(36 days)
No
The description focuses on signal acquisition, transmission, display, and storage without mentioning any analytical or interpretive functions that would typically involve AI/ML. The summary explicitly states "no claims are being made for use as a diagnostic criterion or for the analysis of the acquired signals".
No
The device is strictly for generating and acquiring physiological signals (VEPs and EEGs) for display and storage, not for treating any condition or ailment. It explicitly states "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," which further indicates it's an assessment tool rather than a therapeutic one.
No
The 'Intended Use / Indications for Use' section explicitly states: "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." This indicates it is a signal acquisition and display device, not a diagnostic one.
No
The device description explicitly states that the Nurochek System "combines hardware, firmware and software" and details the hardware components like the headset, LEDs, electrode interfaces, and Bluetooth receiver/transmitter.
Based on the provided information, the Nurochek System 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 obtain information for diagnostic purposes.
- Nurochek System's Function: The Nurochek System directly interacts with the patient's body (scalp and periocular region) to generate and acquire physiological signals (VEPs and EEGs). It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for generating VEPs and acquiring, transmitting, displaying, and storing EEGs. It explicitly states "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." This further reinforces that the device itself is not performing a diagnostic test on a sample.
- Device Description: The description details the hardware and software used to stimulate the patient and acquire electrical signals from the scalp. This is consistent with a physiological monitoring or signal acquisition device, not an IVD.
In summary, the Nurochek System is a device that interacts with the patient's body to acquire physiological data, which is then intended for analysis by a physician. This falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 (comma separated list FDA assigned to the subject device)
GWE, OMC
Device Description
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.
The Nurochek System combines hardware, firmware and software to generate and acquire physiological signals, specifically, VEPs. These VEPs are generated by a visual stimulus delivered through the Nurochek headset worn by the subject. This visual stimulus is a short-duration flash of white light. The Nurochek headset acquires the VEPs from the rear of the head and transmits the resulting EEG to the Nurochek software application to be displayed to the user and stored. These acquired signals are intended to be analyzed by a Physician.
The Nurochek System operates on the principles of generating VEPs via photic simulation and acquiring the VEPs via EEG. Photic stimulation is provided through short-duration flashes of white light from multiple LEDs located in the front of the headset to direct the stimulus into the subject's eyes. The VEPs are acquired by an EEG comprising of a total of 5 electrode interfaces with hydrophilic foam cylinders saturated with saline solution to provide electrical contact to the subject's scalp. A Bluetooth receiver and transmitter located within the Nurochek headset allows it to communicate with and be controlled by the Nurochek software application.
The Nurochek software application provides a graphical user interface which allows:
- Collection of the subject details and consent,
- Initiation of a study and tracking of patient information,
- Acquisition and transmission of signals wirelessly to and from the headset.
- Display of the contact quality of electrodes to the subject's scalp,
- Recording, processing and display of EEG signals received from the headset, and
- Manage previous EEG recordings of VEPs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Scalp, Periocular region of the patient's face
Indicated Patient Age Range
14 years and older
Intended User / Care Setting
Licensed healthcare professionals / Healthcare facilities, Clinical Research Environments
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)
A clinical study was performed to evaluate the functionality of the Nurochek System - headset, firmware and software. The study used the clinical EEG Compumedics Grael EEG as a reference device and benchmark. Data from 20 participants were compared to the Compumedics Grael EEG in its performance to detect steady-state visual-evoked potentials (SSVEPs). Participants were evaluated on the clinical EEG and the investigational device with a common visual stimulus shared between them. All tests were performed successfully with no adverse events. The study concluded that both systems functioned identically in their ability to detect SSVEPs.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 882.1890 Evoked response photic stimulator.
