ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C

The ATMOS C 051 Thorax is a portable, battery-powered thoracic drainage system for removing surgical fluids, gases, and infectious material from a patient's respiratory system after surgery. It features digital monitoring with optical and acoustic alerts, operates mains-independently, and includes a rechargeable battery with internal charging unit. The system works in combination with a sterile secretion canister and hose system to create vacuum drainage in the pleural cavity.

The ATMOS C 051 Thorax shares the same operation principle, vacuum control mechanism, and maximum vacuum specifications as the predicate ATMOS S 201 Thorax. Key differences include: smaller 800 ml secretion canister versus 2 L in predicate; lighter weight at 1.16 kg versus 3.27 kg; lower free flow rate of 5 ±0.5 L/min versus 18 ±2 L/min; and capability for home use, which the predicate does not support.

Testing followed IEC 60601-1, IEC 60601-1-2, and IEC 60601-4-2 for electrical and thermal safety; ISO 10993-1 for biocompatibility; IEC 62366-1:2015 and IEC 60601-1-6:2010 for human factors and usability; ISO 14971:2019 for risk management; and ISO 11135 for sterilization validation of single-use components.

Although the subject device is smaller, lighter, has lower pump performance, and enables home use compared to the predicate, the applicant demonstrated through performance testing, risk analysis, and human factors validation that these differences do not raise new or different safety and effectiveness questions. The same intended use (thoracic drainage), identical operation principles, vacuum control mechanisms, and design specifications, combined with successful completion of all verification, validation, and risk management activities, establish substantial equivalence despite the technological modifications.