Nurochek-II System

K231914 · Headsafe Mfg Pty, Ltd. · PIW · Dec 27, 2023 · Neurology

Device Facts

• Record ID: K231914
• Device Name: Nurochek-II System
• Applicant: Headsafe Mfg Pty, Ltd.
• Product Code: PIW · Neurology
• Decision Date: Dec 27, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1450
• Device Class: Class 2
• Attributes: AI/ML

Intended Use

The Nurochek-II System is intended for prescription use in healthcare facilities for subjects aged between 16 and 46 years old, for the aid in diagnosis of mild traumatic brain injury (mTBI) in conjunction with a standard neurological assessment. The Nurochek-II System is indicated for the generation of visual evoked potentials (VEPs) and to acquire, transmit, display, and store electroencephalograms (EEGs) during the generation of VEPs. Additionally, the system is indicated to analyze captured EEG signals to provide an aid in the diagnosis of mild traumatic brain injury (mTBI) in subjects aged between 16 and 46 years old who have sustained a potential head injury in the past 72 hours (3 days).

Device Story

Portable system for mTBI diagnosis; comprises wearable headset, mobile software application, and server. Headset uses LED lights to generate visual evoked potentials (VEPs) while EEG electrodes (occipital placement) acquire brain signals. System records, transmits, and stores EEG data; software compares captured signals against normative database to assess mTBI likelihood. Used in healthcare facilities by clinicians; output aids clinical decision-making alongside standard neurological exams. Benefits patient by providing objective adjunctive data for concussion assessment.

Clinical Evidence

Clinical validation study (n=110) evaluated Nurochek-II performance against physician diagnosis of mTBI. Study population aged 16-46 years with 39.1% mTBI prevalence. Results: sensitivity 86% (95% CI: 72.07-94.70), specificity 67% (95% CI: 54.60-78.15), PPV 62.7%, NPV 88.2%. Algorithm generated from 372 SSVEP readings (age 14-55).

Technological Characteristics

Reusable headset with front-facing LED lights and rear EEG electrodes; single-use foam electrode cylinders. Rechargeable 3.7V lithium-ion battery. Connectivity via mobile application and server. Biocompatibility per ISO 10993-5/10. Electrical safety per IEC 60601-1, IEC 60601-1-2, IEC 60601-2-40.

Indications for Use

Indicated for aid in diagnosis of mild traumatic brain injury (mTBI) in patients aged 16-46 years who sustained a potential head injury within the past 72 hours, used in conjunction with standard neurological assessment.

Regulatory Classification

Identification

A brain injury adjunctive interpretive electroencephalograph assessment aid is a prescription device that uses a patient's electroencephalograph (EEG) to provide an interpretation of the structural condition of the patient's brain in the setting of trauma. A brain injury adjunctive interpretive EEG assessment aid is for use as an adjunct to standard clinical practice only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis.

Special Controls

In combination with the general controls of the FD&C Act, the Ahead 100 is subject to the following special controls:

*Classification.* Class II (special controls). The special controls for this device are:(1) The technical parameters of the device, hardware and software, must be fully characterized and include the following information: (i) Hardware specifications must be provided. Appropriate verification, validation, and hazard analysis must be performed. (ii) Software, including any proprietary algorithm(s) used by the device to arrive at its interpretation of the patient's condition, must be described in detail in the software requirements specification (SRS) and software design specification (SDS). Appropriate software verification, validation, and hazard analysis must be performed. (2) The device parts that contact the patient must be demonstrated to be biocompatible. (3) The device must be designed and tested for electrical safety, electromagnetic compatibility (EMC), thermal, and mechanical safety. (4) Clinical performance testing must demonstrate the accuracy, precision-repeatability and reproducibility, of determining the EEG-based interpretation, including any specified equivocal zones (cutoffs). (5) Clinical performance testing must demonstrate the ability of the device to function as an assessment aid for the medical condition for which the device is indicated. Performance measures must demonstrate device performance characteristics per the intended use in the intended use environment. Performance measurements must include sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) with respect to the study prevalence per the device intended use. (6) The device design must include safeguards to ensure appropriate clinical interpretation of the device output ( *e.g.,* use in appropriate patient population, or for appropriate clinical decision).(7) The labeling and training information must include: (i) A warning that the device is not to be used as a stand-alone diagnostic. (ii) A detailed summary of the clinical performance testing, including any adverse events and complications. (iii) The intended use population and the intended use environment. (iv) Any instructions technicians should convey to patients regarding the collection of EEG data. (v) Information allowing clinicians to gauge clinical risk associated with integrating the EEG interpretive assessment aid into their diagnostic pathway. (vi) Information allowing clinicians to understand how to integrate the device output into their diagnostic pathway when the device is unable to provide a classification or final result.

