OxyMinder Pro (10310)

The OxyMinder Pro is an oxygen and pressure monitor that measures oxygen concentration (18-100%) and airway pressure (0-60 cmH₂O) for continuous monitoring in hospital and subacute settings. It is intended for patients ranging from newborns to adults and is designed to be mechanically mounted on an air/oxygen blender. The device is not intended as a life-supporting device or for diagnostics.

The device uses a galvanic fuel cell oxygen sensor (Analytical Industries PSR-11-917-J10) identical to the reference device and a pressure transducer with disposable pressure tubing identical to the predicate. Oxygen measurement range is 18-100% with ±1% accuracy; pressure range is 0-60 cmH₂O with ±0.5 cmH₂O accuracy. It includes alarm systems for low/high oxygen and pressure, scheduled auto-purge functionality, and operates on external DC power with internal rechargeable lithium-ion battery.

IEC 60601-1 (general safety), IEC 60601-1-2 (electromagnetic compatibility), IEC 60601-1-8 (alarms), and IEC 80601-2-55 (oxygen analyzers). Additional testing included shelf-life/aging, software verification and validation, oxygen accuracy with blender, and battery performance testing.

The OxyMinder Pro is substantially equivalent to the predicate Maxtec MaxO2ME+p (K221734) because both devices measure oxygen and pressure using identical sensing technologies (galvanic fuel cell and pressure transducer), have nearly identical measurement ranges and accuracy specifications, are indicated for the same patient population and clinical environments, and use the identical disposable pressure tubing. The device's only new feature—the auto-purge function—was previously cleared under reference device K213948 and mitigates gas contamination without raising new safety concerns. Performance testing demonstrated the device meets applicable standards with performance similar to the predicate, and the risk analysis identified no new or different risks.