EyeBOX

K201841 · Oculogica, Inc. · QEA · Sep 6, 2020 · Neurology

Device Facts

• Record ID: K201841
• Device Name: EyeBOX
• Applicant: Oculogica, Inc.
• Product Code: QEA · Neurology
• Decision Date: Sep 6, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1455
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The EyeBOX is intended to measure and analyze eye movements as an aid in the diagnosis of concussion, also known as mild traumatic brain injury (mTBI), within one week of head injury in patients 5 through 67 years of age in conjunction with a standard neurological assessment of concussion. A negative EyeBOX classification may correspond to eye movement that is consistent with a lack of concussion. A positive EyeBOX classification corresponds to eye movement that may be present in both patients with or without concussion.

Device Story

EyeBOX is an eye-tracking device used in clinical settings to aid concussion diagnosis. Patient sits at device, resting chin and forehead on supports; watches video moving around perimeter of LCD monitor. High-speed near-infrared (IR) camera records gaze positions at 500 Hz. Data processing algorithm analyzes eye movements to detect subtle changes associated with concussion; produces 'BOX score' output. Healthcare provider uses output in conjunction with standard neurological assessment to assist clinical decision-making. Device benefits patient by providing objective data to support concussion diagnosis.

Clinical Evidence

Bench testing performed on artificial eye to verify spatial precision and step response. Human participant testing (N=84) conducted to demonstrate reliability of new camera and analysis in detecting blinks and gaze positions across the measured range. Software verification and user testing also performed.

Technological Characteristics

Table-top eye-tracking system; includes host PC, touchscreen, LCD stimulus screen, head/chin rest, and high-speed near-infrared (IR) camera. Connectivity includes WiFi. Standards: IEC 60601-1-2:2014 (EMC), Z80.36-2016 (Light Hazard Protection). Proprietary algorithm processes gaze data to output BOX score.

Indications for Use

Indicated for patients 5-67 years of age with suspected concussion (mTBI) within one week of head injury, used as an aid to standard neurological assessment.

Regulatory Classification

Identification

A traumatic brain injury eye movement assessment aid is a prescription device that uses a patient's tracked eye movements to provide an interpretation of the functional condition of the patient's brain. This device is an assessment aid that is not intended for standalone detection or diagnostic purposes.

Special Controls

In combination with the general controls of the FD&C Act, the traumatic brain injury eye movement assessment aid is subject to the following special controls:

*Classification.* Class II (special controls). The special controls for this device are:(1) Clinical performance data under anticipated conditions of use must evaluate tracked eye movement in supporting the indications for use and include the following: (i) Evaluation of sensitivity, specificity, positive predictive value, and negative predictive value using a reference method of diagnosis; (ii) Evaluation of device test-retest reliability; and (iii) A description of the development of the reference method of diagnosis, which may include a normative database, to include the following: (A) A discussion of how the clinical work-up was completed to establish the reference method of diagnosis, including the establishment of inclusion and exclusion criteria; and (B) If using a normative database, a description of how the “normal” population was established, and the statistical methods and model assumptions used. (2) Software verification, validation, and hazard analysis must be performed. Software documentation must include a description of the algorithms used to generate device output. (3) Performance testing must demonstrate the electrical safety and electromagnetic compatibility (EMC) of the device. (4) The patient-contacting components of the device must be demonstrated to be biocompatible. (5) A light hazard assessment must be performed for all eye-tracking and visual display light sources. (6) Labeling must include: (i) A summary of clinical performance testing conducted with the device, including sensitivity, specificity, positive predictive value, negative predictive value, and test-retest reliability; (ii) A description of any normative database that includes the following: (A) The clinical definition used to establish a “normal” population and the specific selection criteria; (B) The format for reporting normal values; (C) Examples of screen displays and reports generated to provide the user results and normative data; (D) Statistical methods and model assumptions; and (E) Any adjustments for age and gender. (iii) A warning that the device should only be used by trained healthcare professionals; (iv) A warning that the device does not identify the presence or absence of traumatic brain injury or other clinical diagnoses; (v) A warning that the device is not a standalone diagnostic; and (vi) Any instructions to convey to patients regarding the administration of the test and collection of test data.

Predicate Devices

• EyeBOX, Model OCL 02 (K191183)

Submission Summary (Full Text)

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Oculogica, Inc. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street Suite 2300 Philadelphia, Pennsylvania 19103

Re: K201841

Trade/Device Name: EyeBOX Regulation Number: 21 CFR 882.1455 Regulation Name: Traumatic brain injury eye movement assessment aid Regulatory Class: Class II Product Code: QEA Dated: July 2, 2020 Received: July 2, 2020

Dear Janice Hogan:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

Device Name

EyeBOX

Indications for Use (Describe)

The EyeBOX is intended to measure and analyze eye movements as an aid in the diagnosis of concussion, also known as mild traumatic brain injury (mTBI), within one week of head injury in patients 5 through 67 years of age in conjunction with a standard neurological assessment of concussion.

