Embrace

K172935 · Empatica S.r.l. · POS · Jan 26, 2018 · Neurology

Device Facts

• Record ID: K172935
• Device Name: Embrace
• Applicant: Empatica S.r.l.
• Product Code: POS · Neurology
• Decision Date: Jan 26, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1580
• Device Class: Class 2
• Attributes: AI/ML

Intended 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.

Device Story

Wearable wrist-worn biosensor; captures Electrodermal Activity (EDA), motion (accelerometer), and temperature data. On-board algorithm processes sensor data to detect patterns associated with generalized tonic-clonic (GTC) seizures. Upon detection, device sends command to paired smartphone app; app initiates alerts (calls/texts) to designated caregivers. Used in home or healthcare facilities; operated by patient. Healthcare professionals review stored data post-event. Facilitates timely caregiver intervention during seizure events.

Clinical Evidence

Clinical study in Epilepsy Monitoring Unit (EMU) with 135 patients (76 children, 59 adults). Analyzed 272.1 days of data. 22 patients experienced 40 GTC seizures. Primary endpoints: Positive Percent Agreement (PPA) and False Alarm Rate (FAR). Results: PPA 0.9334 (95% CI: 0.9213, 0.9424); mean FAR 0.5894 per 24 hours (95% CI: 0.3425, 0.7002).

Technological Characteristics

Wrist-worn wearable biosensor. Sensors: Electrodermal Activity (EDA), accelerometer, temperature. Connectivity: Bluetooth to smartphone. Biocompatibility: ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization/irritation). Electrical safety: IEC 60601-1, IEC 60601-1-2 (EMC). Software level of concern: Moderate.

Indications for Use

Indicated for adults with epilepsy or at risk of epilepsy in home or healthcare settings during rest as an adjunct to seizure monitoring for detection of generalized tonic-clonic seizures.

Regulatory Classification

Identification

A non-electroencephalogram (non-EEG) physiological signal based seizure monitoring system is a noninvasive prescription device that collects physiological signals other than EEG to identify physiological signals that may be associated with a seizure.

Special Controls

In combination with the general controls of the FD&C Act, the Non-EEG physiological signal based seizure monitoring system is subject to the following special controls:

*Classification.* Class II (special controls). The special controls for this device are:(1) The technical parameters of the device, hardware and software, must be fully characterized and include the following information: (i) Hardware specifications must be provided. Appropriate verification, validation, and hazard analysis must be performed. (ii) Software, including any proprietary algorithm(s) used by the device to achieve its intended use, must be described in detail in the Software Requirements Specification (SRS) and Software Design Specification (SDS). Appropriate software verification, validation, and hazard analysis must be performed. (2) The patient-contacting components of the device must be demonstrated to be biocompatible. (3) The device must be designed and tested for electrical, thermal, and mechanical safety and electromagnetic compatibility (EMC). (4) Clinical performance testing must demonstrate the ability of the device to function as an assessment aid for monitoring for seizure-related activity in the intended population and for the intended use setting. Performance measurements must include positive percent agreement and false alarm rate. (5) Training must be provided for intended users that includes information regarding the proper use of the device and factors that may affect the collection of the physiologic data. (6) The labeling must include health care professional labeling and patient-caregiver labeling. The health care professional and the patient-caregiver labeling must include the following information: (i) A detailed summary of the clinical performance testing, including any adverse events and complications. (ii) Any instructions technicians and clinicians should convey to patients and caregivers regarding the proper use of the device and factors that may affect the collection of the physiologic data. (iii) Instructions to technicians and clinicians regarding how to set the device threshold to achieve the intended performance of the device.

Predicate Devices

• Companion (DEN140033)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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| 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)

K172935

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.

