Who is the manufacturer of NeuroMatch?

LVIS Corporation filed the 510(k) submission for NeuroMatch (K241390).

What is the FDA product code for NeuroMatch?

OMB. It is classified under 21 CFR 882.1400 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for NeuroMatch?

510(k) clearance (submission type: Traditional).

Does NeuroMatch use AI or machine learning?

Yes. NeuroMatch (K241390) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like NeuroMatch?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like NeuroMatch get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

NeuroMatch

Q: What are the predicate devices for NeuroMatch?

Persyst 14, EEG Review and Analysis Software (K182181).

K241390 · LVIS Corporation · OMB · Nov 26, 2024 · Neurology

Device Facts

Record ID	K241390
Device Name	NeuroMatch
Applicant	LVIS Corporation
Product Code	OMB · Neurology
Decision Date	Nov 26, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1400
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Seizure Detection	Deep learning-based algorithm	Upper limit of 95% CI for difference in sensitivity < 10%; lower limit of 95% CI for difference in FDR > -4 per 24hr	Sensitivity: 75.01% [72.62, 77.57]; FDR: 3.74 [2.59, 5.44] per 24 hrs	—	—	Validation dataset of EEG recordings from 191 adult patients (181 with seizures, 10 controls) across three independent medical institutions	3 (EEG trained neurologists)
Spike Detection	Deep learning-based algorithm	Upper limit of 95% CI for difference in sensitivity < 15%; lower limit of 95% CI for difference in FDR > -1.5 per minute	Sensitivity: 72.18% [66.81, 77.54]; FDR: 3.24 [2.15, 4.33] per minute	—	—	Validation dataset of EEG recordings from 149 adult patients across three independent medical institutions	3 (EEG trained neurologists)

Indications for Use

LVIS NeuroMatch Software is intended for the review, monitoring and analysis of electroencephalogram (EEG) recordings made by EEG devices using scalp electrodes and to aid neurologists in the assessment of EEG. The device is intended to be used by qualified medical practitioners who will exercise professional judgement in using the information. The Seizure Detection component of LVIS NeuroMatch is intended to mark previously acquired sections of adult EEG recordings from patients greater than or equal to 18 years old that may correspond to electrographic seizures, in order to assist qualified medical practitioners in the assessment of EEG traces. EEG recordings should be obtained with a full scalp montage according to the electrodes from the International Standard 10-20 placement. The Spike Detection component of LVIS NeuroMatch is intended to mark previously acquired sections of adult EEG recordings from patients >18 years old that may correspond to spikes, in order to assist qualified medical practitioners in the assessment of EEG traces. LVIS NeuroMatch Spike Detection performance has not been assessed for intracranial recordings. LVIS NeuroMatch includes the calculation and display of a set of quantitative measures intended to monitor and analyze EEG waveforms. These include Artifact Strength, Asymmetry Spectrogram, and Fast Fourier Transform (FFT) Spectrogram. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveforms. LVIS NeuroMatch displays physiological signals such as electrocardiogram (ECG/EKG) if it is provided in the EEG recording. The aEEG functionality included in LVIS NeuroMatch is intended to monitor the state of the brain. LVIS NeuroMatch Artifact Reduction (AR) is intended to reduce muscle and eye movements, in EEG signals from the International Standard 10-20 placement. AR does not remove the entire artifact signal and is not effective for other types of artifacts. AR may modify portions of waveforms representing cerebral activity. Waveforms must still be read by a qualified medical practitioner trained in recognizing artifacts, and any interpretation or diagnosis must be made with reference to the original waveforms. This device does not provide any diagnostic conclusion about the patient's condition to the user.

Device Story

NeuroMatch is a cloud-based SaMD for reviewing, monitoring, and analyzing previously acquired or near real-time EEG data. Input consists of EEG recordings (10-20 scalp montage) and optional ECG signals. The device uses deep learning algorithms to perform artifact reduction, seizure detection, and spike detection, and calculates quantitative measures (FFT, spectrograms, aEEG). Output is displayed to neurologists/qualified practitioners as annotated EEG traces and quantitative metrics. The device does not provide diagnostic conclusions; clinicians must interpret outputs in conjunction with original waveforms. It assists in identifying potential electrographic seizures and spikes, potentially improving clinical efficiency in EEG review and patient monitoring.

