and communicates wirelessly to an off-the-shelf mobile device running the DCM app, which relays data to cloud storage. The predicate Actigraph LEAP also uses triaxial MEMS acceleration measurement in 3 axes, mounted on wrist-worn hardware, though with different technical specifications (3 mg/LSB sensitivity, ±8g range, 32-256 Hz frequency).

Testing included IEC 62366-1 (usability), IEC 60601-1-2 (EMC), 47 CFR Part 15 Subpart B (electromagnetic emissions), ANSI C63.27 (wireless coexistence), 47 CFR 15.247 (spurious emissions), IEC 60601-1 and IEC 60601-1-11 (electrical safety), and IEC 62304 (software development lifecycle).

Both devices measure linear acceleration in 3 axes to quantify physical movement in wrist-worn form for adult patients using continuous retrospective monitoring. They share identical indications for use (physiological monitoring, sleep activity, circadian rhythm analysis) and prescription classification. Although the DCM has different technical specifications (lower sensitivity, narrower range, lower frequency), these represent equivalent performance ranges suitable for the same intended purpose. Both employ triaxial MEMS accelerometry, non-sterile delivery, and lack respiratory rate measurement, apnea claims, or patient alarms—establishing technological equivalence despite implementation differences.