(271 days)
Not Found
Unknown
The summary mentions an "algorithm" used for analyzing sEMG data and detecting seizure patterns, but it does not explicitly state whether this algorithm utilizes AI or ML techniques. The lack of mention of AI/ML terms, training/test sets, or performance metrics commonly associated with AI/ML models makes it difficult to definitively confirm or deny the presence of such technology.
No.
The device is a monitoring and alerting system for seizure events, not a device that treats or prevents a disease or condition.
Yes
The device records and stores surface electromyographic (sEMG) data for subsequent review by a trained healthcare professional to characterize seizure events, which is a diagnostic function.
No
The device description clearly outlines hardware components: an sEMG monitor worn on the arm and a Base Station for charging and data transfer. While software is involved in data analysis and alerting, the system relies on physical hardware for data acquisition and transmission.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- SPEAC System Function: The SPEAC System works by recording and analyzing surface electromyographic (sEMG) data directly from the patient's biceps muscle. This is a physiological measurement taken from the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is to monitor physiological signals (sEMG) as an adjunct to seizure monitoring, not to diagnose a condition based on analysis of a biological sample.
The SPEAC System is a physiological monitoring device, not an in vitro diagnostic device.
N/A
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-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.
Product codes (comma separated list FDA assigned to the subject device)
POS
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
belly of the biceps muscle
Indicated Patient Age Range
adults
Intended User / Care Setting
trained healthcare professional, home or healthcare facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software Verification and Validation
Performance Validation of SPEAC System
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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 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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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3
K182180 Traditional 510(k) Summary
| Date Prepared | May 10, 2019 |
|---|---|
| Submitter | Brain Sentinel, Inc |
| 8023 Vantage Drive, Suite 216 | |
| San Antonio, TX 78230 | |
| (210) 951-8681 | |
| Contact Person | Richard Waite, Sr. |
| Director of Quality Assurance/Regulatory Affairs | |
| Brain Sentinel, Inc | |
| (214) 662-9277 | |
| Richard.Waite@brainsentinel.com |
Subject Device K182180
- SPEAC® System Device Name
- Physiological signal-based seizure monitoring system Common Name
Device Classification Class II
| Product Code &
| 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.
4
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
Functional Mode | Left
LED
Light | Right
LED
Light | Daily Monitoring
Application Screen View | Description of the
Functional Mode |
|----------------------------------|----------------------|-----------------------|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Seizure Monitoring
Mode ON |
SOLID |
SOLID | | GTC Seizure Monitoring Mode: The patient is within the Wi-Fi
covered area and being monitored for potential GTC seizure events.
Seizure Alarms and Operational Alerts function in this mode. |
| Record Only Mode
Activated |
SOLID |
SOLID | | Record Only Mode allows the patient to leave the Wi-Fi covered area
while recording sEMG data for subsequent review by the referring
physician. Seizure Alarms and Operational Alerts do not function in
Record Only Mode. |
| Seizure
Alarm
Mode |
SOLID |
FLASH | | If a Seizure Alarm condition has been received, the Seizure Alarm
is automatically activated. The patient or caregiver may select the
CLICK TO SILENCE button to silence the audible part of the
alarm for a duration of 5 minutes. A new Seizure Alarm screen will
appear asking, "Did the patient have a seizure?"
The User may respond by clicking one answer: YES, I Don't Know
or NO |
Table 1: Functional and Operational Outputs
5
| SPEAC® System
Functional Mode | Left
LED
Light | Right
LED
Light | Daily Monitoring
Application Screen View | Description of the
Functional Mode |
|------------------------------------------------|----------------------|-----------------------|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Loose
Electrode Alert | FLASH | FLASH | | The Electrode Patch is not making good contact with the patient's arm
and needs to be replaced. Patient should follow the same steps for
removing, replacing, and calibrating an Electrode Patch by applying
gentle pressure to the sEMG Monitor for 2 minutes to allow for
electrode adherence to the patient's skin. If the issue persists, ensure all
electrode snaps are properly fastened to the sEMG Monitor before
adhering to the patient. |
| sEMG Monitor
Low Battery
Alert | FLASH | FLASH | | The battery is critically low on the sEMG Monitor in use and must
be connected to the Laptop Base Station for recharging. Swap the
low battery sEMG Monitor with the sEMG Monitor that is fully
charged. Follow the same steps for removing, replacing, and
calibrating an Electrode Patch. |
| Lost Connection
Out of Wi-Fi Range
Alert | SOLID | FLASH | | The sEMG Monitor in use is outside the covered range and has lost
wireless connection with the SPEAC System, notifying the patient
to immediately return to a part of the Wi-Fi covered zone. If the
router is working properly, 4 blue glowing Signal Strength LEDs
will be visible. If the LEDs are not lit, unplug and replug the router
to the electrical wall outlet.
