The non-EEG Physiological Signal Based Seizure Monitoring System continuously records and stores surface electromyographic (sEMG) data for subsequent review.

Trained healthcare professionals may use the electrophysiological sEMG data during a post-hoc review, with other contextual data, to characterize upper-extremity motor activity (UEMA) ipsilateral to the activity.

Audio data recorded during seizure monitoring may be available for review by a trained healthcare professional.

The device is to be used on the belly of the biceps muscle to analyze sEMG signals. When sEMG signal patterns associated with a unilateral, appendicular, tonic extension that could be associated with a GTC seizure are detected, the SPEAC System sends adjunctive alarms to alert caregivers.

Adjunctive alarms may be disabled by a physician order while continuing to record sEMG data for subsequent review.

Device Description

The SPEAC System is a wireless, non-invasive, physiological, surface electromyography (sEMG) recording, monitoring, and alerting system to be used as an adjunct to seizure monitoring during periods of rest. The System continuously records and stores surface electromyographic (sEMG) data for subsequent review by a physician. Trained healthcare professionals may use the electrophysiological sEMG data, with other contextual data, to characterize seizures with upper-extremity motor activity ipsilateral to the device from other activity. SPEAC data gives healthcare professionals another diagnostic tool to characterize seizure events in a home or hospital setting.

The System continuously records and distributes sEMG data at 1,000 Hz (and audio around detected events) for post-hoc review by physicians (or other trained healthcare professionals) for the characterization of seizure events. A physician may perform post-hoc review of the SPEAC System data to characterize motor events that may be associated with seizures.

The seizure monitoring algorithm is able to send alarms to notify patients and caregivers when a pattern that may be associated with a generalized tonic-clonic (GTC) seizure is measured. Physicians may order the System with or without alarms and may order threshold adjustments to customize the level at which the System alarms.

The SPEAC System remains the same with no alterations of any kind. The sEMG-based seizure monitoring algorithm is identical to the predicate SPEAC System. The purpose of this submission is to expand the indications for use based on clinical performance testing that was submitted to support a determination of substantial equivalence. When trained appropriately, clinicians may use the subject device to perform post-hoc analysis of the sEMG data from the device, with other contextual patient data, to characterize seizures with upper-extremity motor activity ipsilateral to the device from other activity.

AI/ML Overview

The SPEAC System (K200276) is intended for use as an adjunct to seizure monitoring in adults. The system records and stores surface electromyographic (sEMG) data for subsequent review by trained healthcare professionals to characterize upper-extremity motor activity (UEMA) ipsilateral to the device. The system also sends alarms to alert caregivers when sEMG signal patterns associated with a unilateral, appendicular, tonic extension that could be associated with a Generalized Tonic-Clonic (GTC) seizure are detected.

Here's a breakdown of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with specific numerical thresholds for the clinical study. Instead, the study evaluates the accuracy of expert reviewers in classifying seizure events using sEMG data. The reported device performance is presented as the accuracy of these expert reviewers.

Performance Metric	Acceptance Criteria (Not Explicitly Stated as Numerical Thresholds)	Reported Device Performance (Accuracy from combined studies)
Overall Accuracy (individual assessments)	Implied: Ability of clinicians to characterize and differentiate types of seizure events with sEMG data	83% (95% CI [0.78 0.88], n = 243)
Overall Accuracy (committee approach)	Implied: Ability of clinicians to characterize and differentiate types of seizure events with sEMG data	86% (95% CI [0.77 0.93], n = 81)
Tonic-Clonic (TC) Seizures Accuracy (Committee)	Implied: High accuracy for GTC seizure characterization	92% (95% CI [0.75 0.99])
PNES (Psychogenic Non-Epileptic Seizures) Accuracy (Committee)	Implied: High accuracy for PNES characterization	100% (95% CI [0.82 1.00])

2. Sample Size and Data Provenance

Test Set Sample Size:
- Individual assessments: 243 events (n=243)
- Committee approach: 81 events (n=81)
- Specific breakdown by event type (for committee):
  - Tonic-Clonic: 26
  - Simple Motor ES (Tonic & Clonic): 14
  - Complex Motor ES ("Other"): 22
  - All ES (Epileptic Seizures): 62
  - PNES, whole body involvement: 4
  - PNES, arm jerks/hand tremors only: 15
  - All PNES: 19
Data Provenance: Prospective clinical trials conducted in an Epilepsy Monitoring Unit (EMU). The country of origin is not explicitly stated, but clinical trials subject to FDA review are typically conducted in the US or under internationally recognized standards.

