V series portable oxygen concentrator (V5, V5C, V6, V6C)

The V series portable oxygen concentrator (models V5, V5C, V6, V6C) delivers high-concentration supplemental oxygen to patients requiring respiratory therapy on a prescription basis in home, institutional, or travel settings. The device uses pressure swing adsorption with molecular sieves to concentrate oxygen and can operate in pulse dose mode (6 levels) or continuous mode (1 level at 1.2 L/min for V5C and V6C models). It is not intended for life support and provides no patient monitoring.

The device uses breath detection technology and molecular sieve/pressure swing adsorption to concentrate oxygen, similar to predicate devices. It delivers oxygen at rated flow rates from 210 mL/min (Level 1) to 1200 mL/min (Level 6) in pulse mode and 1.2 L/min in continuous mode. Oxygen purity is ≥90% at all settings with inspiratory trigger sensitivity ≤0.12 cmH2O and maximum outlet pressure <199.3 kPa. The four models differ only in firmware/software configuration of available gear settings.

IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-11, ISO 80601-2-67, ISO 80601-2-69, IEC 62133-2, ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-23, ISO 18562-1, ISO 18562-2, and ISO 18562-3 for electrical safety, EMC, biocompatibility, and breathing gas pathway evaluation.

The subject device is substantially equivalent to the Inogen Rove 6 (K230052) and Kingon P2-TOC (K242718) predicates because it shares the same indications for use, operating principle (breath detection and molecular sieve pressure swing adsorption), and similar technological characteristics. All three devices are Class II portable oxygen generators with comparable safety and performance profiles, identical product code (CAW), and compliance with the same regulatory standards. Differences in alarm descriptions, power specifications, continuous mode availability, and pulse volumes are minor and mitigated by standard compliance testing, posing no different safety or effectiveness questions.