Who is the manufacturer of EpiMonitor?

Empatica S.r.l. filed the 510(k) submission for EpiMonitor (K232915).

What is the FDA product code for EpiMonitor?

POS. It is classified under 21 CFR 882.1580 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for EpiMonitor?

510(k) clearance (submission type: Traditional).

What are the predicate devices for EpiMonitor?

Embrace (K181861); Empatica Health Monitoring Platform (K221282).

Who can help prepare an FDA 510(k) submission like EpiMonitor?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

EpiMonitor

K232915 · Empatica S.r.l. · POS · Feb 15, 2024 · Neurology

Device Facts

Record ID	K232915
Device Name	EpiMonitor
Applicant	Empatica S.r.l.
Product Code	POS · Neurology
Decision Date	Feb 15, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1580
Device Class	Class 2
Attributes	Real-World Evidence, Pediatric

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K232915 · Feb 15, 2024	EpiMonitor	Empatica S.r.l.	Longitudinal real-world data captured by Embrace2 wearable device	Retrospective analysis of real-world data from home settings was used to evaluate the performance (PPA and False Alarm Rate) of the new 'Low-Sensitivity' alerting threshold for the EpiMonitor seizure detection algorithm.	Real-world data; Longitudinal analysis; Home environment; 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 (601 pediatric, 843 adult)	Not applicable for this study	Positive Percentage Agreement (PPA) and False Alarm Rate (FAR) for GTCS detection

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Generalized tonic-clonic seizure detection	EpiAlgo 2.1 algorithm	—	PPA 0.87 (pediatric), 0.80 (adult) in real-world data; FAR 0.35 (pediatric), 0.29 (adult) in real-world data	—	—	Retrospective analysis of Epilepsy Monitoring Unit data: 12 pediatric patients (19 GTCS), 12 adult patients (17 GTCS). Longitudinal analysis of real-world data: 601 pediatric patients (1157 GTCS), 843 adult patients (3625 GTCS).	—

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

Device Story

System comprises EmbracePlus wrist-worn wearable and EpiMonitor mobile app; continuously collects EDA, motion, and peripheral skin temperature data. On-board EpiAlgo 2.1 algorithm analyzes EDA and motion to detect generalized tonic-clonic seizures (GTCS). Upon detection, wearable sends command to mobile app via Bluetooth Low Energy; app triggers voice call/SMS alert to designated caregiver via cloud service. App includes 'high' (rest/sleep) and 'low' (low-intensity activity) sensitivity modes to manage false alarms. Raw data and computed parameters (e.g., sleep activity) transmitted to Empatica Cloud for retrospective review by healthcare professionals via Care Monitoring Portal. Benefits patients by providing automated seizure alerts and remote monitoring support.

Clinical Evidence

No prospective clinical studies performed. Performance validated via two retrospective analyses of previously collected clinical data (EMU and real-world) using EpiAlgo 2.1. EMU data (n=12 pediatric, n=12 adult) showed PPA of 0.895 (pediatric) and 1.000 (adult) for low-sensitivity mode. Real-world longitudinal analysis (n=601 pediatric, n=843 adult) showed PPA of 0.87 (pediatric) and 0.80 (adult) with mean false alarm rates (FAR) of 0.35/24h (pediatric) and 0.29/24h (adult). Bench testing confirmed equivalence to predicate for standard sensitivity.

Technological Characteristics

Wrist-worn wearable (EmbracePlus) and mobile app. Materials: Polycarbonate, stainless steel, Gorilla Glass 3, thermoplastic, polyurethane, silicone rubber (ISO 10993-1 compliant). Sensors: EDA, accelerometer, temperature. Connectivity: Bluetooth LE (device-to-mobile), Wi-Fi/cellular (mobile-to-cloud). Energy: Rechargeable Li-ion battery. Software: EpiAlgo 2.1 (seizure detection) and EmpaDSP (parameter computation). Non-sterile. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and ISO 80601-2-56.

Indications for Use

Indicated for adjunct seizure monitoring in adults and children aged 6+ with epilepsy or at risk of epilepsy in home or healthcare settings. Detects patterns associated with primary or secondary generalized tonic-clonic seizures.

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

Embrace (K181861)
Empatica Health Monitoring Platform (K221282)

Submission Summary (Full Text)

