Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

Yes
The "Mentions AI, DNN, or ML" section explicitly states that the Spike Detection and Seizure Detection features use a deep learning-based algorithm.

Therapeutic

No
The device is strictly for review, monitoring, and analysis of EEG recordings to aid neurologists in assessment; it does not provide any therapy or treatment.

Diagnostic

Yes

Explanation: The device is intended for the "review, monitoring and analysis of electroencephalogram (EEG) recordings" and aids in "the assessment of EEG." It helps mark sections for potential seizures and spikes. Although it "does not provide any diagnostic conclusion," it processes data to assist medical practitioners in diagnosis, which is a key function of a diagnostic device.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states it is a "cloud-based software as a medical device (SaMD)". While it processes data from EEG devices, the device itself is the software component.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that LVIS NeuroMatch Software is for the review, monitoring, and analysis of electroencephalogram (EEG) recordings made by EEG devices using scalp electrodes. EEG recordings are electrical signals measured from the scalp, not specimens derived from the body in the way that blood, urine, or tissue samples are.
The device processes physiological signals directly. The input modality is EEG, which is a measurement of electrical activity in the brain. This is a direct physiological measurement, not an analysis of a biological specimen.
The device aids in the assessment of EEG. The software provides tools and algorithms to help qualified medical practitioners interpret EEG data. This is distinct from performing a diagnostic test on a biological sample.

While the device is a medical device and uses advanced algorithms (including deep learning), its function is centered around the analysis of physiological signals obtained non-invasively from the body's surface, not the analysis of in vitro specimens.

PCCP (Predetermined Change Control Plan) Authorized

No
The letter does not state that the FDA has reviewed and approved or cleared a PCCP for this specific device.

Overview

Intended Use / 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.

Product codes

OMB, OLT, OMA

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;
1. 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

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 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.

Input Imaging Modality

electroencephalogram (EEG) recordings

Anatomical Site

Not Found

Indicated Patient Age Range

patients greater than or equal to 18 years old
patients ≥18 years old
Individuals ≥18 years

Intended User / Care Setting

qualified medical practitioners who will exercise professional judgement in using the information.

Description of the training set, sample size, data source, and annotation protocol

A validation dataset of EEG recordings obtained from adult (18 years and older) patients were utilized for validation testing. This dataset was completely separate and independent from the data used to design and train the algorithm.

Description of the test set, sample size, data source, and annotation protocol

Seizure Detection Validation:
Clinical Sites:
Validation of the NeuroMatch seizure detection feature was conducted using EEG data collected in three independent and geographically diverse medical institutions.

Dataset Characteristics and subject demographics:

| | Patient
with at least 1 verified seizure
event | Control
With 0 verified seizure event |
|----------------------------|------------------------------------------------------|------------------------------------------|
| Number of subjects | 181 | 10 |
| Total EEG hours | 979.40 | 80 |
| (mean, median, [min, max]) | (5.41, 6.0, [1.00, 8.00]) | (8.00, 8.00, [8.00, 8.00]) |
| Age, years (mean) | 42.05 | 52.3 |
| (median and [min, max]) | (39, [18, 89]) | (60, [25, 78]) |
| Gender
(Male : Female) | 95:86 | 4 : 6 |

Summary of Validation Testing

A reference standard was established for the validation dataset by a panel of three independent EEG trained neurologists who reviewed and annotated the EEG recordings for seizure episodes. Seizures were identified based on a 2 out of 3 majority rule.
Both NeuroMatch and predicate Persyst 14 (K182181) Seizure Detection modules were run on the validation dataset and performance metrics were calculated for each as compared to the reference standard established per above.
Statistical analysis was performed on the results to evaluate non-inferiority to the predicate device based on both sensitivity and false detection rate (FDR).
Conducting an event-level analysis, with potentially an unlimited number of events per patient, introduces bias by disproportionately affecting the data distribution in favor of patients with many events. To avoid such bias, the study reports an event-level analysis with a capping value of six events per patient for seizure detection sensitivity.

