Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

Unknown
The summary mentions an "on-board algorithm" that processes sensor data to detect patterns associated with seizures. While this could potentially be an AI/ML algorithm, the summary does not explicitly state that AI or ML is used. The description of the algorithm's validation on labeled data is consistent with ML training, but it doesn't definitively confirm the use of AI/ML.

Therapeutic

No.
The device is indicated for use as an adjunct to seizure monitoring, meaning it aids in monitoring but does not directly treat or prevent seizures. It senses, detects, and alerts, but does not provide therapy.

Diagnostic

Yes
The device is used to detect patterns associated with generalized tonic-clonic seizures, indicating that it aids in the identification or diagnosis of such events.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the Embrace is a "wearable biosensor device" that captures, stores, and transmits sensor data. This indicates the presence of hardware components (sensors, storage, wireless transmission) beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Embrace device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs analyze samples from the human body. IVDs are designed to examine specimens like blood, urine, tissue, or other bodily fluids to provide information about a person's health.
The Embrace device analyzes physiological signals. The Embrace device measures Electrodermal Activity (EDA) and motion data directly from the patient's wrist. It does not analyze any samples taken from the body.
The intended use is for seizure monitoring. The device is used as an adjunct to seizure monitoring by detecting patterns in physiological data that may be associated with seizures. This is a form of physiological monitoring, not in vitro analysis.

Therefore, the Embrace device falls under the category of a wearable biosensor for physiological monitoring, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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 and children age 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 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.

Product codes

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 (GTCS). 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 6 epilepsy centers, from epilepsy patients experiencing GTCSs in hospital Epilepsy Monitoring Units. When a likely GTCS is detected, the Embrace sends a message to the Alert smartphone application, which initiates calls and texts to summon the attention of designated caregivers. The device also enables patients to manually record seizure events, and provides contextual information related to activity and sleep.

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 and children age 6 and up

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 6 epilepsy centers, from epilepsy patients experiencing GTCSs in hospital Epilepsy Monitoring Units.

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 Testing: 141 patients diagnosed with epilepsy were admitted to the Epilepsy Monitoring Unit (EMU) for standard care were enrolled in the studies: 80 pediatrics, ages 6-21 years, median: 13 years; 61 adults, ages: 22-63 years, median: 39 years.
31 EMU patients experienced a total of 54 generalized tonic clonic seizures (GTCSs) while 110 EMU patients did not experience any seizure. Every recorded seizure was classified as epileptic.
141 patients provided overall 409 days (9,806 hours), with a median of 49.2 hours of data per patient of ACM and EDA measurements.
On all the 141 patients, the Positive percent agreement (PPA) was found to be 0.9815 (53 out of 54 GTCSs detected), with a 95% confidence interval (CI) of [0.9028; 0.9702], relative to a panel of three readers, and the overall false alarm rate (FAR) was found to be 0.94 false alarms per 24 hours with a 95% confidence interval of [0.71, 1.21], corresponding to a mean FAR (average of FARs across patients) of 1.25.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Positive percent agreement (PPA), false alarm rate (FAR).

Predicate Device(s)

Embrace, K172935

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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December 20, 2018

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.

Empatica Srl % Rakesh Lal Consultant Rakesh Lal 318 Rindge Ave 407 Cambridge, Massachusetts 02140

Re: K181861

Trade/Device Name: Embrace Regulation Number: 21 CFR 882.1580 Regulation Name: Non-Electroencephalogram (EEG) Physiological Signal Based Seizure Monitoring System Regulatory Class: Class II Product Code: POS Dated: November 20, 2018 Received: November 20, 2018

Dear Rakesh 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 mav, 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 avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-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.

Jay R. Gupta -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

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Indications for Use

510(k) Number (if known) K181861

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 and children age 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 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.

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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510K Embrace Documentation

510(k) Summary

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Submitter Name:	Empatica S.r.l.
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:	December 19, 2018
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:	Embrace, K172935
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 (GTCS). 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 6 epilepsy centers, from epilepsy
patients experiencing GTCSs in hospital Epilepsy Monitoring Units. When a
likely GTCS is detected, the Embrace sends a message to the Alert smartphone
application, which initiates calls and texts to summon the attention of
designated caregivers. The device also enables patients to manually record
seizure events, and provides contextual information related to activity and
sleep.
Indications for Use:	The Embrace is a prescription only device that is indicated for use as an adjunct
to seizure monitoring of adults and children age 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
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.