3. Number of Experts and Qualifications

Number of Experts: Three (3) sEMG reviewers participated in both studies.
Qualifications of Experts: The document states "Physicians" for the sEMG review. For the ground truth, "Epileptologists" reviewed vEEG data, implying these are highly qualified medical professionals specializing in epilepsy. Specific years of experience are not mentioned for any of the reviewers.

4. Adjudication Method for the Test Set

The study used a "committee" style approach, which is defined as majority rules (2/3) for combining the assessments of the three sEMG reviewers.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Yes, a form of MRMC study was done. The study involved multiple expert readers (three sEMG reviewers) evaluating multiple cases (seizure events).
Effect Size of Human Readers with AI vs. without AI: This study's primary goal was not to measure the improvement of human readers with AI assistance. Instead, it evaluated the ability of clinicians to characterize events using sEMG data alone (from the device) and compared these characterizations to vEEG data and automated processing. The sEMG data from the SPEAC system is intended as an adjunct to monitoring, meaning human clinicians still interpret the data. Thus, an "AI vs. without AI assistance" effect size is not directly provided in the context of human reader improvement via an AI algorithm, but rather the utility of the sEMG data itself for expert interpretation.

6. Standalone (Algorithm Only) Performance

Yes, a standalone component of performance was done. The clinical endpoints included comparison of the expert sEMG review to "automated event characterization". However, the results presented in the table specifically detail the "Expert Reviewer Accuracy" and indicate "No automated processing for seizure characterization was cleared in this 510(k)." This suggests that while automated processing was evaluated, its performance results are not provided here for clearance, and the focus for clearance is on the expert interpretation of the sEMG data.

7. Type of Ground Truth Used

The ground truth for seizure characterization was established using Video-EEG (vEEG) data interpreted by epileptologists.

8. Sample Size for the Training Set

The document does not specify a separate sample size for a training set. The study describes training physicians in interpreting sEMG data, but it refers to a prospective clinical trial where data was collected. It's unclear if a separate training data set for an algorithm was used, as the focus of the presented clinical performance is on human interpretation of sEMG data. The statement "The sEMG-based seizure monitoring algorithm is identical to the predicate SPEAC System" suggests the algorithm was already established, and this submission focused on expanding the indications for human interpretation of its output.

9. How Ground Truth for the Training Set Was Established

If there was a training set for an algorithm, the document does not describe how its ground truth was established. For the training of physicians, the ground truth would implicitly be their consensus or established medical knowledge based on reference methods like vEEG, as discussed in the study.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.

Brain Sentinel, Inc. Richard Waite Regulatory Consultant 8023 Vantage Drive Suite 216 San Antonio, Texas 78230

Re: K200276

Trade/Device Name: SPEAC System Regulation Number: 21 CFR 882.1580 Regulation Name: Non-Electroencephalogram (EEG) Physiological Signal Based Seizure Monitoring System Regulatory Class: Class II Product Code: POS Dated: January 22, 2021 Received: February 2, 2021

Dear Richard Waite:

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 (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 located 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.

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 803) for

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devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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

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Indications for Use

510(k) Number (if known) K200276

Device Name SPEAC System

Indications for Use (Describe)

The SPEAC® System is intended for use as an adjunct to seizure monitoring in adults in the home or healthcare facilities during periods of rest.

The non-EEG Physiological Signal Based Seizure Monitoring System continuously records and stores surface electromyographic (sEMG) data for subsequent review.

Audio data recorded during seizure monitoring may be available for review by a trained healthcare professional.

Adjunctive alarms may be disabled by a physician order while continuing to record sEMG data for subsequent review.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	☑
Over-The-Counter Use (21 CFR 801 Subpart C)	☐

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K200276 Traditional 510(k) Summarv

This 510(k) summary is prepared according to the elements outlined in 21 CFR 807.92 Content and format of a 510(k) summary.