Spike Detection Validation:
Clinical Sites:
Validation of the NeuroMatch spike detection feature was conducted using EEG data collected in three independent and geographically diverse medical institutions.

Dataset Characteristics and Subject Demographics Summary Table:

	Patient
	with at least 1 verified spike event
Number of subjects	149
Total EEG minutes (hours)	2752.72 (~45.9)
(mean, median, [min, max])	(18.47, 20 [10.0,0 20.00])
Age (mean)	42.56
(median, [min, max])	(39, [18, 92])
Gender
(Male : Female : Unspecified -
Number of Subjects)	73 : 75 : 1

Summary of Validation Testing

A reference standard was established for the validation dataset by a panel of three independent EEG trained neurologists who reviewed and annotated the EEG recordings for spike events. The reference standard for spike is established with majority consensus among the annotating physicians (i.e., consensus of at least 2 out of the 3 physicians).
Both NeuroMatch and predicate Persyst 14 (K182181) Spike Detection modules were run on the validation dataset and performance metrics were calculated for each as compared to the reference standard established per above.
Statistical analysis was performed on the results to evaluate non-inferiority to the performance of the predicate device in terms of sensitivity and false detection rate.

Summary of Performance Studies

Study Type: Non-Clinical Testing and Clinical Testing

Non-Clinical Testing:
Software verification and validation testing

Verification Tests and Regression Tests
Unit/Module Level and Integration Testing
Visualization Testing
Performance Testing
All tests successfully met their respective acceptance criteria and confirmed the software met its requirements and design.

Cybersecurity Testing
A comprehensive battery of cybersecurity testing per FDA's guidance entitled "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" (issued September 2023), including Configuration Assessment, Vulnerability Scanning, and Penetration Testing, was conducted.

Clinical Testing:
Seizure Detection Validation:
Sample Size:
Patient with at least 1 verified seizure event: 181 subjects, 979.40 total EEG hours.
Control with 0 verified seizure event: 10 subjects, 80 total EEG hours.
Key Results:
| | Sensitivity
(N = 504 events) | False Detection Rate (FDR)
(per 24 hrs) |
|------------|---------------------------------|--------------------------------------------|
| Persyst 14 | 59.37 [56.94, 61.71] | 4.26 [3.15, 7.39] |
| NeuroMatch | 75.01 [72.62, 77.57] | 3.74 [2.59, 5.44] |
NeuroMatch Seizure Detection passed non-inferiority testing to the Persyst14 ( K182181), in both sensitivity and false-detection rate (FDR).

Spike Detection Validation:
Sample Size:
Patient with at least 1 verified spike event: 149 subjects, 2752.72 (~45.9) total EEG minutes.
Key Results:
| | Sensitivity | False Detection Rate
(FDR)
(per minute) |
|------------|----------------------|-----------------------------------------------|
| Persyst 14 | 67.92 [61.96, 73.87] | 3.61 [2.68, 4.53] |
| NeuroMatch | 72.18 [66.81, 77.54] | 3.24 [2.15, 4.33] |
The acceptance criterion for non-inferiority was met for both sensitivity and FDR, confirming that NeuroMatch is non-inferior to Persyst 14.

Key Metrics

Seizure Detection:
Sensitivity:

Persyst 14: 59.37% [95% CI: 56.94, 61.71]
NeuroMatch: 75.01% [95% CI: 72.62, 77.57]
False Detection Rate (FDR) (per 24 hrs):
Persyst 14: 4.26 [95% CI: 3.15, 7.39]
NeuroMatch: 3.74 [95% CI: 2.59, 5.44]

Spike Detection:
Sensitivity:

Persyst 14: 67.92% [95% CI: 61.96, 73.87]
NeuroMatch: 72.18% [95% CI: 66.81, 77.54]
False Detection Rate (FDR) (per minute):
Persyst 14: 3.61 [95% CI: 2.68, 4.53]
NeuroMatch: 3.24 [95% CI: 2.15, 4.33]

Predicate Device(s)

Persyst 14, EEG Review and Analysis Software, K182181

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 882.1400 Electroencephalograph.

