Arctic Sun Stat Temperature Management System

The Arctic Sun Stat Temperature Management System is a non-invasive thermal regulating device that monitors and controls patient temperature between 32°C and 38.5°C in adult and pediatric patients of all ages. It circulates temperature-controlled water through ArcticGel Pads to achieve heat exchange with the patient, with a clinician-set target temperature maintained by an internal control algorithm.

The subject device is identical to the predicate in intended use, indications, target population, control processes, principle of operation, control algorithm, temperature range, and therapy modes. The primary modifications are software changes to one water temperature alarm's conditions and prioritization, plus minor software enhancements for manual mode notifications, WPA2 Enterprise Wi-Fi support, and anomaly corrections, along with related labeling updates.

Not stated in this summary. The document references that testing was performed according to internal design control procedures, software FDA Guidance documents, and applicable FDA recognized consensus standards, but does not name specific standards such as ISO, IEC, or ASTM numbers.

The device maintains substantial equivalence because all fundamental technological aspects—intended use, indications, control algorithms, temperature range, and therapy modes—remain identical to the predicate device K200225. The modifications consist only of software refinements to alarm prioritization and minor feature additions (Wi-Fi support, manual mode banner), which do not alter the core thermal regulation mechanism or clinical function. Comprehensive nonclinical testing including software verification, control accuracy, alarm functionality, and cybersecurity confirmed the modifications perform equivalently to the predicate without raising new safety or effectiveness concerns.