(271 days)
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.
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.
Here's an analysis of the provided text to extract the acceptance criteria and study information:
Acceptance Criteria and Device Performance Study for the SPEAC® System
The information provided describes the Brain Sentinel, Inc. SPEAC® System, a non-EEG physiological signal-based seizure monitoring system. This 510(k) submission (K182180) emphasizes the substantial equivalence to its predicate device (DEN140033), also from Brain Sentinel.
The document focuses on demonstrating that the modified SPEAC® System remains substantially equivalent to the predicate device rather than presenting a new, comprehensive study with specific acceptance criteria directly tied to a new device performance study. Instead, it relies on the predicate's established performance and confirms that the changes to the subject device (SPEAC® System) do not negatively impact those established characteristics.
Therefore, the "acceptance criteria and reported device performance" as requested would primarily refer to the performance established for the predicate device, which is maintained by the subject device. The primary "study" that proves the device meets "acceptance criteria" here is a demonstration of substantial equivalence, relying heavily on the predicate's performance and verification that minor changes do not alter essential safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) for substantial equivalence and the provided document, the "acceptance criteria" are implied to be the established performance characteristics of the predicate device, which the subject device is shown to maintain. The reported device performance is largely a re-affirmation of the predicate's performance, as the core seizure detection algorithm is identical.
| Characteristic | Acceptance Criteria (from Predicate) | Reported Device Performance (Subject Device) |
|---|---|---|
| Seizure Detection Algorithm Performance (GTC Seizures) | Detects GTC seizure patterns associated with unilateral, appendicular, tonic extension. | Algorithm is identical to the predicate. |
| Alarm Latency | 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. | 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. (Explicitly stated in Limitations, implying maintained performance). |
| sEMG Sampling Rate | 1,000 Hz | 1,000 Hz |
| 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 |
| Default Alarm Threshold | 135 | 135 |
| Physical Dimensions, Mass, Controls | H=3.44", W=2.34", D=1.33"; 127g; Power On/Off, Alarm, Cancel Buttons | H=3.44", W=2.34", D=1.33"; 127g; Power On/Off, Alarm, Cancel Buttons |
| Biocompatibility | Meets ISO 10993 standards (Parts 1, 5, 10). | Electrode patch underwent biocompatibility testing per ISO 10993 (Parts 1, 5, 10) to validate new electrode. |
| Electrical Safety & EMC | Meets IEC 60601-1:2005 (3rd Ed.), IEC 60601-1-2:2014 (4th Ed.), IEC 60601-1-8 (as applicable). | Verification conducted against these standards. |
| Usability | Meets IEC 60601-1-6. | Usability testing performed. |
| Home Healthcare Environment | Meets IEC 60601-1-11:2010 (1st Ed.). | Version no longer FDA recognized, but design changes are minor and outside the scope of this test (e.g., electrode patch testing). Implied continued compliance due to minor changes. |
| Electrode Adherence/Comfort | Adequate contact with patient's arm (implied by predicate function). | New electrode patch increased in surface area to improve comfort while maintaining integrity; electrode testing performed to validate. |
| Software Functionality (Record Only Mode) | Recording of sEMG data. | New feature to disable alarms for "Record Only Mode" while continuing to record sEMG data. Verified to maintain intended use. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "The sEMG based seizure detection algorithm is identical to the predicate." It does not provide new clinical data or a new test set for the algorithm's performance. The performance metrics cited (e.g., alarm latency) appear to be derived from the studies that supported the predicate device (DEN140033). Therefore:
- Sample Size for Test Set: Not specified in this document for the algorithm's core performance, as it relies on the predicate's established performance. The "Performance Validation of SPEAC System" would likely have involved technical validation rather than a new clinical test set for algorithm accuracy.
- Data Provenance: Not specified in this document for the original algorithm validation. Given the company is U.S.-based (San Antonio, Texas), it is likely the original predicate studies were conducted in the U.S. The studies for the predicate device would have been prospective to demonstrate its initial effectiveness. This submission (K182180) focuses on equivalence rather than new prospective clinical data for algorithm performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the current document. Since the algorithm is identical to the predicate, any expert review and ground truth establishment would have occurred during the predicate's development and regulatory clearance process (DEN140033).
