EpiMonitor is a prescription only medical device system composed of a wearable device "EmbracePlus" and paired mobile software application "EpiMonitor" intended as an adjunct to seizure monitoring in adults and children aged 6 and up in a home environment or healthcare facilities. The device is worn on the wrist and senses Electrodermal Activity (EDA) and motion data to detect patterns that may be associated with either primary or secondary generalized tonic clonic clonic clonic seizures in patients with epilepsy or at risk of having epilepsy. When a seizure event is detected, the wearable device component of EpiMonitor sends a command to a paired mobile device where the EpiMonitor App is programmed to initiate an alert to a designated caregiver. The EpiMonitor app incorporates additional detection sensitivity modes, "high" for use during periods of rest or sleeping or "low" for use during periods of low-intensity activity, in order to reduce false alarm incidents.

EpiMonitor records, stores and transmits accelerometer. EDA, peripheral skin temperature and activity data for subsequent retrospective review by a trained healthcare professional via a cloud-based software.

Device Description

The EpiMonitor system consists of a wearable device and mobile application:

A wearable medical device called EmbracePlus,
A mobile application running on smartphones called "EpiMonitor"

The EmbracePlus is worn on the user's wrist and continuously collects raw data via specific sensors, these data are continuously analyzed by an on-board algorithm (EpiAlgo 2.1), which assesses the physiological data and determines if the user may be undergoing a generalized tonic-clonic seizure (GTCS). The EpiAlgo has been validated through testing, using the gold-standard video-Electroencephalogram (EEG) methodology designed by a group of epileptologists at a top level 4 epilepsy center, from epilepsy patients experiencing GTCSs in hospital Epilepsy Monitoring Units. When a likely GTCS is detected, EmbracePlus sends, via Bluetooth Low Energy, a message to the EpiMonitor app. The EpiMonitor app communicates to the Empatica Cloud which initiates, through the external provider a voice call and SMS text message is sent to summon the attention of userdesignated caregiver(s).

In addition to initiating alerts, the EpiMonitor app also continuously receives all the raw sensor data collected by the EmbracePlus. These data are analyzed by one of the EpiMonitor app software modules, EmpaDSP (paragraph 2.3.2), which computes the additional physiological parameters, such as activity during sleep and peripheral skin temperature.

The EpiMonitor App is also responsible for transmitting, over a cellular data plan or Wi-Fi connection the sensors' raw data, device information, and computed physiological parameters to the Empatica Cloud. On the Empatica Cloud, these data are stored, and made available to healthcare providers via a specific cloud-based software called Care Monitoring Portal.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the EpiMonitor device, derived from the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the EpiMonitor device's Low-Sensitivity mode were evaluated based on Positive Percent Agreement (PPA) for seizure detection and False Alarm Rate (FAR) for both Epilepsy Monitoring Unit (EMU) data and real-world data.

Metric (Low-Sensitivity Mode)	Acceptance Criteria (Implicit from "Acceptable")	Reported Device Performance (EMU Data)	Reported Device Performance (Real-World Data)
Positive Percent Agreement (PPA)	Acceptable seizure detection accuracy	Age 6-21: 0.895 (corrected 0.791, CI: 0.619-0.925) Age >21: 1.000 (corrected 0.905, CI: 0.891-0.917)	Age 6-21: 0.87 (corrected 0.86, CI: 0.78-0.92) Age >21: 0.80 (corrected 0.77, CI: 0.64-0.87)
False Alarm Rate (FAR) per 24 hours	Reduced rate of false alerts	Age 6-21: 0.70 (Overall), 0.91 (Mean) Age >21: 0.28 (Overall), 0.33 (Mean)	Age 6-21: 0.34 (Overall), 0.35 (Mean) Age >21: 0.25 (Overall), 0.29 (Mean)

Note: The document explicitly states "Analysis of performance for the Low-Sensitivity alerting mode in the EpiMonitor system demonstrated acceptable seizure detection accuracy and a reduced rate of false alerts." This implies that the reported performance met the sponsor's internal acceptance criteria for these metrics. Specific numerical thresholds for "acceptable" are not explicitly stated within the provided text.

