← Product Code [OLT](/productcode/OLT) · K253767 # UB ERP System (K253767) _Universal Brain · OLT · Jun 30, 2026 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K253767 ## Device Facts - **Applicant:** Universal Brain - **Product Code:** [OLT](/productcode/OLT.md) - **Decision Date:** Jun 30, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 882.1400 - **Device Class:** Class 2 - **Review Panel:** Neurology ## Indications for Use The UB ERP System is intended for the acquisition, display, analysis, storage and reporting of electrical activity of a patient's brain, including electroencephalography (EEG) signals and event-related potentials (ERPs), obtained by placing two or more electrodes on the head of adults and adolescent patients to aid in diagnosis. The EEG signals are time-stamped. It is used with an UB EEG Cap loaded with appropriate software and connected to a Windows PC using a USB cable. The UB ERP system is to be used in a health care facility or a clinic under the direction of a healthcare professional. The UB ERP System does not draw any diagnostic conclusion. A clinical expert must interpret recorded EEG signals and ERPs. The results of such interpretation should be considered only in conjunction with other clinical findings. ## Device Story EEG-based system for recording/analyzing brain electrical activity and ERPs; utilizes wearable cap with dry electrodes, amplifier, and electronics module; connects via USB to Windows PC running Neurotique-2 software. Operator manages sessions, presents visual stimuli (Oddball, Flankers, Doors tasks), and collects EEG signals; system includes EOG cable for blink artifact correction and photodiode for stimulus timing accuracy. Software automates ERP report generation (amplitude/latency) for physician review. Used in clinical settings by healthcare professionals to aid diagnosis; does not provide automated diagnostic conclusions. ## Clinical Evidence Clinical study evaluated P300 ERP measurement across Oddball, Flankers, and Doors tasks. Primary endpoint: successful P300 measurement in 80% of participants (defined by peak amplitude >5µV at 300-600ms post-stimulus). Results demonstrated successful P300 measurement and system safety with no adverse events. Usability assessment confirmed clear interface and labeling. ## Technological Characteristics EEG system with 7 EEG channels (9 total); dry electrodes; 24-bit ADC; >1 GΩ input impedance; >110 dB CMRR; 0.1-50 Hz bandpass. Components: Inner/Outer Cap, electronics module, USB-C connectivity. Software: Neurotique-2 App on Windows PC. Sterilization: Not specified. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26, IEC 62304, ISTA 3A. ## Regulatory Identification An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head. ## Predicate Devices - NeuralScan System ([K192753](/device/K192753.md)) - Cumulus Functional Neurophysiology Platform ([K221963](/device/K221963.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} **FDA** **U.S. FOOD & DRUG** ADMINISTRATION June 30, 2026 Universal Brain % Janice Hogan Partner Hogan Lovells US LLP 1735 Market St., Floor 23 Philadelphia, Pennsylvania 19103 Re: K253767 Trade/Device Name: UB ERP System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLT, GWQ, GWJ Dated: November 25, 2025 Received: November 25, 2025 Dear Janice Hogan: 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K253767 - Janice Hogan Page 2 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' (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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ('UDI Rule'). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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 {2} K253767 - Janice Hogan Page 3 the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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 Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} # Indications for Use Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. K253767 ? Please provide the device trade name(s). ? UB ERP System Please provide your Indications for Use below. ? The UB ERP System is intended for the acquisition, display, analysis, storage and reporting of electrical activity of a patient's brain, including electroencephalography (EEG) signals and event-related potentials (ERPs), obtained