(122 days)
Not Found
Unknown
The summary mentions an "on-board algorithm" that processes sensor data and makes decisions, and that this algorithm was "validated on data". While this suggests a data-driven approach, the term "algorithm" is too general to definitively confirm the use of AI/ML. The summary does not explicitly mention AI, ML, or related terms like neural networks or deep learning.
No.
The device is indicated for use as an adjunct to seizure monitoring and detection; it does not directly treat or prevent a disease or condition.
Yes
The device "senses Electrodermal Activity (EDA) and motion data to detect patterns that may be associated with generalized tonic seizures" and "runs an on-board algorithm to continuously process sensor data and make a decision about whether the data might indicate a generalized tonic clonic seizure (GTC)." This indicates it is used to identify a medical condition (seizures), which is the definition of a diagnostic device. While it also initiates an alert, its primary function described is the detection of specific physiological patterns for medical assessment.
No
The device description explicitly states "The Embrace is a wearable biosensor device" and mentions capturing, storing, and transmitting sensor data via Bluetooth. This indicates the presence of hardware components beyond just software.
Based on the provided information, the Embrace device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The Embrace device is a wearable biosensor that senses physiological data (Electrodermal Activity and motion) directly from the patient's wrist. It does not analyze blood, urine, tissue, or any other sample taken from the body.
- The intended use is for monitoring and alerting. The device is used to detect patterns associated with seizures and send alerts to caregivers. It is not used to diagnose a condition by analyzing a biological sample.
The Embrace device falls under the category of a medical device that monitors physiological signals. Its function is to detect and alert based on these signals, not to perform a diagnostic test on a biological specimen.
N/A
Intended Use / Indications for Use
The Embrace is a prescription only device that is indicated for use as an adjunct to seizure monitoring of adults 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 seizures in patients with epilepsy or at 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 Accelerometers, EDA, and Temperature for subsequent review by a trained healthcare professional.
Product codes (comma separated list FDA assigned to the subject device)
POS
Device Description
The Embrace is a wearable biosensor device that can capture, store, and wirelessly transmit sensor data via Bluetooth to a paired remote device. Embrace runs an on-board algorithm to continuously process sensor data and make a decision about whether the data might indicate a generalized tonic clonic seizure (GTC). The algorithm has been validated on data, labeled 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 GTCs in hospital Epilepsy Monitoring Units. When a likely GTC is detected, the Embrace sends a message to the Alert smartphone application, which initiates calls and texts to summon the attention of designated caregivers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
worn on the wrist
Indicated Patient Age Range
Adults
Intended User / Care Setting
Home or healthcare facilities / Trained healthcare professional / designated caregiver
Description of the training set, sample size, data source, and annotation protocol
The algorithm has been validated on data, labeled 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 GTCs in hospital Epilepsy Monitoring Units.
Description of the test set, sample size, data source, and annotation protocol
135 patients diagnosed with epilepsy were admitted to the Epilepsy Monitoring Unit (EMU) for standard care were enrolled in the studies: 76 children (39 males), ages 5 months -17 years, median: 10.5 years; 59 adults (23 males), ages: 18-63 years, median: 37 years. 22 EMU patients experienced a total of 40 generalized tonic clonic seizures (GTCSs) while 113 EMU patients didn't experience any seizure. The 40 recorded GTCSs included 10 primarily generalized tonic-clonic seizures and 30 secondarily generalized tonic-clonic seizures. Every recorded seizure was classified as epileptic. Seizures other than GTCSs were discarded from the analysis. 135 patients provided overall 272.1 days (6,530.0 hours), with a median of 34.5 hours of data per patient (min-max range = 3 - 386.8 hours) of ACM and EDA measurements.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Testing was performed to demonstrate the ability of the Embrace to function as an assessment aid for monitoring for seizure related activity in the intended population and for the intended use setting.
135 patients were enrolled.
Positive percent agreement (PPA) was found to be 1.0 (corrected PPA=0.9334), with a 95% confidence interval of [0.9213, 0.9424], relative to a panel of three readers, and false alarm rate (FAR) was found to be 0.4286 false alarms per 24 hours with a 95% confidence interval of [0.3425, 0.7002], corresponding to a mean FAR (average of FARs across patients) of 0.5894.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive percent agreement (PPA) = 1.0 (corrected PPA=0.9334)
False alarm rate (FAR) = 0.4286 false alarms per 24 hours (mean FAR = 0.5894)
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.
Companion, DEN140033
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.
