Rugged Oxygen Generator (ROG) (RO01-00001)

The Rugged Oxygen Generator (ROG) is a single-use, over-the-counter chemical oxygen generator designed to produce a minimum of 90 liters of oxygen at ≥96% purity over at least 15 minutes at a 6 liter-per-minute flow rate. It is intended for emergency, home, and commercial use by individuals 17 years and older requiring emergency or supplemental oxygen, and is initiated through a friction interaction between an integrated phosphorous match and a candle block.

The subject device uses identical chemical reaction technology and principle of operation as the predicate ROG (K131016), generating oxygen via the same method. Key differences are that the subject device produces 96% oxygen purity versus the predicate's 99%, does not include oxygen tubing and mask accessories (user-supplied instead), but maintains identical flow rate (6 LPM minimum), duration (15 minutes), initiation time (5 seconds), temperature specifications, housing dimensions, and weight.

ISO 18562-2 and ISO 18562-3 biocompatibility testing were performed. Performance testing included casing and gas temperature testing, shock and vibration, drop testing, sand and rain blow testing, and flow duration validation.

The subject device is substantially equivalent because it employs the identical chemical oxygen generation technology and principle of operation as the predicate, maintains equivalent performance specifications for flow rate, duration, and initiation time, and demonstrated comparable bench test results within pre-defined acceptance criteria. The minor differences—lower oxygen purity (96% vs 99%, both exceeding USP's >93% medical oxygen standard) and user-supplied versus included accessories—do not raise new safety or effectiveness concerns since the core functional performance and intended use remain unchanged.