Fecobionics Anorectal System

The Fecobionics Anorectal System is a portable, battery-powered anorectal manometry device for adult patients requiring pressure studies and defecatory function testing. It consists of a single-use disposable probe (AR-100), a reusable data hub (DH-100), and software (Fecotracker App), and enables evaluation of rectal sensitivity, rectal volume and shape, recto-anal inhibitory reflex, anal diameter during defecation, defecatory push pressure, and anorectal angle changes.

The Fecobionics probe is bendable with embedded sensors and batteries inside a saline-filled bag (vs. the predicate's stiff catheter with air-filled balloons). It provides real-time geometric mapping and manometric profile data in a single examination. The probe transmits data wirelessly via RF to the data hub, then Wi-Fi to the app (vs. wired transmission and Bluetooth in the predicate). Both systems are non-sterile, single-use probes with reusable console components intended for clinical diagnostic use in adults.

ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-23 (biocompatibility); IEC 60601-1 (electrical safety); IEC 60601-1-2 (electromagnetic compatibility); IEC 62304 (software verification and validation). Clinical testing included a non-significant risk, observational, randomized study on 10 patients.

Both devices share the same product code (KLA), regulatory class (Class II), and intended use for anorectal manometry in adult patients. Although the Fecobionics probe is bendable with saline-filled configuration versus the predicate's stiff air-filled design, these differences do not raise new safety or efficacy questions because both measure the same parameters (pressure, sensation, RAIR) using equivalent mechanical principles. Performance testing and a clinical study demonstrated the Fecobionics achieves comparable accuracy and results to the predicate, with no safety concerns identified.