| Device |
adjunctive pain measurement device for anesthesiology |
| 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 |
|---|
| Product Code | QVE |
|---|
| Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Division of Anesthesia, Respiratory, and Sleep Devices
(DHT1C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
868.2200
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
|
|