A negative EyeBOX classification may correspond to eye movement that is consistent with a lack of concussion. A positive EyeBOX classification corresponds to eye movement that may be present in both patients with or without concussion.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| <div> <span> × Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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## 510(k) Summary [21 CFR 807.92]

9/4/2020 Date Prepared: Submission Number: K201841 Submitted by: Oculogica Inc. 33 IRVING PLACE NEW YORK, NY 10003 ROSINA SAMADANI, PH.D. 484-393-2694 Subject Device Name: EyeBOX, Model OCL 02.5 EyeBOX, Model OCL 02, K191183 Predicate Device Name: Regulation Number: 21 CFR 882.1455 Traumatic brain injury eye movement assessment aid Regulation Name: Regulatory Class: Class II Product Code: QEA Review Panel: Neurology Oculogica Inc. Manufacturer: 33 IRVING PLACE NEW YORK, NY 10003 301453677 Registration Number: Manufacturer Contact: ROSINA SAMADANI, PH.D. 484-393-2694 [e-mail]

The company's EyeBOX Model OCL 02.5 device is a modification to the EyeBOX Model OCL 02 device, which was cleared under premarket notification K191183. The EyeBOX Model OCL 02.5 device has the same intended use, the same principles of operation, and similar technological characteristics as the previously cleared EyeBOX Model OCL 02 device. None of the changes in technology raise new questions of safety or effectiveness, and comprehensive testing demonstrates that these changes do not adversely impact performance.

The following table presents a comparison of the device of this submission to the predicate device.

| | Predicate Device | Subject Device |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| 510(k) Number | K191183 | K201841 |
| Trade Name | EyeBOX | Same |
| Model Number | OCL 02 | OCL 02.5 |
| Manufacturer | Oculogica, Inc. | Same |
| Product Code | QEA | Same |
| Regulation | 21 CFR 882.1455 Traumatic brain injury<br>eye movement assessment aid | Same |
| | | |
| Indications<br>for Use | The EyeBOX is intended to measure and<br>analyze eye movements as an aid in the<br>diagnosis of concussion, also known as<br>mild traumatic brain injury (mTBI), within<br>one week of head injury in patients 5<br>through 67 years of age in conjunction with<br>a standard neurological assessment of<br>concussion.<br>A negative EyeBOX classification may<br>correspond to eye movement that is<br>consistent with a lack of concussion.<br>EyeBOX classification<br>positive -<br>A<br>corresponds to eye movement that may be<br>present in both patients with or without<br>concussion. | Same |
| Device<br>Description | Oculogica's EyeBOX is an eye-tracking<br>device with custom software. The device is<br>comprised of a host PC with integrated<br>touchscreen interface for the operator, eye<br>tracking camera, LCD stimulus screen and<br>head-stabilizing rest (chin rest and<br>forehead rest) for the patient, and data<br>processing algorithm. The data processing<br>algorithm detects subtle changes in eye<br>movements resulting from concussion.<br>The eye tracking task takes about 4<br>minutes to complete and involves watching<br>a video move around the perimeter of an<br>LCD monitor positioned in front of the<br>patient while a high speed near-infrared<br>(IR) camera records gaze positions 500<br>times per second. The post-processed<br>data<br>are analyzed automatically to<br>produce one or more outcome measures. | Same |
| Principle of<br>operation | The data processing algorithm detects<br>subtle changes in eye movements<br>resulting from concussion. The eye<br>tracking task takes about 4 minutes to<br>complete and involves watching a video<br>move around the perimeter of an LCD<br>monitor positioned in front of the patient<br>while a high speed near-infrared (IR)<br>camera records gaze positions 500 times<br>per second. The post-processed data are<br>analyzed automatically to produce a BOX<br>score. | Same |
| WiFi Functionality | Provided | Same |
| Enclosure | Table-top | Same |
| Patient position | Seated only | Same |

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#### 1. Intended Use and Indications for Use Statement

No change is made to the intended use of the device, the patient population or intended user.

The EyeBOX is intended to measure and analyze eye movements as an aid in the diagnosis of concussion, also known as mild traumatic brain injury (mTBI), within one week of head injury in patients 5 through 67 years of age in conjunction with a standard neurological assessment of concussion.

A negative EyeBOX classification may correspond to eye movement that is consistent with a lack of concussion.

A positive EyeBOX classification corresponds to eye movement that may be present in both patients with or without concussion.

#### 2. Technological Characteristics

Oculogica's EyeBOX uses eye-tracking technology and a data processing algorithm to detect subtle changes in eye movements resulting from concussion. The EyeBOX principles of operation have not changed. The principles of operation are identical to its predicate device. The technological characteristics important to device function as an aid in diagnosis of concussion are not changed; the eye tracking performance and proprietary EyeBOX algorithm, which processes the eye tracking data and outputs the BOX score, are not changed.

The following changes have been implemented.

- The eye tracking camera is replaced with a camera system having equivalent function. ●
- Certain components are replaced with components having equivalent function.
- . Minor changes to the user interface to simplify user interaction.
- Minor changes to the EyeBOX report to assist interpretation of results.

None of the changes in technology raise new questions of safety or effectiveness.

#### 3. Performance Testing

The following verification / validation activities were performed by the risk assessment of the changes according to the Oculogica Quality Management System. Results of this comprehensive testing demonstrate that these changes also do not adversely impact performance.

- Electromagnetic emissions and immunity testing according to IEC 60601-1-2:2014 (4TH EDITION) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- Z80.36-2016 Light Hazard Protection For Ophthalmic Instruments ●
- Bench testing was performed on an artificial eye (designed with similar geometry to a ● human eye) to demonstrate that the spatial precision and step response of the new camera met performance requirements.
- Testing was performed in N=84 human participants to demonstrate that the new camera and analysis could reliably detect blinks and gaze position across the range of gaze positions measured by the device.

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- Software verification and user testing ●
#### Conclusion 4.

The EyeBOX Model OCL 02.5 device has the same intended use and principle of operation as the previously cleared EyeBOX Model OCL 02 device. In addition, the EyeBOX Model OCL 02.5 device has comparable technological characteristics as its predicate. None of the changes in technology raise new questions of safety or effectiveness, and comprehensive testing demonstrates that these changes do not adversely impact performance. Thus, the EyeBOX Model OCL 02 device is substantially equivalent to its predicate device.