by placing two or more electrodes on the head of adults and adolescent patients to aid in diagnosis. The EEG signals are time-stamped. It is used with an UB EEG Cap loaded with appropriate software and connected to a Windows PC using a USB cable. The UB ERP system is to be used in a health care facility or a clinic under the direction of a healthcare professional. The UB ERP System does not draw any diagnostic conclusion. A clinical expert must interpret recorded EEG signals. The results of such interpretation should be considered only in conjunction with other clinical findings. Please select the types of uses (select one or both, as applicable). ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) ? {4} # 510(K) SUMMARY ## Universal Brain's UB ERP System #### **Submitter's Name, Address, Telephone Number, Contact Person, and Date Prepared** Universal Brain, Inc. 212-214 Homer Avenue Palo Alto, CA 94301 Contact: Kazutaka Okuda #### Submission Correspondent: Janice M. Hogan Hogan Lovells US LLP janice.hogan@hoganlovells.com (267) 675-4611 Date Prepared: May 29, 2026 **Name of Device:** UB ERP System **Common or Usual Name:** EEG/EP System, EEG Amplifier, and ERP Measurement System **Classification Name:** Electroencephalograph **Regulatory Class:** Class II **Regulation Number:** 21 CFR 882.1400 **Product Code:** OLT, GWJ, GWQ #### **Primary Predicate Device** NeuralScan System, Medeia, Inc., NeuralScan System, K192753 #### **Secondary Predicate Device** Cumulus Functional Neurophysiology Platform, Cumulus Neuroscience Limited, K221963 #### **Device Description** The UB ERP System is an electroencephalography (EEG)-based device used to record, store and report electrical activity in the brain and measure event-related potentials (ERPs) by placing two or more electrodes on the head of adults and adolescent patients to aid in diagnosis. UB ERP System 510k Summary Page 1 of 13 Page 1 of 13 {5} The UB ERP System hardware consists of an UB EEG device with electrodes, amplifier and electronics in the form factor of a Cap. The Cap has a modular design with an Inner Cap and Outer Cap. The Inner Cap is integrated with EEG electrodes and the Outer Cap holds the electronic module with firmware and covers the Inner Cap with an adjustable strap for a snug fit. The UB ERP System package consists of the following components: 1. 1. Outer Cap with Electronics Module 2. 2. Inner Cap with Electrodes 3. 3. Dry Electrode Kit- Medium, Flat 4. 4. Disposable Electrodes 5. 5. Ear Clip with Reference Cable 6. 6. Electro-oculography (EOG) Cable 7. 7. Photodiode Cable The UB ERP System software consists of firmware (embedded in the Cap's electronic module) and Neurotique-2 software application (or App) for presenting stimuli and measuring ERPs based on the participant's response to these stimuli. The App software is installed and runs from the user's Windows personal computer (PC, not provided). The Neurotique-2 App software is run on the PC by a healthcare professional. After successful authentication, the App runs and enables the Operator Window (OW, on the Operator PC display) to set up the system, create participants, configure settings, and manage EEG recording sessions (e.g. task selection, data quality review, calibration completion, etc.). After a session starts, the Participant Window (PW, shown on the Participant Display) is opened and the App presents stimuli related to various tasks and collects EEG signals. Raw EEG and participant response data are stored in the Windows filesystem after each task is completed. After a recording session is completed, all data are analyzed and output as an ERP report in PDF format using the Reporting Service. ### **Intended Use / Indications for Use** *The UB ERP System is intended for the acquisition, display, analysis, storage and reporting of electrical activity of a patient's brain, including electroencephalography (EEG) signals and event-related potentials (ERPs), obtained by placing two or more electrodes on the head of adults and adolescent patients to aid in diagnosis. The EEG signals are time-stamped. It is used with an UB EEG Cap loaded with appropriate software and connected to a Windows PC using a USB cable.* *The UB ERP System is to be used in a health care facility or a clinic under the direction of a healthcare professional.