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…

Registry build 21.09.26

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.

2manufacturers in China registered for this device type
2catalogue numbers in this listing
1510(k) clearance

Who Else Makes It

All of them in Jiangsu.

Chinese manufacturers registered for FDA product code HLL
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

Regulatory record for Saccadometer
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

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 numbers for Saccadometer
Catalogue number Size Status
PLUS In distribution
ADVANCED In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Eli Ezer U.S. Ophthalmic, L.L.C. 2
Retitrack C. Light Technologies, Inc. 1

510(K) Clearances

FDA 510(k) clearances naming this product code
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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer