SPEAC System

K182180 · Brain Sentinel, Inc. · POS · May 11, 2019 · Neurology

Device Facts

• Record ID: K182180
• Device Name: SPEAC System
• Applicant: Brain Sentinel, Inc.
• Product Code: POS · Neurology
• Decision Date: May 11, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1580
• Device Class: Class 2

Intended Use

The SPEAC® System is indicated for use as an adjunct to seizure monitoring in adults in the home or healthcare facilities during periods of rest. The System records and stores surface electromyographic (sEMG) data for subsequent review by a trained healthcare professional. The device is to be used on the belly of the biceps muscle to analyze sEMG signals that may be associated with generalized tonic-clonic (GTC) seizures. When sEMG signal patterns associated with a unilateral, appendicular, tonic extension that could be associated with a GTC seizure are detected, the SPEAC System sends adjunctive alarms to alert caregivers. Adjunctive alarms may be disabled by a physician order while continuing to record sEMG data for subsequent review.

Device Story

SPEAC System is a physiological sEMG monitor worn unilaterally on the biceps; records/stores sEMG data at 1,000 Hz. Proprietary algorithm identifies sustained sEMG contraction patterns (tonic phase/early clonic transition) pathognomonic of GTC seizures. Device provides local, remote, audible, and visual alarms to caregivers; alarms can be disabled by physician for 'record-only' mode. Data downloaded via Base Station to cloud-based Data Distribution System (DDS) for physician post-hoc review. Used in home/healthcare settings; operated by patient/caregiver. Benefits include adjunctive monitoring for GTC seizures. Patient data secured in FedRAMP-certified Microsoft Azure. System includes sEMG monitor, Base Station, and physician portal (SPEAC2ME).

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), usability (IEC 60601-1-6), alarm system standards (IEC 60601-1-8), biocompatibility (ISO 10993-1, -5, -10), and performance validation of the SPEAC system.

Technological Characteristics

sEMG monitor (127g, 3.44"x2.34"x1.33"); 2200 mAh Li-Polymer battery. Sensing: sEMG at 1,000 Hz; frequency bands 30-40 Hz, 130-240 Hz, 300-400 Hz. Connectivity: Wi-Fi/Cellular router to cloud (Microsoft Azure). Software: Proprietary algorithm for GTC seizure pattern detection. Biocompatibility per ISO 10993. Standards: IEC 60601-1, 60601-1-2, 60601-1-6, 60601-1-8.

Indications for Use

Indicated for adults in home or healthcare facilities during rest. Used as adjunct to seizure monitoring for GTC seizures via sEMG signal analysis of the biceps muscle. Not for pediatric use. Not for use during physical activity.

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

• Brain Sentinel Monitoring and Alerting System (DEN140033)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Brain Sentinel, Inc. Richard Waite Sr. Director of Quality Assurance/Regulatory Affairs 8023 Vantage Dr., Suite 216 San Antonio, Texas 78230

Re: K182180

Trade/Device Name: SPEAC® System 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: April 10, 2019 Received: April 12, 2019

Dear Richard Waite:

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. 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 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 807); labeling (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.htm); 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For Carlos L. Peña. PhD. MS Director OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K182180

Device Name SPEAC System

#### Indications for Use (Describe)

The SPEAC® System is indicated for use as an adjunct to seizure monitoring in adults in the home or healthcare facilities during periods of rest. The System records and stores surface electromyographic (sEMG) data for subsequent review by a trained healthcare professional.