* *The UB ERP System does not draw any diagnostic conclusion. A clinical expert must interpret recorded EEG signals and ERPs. The results of such interpretation should be considered only in conjunction with other clinical findings.* The indications for use of the subject device are substantially equivalent to those of UB ERP System 510k Summary Page 2 of 13 Page 2 of 13 {6} the predicate. The UB ERP indications for use include additional language clarifying the use environment for the device and its limitations, as it is not a standalone diagnostic. These additions do not raise different questions of safety and effectiveness, nor alter the intended use of the proposed device. Thus, the UB ERP System satisfies the first criterion for a finding of substantial equivalence. ## Summary of Technological Characteristics / Principle of Operation Both the UB ERP System and the NeuralScan System (predicate) use an EEG system for acquisition of physiological signals from the brain using two or more channels or electrodes. Both devices consist of an EEG device with an amplifier (electronics and embedded firmware) to record EEG data, recording electrodes, cables, a personal computer (base station), application software and subject response buttons to measure ERPs. At a high level, the subject and predicate devices are based on the same technological elements: using an EEG device and collecting EEG data to measure ERPs. The following technological differences exist between the subject and predicate device: - The UB ERP System utilizes dry electrodes to record EEG data. - The UB ERP system utilizes seven (7) EEG channels and nine (9) total channels to collect data vs. 21 EEG channels and 23 total channels for the predicate. - The UB ERP System measures blinks using an EOG cable that is connected to disposable gel electrodes, to monitor and correct EEG signals for artifacts from eye blinks. Similarly, the predicate device has 2 bio-channels for measuring electrocardiogram / electromyography (ECG/EMG) and peripheral capillary oxygen saturation (SpO2) physiological signals during EEG/ERP measurement. - The UB ERP System has a photodiode and cable to improve the accuracy of ERP measurement. - The UB ERP System utilizes only visual stimuli, whereas the predicate device utilizes audio and visual stimuli. - The predicate device utilizes only the Oddball task for measuring P300 ERPs, whereas the UB ERP System utilizes Oddball, Flankers and Doors tasks to measure P300 ERPs. - The UB ERP System is able to generate an ERP report. The technological differences of the device hardware do not raise new questions of safety or effectiveness because they are design modifications intended to enhance signal quality and workflow and fall within the range of product features for similar, FDA-cleared devices in product code GWQ (which include multiple bio-channels and gel electrodes). Specifically: - The dry electrodes met performance specifications and measured EEG signals with good quality. FDA has cleared dry electrodes in similar devices in product UB ERP System 510k Summary Page 3 of 13 Page 3 of 13 {7} code GWQ (e.g., Cumulus Functional Neurophysiology Platform (K221963). The substantial equivalence (SE) chart includes Cumulus Functional Neurophysiology Platform as a secondary predicate. - The reduced channel count does not affect device functionality, ERP measurement accuracy or clinical utility. Specifically, seven (7) EEG channels were sufficient for recording good EEG data and measuring ERPs as evidenced via device testing. - The blink detection or EOG capability is within the range of its predicates' features. The NeuralScan System has 2 bio-channels for measuring electrocardiogram / electromyography (ECG/EMG) and peripheral capillary oxygen saturation (SpO2) signals during ERP measurement. Thus, other cleared devices also collect various biosignals or physiological information during ERP measurement. Bench and clinical testing confirm the UB ERP System, with these technological differences, performs in accordance with its specifications and is as safe and effective as the predicate devices. The differences in stimuli type and number of tasks used to measure ERPs do not raise new questions because both provide similar ERP information using well-known