(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).

Summary

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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.

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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)

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.

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.

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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;
1. 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.

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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.
1. 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.
1. 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.
1. 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.
1. LVIS NeuroMatch displays physiological signals such as electrocardiogram (ECG/EKG) if it is provided in the EEG recording.
1. The aEEG functionality included in LVIS NeuroMatch is intended to monitor the state of the brain.
1. 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.

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.
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.
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 | is not applicable to the
quantitative measures.
These quantitative EEG
measures should always
be interpreted in
conjunction with review
of the original EEG
waveforms.
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.
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.
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.
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.
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.
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 | Yes, notifications for seizure
detection, quantitative EEG,
and aEEG. | This difference to the Predicate
does not raise different
questions of safety and
effectiveness as the clinician
should be | |
| Device | NeuroMatch
(Proposed Device)
K241390
LVIS | Persyst 14 EEG Review and
Analysis Software
(Predicate Device)
K182181
Persyst Development
Corporation | Rationale for
Substantial
Equivalence | |
| | | | reviewing and
analyzing all
data including
the original EEG
waveforms
holistically. | |

8

9

10

11

¹ Persyst 14 User Manual, Persyst 14 Spike and Seizure Detection Description ² Persyst 14c Release Notes, Persyst EEG Electrical Source Imaging (ESI),

https://www.persyst.com/support/persyst-release-notes/

12

13

Performance Data:

The following performance data were provided to demonstrate safety and efficacy in support of substantial equivalence determination:

Non-Clinical Testing

Software verification and validation testing ●

The following software verification and validation tests were completed per FDA's guidance entitled "Content of Premarket Submissions for Device Software Functions" issued June 2023:

Verification Tests and Regression Tests o
Unit/Module Level and Integration Testing O
Visualization Testing O
o Performance Testing

All tests successfully met their respective acceptance criteria and confirmed the software met its requirements and design.

. Cybersecurity Testing

A comprehensive battery of cybersecurity testing per FDA's guidance entitled "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" (issued September 2023), including Configuration Assessment, Vulnerability Scanning, and Penetration Testing, was conducted.

14

Clinical Testing ●

Seizure Detection Validation:

Clinical Sites:

Validation of the NeuroMatch seizure detection feature was conducted using EEG data collected in three independent and geographically diverse medical institutions.

Dataset Characteristics and subject demographics:

The demographics of seizure detection validation dataset are as follows:

| | Patient
with at least 1 verified seizure
event | Control
With 0 verified seizure event |
|----------------------------|------------------------------------------------------|------------------------------------------|
| Number of subjects | 181 | 10 |
| Total EEG hours | 979.40 | 80 |
| (mean, median, [min, max]) | (5.41, 6.0, [1.00, 8.00]) | (8.00, 8.00, [8.00, 8.00]) |
| Age, years (mean) | 42.05 | 52.3 |
| (median and [min, max]) | (39, [18, 89]) | (60, [25, 78]) |
| Gender
(Male : Female) | 95:86 | 4 : 6 |

Summary of Validation Testing

The following is a summary of the validation procedure performed:

. A validation dataset of EEG recordings obtained from adult (18 years and older) patients were utilized for validation testing. This dataset was completely separate and independent from the data used to design and train the algorithm.
. A reference standard was established for the validation dataset by a panel of three independent EEG trained neurologists who reviewed and annotated the EEG recordings for seizure episodes. Seizures were identified based on a 2 out of 3 majority rule.
. Both NeuroMatch and predicate Persyst 14 (K182181) Seizure Detection modules were run on the validation dataset and performance metrics were calculated for each as compared to the reference standard established per above.
. Statistical analysis was performed on the results to evaluate non-inferiority to the predicate device based on both sensitivity and false detection rate (FDR).
. Conducting an event-level analysis, with potentially an unlimited number of events per patient, introduces bias by disproportionately affecting the data distribution in favor of patients with many events. To avoid such bias, the study reports an event-level analysis with a capping value of six events per patient for seizure detection sensitivity.