(a)
Identification. An evoked response photic stimulator is a device used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye for use in evoked response measurements or for electroencephalogram (EEG) activation.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
Cryptych Pty Ltd % Rafael Aguila Responsible Third-Party Official Accelerated Device Approval Services, LLC 6800 S.W. 40th Street, Ste. 444 Ludlum, Florida 33155-3708
Re: K200705
Trade/Device Name: Nurochek System Regulation Number: 21 CFR 882.1890 Regulation Name: Evoked response photic stimulator Regulatory Class: Class II Product Code: GWE, OMC Dated: April 21, 2020 Received: April 22, 2020
Dear Rafael Aguila:
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,
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
2
510(k) Number (if known)
K200705
Device Name
Nurochek System Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows a 3D rendering of a hollow square or rectangular frame. The frame is composed of four segments, with two segments appearing in a darker shade of gray or black and the other two in a lighter shade of gray. The segments are joined at the corners to form the square shape, and there is a small notch or cutout visible on the left side of the frame.
510(k) SUMMARY
for
Nurochek System
| 510(k) Owner:
Address:
Phone and fax numbers: | Cryptych Pty Ltd
Level 15, Suite 1502
275 Alfred Street
North Sydney NSW 2060
+61 299 595 820 |
|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Name of contact person: | Angela Roche |
| Trade Name:
Common Name:
Classification name: | Nurochek System
Visual Evoked Photic Stimulator
Stimulator, Photic, Evoked Response |
| Regulation number: | 882.1890 |
| Product Code:
Device Class:
Manufacturer:
Submitter: | GWE, OMC
II
Cryptych Pty Ltd
Cryptych Pty Ltd |
| Preparation Date:
Predicate Devices: | March 05, 2020
SightSaver Visual Stimulator by Anschel Technology INC.(K113785)
X-Series System by Advanced Brain Monitoring (K131383) |
DEVICE DESCRIPTION
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.
The Nurochek System combines hardware, firmware and software to generate and acquire physiological signals, specifically, VEPs. These VEPs are generated by a visual stimulus delivered through the Nurochek headset worn by the subject. This visual stimulus is a short-duration flash of white light. The Nurochek headset acquires the VEPs from the rear of the head and transmits the resulting EEG to the Nurochek software application to be displayed to the user and stored. These acquired signals are intended to be analyzed by a Physician.
The Nurochek System operates on the principles of generating VEPs via photic simulation and acquiring the VEPs via EEG. Photic stimulation is provided through short-duration flashes of white light from multiple LEDs located in the front of the headset to direct the stimulus into the subject's eyes. The VEPs are acquired by an EEG comprising of a total of 5 electrode interfaces with hydrophilic foam cylinders saturated with saline solution to provide electrical contact to the subject's scalp. A Bluetooth receiver and
4
Image /page/4/Picture/0 description: The image shows a 3D rendering of a hollow square or cube shape. The cube is constructed from four separate rectangular pieces that are joined at the corners. The color of the cube is a gradient, transitioning from a darker shade on the left to a lighter shade on the right, giving it a sense of depth and dimension. The cube appears to be floating or suspended in space, as there is no visible surface or background.
transmitter located within the Nurochek headset allows it to communicate with and be controlled by the Nurochek software application.
The Nurochek software application provides a graphical user interface which allows:
- Collection of the subject details and consent,
- Initiation of a study and tracking of patient information,
- Acquisition and transmission of signals wirelessly to and from the headset.
- Display of the contact quality of electrodes to the subject's scalp,
- Recording, processing and display of EEG signals received from the headset, and ●
- Manage previous EEG recordings of VEPs. ●
INTENDED USE
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.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICES
The Nurochek System uses the same fundamental technology as its predicates for the generation of visualevoked potentials (VEPs) via photic stimulation, the capture of electroencephalograph (EEG) signals, wireless acquisition and software. The technologies used in the Nurochek System are used in the same manner as the predicate devices and do not raise new questions related to safety and effectiveness.
The Nurochek System is substantially equivalent to the legally marketed evoked-response photic stimulator and electroencephalograph (EEG) devices:
(1) Evoked-response photic stimulator technology: Device name: SightSaver Visual Stimulator 510(k) number: K113785 510(k) submitter: Anschel Technology Inc. Classification regulation: 882.1890 Product code: GWE
- (2) Electroencephalograph technology: Device name: X-Series System 510(k) number: K131383 Model number: X10 / X24 510(k) submitter: Advanced Brain Monitoring Classification regulation: 882.1400 Product code: GWO, OMC
The Nurochek headset is worn by a subject and combines hardware, firmware and software to generate and acquire physiological signals, specifically, visual-evoked potentials (VEPs). The Nurochek operates on the principles of generating VEPs via photic activation and acquiring the VEPs via EEG.