2. Sample Sizes Used for the Test Set and Data Provenance

For Epilepsy Monitoring Unit (EMU) Data (Retrospective Analysis):

Seizure Detection (PPA):
- Patients: 24 (12 for age 6-21, 12 for age >21)
- GTCS events: 36 (19 for age 6-21, 17 for age >21)
False Alarm Rate (FAR):
- Patients: 141 (80 for age 6-21, 61 for age >21)
- Days of monitoring: 241.62 (88.94 for age 6-21, 152.68 for age >21)
Data Provenance: The data was collected from patients observed in Epilepsy Monitoring Units. The exact geographic origin (country) is not specified, but the data was from "a top level 4 epilepsy center" (mentioned in device description for original EpiAlgo validation). This was a retrospective analysis of previously collected clinical data.

For Real-World Data (Longitudinal Analysis) - based on Embrace2 wearable device:

Seizure Detection (PPA):
- Patients: 1444 (601 for age 6-21, 843 for age >21)
- GTCS events: 4782 (1157 for age 6-21, 3625 for age >21)
False Alarm Rate (FAR):
- Patients: 1444 (601 for age 6-21, 843 for age >21)
- Days of monitoring: 93983.3 (37594.2 for age 6-21, 56389.1 for age >21)
Data Provenance: "real-world data" captured using the Embrace2 wearable device, likely from home settings. The exact geographic origin (country) is not specified. This was a retrospective longitudinal analysis of real-world data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document states that the EpiAlgo was validated "using the gold-standard video-Electroencephalogram (EEG) methodology designed by a group of epileptologists at a top level 4 epilepsy center". It also refers to "adjudicated tonic-clonic seizure data" for the EMU data. This implies that epileptologists were involved in establishing the ground truth.

Number of experts: Not explicitly stated, but referred to as "a group of epileptologists."
Qualifications of experts: "epileptologists at a top level 4 epilepsy center." No specific experience (e.g., 10 years of experience) is detailed.

4. Adjudication Method for the Test Set

The document mentions "adjudicated tonic-clonic seizure data" for the EMU study. However, the specific adjudication method (e.g., 2+1, 3+1) is not explicitly described in the provided text.

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

Was an MRMC study done? No.
The study focuses on the performance of the algorithm itself (standalone and with different sensitivity modes), not on how human readers improve with or without AI assistance.
The effect size of human readers improving with AI vs. without AI assistance is not applicable as this type of study was not performed.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone study was done. The entire performance analysis for PPA and FAR presented in Tables 1-4 reflects the algorithm's performance (EpiAlgo ver 2.1) using the Low-Sensitivity mode, without human intervention in the detection process. The device detects an event, and the app initiates an alert; there's no mention of a human-in-the-loop directly influencing the detection sensitivity.

7. Type of Ground Truth Used

Expert Consensus / Gold Standard (Video-EEG): The ground truth for seizure events was primarily established using gold-standard video-Electroencephalogram (EEG) methodology and "adjudicated tonic-clonic seizure data." This indicates expert consensus based on clinical and physiological evidence.

8. Sample Size for the Training Set

The provided text does not specify the sample size used for the training set of the EpiAlgo. It only describes the validation phases for the Low-Sensitivity mode.

9. How the Ground Truth for the Training Set Was Established

The provided text states: "The EpiAlgo has been validated through testing, using the gold-standard video-Electroencephalogram (EEG) methodology designed by a group of epileptologists at a top level 4 epilepsy center, from epilepsy patients experiencing GTCSs in hospital Epilepsy Monitoring Units."

This implies that the training data's ground truth was established by epileptologists using video-EEG data from patients with generalized tonic-clonic seizures (GTCSs) in hospital Epilepsy Monitoring Units. This is consistent with clinical gold standards for seizure identification.

Summary

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February 15, 2024

Image /page/0/Picture/1 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Empatica, S.r.1. Alberto Poli Director, Quality & Regulatory Compliance Via Stendhal. 36 Milan, 20144 Italy

Re: K232915

Trade/Device Name: EpiMonitor Regulation Number: 21 CFR 882.1580 Regulation Name: Non-Electroencephalogram (EEG) Physiological Signal Based Seizure Monitoring System Regulatory Class: Class II Product Code: POS, LEL, FLL Dated: January 18, 2024 Received: January 18, 2024

Dear Alberto Poli:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Patrick
Antkowiak -S

for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional

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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) K232915

Device Name EpiMonitor

Indications for Use (Describe)

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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EpiMonitor — 510(k)

510(k) Summary

Version 3.0

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EpiMonitor

510(k) Summary

SUBMITTER l.

