(175 days)
Not Found
No
The summary describes a system for acquiring, displaying, and storing EEG signals for review and analysis by trained medical professionals. There is no mention of automated analysis, interpretation, or any features that would typically involve AI/ML. The device explicitly states it does not provide diagnostic conclusions.
No.
The device is intended to measure and record electrical activity of the brain and display EEG signals, not to treat a condition. The "Intended Use" states it "does not provide any diagnostic conclusion" and "is not to be used as a stand-alone in the evaluation or diagnosis of a disease or other condition."
No
The "Intended Use / Indications for Use" section explicitly states, "The VEEGix EEG System does not provide any diagnostic conclusion about the patient's condition" and "The VEEGix EEG System is not to be used as a stand-alone in the evaluation or diagnosis of a disease or other condition." This indicates it's for monitoring and recording, not diagnosis.
No
The device description explicitly mentions hardware components like the "VEEGix Electrode" and the "VEEGix EEG module" which acquire and transmit the EEG signals. The software component (VEEGix iOS app) is only part of the larger system.
Based on the provided information, the VEEGix EEG System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- VEEGix EEG System Function: The VEEGix EEG System measures and records electrical activity directly from the patient's brain by placing electrodes on the forehead. This is a measurement of physiological activity within the body (in vivo).
- Intended Use: The intended use clearly states the device is for "measuring and recording the electrical activity of a patient's brain" and "acquisition of EEG signals, displaying them in real time and storing them for later review and analysis." This is consistent with an in vivo physiological monitoring device, not an in vitro diagnostic test.
- No Specimen Analysis: There is no mention of collecting or analyzing any biological specimens from the patient.
Therefore, the VEEGix EEG System falls under the category of a physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VEEGix EEG System, is intended to be used for measuring and recording the electrical activity of a patient's brain, obtained by placing electrodes on the forehead and wirelessly transmitting the electroencephalographic (EEG) signals for storage and display.
The VEEGix EEG System, is intended for use in the acquisition of EEG signals, displaying them in real time and storing them for later review and analysis.
The VEEGix EEG System, is intended for use in a hospital Operating Room. Post Anesthesia Care Unit, Intensive Care Unit, Emergency Department, or in other medical facilities such as inpatient and outpatient (ambulatory) surgery settings.
The VEEGix EEG System is indicated for use on patients 18 years of age or older and is to be used by licensed medical professionals who have been adequately trained in the use and interpretation of EEG data for determination of brain state.
The VEEGix EEG System does not provide any diagnostic conclusion about the patient's condition.
The VEEGix EEG System is not to be used as a stand-alone in the evaluation or diagnosis of a disease or other condition.
The VEEGix EEG System is not intended for use in life support systems.
Product codes (comma separated list FDA assigned to the subject device)
OLT, OMC, ORT, GXY
Device Description
The VEEGix™ EEG system (subject device) is a Electrocochleographic (EEG) device to allow healthcare practitioners, nurses, neurologists and qualified technicians working in hospital Operating Room, Post Anesthesia Care Unit, Intensive Care Unit, Emergency Department, or in other medical facilities such as inpatient and outpatient (ambulatory) surgery settings to observe a patient's EEG signals and its derivatives.
The use of the subject device is a straight-forward procedure of applying the VEEGix Electrode, which is a lightweight band, onto the patient's scalp in which the electrodes acquire the patient's EEG signals. Those signals are transmitted via the VEEGix EEG module) to the VEEGix iOS app (application) which display the patient's EEG measurements in real-time to allow healthcare practitioners, nurses, neurologists and qualified technicians to monitor and record those EEG measurements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
EEG
Anatomical Site
Patient's brain (electrodes on the forehead)
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
Licensed medical professionals who have been adequately trained in the use and interpretation of EEG data for determination of brain state.
Hospital Operating Room, Post Anesthesia Care Unit, Intensive Care Unit, Emergency Department, or in other medical facilities such as inpatient and outpatient (ambulatory) surgery settings.
