Hot Pink Pad Warming System

The Hot Pink Pad Warming System is a non-sterile, electrically conductive patient warming device with adjustable temperature control (36.0°C to 40.0°C in 0.5°C increments) designed to assist in patient temperature management and prevent inadvertent hypothermia during surgical procedures. It consists of a reusable controller with display panel, a reusable signal cable, and a single-use foam warming pad, intended for use in hospitals and surgery centers for adult and pediatric patients (excluding neonates).

The subject device uses resistive conductive heating via a single-use foam pad (versus the predicate's reusable fabric-covered pad), has one controller output (versus the predicate's two outputs), and operates on mains power only (versus the predicate's mains with optional battery). Both devices feature multiple integrated temperature sensors, visual/audible alarms, automatic shutoff with overtemperature protection, setpoint control via display panel, and universal control unit mounting.

IEC 60601-1, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-2-35 (safety); IEC 60601-1-2 (EMC); IEC 62304 (software verification and validation); IEC 60601-1-6 and IEC 62366-1 (human factors validation); cleaning and disinfection validation testing per reprocessing requirements.

Both devices are non-invasive patient warming systems with identical intended use, use environment, and patient population (adult/pediatric, excluding neonatal). They share the same regulatory classification (Class II, 21 CFR 870.5900, product code DWJ), heating mechanism, temperature sensor implementation, and safety features. Differences in applied part material (single-use versus reusable) and controller outputs represent acceptable variations mitigated by risk analysis and safety testing, with the single-use pad actually presenting lower cross-contamination risk.