{0}------------------------------------------------ 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" {1}------------------------------------------------ (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 {2}------------------------------------------------ and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K232915 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 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. 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: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "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." {4}------------------------------------------------ EpiMonitor — 510(k) # 510(k) Summary Version 3.0 {5}------------------------------------------------ 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: | 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 | Embrace | Empatica S.r.l. | POS | K181861 | | Secondary | Empatica Health Monitoring 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. {6}------------------------------------------------ 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" 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. #### 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. {7}------------------------------------------------ #### 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 Monitoring Platform (K221282) Secondary Predicate | Analysis of differences | |---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name | Non-EEG physiological signal based seizure monitoring system | Non-EEG physiological signal based seizure monitoring system | Oximeter | N/A | | Device Manufacturer | Empatica S.r.l. | Empatica S.r.l | Empatica S.r.l. | N/A | | Device Classification | II | II | II | N/A | | 510(k) number | N/A | K181861 | K221282 | N/A | | Primary Product Code | POS | POS | DQA | N/A | | Secondary Product Code | N/A | N/A | DRG, GZO, LEL, FLL | N/A | | Sterility | Non-Sterile | Non-Sterile | Non-Sterile | N/A | | Intended Use | EpiMonitor is intended as an adjunct for the detection and alerting of possible seizures in | Non-EEG physiological signal based seizure monitoring system | The Empatica Health Monitoring Platform is intended for the remote monitoring of physiological | The subject device and primary predicate device are intended to provide remote patient monitoring with a wearable | | Features | EpiMonitor (Subject Device) | Embrace (K181861) Primary Predicate | Empatica Health Monitoring Platform (K221282) Secondary Predicate | Analysis of differences | | | patients with epilepsy or at risk of having epilepsy, and for remote monitoring of physiological parameters which may provide supplementary support in the clinical management of epilepsy. | parameters in ambulatory adults in home-healthcare environments. | | device, and to issue alerts to caregivers following detection of patterns that may be associated with a user experiencing a generalized tonic clonic seizure, and are therefore equivalent. The subject device and the secondary predicate are intended for remote monitoring of physiologic parameters to support clinical management, and are therefore equivalent. | | 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 | The Embrace is a prescription only device that is indicated for use as an adjunct to seizure monitoring of adults and children aged 6 and up in home or healthcare facilities during periods of rest. The device is worn on the wrist and senses Electrodermal Activity (EDA) and motion data to detect patterns that may be associated with generalized tonic clonic seizures in patients with epilepsy or at | The Empatica Health Monitoring Platform is a wearable device and paired mobile and cloud-based software platform intended to be used by trained healthcare professionals or researchers to remotely monitor physiologic parameters in ambulatory individuals 18 years of age and older in home-healthcare environments. | The subject device and primary predicate device are intended to provide remote patient monitoring with a wearable device, and to issue alerts following detection of patterns that may be associated with a user experiencing a generalized tonic clonic seizure, and are therefore equivalent. The subject device and primary predicate device are indicated for | | Features | EpiMonitor (Subject Device) | Embrace (K181861) Primary Predicate | Empatica Health Monitoring Platform (K221282) Secondary Predicate | Analysis of differences | | | 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 | risk of having epilepsy. When a seizure event is detected, Embrace sends a command to a paired wireless device that is programmed to initiate an alert to a designated caregiver. The System records and stores data from Accelerometer, EDA, and Temperature sensors for subsequent review by a trained healthcare professional. | The device supports the continuous monitoring of the following: ● Peripheral skin temperature, ● Electrodermal activity ● Blood Oxygen Saturation under no motion conditions ● Activity associated with movement during sleep The Empatica Health Monitoring Platform can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable. The Empatica Health Monitoring Platform is not intended for SpO2 monitoring in conditions of motion or low perfusion. The Empatica Health Monitoring Platform is intended for peripheral skin | use in adults and children over 6 years old, and therefore have the same indicated age ranges. The subject device, primary and secondary predicate devices monitor physiological data from the user. This data is made available for healthcare professionals to view retrospectively. The subject device gathers Peripheral skin temperature and activity data as physiological parameters. These differ from the configuration on the predicate devices, as the primary predicate does not include activity data and the secondary predicate also includes blood oxygen saturation. The configuration of the subject device therefore incorporates features of both and can therefore be considered equivalent. | | Features | EpiMonitor (Subject Device) | Embrace (K181861) Primary Predicate | Empatica Health Monitoring Platform (K221282) Secondary Predicate | Analysis of differences | | | 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. | | temperature monitoring, where monitoring temperature at the wrist is clinically indicated. | The subject device allows the use to temporarily change the detection sensitivity to either a low detection sensitivity setting or to turn it off. These have been introduced to allow the patient to participate in activities which previously may have triggered a false alarm. The differences in physiological parameters collected by the subject device as compared to the predicate devices do not impact the effectiveness or safety of the subject device, as SpO2 and activity data are not used as inputs to the algorithm used to detect patterns associated with generalized tonic-clonic seizures. | | Target Population | Adults and Children aged 6 years and above | Adults and Children aged 6 years and above | Adult | The subject device and primary predicate are identical | | Anatomical Site | Wrist | Wrist | Wrist | The subject device and the predicates are identical | | Features | EpiMonitor (Subject Device) | Embrace (K181861) Primary Predicate | Empatica Health Monitoring Platform (K221282) Secondary Predicate | Analysis of differences | | Over the Counter or Rx | Rx | Rx | Rx | The subject device and the predicates are identical | | Environment | Professional Healthcare Facilities & Home environment | Professional Healthcare Facilities & Home environment | Home environment | The subject device and primary predicate are identical. The subject device and the secondary predicate are intended for remote periodic monitoring of physiologic parameters to support clinical management, and are therefore equivalent. | | User Interface | Layperson: Device screen with two side buttons Mobile device application (EpiMonitor) Caregiver(s): Voice call and SMS | Layperson: Device Top Cover with a central push button Mobile device application (Alert App) Caregiver(s): Voice call and SMS | Layperson: Device screen with two side buttons Mobile device application (Care App) Caregiver(s): Not Applicable | The subject device and primary predicate have minor differences in their interface, with a change in the button location from a central tap to two side buttons. This allows for a ink-white display to inform the user of the time and battery percentage as an aide for daily compliance. These do not affect clinical functionality which is the same as the primary predicate. The subject device and predicate devices use different companion applications, which represent | | Features | EpiMonitor (Subject Device) | Embrace (K181861) Primary Predicate | Empatica Health Monitoring Platform (K221282) Secondary Predicate | Analysis of differences | | | | |…

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