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)
Bench testing:
Bench testing was performed in hospital to compare the quality and medical EEG feature similarity of electroencephalography (EEG) signals obtained by the NeuroServo (NS) device and those recorded with a conventional clinical EEG system (N1) (NicoletOne, Natus Medical Inc., Pleasanton, CA) in an ICU setting.
To investigate the equivalency of the EEG signals acquired by NS and N1 systems, we conducted a visual comparison of the signals in the time domain. A point-by-point comparison of the amplitude of the waveforms requires precise temporal alignment of the signals obtained from NS and N1 systems were initially sampled in 2048 and 512 samples per second, respectively. Therefore, we downsampled the NS signal by decimation with a factor of 4 to ensure a point-by-point comparison. The signal then was band-pass filtered at corner frequencies at 0.5 and notch filtered at 58-62 Hz. Next, we used the prominent artifacts present in the data to roughly align the signals in the time domain. For precise alignment, we segmented the data int nonoverlapping 10-second epochs and used the crosscorrelation function "xcorr" in MATLAB (Mathworks, Natick, MA) to find the time lag (often less than 100 ms) with the highest correlation which then was used to realign the signals in time-domain. We used 10second epochs as this is a common temporal range used by experts for the offline or online visualization of data. Next, we repeated the same process for all segments to compensate for the occasional sample drifts in the data which could occur due to independent sampling clocks. An exemplar snippet of timealigned EEG signals obtained by N1 and NS systems is shown in Fig. 1A in blue and red traces, respectively. This example demonstrates a substantial overlap between the waveforms. To quantify the similarity, we computed Pearson's correlation coefficient between the two waveforms which demonstrated a high correlation coefficient between the two waveforms (Fig. 1B; r=0.84, p
§ 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
August 23, 2024
Image /page/0/Picture/1 description: The image shows the logo for 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
NeuroServo Inc. Nicolas Tremblay CEO 2065 Parthenais. Suite 416 Montreal, QC H2K3T1 Canada
Re: K240593
Trade/Device Name: VEEGix EEG System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLT, OMC, ORT, GXY Dated: March 1, 2024 Received: March 1, 2024
Dear Nicolas Tremblay:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Patrick Antkowiak -S for
Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and
2
Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
VEEGix EEG System
Indications for Use (Describe)
The VEEGix EEG System, is intended to be used for measuring and recording the electrical activity of a patient's brain, obtained by placing electrodes on the forehead and wirelessly transmitting the electroencephalographic (EEG) signals for storage and display.
The VEEGix EEG System, is intended for use in the acquisition of EEG signals, displaying them in real time and storing them for later review and analysis.
The VEEGix EEG System, is intended for use in a hospital Operating Room. Post Anesthesia Care Unit, Intensive Care Unit, Emergency Department, or in other medical facilities such as inpatient and outpatient (ambulatory) surgery settings.
The VEEGix EEG System is indicated for use on patients 18 years of age or older and is to be used by licensed medical professionals who have been adequately trained in the use and interpretation of EEG data for determination of brain state.
The VEEGix EEG System does not provide any diagnostic conclusion about the patient's condition.
The VEEGix EEG System is not to be used as a stand-alone in the evaluation or diagnosis of a disease or other condition.
The VEEGix EEG System is not intended for use in life support systems.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the logo for Neuroservo. The logo consists of a black circle with a white waveform inside. Below the circle, the word "NEUROSERVO" is written in a sans-serif font, with "NEURO" in black and "SERVO" in gray.