Date Prepared	February 05, 2020
Submitter	Brain Sentinel, Inc8023 Vantage Drive, Suite 216San Antonio, TX 78230(210) 951-8681
Contact Person	Richard Waite, Sr.(214) 662-9277Richard Waite@outlook.com

Subject Device K200276

Trade Name	SPEAC® System
Common Name	Physiological signal-based seizure monitoring system
Device Classification	Class II
Product Code &Regulation	POS; Non-EEG physiological signal-based seizure monitoring system21 CFR 882.1580
Review Panel	Neurodiagnostic Devices; Neurology

Predicate Device K182180

Manufacturer Brain Sentinel, Inc. Device Name Brain Sentinel Monitoring and Alerting System Regulation Name Non-EEG physiological signal-based seizure monitoring system Product Code POS Regulation Number 21 CFR 882.1580 Device Classification Class II

Device Description

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activity. SPEAC data gives healthcare professionals another diagnostic tool to characterize seizure events in a home or hospital setting.

Data collected by the System is uploaded to Brain Sentinel's secure remote storage, the Data Distribution System (DDS), and is remotely accessible for physician review. All patient data is cyber-secured within Microsoft Azure which is FedRAMP certified. Below, Tables 1 and 2 list the functional and operational outputs designed to provide feedback to the patient and caregiver. These modes and outputs are identical to those cleared in the predicate, K182180.

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Image /page/5/Figure/0 description: This image describes the SPEAC system functional modes. The table describes the seizure monitoring mode, seizure alarm mode, record only mode activated, loose electrode alert, sEMG monitor critical battery alert, laptop base station critical battery alert, and lost connection out of Wi-Fi range alert. The table also describes the left and right LED light colors, daily monitoring application screen view, and a description of the functional mode. For example, the seizure monitoring mode has green solid lights for both the left and right LEDs, and the daily monitoring application screen view shows a green checkmark with the text "You are being monitored".

Table 1: System Functional and Operational Outputs

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Table 2: SPEAC System Outputs Intended for Patients and Caregivers

Name	Application View	Description
Settings Button	Image: SETTINGS	Click the Settings button to swap functional modes between Seizure Monitoring Mode and Record Only Mode.
Night ModeButton	Image: NIGHT MODE	To help the patient sleep soundly, the Laptop Base Station display screen and lights on the sEMG Monitor may bedimmed. Click the Night Mode button to turn Night Mode ON.
Night ModeOn Button	Image: NIGHT MODE ON	Click the dark grey Night Mode ON button to disable Night Mode setting and return the SPEAC Systemdisplay screen to regular brightness. You can alternate between Night Mode OFF and Night Mode ON asoften as necessary.
Electrode SetupButton	Image: ELECTRODE SETUP	Click the Electrode Setup button every time a new Electrode Patch is placed on a patient. Calibration of a newElectrode Patch should be performed daily when using the System in Seizure Monitoring Mode or Record Only Mode.
Alarm HistoryButton	Image: ALARM HISTORY	Click the Alarm History button to display a list of all Seizure Alarms and Operational Alerts that have occurredduring the prescribed monitoring period. Use the scroll bar to review the cumulative list. A new or existingSeizure Diary entry can be accessed from this list, as well as using the Seizure Diary button noted below.
Seizure DiaryButton	Image: SEIZURE DIARY	A yellow exclamation point will appear over the Seizure Diary button to indicate a new Seizure Diary entry hasbeen automatically created. Click the Seizure Diary Button to open the electronic form that will allow thepatient or caregiver to record specific details about the event.
Wi-Fi-StatusIndicator Bar	Image: Wi-Fi signal strength bars	The Laptop Base Station serves as the control hub for the entire SPEAC System. The Wireless Router providesa communications link between the sEMG Monitor in use and the Laptop Base Station. The Wireless Routercan communicate with the sEMG Monitor up to a 200-foot range (approximate). The Wi-Fi Status Bars indicateconnection signal strength.

Intended Use

The SPEAC® System is intended for use as an adjunct to seizure monitoring in adults in the home or healthcare facilities during periods of rest. The non-EEG Physiological Signal Based Seizure Monitoring System continuously records and stores surface electromyographic (sEMG) data for subsequent review. Trained healthcare professionals may use the electrophysiological sEMG data during a post-hoc review, with other contextual data, to characterize upper-extremity motor activity ipsilateral to the device from other activity. Audio data recorded during seizure monitoring may be available for review by a trained healthcare professional.

