(263 days)
Not Found
No
The summary describes standard EEG signal processing and display features, with no mention of AI or ML algorithms for analysis, interpretation, or prediction.
No.
The description explicitly states, "The system provides no function that will directly prevent, mitigate, screen, treat or diagnose a specific disease or condition," which indicates it is not a therapeutic device. It is a neuromonitoring platform designed to record and display EEG signals and other vital signs.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states: "The system provides no function that will directly prevent, mitigate, screen, treat or diagnose a specific disease or condition." While it monitors brain signals and physiological data, it is not intended for diagnostic purposes.
No
The device description explicitly states that the iCEWav Neuromonitoring Platform includes a "computer hardware element and associated touchscreen monitor that are affixed to a wheeled cart" and connects to third-party hardware like EEG amplifiers and physiological monitors. This indicates it is not solely software.
Based on the provided information, the iCEWav Neuromonitoring Platform 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, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- iCEWav Function: The iCEWav system monitors the state of the brain by recording and displaying EEG signals, which are electrical signals from the brain. It also receives and displays vital signs from third-party devices. These are measurements taken directly from the patient's body or from other medical devices, not from specimens collected from the body for in vitro analysis.
- Intended Use: The intended use explicitly states it is for monitoring the state of the brain by recording and displaying EEG signals and vital signs. It also states that the system provides no function that will directly prevent, mitigate, screen, treat or diagnose a specific disease or condition. This aligns with a monitoring function, not an in vitro diagnostic function.
Therefore, the iCEWav Neuromonitoring Platform falls under the category of a neuromonitoring device that collects and displays physiological data directly from the patient.
N/A
Intended Use / 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.
Product codes
GWQ, OLT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Brain
Indicated Patient Age Range
patients of all ages
Intended User / Care Setting
physician or other qualified medical personnel / hospital or medical environment including the intensive care unit, operating room, emergency room, and other clinical settings where brain monitoring may be indicated.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
§ 882.1400 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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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3
1. 510(k) SUMMARY - K191868
| Submitter: | iCE Neurosystems, Inc.
1875 Connecticut Ave NW, Suite 12117
Washington, DC 20007
Phone: (646) 250-9166
Email: allen.waziri@iceneurosystems.com |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Allison Komiyama, PhD, RAC
AcKnowledge Regulatory Strategies, LLC
2251 San Diego Ave., Suite B-257
San Diego, CA 92110
Phone: (619) 458-9547 (office)
Email: akomiyama@acknowledge-rs.com |
| Device Trade Name:
Common Name:
Classification Name: | iCEWav Neuromonitoring Platform
Electroencephalograph
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.
4
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.
5
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
FEATURE | iCEWav Neuromonitoring
Platform | Component
Neuromonitoring 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 |
| Classifying
Regulation
(primary) | 882.1400 | 882.1400 | 882.1400 | Equivalent |
| Intended User | Qualified medical
practitioners | Qualified medical
practitioners | Qualified medical
practitioners | Equivalent |
| 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 | The Component
Neuromonitoring System 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 monitoring | Persyst 13 EEG review
and analysis software is
intended for the review,
monitoring and analysis
of EEG recordings made
by EEG devices and to
aid in the assessment of
EEG. | Equivalent |
| | | | | |
| | 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. | devices (such as ICP,
ECG, SpO2, and others). It
also has the optional
capability to record and
display patient video.
The Component
Neuromonitoring System 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
operating room, intensive
care unit, emergency
room, and clinical research
settings. | | |
| Clinical
Application | Intended for use in
patients of all ages who
require brain physiological
monitoring | Intended for use in
patients of all ages who
require brain physiological
monitoring | Intended for use in
adults (greater than or
equal to 18 years) | Equivalent |
| Contraindica-
tions | None | None | None | Equivalent |
| Environment of
use | Clinical settings in which
patients requiring
physiological monitoring of
the brain are encountered | Same | Same | Equivalent |
| Duration of use | Per the requirements of
the clinician-user. | Same | Same | Equivalent |
| Hardware
components of
system | Integrated computer
system, flat panel touch
screen display, third-party
clinical EEG amplifier
system, wheeled cart with
associated power supply,
and cabling necessary for
connection to external | Brand-specific EEG
amplifier 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 |
| SYSTEM
CHARACTER-
ISTIC | iCEWav Neuromonitoring
Platform | Component Neuromonitoring
System - Moberg Research | Persyst 13 | Comment |
| Records and
displays raw
EEG data from
amplifier,
performs gain
and filtering
functions that
may be
modified by the
user | Raw digitized EEG signals
recorded directly from the
amplifier at hardware-
specified sampling rate;
50/60Hz notch filter may be
activated/deactivated by
User; hi-pass and low-pass
filters may be set by User;
gain and other display
specifications (time interval
displayed, time between
intervals, etc); user may
select from preset electrode
montage or modify montage
according to user
specifications. | Same | Same | Equivalent |
| Records and
displays data
from bedside
physiological
monitors | System is connected to
bedside monitors using USB,
serial or Ethernet
connection; device-specific
data integration; detection of
external device-specific data
labeling; user-controlled
selection for display of
subsets of available data;
data displayed in traditional
two-dimensional line graph
format; user can modify
scaling of individual graphs
for each data input. | Same | (n/a) | Equivalent |
| Continuously
monitors
impedance of
recording
electrodes | Continuous impedance data
available for user review;
continuous impedance
review may be turned off by
User; system provides User
with information regarding
signal quality based on
impedance that can be used
to disable channels
demonstrating poor | Same | (n/a) | Equivalent |
| impedance; User may disable impedance-based signal quality monitoring | | | | |
| | | | | |
Table 1: Substantial Equivalence Technical Characteristics - Overview
6
7
8
Table 2: Substantial Equivalence Technical Characteristics – Data input and display
9
Table 3: Patient admission process and data storage
| SYSTEM
FEATURE | iCEWav
Neuromonitoring
Platform | Component Neuromonitoring
System - Moberg Research | Persyst 13 | Comment |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|------------|------------|
| Patient
identification | User can input patient
name, date of birth
and medical record
number for
subsequent file
identification; data files
can be searched for
recall of previously
recorded data or to
add files to previously
monitored patients | Same | (n/a) | Equivalent |
| Data storage | Time-locked EEG and
systemic physiological
data are stored locally
on system hardware;
user may load
previously recorded
data for retrospective
review | Same | (n/a) | Equivalent |
10
Table 4: Quantitative EEG parameter calculation and display
| SYSTEM
FEATURE | iCEWav
Neuromonitoring
Platform | Component Neuromonitoring
System - Moberg Research | Persyst 13 | Comment |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|------------|------------|
| System generates
and makes
available for display
quantitative EEG
(qEEG) parameters | System utilizes Fast
Fourier Transform
processes to generate
Compressed Spectral
Array (CSA) data;
additional parameters
available include Total
Power, Alpha/Delta
ratio and Burst
Suppression Ratio;
qEEG parameters can
be individually
selected/displayed per
user specifications;
gain function for CSA
can be set by User;
scaling for graphs of
qEEG outputs can be
manipulated per user
specifications | (n/a) | Same | Equivalent |