VEEGix™ EEG System Traditional 510(k) Summary K240593
510(k) Summary:
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92
Applicant Information:
NeuroServo Inc. 2065 Parthenais Street, Suite 416 Montréal, Québec Canada H2K 3T1
Contact Information:
Nicolas Tremblay CEO Telephone: +1 514 536-0250 E-mail: ntremblay@neuroservo.com
Date Prepared:
June 27, 2024, updated: August 22, 2024
Subject Device Information:
| 510(k) Number: | K240593 (Pre-Market) |
|---|---|
| Trade Name: | VEEGix EEG System |
| Manufacturer: | NeuroServo, Inc. |
| Classification Name: | Electroencephalograph, 21 CFR 882.1400 |
| Device Class: | Class II |
| Product Code: | OLT – Sec. OMC, ORT, GXY |
Primary Predicate Device Information:
| 510(k) Number: | K213299 |
|---|---|
| Trade Name: | Wireless EEG System |
| Manufacturer: | Pascall Systems, Inc. |
| Classification Name: | Electroencephalograph, 21 CFR 882.1400 |
| Device Class: | Class II |
| Product Code: | OLT - Sec. OMC, ORT, GXY |
Secondary Predicate Device Information:
| 510(k) Number: | K221563 |
|---|---|
| Trade Name: | Neurosteer EEG Recorder |
| Manufacturer: | Neurosteer Inc. |
| Classification Name: | Electroencephalograph, 21 CFR 882.1400 |
| Device Class: | Class II |
| Product Code: | OMC, GXY |
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Image /page/5/Picture/0 description: The image shows the logo for Neuroservo. The logo consists of a black circle with a white waveform inside. Below the circle, the word "NEUROSERVO" is written in a sans-serif font, with the "S" in "SERVO" being slightly larger and a different shade of gray.
Device Description:
The VEEGix™ EEG system (subject device) is a Electrocochleographic (EEG) device to allow healthcare practitioners, nurses, neurologists and qualified technicians working in hospital Operating Room, Post Anesthesia Care Unit, Intensive Care Unit, Emergency Department, or in other medical facilities such as inpatient and outpatient (ambulatory) surgery settings to observe a patient's EEG signals and its derivatives.
The use of the subject device is a straight-forward procedure of applying the VEEGix Electrode, which is a lightweight band, onto the patient's scalp in which the electrodes acquire the patient's EEG signals. Those signals are transmitted via the VEEGix EEG module) to the VEEGix iOS app (application) which display the patient's EEG measurements in real-time to allow healthcare practitioners, nurses, neurologists and qualified technicians to monitor and record those EEG measurements.
Indications for Use:
The VEEGix EEG System is intended to be used for measuring the electrical activity of a patient's brain, obtained by placing electrodes on the forehead and wirelessly transmitting the electroencephalographic (EEG) signals for storage and display.
The VEEGix EEG System is intended for use in the acquisition of EEG signals, displaying them in real time and storing them for later review and analysis.
The VEEGix EEG System is intended for use in a hospital Operating Room, Post Anesthesia Care Unit, Intensive Care Unit, Emergency Department, or in other medical facilities such as inpatient (ambulatory) surgery settings.
The VEEGix EEG System is indicated for use on patients 18 years of age or older and is to be used by licensed medical professionals who have been adequately trained in the use and interpretation of EEG data for the determination of brain state.
The VEEGix EEG System does not provide any diagnostic conclusion about the patient's condition.
The VEEGix EEG System is not to be used as a stand-alone in the evaluation or diagnosis of a disease or other condition.
The VEEGix EEG System is not intended for use in life support systems.
Summary of substantial equivalence
The primary predicate device is Wireless EEG System, manufactured by Pascall Systems, and cleared under K213299. The secondary predicate device, Neurosteer EEG Recorder System by Neurosteer Inc., cleared under K221563 is cited for the intent for use and same number of electrodes.
The indications for use of the subject device are a subset of (narrower than and encompassed by) the primary (Wireless EEG System by Pascall Systems, Inc) predicate device's indications and falls within the same intended use as that of the secondary predicate device (Neurosteer EEG Recorder). All three devices
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Image /page/6/Picture/1 description: The image shows the logo for Neuroservo. The logo consists of a black circle with a white waveform inside, above the word "NEUROSERVO" in a sans-serif font. The "NEURO" part of the word is in a darker gray than the "SERVO" part.
are intended to monitor the brain by real-time data acquisition and processing of electroencephalograph signals.
Same as for the primary predicate, the subject device is intended to be used with adult patients 18 years of age or older. Both the subject and primary predicate devices are intended to be used in a hospital Operating Room, Post Anesthesia Care Unit, Intensive Care Unit, Emergency Department, or in other medical facilities such as inpatient and outpatient (ambulatory) surgery settings.
