iCEWav Neuromonitoring Platform

K191868 · Ice Neurosystems, Inc. · GWQ · Mar 31, 2020 · Neurology

Device Facts

• Record ID: K191868
• Device Name: iCEWav Neuromonitoring Platform
• Applicant: Ice Neurosystems, Inc.
• Product Code: GWQ · Neurology
• Decision Date: Mar 31, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended Use

The iCEWav Neuromonitoring Platform (iCEWav) is intended to monitor the state of the brain by recording and displaying EEG signals and can also receive and display a variety of vital signs and other measurements from third-party devices. The iCEWav Neuromonitoring Platform is intended for use by a physician or other qualified medical personnel. It is intended for use on patients of all ages within a hospital or medical environment including the intensive care unit, operating room, emergency room, and other clinical settings where brain monitoring may be indicated. The system provides no function that will directly prevent, mitigate, screen, treat or diagnose a specific disease or condition.

Device Story

iCEWav Neuromonitoring Platform collects, integrates, and displays high-fidelity EEG data and systemic physiological data (e.g., heart rate, blood pressure) to assist clinicians in monitoring brain-injured patients. System consists of computer hardware, touchscreen monitor, and wheeled cart; connects via USB to third-party EEG amplifiers and via USB/serial/Ethernet to bedside physiological monitors. Software gathers data, automates performance functions, and provides GUI for real-time/retrospective evaluation. Clinicians use system to monitor brain electrical activity and systemic physiology in parallel; identify clinical developments affecting brain health. Features include step-by-step patient admission, electrode impedance testing, and customizable recording montages. Quantitative EEG parameters (CSA, Total Power, Alpha/Delta Ratio, Burst Suppression Ratio, Asymmetry Index) are generated via Fast Fourier Transform. Data stored locally on hardware. Used by physicians/qualified personnel in clinical environments.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics.

Technological Characteristics

System includes integrated computer, touchscreen, and wheeled cart. Connects to third-party EEG amplifiers (USB) and physiological monitors (USB, serial, Ethernet). Performs signal processing including 50/60Hz notch filtering, high-pass/low-pass filtering, and Fast Fourier Transform for qEEG. Supports continuous electrode impedance monitoring. Software-based data acquisition and display. No patient-contact materials (no implants).

Indications for Use

Indicated for patients of all ages requiring brain physiological monitoring in hospital settings (ICU, OR, ER). No contraindications.

Regulatory Classification

Identification

An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

Predicate Devices

• Component Neuromonitoring System (K080217)
• Persyst 13 (K151929)

Submission Summary (Full Text)

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iCE Neurosystems, Inc. % Allison Komiyama, Ph.D., R.A.C. Principal Consultant EAS Consulting Group, LLC 33 Golden Eagle Lane Littleton, Colorado 80127

Re: K191868

Trade/Device Name: iCEWav Neuromonitoring Platform Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWQ, OLT Dated: January 20, 2020 Received: January 21, 2020

### Dear Dr. Komiyama:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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 ([e-mail]) or phone [phone] 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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# Indications for Use

510(k) Number (if known) K191868

Device Name iCEWav Neuromonitoring Platform

#### Indications for Use (Describe)

The iCEWav Neuromonitoring Platform (iCEWav) is intended to monitor the state of the brain by recording and displaying EEG signals and can also receive and display a variety of vital signs and other measurements from third-party devices.

The iCEWav Neuromonitoring Platform is intended for use by a physician or other qualified medical personnel. It is intended for use on patients of all ages within a hospital or medical environment including the intensive care unit, operating room, emergency room, and other clinical settings where brain monitoring may be indicated. The system provides no function that will directly prevent, mitigate, screen, treat or diagnose a specific disease or condition.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### 1. 510(k) SUMMARY - K191868

| Submitter: | iCE Neurosystems, Inc.<br>1875 Connecticut Ave NW, Suite 12117<br>Washington, DC 20007<br>Phone: [phone]<br>Email: [e-mail] |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Allison Komiyama, PhD, RAC<br>AcKnowledge Regulatory Strategies, LLC<br>2251 San Diego Ave., Suite B-257<br>San Diego, CA 92110<br>Phone: [phone] (office)<br>Email: [e-mail] |
| Device Trade Name:<br>Common Name:<br>Classification Name: | iCEWav Neuromonitoring Platform<br>Electroencephalograph<br>Electroencephalograph (21CFR882.1400, Product Code GWQ, OLT) |
| Date of Preparation: | January 20, 2020 |

