EpiMonitor

K250515 · Empatica S.r.l. · POS · Jun 19, 2025 · Neurology

Device Facts

• Record ID: K250515
• Device Name: EpiMonitor
• Applicant: Empatica S.r.l.
• Product Code: POS · Neurology
• Decision Date: Jun 19, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1580
• Device Class: Class 2
• Attributes: AI/ML, Real-World Evidence, Pediatric

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K250515 · Jun 19, 2025	EpiMonitor	Empatica S.r.l.	Longitudinal real-world sensor data captured by Embrace2 wearable device	Retrospective analysis of real-world data was conducted to evaluate the performance (PPA and False Alarm Rate) of the EpiAlgo ver 2.1 'Low-Sensitivity' mode during non-rest activities in home settings for adult and pediatric populations.	Real-world data; Longitudinal analysis; Home setting; Seizure monitoring; False alarm rate

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Longitudinal analysis of real-world data; Retrospective longitudinal analysis; Follow-up/Duration: 56,389.1 days (adults); 37,594.2 days (pediatric)	Adult and pediatric (6-21 years) patients with epilepsy; Sample Size: 1,444 patients total (601 pediatric, 843 adult)	Not applicable for this study	Positive Percentage Agreement (PPA) and False Alarm Rate (FAR)

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Generalized tonic-clonic seizure detection	EpiAlgo 2.1 algorithm	—	PPA 0.895 (6-21 years), 1.000 (>21 years) in EMU; PPA 0.87 (6-21 years), 0.80 (>21 years) in real-world	—	—	Epilepsy Monitoring Unit (EMU) data: 24 patients (12 aged 6-21, 12 aged >21). Real-world data: 1,444 patients (601 aged 6-21, 843 aged >21).	—

Indications 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 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 accelerometers, EDA, Peripheral skin temperature and activity data for subsequent retrospective review by a trained healthcare professional via a cloud-based software.

Device Story

EpiMonitor system comprises EmbracePlus wrist-worn wearable and EpiMonitor mobile app. Wearable continuously collects EDA and motion data; on-board EpiAlgo 2.1 algorithm analyzes data to detect patterns associated with generalized tonic-clonic seizures (GTCS). Upon detection, wearable sends command via Bluetooth Low Energy to mobile app, which triggers voice call/SMS alert to designated caregiver via cloud service. App also computes activity and peripheral skin temperature; transmits raw/computed data to Empatica Cloud for retrospective review by healthcare professionals via Care Monitoring Portal. System features 'high' sensitivity (rest/sleep) and 'low' sensitivity (low-intensity activity) modes to manage false alarms. Used by patients in home or clinical settings; operated by patient/caregiver; output informs clinical management of epilepsy.

Clinical Evidence

No new clinical studies performed. Evidence relies on retrospective analysis of previously collected clinical data (EMU and real-world) to validate the 'low-sensitivity' mode. EMU data (n=24) showed PPA of 0.895 (6-21 yrs) and 1.000 (>21 yrs). Real-world data (n=1444) showed PPA of 0.87 (6-21 yrs) and 0.80 (>21 yrs). False alarm rates (FAR) were calculated for both cohorts, demonstrating reduced false alerts compared to standard settings.

Technological Characteristics

Wrist-worn device; housing: polycarbonate, stainless steel, Gorilla Glass 3, thermoplastic polyurethane; band: elastane/polyamide. Sensors: EDA, accelerometer, temperature. Energy: rechargeable Li-ion battery. Connectivity: Bluetooth LE (device-to-mobile), Wi-Fi/cellular (mobile-to-cloud). Software: EpiAlgo 2.1 (seizure detection), EmpaDSP (parameter computation). Compliant with ISO 10993-1 for biocompatibility.

Indications for Use

Indicated for seizure monitoring in adults and children aged 6+ with epilepsy or at risk of epilepsy. Used in home or healthcare facilities as an adjunct to detect patterns associated with primary or secondary generalized tonic-clonic seizures (GTCS).

Regulatory Classification

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.

Special Controls

In combination with the general controls of the FD&C Act, the Non-EEG physiological signal based seizure monitoring system is subject to the following special controls:

*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.