Clinical Evidence

Clinical validation used independent datasets from three institutions. Seizure detection (N=191 subjects, 1059.4 hours) showed 75.01% sensitivity and 3.74 FDR/24hr, meeting non-inferiority criteria against Persyst 14. Spike detection (N=149 subjects, 45.9 hours) showed 72.18% sensitivity and 3.24 FDR/min, meeting non-inferiority criteria. Reference standards were established by a panel of three neurologists using a 2/3 majority rule. Testing confirmed non-inferiority in both sensitivity and false detection rates.

Technological Characteristics

Cloud-based SaMD; utilizes deep learning-based algorithms for event detection. Compatible with standard 10-20 scalp EEG electrode placement. Provides quantitative EEG measures (FFT, spectrograms, artifact strength) and artifact reduction. Operates on previously acquired or near real-time EEG data. No hardware components; software-only.

Indications for Use

Indicated for review, monitoring, and analysis of EEG recordings in adults (≥18 years) using scalp electrodes (10-20 system). Includes seizure and spike detection, quantitative EEG measures (Artifact Strength, Spectrograms, FFT), aEEG, and artifact reduction. Intended for use by qualified medical practitioners to aid in EEG assessment. Not for intracranial recordings.

Regulatory Classification

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

Persyst 14, EEG Review and Analysis Software (K182181)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION". November 26, 2024 LVIS Corporation % Devjani Saha, PhD Director, Neurology Regulatory Affairs MCRA, Llc 803 7th St NW. 3rd Floor Washington, District of Columbia 20001 Re: K241390 Trade/Device Name: NeuroMatch Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMB, OLT, OMA Dated: October 24, 2024 Received: October 25, 2024 Dear Devjani Saha: 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. {1}------------------------------------------------ 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 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 QS 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. 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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-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/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-regulatory {2}------------------------------------------------ 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 510(k) Number (if known) K241390 Device Name NeuroMatch ### Indications for Use (Describe) 1. LVIS NeuroMatch Software is intended for the review, monitoring and analysis of electroencephalogram (EEG) recordings made by EEG devices using scalp electrodes and to aid neurologists in the assessment of EEG. The device is intended to be used by qualified medical practitioners who will exercise professional judgement in using the information. 2. The Seizure Detection component of LVIS NeuroMatch is intended to mark previously acquired sections of adult EEG recordings from patients greater than or equal to 18 years old that may correspond to electrographic seizures, in order to assist qualified medical practitioners in the assessment of EEG traces. EEG recordings should be obtained with a full scalp montage according to the electrodes from the International Standard 10-20 placement. 3. The Spike Detection component of LVIS NeuroMatch is intended to mark previously acquired sections of adult EEG recordings from patients >18 years old that may correspond to spikes, in order to assist qualified medical practitioners in the assessment of EEG traces. LVIS NeuroMatch Spike Detection performance has not been assessed for intracranial recordings. 4. LVIS NeuroMatch includes the calculation and display of a set of quantitative measures intended to monitor and analyze EEG waveforms. These include Artifact Strength, Asymmetry Spectrogram, and Fast Fourier Transform (FFT) Spectrogram. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveforms. 5. LVIS NeuroMatch displays physiological signals such as electrocardiogram (ECG/EKG) if it is provided in the EEG recording. 6. The aEEG functionality included in LVIS NeuroMatch is intended to monitor the state of the brain. 7. LVIS NeuroMatch Artifact Reduction (AR) is intended to reduce muscle and eye movements, in EEG signals from the International Standard 10-20 placement. AR does not remove the entire artifact signal and is not effective for other types of artifacts. AR may modify portions of waveforms representing cerebral activity. Waveforms must still be read by a qualified medical practitioner trained in recognizing artifacts, and any interpretation or diagnosis must be made with reference to the original waveforms. 8. This device does not provide any diagnostic conclusion about the patient's condition to the user. