Saccadometer
Saccadometer Plus and Saccadometer Advanced measure horizontal eye movements and the timing of saccadic refixation responses to lateral visual stimuli. The FDA filing says measurements use…
Saccadometer Plus and Saccadometer Advanced measure horizontal eye movements and the timing of saccadic refixation responses to lateral visual stimuli. The FDA filing says measurements use infrared light reflected from the eye orbit.
Both systems include an eye-movement sensor, control unit and software. Saccadometer Plus has three red laser projectors; Saccadometer Advanced adds a green laser projector for more complex saccadic tasks.
Listed Item
The Saccadometer Adavnced system measures eye movements in horizontal axis with temporal 1kHz and spatial resolution < 5 arc min. The system incorporates a built in visual target presentation using miniature laser projectors mounted on the sensor forehead plate. Saccadometer Advanced is equipped with three red laser projectors with 10º separation and green laser located centrally over the red. Eighteen experiments are included in embedded software. The information about the eye movement is stored in a small, self-contained control unit, and can be downloaded for computer analysis at a later stage. Information about eye movement is acquired by analyzing the infrared light reflected from eye orbit. The left and right eye orbit are illuminated by two infrared LEDs, providing eye surface irradiance below 1mW/cm 2 (operating condition). Due to the conjugacy and synchronicity of the saccadic eye movements, the rotation of left and right eyes, can be added and averaged. The inner canthi of the left and right eyes are illuminated with the low intensity IR. The difference between the amounts of IR reflected back from the eye surfaces toward the photodetecting circuitry, carries the information about the eye position changes. Two eye landmarks are taking part in generation of the eye movement signal: the corneal bulge and the limbus (the border between darker iris and white sclera). Main contributor to the eye movement signal is the corneal bulge. Being the relative eye position measurement system, it requires to define the initial eye position. It means that at the beginning of every measurement, a steady eye fixation point needs to be provided. In Saccadometer the central fixation target serves this purpose.
Eye Movement Measurement
The filing states that the systems measure eye movements at a temporal sampling rate of 1 kHz. Their built-in visual targets are miniature laser projectors mounted on the sensor fo rehead plate.
Who Else Makes It
All of them in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| 66 Vision Tech Co., Ltd. | Suzhou | Jiangsu | Private-label distributor | 24 |
Record
| Listed by | Ober Consulting Sp. Z.O.O., Poland |
|---|---|
| FDA product code | HLL |
| Device type | Monitor, Eye Movement |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1510 |
| 510(k) | K152890 |
| Record published | 2017-01-26 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature 50 to 104 °F; Handling environment temperature 10 to 40 °C; Storage environment temperature 32 to 113 °F; Storage environment temperature 0 to 45 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PLUS | In distribution | |
| ADVANCED | In distribution |
Same Product Code
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K152890 | 2016-08-11 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.