Not Found
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
Image /page/0/Picture/0 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 26, 2018
Empatica Srl % Rakesh Lal Consultant 318 Rindge Ave 407 Cambridge, Massachusetts 02140
Re: K172935
Trade/Device Name: Embrace Regulation Number: 21 CFR 882.1580 Regulation Name: Non-EEG Physiological Signal Based Seizure Monitoring System Regulatory Class: Class II Product Code: POS Dated: December 27, 2017 Received: December 27, 2017
Dear Mr. Lal,
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 (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. 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.
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 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Hoffmann -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Druq Administration |
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name Embrace
Indications for Use (Describe)
The Embrace is a prescription only device that is indicated for use as an adjunct to seizure monitoring of adults 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 seizures in patients with epilepsy or at 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 Accelerometers, EDA, and Temperature for subsequent review by a trained healthcare professional.
| 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."
3
510(k) Summary
| Submitter Name: | Empatica, Srl |
|---|---|
| Submitter Address: | Via Stendhal 36 |
| 20144 Milano, Italy | |
| 510(k) Submission Contact: | Rakesh Lal |
| 817-734-8303 | |
| Sponsor Contact Person: | Matteo Lai, |
| +393497888125 | |
| Date Prepared: | September 22, 2017 |
| Device Trade Name: | |
| Device Common Name: | |
| Device Classification: | Embrace |
| Non-EEG physiological signal based seizure monitoring system | |
| 21 CFR 882.1580, Product Code POS | |
| Predicate Device: | |
| Predicate Device Classification: | Companion, DEN140033 |
| 21 CFR 882.1580, Product Code POS | |
| Device Description: | The Embrace is a wearable biosensor device that can capture, store, and |
| wirelessly transmit sensor data via Bluetooth to a paired remote device. | |
| Embrace runs an on-board algorithm to continuously process sensor data and | |
| make a decision about whether the data might indicate a generalized tonic | |
| clonic seizure (GTC). The algorithm has been validated on data, labeled 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 GTCs in hospital Epilepsy Monitoring Units. When a likely GTC is | |
| detected, the Embrace sends a message to the Alert smartphone application, | |
| which initiates calls and texts to summon the attention of designated | |
| caregivers. | |
| Indications for Use: | The Embrace is a prescription only device that is indicated for use as an adjunct |
| to seizure monitoring of adults 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 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 Accelerometers, EDA, and Temperature | |
| for subsequent review by a trained healthcare professional |
4
Substantial Equivalence:
A comparison of Embrace to the predicate device is provided in the table below.
| Attribute | Embrace | Brain Sentinel
Monitoring and Alerting
System | Comparison |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Non-EEG physiological
signal based seizure
monitoring system. | Non-EEG physiological
signal based seizure
monitoring system. | EQUIVALENT
Both devices have the
same intended use. |
| Indications for use | The Embrace is a
prescription only device
that is indicated for use
as an adjunct to seizure
monitoring of adults 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 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 Accelerometers,
EDA, and Temperature
for subsequent review by
a trained healthcare
professional. | The Brain Sentinel
Monitoring and Alerting
System is indicated for
use as an adjunct to
seizure monitoring of
adults in the home or
healthcare facilities
during periods of rest.
The device is to be used
on the bicep muscle's
belly to analyze surface
electromyographs (sEMG)
signals that may be
associated with
generalized tonic-clonic
(GTC) seizures and to
generate an alarm to
alert caregivers of
unilateral, appendicular,
tonic extension that could
be associated with a GTC
seizure. The System
records and stores sEMG
data for subsequent
review by a trained
healthcare professional. | Patient Population:
EQUIVALENT
Both devices are
indicated for use on
adults.
Healthcare Environment:
EQUIVALENT
Both the subject and
predicate devices are
indicated for use in the
home and healthcare
settings.
Seizure Type:
EQUIVALENT
Both devices are
indicated to provide an
alert to caregivers when
they each detect GTC.
The predicate device
provides alerts of
unilateral, appendicular
or tonic extensions that
may be associated with a
GTC seizure, while the
subject device generates
alerts of patterns in
electrodermal and
movement signals that
may be associated with
generalized tonic clonic
seizures. Both devices
monitor physiological
signals while the patient
is at rest
Effect on Clinical
Outcome: EQUIVALENT
Both devices are |
| Sensor Technology | Utilizes an electrodermal
sensor to acquire
Electrodermal Activity,
and an accelerometer
sensor to acquire
movement data. | Utilizes a surface EMG
sensor to acquire sEMG
data. | indicated as an adjunct to
other monitoring devices
in the EMU. Neither of
the devices is intended to
guide therapy decisions.
EQUIVALENT
The difference in type of
sensor does not raise
different questions of
safety and effectiveness.
EDA sensors and
accelerometer sensors
are commonly used in
many kinds of consumer
and healthcare
technology and are
generally safe.
EQUIVALENT |
| Software Level of
Concern | Moderate | Moderate | EQUIVALENT |
| Data Communication | The Embrace device
communicates wirelessly
to a smartphone
application, which alerts
the healthcare provider
or caregiver in one or
more ways (phone call,
text message, etc.). | The sEMG monitor
communicates wirelessly
to the base station, which
alerts a healthcare
provider or caregiver in
one or more ways (e.g.,
audible alarm, text
message, e-mail, etc.). | EQUIVALENT
Both systems utilize
wireless communication
between the sensor and a
base station or app, and
technologies such as text
messaging to alert the
caregiver. |
| Algorithm | Uses algorithms to
analyze EDA and
accelerometer data to
detect patterns in the
data that may be
associated with
generalized tonic clonic
seizures | Uses algorithms to
analyze sEMG data to
detect unilateral,
appendicular, tonic
extension that could be
associated with a GTC
seizure | EQUIVALENT
The difference in the
algorithms do not raise
different questions of
safety and effectiveness.
The same questions of
safety and effectiveness
regarding performance of
the algorithms (PPA and
FAR) apply to both
devices. |
| Biocompatibility | All patient contacting
parts are tested to
applicable tests in ISO
10993 (Cytotoxicity - ISO
10993-5, Sensitization -
ISO 10993-10, and Skin
Irritation - ISO 10993-10). | All patient contacting
parts are tested to
applicable tests in ISO
10993 (Cytotoxicity - ISO
10993-5, Sensitization -
ISO 10993-10, and Skin
Irritation - ISO 10993-10). | EQUIVALENT
Both devices have patient
contacting parts that
come into contact with
intact skin for a duration
that may exceed 24
hours. Both devices meet
the requirements of ISO
10993. |
| Electrical Safety | Electrical Safety testing | | EQUIVALENT |
| | performed to IEC 60601-1
Electromagnetic
compatibility testing
performed to IEC 60601-
1-2 4th Edition | | |
| Thermal Safety | Not applicable. The
device does not generate
any localized heat | Not applicable. The
device does not generate
any localized heat | EQUIVALENT |
| Chemical Safety | Not applicable. Patient is
not exposed to any
chemicals during use of
the device | Not applicable. Patient is
not exposed to any
chemicals during use of
the device | EQUIVALENT |
| Radiation Safety | Not applicable. Device
does not use any ionizing
radiation | Not applicable. Device
does not use any ionizing
radiation | EQUIVALENT |
5
6
Performance Testing:
Performance testing demonstrates that Embrace complies with IEC 60601-1:2005+AMD1:2012, IEC 60601-1-2:2014, ISO 10993-5:2009, and ISO 10993-10:2010
Clinical Testing:
Clinical testing was performed to demonstrate the ability of the Embrace to function as an assessment aid for monitoring for seizure related activity in the intended population and for the intended use setting.
Patients:
135 patients diagnosed with epilepsy were admitted to the Epilepsy Monitoring Unit (EMU) for standard care were enrolled in the studies: 76 children (39 males), ages 5 months -17 years, median: 10.5 years; 59 adults (23 males), ages: 18-63 years, median: 37 years.
Observed GTCS:
22 EMU patients experienced a total of 40 generalized tonic clonic seizures (GTCSs) while 113 EMU patients didn't experience any seizure. The 40 recorded GTCSs included 10 primarily generalized tonic-clonic seizures and 30 secondarily generalized tonic-clonic seizures. Every recorded seizure was classified as epileptic. Seizures other than GTCSs were discarded from the analysis.
Recorded data:
135 patients provided overall 272.1 days (6,530.0 hours), with a median of 34.5 hours of data per patient (min-max range = 3 - 386.8 hours) of ACM and EDA measurements.
Performance:
Positive percent agreement (PPA) was found to be 1.0 (corrected PPA=0.9334), with a 95% confidence interval of [0.9213, 0.9424], relative to a panel of three readers, and false alarm rate (FAR) was found to be 0.4286 false alarms per 24 hours with a 95% confidence interval of [0.3425, 0.7002], corresponding to a mean FAR (average of FARs across patients) of 0.5894.
7
Conclusion:
The subject device has the same intended use as the predicate device, and differences in technological characteristics do not raise different questions of safety and effectiveness. On this basis, Embrace is substantially equivalent to the legally marketed predicate device.