The device is to be used on the belly of the biceps muscle to analyze sEMG signals that may be associated with generalized tonic-clonic (GTC) seizures. When sEMG signal patterns associated with a unilateral, appendicular, tonic extension that could be associated with a GTC seizure are detected, the SPEAC System sends adjunctive alarms to alert caregivers. Adjunctive alarms may be disabled by a physician order while continuing to record sEMG data for subsequent review.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------------|
| X Prescription Use (Part 21 CFR 801 Subpart D) | l _ Over-The-Counter Use (21 CFR 801 Subpart C) |

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## K182180 Traditional 510(k) Summary

| Date Prepared | May 10, 2019 |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Brain Sentinel, Inc<br>8023 Vantage Drive, Suite 216<br>San Antonio, TX 78230<br>[phone] |
| Contact Person | Richard Waite, Sr.<br>Director of Quality Assurance/Regulatory Affairs<br>Brain Sentinel, Inc<br>[phone]<br>[e-mail] |

#### Subject Device K182180

- SPEAC® System Device Name
- Physiological signal-based seizure monitoring system Common Name

Device Classification Class II

| Product Code &<br>Regulation | POS; Non-EEG physiological signal-based seizure monitoring system |
|------------------------------|-------------------------------------------------------------------|
| | 21 CFR 882.1580 |

- Review Panel Neurodiagnostic Devices; Neurology
### Predicate Device DEN140033

| Manufacturer | Brain Sentinel, Inc. |
|-----------------------|--------------------------------------------------------------|
| Device Name | Brain Sentinel Monitoring and Alerting System |
| Regulation Name | Non-EEG physiological signal-based seizure monitoring system |
| De Novo Number | DEN140033 |
| Product Code | POS |
| Regulation Number | 21 CFR 882.1580 |
| Device Classification | Class II |

### Subject Device Description

The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and Alerting System (Predicate), is a physiological, surface electromyography (sEMG) monitor with or without alarms that records and stores data for review by a physician for characterization of seizure events.

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The System records sEMG data at 1,000 Hz and distributes physiological data. Data can be analyzed with an algorithm using the default threshold or by a modified threshold ordered by the physician.

The sEMG monitor is worn unilaterally on the belly of the patient's biceps and it analyzes for sEMG GTC seizures and provide local, remote, audible, and visual seizure alarms when a GTC Seizure pattern that may be associated with such seizures that are detected.

The SPEAC System provides sEMG recordings and audio data to physicians (or other trained healthcare professionals) for post-hoc review so that they may quantify and qualify the types of seizure events that their patients experience. Every 24 hours, the sEMG monitor is removed from the patient and replaced with the second sEMG Monitor on the opposite arm of the patient.

The sEMG that is removed after 24-hours is then attached to a Base Station. By connecting the sEMG Monitor to the Base Station, the monitor charges and the recorded data is downloaded to the Base Station. The recorded data is then automatically uploaded to Brain Sentinel's cloudbased storage unit, Data Distribution System (DDS), where they await review by a physician. All patient data is cyber-secured within Microsoft Azure which is FedRAMP certified. Below, Tables 1 and 2 list the functional and operational outputs designed to provide feedback to the patient and caregiver. These modes and outputs are no different than those which were cleared in the Predicate, DEN140033.

| SPEAC® System<br>Functional Mode | Left<br>LED<br>Light | Right<br>LED<br>Light | Daily Monitoring<br>Application Screen View | Description of the<br>Functional Mode |
|----------------------------------|----------------------|-----------------------|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Seizure Monitoring<br>Mode ON | <br>SOLID | <br>SOLID | | GTC Seizure Monitoring Mode: The patient is within the Wi-Fi<br>covered area and being monitored for potential GTC seizure events.<br>Seizure Alarms and Operational Alerts function in this mode. |
| Record Only Mode<br>Activated | <br>SOLID | <br>SOLID | | Record Only Mode allows the patient to leave the Wi-Fi covered area<br>while recording sEMG data for subsequent review by the referring<br>physician. Seizure Alarms and Operational Alerts do not function in<br>Record Only Mode. |
| Seizure<br>Alarm<br>Mode | <br>SOLID | <br>FLASH | | If a Seizure Alarm condition has been received, the Seizure Alarm<br>is automatically activated. The patient or caregiver may select the<br>CLICK TO SILENCE button to silence the audible part of the<br>alarm for a duration of 5 minutes. A new Seizure Alarm screen will<br>appear asking, "Did the patient have a seizure?"<br>The User may respond by clicking one answer: YES, I Don't Know<br>or NO |