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Substantial Equivalence:

A comparison of Embrace to the predicate device is provided in the table below.

Attribute	Embrace	Embrace (K172935)	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 and
children age 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 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 Embrace is a
prescription only device
that 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 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.	Patient Population:
EQUIVALENT
Both devices are
indicated for use on
patients with epilepsy or
at risk of having epilepsy.
Embrace 2.0 is
additionally indicated for
use in children age 6 and
up. This difference does
not raise new questions
of safety and
effectiveness.

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
while the patient is at
rest.

Effect on Clinical
Outcome: EQUIVALENT
Both devices are
indicated as an adjunct to
other monitoring devices
in the EMU. Neither of
the devices is intended to
guide therapy decisions. |
| Sensor Technology | Utilizes an electrodermal
sensor to acquire | Utilizes an electrodermal
sensor to acquire | EQUIVALENT |
| | | | |
| | and an accelerometer
sensor to acquire
movement data. | and an accelerometer
sensor to acquire
movement data. | |
| Software Level of
Concern | Moderate | Moderate | EQUIVALENT |
| Data Communication | Communicates wirelessly
to a smartphone
application, which alerts
the healthcare provider
or caregiver in one or
more ways (phone call,
text message, etc.). | Communicates wirelessly
to a smartphone
application, which alerts
the healthcare provider
or caregiver in one or
more ways (phone call,
text message, etc.). | EQUIVALENT |
| Algorithm | Uses algorithms to
analyze EDA and
accelerometer data to
detect patterns in the
data that may be
associated with GTC
seizures. | Uses algorithms to
analyze EDA and
accelerometer data to
detect patterns in the
data that may be
associated with GTC
seizures. | EQUIVALENT |
| Biocompatibility | All patient contacting
parts are identical to the
predicate device. | 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 |
| Electrical Safety | All electrical and
electronic parts are
identical to the predicate
device. | Electrical Safety testing
performed to IEC 60601-1

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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 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:

Clinical Testing:

141 patients diagnosed with epilepsy were admitted to the Epilepsy Monitoring Unit (EMU) for standard care were enrolled in the studies: 80 pediatrics, ages 6-21 years, median: 13 years; 61 adults, ages: 22-63 years, median: 39 years.

Observed GTCS:

31 EMU patients experienced a total of 54 generalized tonic clonic seizures (GTCSs) while 110 EMU patients did not experience any seizure. Every recorded seizure was classified as epileptic.

Recorded data:

141 patients provided overall 409 days (9,806 hours), with a median of 49.2 hours of data per patient of ACM and EDA measurements.

Performance:

On all the 141 patients, the Positive percent agreement (PPA) was found to be 0.9815 (53 out of 54 GTCSs detected), with a 95% confidence interval (CI) of [0.9028; 0.9702], relative to a panel of three readers, and the overall false alarm rate (FAR) was found to be 0.94 false alarms per 24 hours with a 95% confidence interval of [0.71, 1.21], corresponding to a mean FAR (average of FARs across patients) of 1.25. Table 1 and Table 2 report the PPA and the FAR separately on the adult patients (age 22 and up) and on pediatrics subgroups.

	Table 1
age	#patients	#GTCS	# detected
GTCS	PPA	corrected
PPA1	CI PPA
6-12	6	12	11	0.917	0.799	0.601	0.895
13-21	11	20	20	1	0.915	0.889	0.934
6-21	17	32	31	0.969	0.915	0.834	0.953
>21	14	22	22	1	0.924	0.910	0.931

| age | #
patients | #FA | #days | Overall
FAR | CI overall FAR | Mean
FAR | CI mean FAR |
|-------|---------------|-----|-------|----------------|----------------|-------------|-------------|
| 6-12 | 39 | 89 | 67.02 | 1.33 | 0.82 1.98 | 1.79 | 0.99 2.73 |
| 13-21 | 41 | 129 | 93.98 | 1.37 | 0.75 2.17 | 1.47 | 0.72 2.41 |
| 6-21 | 80 | 218 | 161 | 1.35 | 0.92 1.87 | 1.63 | 1.06 2.28 |
| >21 | 61 | 165 | 247.6 | 0.67 | 0.43 0.95 | 0.76 | 0.43 1.17 |

Tahla 2

1 A conservative correction was applied to PPA to account for extreme probability values (PPA ~= 1) and the presence of multiple seizures for some patients (Chew, The American Statistician, 25(5), 47-50, 1971; Saha et al, Int J Biostat., 12(2), 2016).

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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.