Adjunctive Pain Measurement Device For Anesthesiology
QVE · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.2200
Classification
FDA Product Code
QVE
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 868.2200
Review panel
AN
Medical specialty
Anesthesiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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 patients actual response to painful stimuli and is not intended to independently direct decision-making.