tasks, and bench and clinical testing confirmed performance to specifications. Both systems use software to acquire EEG data and analyze ERPs; the UB ERP System's report simply automates the manual workflow for physicians, presenting amplitude and latency data derived from raw EEG signals. It does not change the underlying data, is provided as a convenience, and does not affect device performance or introduce new risks based on clinical assessment and physician feedback. Therefore, as none of the differences raise new questions of safety or effectiveness, the UB ERP System is substantially equivalent to the predicate device. A table comparing the subject and predicate devices is provided at the end of this 510(k) summary. ### Performance Data The following non-clinical tests were conducted on the UB ERP System. | Test | Applicable Standard | Test Result | | --- | --- | --- | | Electrical Safety | IEC 60601-1:2005+AMD1:2012 (ed 3.1) Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance. | Pass | | Electromagnetic Compatibility (EMC) and Electro-Static Discharge (ESD) | IEC 60601-1-2:2015 Medical Electrical Equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests. | Pass | UB ERP System 510k Summary Page 4 of 13 Page 4 of 13 {8} | Test | Applicable Standard | Test Result | | --- | --- | --- | | Electroencephalographs | IEC 60601-2-26:2019 Medical Electrical Equipment Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs. | Pass | | Software Verification Testing | IEC 62304 Edition 1.1 2015 -06 Consolidated Version Medical device software – Software life cycle processes | Pass | | Transit Testing | ISTA 3A 2018 Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less. | Pass | | Design Verification Testing | Testing per product specifications. | Pass | In all instances, the UB ERP System functioned as intended and results obtained were as expected. Blink detection validation testing was conducted to demonstrate the system accurately detects and adjusts for blinks. A clinical study was conducted to assess the measurement of brain activity using electroencephalography (EEG) and event-related potentials (ERPs) with the UB ERP System and Neurotique-2 App software. Usability data were collected from representative users of the system as part of the clinical study. EEG data were collected using the UB Cap while the participants viewed stimuli and performed tasks presented by Neurotique-2 App software. P300 (a positive deflection in the EEG signal 300 milliseconds (ms) after stimulus presentation) ERPs were measured for a range of Oddball tasks (e.g., active, passive, and novel); a Flankers task (speeded response task) and a Doors guessing task. The safety endpoints were the frequency of device and data-collection related serious adverse events and adverse events. The device effectiveness endpoint was the successful measurement of P300 in 80% of the participants. At a minimum, the P300 success criteria were defined by: (a) large and transient positive voltage deflection in the ERP at Cz that peaks 300–600 ms following stimulus presentation; (b) lower amplitude activity in the baseline period ((i.e., -200 to 0 ms) than in the post-stimulus ERP period; and (c) P300 Peak Amplitude > 5µV. Additional criteria were used for P300 measurement using variations of these tasks. Results from the clinical study demonstrated that the UB ERP System is safe with no adverse events and able to successfully measure the P300 ERPs across three Oddball tasks utilized by the predicate device. In addition, robust P300s were obtained utilizing the Flankers and Doors tasks of the Neurotique-2 software. The study concluded that the UB ERP System is safe and effective for EEG and ERP measurements using the Oddball, Doors and Flankers tasks. The usability assessment confirmed that the user interface, labeling, and instructions for use are clear and effective. ## Conclusion The UB ERP System is substantially equivalent to the NeuralScan System predicate device, as well as the Cumulus Functional Neurophysiology Platform. The UB ERP System has the same intended uses and similar indications for use, technological characteristics, and principles of operation as its primary predicate device. The minor UB ERP System 510k Summary Page 5 of 13 Page 5 of 13 {9} technological differences between the UB ERP System and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the UB ERP System is as safe and effective as the NeuralScan System. Thus, the UB ERP System is substantially equivalent to the predicate devices. UB ERP System 510k Summary Page 6 of 13 Page 6 of 13 {10} # **UNIVERSAL BRAIN, INC.