## Table 1: Functional and Operational Outputs

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| SPEAC® System<br>Functional Mode | Left<br>LED<br>Light | Right<br>LED<br>Light | Daily Monitoring<br>Application Screen View | Description of the<br>Functional Mode |
|------------------------------------------------|----------------------|-----------------------|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Loose<br>Electrode Alert | FLASH | FLASH | | The Electrode Patch is not making good contact with the patient's arm<br>and needs to be replaced. Patient should follow the same steps for<br>removing, replacing, and calibrating an Electrode Patch by applying<br>gentle pressure to the sEMG Monitor for 2 minutes to allow for<br>electrode adherence to the patient's skin. If the issue persists, ensure all<br>electrode snaps are properly fastened to the sEMG Monitor before<br>adhering to the patient. |
| sEMG Monitor<br>Low Battery<br>Alert | FLASH | FLASH | | The battery is critically low on the sEMG Monitor in use and must<br>be connected to the Laptop Base Station for recharging. Swap the<br>low battery sEMG Monitor with the sEMG Monitor that is fully<br>charged. Follow the same steps for removing, replacing, and<br>calibrating an Electrode Patch. |
| Lost Connection<br>Out of Wi-Fi Range<br>Alert | SOLID | FLASH | | The sEMG Monitor in use is outside the covered range and has lost<br>wireless connection with the SPEAC System, notifying the patient<br>to immediately return to a part of the Wi-Fi covered zone. If the<br>router is working properly, 4 blue glowing Signal Strength LEDs<br>will be visible. If the LEDs are not lit, unplug and replug the router<br>to the electrical wall outlet.<br>Wait 4 minutes for the Wi-Fi connection to be restored. |

# Table 2– SPEAC System Outputs Intended for Patients and Caregivers

| SPEAC System<br>Operational Alert Condition | Application View | Description |
|---------------------------------------------|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Settings Button | Image: Settings | Used to swap functional modes between GTC Seizure Monitoring Mode and Record<br>Only Mode. |
| Night Mode Button | Image: Night Mode | Used to help the patient sleep soundly since the Laptop Base Station display screen<br>and lights on the sEMG Monitor may be dimmed. Users may click the Night Mode<br>button to turn Night Mode ON. |
| Night Mode<br>ON Button | Image: Night Mode ON | Used to disable Night Mode setting and return the SPEAC System display<br>screen to regular brightness. Users may alternate between Night Mode and<br>Night Mode ON as often as necessary. |
| Electrode Setup Button | Image: Electrode Setup | Used to initiate the Electrode Setup process every time a new Electrode Patch is<br>placed on a patient. Daily calibration of a new Electrode Patch is required for<br>using the System in GTC Seizure Monitoring Mode or Record Only Mode. |
| Alarm History Button | Image: Alarm History | Used to display a list of all Seizure Alarms and Operational Alerts that have<br>occurred during the prescribed monitoring period. Use the scroll bar to review the<br>cumulative list. A new or existing Seizure Diary entry can be accessed from this<br>list as well as using the Seizure Diary button noted below. |

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| SPEAC® System<br>Operational Alert Condition | Application View | Description |
|----------------------------------------------|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Seizure Diary Button | Image: Seizure Diary Icon with Exclamation Point | If the System sends a Seizure Alarm for a potential GTC Seizure event, a yellow<br>exclamation point will appear over the Seizure Diary button to indicate a new<br>Seizure Diary entry has been automatically created. Users may click this button to<br>open the electronic form that will allow the patient or caregiver to record specific<br>details about the event. |
| Wi-Fi-Status Indicator<br>Bar | Image: Wi-Fi Status Bars | The Laptop Base Station serves as the control hub for the entire SPEAC System.<br>The Wireless Router provides a communications link between the sEMG<br>Monitor in use and the Laptop Base Station. The Wireless Router can<br>communicate with the sEMG Monitor up to a 300-foot range (approximate). The<br>Wi-Fi Status Bars indicate connection signal strength. |

### Intended Use/ Indications for Use

The SPEAC® System is indicated for use as an adjunct to seizure monitoring in adults in the home or healthcare facilities during periods of rest. The System records and stores surface electromyographic (sEMG) data for subsequent review by a trained healthcare professional.