Wait 4 minutes for the Wi-Fi connection to be restored. |
Table 2– SPEAC System Outputs Intended for Patients and Caregivers
| SPEAC System
| Operational Alert Condition | Application View | Description |
|---|---|---|
| Settings Button | Image: Settings | Used to swap functional modes between GTC Seizure Monitoring Mode and Record |
| Only Mode. | ||
| Night Mode Button | Image: Night Mode | Used to help the patient sleep soundly since the Laptop Base Station display screen |
| and lights on the sEMG Monitor may be dimmed. Users may click the Night Mode | ||
| button to turn Night Mode ON. | ||
| Night Mode | ||
| ON Button | Image: Night Mode ON | Used to disable Night Mode setting and return the SPEAC System display |
| screen to regular brightness. Users may alternate between Night Mode and | ||
| 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 |
| placed on a patient. Daily calibration of a new Electrode Patch is required for | ||
| 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 |
| occurred during the prescribed monitoring period. Use the scroll bar to review the | ||
| cumulative list. A new or existing Seizure Diary entry can be accessed from this | ||
| list as well as using the Seizure Diary button noted below. |
6
| SPEAC® System
| 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 |
| exclamation point will appear over the Seizure Diary button to indicate a new | ||
| Seizure Diary entry has been automatically created. Users may click this button to | ||
| open the electronic form that will allow the patient or caregiver to record specific | ||
| details about the event. | ||
| Wi-Fi-Status Indicator | ||
| Bar | Image: Wi-Fi Status Bars | The Laptop Base Station serves as the control hub for the entire SPEAC System. |
| The Wireless Router provides a communications link between the sEMG | ||
| Monitor in use and the Laptop Base Station. The Wireless Router can | ||
| communicate with the sEMG Monitor up to a 300-foot range (approximate). The | ||
| 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 | |
| Edition), Medical Electrical Equipment - Part 1: General | |
| Requirements for Basic Safety and Essential Performance | 19-4 |
| IEC 60601-1-2: 2014-02 (4th Edition), Medical Electrical Equipment – | |
| Part 1-2: General Requirements for Basic Safety and Essential | |
| Performance, Collateral Standard, Electromagnetic Compatibility | 19-8 |
| IEC 60601-1-6: Medical electrical equipment – Part 1-6: general | |
| requirements for basic safety and essential performance – collateral | |
| standard: usability | 5-89 |
| IEC 60601-1-8: Medical electrical equipment – Part 1-8: general | |
| requirements for basic safety and essential performance – collateral | |
| standard: general requirements, tests, and guidance for alarm systems | |
| in medical electrical equipment and medical electrical systems | 5-76 |
7
| Test | FDA Recognition Number |
|---|---|
| IEC 60601-1-11: 2010 (1st Edition) General requirements for basic | |
| safety and essential performance – Collateral Standard: Requirements | |
| for medical electrical equipment and medical electrical systems used | |
| in the home healthcare environment. | This version is no longer |
| FDA recognized but the | |
| design changes to the | |
| subject device do not | |
| require additional testing. | |
| All design changes are | |
| minor and outside the scope | |
| of this test (e.g., electrode | |
| patch testing). | |
| IEC 60601-2-40: 2016 (2nd Edition) Medical electrical equipment – | |
| Part 2-40: Particular requirements for the basic safety and essential | |
| performance of electromyographs and evoked response equipment | N/A Not an FDA |
| recognized standard; This | |
| testing has been voluntarily | |
| performed by the company | |
| to demonstrate performance | |
| and validate the system. | |
| Biocompatibility Testing | |
| ISO 10993-1: Biological evaluation of medical devices - Part 1: | |
| Evaluation and testing within a risk management process; Fourth | |
| edition | 2-220 |
| ISO 10993-5 Third edition 2009-06-01: Biological evaluation of | |