Company Name	Empatica Srl
Establishment Registration Number	3012933969
Contact Person	Alberto Poli, Regulatory Affairs & Quality Manager
Contact Person email	apo@empatica.com
Address	Via Stendhal, 36 - 20144, Milan, Italy
Telephone Number	+39 02 36165068
Date prepared	February 14, 2024

II. DEVICE

Trade/Proprietary Name: EpiMonitor Common/Usual Name: non-EEG physiological signal based seizure monitoring system

Primary Product Code:

ClassificationRegulation	Classification Name	DeviceClass	ProductCode	ClassificationPanel
882.1580	Non-electroencephalogram (EEG)physiological signal based seizuremonitoring system	Class II	POS	Neurology

Secondary Product Codes:

ClassificationRegulation	Classification Name	DeviceClass	ProductCode	ClassificationPanel
882.5050	Device, Sleep Assessment	Class II	LEL	Neurology
880.2910	Thermometer, Electronic, Clinical	Class II	FLL	General Hospital

III. PREDICATE DEVICES

PredicateDevice	Name	Submitter	Product Code(s)Primary (Secondary)	510(k)Number
Primary	Embrace	Empatica S.r.l.	POS	K181861
Secondary	Empatica HealthMonitoring Platform	Empatica S.r.l.	DQA (DRG, FLL, GZO, LEL)	K221282

None of these predicates have been subject to a design-related recall.

No reference devices were used in this submission.

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EpiMonitor

DEVICE DESCRIPTION IV.

The EpiMonitor system consists of a wearable device and mobile application:

A wearable medical device called EmbracePlus, ●
A mobile application running on smartphones called "EpiMonitor"

V. INDICATION FOR USE

EpiMonitor is a prescription only medical device system composed of a wearable device "EmbracePlus" and paired mobile software application "EpiMonitor" intended as an adjunct to seizure monitoring in adults and children aged 6 and up in a home environment or healthcare facilities. The device is worn on the wrist and senses Electrodermal Activity (EDA) and motion data to detect patterns that may be associated with either primary or secondary generalized tonic seizures in patients with epilepsy or at risk of having epilepsy. When a seizure event is detected, the wearable device component of EpiMonitor sends a command to a paired mobile device where the EpiMonitor App is programmed to initiate an alert to a designated caregiver. The EpiMonitor app incorporates additional detection sensitivity modes, "high" for use during periods of rest or sleeping or "low" for use during periods of low-intensity activity, in order to reduce false alarm incidents.

EpiMonitor records, stores and transmits accelerometer, EDA, peripheral skin temperature and activity data for subsequent retrospective review by a trained healthcare professional via a cloudbased software.

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES l.

The EpiMonitor system, including the EmbracePlus wearable and EpiMonitor App, is substantially equivalent to the idenices.

The devices have similar Indications for Use, features, technology, and accuracy.