Photic activation is achieved through short-duration flashes of white light from multiple LEDs located in the front of the headset (LED visual stimulator goggle) to direct the subject's eyes. This is technologically equivalent to the SightSaver Visual Stimulator (K1113785).
5
Image /page/5/Picture/0 description: The image shows a 3D rendering of a hollow cube-like structure. The structure is composed of four rectangular segments that are joined at the corners to form an open, square frame. The segments are shaded in varying tones of gray, suggesting a light source from above. There is a small notch or cutout visible on the left side of the structure.
The VEP is acquired by an EEG located on the rear part of the headset that contacts the subject's scalp (the sensor). The resulting EEG signal is transmitted via Bluetooth to the Nurochek software application to be displayed and stored. These acquired signals are intended to be analyzed by a Physician. This is technologically equivalent to X-Series System (K131383).
The Nurochek System uses software that is technologically equivalent to the X-Series System to control the headset and display the acquired physiological signals. Like the X-Series System, the Nurochek System only acquires and displays the physiological signals and makes no claims in relation to diagnoses.
Table 1 provides a summary of the comparison of the key features between the Nurochek System and its predicates: SightSaver Visual Stimulator and the X-Series System.
6
| Table 1: Comparison table of Nurochek with predicates devices | |||||
|---|---|---|---|---|---|
| Device Name | Subject device: Nurochek System | Primary Predicate SightSaver Visual
Stimulator | Predicate X-Series System | Discussion |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Cryptych Pty Ltd | Anschel Technology Inc | Advanced Brain Monitoring | N/A |
| K Number | K | K113785 | K131383 | N/A |
| Indications for
Use | 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. | The SightSaver is an evoked response
photic stimulator that is used to apply a
visible light stimulus to a patient's eyes
for use in evoked response measurements
or for electroencephalogram (EEG)
activation.
The SightSaver Visual Stimulator is
designed to be used in hospital and
clinical settings by trained medical
personnel and is for prescription use only. | The X-Series System is intended for
prescription use in the home, healthcare
facility, or clinical research
environment to acquire, transmit,
display and store physiological signals
from patients ages 6 and older. The X-
Series system requires operation by a
trained technician. The X-Series
System acquires, transmits, displays
and stores electroencephalogram
(EEG), electrooculogram (EOG),
electrocardiogram (ECG), and/or
electromyogram (EMG), and
accelerometer signals. The X-Series
System only acquires and displays
physiological signals, no claims are
being made for analysis of the acquired
signals with respect to the accuracy,
precision and reliability. | Equivalent
The predicate devices generate a
visual stimulus and acquire,
transmit, displays and store
electroencephalograms (EEGs) |
| Patient population | Ages 14 and older | Children and adults | Ages 6 or older | Equivalent
Patient population of the Nurochek
System device is within the patient
population of the predicates. |
| Users | Licensed healthcare professionals | Trained medical personnel | Trained Technician | Equivalent
All devices require professional
operators and are prescription
only. |
| Anatomical sites
for EEG readings | Scalp | N/A (does not measure patient) | Scalp and Chest | Equivalent
Nurochek System's EEG sites are
the same (the scalp) as the X-
Series System. The chest site is not
relevant as the Nurochek System
does not utilize ECG technology. |
| Device Name | Subject device: Nurochek System | Primary Predicate SightSaver Visual
Stimulator | Predicate X-Series System | Discussion |
| Anatomical sites
for visual stimulus | Periocular region of the patient's face | Periocular region of the patient's face | N/A (is not a visual stimulator) | Equivalent
Both the Nurochek and SightSaver
contact the periocular region of
patient's face to deliver the visual
stimulus. |
| Prescription use
or OTC | Prescription use only | Prescription use only | Prescription use only | Identical |
