(181 days)
Yes
The description mentions a "Headsafe classification algorithm" that was "generated with 372 individual steady-state visual-evoked potential (SSVEP) readings" and used to "generate the database, to which the device compares new results." This process of training an algorithm on data to make classifications is characteristic of machine learning.
No
The device is described as an "aid in diagnosis" of mild traumatic brain injury (mTBI) and is not intended for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Nurochek-II System is "for the aid in diagnosis of mild traumatic brain injury (mTBI) in conjunction with a standard neurological assessment." It also mentions that the system is "indicated to analyze captured EEG signals to provide an aid in the diagnosis of mild traumatic brain injury (mTBI)". These statements clearly indicate its purpose as a diagnostic device.
No
The device description explicitly states that the Nurochek-II System includes a "wearable headset" as a primary component, in addition to the software application and server. This indicates the presence of hardware.
Based on the provided information, the Nurochek-II System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens from the human body. The Nurochek-II System acquires and analyzes electroencephalograms (EEGs) and visual evoked potentials (VEPs) directly from the patient's head. It does not process biological samples like blood, urine, or tissue.
- The device description and intended use focus on physiological measurements. The system generates VEPs and acquires EEG signals, which are electrical activity measurements from the brain. This is a physiological measurement, not an in vitro analysis of a biological specimen.
- The performance studies evaluate the device's ability to differentiate between subjects with and without mTBI based on these physiological signals. The metrics provided (sensitivity, specificity, PPV, NPV) relate to the device's diagnostic performance using these in vivo measurements.
Therefore, the Nurochek-II System falls under the category of a medical device that performs physiological measurements and analysis to aid in diagnosis, but it does not meet the definition of an In Vitro Diagnostic device.
No
Intended Use / 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).
Product codes (comma separated list FDA assigned to the subject device)
PIW, OMC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Occipital lobe
Indicated Patient Age Range
16 and 46 years old
Intended User / Care Setting
healthcare facilities
Description of the training set, sample size, data source, and annotation protocol
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.
Description of the test set, sample size, data source, and annotation protocol
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). Clinical diagnosis by a licensed healthcare professional was used as the ground truth.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 0.8605 (95% confidence intervals (0.7207, 0.9470))
Specificity: 0.6716 (95% confidence limits of (0.5460, 0.7815))
Positive Predictive Value (PPV): 62.7% (95% CI 53.92-70.75)
Negative Predictive Value (NPV): 88.2% (95% CI 77.79-94.13)
Prevalence of mTBI in Validation Study: 39.1%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.1450 Brain injury adjunctive interpretive electroencephalograph assessment aid.
(a)
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.(b)
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.
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December 27, 2023
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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"
1
Page
2
(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.
2
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,
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
3
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)
| ☑ Registration Use (Part 31, GER, 301, Subpart D) | ☐ On-Site Composting (31.25) |
|---|---|
| -------------------------------------------------------------- | ----------------------------------------- |
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: +61 418 25 3333 Official Contact: Adrian Cohen, MD, CEO
REPRESENTATIVE/CONSULTANT
Erin A. Gontang, PhD RQM+ +1 (412) 899-7422 Telephone: Email: egontang@rqmplus.com
DEVICE INFORMATION
| Proprietary Name/Trade Name: | Nurochek-II System |
|---|---|
| Common Name: | Brain injury adjunctive interpretive electroencephalograph |
| assessment aid | |
| Regulation Number: | 21 CFR 882.1450 |
| Class: | II |
| Product Code: | PIW, OMC |
| Premarket Review: | Neurosurgical, Neurointerventional and Neurodiagnostic |
| 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
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, | |||
| Inc. | Oculogica Inc. | Headsafe | ||
| Nurochek-II System | ||||
| K231914 | BrainScope TBI | |||
| K190815 | EyeBOX | |||
| DEN170091/K191183 | Nurochek System | |||
| K200705 | ||||
| Image | Image: Nurochek-II System K231914 | Image: BrainScope TBI K190815 | Image: EyeBOX DEN170091/K191183 | Image: Nurochek System K200705 |
| 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). | BrainScope TBI is a
multi-modal, multi-
parameter assessment
indicated for use as an
adjunct to standard
clinical practice to aid
in the evaluation of
patients who have
sustained a closed
head injury, and have
a Glasgow Coma
Scale (GCS) score of
13-15 (including
patients with
concussion/mild
traumatic brain injury
(mTBI)). | 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.
