(118 days)
Yes
The "EpiAlgo 2.1" is described as an "on-board algorithm" that "assesses the physiological data and determines if the user may be undergoing a generalized tonic-clonic seizure (GTCS)". While the term "AI model" is not explicitly used, the function of analyzing complex physiological data (EDA and motion) to detect patterns indicative of a seizure, especially within a medical device context where 'algorithms' often refer to sophisticated computational methods, strongly suggests the application of an AI/ML model. The validation using "gold-standard video-Electroencephalogram (EEG) methodology" also implies a data-driven approach typical of AI model development.
No
The device is described as an "adjunct to seizure monitoring" and its primary function is to detect seizures and alert caregivers. It does not provide any therapy or treatment for the condition.
Yes
The device detects patterns that may be associated with seizures, and records, stores, and transmits data for subsequent retrospective review by a trained healthcare professional, indicating a diagnostic function.
No
The device is not a software-only medical device because the system explicitly includes a "wearable device EmbracePlus" that "continuously collects raw data via specific sensors." The 510(k) summary also details hardware-specific testing such as "Electrodermal Activity measurement" and "Algorithm Performance (Bench Testing)" using simulated seizure patterns which applies to the hardware component.
No.
The device measures physiological signals (electrodermal activity and motion data) from the body to detect seizure patterns; it does not analyze samples derived from the human body.
No
The letter does not state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / 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.
Product codes
POS, LEL, FLL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found. The device uses an "algorithm" (EpiAlgo 2.1) to analyze data and detect patterns but does not specify if it is AI/DNN/ML.
Input Imaging Modality
Not Found
Anatomical Site
Wrist
Indicated Patient Age Range
adults and children aged 6 and up
Intended User / Care Setting
Prescription Use
Home environment or healthcare facilities.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical testing (Bench testing)
- 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. Results: 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. Results: 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. Results: 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).
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.
Performance with Low-Sensitivity Mode to Epilepsy Monitoring Unit data (Tables 1 and 2):
- Age 6-21: 12 patients, 19 GTCS, 17 detected GTCS, PPA: 0.895 (corrected PPA: 0.791, CI: 0.619-0.925). FAR (Overall): 0.70 (CI: 0.41-1.06), Mean FAR: 0.91 (CI: 0.44-1.57).
- Age >21: 12 patients, 17 GTCS, 17 detected GTCS, PPA: 1.000 (corrected PPA: 0.905, CI: 0.891-0.917). FAR (Overall): 0.28 (CI: 0.15-0.46), Mean FAR: 0.33 (CI: 0.17-0.53).
Performance with Low-Sensitivity Mode to real-world data captured by Embrace2 (Tables 3 and 4):
- Age 6-21: 601 patients, 1157 GTCS, 1011 detected GTCS, PPA: 0.87 (corrected PPA: 0.86, CI: 0.78-0.92). FAR (Overall): 0.34 (CI: 0.23-0.50), Mean FAR: 0.35 (CI: 0.28-0.45).
- Age >21: 843 patients, 3625 GTCS, 2896 detected GTCS, PPA: 0.8 (corrected PPA: 0.77, CI: 0.64-0.87). FAR (Overall): 0.25 (CI: 0.22-0.30), Mean FAR: 0.29 (CI: 0.26-0.33).
Key results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive Percentage Agreement (PPA)
False Alarm Rate (FAR)
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
U.S. Food & Drug Administration FDA Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
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"
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K250515 - Alberto Poli Page 2
(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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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K250515 - Alberto Poli Page 3
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
Page 4
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
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Empatica Srl Special 510(k)
EpiMonitor
EpiMonitor – 510(k)
510(k) Summary
Page 1 of 13
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Empatica Srl Special 510(k)
EpiMonitor
510(k) Summary
I. SUBMITTER
| Field | Value |
|---|---|
| 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 | 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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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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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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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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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. | ||
| 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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EpiMonitor
| Features | EpiMonitor (Subject Device) | EpiMonitor (K232915) Predicate | Analysis of differences |
|---|---|---|---|
| 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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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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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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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 |
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| >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.
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