DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)

The DeVilbiss PulmO2 10-Liter Oxygen Concentrator is a portable medical device that extracts nitrogen from room air using pressure swing adsorption to produce oxygen-enriched gas. It delivers supplemental oxygen at adjustable flow rates (1–10 liters per minute) to adult and pediatric patients weighing over 10 kg in home or institutional settings, and is not intended to be life-sustaining.

The device uses pressure swing adsorption with molecular sieve technology, operates on universal AC power (100–240 VAC, 50/60 Hz), delivers oxygen at 87%–96% concentration with regulated outlet pressure of 8.5 PSIG, and includes multiple safety alarms. Key differences from the predicate (JUMAO 5L/min device) include doubled flow capacity (10 vs. 5 LPM), universal power supply versus fixed voltage, and expanded alarm diagnostics, though both share identical product code (CAW) and operating principles.

Testing conducted per ISO 18562 series (breathing gas pathway biocompatibility), ISO 10993-17 (toxicological risk assessment), ISO 80601-2-69 (oxygen concentrator safety and performance), IEC 60601-1-2 (electromagnetic compatibility), IEC 60601-1-8 (alarm systems), IEC 60601-1-11 (home healthcare use), IEC 62304 (software life cycle), ANSI/AAMI/IEC 62366-1 (usability engineering), and ISTA 3A (packaging/shipment).

Substantial equivalence is established through identical product code (CAW), equivalent intended use (supplemental oxygen provision), same pressure swing adsorption technology with molecular sieves, biocompatible materials, and comprehensive performance testing demonstrating safety and effectiveness equivalent to the predicate. Technological differences (higher flow capacity, universal power, expanded alarms) do not raise new safety or effectiveness questions and are attributable to enhanced capability rather than fundamental design changes.