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. {4}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {5}------------------------------------------------ # 510(k) Summary ### Applicant Information: LVIS Corporation 2600 E. Bayshore Rd., Palo Alto, CA 94303 ### Contact Person: Sweta Srivastava Head of Regulatory Affairs Email: ssrivastava@lviscorp.com Phone: 415-997-7337 ### Device Information: | Trade Name: | NeuroMatch | |----------------------|---------------------------------------------------------------------------| | Common Name: | Automatic Event Detection Software For Full-Montage Electroencephalograph | | Classification Name: | Electroencephalograph (21CFR 882.1400) | | Device Class: | II | | Product Code: | OMB, OLT, OMA | ### Predicate Device: Persyst 14, EEG Review and Analysis Software, K182181 ### Date Prepared: November 25, 2024 ### Device Description: NeuroMatch is a cloud-based software as a medical device (SaMD) intended to review, monitor, display, and analyze previously acquired and/or near real-time electroencephalogram (EEG) data from patients 18 years old or older. The device is not intended to substitute for real-time monitoring of EEG. The software includes advanced algorithms that perform artifact reduction, seizure detection, and spike detection. The subject device is identical to the NeuroMatch device cleared under K222450, with exception of the following additional features: - 1. Spike detection; - 2. Seizure detection; Seizure and spike detection are substantially equivalent to the Persyst 14 device (K182181: Predicate). Apart from the proposed additional software changes and associated changes to the Indications for Use and labeling, there are no changes to the intended use or to the software features that were previously cleared. Below is a description of the software functions that will be added to the cleared NeuroMatch Device. {6}------------------------------------------------ # 1. Spike Detection NeuroMatch Spike Detection identifies both spike waves and sharp waves. The NeuroMatch Spike Detection feature uses a deep learning-based algorithm that detects potential epileptiform spikes and annotates each detected potential spike with a unique identification. The detection of spikes in the EEG data is automatically triggered when an EEG file is uploaded by the user. The NeuroMatch Spike Detection feature identifies spikes and displays the spikes based upon the order (time) when the spike occurred. ## 2. Seizure Detection The NeuroMatch Seizure Detection feature uses a deep learning-based algorithm to identify potential seizure events and annotates each detected potential seizure with a unique identification. Each annotation includes the start and end positions of the potential identified seizures. ## Indications for Use: - 1. LVIS NeuroMatch Software is intended for the review, monitoring and analysis of electroencephalogram (EEG) recordings made by EEG devices using scalp electrodes and to aid neurologists in the assessment of EEG. The device is intended to be used by qualified medical practitioners who will exercise professional judgement in using the information. - 2. The Seizure Detection component of LVIS NeuroMatch is intended to mark previously acquired sections of adult EEG recordings from patients greater than or equal to 18 years old that may correspond to electrographic seizures, in order to assist qualified medical practitioners in the assessment of EEG traces. EEG recordings should be obtained with a full scalp montage according to the electrodes from the International Standard 10-20 placement. - 3. The Spike Detection component of LVIS NeuroMatch is intended to mark previously acquired sections of adult EEG recordings from patients ≥18 years old that may correspond to spikes, in order to assist qualified medical practitioners in the assessment of EEG traces. LVIS NeuroMatch Spike Detection performance has not been assessed for intracranial recordings. - 4. LVIS NeuroMatch includes the calculation and display of a set of quantitative measures intended to monitor and analyze EEG waveforms. These include Artifact Strength, Asymmetry Spectrogram, Autocorrelation Spectrogram, and Fast Fourier Transform (FFT) Spectrogram. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveforms. - 5. LVIS NeuroMatch displays physiological signals such as electrocardiogram (ECG/EKG) if it is provided in the EEG recording. - 6. The aEEG functionality included in LVIS NeuroMatch is intended to monitor the state of the brain. - 7. I VIS NeuroMatch Artifact Reduction (AR) is intended to reduce muscle and eye movements, in EEG signals from the International Standard 10-20 placement. AR does not remove the entire artifact signal and is not effective for other types of artifacts. AR may modify portions of waveforms representing cerebral activity. Waveforms must still be read by a qualified medical practitioner trained in recognizing artifacts, and any interpretationor diagnosis must be made with reference to the original waveforms. - This device does not provide any diagnostic conclusion about the patient's condition to the user. 8. {7}------------------------------------------------ # Comparison of Intended Use and Technological Characteristics with the Predicate Devices: # TABLE 1: NEUROMATCH SUBSTANTIAL EQUIVALENCE TABLE | Device | NeuroMatch (Proposed Device) K241390 LVIS | Persyst 14 EEG Review and Analysis Software (Predicate Device) K182181 Persyst Development Corporation | Rationale for Substantial Equivalence | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| | Classification | 21 CFR§882.1400, Electroencephalograph | 21 CFR§882.1400, Electroencephalograph | Same classification as the Predicate device. | | | Product Code | OMB, OLT, OMA | OMB, OLT, OMA | Same product code as the Predicate device. | | | Indications for Use: For the subject device new indications are highlighted in bold while previously cleared indications are in normal font. | 1. LVIS NeuroMatch Software is intended for the review, monitoring and analysis of electroencephalogram (EEG) recordings made by EEG devices using scalp electrodes and to aid neurologists in the assessment of EEG. The device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information. 2. The Seizure Detection component of LVIS NeuroMatch is intended to mark previously acquired sections of adult EEG recordings from patients greater than or equal to 18 years old that may correspond to electrographic seizures. | 1. Persyst 14 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices using scalp electrodes and to aid neurologists in the assessment of EEG. The device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information. 2. The Seizure Detection component of Persyst 14 is intended to mark previously acquired sections of adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures, in order to assist qualified clinical practitioners in | The Proposed Device and the Predicate, have similar Indications for Use. The Proposed Device's Indications for Use was developed to incorporate wording from the predicate device. | | | Device | NeuroMatch (Proposed Device) K241390 LVIS | Persyst 14 EEG Review and Analysis Software (Predicate Device) K182181 Persyst Development Corporation | Rationale for Substantial Equivalence | | | | in order to assist qualified medical practitioners in the assessment of EEG traces. EEG recordings should be obtained with a full scalp montage according to the electrodes from the International Standard 10-20 placement. | the assessment of EEG traces. EEG recordings should be obtained with a full scalp montage according to the standard 10/20 system. | | | | | 3. The Spike Detection component of LVIS NeuroMatch is intended to mark previously acquired sections of adult EEG recordings from patients ≥18 years old that may correspond to spikes, in order to assist qualified medical practitioners in | 3. The Spike Detection component of Persyst 14 is intended to mark previously acquired sections of the patient's EEG recordings that may correspond to spikes, in order to assist qualified clinical practitioners in the assessment of EEG traces. The Spike Detection component is intended to be used in patients at least one month old. Persyst 14 Spike Detection performance has not been | | | | | the assessment of EEG traces. LVIS NeuroMatch Spike Detection performance has not been assessed for intracranial recordings. | assessed for intracranial recordings. | | | | | 4. LVIS NeuroMatch includes the calculation and display of a set of quantitative measures intended to monitor and analyze EEG waveforms. These include Artifact | 4. Persyst 14 includes the calculation and display of a set of qualitative measures intended to monitor and analyze the EEG waveform. These include FFT, Rhythmicity, Peak Envelope, Artifact Intensity, Amplitude, Relative Symmetry and Suppression Ratio. Automatic event marking | | | | Device | NeuroMatch (Proposed Device) K241390 LVIS | Persyst 14 EEG Review and Analysis Software (Predicate Device) K182181 Persyst Development Corporation | Rationale for Substantial Equivalence | | | | Strength, Asymmetry Spectrogram, Autocorrelation Spectrogram, and Fast Fourier Transform (FFT) Spectrogram. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveforms. 5. LVIS NeuroMatch displays physiological signals such as electrocardiogram (ECG/EKG) if it is provided in the EEG recording. 6. The aEEG functionality included in LVIS NeuroMatch is intended to monitor the state of the brain. 