VEEGix EEG System

{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) K240593 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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 | {5}------------------------------------------------ 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 {6}------------------------------------------------ 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. {7}------------------------------------------------ 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. {8}------------------------------------------------ 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<br>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<br>System, is intended to be used for<br>measuring and recording the electrical<br>activity of a patient's brain, obtained by<br>placing electrodes on the forehead and<br>wirelessly transmitting the<br>electroencephalographic (EEG) signals for<br>storage and display.<br><br>The Pascall Systems, Inc. Wireless EEG<br>System, is intended for use in the<br>acquisition of EEG signals, displaying them<br>in real time and storing them for later review<br>and analysis.<br><br>The Pascall Systems, Inc. Wireless EEG<br>System, is intended for use in a hospital<br>Operating Room, Post Anesthesia Care<br>Unit, Intensive Care Unit, Emergency<br>Department, or in other medical facilities<br>such as inpatient and outpatient<br>(ambulatory) surgery settings.<br><br>The Pascall Systems, Inc. Wireless EEG<br>System is indicated for use on patients 18<br>years of age or older and is to be used by<br>licensed medical professionals that have<br>been adequately trained in the use and<br>interpretation of raw EEG data for<br>determination of brain state during<br>anesthesia.<br><br>The Pascall Systems, Inc. Wireless EEG<br>System does not provide any diagnostic<br>conclusion about the patient's condition. | The Neurosteer EEG Recorder is<br>intended to record and store EEG<br>signals, and to present the EEG<br>signals in visual formats in real time.<br>The visual signals assist trained<br>medical staff to make neurological<br>diagnoses. The EEG Recorder does<br>not provide any diagnostic conclusion<br>about the subject's condition and<br>does not provide any automated<br>alerts of an adverse clinical event.<br>The EEG Recorder is intended to be<br>used in a professional healthcare<br>facility environment | The VEEGix EEG System, is intended<br>to be used for measuring and recording<br>the electrical activity of a patient's<br>brain, obtained by placing electrodes<br>on the forehead and wirelessly<br>transmitting the<br>electroencephalographic (EEG) signals<br>for storage and display.<br><br>The VEEGix EEG System is intended<br>for use in the acquisition of EEG<br>signals, displaying them in real time<br>and storing them for later review and<br>analysis.<br><br>The VEEGix EEG System, is intended<br>for use in a hospital Operating Room,<br>Post Anesthesia Care Unit, Intensive<br>Care Unit, Emergency Department, or<br>in other medical facilities such as<br>inpatient and outpatient (ambulatory)<br>surgery settings.<br><br>The VEEGix EEG System is indicated<br>for use on patients 18 years of age or<br>older and is to be used by licensed<br>medical professionals that have been<br>adequately trained in the use and<br>interpretation of EEG data for<br>determination of brain state.<br><br>The VEEGix EEG System does not<br>provide any diagnostic conclusion<br>about the patient's condition.<br><br>The VEEGix EEG System is not to be<br>used as a stand-alone in the evaluation | The indications for use of<br>the subject device are a<br>subset of (narrower than<br>and encompassed by) the<br>primary predicate device's<br>indications and falls within<br>the same intended use as<br>that of the secondary<br>predicate. Thus, no new or<br>different questions of<br>safety or effectiveness<br>arise for the subject device<br>when used as labelled. | | | | | or diagnosis of a disease or other<br>condition.<br>The VEEGix EEG System is not<br>intended for use in life support systems. | | | Modalities | EEG | EEG | EEG | Same | | Environment of Use | Operating Room, Post Anesthesia Care<br>Unit, Intensive Care Unit, Emergency<br>Department, or in other medical facilities<br>such as inpatient and outpatient<br>(ambulatory) surgery settings | Professional healthcare facility<br>environment settings | Operating Room, Post Anesthesia<br>Care Unit, Intensive Care Unit,<br>Emergency Department, or in other<br>medical facilities such as inpatient and<br>outpatient (ambulatory) surgery<br>settings | Same as primary predicate<br>and included in the<br>environment of the<br>secondary predicate | | Number of EEG<br>channels | 4 (2 frontotemporal channels, and<br>2 temporal channels) | 1 bipolar | 1 bipolar | Same as the secondary<br>predicate and substantially<br>equivalent as the primary<br>predicate | | Number of<br>electrodes | 6 (4 measurement, 1 reference, 1 ground),<br>single use | 3 (Locations: Fp1, Fpz, Fp2) | 3 (Locations: Fp1, Fpz, Fp2) | Same as the secondary<br>predicate and substantially<br>equivalent as the primary<br>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<br>module, acquisition, Tablet for memory and<br>data viewing | Electrode Array (disposable patch),<br>Sensor module, acquisition, Tablet<br>for data viewing, and cloud platform<br>for data storage | Electrode Array (disposable patch),<br>Sensor module, acquisition, Tablet for<br>memory and data viewing | Same as primary predicate<br>and similar as the<br>secondary predicate | | Screen<br>Display<br>Details | • 4 Raw EEG Waveforms<br><br>• Signal Quality information:<br>Channel Connection flags, Impedance<br>values(electrode contact signal strength),<br>Artifact (ART),Noise Level (EMG)<br><br>• Spectral Parameters: EEG power<br>spectrum and frequency bands including:<br>Two horizontal lines at 10 and 20 Hz<br>provided as an aid to help identify the<br>frequency components of the spectrogram,<br>SEF 95% Power spectrum displayed as<br>Density Spectral Array (DSA) Spectral<br>Powers in EEG frequency bands<br>traditionally used to quantify EEG signals<br>(α, β1, β2, δ, θ and γ) | • Raw EEG Waveforms<br><br>• Spectrogram<br><br>• Metrics and bar graph views | • Raw EEG Waveforms<br><br>• Signal Quality information:<br>Channel Connection flags, Artifact<br>(ART), Noise Level (EMG) and<br>Interference Level<br><br>• Spectral Parameters: EEG power<br>spectrum and SEF 95%. Power<br>spectrum displayed as Density<br>Spectral Array (DSA) Spectral Powers<br>in EEG frequency bands traditionally<br>used to quantify EEG signals (α, Β, δ, θ<br>and γ) | Substantially equivalent to<br>the primary predicate, the<br>missing two horizontal<br>lines at 10 and 20 Hz in the<br>subject device, which<br>serve as aids to identify the<br>frequency components of<br>the spectrogram and<br>division of B Band into β1<br>and β2, does not raise any<br>new questions of safety or<br>effectiveness.<br><br>Secondary predicate<br>display capabilities<br>included in the subject<br>device. | | | | | | | | Storage for offline<br>recording | Yes, in the tablet display | Cloud storage | Yes, in the tablet display | Same as primary predicate | | Electrode<br>Impedance | Yes | Unknown | Yes | Same as primary predicate…