Substantially equivalent devices:

The iCEWav Neuromonitoring Platform is being compared to the software applications in the predicate Component Neuromonitoring System, manufactured by Moberg Research, Inc. (K080217) and Persyst 13 manufactured by Persyst Development Corporation (K151929). The Moberg software application acquires, displays, stores and archives electroencephalographic signals from the brain in addition to allowing the user to configure the EEG recording montage and providing real-time feedback on electrode impedance. The Moberg application also collects data from bedside systemic physiological monitors for display and storage in parallel to collected EEG data. The Persyst software application offers offline quantitative EEG analytical processes for a range of derivatives from raw EEG data.

#### 1.1 Device Description

The iCEWav Neuromonitoring Platform (iCEWav) is a clinical neuromonitoring system designed to streamline the collection and integration of high-fidelity electroencephalographic (EEG) data and matched systemic physiological data to assist clinicians caring for patients with brain injury.

The iCEWav Neuromonitoring Platform includes a computer hardware element and associated touchscreen monitor that are affixed to a wheeled cart approved for use in the clinical environment. The computer hardware system is attached via USB connection to a third-party EEG amplifier system. A separate storage basket is included on the cart for storage of the EEG amplifier when not in use. The computer hardware element includes a range of standard USB. Ethernet and serial ports to allow for connection with a range of third-party physiological monitoring systems found in the clinical environment.

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The iCEWav Neuromonitoring Platform encompasses in-house iCEWav software that serves to gather EEG and systemic data, automate functions of device performance to allow ease-of-use by clinicians, combine data in a format that allows for seamless real-time and retrospective evaluation, and provide a Graphical User Interface that allows a clinician to evaluate data according to preferences of the clinician.

EEG data collection utilizes disposable third-party clinical EEG electrodes connected to a thirdparty clinical EEG amplifier, with resulting digital signals transmitted to the iCEWav computer hardware element. In parallel, correlative physiological data (heart rate, blood pressure, etc.) from third-party monitors are transferred into the system using standard data connections (serial, Ethernet or USB). Time-locked EEG and systemic physiological data are made available for real-time display as well as local hardware-based storage. Using iCEWav, a clinician can simultaneously monitor aspects of systemic physiology and brain electrical activity to help identify and interpret ongoing clinical developments which may have negative effects on brain health.

EEG data can be displayed as raw waveforms or can be displayed using a range of quantitative measures including Compressed Spectral Array (CSA), Total Power, Alpha/Delta Ratio, Burst Suppression Ratio, and Asymmetry Index. Data can be viewed as it is collected in real time; alternatively, stored data can be reviewed retrospectively. EEG and physiological data can be viewed in parallel fashion. Scaling parameters for each data variable as well as the time window to be reviewed can be controlled by a clinical user.

The iCEWav system has several features to optimize ease of use. The patient Admission procedure includes a step-by-step walkthrough process to assist the user in configuring the EEG system and perform initial electrode impedance testing to ensure correct connection to the third-party EEG amplifier. The system provides several options for baseline EEG recording montages that the user can select to streamline the initiation of EEG recording. The user can also easily customize the recording montage. The system automatically detects availability of data inputs from other third-party physiological monitors that are connected to the system hardware and offers the user the list of the available inputs to be selected for display. The system offers the option for continuous impedance checking of connected electrodes through the third-party EEG amplifier, and for convenience the user may select to remove channels demonstrating poor impedance from the raw and quantitative EEG displays.

During or following a period of recording, patient data may be accessed and reviewed from local storage.

### 1.2 Indications for Use

The iCEWav Neuromonitoring Platform (iCEWav) is intended to monitor the state of the brain by recording and displaying EEG signals and can also receive and display a variety of vital signs and other measurements from third-party devices.

