Portable Oxygen Concentrator (Spirit-3)

The Portable Oxygen Concentrator (Spirit-3) is a portable oxygen generator that delivers supplemental oxygen to adult patients in home, institutional, or travel environments using a nasal cannula. It operates via molecular sieve technology to concentrate oxygen from ambient air and can be powered by AC mains, DC supply, or a rechargeable lithium-ion battery.

The Spirit-3 differs from its predicate (Kingon P2-K4, P2-S4) in several ways: different patient-contact materials (PC/PMMA coextruded film and ABS housing versus Kingon's composition); slightly higher oxygen discharge pressure (150 kPa vs. 110 kPa); marginally smaller pulse bolus volume (37.5 mL vs. 42 mL at setting 4); narrower operating temperature range (10–35°C vs. 5–40°C); and different alarm features (no fan-failure or EEPROM-failure alarms). Battery duration is comparable (~5 hours at 0.21 LPM).

The device was tested against ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-1-8, IEC 60601-1-6, ISO 80601-2-69, ISO 80601-2-67, ISO 18562-2, ISO 18562-3, IEC 62133-2, ISO 10993-5/10/23, and IEC 62304. Biocompatibility testing included cytotoxicity, skin sensitization, irritation, and volatile organic compound emissions.

Although the Spirit-3 has different materials and some functional differences (e.g., alarm configuration, pressure range), these differences do not raise new safety or effectiveness concerns because: (1) biocompatibility testing confirmed material safety per ISO 10993 standards; (2) the narrower operating range is acceptable and disclosed in labeling; (3) the higher discharge pressure aligns with reference device specifications; (4) the device meets all applicable consensus standards (ISO 80601-2-67/69, IEC 62133-2); and (5) performance bench testing (oxygen concentration, flow, acoustic noise, battery duration) demonstrates equivalence to the predicate. The same intended use, patient population, principle of operation, and safety/performance endpoints establish substantial equivalence.