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510(k) Data Aggregation
K Number
K222484Device Name
Retitrack
Manufacturer
C. Light Technologies, Inc.
Date Cleared
2023-05-09
(265 days)
Product Code
HLL
Regulation Number
886.1510Why did this record match?
Product Code :
HLL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Retitrack™ is intended for recording, viewing, and analyzing temporal characteristics of fixation and saccadic responses when viewing a visual stimulus. The Retitrack™ is intended for use by healthcare practitioners in healthcare settings (e.g., physician's office, clinic, laboratory).
Device Description
The Retitrack™ is a monocular, bench-top saccadometer that incorporates scanning laser ophthalmoscope (SLO) technology and eye tracking software to record, view, measure, and analyze eye motion. The Retitrack™ is comprised of an optical head containing an illumination system and an optical system; a base unit with a computer, electronics, and a power distribution system; connections for external input/output devices (e.g., monitor, keyboard, mouse, and storage media); a patient forehead and chin rest; and operational software.
The Retitrack™ interacts with the patient by directing light from an infrared (840 nm) superluminescent diode (SLD) into the patient's eye. The only parts of the device that contact the patient are the forehead and chin rest with adjustable temple pads and an optional attachable head strap to stabilize the patient's head.
The Retitrack™ uses the SLD light to scan the patient's retina in two dimensions while the patient is viewing a visual stimulus. The optical imaging system detects the reflected (or returned) light from the retina and creates high-resolution, digital retinal video sequences over time. The eye tracking software uses eye motion corrected frames to measure the translational retinal movement over time. The device displays the analysis of the eye motion results and saves the retinal video and a report. The Retitrack™ does not provide a diagnosis or treatment recommendation.
The Retitrack™ has separate tests that measure fixation stability (including microsaccades and drift) and visually guided horizontal saccade tracking. The Retitrack™ can be programmed by the user with specific visual stimuli presentations, including a single fixed stimulus to measure fixation stability or two alternating stimuli in different orientations to measure horizontal saccades. For the fixation stability test, the Retitrack™ analyzes the fixation responses, including microsaccade amplitude, microsaccade frequency, microsaccade velocity, drift velocity, and drift ratio over time. For the saccade tracking tests, the Retitrack™ analyzes the saccadic responses, including duration, amplitude, target accuracy, latency, and velocity.
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K Number
K152890Device Name
SACCADOMETER PLUS, SACCADOMETER ADVANCED
Manufacturer
OBER CONSULTING SP. Z.O.O.
Date Cleared
2016-08-11
(316 days)
Product Code
HLL
Regulation Number
886.1510Why did this record match?
Product Code :
HLL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Measuring temporal characteristics of saccadic refixation responses when viewing lateral visual stimulus and identifying the individual time delays of moving the eyes toward the stimuli.
Device Description
The Saccadometer 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 Plus is equipped with three red laser projectors with 10° separation. Saccadometer Advanced has additional extra green laser and it allows to perform more complex saccadic task. Information about eye movement is acquired by analyzing the infrared light reflected from eye orbit. The left and right eve orbit are illuminated by two infrared LEDs, providing eve surface irradiance below 1mW/cm-(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. The 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. The Saccadometer Plus and Saccadometer Advanced systems are composed of: - proprietary hardware and firmware, enclosed in - examination control unit with 2 x 1.5V AA batteries, and the - eye movement sensor with integrated miniature laser spot projectors - proprietary software application LatencyMeter. - optical fiber to USB data transmitter
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K Number
K033949Device Name
VARILUX VISIONPRINT SYSTEM (VPS)
Manufacturer
ESSILOR INTL.
Date Cleared
2004-07-02
(196 days)
Product Code
HLL
Regulation Number
886.1510Why did this record match?
Product Code :
HLL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VPS is a non-invasive ultrasonic device intended to measure the pattern of eye and head movement when viewing lateral visual stimulus, to use as a guide for prescribing progressive power eyeglass lenses.
Device Description
The VPS is a non-invasive ultrasonic device intended to measure the pattern of eye and head movement when viewing lateral LED fixation lamps. It consists of a headset and a main body with an ultrasonic transmitter. Two ultrasonic receivers are imbedded in the center nosepiece of the headset. The patient wears the headset and looks at three orange LED fixation lamps in the main body as they light up in succession. As the patient follows the lights from side to side, the device measures the degree of head movement from the center light against a target angle of 40° and a standard deviation. Eye movement is extrapolated to fill the remaining vision angle. The calculated ratio of head/eye movement is used to determine the shape of the peripheral and central fields of the progressive spectacle lenses.
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