*underlined text
indicates IFU update in
K191183. | The Nurochek System is
intended for prescription
use in healthcare
facilities or clinical
research environments
for subjects ages 14
years and older.
The Nurochek 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.
The Nurochek System
only acquires and
displays physiological
signals: no claims are
being made for use as a
diagnostic criterion or for
the analysis of the
acquired signals with
respect to the accuracy,
precision and reliability. |
| Product
Codes /
Regulation
Number | PIW, OMC
21 CFR 882.1450 | PIW, PKQ, OLU
21 CFR 882.1450 | QEA
21 CFR 882.1455 | GWE, OMC
21 CFR 882.1890 |
| Regulation
Description | Brain injury adjunctive
interpretive
electroencephalograph
assessment aid | Brain injury adjunctive
interpretive
electroencephalograph
assessment aid | Brain injury adjunctive
interpretive oculomotor
assessment aid | Evoked response photic
stimulator |
| Components | Software in a mobile
application, reusable
headset (LED lights in
front, EEG electrodes in
back) | Software on handheld
device, disposable
electrode headset | A PC with integrated
touchscreen interface,
eye tracking camera,
LCD stimulus screen,
head-stabilizing rests for
chin and forehead, and
data processing | Software in a mobile
application, reusable
headset (LED lights in
front, EEG electrodes in
back) |
| | Subject Device | Predicate Device | Reference Device | Reference Device |
| | Headsafe | BrainScope Company, Inc. | Oculogica Inc. | Headsafe |
| | Nurochek-II System
K231914 | BrainScope TBI
K190815 | EyeBOX
DEN170091/K191183 | Nurochek System
K200705 |
| Power source | Rechargeable 3.7V
lithium-ion battery | Rechargeable | Mains power input | Rechargeable 3.7V
lithium-ion battery |
| Inputs | Patient identifying
information | Patient identifying
information | Patient identifying
information | Patient identifying
information |
| Electrode
Placement | Occipital lobe | Frontal lobe | None | Occipital lobe |
| Outputs | • EEG
• Quality of electrode contact with patient
• Assessment of mTBI likelihood | • Concussion index
• Structural injury classification
• Brain function index | • Concussion score | • EEG
• Quality of electrode contact with patient
• Signal-to-noise ratio |
| Data
Analysis &
Storage | Records and stores EEGs
Compares results to normative EEG data. | Records and stores EEGs
Compares results to normative EEG data. | Records gaze positions 500 times per second.
Processed data are analyzed automatically to produce a EyeBOX score/clinical report. | Records and stores EEGs
Compares results to normative EEG data. |
| Patient
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
(Foam cylinders for electrodes are single use only) | Electrodes are disposable
Handheld device is reusable | Reusable | Headset is reusable
(Foam cylinders for electrodes are single use only) |
| Sensitivity | 0.8605
95% confidence intervals
(0.7207, 0.9470) | 0.8599
95% confidence
intervals (0.8050,
0.9041) | 0.8040
95% confidence
intervals (0.6610,
0.9190) | N/A |
| Specificity | 0.6716
95% confidence limits of
(0.5460, 0.7815) | 0.7078
95% confidence limits
of (0.6588, 0.7535) | 0.6610
95% confidence limits of
(0.5970, 0.7210) | N/A |
| Patient
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
[FDA Reference #] | Nurochek-II
System
[K231914]
Subject Device | BrainScope TBI
[K190815]
Predicate Device | EyeBOX
[DEN170091/K191183]
Reference Device |
|-------------------------------------------------------|------------------------------------------------------|-------------------------------------------------|---------------------------------------------------|
| Sensitivity %
[95% CI] | 86.05 [72.07-94.70] | 85.99 [80.50-90.41] | 80.40 [66.10-91.90] |
| Specificity
[95% CI] | 67.16 [54.60-78.15] | 70.78 [65.88-75.35] | 66.10 [59.70-72.10] |
| #Patients clinically
diagnosed as
Concussed | 43 | 207 | 46 |
| #Patients clinically
diagnosed as
not concussed | 67 | 373 | 236 |
| Prevalence of mTBI
in Validation Study | 39.1 | 35.69 | 16.31 |
| Positive Predictive
Value (PPV) %
[95% CI] | 62.7 [53.92-70.75] | 62.0 | 31.6 [26.89-36.73] |
| Negative Predictive
Value (NPV) %
[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.