Celsi Warmer

The Celsi Warmer is a portable, non-invasive thermal regulating system for neonates in hospital settings. It continuously monitors skin temperature using a non-invasive probe and controls a warming mattress to maintain physician-set body temperature in neonates over 28 weeks gestational age weighing 1-4 kg.

Both the subject device and predicate use closed-loop feedback control with skin temperature probes to regulate patient temperature. The Celsi Warmer measures temperature at 0.1°C resolution over 34-42°C, operates in automatic/manual/monitor modes, and provides audio-visual alarms. The main difference is the Celsi Warmer uses a warming mattress while the predicate uses temperature-controlled water-filled blankets or wraps, but warming mattresses are an established technology for patient warming.

IEC 60601-1 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility), IEC 60601-1-8 (alarm systems), IEC 60601-1-10 (physiologic closed-loop controllers), IEC 80601-2-35 (heating blankets/pads/mattresses), ISO 80601-2-56 (clinical thermometers), ISO 10993-1, ISO 10993-5, ISO 10993-10 (biocompatibility), IEC 62304 (software lifecycle), and AAMI TIR57 (cybersecurity).

Both devices have identical intended uses—thermal treatment and temperature monitoring of patients using closed-loop skin temperature feedback. They share the same product code (DWJ), regulation (21 CFR 870.5900), components (controller, thermal transfer devices, temperature probes), temperature measurement ranges, and operating environment. The only material difference is the thermal transfer method (mattress versus water-filled blanket), which represents a known technology with no new safety or effectiveness questions. Performance testing confirmed equivalence across all measured parameters.