Predicate Devices

• BrainScope TBI (K190815)

Reference Devices

• EyeBOX (DEN170091/K191183)
• Nurochek System (K200705)

Submission Summary (Full Text)

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December 27, 2023

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. The FDA logo is on the right, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are placed side by side.

Headsafe MFG Pty Ltd. % Erin Gontang, Ph.D. Senior Consultant RQM+ 2251 San Diego Avenue, Suite B-257 San Diego, California 92110

Re: K231914

Trade/Device Name: Nurochek-II System Regulation Number: 21 CFR 882.1450 Regulation Name: Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid Regulatory Class: Class II Product Code: PIW, OMC Dated: November 24, 2023 Received: November 27, 2023

Dear Erin Gontang:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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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,

# Xiaolin Zheng -S

Xiaolin Zheng, Ph.D. 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) K231914

Device Name Nurochek-II System

Indications for Use (Describe)

The Nurochek-II System is intended for prescription use in healthcare facilities for subjects aged between 16 and 46 years old, for the aid in diagnosis of mild traumatic brain injury (mTBI) in conjunction with a standard neurological assessment.

The Nurochek-II System is indicated for the generation of visual evoked potentials (VEPs) and to acquire, transmit, display, and store electroencephalograms (EEGs) during the generation of VEPs. Additionally, the system is indicated to analyze captured EEG signals to provide an aid in the diagnosis of mild traumatic brain injury (mTBI) in subjects aged between 16 and 46 years old who have sustained a potential head injury in the past 72 hours (3 days).

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

| <div>☑ Registration Use (Part 31, GER, 301, Subpart D)</div> | <div>☐ On-Site Composting (31.25)</div> |
|--------------------------------------------------------------|-----------------------------------------|
|--------------------------------------------------------------|-----------------------------------------|

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/4/Picture/0 description: The image shows the logo for Headsafe. The logo consists of a green icon on the left and the word "HEADSAFE" in dark gray on the right. The icon is a stylized head with a gauge inside, suggesting a focus on safety and measurement related to the head.

# 510(k) Summary K231914

#### DATE PREPARED

December 26, 2023

### MANUFACTURER AND 510(k) OWNER

Headsafe MFG Pty Ltd. 61 Marlborough Street, Suite 76 Surry Hills NSW 2010 Australia Telephone: [phone] Official Contact: Adrian Cohen, MD, CEO

#### REPRESENTATIVE/CONSULTANT

Erin A. Gontang, PhD RQM+ [phone] Telephone: Email: [e-mail]

#### DEVICE INFORMATION

| Proprietary Name/Trade Name: | Nurochek-II System |
|------------------------------|------------------------------------------------------------------------------|
| Common Name: | Brain injury adjunctive interpretive electroencephalograph<br>assessment aid |
| Regulation Number: | 21 CFR 882.1450 |
| Class: | II |
| Product Code: | PIW, OMC |
| Premarket Review: | Neurosurgical, Neurointerventional and Neurodiagnostic<br>Devices (DHT5A) |
| Review Panel: | Neurology |

#### PREDICATE DEVICE IDENTIFICATION

The Nurochek-II System is substantially equivalent to the following predicates:

| 510(k) Number | Predicate Device Name / Manufacturer | Primary<br>Predicate |
|-------------------|-------------------------------------------|----------------------|
| K190815 | BrainScope TBI / BrainScope Company, Inc. | ✓ |
| DEN170091/K191183 | EyeBOX / Oculogica Inc. | Reference |
| K200705 | Nurochek System / Headsafe MFG Pty Ltd. | Reference |

The predicate devices have not been subject to a design related recall.

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Image /page/5/Picture/0 description: The image shows the logo for Headsafe. On the left side of the logo is a green speedometer-like graphic that is also shaped like a head in profile. To the right of the graphic is the word "HEADSAFE" in bold, sans-serif font.

