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 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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the iCEWav Neuromonitoring Platform. It aims to demonstrate substantial equivalence to predicate devices, rather than proving device performance against specific acceptance criteria through a clinical study.

Therefore, the document does NOT contain information regarding:

A table of acceptance criteria and reported device performance: The document presents a "Substantial Equivalence Technical Characteristics" table, which compares features of the iCEWav platform to predicate devices, but it does not specify quantitative acceptance criteria for performance metrics (e.g., accuracy, sensitivity, specificity) and then report actual device performance against those criteria.
Sample size and data provenance for a test set: There is no mention of a test set, sample size, or whether the data was retrospective or prospective.
Number and qualifications of experts for ground truth: No experts are mentioned as establishing ground truth for a test set.
Adjudication method for the test set: Not applicable as no test set or ground truth establishment by experts is described.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study: The document does not describe any study involving human readers or AI assistance, nor does it discuss effect sizes.
Standalone (algorithm only) performance: The device is a neuromonitoring platform that processes and displays data, not an algorithm providing a diagnostic output for which standalone performance would typically be evaluated in this context.
Type of ground truth used: No ground truth based on expert consensus, pathology, or outcomes data is described.
Sample size for the training set: There is no mention of a training set or corresponding sample size.
How ground truth for the training set was established: Not applicable as no training set is described.

In summary, this document does not describe a study to prove the device meets acceptance criteria related to its performance in a clinical setting (e.g., diagnostic accuracy). Instead, it focuses on demonstrating substantial equivalence of the iCEWav Neuromonitoring Platform's technical characteristics and intended use to existing legally marketed predicate devices.

The bulk of the relevant information provided in the document focuses on:

Device Description: The iCEWav Neuromonitoring Platform gathers, processes, and displays EEG and systemic physiological data.
Indications for Use: Intended to monitor the state of the brain by recording and displaying EEG signals and vital signs from third-party devices for patients of all ages in hospital settings. It explicitly states, "The system provides no function that will directly prevent, mitigate, screen, treat or diagnose a specific disease or condition."
Substantial Equivalence Comparison (Tables 1-4): This section directly compares the iCEWav platform with two predicate devices (Moberg Research's Component Neuromonitoring System and Persyst 13) across various features such as device class, intended user, indications for use, clinical application, hardware components, data input and display, patient admission process, data storage, and quantitative EEG parameter calculation. The "Comment" column consistently states "Equivalent," indicating that the manufacturer believes the new device performs similarly to the predicate devices in these aspects.

Summary

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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 (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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Indications for Use

510(k) Number (if known) K191868

Device Name iCEWav Neuromonitoring Platform

Indications for Use (Describe)

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.1875 Connecticut Ave NW, Suite 12117Washington, DC 20007Phone: (646) 250-9166Email: allen.waziri@iceneurosystems.com
Contact Person:	Allison Komiyama, PhD, RACAcKnowledge Regulatory Strategies, LLC2251 San Diego Ave., Suite B-257San Diego, CA 92110Phone: (619) 458-9547 (office)Email: akomiyama@acknowledge-rs.com
Device Trade Name:Common Name:Classification Name:	iCEWav Neuromonitoring PlatformElectroencephalographElectroencephalograph (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

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

1.2 Indications for Use

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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.

SYSTEMFEATURE	iCEWav NeuromonitoringPlatform	ComponentNeuromonitoring System -Moberg Research	Persyst 13	Comment
510(k) Number	Pending	K080217	K151929	Equivalent
Device Class	Class II	Same	Same	Equivalent
Class Name	Electroencephalograph(EEG)	Electroencephalograph(EEG)	Electroencephalograph(EEG)	Equivalent
Product Code	GWQ, OLT	OMA, GWQ, OLT, MUD,MHX, ORT	OMB, OLT, OMA	Equivalent
ClassifyingRegulation(primary)	882.1400	882.1400	882.1400	Equivalent
Intended User	Qualified medicalpractitioners	Qualified medicalpractitioners	Qualified medicalpractitioners	Equivalent
Indications forUse	The iCEWavNeuromonitoring Platform(iCEWav) is intended tomonitor the state of thebrain by recording anddisplaying EEG signalsand can also receive anddisplay a variety of vitalsigns and other	The ComponentNeuromonitoring System isintended to monitor thestate of the brain byrecording and displayingEEG signals, and can alsoreceive and display avariety of vital signs andother measurements fromthird-party monitoring	Persyst 13 EEG reviewand analysis software isintended for the review,monitoring and analysisof EEG recordings madeby EEG devices and toaid in the assessment ofEEG.	Equivalent

