SACCADOMETER PLUS, SACCADOMETER ADVANCED

K152890 · Ober Consulting Sp. Z.O.O. · HLL · Aug 11, 2016 · Ophthalmic

Device Facts

• Record ID: K152890
• Device Name: SACCADOMETER PLUS, SACCADOMETER ADVANCED
• Applicant: Ober Consulting Sp. Z.O.O.
• Product Code: HLL · Ophthalmic
• Decision Date: Aug 11, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1510
• Device Class: Class 2

Indications for 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 Story

Saccadometer Plus and Advanced are head-worn devices for measuring horizontal eye movement latency. The device uses infrared (IR) LEDs to illuminate the eye orbit and photodetectors to measure IR light reflected from the corneal bulge and limbus. Integrated miniature laser projectors provide visual targets for the patient to follow. The system captures eye position data at 1kHz. Data is processed by the LatencyMeter software to identify saccadic refixation responses and calculate time delays. The device is intended for prescription use in a clinical setting. Healthcare providers use the output to assess saccadic performance, which aids in evaluating oculomotor function. The device benefits patients by providing objective, quantitative data on eye movement timing.

Clinical Evidence

No clinical trials were conducted in the United States. Performance data includes bench testing and non-US studies. Algorithmic verification using a photoelectric simulator demonstrated a mean absolute error in saccadic latency measurement of <2 ms. Linearity and spatial resolution were evaluated in 12 subjects (ages 22-69), confirming resolution of 5 arcmin or better. Reliability was assessed in 17 subjects (ages 22-69) via test-retest studies, showing high reliability and no significant within-session differences. Biocompatibility, electrical safety (IEC 60601-1), and photobiological safety (IEC 62471) testing were performed.

Technological Characteristics

Materials: Polyamide/synthetic rubber (OEKO-TEX 100), silicone, M90 acetal (POM), PVC. Sensing: Infrared (940 nm) reflection from corneal bulge/limbus. Sampling: 1kHz. Bandwidth: 0-200 Hz (-3dB). Connectivity: Optical fiber to USB. Power: 2 x 1.5V AA batteries. Form factor: Head-worn sensor with integrated laser projectors. Software: LatencyMeter application.

Indications for Use

Indicated for measuring temporal characteristics of saccadic refixation responses and identifying individual time delays of eye movements toward lateral visual stimuli in patients requiring clinical assessment of saccadic latency.

Regulatory Classification

Identification

An eye movement monitor is an AC-powered device with an electrode intended to measure and record ocular movements.

Predicate Devices

• Permobil Meditech, Ober2 (K902954)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles three human profiles facing right, stacked on top of each other, with a stylized wing-like shape extending from the top profile.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 11, 2016

Ober Consulting Sp. Z.o.o. Mr. Jan Krzysztof Ober Brzechwy 6, 60-195 Poznan Poland

Re: K152890 Trade/Device Name: Saccadometer Plus and Saccadometer Advanced Regulation Number: 21 CFR 886.1510 Regulation Name: Eye Movement Monitor Regulatory Class: Class II Product Code: HLL Dated: July 8, 2016 Received: July 11, 2016

Dear Mr. Ober:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Alexander

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K152890

Device Name Trade / family name: Saccadometer model name: Plus, Advanced

#### Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) Summary

## 06 July 2016

# I. SUBMITTER

Submitter's contact: Mr. Jan Krzysztof Ober Submitter's name: Ober Consulting sp. z o.o. Submitter address and contact data: Brzechwy 6, 60-195 Poznan Poland [phone] [e-mail]

# II. DEVICE

There is no prior submission for the device. The assigned 510(k) number is K152890/S001.

Proprietary name: Saccadometer Plus, Saccadometer Advanced

Common or usual name: Saccadometer

Classification name: EYE MOVEMENT MONITOR (21 CFR 886.1510)

Classification code: HLL

# III. PREDICATE DEVICE

Permobil Meditech, Ober2, K902954

# VI. 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

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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

Saccadometer's control unit is made of ABS material and it is not used by the tested subject. Saccadometer uses only three materials that have direct contact with head skin:

- a) Elastic tape with OEKO-TEX 100 certificate
- b) Silicone nose pads
- c) Ring made from M90 acetal (POM) homopolymer plastic
- d) Flex flat cable insulation material: polyvinyl chloride (PVC)

Saccadometers are supplied in a plastic non sterile boxes filled with a sponge for mechanical safety.

Saccadometer is non sterile device and cannot be sterilized with high temperature processes.

The device is worn on head so it have direct contact with the skin, hairs and sweat. The proper method for cleaning Saccadometer surfaces (having contact with skin) is the disinfection with the use of cotton wipe moistured with ethyl alcohol.

Saccadometer Plus and Saccadometer Advanced is Rx only device. Manual includes the information that the device is for prescription only. The label with the statement (Rx Only) is placed on control unit of Saccadometer (small label) as well as the on plastic box in which Saccadometer is supplied (large label). Device is also labeled by Laser warning label (placed on sensor), Laser class label (sensor), Serial number label (control unit, box), Laser details label on control unit and box, Battery label (control unit, box).

### V. INDICATION FOR USE

### Indication for 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.

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# VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Ober Consulting has determined that the Saccadometer Plus and Saccadometer Advanced is substantially equivalent to the predicate device Permobil Meditech Ober2.The main similarity between Saccadometer Plus/Advanced and Permobil Meditech Ober2 is the same infrared technology used to capture horizontal axis eye movements data with the same high 1kHz sampling rate. The eye movement sensor uses the same material - the PCB board, for carrying the IR illuminators, photodetectors and electronics for signal amplification and IR illumination control.