| Environment of
Use | Healthcare facility
Clinical Research Environment | Hospital
Clinical settings | Home
Healthcare facility
Clinical Research Environment | Equivalent
Nurochek System and both
predicates are used in a healthcare
facility. |
| Cleaning | Cleaned and disinfected by rubbing with
disinfectant wipes | N/A (the device is disposable) | Cleaned and disinfected by rubbing
isopropyl alcohol | Equivalent
The Nurochek headset is cleaned
and disinfected to a higher
standard. A higher standard is used
due to the design of Nurochek's
headset. The Nurochek headset
contains an anterior visor while the
X-series System does not. As tests
were performed to demonstrated
that cleaning methods are
appropriate for ensuring the
Nurochek headset is clean between
uses they are considered
equivalent. |
| | | Technical specifications | | |
| User Interface | User control, visual indicators | N/A (does not contain any controls) | User control, visual indicators | Equivalent
Nurochek System has same user
interface features as X-Series
System. |
| Wireless data
transfer | Bluetooth | N/A (does not transfer data) | Bluetooth | Equivalent
Nurochek uses the same
technology as X-Series System. |
| Signals Acquired | Scalp EEG | N/A (does not acquire signals) | Scalp EEG
3-D actigraphy | Equivalent
Nurochek System only utilizes
scalp EEG technology and does
not utilize 3-D actigraphy nor the
optional channels of the X-Series |
| Device Name | Subject device: Nurochek System | Primary Predicate SightSaver Visual
Stimulator | Predicate X-Series System | Discussion |
| | | | Optional channels
ECG/EEG/EOG/EMG | System. Therefore, the other
signals are not relevant for the
Nurochek System. |
| Power Supply | 3.7V, 800 mAH Li-Ion battery | Externally powered by trigger device. | 2 to 4 240 mAH 3.7V, 240 mAH Li-Ion
batteries | No Significant Differences
Both Nurochek System and X-
series System use rechargeable
3.7V lithium-ion batteries. The
difference in charge capacity and
number of batteries, which only
dictates the length of use.
The SightSaver is to be connected
to a separate control device which
supplies the power. |
| Operating time | After full charge, unit is capable of at
least 30 complete tests (30 minutes) | N/A (controlled by external trigger) | Monitoring days after charge hours of
use:
0-4 days: 16 to 17 hours
5-10 days: 14 to 15 hours. | No significant differences
The Nurochek System is indicated
for short-term use i.e. 2 sets of 30
second tests completed
consecutively.
The X-Series System is indicated
for long-term monitoring over a
large period of time. |
| Battery Charging | Via USB cable from a wall charger | N/A (does not contain battery) | Via JED Connector connected to the
USB port or USB wall charger | Equivalent
The charging mechanisms between
the Nurochek System and X-Series
System are the same, differing
only in the connector style which
does not affect safety of Nurochek
System. |
| Typical Charging
Time | Typical: 0.5- 3 hours | N/A (does not contain battery) | Typical: 0.5-5 hours. | No significant difference
The charging time for a full charge
for the Nurochek device is less
than the X-Series System, allowing
it to be used more frequently. |
| Photic Stimulation Technology | | | | |
| Mode of
Operation | Photic stimulator positioned on the
periocular region of the patient's face to
expose the eyes to LED light in order to
generate a physiological response. | Photic stimulator positioned on the
periocular region of the patient's face to
expose the eyes to LED light in order to
generate a physiological response. | N/A (does not contain photic
stimulation technology) | Equivalent
The Nurochek uses the same visual
stimulator LED technology as the |
| Device Name | Subject device: Nurochek System | Primary Predicate SightSaver Visual
Stimulator | Predicate X-Series System | Discussion |
| Light source | LED | LED | N/A (does not contain photic
stimulation technology) | Equivalent
The Nurochek System uses the
same technology of light (Light-
emitting diodes - LED) as the
SightSaver device. |
| Flash Rate | 15Hz fixed | Typically 0.5-1.0Hz, up to 100Hz | N/A (does not contain photic
stimulation technology) | Equivalent
The SightSaver's flash rate
depends on the external trigger.
