Origin™

The Origin™ system is an inline biosensor that continuously monitors the pH of surgical wound drainage fluid during postoperative recovery in hospitals. It consists of an inline device placed between a drainage catheter and reservoir, connected via Bluetooth to a mobile app that displays and analyzes the pH data. The device provides additional information on effluent characteristics but is not intended to diagnose or treat any clinical condition.

Origin™ uses an ion-sensitive field-effect transistor (ISFET) pH electrode with Ag/AgCl reference and 1-point liquid calibration, versus the predicate's glass ion-sensitive electrode (ISE) with 2-point calibration. Origin™ measures continuously from drain effluent (5-9 pH range) with 0.01 pH resolution on a battery-powered point-of-care device, whereas the predicate measures discrete samples (7-7.5 pH) with 0.001 pH resolution in a wall-powered laboratory setting. Both use potentiometric pH measurement principles.

IEC 62304:2006, IEC 60601-1:2005, IEC 60601-1-2:2014, IEC 61010-1:2010, IEC 61326-2-6:2020. CLSI EP05-A3 (precision), EP06 (linearity), EP07 (interference), EP09c (method comparison), EP37, and EP39 were referenced for analytical testing.

Both devices measure pH using potentiometric measurement with the same reference electrode, and the submission demonstrates equivalent analytical performance through precision testing (repeatability and within-lab precision <2.1% CV), linearity across the operating range (≤0.1446 pH units deviation), absence of significant interference from clinically relevant substances, and method comparison showing strong correlation (r² ≥0.576) with acceptable bias (≤0.251 pH units). Although Origin™ differs by using ISFET technology, continuous sampling, and point-of-care deployment versus the predicate's discrete laboratory measurements, the submission argues these differences do not raise new safety or efficacy questions because the underlying measurement principle is the same and analytical performance is demonstrated as equivalent.