The iCEWav Neuromonitoring Platform is intended for use by a physician or other qualified medical personnel. It is intended for use on patients of all ages within a hospital or medical environment including the intensive care unit, operating room, emergency room, and other clinical settings where brain monitoring may be indicated. The system provides no function that will directly prevent, mitigate, screen, treat or diagnose a specific disease or condition.

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### 1.3 Summary of Technological Characteristics and Substantial Equivalence

The iCEWav Neuromonitoring Platform has the combined technical characteristics of the specified Predicate Devices. The system can record, store, process, and display EEG from an EEG amplifier and/or physiological data from other physiological monitoring devices. Quantitative EEG parameters can be generated and displayed in parallel with systemic physiological data. Impedance data from the third-party EEG amplifier can be used to evaluate recording quality from individual EEG electrodes.

The following table provides a substantial equivalence comparison of the iCEWav Neuromonitoring Platform under review to the two predicate devices.

| SYSTEM<br>FEATURE | iCEWav Neuromonitoring<br>Platform | Component<br>Neuromonitoring System -<br>Moberg Research | Persyst 13 | Comment |
|-----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510(k) Number | Pending | K080217 | K151929 | Equivalent |
| Device Class | Class II | Same | Same | Equivalent |
| Class Name | Electroencephalograph<br>(EEG) | Electroencephalograph<br>(EEG) | Electroencephalograph<br>(EEG) | Equivalent |
| Product Code | GWQ, OLT | OMA, GWQ, OLT, MUD,<br>MHX, ORT | OMB, OLT, OMA | Equivalent |
| Classifying<br>Regulation<br>(primary) | 882.1400 | 882.1400 | 882.1400 | Equivalent |
| Intended User | Qualified medical<br>practitioners | Qualified medical<br>practitioners | Qualified medical<br>practitioners | Equivalent |
| Indications for<br>Use | The iCEWav<br>Neuromonitoring Platform<br>(iCEWav) is intended to<br>monitor the state of the<br>brain by recording and<br>displaying EEG signals<br>and can also receive and<br>display a variety of vital<br>signs and other | The Component<br>Neuromonitoring System is<br>intended to monitor the<br>state of the brain by<br>recording and displaying<br>EEG signals, and can also<br>receive and display a<br>variety of vital signs and<br>other measurements from<br>third-party monitoring | Persyst 13 EEG review<br>and analysis software is<br>intended for the review,<br>monitoring and analysis<br>of EEG recordings made<br>by EEG devices and to<br>aid in the assessment of<br>EEG. | Equivalent |
| | | | | |
| | measurements from third-<br>party devices.<br>The iCEWav<br>Neuromonitoring Platform<br>is intended for use by a<br>physician or other qualified<br>medical personnel. It is<br>intended for use on<br>patients of all ages within a<br>hospital or medical<br>environment including the<br>intensive care unit,<br>operating room,<br>emergency room, and<br>other clinical settings<br>where brain monitoring<br>may be indicated. The<br>system provides no<br>function that will directly<br>prevent, mitigate, screen,<br>treat or diagnose a specific<br>disease or condition. | devices (such as ICP,<br>ECG, SpO2, and others). It<br>also has the optional<br>capability to record and<br>display patient video.<br>The Component<br>Neuromonitoring System is<br>intended for use by a<br>physician or other qualified<br>medical personnel. It is<br>intended for use on<br>patients of all ages within a<br>hospital or medical<br>environment, including the<br>operating room, intensive<br>care unit, emergency<br>room, and clinical research<br>settings. | | |
| Clinical<br>Application | Intended for use in<br>patients of all ages who<br>require brain physiological<br>monitoring | Intended for use in<br>patients of all ages who<br>require brain physiological<br>monitoring | Intended for use in<br>adults (greater than or<br>equal to 18 years) | Equivalent |
| Contraindica-<br>tions | None | None | None | Equivalent |
| Environment of<br>use | Clinical settings in which<br>patients requiring<br>physiological monitoring of<br>the brain are encountered | Same | Same | Equivalent |
| Duration of use | Per the requirements of<br>the clinician-user. | Same | Same | Equivalent |
| Hardware<br>components of<br>system | Integrated computer<br>system, flat panel touch<br>screen display, third-party<br>clinical EEG amplifier<br>system, wheeled cart with<br>associated power supply,<br>and cabling necessary for<br>connection to external | Brand-specific EEG<br>amplifier system;<br>otherwise the same | None - software only. | Equivalent |
| | monitors via USB, serial or Ethernet connection. | | | |
| Device materials | N/A – there are no implants or other elements that come into patient contact. | Same | Same | Equivalent |
| User input | Touchscreen monitor | Touchscreen monitor | Mouse/keyboard associated with host computer | Equivalent |
| Third party device inputs | Separate third-party EEG amplifier via USB; systemic data from bedside physiological monitor via standard USB to serial port cabling (see below) | Product-specific EEG amplifier via USB; systemic data from bedside physiological monitor via standard USB to serial port cabling (see below) | (n/a) | Equivalent |
| SYSTEM<br>CHARACTER-<br>ISTIC | iCEWav Neuromonitoring<br>Platform | Component Neuromonitoring<br>System - Moberg Research | Persyst 13 | Comment |
| Records and<br>displays raw<br>EEG data from<br>amplifier,<br>performs gain<br>and filtering<br>functions that<br>may be<br>modified by the<br>user | Raw digitized EEG signals<br>recorded directly from the<br>amplifier at hardware-<br>specified sampling rate;<br>50/60Hz notch filter may be<br>activated/deactivated by<br>User; hi-pass and low-pass<br>filters may be set by User;<br>gain and other display<br>specifications (time interval<br>displayed, time between<br>intervals, etc); user may<br>select from preset electrode<br>montage or modify montage<br>according to user<br>specifications. | Same | Same | Equivalent |
| Records and<br>displays data<br>from bedside<br>physiological<br>monitors | System is connected to<br>bedside monitors using USB,<br>serial or Ethernet<br>connection; device-specific<br>data integration; detection of<br>external device-specific data<br>labeling; user-controlled<br>selection for display of<br>subsets of available data;<br>data displayed in traditional<br>two-dimensional line graph<br>format; user can modify<br>scaling of individual graphs<br>for each data input. | Same | (n/a) | Equivalent |
| Continuously<br>monitors<br>impedance of<br>recording<br>electrodes | Continuous impedance data<br>available for user review;<br>continuous impedance<br>review may be turned off by<br>User; system provides User<br>with information regarding<br>signal quality based on<br>impedance that can be used<br>to disable channels<br>demonstrating poor | Same | (n/a) | Equivalent |
| impedance; User may disable impedance-based signal quality monitoring | | | | |
| | | | | |