4. Adjudication Method
This information is not provided in the current document. As with ground truth establishment, this would have been part of the predicate device's validation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no indication of an MRMC comparative effectiveness study being performed for this 510(k) submission. The device is a "non-EEG physiological signal-based seizure monitoring system" with automated alarm capabilities, not a diagnostic imaging AI that assists human readers in interpretation. Its primary function is to detect specific sEMG patterns and alert caregivers, and to record data for subsequent review by a trained healthcare professional. The focus is on the device's ability to identify specific sEMG patterns, not on how it enhances human interpretation of complex data in a comparative setting.
6. Standalone (Algorithm Only) Performance Study
Yes, the algorithm only performance was established as part of the predicate clearance (DEN140033). The document states: "The sEMG based seizure detection algorithm is identical to the predicate." The performance claim for alarm latency ("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.") directly reflects the standalone performance of this algorithm. This 510(k) reaffirms that this standalone performance is maintained.
7. Type of Ground Truth Used
The type of ground truth used for validating the sEMG patterns would typically be expert consensus or adjudicated clinical events, correlating the sEMG signals with observed generalized tonic-clonic (GTC) seizures. The document indicates that the system analyzes "sEMG signals that may be associated with generalized tonic-clonic (GTC) seizures" and identifies "sustained sEMG contraction patterns—during the tonic phase and early transition to the clonic phase—that are pathognomonic of GTC seizures." This strongly implies that the ground truth for detection was based on clinically confirmed GTC seizures, likely verified by neurologists or experts in epileptology, alongside simultaneous sEMG recordings.
8. Sample Size for the Training Set
The document does not provide the sample size for the training set. This information would have been part of the original development and validation of the algorithm for the predicate device.
9. How the Ground Truth for the Training Set Was Established
The document does not explicitly state how the ground truth for the training set was established. However, given the nature of the device and its indications, it is highly probable that the training data collected for the predicate device involved:
- Prospective collection of sEMG data from patients with confirmed epilepsy, particularly those prone to GTC seizures.
- Simultaneous video-EEG monitoring and direct clinical observation by trained medical staff to accurately identify and timestamp the onset and characteristics of GTC seizures.
- Annotation of sEMG recordings by experts (e.g., epileptologists, neurophysiologists) to delineate the specific sEMG patterns "pathognomonic of GTC seizures" as input for algorithm development.
This would involve a rigorous clinical process to ensure accurate correlation between the sEMG signals and the actual seizure events for both training and validation of the algorithm.
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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 (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
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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, Inc8023 Vantage Drive, Suite 216San Antonio, TX 78230(210) 951-8681 |
| Contact Person | Richard Waite, Sr.Director of Quality Assurance/Regulatory AffairsBrain Sentinel, Inc(214) 662-9277Richard.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.