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# 510(k) Summary

| Submitter Name: | Empatica, Srl |
|---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | Via Stendhal 36<br>20144 Milano, Italy |
| 510(k) Submission Contact: | Rakesh Lal<br>817-734-8303 |
| Sponsor Contact Person: | Matteo Lai,<br>[phone] |
| Date Prepared: | September 22, 2017 |
| Device Trade Name:<br>Device Common Name:<br>Device Classification: | Embrace<br>Non-EEG physiological signal based seizure monitoring system<br>21 CFR 882.1580, Product Code POS |
| Predicate Device:<br>Predicate Device Classification: | Companion, DEN140033<br>21 CFR 882.1580, Product Code POS |
| Device Description: | The Embrace is a wearable biosensor device that can capture, store, and<br>wirelessly transmit sensor data via Bluetooth to a paired remote device.<br>Embrace runs an on-board algorithm to continuously process sensor data and<br>make a decision about whether the data might indicate a generalized tonic<br>clonic seizure (GTC). The algorithm has been validated on data, labeled using<br>the gold-standard video-Electroencephalogram (EEG) methodology designed by<br>a group of epileptologists at a top level 4 epilepsy center, from epilepsy patients<br>experiencing GTCs in hospital Epilepsy Monitoring Units. When a likely GTC is<br>detected, the Embrace sends a message to the Alert smartphone application,<br>which initiates calls and texts to summon the attention of designated<br>caregivers. |
| Indications for Use: | The Embrace is a prescription only device that is indicated for use as an adjunct<br>to seizure monitoring of adults in home or healthcare facilities during periods of<br>rest. The device is worn on the wrist, and senses Electrodermal Activity (EDA)<br>and motion data to detect patterns that may be associated with generalized<br>tonic clonic seizures in patients with epilepsy or at risk of having epilepsy. When<br>a seizure event is detected, Embrace sends a command to a paired wireless<br>device that is programmed to initiate an alert to a designated caregiver. The<br>System records and stores data from Accelerometers, EDA, and Temperature<br>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 | Brain Sentinel<br>Monitoring and Alerting<br>System | Comparison |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Non-EEG physiological<br>signal based seizure<br>monitoring system. | Non-EEG physiological<br>signal based seizure<br>monitoring system. | EQUIVALENT<br>Both devices have the<br>same intended use. |
| Indications for use | The Embrace is a<br>prescription only device<br>that is indicated for use<br>as an adjunct to seizure<br>monitoring of adults in<br>home or healthcare<br>facilities during periods<br>of rest. The device is<br>worn on the wrist, and<br>senses Electrodermal<br>Activity (EDA) and<br>motion data to detect<br>patterns that may be<br>associated with<br>generalized tonic clonic<br>seizures in patients with<br>epilepsy or at risk of<br>having epilepsy. When a<br>seizure event is<br>detected, Embrace<br>sends a command to a<br>paired wireless device<br>that is programmed to<br>initiate an alert to a<br>designated caregiver.<br>The System records and<br>stores data<br>from Accelerometers,<br>EDA, and Temperature<br>for subsequent review by<br>a trained healthcare<br>professional. | The Brain Sentinel<br>Monitoring and Alerting<br>System is indicated for<br>use as an adjunct to<br>seizure monitoring of<br>adults in the home or<br>healthcare facilities<br>during periods of rest.<br>The device is to be used<br>on the bicep muscle's<br>belly to analyze surface<br>electromyographs (sEMG)<br>signals that may be<br>associated with<br>generalized tonic-clonic<br>(GTC) seizures and to<br>generate an alarm to<br>alert caregivers of<br>unilateral, appendicular,<br>tonic extension that could<br>be associated with a GTC<br>seizure. The System<br>records and stores sEMG<br>data for subsequent<br>review by a trained<br>healthcare professional. | Patient Population:<br>EQUIVALENT<br>Both devices are<br>indicated for use on<br>adults.<br><br>Healthcare Environment:<br>EQUIVALENT<br>Both the subject and<br>predicate devices are<br>indicated for use in the<br>home and healthcare<br>settings.