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Clinical Performance Testing

Prospective clinical trials entitled, "Using sEMG to Identify Epileptic Seizure Semiology" (Study 1), and "Differentiation of Epileptic and Psychogenic Non-Epileptic Seizures Using Single-Channel Surface Electromyography'' (Study 2) evaluated the ability of trained clinicians to differentiate and characterize different types of seizure events using the sEMG data collected by the SPEAC System.

Once characterized, the results of these sEMG-trained healthcare professionals were compared to characterizations of the same seizure events using EEG data interpreted by epileptologists and compared to automated processing for characterization of the seizures.

Clinical Inclusion and Exclusion Criteria

Enrollment in the studies was limited to patients who met the following selection criteria: Patients with a history of epileptic seizures or psychogenic non epileptic seizures with positive motor involvement of the upper extremities admitted to the EMU for routine seizure characterization were eligible for inclusion. Subjects were not eligible if intracranial EEG monitoring was used.

Training of Physicians in the Study

Physicians were provided with a brief (less than an hour) sEMG data training session describing characteristics of: voluntary activity, epileptic and non-epileptic seizure events, and artifact from the device. False positives were non-seizure events that could have resulted from either voluntary movement, signal spikes or RF noise from loose electrodes, or ambient background signals with no associated event data. Physicians were asked to evaluate normalized, transformed, and raw sEMG data. Epileptologists reviewing sEMG data were blinded to all other data.

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Clinical Endpoints. Trained clinicians were evaluated by determining if they could characterize and differentiate types of seizure events with sEMG data collected by the SPEAC System, and then those results were compared to vEEG data as well as automated event characterization.

Study Methods

Expert Review

Both Study 1 (CLN0055.001) and Study 2 (CLN0053.001) simultaneously captured vEEG and sEMG data, and three of the total four sEMG reviewers were the same in both studies. The goal in Study 1 was to review epileptic seizures and try to describe the semiology. The goal in Study 2 was to review both epileptic and non-epileptic seizures and to try to properly classify events into those two categories. The similarity between these studies is that epileptic seizures included GTC seizures (referred to as TC seizures in the studies), and focal seizures that contained clonic jerking and complex motor activity (automatisms). Tonic seizures were only recorded during Study 1, and PNES was only recorded during Study 2.

The data from the three common sEMG reviewers was combined from both studies to assess the accuracy for the intended goal in both studies. This analysis combines data that has two different goals but testing the same types of events. The combined accuracy for the studies given a "committee" style approach (majority rules, 2/3) was also analyzed to make the reviews more comparable to the format for used for vEEG.

Results

Expert Reviewer Accuracy

The accuracy from the three reviewers that participated in both studies was combined for each event. The accuracies are presented for each individual reviewer as well as a committee approach for each event. The objective of Study 1 was to categorize ES by semiology. The objective of Study 2 was to categorize seizures as epileptic or non-epileptic. The overall accuracy for individual assessments was 83% (95% CI [0.78 0.88], n = 243), and the overall accuracy for the committee approach was 86% (95% CI [0.77 0.93], n = 81). Table 1 summarizes the accuracies from the reviewers. These results support how the device can be used by clinicians to characterize upper-extremity motor activity (UEMA) ipsilateral to the device from other activity.