Neither devices provide any diagnostic conclusion about the patient's condition. However, the indication for use of VEEGix EEG System explicitly prohibits the use of device in life support systems and its standalone use in the evaluation or diagnosis of diseases or other conditions.
All three devices use an electrode array and sensor/amplifier to detect and communicate the electroencephalograph signals wirelessly to a display unit that provides raw EEG waveforms and a digital spectral analysis presentation to a clinical user.
All three devices use a reduced montage of disposable EEG Electrode to archive the indication for use. The primary predicate device uses 6 electrodes. The secondary predicate device uses 3 electrodes, same as the VEEGix EEG system. This difference does not affect the indication for use and do not affect safety nor effectiveness as all three devices has been successfully tested for essential performances of Electroencephalograph as per requirements defined in clause 201.4.3.101 in the IEC 80601-2-26 Standard.
The subject and the primary predicate devices both provide signal quality indications including electrode impedance alert in the case of poor electrode contact, noise (EMG) indicator and automatic artifact detection/marker.
The Processed EEG Bandwidth, common mode rejection, and amplifier input impedance of the VEEGix EEG System is substantially equivalent to the primary predicate device since the performance of the VEEGix EEG System on these technical characteristics points is better so it does not affect the safety or effectiveness of the device.
Like primary predicate device, the subject device displays a spectrogram and indicate 95% Spectral Edge Frequency (SEF) along with the quality indicators for artifact, electrode impedance, and EMG. The primary predicate device presents markers at 10 and 20 Hz on the 0 - 30 Hz scale as aids to identify the frequency components of the spectrogram while the VEEGix EEG System does not include these markers. Those markers were provided as aids by the predicate device while the VEEGix EEG System present 2 spectrograms with different time spans to help with identifying current frequency components. The difference in these data presentations does not affect safety and effectiveness as both of these devices provide an equivalent way to display frequency component.
Both the subject device and the primary predicate device display a presentation of burst suppression. The primary predicate device displays burst suppression probability that suppression varies smoothly in time and measures only those frequencies that are within a certain range. The VEEGix EEG System displays suppression ratio in % which is in accordance with the definition of the 2021 definition of the American Clinical Neurophysiology Society. These differences are not significant and do not affect safety and efficacy as both devices present a means of determining suppression percentage.
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Image /page/7/Picture/0 description: The image contains the logo for Neuroservo. The logo consists of a black circle with a white waveform inside, above the word "NEUROSERVO" in a sans-serif font. The "NEURO" part of the word is in a darker gray than the "SERVO" part.
Overall, all the three devices display additional tools for the medical professional. Those additional tools are aimed to help the medical professional in their overall appreciation of patient brain state. The primary predicate device adds a phase-amplitude modulogram who is a color-intensity display that promoted to help visualize the relationship between the amplitude of the high- frequency components of the EEG and the phase of the low-frequency components in the EEG signal. The VEEGix EEG System, on its side, incorporates an amplitude-integrated EEG, which have undergone bench testing against gold standards for the purpose. The differences in additional tools do not affect the indication for use or the safety and effectiveness of the subject device.
The skin-contacting components of all the three devices underwent evaluation according to the requirements outlined in ISO 10993 standards for cytotoxicity, skin irritation, and skin sensitization.
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Image /page/8/Picture/0 description: The image contains the logo for Neuroservo. The logo consists of a black circle with a white waveform inside, above the word "NEUROSERVO" in a sans-serif font. The waveform appears to represent brain activity or neural signals.
