Gastric Alimetry

The Gastric Alimetry System is a non-invasive electrogastrography (EGG) device that records, stores, views, and processes gastric myoelectrical activity to aid in diagnosing various gastric disorders. It uses disposable electrode patches applied to the abdomen, a portable reader, and an iPad app to capture and analyze stomach electrical signals. The system is indicated for patients 12 years and older and is used in healthcare facilities.

The device retains identical hardware (Alimetry Reader, Gastric Alimetry Array, Dock, iPad mini) and the same core function as the predicate. Key modifications include: replacement of the signal noise filter with a convolutional neural network (CNN) for improved artifact detection, updated channel-ranking parameters for spectral analysis, and reorganized report presentation with symptom subgrouping, visual indicators for out-of-range spectral metrics, caution statements for quality issues, and expanded Gut-Brain Wellbeing questions for adolescents aged 12–17 years.

ANSI/AAMI EC12:2000 for electrodes, IEC 60601-1 for medical electrical equipment, and IEC 60601-1-2 for electromagnetic compatibility.

The modified device is substantially equivalent because it maintains the same intended use, indications, and core technological principles as the predicate (K240946). All modifications—algorithm updates, report reorganization, and expanded wellbeing questions—are characterized as minor with no significant impact on safety or performance. Bench testing confirms the device outputs remain substantially equivalent to the predicate, and the changes raise no new safety or efficacy questions.