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Committee Review ofsEMG Classification	Reviewer 1	Reviewer 2	Reviewer 3	Average (Ind.Assess.)(N = n*3) a	Committee
Tonic-Clonic (n = 26)	88% (95% CI[0.70 0.98])	88% (95% CI[0.70 0.98])	100% (95% CI[0.87 1.00])	92% (95% CI[0.84 0.97])	92% (95% CI[0.75 0.99])
Simple Motor ES (Tonic& Clonic, n = 14)	71% (95% CI[0.42 0.92])	79% (95% CI[0.49 0.95])	64% (95% CI[0.35 0.87])	71% (95% CI[0.55 0.84])	79% (95% CI[0.49 0.95])
Complex Motor ES("Other", n = 22)	73% (95% CI[0.50 0.89])	68% (95% CI[0.45 0.86])	63% (95% CI[0.40 0.83])	68% (95% CI[0.56 0.79])	73% (95% CI[0.50 0.89])
All ES (n = 62)	79% (95% CI[0.67 0.88])	79% (95% CI[0.67 0.88])	79% (95% CI[0.67 0.88])	79% (95% CI[0.72 0.85])	82% (95% CI[0.70 0.91])
PNES, whole bodyinvolvement (n = 4)	100% (95% CI[0.40 1.00])	100% (95% CI[0.40 1.00])	100% (95% CI[0.74 1.00])	100% (95% CI[0.67 0.88])	100% (95% CI[0.40 1.00])
PNES, armjerks/hand tremorsonly (n = 15)	100% (95% CI[0.78 1.00])	93% (95% CI[0.68 1.00])	93% (95% CI[0.68 1.00])	96% (95% CI[0.85 0.99])	100% (95% CI[0.78 1.00])
All PNES (n = 19)	100% (95% CI[0.82 1.00])	95% (95% CI[0.74 1.00])	95% (95% CI[0.74 1.00])	96% (95% CI[0.88 1.00])	100% (95% CI[0.82 1.00])
Overall Accuracy (n =81)	84% (95% CI[0.74 0.91])	83% (95% CI[0.73 0.90])	83% (95% CI[0.73 0.90])	83% (95% CI[0.78 0.88])	86% (95% CI[0.77 0.93])
a - The sample size for this column is: TC: 78, Simple Motor ES: 42, Complex Motor ES: 66, All ES: 186,PNES whole body: 12, PNES arm jerks/hand tremors: 45, PNES: 57, Total: 243

Table 1– Accuracy of (Common) Expert Reviewers' Classification of Events from Studies 1 and 2

The device used in the studies which represent the data collected were the same as the commercial version of the SPEAC System previously cleared by the FDA. sEMG collected using the SPEAC System has been used by clinicians to characterize seizures. Data provided by the SPEAC System provides healthcare professionals a diagnostic tool based on bicep sEMG signal monitoring to characterize seizure events measured in a home or hospital setting.

Non-clinical Test Summary

Test	Summary Results	FDA Recognition Number
IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) (3rd Edition), Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance	Passed	19-4
IEC 60601-1-2: 2014-02 (4th Edition), Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance, Collateral Standard, Electromagnetic Compatibility	Passed	19-8
Test	Summary Results	FDA Recognition Number
IEC 60601-1-6: Medical electrical equipment - Part 1-6:general requirements for basic safety and essentialperformance - collateral standard: usability	Passed	5-89
IEC 60601-1-8: Medical electrical equipment - Part 1-8:general requirements for basic safety and essentialperformance - collateral standard: general requirements,tests, and guidance for alarm systems in medicalelectrical equipment and medical electrical systems	Passed	5-76
IEC 60601-1-11: 2010 (1st Edition) Generalrequirements for basic safety and essential performance- Collateral Standard: Requirements for medicalelectrical equipment and medical electrical systems usedin the home healthcare environment.	Passed	This version is no longer FDArecognized but the changesevaluated in this 510(k)submission do not requireadditional testing to account forthis lack of recognition. Changesto the subject device proposed(indications for use) are outsidethe scope of this test.
IEC 60601-2-40: 2016 (2nd Edition) Medical electricalequipment - Part 2-40: Particular requirements for thebasic safety and essential performance ofelectromyographs and evoked response equipment	Passed	N/A Not an FDA recognizedstandard; This testing has beenvoluntarily performed by thecompany to demonstrateperformance and validate thesystem.
Biocompatibility TestingISO 10993-1: Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk managementprocess.	Passed	2-220
ISO 10993-5: Biological evaluation of medical devices -Part 5: Tests for vitro cytotoxicity	Passed	2-245
ISO 10993-10: Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization	Passed	2-174
Shipping and Distribution Test (ISTA 3A)	Passed	5-110
Software Verification and Validation (Appendix H)	Passed	N/A

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SPEAC System Comparison to Predicate Device and Conclusion:

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Parameter	SPEAC System	SPEAC System	Comparison
510(k)	K200276	K182180
Indications forUse	The SPEAC® System is intendedfor use as an adjunct to seizuremonitoring in adults in the homeor healthcare facilities duringperiods of rest.The non-EEG PhysiologicalSignal Based Seizure MonitoringSystem continuously records andstores surface electromyographic(SEMG) data for subsequentreview.Trained healthcare professionalsmay use the electrophysiologicalsEMG data during a post-hocreview, with other contextual data,to characterize upper-extremitymotor activity (UEMA) ipsilateral	The SPEAC® System is indicatedfor use as an adjunct to seizuremonitoring in adults in the homeor healthcare facilities duringperiods of rest.The System records and storessurface electromyographic(sEMG) data for subsequentreview by a trained healthcareprofessional.The device is to be used on thebelly of the biceps muscle toanalyze sEMG signals that may beassociated with generalized tonic-clonic (GTC) seizures.	Similar with newinformation added;The indicationshave been modifiedto clarify theintended use byspecifically statingthat the device maybe used tocharacterize upperextremity motoractivity by a trainedhealthcareprofessional. For
	to the device from other activity.Audio data recorded duringseizure monitoring may beavailable for review by a trainedhealthcare professional.The device is to be used on thebelly of the biceps muscle toanalyze sEMG signals.When sEMG signal patternsassociated with a unilateral,appendicular, tonic extension thatcould be associated with a GTCseizure are detected, the SPEACSystem sends adjunctive alarms toalert caregivers.Adjunctive alarms may bedisabled by a physician orderwhile continuing to record sEMGdata for subsequent review.	When sEMG signal patternsassociated with a unilateral,appendicular, tonic extension thatcould be associated with a GTCseizure are detected, the SPEACSystem sends adjunctive alarms toalert caregivers.Adjunctive alarms may bedisabled by a physician orderwhile continuing to record sEMGdata for subsequent review.	clarification, BrainSentinel removed"that may beassociated withgeneralized tonic-clonic (GTC)seizures" in thesecond paragraphbecause theSPEAC Systemanalyzes all sEMGto alarm forpotential GTCseizures. Thesechanges aresupported byclinicalperformance testingincluded in thesubmission. Allother claims werepreciously clearedin K182180 (the
Parameter	SPEAC System	SPEAC System	Comparison
510(k)	K200276	K182180
Classification	Class II21 CFR 882.1580Non-EEG physiologicalsignal-based seizuremonitoring system	Class II21 CFR 882.1580Non-EEG physiologicalsignal-based seizuremonitoring system	Same, No change
Product Code	POS	POS	Same, No change
Principle ofOperation	sEMG signal, sampled at therate of 1000 Hz, from thebiceps brachii are processedby a proprietary algorithm toidentify sustained sEMGcontraction patterns—duringthe tonic phase and earlytransition to the clonicphase—that arepathognomonic of GTCseizures.	sEMG signal, sampled at therate of 1000 Hz, from thebiceps brachii are processedby a proprietary algorithm toidentify sustained sEMGcontraction patterns—duringthe tonic phase and earlytransition to the clonicphase—that arepathognomonic of GTCseizures.	Same, No change
Dimensions	3.44" x 2.34" x 1.33"(H x W x D)	3.44" x 2.34" x 1.33"(H x W x D)	Same, No change
Mass	127 g.	127 g.	Same, No change
PhysicalControls	Power On/Off Button(Manual) Alarm ButtonCancel Button	Power On/Off Button(Manual) Alarm ButtonCancel Button	Same, No change
sEMG samplingrate	1,000 Hz	1,000 Hz	Same, No change
sEMGFrequency Bandsof Interest	30-40 Hz, 130-240 Hz, and300-400 Hz	30-40 Hz, 130-240 Hz, and300-400 Hz	Same, No change
Event Monitored	Potential GTC Seizure	Potential GTC Seizure	Same, No change
Default AlarmThreshold	135	135	Same, No change
sEMG MonitorPower	Rechargeable Battery	Rechargeable Battery	Same, No change
Parameter	SPEAC System	SPEAC System	Comparison
510(k)	K200276	K182180
Model	COTS Laptop	COTS Laptop	Same, No change
Input Power	115/230 VAC 50/60 Hz	115/230 VAC 50/60 Hz	Same, No change
Graphical UserInterface	Laptop Base Station	Laptop Base Station	Same, No change
SoftwareControls	Alert Mode (adjunctive seizure detection and sEMG recording),Record Only (sEMG recording)	Alert Mode (adjunctive seizure detection and sEMG recording),Record Only (sEMG recording)	Same, No change
sEMG Electrode	sEMG Electrode	sEMG Electrode	Same, No change
Cellular Router	Cradlepoint Router	Cradlepoint Router	Same, No change
sEMG MonitorRechargingAccessories	USB – Micro-USB	USB – Micro-USB	Same, No change
Laptop BaseStationRechargingAccessories	Medical-Grade PowerSupply	Medical-Grade PowerSupply	Same, No change
sEMG MonitorArm Strap	Black Spandex Arm Strap	Black Spandex Arm Strap	Same, No change
Medical DeviceData Systems	Physician Portal(SPEAC2ME®)	Physician Portal(SPEAC2ME®)	Same, No change