The device is to be used on the belly of the biceps muscle to analyze sEMG signals that may be associated with generalized tonic (GTC) seizures. When sEMG signal patterns associated with a unilateral, appendicular, tonic extension that could be associated with a GTC seizure are detected, the SPEAC System sends adjunctive alarms to alert caregivers. Adjunctive alarms may be disabled by a physician order while continuing to record sEMG data for subsequent review.

## Table 3: Non-Clinical Test Summary for the SPEAC® System in K182180

| Test | FDA Recognition Number |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) (3rd<br>Edition), Medical Electrical Equipment - Part 1: General<br>Requirements for Basic Safety and Essential Performance | 19-4 |
| IEC 60601-1-2: 2014-02 (4th Edition), Medical Electrical Equipment –<br>Part 1-2: General Requirements for Basic Safety and Essential<br>Performance, Collateral Standard, Electromagnetic Compatibility | 19-8 |
| IEC 60601-1-6: Medical electrical equipment – Part 1-6: general<br>requirements for basic safety and essential performance – collateral<br>standard: usability | 5-89 |
| IEC 60601-1-8: Medical electrical equipment – Part 1-8: general<br>requirements for basic safety and essential performance – collateral<br>standard: general requirements, tests, and guidance for alarm systems<br>in medical electrical equipment and medical electrical systems | 5-76 |

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| Test | FDA Recognition Number |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-11: 2010 (1st Edition) General requirements for basic<br>safety and essential performance – Collateral Standard: Requirements<br>for medical electrical equipment and medical electrical systems used<br>in the home healthcare environment. | This version is no longer<br>FDA recognized but the<br>design changes to the<br>subject device do not<br>require additional testing.<br>All design changes are<br>minor and outside the scope<br>of this test (e.g., electrode<br>patch testing). |
| IEC 60601-2-40: 2016 (2nd Edition) Medical electrical equipment –<br>Part 2-40: Particular requirements for the basic safety and essential<br>performance of electromyographs and evoked response equipment | N/A Not an FDA<br>recognized standard; This<br>testing has been voluntarily<br>performed by the company<br>to demonstrate performance<br>and validate the system. |
| Biocompatibility Testing<br>ISO 10993-1: Biological evaluation of medical devices - Part 1:<br>Evaluation and testing within a risk management process; Fourth<br>edition | 2-220 |
| ISO 10993-5 Third edition 2009-06-01: Biological evaluation of<br>medical devices – Part 5: Tests for vitro cytotoxicity | 2-245 |
| ISO 10993-10 Third Edition 2010-08-01: Biological evaluation of<br>medical devices – Part 10: Tests for irritation and skin sensitization | 2-174 |
| Shipping and Distribution Test (ISTA 3A) | 5-110 |
| Software Verification and Validation | N/A |
| Performance Validation of SPEAC System | N/A |

