Portable Oxygen Concentrator (P2-TOC)

The Portable Oxygen Concentrator P2-TOC is a device that concentrates oxygen from ambient air using pressure swing adsorption with molecular sieves. It delivers supplemental low-flow oxygen to adults via a nasal cannula in either continuous or pulse-dose modes. The device is not intended for life support and provides no patient monitoring capabilities.

The P2-TOC uses pressure swing adsorption technology identical to predicate devices (CAIRE Model 1000 and Model 4000). It offers continuous flow modes of 1.0–3.0 LPM and pulse-dose modes with 5–200 mL pulse volumes. Key differences include smaller physical dimensions (11.1 × 6.7 × 15 inches vs. larger predicates), lower maximum pulse flow rates (2000 mL vs. 2400–2880 mL), slightly higher acoustic noise levels (≤60 dB), and extended battery duration (up to 9 hours vs. 5.4–5.94 hours). Oxygen concentration output is 90%–3%/+6% compared to 90%±3% in predicates.

Testing per ANSI AAMI ES60601-1:2005/A1:2012/A2:2020, IEC 60601-1-2:2020, IEC 60601-1-8:2020, ISO 80601-2-69:2020, ISO 80601-2-67:2020, ISO 18562-1/2/3:2017, ISO 10993-1/5/10/23, and IEC 62133-2:2017 for biocompatibility, electrical safety, electromagnetic compatibility, software validation, and battery performance.

The P2-TOC has the same intended use and operates via identical pressure swing adsorption technology as the predicate devices. Although dimensional, weight, flow rate, and environmental parameter differences exist, comprehensive bench testing demonstrates these differences do not raise new safety or effectiveness questions—the device complies with all applicable consensus standards (ISO 80601-2-69, IEC 60601-1, and biocompatibility standards). Performance testing shows the P2-TOC performs comparably to predicates despite narrower pulse flow ranges and slight acoustic noise increases. No clinical testing was needed because the technology, mechanism, and therapeutic function are substantially equivalent.