Technology Comparison:
| Attributes | Primary Predicate | Secondary Predicate | Subject Device | Comments |
|---|---|---|---|---|
| Pascall Systems, Inc. Wireless EEG System (K213299) | Neurosteer EEG Recorder (K221563) | VEEGix EEG System | ||
| Classification | ||||
| Regulation | Class II per 882.1400 | Class II per 882.1400 | Class II per 882.1400 | Same as primary predicate |
| Product Code(s) | OLT, OMC, ORT, GXY | OMC, GXY | OLT, OMC, ORT, GXY | Same as primary predicate |
| Indications for Use | The Pascall Systems, Inc. Wireless EEG | |||
| System, is intended to be used for | ||||
| measuring and recording the electrical | ||||
| activity of a patient's brain, obtained by | ||||
| placing electrodes on the forehead and | ||||
| wirelessly transmitting the | ||||
| electroencephalographic (EEG) signals for | ||||
| storage and display. |
The Pascall Systems, Inc. Wireless EEG
System, is intended for use in the
acquisition of EEG signals, displaying them
in real time and storing them for later review
and analysis.
The Pascall Systems, Inc. Wireless EEG
System, is intended for use in a hospital
Operating Room, Post Anesthesia Care
Unit, Intensive Care Unit, Emergency
Department, or in other medical facilities
such as inpatient and outpatient
(ambulatory) surgery settings.
The Pascall Systems, Inc. Wireless EEG
System is indicated for use on patients 18
years of age or older and is to be used by
licensed medical professionals that have
been adequately trained in the use and
interpretation of raw EEG data for
determination of brain state during
anesthesia.
The Pascall Systems, Inc. Wireless EEG
System does not provide any diagnostic
conclusion about the patient's condition. | The Neurosteer EEG Recorder is
intended to record and store EEG
signals, and to present the EEG
signals in visual formats in real time.
The visual signals assist trained
medical staff to make neurological
diagnoses. The EEG Recorder does
not provide any diagnostic conclusion
about the subject's condition and
does not provide any automated
alerts of an adverse clinical event.
The EEG Recorder is intended to be
used in a professional healthcare
facility environment | The VEEGix EEG System, is intended
to be used for measuring and recording
the electrical activity of a patient's
brain, obtained by placing electrodes
on the forehead and wirelessly
transmitting the
electroencephalographic (EEG) signals
for storage and display.
The VEEGix EEG System is intended
for use in the acquisition of EEG
signals, displaying them in real time
and storing them for later review and
analysis.
The VEEGix EEG System, is intended
for use in a hospital Operating Room,
Post Anesthesia Care Unit, Intensive
Care Unit, Emergency Department, or
in other medical facilities such as
inpatient and outpatient (ambulatory)
surgery settings.
The VEEGix EEG System is indicated
for use on patients 18 years of age or
older and is to be used by licensed
medical professionals that have been
adequately trained in the use and
interpretation of EEG data for
determination of brain state.
The VEEGix EEG System does not
provide any diagnostic conclusion
about the patient's condition.
The VEEGix EEG System is not to be
used as a stand-alone in the evaluation | The indications for use of
the subject device are a
subset of (narrower than
and encompassed by) the
primary predicate device's
indications and falls within
the same intended use as
that of the secondary
predicate. Thus, no new or
different questions of
safety or effectiveness
arise for the subject device
when used as labelled. |
| | | | or diagnosis of a disease or other
condition.
