MotiliCap GI Monitoring System

The MotiliCap GI Monitoring System is a capsule-based device that measures pressure, pH, and temperature in the gastrointestinal tract to determine transit times through the stomach, small bowel, and colon. It is used to evaluate motility disorders including gastroparesis, dyspepsia, and chronic constipation in adult patients, with data collected via a data recorder and analyzed through computer software and smartphone app.

The MotiliCap system consists of a single-use capsule with integrated pressure, pH, and temperature sensors; a data recorder to capture transmitted data; MotiliScan software for data processing and motility index calculation; and a smartphone app for connection status and capsule monitoring. These components are technologically identical to the SmartPill predicate device, with the primary difference being use of a smartphone app versus a dedicated data recorder for event capture.

Not stated in this summary. The document references compliance testing including battery life and safety, pH and temperature and pressure accuracy, FCC data transmission, bite test, pH resistance, bioburden, biocompatibility, EMC testing, transit simulation, and shelf-life testing, but does not cite specific consensus standards (ISO, IEC, ASTM).

The MotiliCap and SmartPill devices share identical indications for use and technological characteristics—both measure the same parameters (pressure, pH, temperature) using a capsule with three integrated sensors to calculate gastric, small bowel, and colonic transit times. Because the devices are equivalent in function, intended use, and mechanism of action, and the MotiliCap demonstrated compliance with applicable bench testing requirements including sensor accuracy and safety standards, substantial equivalence is supported by technological parity rather than requiring new clinical data.