Nurochek System
Device Facts
| Record ID | K200705 |
|---|---|
| Device Name | Nurochek System |
| Applicant | Cryptych Pty, Ltd. |
| Product Code | GWE · Neurology |
| Decision Date | Apr 23, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1890 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
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.
Device Story
Nurochek System is a headset-based device for generating visual evoked potentials (VEPs) and acquiring EEG signals. Input: short-duration white light flashes from LEDs in the headset front directed at the subject's eyes. Output: EEG signals acquired from the rear of the head via 5 electrode interfaces (hydrophilic foam cylinders with saline). The headset transmits data via Bluetooth to a software application for display and storage. Used in healthcare facilities or clinical research environments by licensed healthcare professionals. The system provides a GUI for study initiation, electrode contact quality monitoring, and signal recording. Acquired signals are intended for physician analysis. Benefits include standardized VEP generation and EEG acquisition for clinical assessment.
Clinical Evidence
Clinical study with 20 participants compared the Nurochek System to the Compumedics Grael EEG (reference device) to evaluate the ability to detect steady-state visual-evoked potentials (SSVEPs). Both systems used a common visual stimulus. Results showed both systems functioned identically in their ability to detect SSVEPs. No adverse events reported.
Technological Characteristics
Headset with LED visual stimulator and 5 EEG electrode interfaces (hydrophilic polyurethane foam on gold-plated copper). Connectivity: Bluetooth wireless. Power: 3.7V, 800 mAH Li-Ion battery. Standards: IEC 60601-1, IEC 60601-2-40, IEC 60601-1-2, ISO 15004-2, ANSI Z80.36, ISO 10993. Software: Firmware and application software for signal acquisition and display. Cleaning: Validated for disinfection via wipes per AAMI TIR12/TIR30.
Indications for Use
Indicated for subjects ages 14 years and older in healthcare or clinical research settings for the generation of visual evoked potentials (VEPs) and acquisition, transmission, display, and storage of EEGs during VEP generation. No diagnostic claims.
Regulatory Classification
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.
Predicate Devices
Reference Devices
Submission Summary (Full Text)
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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
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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
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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)
| <span style="font-family: sans-serif;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
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| <span style="font-family: sans-serif;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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# 510(k) SUMMARY
#### for
## Nurochek System
| 510(k) Owner:<br>Address:<br>Phone and fax numbers: | Cryptych Pty Ltd<br>Level 15, Suite 1502<br>275 Alfred Street<br>North Sydney NSW 2060<br>+61 299 595 820 |
|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Name of contact person: | Angela Roche |
| Trade Name:<br>Common Name:<br>Classification name: | Nurochek System<br>Visual Evoked Photic Stimulator<br>Stimulator, Photic, Evoked Response |
| Regulation number: | 882.1890 |
| Product Code:<br>Device Class:<br>Manufacturer:<br>Submitter: | GWE, OMC<br>II<br>Cryptych Pty Ltd<br>Cryptych Pty Ltd |
| Preparation Date:<br>Predicate Devices: | March 05, 2020<br>SightSaver Visual Stimulator by Anschel Technology INC.(K113785)<br>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
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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).
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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.
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| | | | | Table 1: Comparison table of Nurochek with predicates devices | |
|--|--|--|--|---------------------------------------------------------------|--|
| | | | | | |
| Device Name | Subject device: Nurochek System | Primary Predicate SightSaver Visual<br>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<br>Use | The Nurochek System is intended for<br>prescription use in healthcare facilities<br>or clinical research environments for<br>subjects ages 14 years and older. The<br>Nurochek System is indicated for the<br>generation of visual evoked potentials<br>(VEPs) and to acquire, transmit, display<br>and store electroencephalograms (EEGs)<br>during the generation of VEPs. The<br>Nurochek System only acquires and<br>displays physiological signals: no claims<br>are being made for use as a diagnostic<br>criterion or for the analysis of the<br>acquired signals with respect to the<br>accuracy, precision and reliability. | The SightSaver is an evoked response<br>photic stimulator that is used to apply a<br>visible light stimulus to a patient's eyes<br>for use in evoked response measurements<br>or for electroencephalogram (EEG)<br>activation.