Adjunctive Pain Measurement Device For Anesthesiology
Medical specialty
Anesthesiology
Device class
2
Regulation number
868.2200
Review panel
AN
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
An adjunctive pain measurement device for anesthesiology is a prescription device that includes software algorithms to analyze physiological sensor data and measure response to painful stimuli in patients under general anesthesia. The device may be software-only or it may include hardware such as physiological sensors. This device type is intended for adjunctive use to tailor analgesic administration to a patient’s actual response to painful stimuli and is not intended to independently direct decision-making.