Table 1: Substantial Equivalence Technical Characteristics - Overview

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# Table 2: Substantial Equivalence Technical Characteristics – Data input and display

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## Table 3: Patient admission process and data storage

| SYSTEM<br>FEATURE | iCEWav<br>Neuromonitoring<br>Platform | Component Neuromonitoring<br>System - Moberg Research | Persyst 13 | Comment |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|------------|------------|
| Patient<br>identification | User can input patient<br>name, date of birth<br>and medical record<br>number for<br>subsequent file<br>identification; data files<br>can be searched for<br>recall of previously<br>recorded data or to<br>add files to previously<br>monitored patients | Same | (n/a) | Equivalent |
| Data storage | Time-locked EEG and<br>systemic physiological<br>data are stored locally<br>on system hardware;<br>user may load<br>previously recorded<br>data for retrospective<br>review | Same | (n/a) | Equivalent |

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Table 4: Quantitative EEG parameter calculation and display

| SYSTEM<br>FEATURE | iCEWav<br>Neuromonitoring<br>Platform | Component Neuromonitoring<br>System - Moberg Research | Persyst 13 | Comment |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|------------|------------|
| System generates<br>and makes<br>available for display<br>quantitative EEG<br>(qEEG) parameters | System utilizes Fast<br>Fourier Transform<br>processes to generate<br>Compressed Spectral<br>Array (CSA) data;<br>additional parameters<br>available include Total<br>Power, Alpha/Delta<br>ratio and Burst<br>Suppression Ratio;<br>qEEG parameters can<br>be individually<br>selected/displayed per<br>user specifications;<br>gain function for CSA<br>can be set by User;<br>scaling for graphs of<br>qEEG outputs can be<br>manipulated per user<br>specifications | (n/a) | Same | Equivalent |