| medical devices – Part 5: Tests for vitro cytotoxicity | 2-245 |
| ISO 10993-10 Third Edition 2010-08-01: Biological evaluation of | |
| 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 |
8
| Characteristic | K182180 | DEN140033 | Comment |
|---|---|---|---|
| Subject Device | Predicate Device | ||
| SPEAC® System | Brain Sentinel® Monitoring and Alerting | ||
| 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. |
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
SPEAC® System | Predicate Device
Brain Sentinel® Monitoring and Alerting
System | |
| Classification | Class II
21 CFR 882.1580
Non-EEG physiological signal-based
seizure monitoring system | Class II
21 CFR 882.1580
Non-EEG physiological signal-based seizure
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
a proprietary algorithm to identify sustained
sEMG contraction patterns—during the
tonic phase and early transition to the clonic
phase—that are pathognomonic of GTC
seizures. | sEMG signal, sampled at the rate of 1000 Hz,
from the biceps brachii are processed by a
proprietary algorithm to identify sustained
sEMG contraction patterns—during the tonic
phase and early transition to the clonic
phase—that are pathognomonic of GTC
seizures. | Same; No change |
| Dimensions | 3.44" x 2.34" x 1.33"
(H x W x D) | 3.44" x 2.34" x 1.33"
(H x W x D) | Same; No change |
| Mass | 127 g. | 127 g. | Same; No change |
| Physical Controls | Power On/Off Button
(Manual) Alarm Button
Cancel Button | Power On/Off Button
(Manual) Alarm Button
Cancel Button | Same; No change |
| Characteristic | K182180 | DEN140033 | Comment |
| | Subject Device | Predicate Device | |
| | SPEAC® System | Brain Sentinel® Monitoring and Alerting
System | |
| sEMG sampling rate | 1,000 Hz | 1,000 Hz | Same; No change |
| sEMG Frequency Bands
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
that could be associated with a GTC seizure | Unilateral, appendicular, tonic extension that
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-
Polymer) | Rechargeable Battery; 2200 mAh (Li-
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
SPEAC® System | Predicate Device
Brain Sentinel® Monitoring and Alerting
System | |
| Software Controls | Alert Mode (adjunctive seizure monitoring
and sEMG recording),
Record Only (sEMG recording) | Alert Mode (adjunctive seizure monitoring
and sEMG recording) | Similar; sEMG recording was
previously cleared but in this 510(k),
the physician can now disable the alarm
so that they device is recording only
and therefore does not alarm. |
| sEMG Electrode | | | |
| | sEMG Electrode | sEMG Electrode | Similar; The electrode patch has
increased in surface area to improve the
comfort to the user in wearing the
device while maintaining patch
integrity. Electrode testing was
performed to validate the new
electrode. |
| Network Connection | | | |
| | Cellular Router | Cradlepoint Router | Cradlepoint Router |
| Recharging Accessories | | | |
| | sEMG Monitor
Recharging Accessories | USB - Micro-USB | USB - Micro-USB |
| Characteristic | K182180 | DEN140033 | Comment |
| | Subject Device
SPEAC® System | Predicate Device
Brain Sentinel® Monitoring and Alerting
System | |
| Laptop Base Station
Recharging Accessories | 12V / 1.5A | 12V / 1.5A | Same; No change. |
| Arm Strap | | | |
| sEMG Monitor Arm
Strap
MDDS | Black Spandex Arm Strap | Black Spandex Arm Strap | Same; No change. |
| Medical Device Data
Systems | Physician Portal (SPEAC2ME®) | Physician Portal (SPEAC2ME®) | Similar; The portal has been upgraded
to allow physicians to disable the alert
mode for record only mode. |
| Limitations | | | |
| Warnings & Limitations | The System is available by
prescription only from a physician or
properly licensed practitioner. The System should not be used as a
standalone monitor for monitoring
seizures and is not intended to be
used during physical activity. The device is not a seizure detection
device. | For prescription use only. The device is not a GTC seizure
detection device and should not be
used to guide medical therapy
decisions. The safety and effectiveness of the
Brain Sentinel® Monitoring and
