Atmo Gas Capsule System

The Atmo Gas Capsule System is an ingestible telemetric medical device that measures gastrointestinal transit times to evaluate motility disorders. It measures gastric emptying time (GET) for suspected gastroparesis and colonic transit time (CTT) for chronic constipation by using onboard sensors to detect temperature, hydrogen, carbon dioxide, oxygen levels, capsule tumble, and antenna reflectance as it passes through the GI tract.

The Atmo Capsule uses temperature, humidity, thermal conductivity, volatile organic compound, accelerometer, and antenna reflectometer sensors, compared to the predicate's temperature, pH, and pressure sensors. The Atmo operates at 433.9 MHz RF frequency versus the predicate's 434.2 MHz. The Atmo Capsule is smaller (27.8 mm × 11.1 mm, 3.8 g) and has longer battery life (>240 hours) than the predicate. Data flows from capsule to receiver to cloud portal, whereas the predicate uses local PC analysis. Both are single-use, non-sterile, and provide similar transit time measurements with automatic marker identification requiring manual confirmation.

Not stated in this summary.

The Atmo Gas Capsule System is substantially equivalent because it has the same intended use and indications as the SmartPill predicate—measuring GI transit times to evaluate motility disorders. Although the Atmo uses different sensors and algorithms, clinical testing in 213 participants showed Bland-Altman agreement between the two devices for GET and CTT with all pre-determined endpoints met. No serious adverse events were observed, and the safety/effectiveness profile matches the predicate. The minor differences in technological design (sensors, RF frequency, data transmission pathway) do not create new safety or effectiveness concerns and do not alter the diagnostic function.