Features	EpiMonitor(Subject Device)	Embrace (K181861)Primary Predicate	Empatica Health MonitoringPlatform (K221282)Secondary Predicate	Analysis of differences
Common Name	Non-EEG physiologicalsignal based seizuremonitoring system	Non-EEG physiological signalbased seizure monitoringsystem	Oximeter	N/A
DeviceManufacturer	Empatica S.r.l.	Empatica S.r.l	Empatica S.r.l.	N/A
DeviceClassification	II	II	II	N/A
510(k) number	N/A	K181861	K221282	N/A
Primary ProductCode	POS	POS	DQA	N/A
Secondary ProductCode	N/A	N/A	DRG, GZO, LEL, FLL	N/A
Sterility	Non-Sterile	Non-Sterile	Non-Sterile	N/A
Intended Use	EpiMonitor is intended asan adjunct for thedetection and alerting ofpossible seizures in	Non-EEG physiologicalsignal based seizuremonitoring system	The Empatica HealthMonitoring Platform isintended for the remotemonitoring of physiological	The subject device and primarypredicate device are intended toprovide remote patientmonitoring with a wearable
Features	EpiMonitor(Subject Device)	Embrace (K181861)Primary Predicate	Empatica Health MonitoringPlatform (K221282)Secondary Predicate	Analysis of differences
	patients with epilepsy or atrisk of having epilepsy, andfor remote monitoring ofphysiological parameterswhich may providesupplementary support inthe clinical management ofepilepsy.	parameters in ambulatoryadults in home-healthcareenvironments.		device, and to issue alerts tocaregivers following detection ofpatterns that may be associatedwith a user experiencing ageneralized tonic clonic seizure,and are therefore equivalent.The subject device and thesecondary predicate are intendedfor remote monitoring ofphysiologic parameters to supportclinical management, and aretherefore equivalent.
Indications for Use	EpiMonitor is aprescription only medicaldevice system composedof a wearable device"EmbracePlus" and pairedmobile softwareapplication "EpiMonitor"intended as an adjunct toseizure monitoring inadults and children aged 6and up in a homeenvironment or healthcarefacilities. The device is	The Embrace is a prescriptiononly device that is indicated foruse as an adjunct to seizuremonitoring of adults andchildren aged 6 and up in homeor healthcare facilities duringperiods of rest. The device isworn on the wrist and sensesElectrodermal Activity (EDA) andmotion data to detect patternsthat may be associated withgeneralized tonic clonic seizuresin patients with epilepsy or at	The Empatica HealthMonitoring Platform is awearable device and pairedmobile and cloud-basedsoftware platform intended tobe used by trained healthcareprofessionals or researchers toremotely monitor physiologicparameters in ambulatoryindividuals 18 years of age andolder in home-healthcareenvironments.	The subject device and primarypredicate device are intended toprovide remote patientmonitoring with a wearabledevice, and to issue alertsfollowing detection of patternsthat may be associated with auser experiencing a generalizedtonic clonic seizure, and aretherefore equivalent.The subject device and primarypredicate device are indicated for
Features	EpiMonitor(Subject Device)	Embrace (K181861)Primary Predicate	Empatica Health MonitoringPlatform (K221282)Secondary Predicate	Analysis of differences
	worn on the wrist andsenses ElectrodermalActivity (EDA) and motiondata to detect patternsthat may be associatedwith either primary orsecondary generalizedtonic clonic seizures inpatients with epilepsy or atrisk of having epilepsy.When a seizure event isdetected, the wearabledevice component ofEpiMonitor sends acommand to a pairedmobile device where theEpiMonitor App isprogrammed to initiate analert to a designatedcaregiver. The EpiMonitorapp incorporatesadditional detectionsensitivity modes, "high"for use during periods ofrest or sleeping or "low"for use during periods oflow-intensity activity, in	risk of having epilepsy. When aseizure event is detected,Embrace sends a command to apaired wireless device that isprogrammed to initiate an alertto a designated caregiver. TheSystem records and stores datafrom Accelerometer, EDA, andTemperature sensors forsubsequent review by a trainedhealthcare professional.	The device supports thecontinuous monitoring of thefollowing:● Peripheral skintemperature,● Electrodermal activity● Blood Oxygen Saturationunder no motion conditions● Activity associated withmovement during sleepThe Empatica HealthMonitoring Platform can beused to analyze circadianrhythms and assess activity inany instance wherequantifiable analysis of physicalmotion is desirable.The Empatica HealthMonitoring Platform is notintended for SpO2 monitoringin conditions of motion or lowperfusion.The Empatica HealthMonitoring Platform isintended for peripheral skin	use in adults and children over 6years old, and therefore have thesame indicated age ranges.The subject device, primary andsecondary predicate devicesmonitor physiological data fromthe user.This data is made available forhealthcare professionals to viewretrospectively.The subject device gathersPeripheral skin temperature andactivity data as physiologicalparameters. These differ from theconfiguration on the predicatedevices, as the primary predicatedoes not include activity data andthe secondary predicate alsoincludes blood oxygen saturation.The configuration of the subjectdevice therefore incorporatesfeatures of both and cantherefore be consideredequivalent.
Features	EpiMonitor(Subject Device)	Embrace (K181861)Primary Predicate	Empatica Health MonitoringPlatform (K221282)Secondary Predicate	Analysis of differences