<br><br>Seizure Type:<br>EQUIVALENT<br>Both devices are<br>indicated to provide an<br>alert to caregivers when<br>they each detect GTC.<br>The predicate device<br>provides alerts of<br>unilateral, appendicular<br>or tonic extensions that<br>may be associated with a<br>GTC seizure, while the<br>subject device generates<br>alerts of patterns in<br>electrodermal and<br>movement signals that<br>may be associated with<br>generalized tonic clonic<br>seizures. Both devices<br>monitor physiological<br>signals while the patient<br>is at rest<br><br>Effect on Clinical<br>Outcome: EQUIVALENT<br>Both devices are |
| Sensor Technology | Utilizes an electrodermal<br>sensor to acquire<br>Electrodermal Activity,<br>and an accelerometer<br>sensor to acquire<br>movement data. | Utilizes a surface EMG<br>sensor to acquire sEMG<br>data. | indicated as an adjunct to<br>other monitoring devices<br>in the EMU. Neither of<br>the devices is intended to<br>guide therapy decisions.<br>EQUIVALENT<br>The difference in type of<br>sensor does not raise<br>different questions of<br>safety and effectiveness.<br>EDA sensors and<br>accelerometer sensors<br>are commonly used in<br>many kinds of consumer<br>and healthcare<br>technology and are<br>generally safe.<br>EQUIVALENT |
| Software Level of<br>Concern | Moderate | Moderate | EQUIVALENT |
| Data Communication | The Embrace device<br>communicates wirelessly<br>to a smartphone<br>application, which alerts<br>the healthcare provider<br>or caregiver in one or<br>more ways (phone call,<br>text message, etc.). | The sEMG monitor<br>communicates wirelessly<br>to the base station, which<br>alerts a healthcare<br>provider or caregiver in<br>one or more ways (e.g.,<br>audible alarm, text<br>message, e-mail, etc.). | EQUIVALENT<br>Both systems utilize<br>wireless communication<br>between the sensor and a<br>base station or app, and<br>technologies such as text<br>messaging to alert the<br>caregiver. |
| Algorithm | Uses algorithms to<br>analyze EDA and<br>accelerometer data to<br>detect patterns in the<br>data that may be<br>associated with<br>generalized tonic clonic<br>seizures | Uses algorithms to<br>analyze sEMG data to<br>detect unilateral,<br>appendicular, tonic<br>extension that could be<br>associated with a GTC<br>seizure | EQUIVALENT<br>The difference in the<br>algorithms do not raise<br>different questions of<br>safety and effectiveness.<br>The same questions of<br>safety and effectiveness<br>regarding performance of<br>the algorithms (PPA and<br>FAR) apply to both<br>devices. |
| Biocompatibility | All patient contacting<br>parts are tested to<br>applicable tests in ISO<br>10993 (Cytotoxicity - ISO<br>10993-5, Sensitization -<br>ISO 10993-10, and Skin<br>Irritation - ISO 10993-10). | All patient contacting<br>parts are tested to<br>applicable tests in ISO<br>10993 (Cytotoxicity - ISO<br>10993-5, Sensitization -<br>ISO 10993-10, and Skin<br>Irritation - ISO 10993-10). | EQUIVALENT<br>Both devices have patient<br>contacting parts that<br>come into contact with<br>intact skin for a duration<br>that may exceed 24<br>hours. Both devices meet<br>the requirements of ISO<br>10993. |
| Electrical Safety | Electrical Safety testing | | EQUIVALENT |
| | performed to IEC 60601-1<br>Electromagnetic<br>compatibility testing<br>performed to IEC 60601-<br>1-2 4th Edition | | |
| Thermal Safety | Not applicable. The<br>device does not generate<br>any localized heat | Not applicable. The<br>device does not generate<br>any localized heat | EQUIVALENT |
| Chemical Safety | Not applicable. Patient is<br>not exposed to any<br>chemicals during use of<br>the device | Not applicable. Patient is<br>not exposed to any<br>chemicals during use of<br>the device | EQUIVALENT |
| Radiation Safety | Not applicable. Device<br>does not use any ionizing<br>radiation | Not applicable. Device<br>does not use any ionizing<br>radiation | EQUIVALENT |

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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:

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.

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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.