EyeBOX
Basic Information
- Brand Name
- EyeBOX
- Primary DI
- 00810051680003
- Version / Model
- OCL 02.5
- Company Name
- Oculogica Inc.
- Labeler DUNS
- 078866200
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-21
- Public Version
- 2
- Public Version Date
- 2021-10-19
- Public Version Status
- Update
- Public Device Record Key
- 1b115526-476b-47f6-92d7-147dbd86263d
Device Description
Oculogica’s EyeBOX uses eye-tracking technology and a data processing algorithm to detect subtle changes in eye movements resulting from concussion. The eye tracking task involves watching a video move around the perimeter of an LCD monitor positioned in front of the patient while a high speed near- infrared (IR) camera records gaze positions. The post-processed data are analyzed automatically to produce one or more outcome measures. The device is comprised of a host PC with integrated touchscreen interface for the operator, eye tracking camera, LCD stimulus screen and head-stabilizing rest (chin rest and forehead rest) for the patient, and data processing algorithm. The EyeBOX device tracks a patient’s eye movement and calculates a BOX Score ranging from 0-20. A score of less than 10 is a negative result, while a score of greater than or equal to 10 indicates a positive result.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QEA | Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid | Neurology | 882.1455 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65064 | Eye-tracking neurological/brain injury assessment device | An electrically-powered unit intended to measure and analyse eye movement to assist in the diagnosis/assessment of a neurological disorder [e.g., autism spectrum disorder (ASD), attention-deficit hyperactivity disorder (ADHD), dementia] or potential traumatic brain injury (e.g., concussion). It includes visual stimuli (e.g., videos) and devices for sensing/tracking eye movement (e.g., infrared cameras), dedicated software for analysing results and providing management guidelines, and a user interface for viewing/input. It is intended to be used by a healthcare professional in a clinical setting. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810051680003 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201841 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal