(149 days)
No reference devices were used in this submission.
Unknown
The document describes an "on-board algorithm (EpiAlgo 2.1)" that analyzes physiological data to detect seizure patterns. While this could potentially be an AI/ML algorithm, the summary does not explicitly state that it uses AI, ML, or related technologies like DNNs. The description of the algorithm's validation and performance studies focuses on traditional metrics (PPA, FAR) and does not provide details about the model architecture, training data characteristics, or testing methodology typically associated with AI/ML submissions. Therefore, it's not possible to definitively confirm the presence of AI/ML based on the provided information.
No.
The device is intended as an "adjunct to seizure monitoring" and detects patterns associated with seizures, alerting caregivers. It does not actively treat or provide therapy for seizures.
No
Explanation: The device is described as an "adjunct to seizure monitoring" and detects patterns "that may be associated with" seizures. It alerts caregivers when a seizure event is detected. While it monitors physiological data indirectly related to health conditions, its primary function is monitoring and alerting, not providing a diagnosis of epilepsy or seizures. The retrospective review of data by a trained healthcare professional suggests the data is for their diagnostic work, not that the device itself performs the diagnosis.
No
The device description explicitly states the system consists of a wearable medical device (EmbracePlus) and a mobile application. The wearable device is a hardware component that collects data via sensors and performs on-board analysis.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples from the human body. The core function of an IVD is to examine biological samples like blood, urine, tissue, etc., to provide information about a person's health.
- EpiMonitor analyzes physiological data from a wearable device. The EpiMonitor system collects data like Electrodermal Activity (EDA) and motion directly from the user's wrist via a wearable sensor. It does not analyze biological samples.
- The intended use is seizure monitoring. The purpose of EpiMonitor is to detect patterns associated with seizures based on real-time physiological data, not to diagnose or monitor a condition by analyzing a biological sample.
Therefore, EpiMonitor falls under the category of a medical device that monitors physiological signals, not an In Vitro Diagnostic.
N/A
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 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.
Product codes (comma separated list FDA assigned to the subject device)
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wrist
Indicated Patient Age Range
adults and children aged 6 and up
Intended User / Care Setting
Home environment or healthcare facilities / Layperson, Caregiver(s), trained healthcare professional
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Studies: No prospective clinical studies have been performed on the subject device. Two retrospective analyses of previously collected clinical data were conducted to evaluate the performance of the seizure detection algorithm (EpiAlgo) using the "Low Sensitivity" alerting threshold. This Low-Sensitivity threshold is an optional alerting mode for use in low-intensity daytime activities, optimizing for false alarm rate reduction.
Study 1: Epilepsy Monitoring Unit (EMU) Data
- Study Type: Retrospective Analysis
- Sample Size (Patients): 12 patients aged 6-21, 12 patients aged >21
- Data Source: Adjudicated tonic-clonic seizure data collected from patients observed in Epilepsy Monitoring Units.
- Annotation Protocol: Adjudicated tonic-clonic seizure data.
- Key Metrics (Low-Sensitivity Mode during non-rest activities):
- Positive Percentage Agreement (PPA):
- Age 6-21: 0.895 (corrected PPA: 0.791, CI: 0.619-0.925)
- Age >21: 1.000 (corrected PPA: 0.905, CI: 0.891-0.917)
- False Alarm Rate (FAR) per 24 hours:
- Age 6-21: Overall FAR 0.70 (CI: 0.41-1.06), Mean FAR 0.91 (CI: 0.44-1.57)
- Age >21: Overall FAR 0.28 (CI: 0.15-0.46), Mean FAR 0.33 (CI: 0.17-0.53)
- Positive Percentage Agreement (PPA):
Study 2: Real-World Data
- Study Type: Longitudinal Retrospective Analysis
- Sample Size (Patients): 601 patients aged 6-21, 843 patients aged >21
- Data Source: Analysis of sensor data captured using the Emrace2 wearable device, covering a wide range of non-rest activities in home settings.
- Annotation Protocol: Not explicitly stated, inferred from context as analysis of sensor data for seizure detection.
- Key Metrics (Low-Sensitivity Mode during non-rest activities):
- Positive Percentage Agreement (PPA):
- Age 6-21: 0.87 (corrected PPA: 0.86, CI: 0.78-0.92)
- Age >21: 0.8 (corrected PPA: 0.77, CI: 0.64-0.87)
- False Alarm Rate (FAR) per 24 hours:
- Age 6-21: Overall FAR 0.34 (CI: 0.23-0.50), Mean FAR 0.35 (CI: 0.28-0.45)
- Age >21: Overall FAR 0.25 (CI: 0.22-0.30), Mean FAR 0.29 (CI: 0.26-0.33)
- Positive Percentage Agreement (PPA):
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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) |
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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 |
| | | | | differences in functionality
available to the user such as
sensitivity. This is discussed in a
separate part of this table.
The secondary predicate features
identical hardware, and therefore
is equivalent. |
| Energy Source | Battery | Battery | Battery | The subject device and the
predicates are identical |
| Battery Type | Rechargeable Lithium-Ion | Rechargeable Lithium-Ion | Rechargeable Lithium-Ion | The subject device and the
predicates 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 | Bluetooth® Low Energy (device
to mobile device)
IEEE 802.11 WiFi/cellular to
Empatica cloud | The subject device and the
predicates are identical |
| Patient contacting
materials | Compliant to ISO 10993-1
Device housing:
• Polycarbonate
• Stainless steel
• Gorilla Glass 3
• Thermoplastic
• Polyurethane
Band: | Compliant to ISO 10993-1
Device housing:
• Anodized aluminum
• Polycarbonate
• Stainless steel
Band (stretch variant):
• Polyester
• Polyurethane | Compliant to ISO 10993-1
Device housing:
• Polycarbonate
• Stainless steel
• Gorilla Glass 3
• Thermoplastic
• Polyurethane
Band: | 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. |
| Features | EpiMonitor
(Subject Device) | Embrace (K181861)
Primary Predicate | Empatica Health Monitoring
Platform (K221282)
Secondary Predicate | Analysis of differences |
| | Silicone Rubber Stainless Steel | Aluminum Nickel-free chrome plated buckle or
Chromium Nitride PVD coated stainless steel Band (Vegan Leather variant):Microfiber polyurethane Buckle: Stainless steel, Chromium Nitride PVD coating | Silicone Rubber Stainless Steel | |
| 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 and includes two
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. | 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. | N/A | The "high" sensitivity mode of
EpiMonitor is identical to the
predicate device. The "low"
sensitivity mode of the subject
device is not available in the
predicate. The performance of the
"low" sensitivity mode has been
assessed through a longitudinal
analysis of real-world data
captured using the Embrace2.
The secondary predicate does not
feature seizure detection
capabilities and therefore it is not
applicable. |
8
9
10
11
12
13
14
EpiMonitor
PERFORMANCE DATA II.
Non-Clinical testing (Bench testing)
The following non-clinical (bench) testing was conducted to support a determination of substantial equivalence to the predicates and to demonstrate performance. The non-clinical bench tests included:
| Test Name | Test Description | Results |
|---|---|---|
| Biocompatibility testing | The wearable device component of the EpiMonitor System, called EmbracePlus, was tested in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" September 4, 2020, and International Standard ISO 10993-1:2018 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The testing included the following tests: | |
| • Cytotoxicity | ||
| • Sensitization | ||
| • Irritation | ||
| The EmbracePlus wearable device is considered skin surface contacting for a permanent duration (> 30 days). | Passed | |
| Electrical safety testing | The wearable device component of the EpiMonitor System, EmbracePlus, was tested in accordance with International Standard IEC 60601-1 for electrical safety. | Passed |
| Electromagnetic compatibility (EMC) testing | The wearable device component of the EpiMonitor System, EmbracePlus, was tested in accordance with International Standard IEC 60601-1-2 for EMC. | Passed |
| Wireless Radio Communication | The EpiMonitor System was tested to ensure it can communicate via wireless radio in its intended environment in compliance with FDA Radio Frequency Wireless Technology in Medical Devices Guidance, issued August 2013. | Passed |
| Usability testing | The EpiMonitor System has been assessed with regards to usability for compliance with IEC 62366-1. The EmbracePlus was also tested in accordance with International Standard IEC 60601-1-6 for Usability of medical devices. | Passed |
| Home-Use testing | The wearable device component of the EpiMonitor System, EmbracePlus, was tested in accordance with International Standard IEC 60601-1-11 for medical devices used in home healthcare environments. | Passed |
| Cleaning validation | The wearable device component of the EpiMonitor System, EmbracePlus, has been tested in accordance with International Standard ISO 17664 and AAMI TIR 30 to assess device cleaning procedure. | Passed |
| Test Name | Test Description | Results |
| Manual | ||
| disinfection | The wearable device component of the EpiMonitor System, | |
| EmbracePlus, has been tested in accordance with ASTM | ||
| E1837:2014 and AAMI TIR 12 to assess device low-level disinfection | ||
| procedures. | Passed | |
| Temperature | ||
| measurement | ||
| accuracy | The wearable device component of the EpiMonitor System, | |
| EmbracePlus, has been tested to confirm that the skin temperature | ||
| measurement accuracy and transient time complies with ISO | ||
| 80601-2-56 Medical electrical equipment - Part 2-56: Particular | ||
| requirements for basic safety and essential performance of clinical | ||
| thermometers for body temperature measurement. [Including: | ||
| Amendment 1 (2018)] to assess its accuracy. | 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 | |
| Activity | ||
| and | ||
| Motion | Testing comparing the performance of the Accelerometer Sensors | |
| in the EmbracePlus and Embrace Devices has been performed to | ||
| demonstrate equivalent performance of the wearable device | ||
| component of the EpiMonitor System, EmbracePlus, for activity | ||
| data including with the predicate device. | 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 | |
| Algorithm | ||
| Performance | ||
| (Clinical Testing) | No prospective clinical studies have been performed on the subject | |
| device. Two retrospective analyses of previously collected clinical | ||
| data were conducted in order to evaluate the performance of the | ||
| seizure detection algorithm referred to as EpiAlgo using the "Low | ||
| Sensitivity" alerting threshold. | Passed |
15
EpiMonitor
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
16
EpiMonitor
Medical Devices". All the EpiMonitor System software components underwent appropriate cybersecurity assessment and testing.
Animal study
No animal studies have been conducted as part of this submission to prove substantial equivalence, as the device is not intended for contact with compromised skin.
Clinical Study
No prospective clinical studies have been performed on the subject device. Clinical studies were performed on EpiAlgo ver 2.1 to support clearance of the predicate device (K181861).
Clinical Data Analysis
Clinical performance of the EpiAlgo ver 2.1 on the EmbracePlus device was confirmed by bench testing to be equivalent to the performance of the Embrace device presented in K181861, when using the standard alerting threshold during rest activity). To assess the performance of EpiAlgo ver 2.1 on the EmbracePlus device using the Low-Sensitivity threshold introduced in the EpiMonitor system, two retrospective analyses of previously collected clinical data were conducted. The Low-Sensitivity threshold is an optional alerting mode for use in low-intensity daytime activities, when a patient may prefer an alerting threshold that optimizes for reduction in false alarm rates.
Using adjudicated tonic-clonic seizure data collected from patients observed in Epilepsy Monitoring Units, Positive Percentage Agreement (PPA) and false alarm rate per 24 hours (FAR) were calculated for adult and pediatric subgroups during non-rest activities (Tables 1 and 2).
| age | # patients | # GTCS | # detected GTCS | PPA | corrected PPA | Confidence Interval - PPA | |
|---|---|---|---|---|---|---|---|
| 6-21 | 12 | 19 | 17 | 0.895 | 0.791 | 0.619 | 0.925 |
| >21 | 12 | 17 | 17 | 1.000 | 0.905 | 0.891 | 0.917 |
Table 1 - Positive Percent Agreement applying Low-Sensitivity Mode to Epilepsy Monitoring Unit data
| age | # patients | # FA | # days | Overall FAR | 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 |
Table 2 – False Alarm Rate applying Low-Sensitivity Mode to Epilepsy Monitoring Unit data
A second longitudinal analysis of real-world data was then conducted to ensure that a wide range of non-rest activities in home settings were captured. Tables 3 and 4 describe the performance of the EpiAlgo ver 2.1 during non-rest activities in home settings for both adult and pediatric subgroups.
17
EpiMonitor
| age | # patients | # GTCS | # detected GTCS | PPA | corrected PPA | Confidence Interval PPA | |
|---|---|---|---|---|---|---|---|
| 6-21 | 601 | 1157 | 1011 | 0.87 | 0.86 | 0.78 | 0.92 |
| >21 | 843 | 3625 | 2896 | 0.8 | 0.77 | 0.64 | 0.87 |
Table 3 - Positive Percent Aereement applying Low-Sensitivity Mode to real-world data captured by Embrace2
Table 4 – False Alarm Rate applying Low-Sensitivity Mode to real-world data captured by Embrace2
| age | # patients | # FA | # days | Overall
FAR | Confidence
Interval - Overall
FAR | Confidence
Interval - Overall
FAR | Mean FAR | Confidence
Interval - 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 | 843 | 14308 | 56389.1 | 0.25 | 0.22 | 0.30 | 0.29 | 0.26 | 0.33 |
Analysis of performance for the Low-Sensitivity alerting mode in the EpiMonitor system demonstrated acceptable seizure detection accuracy and a reduced rate of false alerts.
NOTE: The longitudinal analysis of real-world data was based on analysis of sensor data captured using the Embrace2 wearable device.
CONCLUSION lll.
Based on the information presented in this 510(k) premarket notification, EpiMonitor is considered to be substantially equivalent to the predicate devices on the basis of safety and effectiveness.
This has been determined on the basis of the testing, as summarized in this document, and the physical and technological comparisons made to the predicate devices. The EpiMonitor System has demonstrated no adverse indications or results and performs within its design specifications.