Predicate Devices

• EpiMonitor (K232915)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

June 19, 2025

Empatica, Srl
Alberto Poli
Director, Quality & Regulatory Compliance
Via Stendhal 36
Milano, Milano 20144
Italy

Re: K250515
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: February 21, 2025
Received: February 21, 2025

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"

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K250515 - Alberto Poli
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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 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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality 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-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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

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

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K250515 - Alberto Poli
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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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

510(k) Number (if known)
K250515

Device Name
EpiMonitor

Indications for Use (Describe)
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 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 accelerometers, EDA, Peripheral skin temperature and activity data for subsequent retrospective review by a trained healthcare professional via a cloud-based software.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (6/20)
Page 1 of 1
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# Empatica Srl
## Special 510(k)
EpiMonitor

empatica


EpiMonitor – 510(k)

# 510(k) Summary

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# Empatica Srl
# Special 510(k)
EpiMonitor

510(k) Summary

# I. SUBMITTER

| Company Name | Empatica Srl |
| --- | --- |
| Establishment Registration Number | 3012933969 |
| Contact Person | Alberto Poli, Regulatory Affairs & Quality Manager |
| Contact Person email | [e-mail] |
| Address | Via Stendhal, 36 - 20144, Milan, Italy |
| Telephone Number | [phone] |
| Date prepared | May 21, 2025 |

# II. DEVICE

Trade/Proprietary Name: EpiMonitor

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

Primary Product Code:

| Classification Regulation | Classification Name | Device Class | Product Code | Classification Panel |
| --- | --- | --- | --- | --- |
| 882.1580 | Non-electroencephalogram (EEG) physiological signal based seizure monitoring system | Class II | POS | Neurology |

Secondary Product Codes:

| Classification Regulation | Classification Name | Device Class | Product Code | Classification Panel |
| --- | --- | --- | --- | --- |
| 882.5050 | Device, Sleep Assessment | Class II | LEL | Neurology |
| 880.2910 | Thermometer, Electronic, Clinical | Class II | FLL | General Hospital |

# III. PREDICATE DEVICES

| Predicate Device | Name | Submitter | Product Code(s) Primary (Secondary) | 510(k) Number |
| --- | --- | --- | --- | --- |
| Primary | EpiMonitor | Empatica S.r.l. | POS, LEL, FLL | K232915 |

The predicate has been subject to a design-related recall.

No reference devices were used in this submission.

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# Empatica Srl
## Special 510(k)
EpiMonitor

## IV. 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 user-designated 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.

## 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 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.

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# Empatica Srl

# Special 510(k)

EpiMonitor

# I. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

The EpiMonitor system, including the EmbracePlus wearable and EpiMonitor App, is substantially equivalent to the identified predicate devices.

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

| Features | EpiMonitor (Subject Device) | EpiMonitor (K232915) Predicate | Analysis of differences |
| --- | --- | --- | --- |
| Common Name | Non-EEG physiological signal based seizure monitoring system | Non-EEG physiological signal based seizure monitoring system | N/A |
| Device Manufacturer | Empatica S.r.l. | Empatica S.r.l | N/A |
| Device Classification | II | II | N/A |
| 510(k) number | N/A | K232915 | N/A |
| Primary Product Code | POS | POS | N/A |
| Secondary Product Code | LEL, FLL | LEL, FLL | N/A |
| Sterility | Non-Sterile | Non-Sterile | N/A |
| Intended Use | EpiMonitor is intended as an adjunct for the detection and alerting of possible seizures in patients with epilepsy or at risk of having epilepsy, and for remote monitoring of physiological parameters which may provide | EpiMonitor is intended as an adjunct for the detection and alerting of possible seizures in patients with epilepsy or at risk of having epilepsy, and for remote monitoring of physiological parameters which may provide | The subject device and the predicate device have the same intended use. |

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# Empatica Srl

# Special 510(k)

EpiMonitor

| Features | EpiMonitor (Subject Device) | EpiMonitor (K232915) Predicate | Analysis of differences |
| --- | --- | --- | --- |
| | supplementary support in the clinical management of epilepsy. | supplementary support in the clinical management of epilepsy. | |
| Indications 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 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 accelerometers, EDA, Peripheral skin temperature and activity data for subsequent | 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 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 | The subject device and the predicate device have the same indications for use. |

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# Empatica Srl

# Special 510(k)

EpiMonitor

| Features | EpiMonitor (Subject Device) | EpiMonitor (K232915) Predicate | Analysis of differences |
| --- | --- | --- | --- |
| | retrospective review by a trained healthcare professional via a cloud-based software. | EpiMonitor records, stores and transmits accelerometers, EDA, Peripheral skin temperature and activity data for subsequent retrospective review by a trained healthcare professional via a cloud-based software. | |
| Target Population | Adults and Children aged 6 years and above | Adults and Children aged 6 years and above | The subject device and the predicate have the same target population |
| Anatomical Site | Wrist | Wrist | The subject device and the predicates are identical |
| Over the Counter or Rx | Rx | Rx | The subject device and the predicates are identical |
| Environment | Professional Healthcare Facilities & Home environment | Professional Healthcare Facilities & Home environment | The subject device and the predicate are identical. |
| User Interface | Layperson: Device screen with two side buttons Mobile device application (EpiMonitor) Caregiver(s): Voice call and SMS | Layperson: Device screen with two side buttons Mobile device application (EpiMonitor) Caregiver(s): Voice call and SMS | The subject device and the predicate have same user interface. |
| Energy Source | Battery | Battery | The subject device and the predicate are identical |