Limitations/Warnings	•	The System is availableby prescription only froma physician or properlylicensed practitioner.	Same as subject device
	•	The System should notbe used as a standalonemonitor for monitoringseizures and is notintended to be usedduring physical activity.
	•	The device is not aseizure detection device.
	•	The System alarms arenot for standalone useand should not be used toguide medical therapydecisions.
	•	The System has not beendemonstrated to affectany clinical outcomesuch as status epilepticus,brain damage, or deathfollowing a GTC seizure.
	•	The System does notpredict sEMG signalsthat may be associatedwith GTC seizures. Thedevice provides an alertfrom -30.82 – 25.06seconds, with an averageof 5.34 seconds (SEM $\pm$2.86), following the onsetof sEMG activity thatmay be associated with aGTC seizure.		Same, No change
	•	The System does notpredict seizure onset.
	•	The safety andeffectiveness of theSystem has not beenestablished in pediatricpopulations.
	•	The System has not beentested in the homeenvironment.
	•	The safety andeffectiveness of theSPEAC System has not
Parameter	SPEAC System	SPEAC System	Comparison
510(k)	K200276	K182180
	been established inmonitoring sEMGsignals that may beassociated with seizuresother than the GTCseizure.The sEMG ElectrodePatch may result in skinirritation that may lead tohypersensitivity in someindividuals. Never allow the sEMGMonitor to be submergedin any liquid. ContactBrain Sentinel if thesEMG Monitor or LaptopBase Station has beensubmerged. Do notattempt to use or servicea sEMG Monitor or BaseStation that has beensubmerged. Only Brain Sentinelauthorized equipmentshould be used with orconnected to the SPEACSystem. The Laptop Base Stationis optimized for thefunctions performed bythe SPEAC System. Donot install applications,uninstall applications, oralter the configuration or
	environment variables ofthis

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Conclusion

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equivalent to the predicate device, K182180, SPEAC System. No automated processing for seizure characterization was cleared in this 510(k).

Regulation Number and Section

§ 882.1580 Non-electroencephalogram (EEG) physiological signal based seizure monitoring system.

(a)
Identification. A non-electroencephalogram (non-EEG) physiological signal based seizure monitoring system is a noninvasive prescription device that collects physiological signals other than EEG to identify physiological signals that may be associated with a seizure.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The technical parameters of the device, hardware and software, must be fully characterized and include the following information:
(i) Hardware specifications must be provided. Appropriate verification, validation, and hazard analysis must be performed.
(ii) Software, including any proprietary algorithm(s) used by the device to achieve its intended use, must be described in detail in the Software Requirements Specification (SRS) and Software Design Specification (SDS). Appropriate software verification, validation, and hazard analysis must be performed.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) The device must be designed and tested for electrical, thermal, and mechanical safety and electromagnetic compatibility (EMC).
(4) Clinical performance testing must demonstrate the ability of the device to function as an assessment aid for monitoring for seizure-related activity in the intended population and for the intended use setting. Performance measurements must include positive percent agreement and false alarm rate.
(5) Training must be provided for intended users that includes information regarding the proper use of the device and factors that may affect the collection of the physiologic data.
(6) The labeling must include health care professional labeling and patient-caregiver labeling. The health care professional and the patient-caregiver labeling must include the following information:
(i) A detailed summary of the clinical performance testing, including any adverse events and complications.
(ii) Any instructions technicians and clinicians should convey to patients and caregivers regarding the proper use of the device and factors that may affect the collection of the physiologic data.
(iii) Instructions to technicians and clinicians regarding how to set the device threshold to achieve the intended performance of the device.