7. LVIS NeuroMatch Artifact Reduction (AR) is intended to reduce muscle and eye movements, in EEG signals from the International Standard 10-20 placement. AR does not remove the entire artifact signal and is not effective for other types of artifacts. AR may modify portions of waveforms representing | is not applicable to the quantitative measures. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveforms. 5. Persyst 14 displays physiological signals, including the calculation and display of a heart rate measurement based on the ECG channel in the EEG recording, which are intended to aid in the analysis of an EEG. Heart rate measurement of Persyst 14 is not applicable to patients with pacemaker and/or active implantable devices. 6. The aEEG functionality included in Persyst 14 is intended to monitor the state of the brain. The automated event marking function of Persyst 14 is not applicable to aEEG. 7. Persyst 14 provides notifications for seizure detection, quantitative EEG and aEEG that can be used when processing a record during acquisition. These include an on screen display and the optional | | | | Device | NeuroMatch (Proposed Device) K241390 LVIS | Persyst 14 EEG Review and Analysis Software (Predicate Device) K182181 Persyst Development Corporation | Rationale for Substantial Equivalence | | | | cerebral activity. Waveforms must still be read by a qualified medical practitioner trained in recognizing artifacts, and any interpretation or diagnosis must be made with reference to the original waveforms. 8. This device does not provide any diagnostic conclusion about the patient's condition to the user. | sending of an email message. Delays of up to several minutes can occur between the beginning of a seizure and when the Persyst 14 notifications will be shown to a user. Persyst 14 notifications cannot be used as a substitute for real time monitoring of the underlying EEG by a trained expert. 8. Persyst AR (Artifact Reduction) is intended to reduce EMG, eye movement, and electrode artifacts in a standard 10- 20 EEG recording. AR does not remove the entire artifact signal, and is not effective for other types of artifacts. AR may modify portions of waveforms representing cerebral activity. Waveforms must still be read by a qualified medical practitioner trained in recognizing artifact, and any interpretation or diagnosis must be made with reference to the original waveforms. 9. This device does not provide any diagnostic | | | | Device | NeuroMatch (Proposed Device) K241390 LVIS | Persyst 14 EEG Review and Analysis Software (Predicate Device) K182181 Persyst Development Corporation | Rationale for Substantial Equivalence | | | | | patient's condition to the user. | | | | Prescription/ Over-the-Counter | Rx | Rx | Same as the Predicate device. | | | Patient Population | Individuals ≥18 years undergoing EEG assessment | Adults and pediatric patients undergoing EEG assessment: Seizure detection: - Individuals ≥18 years - Spike detection at least one month old | Similar, the Proposed Device age group of at least 18 years old for seizure detection is the same as the predicate device. For spike detection, the subject device is intended for a subset of the population that is cleared for the predicate device. | | | Components | SaMD | SaMD | Same as the Predicate device. | | | EEG Data Source | | 10-20 system | 10-20 system (spike and seizure detection)¹ up to 256 channels² | Similar, the Proposed Device and the Predicate both use 10-20 system. | | EEG Functions | Review, Monitor, and Analyze Recordings | Yes | Yes | Same as the Predicate device. | | | Annotation List | Yes | Yes | Same as the Predicate device. | | Device | NeuroMatch (Proposed Device) K241390 LVIS | Persyst 14 EEG Review and Analysis Software (Predicate Device) K182181 Persyst Development Corporation | Rationale for Substantial Equivalence | | | Measurements | Previously Cleared: • FFT Spectrogram • Artifact Strength • aEEG • Autocorrelation Spectrogram • Asymmetry Spectrogram Added in Current 510(k): • Seizure Detection • Spike Detection | • FFT • Artifact Intensity • Amplitude • Rhythmicity • Peak Envelope • Relative Symmetry • Suppression Ratio • Artifact intensity • FFT spectrogram • FFT power • FFT power ratio • FFT spectral edge • Relative asymmetry spectrogram • Absolute asymmetry index • Relative asymmetry index • aEEG • Rhythmicity spectrogram • Spike detection • Spike density • Seizure detection • Seizure probability • Spike Perception Score • VSBASLINE3 | The Proposed Device and the Predicate both provide seizure and spike detection. | | | Seizure Detection | Yes, full montage | Yes, full montage | Same as the Predicate device. | | | Spike Detection | Yes | Yes | Same as the Predicate device. | | | Notifications | No…

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