** # **UB ERP SYSTEM** # **SUBSTANTIAL EQUIVALENCE COMPARISON TABLE** | Feature | UB ERP System | NeuralScan System | Cumulus Functional Neurophysiology Platform | Comparison to NeuralScan | | --- | --- | --- | --- | --- | | 510(k) Number | N/A | K192753 | K221963 | | | Product Codes | OLT, GWQ, GWJ | OLT, GWQ, GWJ | GWQ | Same | | Indications for Use | The UB ERP System is intended for the acquisition, display, analysis, storage and reporting of electrical activity of a patient's brain, including electroencephalography (EEG) signals and event-related potentials (ERPs), obtained by placing two or more electrodes on the head of adults and adolescent patients to aid in diagnosis. The EEG signals are time-stamped. It is used with an UB EEG Cap loaded with appropriate software and connected to a Windows PC using a USB cable. The UB ERP system is to be used in a health care facility or a clinic under the direction of a healthcare professional. The UB ERP System does not draw any diagnostic conclusion. A clinical expert must interpret recorded EEG signals and ERPs. The results of such interpretation should be considered only in conjunction with other clinical findings. | The NeuralScan System is intended for the acquisition, display, analysis, and storage, of electrical activity of a patient's brain including electroencephalograph (EEG) and Event-related Potentials (ERP), obtained by placing two or more electrodes on the head to aid in diagnosis. | The Cumulus Functional Neurophysiology Platform is intended for the acquisition, display and storage of electroencephalograph (EEG) obtained by placing electrodes on the head of adults and adolescent patients. The EEG signals are time-stamped. The system can be used in the patient's home or a health care facility. | Substantially Equivalent (SE) | UB ERP System 510k Summary Page 7 of 13 Page 7 of 13 {11} | Feature | UB ERP System | NeuralScan System | Cumulus Functional Neurophysiology Platform | Comparison to NeuralScan | | --- | --- | --- | --- | --- | | Principle of Operation | The UB ERP System is an EEG-based device used to monitor and report electrical activity in the brain by placing two or more electrodes on the head. It consists of hardware and software for measuring EEG signals and event-related potentials (ERPs) from the brain. The UB ERP System hardware consists an inner cap with electrodes, outer cap with an electronic module (amplifier and electronics), USB-C cable, dry (medium and flat) electrodes, disposable gel electrodes, ear clip with reference cable, electro-oculography (EOG) cable and photodiode cable. The UB ERP System software consists of firmware (embedded in the Cap's electronic module) and Neurotique-2 software application (or App). The App software is installed and runs from the user's Windows personal computer (PC, not provided). The UB ERP system provides a means to: - Initiate a study, monitor participant EEG signals by presenting stimuli and collect user response to these stimuli - acquire and save signals to the memory of the device, - transmit signal data from the device, - analyze signals and measure ERPs, and - generate ERP reports | The NeuralScan System device is used for acquisition of physiological signals using two or more channels of Electroencephalography (EEG) from the scalp. It consists of a NeuralScan amplifier, a laptop computer (base station), a patient EEG cap, subject response button, ear buds, and a charging cord. The NeuralScan amplifier and software provide a means to: - Initiate a study, track user EEG and ERP data and enter text or questionnaire information - acquire and save signals to the memory of the device, - transmit signal data from the device, - visually inspect the acquired signal, - manage event- related Potentials | The Cumulus Functional Neurophysiology Platform is used for acquisition of physiological signals using 2 or more channels of EEG from the scalp. It consists of a mobile device with mobile app software, a patient EEG