There are following differences between Saccadometer and Permobil Meditech Ober2:

- Ober2 can be used with any external stimuli source,

- Saccadometer Plus/Advanced have its own miniature laser spot projectors providing fixed separation stimuli angle and is specially designed for measuring latency of eyes movements in response to visually stimuli.

Saccadometer Plus/Advanced design provides higher electrical safety standards from its predicate by using low voltage AA batteries (no connection to AC supply) and by using optical fiber isolation from computer's USB port when uploading eye movements data.

## VII. PERFORMANCE DATA

Following performance data were provided in support the substantial equivalence determination.

### Biocompatibility testing

Primary component that have direct contact with forehead skin (a) is made from polyamide 86,5% and synthetic rubber 13,5% and have OEKO-TEX 100, that means it is free of harmful substances and meet human-ecological requirements for product with direct skin contact. The other materials include silicone nose pads (b) which have contact with nose bridge skin and flex flat cable made form PVC which can touch ear skin, head skin or hairs.

Saccadometer Plus/Advanced utilizes the materials that were used in Ober2. No new issues of safety or effectiveness are introduced by using Saccadometer device.

### Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on Saccadometer Plus and Saccadometer Advanced. The Saccadometer Plus and Saccadometer Advanced, complies with standard IEC 60601-1.IEC standards for safety and the 60601-1-2:2014 (emission and immunity).

# Dimension Stability of Saccadometer Enclosure in High Temperature

Saccadometer housing was exposed to a temperature of 70 deg of 7 hours duration. High temperatures did not significantly change the dimensions of the enclosure

### Infrared (IR) photoemission analysis

Saccadometer is using the eye movement measuring technology, based on infrared illumination. For this reason we evaluated the effects of the used radiation (940 nm) on the safety of the person whose eye movement is measured. Our calculations and measurements are based on IEC

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62471 standard: "Photobiological safety of lamps and lamp systems". Both corneal and retinal exposure are at safe level.

## Lasers safety

Power of the lasers doesn't exceed the Class II and is verified at the stage of designing and manufacturing..

### Experimental verification of the saccade detection algorithm

To verify the correctness of the Saccadometer algorithm for automatic saccade detection and measurement of saccadic latency we developed test environment, allowing to simulate the saccade response with given parameters on the photoelectric converter. Beside the evaluation of the latency measurement error we decided also to assess the impact of changes of pseudosaccade parameters on this error. The results showed that the mean absolute error of saccadic latency measurement is below 2 ms. The influence of parameters of pseudosaccade course (amplitude, rising edge, trigger to slope delay-simulated latency) changes on the latency of measurement error is also below the value 1ms.

### Measurement linearity testing

Evaluation of linearity was performed based on the results of 12 subjects aged 22-69. Studies were performed only outside United States. The experiment was performed in the dark room using the head immobilization, visual stimuli was displayed on the LCD screen. Target was displayed randomly in one of 15 possible (0, ±5, ±20, ±25, ±30, ±35) horizontal location, subjects were asked to move their gaze following the target displacements.

Results showed that mean averaged maximal linearity error for range ±15 degree. Linearity error increased with the increase of measurement ranges, however it needs to notice that human fixation is not ideally accurate and it is characterized by the error ±0,3 degree.

Moreover it requires to point that experiments implemented on Saccadometer Plus/Advanced, require only ±10 degree of measurement range.

## Spatial resolution of eve movement measurement

Resolution of measurement was calculated for eye position data of 12 subjects (aged 22-69), which took part in measurement linearity testing. All gathered results were within the declared measurement resolution (5 arcmin or better).

### Temporal resolution and bandwith

The Saccadometer's eye movement measurement bandwith was measured using optical simulator described in "Experimental verification of the saccade detection algorithm". Simulator's IR emitters were driven by sinusoidal wave of controlled frequency. Amplitude change in digitized signal was observed. According to achieved results Saccadometer's eye movement measurement bandwidth (defined as -3dB amplitude loss) is 0 - 200 Hz. Measurement temporal resolution - digitized signal output rate- is 1000 Hz.

# Reliability study

Step task experiment (100 trials) was performed on 17 subjects aged 22-69. Studied performed only outside United States. The same experiment was repeated after 5 minutes break (test and

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after 5 minutest retest). For every person we calculated (using LatencyMeter software) mean saccadic latency and coefficient of variation (CV) as well as mean saccadic duration for test and retest results. We evaluated test-retest reliability, between-session effect, as well as withinsession effects. Evaluation of within-session effect was performed only on the results of first measurement (test). Analysis did not revealed any significant difference between the saccadic parameters measured in the test experiment. Results showed high test-retest reliability and did not differ within the session.

## Summary

Results of conducted studies demonstrate that the safety and effectiveness profile of Saccadometer is similar to the predicate device.

## VIII. CONCLUSIONS

Based upon the 510(k) summaries and statements (21 CFR 807) and information provided herein, Ober Consulting conclude that the Saccadometer Plus and Saccadometer Advanced are substantially equivalent to the predicate device under the Federal Food, Drug and Cosmetic Act. Conducted studies reveled that Saccadometer allows the safe and effective measurement of temporal characteristics of saccadic refixation responses.