There is no limiting mechanism on
the SightSaver itself. For example,
when used with the Nicolet Viking
EDX (K112052), the flash rate can
be set to 0.1-100Hz.
Flash rate of the Nurochek headset
light stimulus is fixed to 15Hz,
which is within the capabilities of
the SightSaver. |
| EEG Technology | | | | |
| Electrodes
Material | Hydrophilic polyurethane foam on gold
plated copper | N/A (does not contain EEG technology) | Ag/AgCl | No significant difference
Both electrodes achieve the same
function. Material difference has
been tested and does not affect
safety and efficacy of Nurochek
System. |
| Definition | 3 EEG scalp channels | N/A (does not contain EEG technology) | Up to 20 EEG scalp channels | Equivalent
The Nurochek System uses a
subset of the channels of the
predicate device. The additional
number of channels on the
predicate device will go unused
when used for the detection of
VEPs: this is because only 3
electrode sites (01, O2 and Oz)
correspond to the visual cortex. |
| Signal processing
techniques | Sampling rate: 250 s/s | N/A (does not contain EEG technology) | Sampling rate: 256 s/s
0.1 Hz High Pass, hardware | Equivalent |
| Device Name | Subject device: Nurochek System | Primary Predicate SightSaver Visual
Stimulator | Predicate X-Series System | Discussion |
| | Digital decimation filters | | 100 Hz Low Pass, hardware | A sampling rate difference only
dictates the maximum frequency
that can be interpreted.
Different filtering systems are used
but both achieve the same goal not
affecting the safety and
effectiveness of Nurochek System. |
| Accuracy,
variance and
error of
measurements, in
comparison to
standard
techniques of
measuring
identical
physiologic
variables. | Sampling rate: 250 Hz
Dynamic range: +/- 187,500 μV
Resolution: 0.02μV
Peak to peak noise: 1.97μV (typical)
110 dB Common rejection ratio
Input impedance: 1GOhm | N/A (does not contain EEG technology) | Sampling rate: 256 Hz
Dynamic range: +/- 1000μV
Resolution: 0.03μV
Peak to peak noise: 3.7μV (typical)
110 dB Common Mode Rejection Ratio
(typically)
Input impedance: 100GOhm | Equivalent
Aa above, a sampling rate
difference only dictates the
maximum frequency that can be
interpreted.
The dynamic range on the
Nurochek System is larger (and
therefore superior) than the X-
Series System.
The dynamic range of the
Nurochek exceeds that of the X-
Series system. A higher dynamic
range means a wider range of
voltages may be interpreted
without saturation.
Nurochek System exceeds the
resolution performance of the X-
Series System. A lower resolution
number means the Nurochek
System can resolve smaller
differences in the signal, making it
more accurate
The Nurochek System has a lower
peak-to-peak noise of the X-Series
System. A lower peak-to-peak
noise level means that the noise
will have less of an effect on the
system.
Both devices have the same
common mode rejection ratio. |
| Device Name | Subject device: Nurochek System | Primary Predicate SightSaver Visual
Stimulator | Predicate X-Series System | Discussion |
| | | | | International Organisation of
Societies for Electrophysiological
Technology (OSET) recommends
at least 10 MOhm, which both
devices exceed substantially. |
| Impedance Check | Yes | N/A (does not contain EEG technology) | Yes | Equivalent
The Nurochek System and the X-
Series System both have an
impedance check. |
| | | Safety and Performance | | |
| Electrical | IEC 60601-1:2013
IEC 60601-2-40 | Unknown | IEC 60601-2-26:2002
IEC 60601-1-11: 2010
IEC 60601-1:1998+A1: 1991+A2: 1995 | Equivalent
The Nurochek System uses more
up-to-date standards.
IEC 60601-2-26 is not used as IEC
60601-2-40 is more suitable for
devices with evoked response
equipment.