Headset, earphones, and charging cord for EEG Headset and mobile device. The technology provides a means to: - Initiate a study, track user EEG data - Acquire and save signals to memory of the device - Transmit signal data from device, - Visually inspect acquired signal | SE | UB ERP System 510k Summary Page 8 of 13 Page 8 of 13 {12} | Feature | UB ERP System | NeuralScan System | Cumulus Functional Neurophysiology Platform | Comparison to NeuralScan | | --- | --- | --- | --- | --- | | Patient Population | Adults and adolescents | Adults and adolescents | Adults and adolescents | SE | | Use Environment | Intended for use in any healthcare facility, medical facility, athletic or sports clinics, or outside of medical facilities provided they are led by qualified medical personnel. | Intended for use in any healthcare facility, medical facility, athletic or sports clinics, or outside of medical facilities provided they are led by qualified medical personnel. | Intended for healthcare and medical facilities, athletic and sports clinics, or outside facilities if led by qualified medical personnel. In addition, it may be used in the home. | Same | | Device Class | Class II | Class II | Class II | Same | | System Components | The UB ERP System consists of: - Outer Cap with Electronics Module - Inner Cap with Electrodes - USB-C cable - Dry Electrode Kit-Medium, Flat - Disposable Electrodes - Ear Clip with Reference Cable - Electro-oculography (EOG) Cable - Photodiode Cable - EEG firmware - Neurotique-2 ERP Application (App) software | NeuralScan System consists of: - a NeuralScan amplifier, - a laptop computer (base station), - a patient EEG cap, - subject response button, ear buds, - and a charging cord. | Cumulus functional neurophysiology platform consists of: - Patient EEG Headset - Mobile device with mobile app software - Earphones - Web dashboard software Charging cords for EEG | SE | | Interface with Amplifier | USB | USB or WiFi to PC | Bluetooth (EEG to mobile device) and WiFi (mobile device to cloud) | Same | | Power Supply | Li-Ion Battery, with USB cable for charging the battery | Li-Ion Battery, with USB cable for charging the battery | Li-Ion Battery, with USB cable for charging the battery | Same | | Rx Use or OTC | Rx Use | Rx Use | Rx Use | Same | | Typical Biopotential Signals Recorded | Electroencephalography (EEG), EP/ERP | Electroencephalography (EEG), EP/ERP | Electroencephalography (EEG) | Same | | **Electroencephalography (EEG), EP/ERP** | | | | | | ERP Stimulus Modality | Visual | Auditory; Visual | NA | SE | UB ERP System 510k Summary Page 9 of 13 Page 9 of 13 {13} | Feature | UB ERP System | NeuralScan System | Cumulus Functional Neurophysiology Platform | Comparison to NeuralScan | | --- | --- | --- | --- | --- | | ERP Paradigm (Auditory and Visual Stimuli) | **P300 Oddball** - Single Deviant (Active - Standard and Target) - Single Deviant (Passive - Standard and Target) - 2 Deviant (Active Novel - Standard, Target and Novel) **Flankers** - Compatible and Incompatible **Doors** - Gain and Loss Outcomes | **P300 Oddball** - Single Stimulus - Single Deviant - 2 Deviant - Active and Passive | NA | SE | | ERP Task Response | User Buttons | User Buttons | NA | Same | | Skin Coupling | Dry electrodes | Custom Electrode Band and Gel | Dry electrodes | SE | | Number of Signal Recording Channels | 9 Channels (7 EEG channels + VBIAS (GND) + Reference (Earlobe)) | Up to 23 channels NeuralScan system has 2 bio-channels | 16 channels | SE | | EEG Input Terminals | up to 7 channels | Up to 21 channels | 16 channels | SE | | EEG Recording Channels Location and Positioning Systems | Electrode positions shall be in the Fp1, Fp2, F3, F4, Fz, Cz, Pz, per International 10-20 system. | Any of the 21 EEG Channels including: Fz, Cz, Pz, F3, P3, F4, P4 Utilizing elastic bands using distance ratios consistent with the 10-20 System | Not reported | SE | | Impedance Test | Yes | Yes | Not reported | Same | | Amplifier Input Impedance | > 1 GΩ | > 200 MΩ | Not reported | SE | | Analog to Digital Conversion | 24 Bit | 24 Bit | 24 Bit | Same | | Sampling Rate | 250 and 500 Hz | 200, 500, 1000 Hz | 250 and 500 Hz | SE | | Common mode rejection | > 110 dB | >110 dB | > 110 dB | Same | UB ERP System 510k Summary Page 10 of 13 Page 10 of 13 {14} | Feature | UB