	order to reduce false alarmincidentsEpiMonitor records, storesand transmitsaccelerometers, EDA,Peripheral skintemperature and activitydata for subsequentretrospective review by atrained healthcareprofessional via a cloud-based software.		temperature monitoring,where monitoring temperatureat the wrist is clinicallyindicated.	The subject device allows the useto temporarily change thedetection sensitivity to either alow detection sensitivity setting orto turn it off. These have beenintroduced to allow the patient toparticipate in activities whichpreviously may have triggered afalse alarm.The differences in physiologicalparameters collected by thesubject device as compared to thepredicate devices do not impactthe effectiveness or safety of thesubject device, as SpO2 andactivity data are not used asinputs to the algorithm used todetect patterns associated withgeneralized tonic-clonic seizures.
Target Population	Adults and Children aged 6years and above	Adults and Children aged 6years and above	Adult	The subject device and primarypredicate are identical
Anatomical Site	Wrist	Wrist	Wrist	The subject device and thepredicates are identical
Features	EpiMonitor(Subject Device)	Embrace (K181861)Primary Predicate	Empatica Health MonitoringPlatform (K221282)Secondary Predicate	Analysis of differences
Over the Counteror Rx	Rx	Rx	Rx	The subject device and thepredicates are identical
Environment	Professional HealthcareFacilities & Homeenvironment	Professional HealthcareFacilities & Home environment	Home environment	The subject device and primarypredicate are identical.The subject device and thesecondary predicate are intendedfor remote periodic monitoring ofphysiologic parameters to supportclinical management, and aretherefore equivalent.
User Interface	Layperson:Device screen with twoside buttonsMobile device application(EpiMonitor)Caregiver(s):Voice call and SMS	Layperson:Device Top Cover with a centralpush buttonMobile device application (AlertApp)Caregiver(s):Voice call and SMS	Layperson:Device screen with two sidebuttonsMobile device application (CareApp)Caregiver(s):Not Applicable	The subject device and primarypredicate have minor differencesin their interface, with a change inthe button location from a centraltap to two side buttons. Thisallows for a ink-white display toinform the user of the time andbattery percentage as an aide fordaily compliance. These do notaffect clinical functionality whichis the same as the primarypredicate.The subject device and predicatedevices use different companionapplications, which represent
Features	EpiMonitor(Subject Device)	Embrace (K181861)Primary Predicate	Empatica Health MonitoringPlatform (K221282)Secondary Predicate	Analysis of differences
				differences in functionalityavailable to the user such assensitivity. This is discussed in aseparate part of this table.The secondary predicate featuresidentical hardware, and thereforeis equivalent.
Energy Source	Battery	Battery	Battery	The subject device and thepredicates are identical
Battery Type	Rechargeable Lithium-Ion	Rechargeable Lithium-Ion	Rechargeable Lithium-Ion	The subject device and thepredicates are identical
WirelessCommunicationInterface	Bluetooth® Low Energy(device to mobile device)IEEE 802.11 WiFi/cellularto Empatica cloud	Bluetooth® Low Energy (deviceto mobile device)IEEE 802.11 WiFi/cellular toEmpatica cloud	Bluetooth® Low Energy (deviceto mobile device)IEEE 802.11 WiFi/cellular toEmpatica cloud	The subject device and thepredicates are identical
Patient contactingmaterials	Compliant to ISO 10993-1Device housing:• Polycarbonate• Stainless steel• Gorilla Glass 3• Thermoplastic• PolyurethaneBand:	Compliant to ISO 10993-1Device housing:• Anodized aluminum• Polycarbonate• Stainless steelBand (stretch variant):• Polyester• Polyurethane	Compliant to ISO 10993-1Device housing:• Polycarbonate• Stainless steel• Gorilla Glass 3• Thermoplastic• PolyurethaneBand:	The subject device and thesecondary predicate are identicalin their contacting materials.The subject device and primarypredicate utilize similar materials.All materials are demonstrated tobe compliant to ISO 10993-1.
Features	EpiMonitor(Subject Device)	Embrace (K181861)Primary Predicate	Empatica Health MonitoringPlatform (K221282)Secondary Predicate	Analysis of differences
	Silicone Rubber Stainless Steel	Aluminum Nickel-free chrome plated buckle orChromium Nitride PVD coated stainless steel Band (Vegan Leather variant):Microfiber polyurethane Buckle: Stainless steel, Chromium Nitride PVD coating	Silicone Rubber Stainless Steel
Principle ofOperation (SeizureDetectionAlgorithm)	EpiAlgo (Version 2.1) -Uses algorithms to analyzeEDA and accelerometerdata to detect patterns inthe data that may beassociated with GTCseizures and includes twosensitivity modes "high"for use during periods ofrest or sleeping or "low"for use during periods oflow-intensity activity, inorder to reduce false alarmincidents.	EpiAlgo (Version 2.1) - Usesalgorithms to analyze EDA andaccelerometer data to detectpatterns in the data that may beassociated with GTC seizures.	N/A	The "high" sensitivity mode ofEpiMonitor is identical to thepredicate device. The "low"sensitivity mode of the subjectdevice is not available in thepredicate. The performance of the"low" sensitivity mode has beenassessed through a longitudinalanalysis of real-world datacaptured using the Embrace2.The secondary predicate does notfeature seizure detectioncapabilities and therefore it is notapplicable.