	measurements from third-party devices.The iCEWavNeuromonitoring Platformis intended for use by aphysician or other qualifiedmedical personnel. It isintended for use onpatients of all ages within ahospital or medicalenvironment including theintensive care unit,operating room,emergency room, andother clinical settingswhere brain monitoringmay be indicated. Thesystem provides nofunction that will directlyprevent, mitigate, screen,treat or diagnose a specificdisease or condition.	devices (such as ICP,ECG, SpO2, and others). Italso has the optionalcapability to record anddisplay patient video.The ComponentNeuromonitoring System isintended for use by aphysician or other qualifiedmedical personnel. It isintended for use onpatients of all ages within ahospital or medicalenvironment, including theoperating room, intensivecare unit, emergencyroom, and clinical researchsettings.
ClinicalApplication	Intended for use inpatients of all ages whorequire brain physiologicalmonitoring	Intended for use inpatients of all ages whorequire brain physiologicalmonitoring	Intended for use inadults (greater than orequal to 18 years)	Equivalent
Contraindica-tions	None	None	None	Equivalent
Environment ofuse	Clinical settings in whichpatients requiringphysiological monitoring ofthe brain are encountered	Same	Same	Equivalent
Duration of use	Per the requirements ofthe clinician-user.	Same	Same	Equivalent
Hardwarecomponents ofsystem	Integrated computersystem, flat panel touchscreen display, third-partyclinical EEG amplifiersystem, wheeled cart withassociated power supply,and cabling necessary forconnection to external	Brand-specific EEGamplifier system;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
SYSTEMCHARACTER-ISTIC	iCEWav NeuromonitoringPlatform	Component NeuromonitoringSystem - Moberg Research	Persyst 13	Comment
Records anddisplays rawEEG data fromamplifier,performs gainand filteringfunctions thatmay bemodified by theuser	Raw digitized EEG signalsrecorded directly from theamplifier at hardware-specified sampling rate;50/60Hz notch filter may beactivated/deactivated byUser; hi-pass and low-passfilters may be set by User;gain and other displayspecifications (time intervaldisplayed, time betweenintervals, etc); user mayselect from preset electrodemontage or modify montageaccording to userspecifications.	Same	Same	Equivalent
Records anddisplays datafrom bedsidephysiologicalmonitors	System is connected tobedside monitors using USB,serial or Ethernetconnection; device-specificdata integration; detection ofexternal device-specific datalabeling; user-controlledselection for display ofsubsets of available data;data displayed in traditionaltwo-dimensional line graphformat; user can modifyscaling of individual graphsfor each data input.	Same	(n/a)	Equivalent
Continuouslymonitorsimpedance ofrecordingelectrodes	Continuous impedance dataavailable for user review;continuous impedancereview may be turned off byUser; system provides Userwith information regardingsignal quality based onimpedance that can be usedto disable channelsdemonstrating 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

SYSTEMFEATURE	iCEWavNeuromonitoringPlatform	Component NeuromonitoringSystem - Moberg Research	Persyst 13	Comment
Patientidentification	User can input patientname, date of birthand medical recordnumber forsubsequent fileidentification; data filescan be searched forrecall of previouslyrecorded data or toadd files to previouslymonitored patients	Same	(n/a)	Equivalent
Data storage	Time-locked EEG andsystemic physiologicaldata are stored locallyon system hardware;user may loadpreviously recordeddata for retrospectivereview	Same	(n/a)	Equivalent

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Table 4: Quantitative EEG parameter calculation and display

SYSTEMFEATURE	iCEWavNeuromonitoringPlatform	Component NeuromonitoringSystem - Moberg Research	Persyst 13	Comment
System generatesand makesavailable for displayquantitative EEG(qEEG) parameters	System utilizes FastFourier Transformprocesses to generateCompressed SpectralArray (CSA) data;additional parametersavailable include TotalPower, Alpha/Deltaratio and BurstSuppression Ratio;qEEG parameters canbe individuallyselected/displayed peruser specifications;gain function for CSAcan be set by User;scaling for graphs ofqEEG outputs can bemanipulated per userspecifications	(n/a)	Same	Equivalent

Regulation Number and Section

§ 882.1400 Electroencephalograph.

(a)
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.(b)
Classification. Class II (performance standards).