15

Results:

| | Sensitivity
(N = 504 events) | False Detection Rate (FDR)
(per 24 hrs) |
|------------|---------------------------------|--------------------------------------------|
| Persyst 14 | 59.37 [56.94, 61.71] | 4.26 [3.15, 7.39] |
| NeuroMatch | 75.01 [72.62, 77.57] | 3.74 [2.59, 5.44] |

NeuroMatch and Persyst 14 sensitivity and false detection rate. Mean and 95% confidence intervals are shown.

Sensitivity: The acceptance criterion for non-inferiority required the upper limit of the 95% CI for the difference in sensitivity (Persyst 14- NeuroMatch) to be less than 10%. This criterion was met, confirming that NeuroMatch is non-inferior to Persyst 14.

FDR: The acceptance criterion for non-inferiority required the lower limit of the 95% CI for the difference in FDR (Persyst 14-NeuroMatch) to be greater than -4 per 24hr. This criterion was met, confirming that NeuroMatch is non-inferior to Persyst 14.

Conclusion:

NeuroMatch Seizure Detection passed non-inferiority testing to the Persyst14 ( K182181), in both sensitivity and false-detection rate (FDR).

Spike Detection Validation:

Clinical Sites:

Validation of the NeuroMatch spike detection feature was conducted using EEG data collected in three independent and geographically diverse medical institutions.

Dataset Characteristics and Subject Demographics Summary Table:

The demographics of spike detection validation dataset are as follows:

	Patient
	with at least 1 verified spike event
Number of subjects	149
Total EEG minutes (hours)	2752.72 (~45.9)
(mean, median, [min, max])	(18.47, 20 [10.0,0 20.00])
Age (mean)	42.56
(median, [min, max])	(39, [18, 92])
Gender
(Male : Female : Unspecified -
Number of Subjects)	73 : 75 : 1

16

Summary of Validation Testing

The following is a summary of the validation procedure performed:

A validation dataset of EEG recordings obtained from adult (18 years and older) . patients were utilized for validation testing. This dataset was completely separate and independent from the data used to design and train the algorithm.
. A reference standard was established for the validation dataset by a panel of three independent EEG trained neurologists who reviewed and annotated the EEG recordings for spike events. The reference standard for spike is established with majority consensus among the annotating physicians (i.e., consensus of at least 2 out of the 3 physicians).
. Both NeuroMatch and predicate Persyst 14 (K182181) Spike Detection modules were run on the validation dataset and performance metrics were calculated for each as compared to the reference standard established per above.
. Statistical analysis was performed on the results to evaluate non-inferiority to the performance of the predicate device in terms of sensitivity and false detection rate.

Results:

| | Sensitivity | False Detection Rate
(FDR)
(per minute) |
|------------|----------------------|-----------------------------------------------|
| Persyst 14 | 67.92 [61.96, 73.87] | 3.61 [2.68, 4.53] |
| NeuroMatch | 72.18 [66.81, 77.54] | 3.24 [2.15, 4.33] |

NeuroMatch and Persyst 14 sensitivity and false detection rate. Mean and 95% confidence intervals are shown.

Conclusion:

Sensitivity: The acceptance criterion for non-inferiority required the upper limit of the 95% CI for the difference in sensitivity (Persyst 14 - NeuroMatch) to be less than 15%. This criterion was met, confirming that NeuroMatch is non-inferior to Persyst 14.

FDR: The acceptance criterion for non-inferiority required the lower limit of the 95% CI for the difference in FDR (Persyst 14-NeuroMatch) to be greater than -1.5 per minute. This criterion was met, confirming that NeuroMatch is non-inferior to Persyst 14.

Summary:

The NeuroMatch device has the same intended use as the predicate device. In addition, it has similar technological characteristics; performance data demonstrates that any differences in technological characteristics do not raise different questions of safety or effectiveness. Therefore, the NeuroMatch device is substantially equivalent to the cleared predicate device.