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EpiMonitor

PERFORMANCE DATA II.

Non-Clinical testing (Bench testing)

The following non-clinical (bench) testing was conducted to support a determination of substantial equivalence to the predicates and to demonstrate performance. The non-clinical bench tests included:

Test Name	Test Description	Results
Biocompatibility testing	The wearable device component of the EpiMonitor System, called EmbracePlus, was tested in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" September 4, 2020, and International Standard ISO 10993-1:2018 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The testing included the following tests:• Cytotoxicity• Sensitization• IrritationThe EmbracePlus wearable device is considered skin surface contacting for a permanent duration (> 30 days).	Passed
Electrical safety testing	The wearable device component of the EpiMonitor System, EmbracePlus, was tested in accordance with International Standard IEC 60601-1 for electrical safety.	Passed
Electromagnetic compatibility (EMC) testing	The wearable device component of the EpiMonitor System, EmbracePlus, was tested in accordance with International Standard IEC 60601-1-2 for EMC.	Passed
Wireless Radio Communication	The EpiMonitor System was tested to ensure it can communicate via wireless radio in its intended environment in compliance with FDA Radio Frequency Wireless Technology in Medical Devices Guidance, issued August 2013.	Passed
Usability testing	The EpiMonitor System has been assessed with regards to usability for compliance with IEC 62366-1. The EmbracePlus was also tested in accordance with International Standard IEC 60601-1-6 for Usability of medical devices.	Passed
Home-Use testing	The wearable device component of the EpiMonitor System, EmbracePlus, was tested in accordance with International Standard IEC 60601-1-11 for medical devices used in home healthcare environments.	Passed
Cleaning validation	The wearable device component of the EpiMonitor System, EmbracePlus, has been tested in accordance with International Standard ISO 17664 and AAMI TIR 30 to assess device cleaning procedure.	Passed
Test Name	Test Description	Results
Manualdisinfection	The wearable device component of the EpiMonitor System,EmbracePlus, has been tested in accordance with ASTME1837:2014 and AAMI TIR 12 to assess device low-level disinfectionprocedures.	Passed
Temperaturemeasurementaccuracy	The wearable device component of the EpiMonitor System,EmbracePlus, has been tested to confirm that the skin temperaturemeasurement accuracy and transient time complies with ISO80601-2-56 Medical electrical equipment - Part 2-56: Particularrequirements for basic safety and essential performance of clinicalthermometers for body temperature measurement. [Including:Amendment 1 (2018)] to assess its accuracy.	Passed
ElectrodermalActivitymeasurement	The wearable device component of the EpiMonitor System,EmbracePlus, computed electrodermal activity (EDA) has beentested to determine its equivalence to the predicate deviceEmbrace.	Passed
ActivityandMotion	Testing comparing the performance of the Accelerometer Sensorsin the EmbracePlus and Embrace Devices has been performed todemonstrate equivalent performance of the wearable devicecomponent of the EpiMonitor System, EmbracePlus, for activitydata including with the predicate device.	Passed
AlgorithmPerformance(Bench Testing)	Bench testing comparing the equivalence in performance ofEmbrace and EpiMonitor devices was conducted using simulatedseizure patterns based on motion and electrodermal activity dataderived from confirmed convulsive seizures.	Passed
AlgorithmPerformance(Clinical Testing)	No prospective clinical studies have been performed on the subjectdevice. Two retrospective analyses of previously collected clinicaldata were conducted in order to evaluate the performance of theseizure detection algorithm referred to as EpiAlgo using the "LowSensitivity" alerting threshold.	Passed

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Software Verification and Validation Testing

Software verification and validation testing have been successfully conducted. Software documentation was provided as recommended by the FDA's Guidance for Industry and FDA Staff "Content of Premarket Submissions for Device Software Functions" for Basic documentation level, along with software documents to comply with the special controls applicable to products regulated under 21 CFR 882.1580. All the EpiMonitor System software components were considered a "moderate" level of concern since a failure or latent flaw in the software could result in minor injury to the patient or operator.