ERP System | NeuralScan System | Cumulus Functional Neurophysiology Platform | Comparison to NeuralScan | | --- | --- | --- | --- | --- | | Analysis Software | Embedded, commercially available, and user defined. | Embedded, commercially available, and user defined. | Embedded and user defined | Same | | Resolution | 24 bits | 24 bits | 24 bits | Same | | Band Pass | 0.1 to 50 Hz | 0.1 to 50 Hz | 0.5 to 50 Hz | Same | | Noise | < 1 uV peak-to-peak | 2-3 uVp-p | 1.6 μV p-p | SE | | Audio Type | Not Applicable (NA) | Burst (White Noise) | Not reported | NA | | Input Voltage Range | ± 400mV Due to the 24x gain that is applied to A/D channels, the dynamic range is ±400 mV for the UB ERP System, which is sufficient for its use environment. | ±400 mV | ±200 mV | SE | | **General Specifications** | | | | | | Safety Standards Compliance | • IEC 60601-1:2005+AMD1:2012 (ed 3.1) Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance. • IEC 60601-1-2:2015 Medical Electrical Equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests. • IEC 60601-2-26:2019 Medical Electrical Equipment Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs. • IEC 62304 Edition 1.1 2015 -06 Consolidated Version Medical device software – Software life cycle processes • ISTA 3A 2018 Packaged-Products for | • IEC 60601-1- Medical Electrical Equipment - Part 1: Basic safety and essential performance Ed3.1 2005+A1:2012 • IEC 60601-1-2:2014 - Medical electrical equipment-basic safety and essential performance-EMC • IEC 60601-2-26:2012 Medical electrical equipment - Part 2-26: Basic safety and essential performance of electroencephalographs • ISO 15223-1:2012 Medical devices - symbols to be used with medical device labels, labelling, and information to be supplied - part 1: general requirements | • DIN EN ISO 10993-1:2018: Biological Evaluation of Medical Devices, Part 1: Evaluation and testing within a risk management system. • DIN EN ISO 10993-5:2009: Biological Evaluation of Medical Devices, Part 5: In vitro cytotoxicity • ISO 10993-10:2021: Biological evaluation of medical devices - Part 10: Tests for skin sensitization • ISO 10993-12:2021: Biological evaluation of medical devices - Part 12: Sample preparation and reference materials • ISO 10993-23:2021: Biological evaluation of medical devices - Part 23: Tests for irritation • IEC 60601-1:2005+AMD1:2012 (ed 3.1) Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance. | SE | UB ERP System 510k Summary Page 11 of 13 Page 11 of 13 {15} | Feature | UB ERP System | NeuralScan System | Cumulus Functional Neurophysiology Platform | Comparison to NeuralScan | | --- | --- | --- | --- | --- | | | Parcel Delivery System Shipment 70 kg (150 lb) or Less. | | • IEC 60601-1-2:2015 Medical Electrical Equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests. • IEC 60601-1-11:2015 Medical Electrical Equipment - Part 1-11: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. • IEC 80601-2-26:2019 Medical Electrical Equipment Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs. • ANSI C63.10 2013 American National Standard of Procedures for Compliance Testing of Unlicensed Wireless Devices • ANSI 63.4 2014 American National Standard for Methods of Measurement of Radio-Noise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz • IEC 62304 Edition 1.1 2015 -06 Consolidated Version Medical device software – Software life cycle processes • ISTA 3A 2018 Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less. | | UB ERP System 510k Summary Page 12 of 13 Page 12 of 13 {16} | Feature | UB ERP System | NeuralScan System | Cumulus Functional Neurophysiology Platform | Comparison to NeuralScan | | --- | --- | --- | --- | --- | | Operating Environment | Temperature: 5 to +40 °C; Relative humidity, 15% to 90% non- condensing | 10 to +45 °C, Relative humidity, 30% to 70% non-condensing | Not reported | SE | | Storage Environment | Temperature: -20 to +60 °C; Relative humidity, 10% to 95% non- condensing | -40° to 70° C, Relative humidity, 5% to 95% non-condensing | Not reported | SE | UB ERP System 510k Summary Page 13 of 13 Page 13 of 13 --- **Source:** [https://fda.innolitics.com/device/K253767](https://fda.innolitics.com/device/K253767) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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