IEC 60601-1-11:2010 is not used
as it applies to home use devices
only. |
| Electromagnetic
Compatibility | IEC 60601-1-2:2014 | Unknown | IEC 60601-1-2: 2007 | Equivalent
The Nurochek System uses more
up-to-date standards. |
| Light Safety | ISO 15004:2
ANSI Z80.36 | ISO 15004:2 | N/A (no visual stimulus) | Equivalent
The Nurochek System uses the
same standard as the predicate, as
well as an additional FDA
recognized standard for light
safety. |
| Software | FDA Guidance for the Content of
Premarket Submission for Software
Contained in Medical Devices
Document (May 11, 2005)
FDA Guidance for Content of Premarket
Submission for Management of
Cybersecurity of Medical Devices | N/A (does not contain software) | FDA Guidance for the Content of
Premarket Submission for Software
Contained in Medical Devices
Document (May 11, 2005) | Equivalent
The Nurochek System uses the
same FDA guidance as the
predicate, as well as an additional
FDA guidance for cybersecurity. |
| Device Name | Subject device: Nurochek System | Primary Predicate SightSaver Visual Stimulator | Predicate X-Series System | Discussion |
| Usability and
Human Factors | IEC 62366
FDA Guidance on Applying Human
Factors and Usability Engineering to
Medical devices | Unknown | Unknown | N/A |
| Cleaning | AAMI TIR 12:2010
AAMI TIR 30:2011
Guidance for Industry and FDA Staff -
Reprocessing Medical Devices in Health
Care Settings: Validation Methods and
Labeling. 2015 | N/A | AAMI TIR 12-94
AAMI TIR 30: 2003 | Equivalent
Same methods; more up-to-date
standards for reprocessing method
validation.
An additional FDA guidance was
used. |
| Biocompatibility | ISO 10993-5 – Cytotoxicity
ISO 10993-10 - Sensitization
ISO 10993-10 - Irritation | Unknown | ISO 10993-5 – Cytotoxicity
ISO 10993-10 - Sensitization
ISO 10993-10 - Irritation | Equivalent
The Nurochek System uses the
same standards for
biocompatibility as the X-Series
System. |
7
Image /page/7/Picture/0 description: The image shows a 3D rendering of a square-shaped structure. The structure appears to be made of a dark gray material and has an opening on one side. The structure is viewed from an isometric perspective, giving a sense of depth and dimension.
8
Image /page/8/Picture/0 description: The image shows a 3D rendering of a square-shaped object. The object appears to be a frame or a hollow cube with one side partially open. The color of the object is a dark gray or charcoal color. The perspective is an isometric view, providing a clear view of the object's structure and shape.
9
Image /page/9/Picture/0 description: The image shows a 3D rendering of a square frame. The frame is composed of thick, gray material and has a cutout on the lower left corner. The perspective is isometric, providing a clear view of the frame's structure and depth.
10
Image /page/10/Picture/0 description: The image shows a 3D rendering of a square-shaped structure. The structure appears to be open in the center, forming a hollow square. The color scheme is primarily gray, with darker shades on the sides and a lighter shade on the top and bottom. There is a small notch or cutout on the lower left side of the structure.
11
Image /page/11/Picture/0 description: The image shows a 3D rendering of a square-shaped structure. The structure appears to be made of a dark gray material and has an opening on one side. The opening is a rectangular notch cut out of the side of the square. The structure has a simple, geometric design and appears to be a hollow frame.
12
Image /page/12/Picture/0 description: The image shows a 3D rendering of a square frame. The frame is gray and has a thick border. There is a small notch cut out of the bottom left corner of the frame. The frame appears to be floating in space.
13
Image /page/13/Picture/0 description: The image shows a 3D rendering of a square-shaped structure. The structure appears to be made of a dark gray material and has a hollow center. There is a small notch or cutout on one of the corners of the square. The structure is viewed from an isometric perspective, giving a sense of depth and dimension.
NON-CLINICAL PERFORMANCE DATA
The Nurochek was developed and manufactured with risk management and safety testing, including electrical safety, biological safety, performance and software testing. This testing has provided assurance of safety and effectiveness within the scope of its intended use.
ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY (EMC)
Electrical safety and EMC testing were conducted on the Nurochek consisting of the headset, firmware and software.