Cybersecurity

Cybersecurity activities have been conducted and an assessment made on individual component risks. Documentation has been provided with this application as recommended by the FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Management of Cybersecurity in

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Medical Devices". All the EpiMonitor System software components underwent appropriate cybersecurity assessment and testing.

Animal study

No animal studies have been conducted as part of this submission to prove substantial equivalence, as the device is not intended for contact with compromised skin.

Clinical Study

No prospective clinical studies have been performed on the subject device. Clinical studies were performed on EpiAlgo ver 2.1 to support clearance of the predicate device (K181861).

Clinical Data Analysis

Clinical performance of the EpiAlgo ver 2.1 on the EmbracePlus device was confirmed by bench testing to be equivalent to the performance of the Embrace device presented in K181861, when using the standard alerting threshold during rest activity). To assess the performance of EpiAlgo ver 2.1 on the EmbracePlus device using the Low-Sensitivity threshold introduced in the EpiMonitor system, two retrospective analyses of previously collected clinical data were conducted. The Low-Sensitivity threshold is an optional alerting mode for use in low-intensity daytime activities, when a patient may prefer an alerting threshold that optimizes for reduction in false alarm rates.

Using adjudicated tonic-clonic seizure data collected from patients observed in Epilepsy Monitoring Units, Positive Percentage Agreement (PPA) and false alarm rate per 24 hours (FAR) were calculated for adult and pediatric subgroups during non-rest activities (Tables 1 and 2).

age	# patients	# GTCS	# detected GTCS	PPA	corrected PPA	Confidence Interval - PPA
6-21	12	19	17	0.895	0.791	0.619	0.925
>21	12	17	17	1.000	0.905	0.891	0.917

Table 1 - Positive Percent Agreement applying Low-Sensitivity Mode to Epilepsy Monitoring Unit data

age	# patients	# FA	# days	Overall FAR	ConfidenceInterval - OverallFAR	Mean FAR	ConfidenceInterval – MeanFAR
6-21	80	62	88.94	0.70	0.411.06	0.91	0.441.57
>21	61	43	152.68	0.28	0.150.46	0.33	0.170.53

Table 2 – False Alarm Rate applying Low-Sensitivity Mode to Epilepsy Monitoring Unit data

A second longitudinal analysis of real-world data was then conducted to ensure that a wide range of non-rest activities in home settings were captured. Tables 3 and 4 describe the performance of the EpiAlgo ver 2.1 during non-rest activities in home settings for both adult and pediatric subgroups.

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age	# patients	# GTCS	# detected GTCS	PPA	corrected PPA	Confidence Interval PPA
6-21	601	1157	1011	0.87	0.86	0.78	0.92
>21	843	3625	2896	0.8	0.77	0.64	0.87

Table 3 - Positive Percent Aereement applying Low-Sensitivity Mode to real-world data captured by Embrace2

Table 4 – False Alarm Rate applying Low-Sensitivity Mode to real-world data captured by Embrace2

age	# patients	# FA	# days	OverallFAR	ConfidenceInterval - OverallFAR	ConfidenceInterval - OverallFAR	Mean FAR	ConfidenceInterval - MeanFAR	ConfidenceInterval - MeanFAR
6-21	601	12808	37594.2	0.34	0.23	0.50	0.35	0.28	0.45
>21	843	14308	56389.1	0.25	0.22	0.30	0.29	0.26	0.33

Analysis of performance for the Low-Sensitivity alerting mode in the EpiMonitor system demonstrated acceptable seizure detection accuracy and a reduced rate of false alerts.

NOTE: The longitudinal analysis of real-world data was based on analysis of sensor data captured using the Embrace2 wearable device.

CONCLUSION lll.

Based on the information presented in this 510(k) premarket notification, EpiMonitor is considered to be substantially equivalent to the predicate devices on the basis of safety and effectiveness.

This has been determined on the basis of the testing, as summarized in this document, and the physical and technological comparisons made to the predicate devices. The EpiMonitor System has demonstrated no adverse indications or results and performs within its design specifications.

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.