# DEVICE DESCRIPTION

The Nurochek-II System is a portable system designed to generate visual evoked potentials (VEPs) in patients and acquire, transmit, display, and store the resulting electroencephalogram (EEG). It is intended for prescription use in healthcare facilities for subjects aged between 16 and 46 years, to aid in the diagnosis of mild traumatic brain injury (mTBI). The primary components of the Nurochek-II System are the wearable headset, the Nurochek-II software application, and the Nurochek-II server.

# INDICATIONS FOR USE

The Nurochek-II System is intended for prescription use in healthcare facilities for subjects aged between 16 and 46 years old, for the aid in diagnosis of mild traumatic brain injury (mTBI) in conjunction with a standard neurological assessment.

The Nurochek-II System is indicated for the generation of visual evoked potentials (VEPs) and to acquire, transmit, display, and store electroencephalograms (EEGs) during the generation of VEPs. Additionally, the system is indicated to analyze captured EEG signals to provide an aid in the diagnosis of mild traumatic brain injury (mTBI) in subjects aged between 16 and 46 years old who have sustained a potential head injury in the past 72 hours (3 days).

# COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

Headsafe believes that the Nurochek-II System is substantially equivalent to the predicate devices based on the information summarized here:

The subject device has a similar design to the device cleared in K190815. It is also identical in physical design and materials to the reference device, the Nurochek System cleared in K200705. Both the subject and predicate devices are worn on the head to record and analyze electroencephalograms (EEGs). They are both intended to aid in the diagnosis of mild traumatic brain injury (mTBI) through the analysis of these recorded EEGs. See below for a table comparing the device's technological characteristics.

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Image /page/6/Picture/0 description: The image shows the logo for HEADSAFE. The logo consists of a green speedometer-like graphic on the left, with the word "HEADSAFE" in bold, dark gray letters on the right. The speedometer graphic is designed to resemble a human head in profile.