<br>The SightSaver Visual Stimulator is<br>designed to be used in hospital and<br>clinical settings by trained medical<br>personnel and is for prescription use only. | The X-Series System is intended for<br>prescription use in the home, healthcare<br>facility, or clinical research<br>environment to acquire, transmit,<br>display and store physiological signals<br>from patients ages 6 and older. The X-<br>Series system requires operation by a<br>trained technician. The X-Series<br>System acquires, transmits, displays<br>and stores electroencephalogram<br>(EEG), electrooculogram (EOG),<br>electrocardiogram (ECG), and/or<br>electromyogram (EMG), and<br>accelerometer signals. The X-Series<br>System only acquires and displays<br>physiological signals, no claims are<br>being made for analysis of the acquired<br>signals with respect to the accuracy,<br>precision and reliability. | Equivalent<br>The predicate devices generate a<br>visual stimulus and acquire,<br>transmit, displays and store<br>electroencephalograms (EEGs) |
| Patient population | Ages 14 and older | Children and adults | Ages 6 or older | Equivalent<br>Patient population of the Nurochek<br>System device is within the patient<br>population of the predicates. |
| Users | Licensed healthcare professionals | Trained medical personnel | Trained Technician | Equivalent<br>All devices require professional<br>operators and are prescription<br>only. |
| Anatomical sites<br>for EEG readings | Scalp | N/A (does not measure patient) | Scalp and Chest | Equivalent<br>Nurochek System's EEG sites are<br>the same (the scalp) as the X-<br>Series System. The chest site is not<br>relevant as the Nurochek System<br>does not utilize ECG technology. |
| Device Name | Subject device: Nurochek System | Primary Predicate SightSaver Visual<br>Stimulator | Predicate X-Series System | Discussion |
| Anatomical sites<br>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<br>Both the Nurochek and SightSaver<br>contact the periocular region of<br>patient's face to deliver the visual<br>stimulus. |
| Prescription use<br>or OTC | Prescription use only | Prescription use only | Prescription use only | Identical |
| Environment of<br>Use | Healthcare facility<br>Clinical Research Environment | Hospital<br>Clinical settings | Home<br>Healthcare facility<br>Clinical Research Environment | Equivalent<br>Nurochek System and both<br>predicates are used in a healthcare<br>facility. |
| Cleaning | Cleaned and disinfected by rubbing with<br>disinfectant wipes | N/A (the device is disposable) | Cleaned and disinfected by rubbing<br>isopropyl alcohol | Equivalent<br>The Nurochek headset is cleaned<br>and disinfected to a higher<br>standard. A higher standard is used<br>due to the design of Nurochek's<br>headset. The Nurochek headset<br>contains an anterior visor while the<br>X-series System does not. As tests<br>were performed to demonstrated<br>that cleaning methods are<br>appropriate for ensuring the<br>Nurochek headset is clean between<br>uses they are considered<br>equivalent. |
| | | Technical specifications | | |
| User Interface | User control, visual indicators | N/A (does not contain any controls) | User control, visual indicators | Equivalent<br>Nurochek System has same user<br>interface features as X-Series<br>System. |
| Wireless data<br>transfer | Bluetooth | N/A (does not transfer data) | Bluetooth | Equivalent<br>Nurochek uses the same<br>technology as X-Series System. |
| Signals Acquired | Scalp EEG | N/A (does not acquire signals) | Scalp EEG<br>3-D actigraphy | Equivalent<br>Nurochek System only utilizes<br>scalp EEG technology and does<br>not utilize 3-D actigraphy nor the<br>optional channels of the X-Series |
| Device Name | Subject device: Nurochek System | Primary Predicate SightSaver Visual<br>Stimulator | Predicate X-Series System | Discussion |
| | | | Optional channels<br>ECG/EEG/EOG/EMG | System. Therefore, the other<br>signals are not relevant for the<br>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<br>batteries | No Significant Differences<br>Both Nurochek System and X-<br>series System use rechargeable<br>3.7V lithium-ion batteries. The<br>difference in charge capacity and<br>number of batteries, which only<br>dictates the length of use.<br>The SightSaver is to be connected<br>to a separate control device which<br>supplies the power. |
| Operating time | After full charge, unit is capable of at<br>least 30 complete tests (30 minutes) | N/A (controlled by external trigger) | Monitoring days after charge hours of<br>use:<br>0-4 days: 16 to 17 hours<br>5-10 days: 14 to 15 hours. | No significant differences<br>The Nurochek System is indicated<br>for short-term use i.e. 2 sets of 30<br>second tests completed<br>consecutively.<br>The X-Series System is indicated<br>for long-term monitoring over a<br>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<br>USB port or USB wall charger | Equivalent<br>The charging mechanisms between<br>the Nurochek System and X-Series<br>System are the same, differing<br>only in the connector style which<br>does not affect safety of Nurochek<br>System. |
| Typical Charging<br>Time | Typical: 0.5- 3 hours | N/A (does not contain battery) | Typical: 0.5-5 hours. | No significant difference<br>The charging time for a full charge<br>for the Nurochek device is less<br>than the X-Series System, allowing<br>it to be used more frequently. |
| Photic Stimulation Technology |…
