(158 days)
The Patient Warming System manufactured by Adroit Medical Systems is designed for the operating room (exclusive of the sterile surgical field), recovery room, anesthetic room, ICU, Medical/Surgical floors, in-hospital patient transport and emergency rooms. The Patient Warming System provides safe and controlled surface warming to assist adult patients to maintain normal body temperature.
Soft Air Patient Warming System: Blower Model SA4000 (110V) Mistral Air Patient Warming System: Blower Model MA0100 (220V) Soft Air Blankets (Non-sterile): Model 1187: Adult Full Body Model 1843: Adult Lower Body Model 1846: Adult Upper Body
This is a 510(k) clearance letter for a patient warming system (blower and blankets). This type of device is not an AI/ML powered device, and therefore the requested information regarding acceptance criteria and studies proving the device meets those criteria, specifically concerning AI/ML performance metrics, is not present in the provided text.
The letter addresses the substantial equivalence of the Soft-Air SA4000 and Mistral-Air MA0100 blanket models to legally marketed predicate devices, which is the basis for 510(k) clearance.
Therefore, I cannot provide the detailed information requested about acceptance criteria and AI/ML study specifics based on this document.
§ 870.5900 Thermal regulating system.
(a)
Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.(b)
Classification. Class II (performance standards).