| | Subject Device | Predicate Device | Reference Device | Reference Device |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Headsafe | BrainScope Company,<br>Inc. | Oculogica Inc. | Headsafe |
| | Nurochek-II System<br>K231914 | BrainScope TBI<br>K190815 | EyeBOX<br>DEN170091/K191183 | Nurochek System<br>K200705 |
| Image | Image: Nurochek-II System K231914 | Image: BrainScope TBI K190815 | Image: EyeBOX DEN170091/K191183 | Image: Nurochek System K200705 |
| Indications<br>for Use | The Nurochek-II System<br>is intended for<br>prescription use in<br>healthcare facilities for<br>subjects aged between 16<br>and 46 years old, for the<br>aid in diagnosis of mild<br>traumatic brain injury<br>(mTBI) in conjunction<br>with a standard<br>neurological assessment.<br><br>The Nurochek-II System<br>is indicated for the<br>generation of visual<br>evoked potentials (VEPs)<br>and to acquire, transmit,<br>display, and store<br>electroencephalograms<br>(EEGs) during the<br>generation of VEPs.<br>Additionally, the system<br>is indicated to analyze<br>captured EEG signals to<br>provide an aid in the<br>diagnosis of mild<br>traumatic brain injury<br>(mTBI) in subjects aged<br>between 16 and 46 years<br>old who have sustained a<br>potential head injury in<br>the past 72 hours (3<br>days). | BrainScope TBI is a<br>multi-modal, multi-<br>parameter assessment<br>indicated for use as an<br>adjunct to standard<br>clinical practice to aid<br>in the evaluation of<br>patients who have<br>sustained a closed<br>head injury, and have<br>a Glasgow Coma<br>Scale (GCS) score of<br>13-15 (including<br>patients with<br>concussion/mild<br>traumatic brain injury<br>(mTBI)). | The EyeBOX is intended<br>to measure and analyze<br>eye movements as an aid<br>in the diagnosis of<br>concussion, also known<br>as mild traumatic brain<br>injury (mTBI)*, within<br>one week of head injury<br>in patients 5 through 67<br>years of age in<br>conjunction with a<br>standard neurological<br>assessment of<br>concussion.<br><br>A negative EyeBOX<br>classification may<br>correspond to eye<br>movement that is<br>consistent with a lack of<br>concussion.<br><br>A positive EyeBOX<br>classification<br>corresponds to eye<br>movement that may be<br>present in both patients<br>with or without<br>concussion.<br><br>*underlined text<br>indicates IFU update in<br>K191183. | The Nurochek System is<br>intended for prescription<br>use in healthcare<br>facilities or clinical<br>research environments<br>for subjects ages 14<br>years and older.<br><br>The Nurochek System is<br>indicated for the<br>generation of visual<br>evoked potentials (VEPs)<br>and to acquire, transmit,<br>display and store<br>electroencephalograms<br>(EEGs) during the<br>generation of VEPs.<br><br>The Nurochek System<br>only acquires and<br>displays physiological<br>signals: no claims are<br>being made for use as a<br>diagnostic criterion or for<br>the analysis of the<br>acquired signals with<br>respect to the accuracy,<br>precision and reliability. |
| Product<br>Codes /<br>Regulation<br>Number | PIW, OMC<br>21 CFR 882.1450 | PIW, PKQ, OLU<br>21 CFR 882.1450 | QEA<br>21 CFR 882.1455 | GWE, OMC<br>21 CFR 882.1890 |
| Regulation<br>Description | Brain injury adjunctive<br>interpretive<br>electroencephalograph<br>assessment aid | Brain injury adjunctive<br>interpretive<br>electroencephalograph<br>assessment aid | Brain injury adjunctive<br>interpretive oculomotor<br>assessment aid | Evoked response photic<br>stimulator |
| Components | Software in a mobile<br>application, reusable<br>headset (LED lights in<br>front, EEG electrodes in<br>back) | Software on handheld<br>device, disposable<br>electrode headset | A PC with integrated<br>touchscreen interface,<br>eye tracking camera,<br>LCD stimulus screen,<br>head-stabilizing rests for<br>chin and forehead, and<br>data processing | Software in a mobile<br>application, reusable<br>headset (LED lights in<br>front, EEG electrodes in<br>back) |
| | Subject Device | Predicate Device | Reference Device | Reference Device |
| | Headsafe | BrainScope Company, Inc. | Oculogica Inc. | Headsafe |
| | Nurochek-II System<br>K231914 | BrainScope TBI<br>K190815 | EyeBOX<br>DEN170091/K191183 | Nurochek System<br>K200705 |
| Power source | Rechargeable 3.7V<br>lithium-ion battery | Rechargeable | Mains power input | Rechargeable 3.7V<br>lithium-ion battery |
| Inputs | Patient identifying<br>information | Patient identifying<br>information | Patient identifying<br>information | Patient identifying<br>information |
| Electrode<br>Placement | Occipital lobe | Frontal lobe | None | Occipital lobe |
| Outputs | • EEG<br>• Quality of electrode contact with patient<br>• Assessment of mTBI likelihood | • Concussion index<br>• Structural injury classification<br>• Brain function index | • Concussion score | • EEG<br>• Quality of electrode contact with patient<br>• Signal-to-noise ratio |
| Data<br>Analysis &<br>Storage | Records and stores EEGs<br>Compares results to normative EEG data. | Records and stores EEGs<br>Compares results to normative EEG data. | Records gaze positions 500 times per second.<br>Processed data are analyzed automatically to produce a EyeBOX score/clinical report. | Records and stores EEGs<br>Compares results to normative EEG data. |
| Patient<br>interface | Worn on patient's head for 2 minutes. | Worn on patient's head for 10-30 minutes. | Patient's rests chin and forehead for ~4 minutes. | Worn on patient's head for 2 minutes. |
| Sterilization | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| Reuse | Headset is reusable<br>(Foam cylinders for electrodes are single use only) | Electrodes are disposable<br>Handheld device is reusable | Reusable | Headset is reusable<br>(Foam cylinders for electrodes are single use only) |
| Sensitivity | 0.8605<br>95% confidence intervals<br>(0.7207, 0.9470) | 0.8599<br>95% confidence<br>intervals (0.8050,<br>0.9041) | 0.8040<br>95% confidence<br>intervals (0.6610,<br>0.9190) | N/A |
| Specificity | 0.6716<br>95% confidence limits of<br>(0.5460, 0.7815) | 0.7078<br>95% confidence limits<br>of (0.6588, 0.7535) | 0.6610<br>95% confidence limits of<br>(0.5970, 0.7210) | N/A |
| Patient<br>Population | Patients 16-46 years who have sustained a potential head injury in the past 72 hours (3 days) | Patients between the ages of 13-25 years who present with a GCS score of 15 following a head injury within the past 72 hours (3 days) | Patients between the ages of 5 to 67 years old who have sustained a head injury within the past week | Patients 14 years and older |

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Image /page/7/Picture/0 description: The image shows the logo for Headsafe. The logo consists of a green icon that resembles a head with a gauge inside, followed by the word "HEADSAFE" in large, bold, dark gray letters. The gauge inside the head icon has a needle pointing towards the right, and the head itself is formed by a combination of curved and straight lines.

