Last synced on 19 July 2024 at 11:05 pm

Adjunctive Pain Measurement Device For Anesthesiology

Page Type
Product Code
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.
Physical State
software/algorithm
Technical Method
Analyzes physiological sensor(s) data to calculate an index
Target Area
various
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.2200
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QVE is linked to regulation 21CFR868.2200, which does not seem to exist yet. It may be pending at the moment.

Adjunctive Pain Measurement Device For Anesthesiology

Page Type
Product Code
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.
Physical State
software/algorithm
Technical Method
Analyzes physiological sensor(s) data to calculate an index
Target Area
various
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.2200
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QVE is linked to regulation 21CFR868.2200, which does not seem to exist yet. It may be pending at the moment.