ENDOFLATOR +

The ENDOFLATOR + is a CO2 insufflator device with integrated smoke evacuation designed for diagnostic and therapeutic endoscopic procedures. It fills and distends body cavities with CO2 gas and offers four operating modes: High Flow, Pediatric, EVH (endoscopic vessel harvesting), and taTME (transanal total mesorectal excision). The device features a touchscreen interface and is compatible with multiple tubing sets offering optional heating and humidification.

The subject device has the same core design as the predicate (high/low pressure units, safety valve, gas heater, control hardware, smoke evacuation unit) with identical maximum pressure (30 mmHg) and flow specifications (50 L/min insufflation, 12 L/min smoke evacuation). Key differences include slightly different dimensions (370 x 150 x 305 mm vs. 318 x 149 x 429 mm), five tubing set options (UI610-UI614) versus the predicate's four, and inclusion of a humidification-only option (UI614) unique to the subject device. Both support heating, humidification, and smoke evacuation functions.

ISO 11135 (sterilization), ISO 10993-7, IEC 60601-1 (2020), IEC 60601-1-6 (2020), IEC 60601-2-18 (2009), ASTM D4169, D4332, D4728, D5276, D6344, D999-08, F88, F1140, F1886, F1929, F2096, and DIN 58953-6. Software validation followed FDA guidance on premarket submissions for device software functions; cybersecurity was evaluated per FDA guidance.

The subject device shares identical intended use with the predicate across all four operating modes (High Flow, Pediatric, EVH, taTME) and target population (adults and pediatrics aged 2+). Design features are substantially equivalent, with the same pressure, flow, heating, and smoke evacuation capabilities. Performance testing confirms all user modes and functions (including new humidification-only option) perform safely and effectively. Differences in tubing sets and minor dimensional changes do not raise different safety or effectiveness questions because the core mechanism, operational principles, and clinical application remain substantially equivalent to the predicate device.