AirSurgN Insufflator (10030/AirSurgN)

The AirSurgN Insufflator is a microprocessor-based CO2 insufflator used during diagnostic and therapeutic laparoscopic procedures to distend the abdominal cavity and maintain pneumoperitoneum. It features an LCD touchscreen interface for user control of pressure (1-30 mmHg) and flow rate (1-50 L/min), includes automatic pressure relief, and provides vacuum-based smoke evacuation functionality.

The AirSurgN Insufflator matches its predicate device (PNEUMOCLEAR K170784) in distension medium (CO2), user interface type (LCD touchscreen), flow range (1-50 L/min), pressure range (1-30 mmHg), automatic pressure relief, electrical compliance (100-240 VAC), and safety/EMC standards. Key differences are that the subject device omits indications for pediatric use and additional cavity types (saphenous vein, colon, rectum), does not include tubing in the package, and has slightly smaller physical dimensions.

IEC 60601-1:2005/AI:2012 and ANSI/AAMI ES60601-1:2005(R)2012 for electrical safety; IEC 60601-1-2 Edition 4.1 En:2020-09 for electromagnetic compatibility; IEC 62304:2006/A1:2016 for software life cycle processes; and the 2023 FDA Guidance on device software functions.

Both devices are CO2 insufflators with identical core functionality for abdominal cavity insufflation during laparoscopic surgery. The subject device has reduced scope (abdominal cavity only, no pediatric modes) compared to the predicate, which does not create new safety or effectiveness questions but rather demonstrates a subset of functionality. Performance testing shows equivalent or superior results in pressure accuracy, flow delivery, volume accuracy, transient leaks, and overpressure response compared to the predicate, supporting the conclusion that differences in mode selection, tubing packaging, and device size do not raise different safety or effectiveness concerns.