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# Empatica Srl

# Special 510(k)

EpiMonitor

| Features | EpiMonitor (Subject Device) | EpiMonitor (K232915) Predicate | Analysis of differences |
| --- | --- | --- | --- |
| Battery Type | Rechargeable Lithium-Ion | Rechargeable Lithium-Ion | The subject device and the predicate are identical |
| Wireless Communication Interface | Bluetooth® Low Energy (device to mobile device)
IEEE 802.11 WiFi/cellular to Empatica cloud | Bluetooth® Low Energy (device to mobile device)
IEEE 802.11 WiFi/cellular to Empatica cloud | The subject device and the predicate are identical |
| Patient contacting materials | Compliant to ISO 10993-1
Device housing:
• Polycarbonate
• Stainless steel
• Gorilla Glass 3
• Thermoplastic Polyurethane
Band:
• Elastane and Polyamide | Compliant to ISO 10993-1
Device housing:
• Polycarbonate
• Stainless steel
• Gorilla Glass 3
• Thermoplastic Polyurethane
Band:
• Silicone Rubber
• Stainless Steel | The subject device and the secondary predicate are identical in their contacting materials.
The subject device and primary predicate utilize similar materials.
All materials are demonstrated to be compliant to ISO 10993-1. |
| EDA Sensors Location | Wrist - Dorsal | Wrist - Ventral | Verification testing demonstrated the equivalence between the subject device and the predicate.
The difference in EDA sensors location does not raise new questions of safety or efficacy. |
| Principle of Operation (Seizure Detection Algorithm) | EpiAlgo (Version 2.1) - Uses algorithms to analyze EDA and accelerometer data to detect patterns in the data that may be associated with GTC seizures. | EpiAlgo (Version 2.1) - Uses algorithms to analyze EDA and accelerometer data to detect patterns in the data that may be associated with GTC seizures. | The subject device and the predicate are identical. |

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# Empatica Srl
# Special 510(k)
EpiMonitor

## II. PERFORMANCE DATA

### Non-Clinical testing (Bench testing)

The following non-clinical (bench) testing was conducted to provide evidence of the implemented changes to EmbracePlus do not affect the product safety and effectiveness and to support a determination of substantial equivalence to the predicate. The non-clinical bench tests included:

| Test Name | Test Description | Results |
| --- | --- | --- |
| 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 |
| Electrodermal Activity measurement | The wearable device component of the EpiMonitor System, EmbracePlus, computed electrodermal activity (EDA) has been tested to determine its equivalence to the predicate device Embrace. | Passed |
| Algorithm Performance (Bench Testing) | Bench testing comparing the equivalence in performance of Embrace and EpiMonitor devices was conducted using simulated seizure patterns based on motion and electrodermal activity data derived from confirmed convulsive seizures. | Passed |

### 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 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 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).

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# Empatica Srl

# Special 510(k)

EpiMonitor

# 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 activities (High-Sensitivity). 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).

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

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

| age | # patients | # FA | # days | Overall FAR | Confidence Interval - Overall FAR | | Mean FAR | Confidence Interval - Mean FAR | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 6-21 | 80 | 62 | 88.94 | 0.70 | 0.41 | 1.06 | 0.91 | 0.44 | 1.57 |
| >21 | 61 | 43 | 152.68 | 0.28 | 0.15 | 0.46 | 0.33 | 0.17 | 0.53 |

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.

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

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

| age | # patients | # FA | # days | Overall FAR | Confidence Interval - Overall FAR | | Mean FAR | Confidence Interval - Mean FAR | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 6-21 | 601 | 12808 | 37594.2 | 0.34 | 0.23 | 0.50 | 0.35 | 0.28 | 0.45 |
| >21 | 61 | 43 | 152.68 | 0.28 | 0.21 | 0.46 | 0.33 | 0.22 | 0.41 |

{13}

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# Empatica Srl
## Special 510(k)
EpiMonitor

| >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.

## III. CONCLUSION

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.