(152 days)
Unknown
The description mentions a "data processing algorithm" but does not provide enough detail to confirm if it utilizes AI or ML techniques. The lack of information on training/test sets and performance metrics typically associated with AI/ML models further contributes to the uncertainty.
No
The device is intended to measure and analyze eye movements to aid in the diagnosis of concussion, not to treat or cure any condition.
Yes
The EyeBOX is intended to "aid in the diagnosis of concussion" by measuring and analyzing eye movements, directly indicating its role as a diagnostic device.
No
The device description explicitly mentions hardware components such as an LCD monitor, high speed near-infrared (IR) camera, face tracking camera, rechargeable battery, and Wi-Fi/Ethernet capabilities. The performance studies also include hardware verification and testing.
Based on the provided information, the EyeBOX is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for diagnostic purposes.
- EyeBOX Function: The EyeBOX measures and analyzes eye movements directly from the patient using a camera. It does not involve the collection or analysis of specimens taken from the body.
- Intended Use: The intended use clearly states it measures and analyzes eye movements as an aid in the diagnosis of concussion. This is a direct measurement of a physiological response, not an analysis of a biological sample.
Therefore, the EyeBOX falls under the category of a medical device that interacts directly with the patient, rather than an IVD device that analyzes samples from the patient.
N/A
Intended Use / Indications for 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 (mTBD), 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.
Product codes
QEA
Device Description
Oculogica's EyeBOX model EBX-4 uses eye-tracking technology and a data processing algorithm to detect subtle changes in eye movements resulting from concussion. The eye tracking task takes about 4 minutes to complete and involves watching a video move around the perimeter of an LCD monitor positioned in front of the patient while a high speed near-infrared (IR) camera, positioned just below the screen, records eye movements. The data are then analyzed to produce one or more outcome measures.
The patient sits in front of the device with their head secured in a chinrest about 40 cm from the middle of the display. A face tracking camera, positioned above the screen, assists the patient and operator with proper placement of the patient by providing a second set of eye coordinates in three-dimensional space to calculate the patient's distance from the screen and the patient face's position relative to the display.
The device contains a rechargeable battery, which makes it possible to use without a direct connection to an active power source.
The device has Wi-Fi and Ethernet capabilities, which optionally can provide the user with the ability to send reports to a remote printer and/or file storage location.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
near-infrared (IR) camera
Anatomical Site
eyes
Indicated Patient Age Range
5 through 67 years of age
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No new clinical data were collected.
The following verification / validation activities were performed subsequent to a risk assessment evaluation of the device modifications per the Oculogica Quality Management System. Results of this comprehensive testing demonstrates these changes do not adversely impact device performance.
- Electromagnetic emissions, immunity, and safety 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 testing
- Hardware specification testing
- Eye-tracking functional testing
- Eye-tracking bench testing
- Software verification
- User acceptance testing
- Light hazard testing for ophthalmic devices
In all instances, the EyeBOX Model EBX-4 functioned as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1455 Traumatic brain injury eye movement assessment aid.
(a)
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.(b)
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.
0
December 22, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Oculogica, Inc. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, Pennsylvania 19103
Re: K212310
Trade/Device Name: EyeBOX (Model EBX-4) Regulation Number: 21 CFR 882.1455 Regulation Name: Traumatic Brain Injury Eye Movement Assessment Aid Regulatory Class: Class II Product Code: QEA Dated: November 29, 2021 Received: November 29, 2021
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for 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 Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: June 30, 2023 See PRA Statement on last page
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 (mTBD), 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) □ Over-The-Counter Use (21 CFR 801 Subpart C) x Prescription Use (Part 21 CFR 801 Subpart D)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) SUMMARY Oculogica's EyeBOX Model EBX-4
| Date Prepared:
Submitted by: | 11/19/2021
Oculogica Inc.
33 IRVING PLACE
NEW YORK, NY 10003
ROSINA SAMADANI, PH.D.
484-393-2694 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device Name:
Predicate Device Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Product Code:
Review Panel:
Manufacturer: | EyeBOX Model EBX-4
Oculogica, Inc. EyeBOX, Model OCL 02.5, K20184
21 CFR 882.1455
Traumatic brain injury eye movement assessment aid
Class II
QEA
Neurology
Oculogica Inc.
