Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad)

The Thermogard HQ and XP Temperature Management Systems with VitalTemp Universal Pad provide therapeutic cooling to patients 2 years and older by recirculating cold fluid through a single-use disposable surface pad placed on the patient's skin. The system is designed for temperature reduction in hyperthermic patients where clinically indicated.

The subject device and predicate share identical thermal regulating functionality, non-invasive surface cooling with patient skin contact, single-use disposable pads, temperature monitoring via probe, and removal of thermal energy from the patient. The key difference is the subject device adds pediatric surface cooling capability (ages 2+) while the predicate does not.

Not stated in this summary.

The Thermogard system with VitalTemp Universal Pad is substantially equivalent to the predicate device (K231182) because both share the same mechanism of action for temperature reduction, identical technological characteristics, non-invasive design, and intended use. Performance testing including dimensional verification, functional testing, temperature/flow/pressure analysis, and standards testing for electrical safety and biocompatibility confirmed equivalent operation with no new safety or effectiveness concerns.