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| Characteristic | K182180 | DEN140033 | Comment |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | Predicate Device | |
| | SPEAC® System | Brain Sentinel® Monitoring and Alerting<br>System | |
| Indications for Use | The SPEAC® System is indicated for use as an adjunct to seizure monitoring in adults in the home or healthcare facilities during periods of rest. The System records and stores surface electromyographic (sEMG) data for subsequent review by a trained healthcare professional.<br><br>The device is to be used on the belly of the biceps muscle to analyze sEMG signals that may be associated with generalized tonic-clonic (GTC) seizures. When sEMG signal patterns associated with a unilateral, appendicular, tonic extension that could be associated with a GTC seizure are detected, the SPEAC System sends adjunctive alarms to alert caregivers. Adjunctive alarms may be disabled by a physician order while continuing to record sEMG data for subsequent review. (Rx-only) | The Brain Sentinel Monitoring and Alerting System is indicated for use as an adjunct to seizure monitoring in adults in the home or healthcare facilities during periods of rest. The device is to be used on the belly of the biceps muscle to analyze surface electromyographs (sEMG) signals that may be associated with generalized tonic-clonic (GTC) seizures and to provide 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. (Rx-only) | Similar; The indications have been modified to clarify the intended use by specifically stating the sEMG recording and alarm controls that are available to the users. These features were cleared in DEN140033. |
| Characteristic | K182180 | DEN140033 | Comment |
| | Subject Device<br>SPEAC® System | Predicate Device<br>Brain Sentinel® Monitoring and Alerting<br>System | |
| Classification | Class II<br>21 CFR 882.1580<br>Non-EEG physiological signal-based<br>seizure monitoring system | Class II<br>21 CFR 882.1580<br>Non-EEG physiological signal-based seizure<br>monitoring system | Same; No change |
| Product Code | POS | POS | Same; No change |
| Major System Components – sEMG Monitor | | | |
| Principle of Operation | sEMG signal, sampled at the rate of 1000 Hz, from the biceps brachii are processed by a<br>a proprietary algorithm to identify sustained<br>sEMG contraction patterns—during the<br>tonic phase and early transition to the clonic<br>phase—that are pathognomonic of GTC<br>seizures. | sEMG signal, sampled at the rate of 1000 Hz,<br>from the biceps brachii are processed by a<br>proprietary algorithm to identify sustained<br>sEMG contraction patterns—during the tonic<br>phase and early transition to the clonic<br>phase—that are pathognomonic of GTC<br>seizures. | Same; No change |
| Dimensions | 3.44" x 2.34" x 1.33"<br>(H x W x D) | 3.44" x 2.34" x 1.33"<br>(H x W x D) | Same; No change |
| Mass | 127 g. | 127 g. | Same; No change |
| Physical Controls | Power On/Off Button<br>(Manual) Alarm Button<br>Cancel Button | Power On/Off Button<br>(Manual) Alarm Button<br>Cancel Button | Same; No change |
| Characteristic | K182180 | DEN140033 | Comment |
| | Subject Device | Predicate Device | |
| | SPEAC® System | Brain Sentinel® Monitoring and Alerting<br>System | |
| sEMG sampling rate | 1,000 Hz | 1,000 Hz | Same; No change |
| sEMG Frequency Bands<br>of Interest | 30-40 Hz, 130-240 Hz, and 300-400 Hz | 30-40 Hz, 130-240 Hz, and 300-400 Hz | Same; No change |
| Type of Monitoring | Unilateral, appendicular, tonic extension<br>that could be associated with a GTC seizure | Unilateral, appendicular, tonic extension that<br>could be associated with a GTC seizure | Same; No change |
| Default Alarm Threshold | 135 | 135 | Same; No change |
| sEMG Monitor Power | Rechargeable Battery; 2200 mAh (Li-<br>Polymer) | Rechargeable Battery; 2200 mAh (Li-<br>Polymer) | Same; No change |
| Laptop Base Station | | | |
| Model | COTS Laptop | COTS Laptop | Same; No change |
| Input Power | 115/230 VAC 50/60 Hz | 115/230 VAC 50/60 Hz | Same; No Change |
| Graphical User Interface | Laptop Base Station | Laptop Base Station | Same; No change |
| Characteristic | K182180 | DEN140033 | Comment |
| | Subject Device<br>SPEAC® System | Predicate Device<br>Brain Sentinel® Monitoring and Alerting<br>System | |
| Software Controls | Alert Mode (adjunctive seizure monitoring<br>and sEMG recording),<br>Record Only (sEMG recording) | Alert Mode (adjunctive seizure monitoring<br>and sEMG recording) | Similar; sEMG recording was<br>previously cleared but in this 510(k),<br>the physician can now disable the alarm<br>so that they device is recording only<br>and therefore does not alarm. |
| sEMG Electrode | | | |
| | sEMG Electrode…