33 IRVING PLACE
NEW YORK, NY 10003 |
| Registration Number:
Manufacturer Contact: | 301453677
ROSINA SAMADANI, PH.D.
484-393-2694
ROSINA@OCULOGICA.COM |
Intended Use / Indications for Use
The EyeBOX is intended to be used as an aid in diagnosis of concussion.
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 Description
Oculogica's EyeBOX model EBX-4 uses eye-tracking technology and a data processing algorithm to detect subtle changes in eye movements resulting from concussion. The eye tracking task takes about 4 minutes to complete and involves watching a video move around the perimeter of an LCD monitor positioned in front of the patient while a high speed near-infrared (IR) camera, positioned just below the screen, records eye movements. The data are then analyzed to produce one or more outcome measures.
4
The patient sits in front of the device with their head secured in a chinrest about 40 cm from the middle of the display. A face tracking camera, positioned above the screen, assists the patient and operator with proper placement of the patient by providing a second set of eye coordinates in three-dimensional space to calculate the patient's distance from the screen and the patient face's position relative to the display.
The device contains a rechargeable battery, which makes it possible to use without a direct connection to an active power source.
The device has Wi-Fi and Ethernet capabilities, which optionally can provide the user with the ability to send reports to a remote printer and/or file storage location.
Technological Characteristics
Oculogica's EveBOX uses eve-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 technological modifications have been implemented compared to the predicate.
- The integrated headrest and chinrest have been removed. ●
- . The eye tracking camera is replaced with a camera system having equivalent function.
- Electronic components have been replaced to accommodate form factor changes.
- Minor changes have been made to the user interface to simplify user interaction.
- . Minor changes have been made to the EyeBOX report to assist interpretation of results.
None of the changes in technology raise new questions of safety or effectiveness. The hardware provides the same functionality as the predicate. Therefore, the safety and effectiveness of the final device is the same as the predicate. The following table presents a comparison of this submission to the predicate device.
| Predicate Device | Subject Device | |
|---|---|---|
| 510(k) Number | K201841 | K212310 |
| Trade Name | EyeBOX | Same |
| Model | OCL 02.5 | EBX-4 / DMR-0004 |
| Manufacturer | Oculogica, Inc. | Same |
| Product Code | QEA | Same |
| Regulation | 21 CFR 882.1455 Traumatic brain | |
| injury eye movement assessment aid | Same | |
| Indications for 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. | Same | |
| Predicate Device | Subject Device | |
| A positive EyeBOX classification | ||
| corresponds to eye movement that may | ||
| be present in both patients with or | ||
| without concussion. | ||
| Overall form factor | The predicate device (OCL 02.5) has | |
| two ends, one for the patient and one for | ||
| the operator. The patient end contains a | ||
| chinrest and a dedicated screen is used | ||
| to display the video stimulus to the | ||
| patient. A moveable operator console is | ||
| used by the technician to control the | ||
| device and enter data. The device's | ||
| dimensions are approximately 21" x 20" | ||
| x 26" (h, w, d) and it weighs about 34 | ||
| pounds. Since it does not have an | ||
| internal battery, it must be connected to | ||
| A/C power. | The EBX-4 is similar in shape to an all-in- | |
| one PC but without a keyboard. The screen | ||
| is mounted on a pedestal that can be tilted | ||
| up or down. The device's dimensions are | ||
| approximately 19" x 12" x 8" (h, w, d) and | ||
| it weighs about 12 pounds. A separate | ||
| chinrest must be used with the device. | ||
| Because it includes a rechargeable battery, | ||
| it can be used with or without a connection | ||
| to A/C power. | ||
| Biocompatibility | The patient's head is stabilized by the | |
| chinrest and headrest. The user manual | ||
| instructs that an appropriate drape be | ||
| used to avoid direct patient contact, so | ||
| no biocompatibility is claimed. | There is no patient contact with the | |
| EyeBOX EBX-4, so no biocompatibility is | ||
| claimed. | ||
| Eye tracking | An IR machine vision camera operates | |
| at 500 fps and calculates gaze | ||
| coordinates from the image data. 3- | ||
| frame smoothing (filtering) is used to | ||
| remove high frequency noise. No head | ||
| movement compensation is employed. | ||
| The eye-tracking system has a spatial | ||
| resolution of |