Electrical safety and performance testing were conducted as per IEC 60601-1 (including collateral IEC 60601-1-2 for EMC testing and particular standard IEC 60601-2-40). Compliance to IEC 60601-2-40:2002 -'Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment' was also conducted.
All test results demonstrated compliance of the Nurochek to standards for electro-medical equipment.
LIGHT SAFETY
Light safety testing was conducted as per ISO 15004-2:2007 and ANSIZ80.36-2016. Testing to both standards classified the Nurochek Headset as a Group Instrument. Both standards define a Group 1 instrument as: ophthalmic instruments for which no potential light hazard exists. Therefore, use of the Nurochek system as per the IFU will not lead to patient or user harm due to optical radiation.
BIOCOMPATIBILITY
Biocompatibility was assessed following FDA Guidance "Use of International Standard ISO10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". Per Table 1 of the guidance, the Nurochek headset is a surface device with limited contact (Category A, less than 24 hours contact) and thus cytotoxicity, sensitization, and irritation reactivity tests were selected. Test methods were performed as per the relevant ISO 10993 standards series for Biological Evaluation of Medical Devices. These standards include cytotoxicity (ISO 10993-5), skin irritation and sensitization (ISO 10993-10). All contacting parts were evaluated, including the foam cylinders and strap components. Results of biocompatibility testing demonstrate that materials of the Nurochek System in contact with the patient are biocompatible.
CLEANING
The Nurochek headset cleaning and disinfection procedures have been validated in compliance with the FDA Guidance Document "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling". Testing was performed in accordance with recommended evaluations according to AAMI TIR30 and AAMI TIR12. All tests passed and demonstrated that the cleaning methods are appropriate for ensuring the Nurochek System is clean between uses.
MECHANICAL TESTING
Cyclic testing was performed to test the durability of the mechanical components of the Nurochek headset. The testing was to ensure that the device will meet its required use lifetime. This cyclic testing includes simulating the fitting, lifting and removal of the Nurochek headset on a patient's head.
Drop, impact and push tests as per IEC 60601-1 Ed. 3.1. were also performed to ensure the Nurochek headset is sufficiently resilient against foreseeable misuse.
All test passed and demonstrated compliance of the Nurochek System to IEC 60601-1 criteria.
14
Image /page/14/Picture/0 description: The image shows a 3D rendering of a square-shaped structure. The structure appears to be made of four separate pieces that are joined together to form the square. The pieces are gray in color and have a smooth, matte finish. The structure is viewed from an isometric perspective, with the top and right sides visible. The background is white.
FIRMWARE AND SOFTWARE
The firmware in the Nurochek headset and the Nurochek software have been thoroughly tested through verification and validation testing, including software validation as recommended by FDA's "Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software in Medical Devices", and according to IEC 62304.
The results of the verification and validation activities performed demonstrate the software meets requirements for safety, function and intended use.
CLINICAL STUDIES
A clinical study was performed to evaluate the functionality of the Nurochek System - headset, firmware and software. The study used the clinical EEG Compumedics Grael EEG as a reference device and benchmark. Compumedics Grael EEG is cleared by FDA under K093223. however, is not a predicate of this 510(k) submission. Data from 20 participants were compared to the Compumedics Grael EEG in its performance to detect steady-state visual-evoked potentials (SSVEPs). Participants were evaluated on the clinical EEG and the investigational device with a common visual stimulus shared between them.
All tests were performed successfully with no adverse events. The study concluded that both systems functioned identically in their ability to detect SSVEPs.
CONCLUSION
Cryptych considers the Nurochek System to be as safe and effective as the predicate devices and, therefore, substantially equivalent. The Nurochek System does not introduce any new questions concerning safety or efficacy. As demonstrated by the results from the non-clinical tests performed, the Nurochek System is safe and effective and meets the pre-defined design and performance acceptance criteria. The Nurochek System and its predicates, the SightSaver Visual Stimulator and X-Series System, have the same intended use and similar indications, technological characteristics and principles of operation. Therefore, the Nurochek System is substantially equivalent to the SightSaver Visual Stimulator and the X-Series System.