Alerting System has not been
established in monitoring sEMG | Similar with modifications to align
and be consistent with the indications
for use (i.e., recording mode) and to
better inform users and patients on
appropriate use of the subject device. |
| Characteristic | K182180 | DEN140033 | Comment |
| | Subject Device | Predicate Device | |
| | SPEAC® System | Brain Sentinel® Monitoring and Alerting
System | |
| | The System alarms are not for
standalone use and should not be
used to guide medical therapy
decisions. The System has not been
demonstrated to affect any clinical
outcome such as status epilepticus,
brain damage, or death following a
GTC seizure. The System does not predict sEMG
signals that may be associated with
GTC seizures. The device provides
an alert from -30.82 – 25.06 seconds,
with an average of 5.34 seconds
(SEM ± 2.86), following the onset of
SEMG activity that may be
associated with a GTC seizure. The System does not predict seizure
onset. The safety and effectiveness of the
System has not been established in
pediatric populations. | signals that may be associated with
seizures other than the GTCS. The safety and effectiveness of the
Brain Sentinel® Monitoring and
Alerting System has not been
established in pediatric populations. The device is not intended to be used
as a stand-alone monitoring device. The device is not intended to be used
during physical activity. This device does not predict seizure
onset. PLEASE REFER TO THE
LABELING FOR A MORE
COMPLETE LIST OF
WARNINGS, PRECAUTIONS AND
CONTRAINDICATIONS. | |
| Characteristic | K182180 | DEN140033 | Comment |
| | Subject Device | Predicate Device | |
| | SPEAC® System | Brain Sentinel® Monitoring and Alerting
System | |
| | The System has not been tested in the home environment. The safety and effectiveness of the SPEAC System has not been established in monitoring sEMG signals that may be associated with seizures other than the GTC seizure. The sEMG Electrode Patch may result in skin irritation that may lead to hypersensitivity in some individuals. Never allow the sEMG Monitor to be submerged in any liquid. Contact Brain Sentinel if the sEMG Monitor or Laptop Base Station has been submerged. Do not attempt to use or service a sEMG Monitor or Base Station that has been submerged. Only Brain Sentinel authorized equipment should be used with or connected to the SPEAC System. The Laptop Base Station is optimized for the functions performed by the SPEAC System. Do not install applications, uninstall | | |
| Characteristic | K182180 | DEN140033 | Comment |
| | Subject Device
SPEAC® System
applications, or alter the
configuration or environment
variables of this. | Predicate Device
Brain Sentinel® Monitoring and Alerting
System | |
Table 4: Comparison of Technological Characteristics to Predicate Device
9
10
11
12
13
14
15
Conclusion
The SPEAC® System has undergone minor hardware and software changes to improve user needs and to better communicate the intended use in the labeling and indications for use. These changes include: a modified indication for use statement, an increase in surface area of the electrode patch to improve the comfort to the patient but maintaining patch integrity, and the housing atop the patch. Verification and validations were performed on the electrode patch along with usability testing, accelerated aging, ship testing, and biocompatibility testing was performed to ensure intended use functionality remains and the product is substantially equivalency to the current Predicate. Minor updates to improve the user experience and keep the technology updated with current technological infrastructure requirements. Verification were performed to ensure intended use was maintained and the product is substantially equivalency to the predicate. The sEMG based seizure detection algorithm is identical to the predicate. Based on device characteristics, indications for use, and testing submitted to support the submission, the SPEAC® System is substantially equivalent to the predicate device (Brain Sentinel Monitoring and Alerting System, manufactured by Brain Sentinel, Inc.).