(25 days)
The WarmTouch Patient Warming System (warming unit and blanket) is intended for prevention and treatment of hypothermia and/or shivering in the critical care environment.
The Warm Touch® CareDrape™ Cardiac Blanket is similar to the CareDrape™ Lower Body Blanket in use, as both are used in the operating room to help manage the patient's body temperature. The WarmTouch® CareDrape™ Cardiac Blanket is similar to the CareQuilt™ Full Body/ Multi-Access Warming Blanket, as both are equipped with slits, which can be opened for access to the patient through the blanket. The kev difference between the Cardiac Blanket and all earlier WarmTouch® blankets is that the Cardiac Blanket is sterile permitting use of the blanket within the sterile field.
The provided text describes performance testing for a medical device (WarmTouch® CareDrape™ Cardiac Blanket) to demonstrate its substantial equivalence. The document is a 510(k) summary, which focuses on device-specific physical and functional characteristics rather than clinical AI algorithm performance. Therefore, many of the requested categories related to AI performance, such as human experts, ground truth establishment, training sets, and AI assistance effect sizes, are not applicable to this submission.
Here's an analysis based on the provided text:
Acceptance Criteria and Reported Device Performance
Acceptance Criteria | Reported Device Performance |
---|---|
Maximum Temperature delivered to patient | Maintained a maximum temperature of 40.5°C |
Temperature Range across blanket area | Temperature difference of |
§ 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).