| Device |
pain assessment software in non-communicative adults |
| Definition |
Pain assessment software in non-communicative adults is a prescription-only device that combines information from clinical pain domains to produce an output indicative of a patient’s current level of pain in conscious adult patients who are unable to communicate their current pain level. This device is intended for adjunctive use and not intended as a stand-alone diagnostic or prognostic tool. |
| Physical State |
Contains recording hardware (e.g., video camera) and Software (e.g., used to process, analyze, display, store, or archive data). |
| Technical Method |
A device that uses facial recognition to detect facial features indicative of the presence of pain |
| Target Area |
Face |
| Regulation Medical Specialty |
Neurology |
| Review Panel |
Neurology |
|---|
| Product Code | SGB |
|---|
| Premarket Review |
Neurosurgical, Neurointerventional and Neurodiagnostic Devices
(DHT5A)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices
(DHT5A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
882.1472
|
|---|
| 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 |
|
|
