| Device |
brain injury adjunctive interpretive oculomotor assessment aid |
| Regulation Description |
Traumatic brain injury eye movement assessment aid. |
| Definition |
A traumatic brain injury eye movement assessment aid is a prescription device that uses a patient’s tracked eye movements to provide an interpretation of the functional condition of the patient’s brain. This device is an assessment aid that is not intended for standalone detection or diagnostic purposes. |
| Physical State |
The device has a screen that displays a stimulus for the patient's eyes to follow during the exam. An eye tracking camera measures the eye movements for the duration of the exam. A computer applies an analysis algorithm to the tracked eye movements. The device may be a standalone device or implemented as a software app on a smartphone/tablet. |
| Technical Method |
Performs an analysis of a patient's tracked eye movements to assess their functional brain injury status. |
| Target Area |
The device measures eye movements to assess brain function. |
| Regulation Medical Specialty |
Neurology |
| Review Panel |
Neurology |
|---|
| Product Code | QEA |
|---|
| Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices
(DHT5A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
882.1455
|
|---|
| 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 |