## SUMMARY OF NON-CLINICAL TESTING

No FDA performance standards have been established for the Nurochek-II System. The following tests were performed to demonstrate safety based on current industry standards:

#### Biocompatibility:

The subject device was evaluated for cytotoxicity, sensitization, and irritation in compliance to ISO 10993-5:2009 and ISO 10993-10:2010.

#### Software Verification:

The software development and testing were executed with consideration to IEC 62304.

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Image /page/8/Picture/0 description: The image contains the logo for "HEADSAFE". To the left of the text is a green icon that resembles a gauge and a head in profile. The gauge is partially filled in with green, and the needle is pointing towards the middle. The text "HEADSAFE" is written in a bold, sans-serif font and is colored in dark gray.

# Electromaqnetic Compatibility and Electrical Safety:

The subject device was tested in compliance to IEC 60601-1:2012, IEC 60601-1-2:2014, IEC 60601-2-40:2016.

## SUMMARY OF CLINICAL TESTING

The primary objective of the clinical investigation was to evaluate the performance of the Nurochek-II System against clinical diagnosis by a licensed healthcare professional in the accurate detection of mild traumatic brain injury (mTBI). The study demonstrated that the device can differentiate between subjects with and without mTBI.

The Headsafe classification algorithm used in this device was generated with 372 individual steady-state visual-evoked potential (SSVEP) readings, in which there was an 11% prevalence of mTBI. The SSVEP readings from the study subjects (age range 14-55 years) were used to generate the database, to which the device compares new results. The clinical research protocol required readings to be collected within 72 hours of the suspected head injury, in addition to a clinical evaluation by a licensed physician. Each highly trained physician used their education and experience to deliver their mTBI determination. At the core of each assessment was a neurological examination, a concussion-related signs and symptom evaluation, and a review of all relevant information provided by the study subject in relation to their injury. A separate validation data set consisting of 110 individual SSVEP readings, in which there was a 39.1% prevalence of mTBI in the population (age range 16-46 years), resulted in a sensitivity of 86% (72.07-94.70, 95% confidence interval) and a specificity of 67% (54.60-78.15, 95% confidence interval). The resulting positive predictive value (PPV) and negative predictive value (NPV) were 62.7% and 88.2%, respectively. The table below tabulates the performance of the Nurochek-II System from this 110-individual study and compares it to the predicate and reference device based on publicly available information from their 510(k) and De Novo decision summaries.

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Image /page/9/Picture/0 description: The image shows the logo for HEADSAFE. The logo consists of a green icon on the left and the word "HEADSAFE" in dark gray on the right. The icon is a stylized head with a gauge inside, suggesting safety and measurement.

| Device<br>[FDA Reference #] | Nurochek-II<br>System<br>[K231914]<br>Subject Device | BrainScope TBI<br>[K190815]<br>Predicate Device | EyeBOX<br>[DEN170091/K191183]<br>Reference Device |
|-------------------------------------------------------|------------------------------------------------------|-------------------------------------------------|---------------------------------------------------|
| Sensitivity %<br>[95% CI] | 86.05 [72.07-94.70] | 85.99 [80.50-90.41] | 80.40 [66.10-91.90] |
| Specificity<br>[95% CI] | 67.16 [54.60-78.15] | 70.78 [65.88-75.35] | 66.10 [59.70-72.10] |
| #Patients clinically<br>diagnosed as<br>Concussed | 43 | 207 | 46 |
| #Patients clinically<br>diagnosed as<br>not concussed | 67 | 373 | 236 |
| Prevalence of mTBI<br>in Validation Study | 39.1 | 35.69 | 16.31 |
| Positive Predictive<br>Value (PPV) %<br>[95% CI] | 62.7 [53.92-70.75] | 62.0 | 31.6 [26.89-36.73] |
| Negative Predictive<br>Value (NPV) %<br>[95% CI] | 88.2 [77.79-94.13] | 90.1 | 94.5 [90.56-96.91] |

# CONCLUSION

Based on the testing performed, it can be concluded that the subject device does not raise different questions of safety or effectiveness compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed Nurochek-II System are assessed to be substantially equivalent to the predicate devices.