The VEEGix EEG System is not
intended for use in life support systems. | |
| Modalities | EEG | EEG | EEG | Same |
| Environment of Use | Operating Room, Post Anesthesia Care
Unit, Intensive Care Unit, Emergency
Department, or in other medical facilities
such as inpatient and outpatient
(ambulatory) surgery settings | Professional healthcare facility
environment settings | Operating Room, Post Anesthesia
Care Unit, Intensive Care Unit,
Emergency Department, or in other
medical facilities such as inpatient and
outpatient (ambulatory) surgery
settings | Same as primary predicate
and included in the
environment of the
secondary predicate |
| Number of EEG
channels | 4 (2 frontotemporal channels, and
2 temporal channels) | 1 bipolar | 1 bipolar | Same as the secondary
predicate and substantially
equivalent as the primary
predicate |
| Number of
electrodes | 6 (4 measurement, 1 reference, 1 ground),
single use | 3 (Locations: Fp1, Fpz, Fp2) | 3 (Locations: Fp1, Fpz, Fp2) | Same as the secondary
predicate and substantially
equivalent as the primary
predicate |
| Sensing Electrodes | Silver/Silver chloride, disposable | Silver/Silver chloride, disposable | Silver, disposable | Substantially equivalent |
| Power Source | Battery | Battery | Battery | Same |
| System Components | Electrode Array (disposable patch), Sensor
module, acquisition, Tablet for memory and
data viewing | Electrode Array (disposable patch),
Sensor module, acquisition, Tablet
for data viewing, and cloud platform
for data storage | Electrode Array (disposable patch),
Sensor module, acquisition, Tablet for
memory and data viewing | Same as primary predicate
and similar as the
secondary predicate |
| Screen
Display
Details | • 4 Raw EEG Waveforms
• Signal Quality information:
Channel Connection flags, Impedance
values(electrode contact signal strength),
Artifact (ART),Noise Level (EMG)
• Spectral Parameters: EEG power
spectrum and frequency bands including:
Two horizontal lines at 10 and 20 Hz
provided as an aid to help identify the
frequency components of the spectrogram,
SEF 95% Power spectrum displayed as
Density Spectral Array (DSA) Spectral
Powers in EEG frequency bands
traditionally used to quantify EEG signals
(α, β1, β2, δ, θ and γ) | • Raw EEG Waveforms
• Spectrogram
• Metrics and bar graph views | • Raw EEG Waveforms
• Signal Quality information:
Channel Connection flags, Artifact
(ART), Noise Level (EMG) and
Interference Level
• Spectral Parameters: EEG power
spectrum and SEF 95%. Power
spectrum displayed as Density
Spectral Array (DSA) Spectral Powers
in EEG frequency bands traditionally
used to quantify EEG signals (α, Β, δ, θ
and γ) | Substantially equivalent to
the primary predicate, the
missing two horizontal
lines at 10 and 20 Hz in the
subject device, which
serve as aids to identify the
frequency components of
the spectrogram and
division of B Band into β1
and β2, does not raise any
new questions of safety or
effectiveness.
Secondary predicate
display capabilities
included in the subject
device. |
| | | | | |
| Storage for offline
recording | Yes, in the tablet display | Cloud storage | Yes, in the tablet display | Same as primary predicate |
| Electrode
Impedance | Yes | Unknown | Yes | Same as primary predicate |
| Detection for Leads
Off | Yes | Yes | Yes | Same |
| File output capability | Yes | Yes | Yes | Same |
| Real
time EEG
Display | Yes, wireless to tablet | Yes, wireless | Yes, wireless to tablet | Same |
| Processed EEG
Bandwidth | 0.5 Hz to 45 Hz | Unknown | 0.5 Hz to 80 Hz | Substantially equivalent as
primary predicate |
| Automatic Artifact
Identification | Yes | Unknown | Yes | Same as primary predicate |
| Common Mode
Rejection | > 90 dB | Unknown | > 100 dB | Substantially equivalent as
primary predicate |
| Amplifier Input
Impedance | > 500 M Ohm | Unknown | 200 GΩ | Substantially equivalent as
primary predicate |
| Electrode
Impedance Test | Yes | Unknown | Yes | Same as primary predicate |
| Patient
Contains
Isolation | Battery powered, thus no connection
between patients and mains power | Battery powered, thus no connection
between patients and mains power | Yes, the subject device has been
designed with reinforced Insulation (2
MOPP) and this isolation has been
validated by external agency testing.
The subject device is battery powered
and can also be used while charging. | Substantially equivalent as
primary predicate |
| Event Markers | Yes, artifact detection | Unknown | Yes, artifact detection | Same as primary predicate |
| Burst
Suppression
Display | Yes, Burst Suppression Probability | N/A | Yes, Suppression Ratio (%) | Substantially equivalent as
primary predicate |
| Display Interface | Tablet display indicates connection and
operation | Portable display monitor | Tablet display indicates connection and
operation. | Same as primary predicate |
| Biocompatibility | The Electrode Array patient contact
materials have been tested and passed the
tests per ISO 10993 for cytotoxicity, primary
skin irritation and sensitization as required
for patient contact