EyeBOX

K191183 · Oculogica, Inc. · QEA · Jul 31, 2019 · Neurology

Device Facts

• Record ID: K191183
• Device Name: EyeBOX
• Applicant: Oculogica, Inc.
• Product Code: QEA · Neurology
• Decision Date: Jul 31, 2019
• 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 (Model OCL 02) is an eye-tracking diagnostic aid for concussion. Patient watches video moving around perimeter of LCD monitor while 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. Used in clinical settings by healthcare providers; patient must be seated and stabilized via chin/forehead rest. Device is a tabletop unit. Output assists clinicians in concussion diagnosis; negative result suggests lack of concussion, positive result indicates eye movement patterns potentially present in both concussed and non-concussed patients. Benefits include objective, automated assessment of oculomotor function to support clinical decision-making.

Clinical Evidence

Bench testing only. Verification and validation activities included safety testing per ANSI/AAMI ES60601-1:2005/A1:2012, electromagnetic emissions/immunity testing per IEC 60601-1-2:2014, hardware verification, and software validation.

Technological Characteristics

Tabletop eye-tracking system; high-speed near-infrared (IR) camera (500 Hz); LCD stimulus screen; head-stabilizing rest (chin/forehead). Connectivity: WiFi enabled. Software: custom algorithm for eye movement analysis. Standards: ANSI/AAMI ES60601-1 (safety), IEC 60601-1-2 (EMC).

Indications for Use

Indicated for patients 5-67 years of age with suspected concussion or mild traumatic brain injury (mTBI) within one week of head injury, to be 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 01 (DEN170091)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

Oculogica, Inc. Rosina Samadani CEO 33 Irving Place New York, New York 10003

Re: K191183

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: May 2, 2019 Received: May 2, 2019

## Dear Rosina Samadani:

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 medical devices and radiation-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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Druq Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K191183

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 neqative EyeBOX classification may correspond to eve 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)

区 Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary [21 CFR 807.92]

| Date Prepared:<br>Submitted by: | July 29, 2019<br>Oculogica Inc.<br>33 IRVING PLACE<br>NEW YORK, NY 10003<br>ROSINA SAMADANI, PH.D.<br>484-393-2694 |
|------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Subject Device Name:<br>Predicate Device Name:<br>Regulation Number:<br>Regulation Name: | EyeBOX, Model OCL 02<br>EyeBOX, Model OCL 01, DEN170091<br>21 CFR 882.1455<br>Traumatic brain injury eye movement assessment aid |
| Regulatory Class:<br>Product Code:<br>Review Panel: | Class II<br>QEA<br>Neurology |
| Manufacturer: | Oculogica Inc.<br>33 IRVING PLACE<br>NEW YORK, NY 10003 |
| Registration Number:<br>Manufacturer Contact: | Pending<br>ROSINA SAMADANI, PH.D.<br>484-393-2694<br>[e-mail] |

The company's EyeBOX Model OCL 02 device is a modification to the EyeBOX Model OCL 01 device, which was granted marketing authorization under De Novo request DEN170091 in December 2018. The EyeBOX Model OCL 02 device has the same intended use, the same principles of operation, and similar technological characteristics as the previously cleared EyeBOX Model OCL 01 device. Thus, the EyeBOX Model OCL 02 device is substantially equivalent to its predicate.

The following table presents a comparison of this submission to the device granted marketing authorization under DEN170091.

| | Predicate Device | Subject Device |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | DEN170091 | TBD |
| Trade Name | EyeBOX | Same |
| Model Number | OCL 01 | OCL 02 |
| 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 within one week of<br>head injury in patients 5 through 67 years<br>of age in conjunction with a standard<br>neurological assessment of concussion.<br>A negative EyeBOX classification may<br>correspond to eye movement that is<br>consistent with a lack of concussion.<br>A positive EyeBOX classification<br>corresponds to eye movement that may be<br>present in both patients with or without<br>concussion. | 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<br>with a standard neurological assessment<br>of concussion.<br>A negative EyeBOX classification may<br>correspond to eye movement that is<br>consistent with a lack of concussion.<br>A positive EyeBOX classification<br>corresponds to eye movement that may<br>be present in both patients with or<br>without concussion. |
| 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 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 | None | Provided |
| Enclosure | Wheeled Chassis | Table-top |
| Patient position | Seated and recumbent | Seated only |

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## Intended Use and Indications for Use Statement

No change is made to the intended use of the device. The company proposes to modify the Indications for Use statement to recognize that mild traumatic brain injury (mTBI) is used interchangeably with concussion in clinical practice and the medical literature. This does not change the intended use population. The proposed wording of the Indications for Use statement is provided below. The phrase ", also known as mild traumatic brain injury (mTBI)." (shown in italicized and bolded text for ease of review only) has been added; no wording is deleted.

The EveBOX is intended to measure and analyze eve 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.

Although this results in a minor modification to the Indications for Use wording, it does not alter the intended diagnostic effect of the device.

### Technological Characteristics

The technological characteristics of the EyeyeBOX Model OCL 02 device are very similar to that of the EyeBOX Model OCL 01 authorized under DEN170091. The principles of operation are not changed. The technological characteristics which are important to device function as an aid in diagnosis of concussion are not changed; these include the following characteristics:

- The principles of operation are not changed; .
- The eye tracking camera is not changed;
- The optical path is not changed; ●
- The EyeBOX alqorithm which processes the eye tracking data and outputs the BOX score is . not changed:

Thus, the device is identical to that of DEN170091 in all aspects important to its use as an aid in diagnosis of concussion. The following changes have been implemented but do not affect the safety and effectiveness of the EyeBOX device.

- Change from a wheeled chassis to a tabletop model
- Change to use with seated patients only
- . Provide WiFi functionality
- . Software changes to allow for licensing of device use.

### Performance Testing

The following verification / validation activities were performed as required by the risk assessment of the changes according to the same well-established methods and procedures presented in DEN170091.

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- . Safety testing according to ANSI/AAMI ES60601-1: 2005 / A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential 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
- Hardware verification
- . Software validation

### Conclusion

the EyeBOX Model OCL 02 device has the same intended use and principle of operation as the previously authorized EyeBOX Model OCL 01 device. In addition, the EyeBOX Model OCL 02 device has very similar indications and technological characteristics as its predicate. Although there are minor differences between the EyeBOX Model OCL 02 device and its predicate devices, those differences do not raise new questions of safety or effectiveness and nonclinical testing demonstrates the device function is equivalent to the legally marketed predicate device. Thus, the EyeBOX Model OCL 02 device is substantially equivalent.