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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® SystemFunctional Mode | LeftLEDLight | RightLEDLight | Daily MonitoringApplication Screen View | Description of theFunctional Mode |
|---|---|---|---|---|
| Seizure MonitoringMode ON | SOLID | SOLID | GTC Seizure Monitoring Mode: The patient is within the Wi-Ficovered area and being monitored for potential GTC seizure events.Seizure Alarms and Operational Alerts function in this mode. | |
| Record Only ModeActivated | SOLID | SOLID | Record Only Mode allows the patient to leave the Wi-Fi covered areawhile recording sEMG data for subsequent review by the referringphysician. Seizure Alarms and Operational Alerts do not function inRecord Only Mode. | |
| SeizureAlarmMode | SOLID | FLASH | If a Seizure Alarm condition has been received, the Seizure Alarmis automatically activated. The patient or caregiver may select theCLICK TO SILENCE button to silence the audible part of thealarm for a duration of 5 minutes. A new Seizure Alarm screen willappear asking, "Did the patient have a seizure?"The User may respond by clicking one answer: YES, I Don't Knowor NO |
Table 1: Functional and Operational Outputs
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| SPEAC® SystemFunctional Mode | LeftLEDLight | RightLEDLight | Daily MonitoringApplication Screen View | Description of theFunctional Mode |
|---|---|---|---|---|
| LooseElectrode Alert | FLASH | FLASH | The Electrode Patch is not making good contact with the patient's armand needs to be replaced. Patient should follow the same steps forremoving, replacing, and calibrating an Electrode Patch by applyinggentle pressure to the sEMG Monitor for 2 minutes to allow forelectrode adherence to the patient's skin. If the issue persists, ensure allelectrode snaps are properly fastened to the sEMG Monitor beforeadhering to the patient. | |
| sEMG MonitorLow BatteryAlert | FLASH | FLASH | The battery is critically low on the sEMG Monitor in use and mustbe connected to the Laptop Base Station for recharging. Swap thelow battery sEMG Monitor with the sEMG Monitor that is fullycharged. Follow the same steps for removing, replacing, andcalibrating an Electrode Patch. | |
| Lost ConnectionOut of Wi-Fi RangeAlert | SOLID | FLASH | The sEMG Monitor in use is outside the covered range and has lostwireless connection with the SPEAC System, notifying the patientto immediately return to a part of the Wi-Fi covered zone. If therouter is working properly, 4 blue glowing Signal Strength LEDswill be visible. If the LEDs are not lit, unplug and replug the routerto 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 SystemOperational Alert Condition | Application View | Description |
|---|---|---|
| Settings Button | Image: Settings | Used to swap functional modes between GTC Seizure Monitoring Mode and RecordOnly Mode. |
| Night Mode Button | Image: Night Mode | Used to help the patient sleep soundly since the Laptop Base Station display screenand lights on the sEMG Monitor may be dimmed. Users may click the Night Modebutton to turn Night Mode ON. |
| Night ModeON Button | Image: Night Mode ON | Used to disable Night Mode setting and return the SPEAC System displayscreen to regular brightness. Users may alternate between Night Mode andNight 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 isplaced on a patient. Daily calibration of a new Electrode Patch is required forusing 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 haveoccurred during the prescribed monitoring period. Use the scroll bar to review thecumulative list. A new or existing Seizure Diary entry can be accessed from thislist as well as using the Seizure Diary button noted below. |
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| SPEAC® SystemOperational 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 yellowexclamation point will appear over the Seizure Diary button to indicate a newSeizure Diary entry has been automatically created. Users may click this button toopen the electronic form that will allow the patient or caregiver to record specificdetails about the event. |
| Wi-Fi-Status IndicatorBar | 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 sEMGMonitor in use and the Laptop Base Station. The Wireless Router cancommunicate with the sEMG Monitor up to a 300-foot range (approximate). TheWi-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) (3rdEdition), Medical Electrical Equipment - Part 1: GeneralRequirements 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 EssentialPerformance, Collateral Standard, Electromagnetic Compatibility | 19-8 |
| IEC 60601-1-6: Medical electrical equipment – Part 1-6: generalrequirements for basic safety and essential performance – collateralstandard: usability | 5-89 |
| IEC 60601-1-8: Medical electrical equipment – Part 1-8: generalrequirements for basic safety and essential performance – collateralstandard: general requirements, tests, and guidance for alarm systemsin 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 basicsafety and essential performance – Collateral Standard: Requirementsfor medical electrical equipment and medical electrical systems usedin the home healthcare environment. | This version is no longerFDA recognized but thedesign changes to thesubject device do notrequire additional testing.All design changes areminor and outside the scopeof this test (e.g., electrodepatch testing). |
| IEC 60601-2-40: 2016 (2nd Edition) Medical electrical equipment –Part 2-40: Particular requirements for the basic safety and essentialperformance of electromyographs and evoked response equipment | N/A Not an FDArecognized standard; Thistesting has been voluntarilyperformed by the companyto demonstrate performanceand validate the system. |
| Biocompatibility TestingISO 10993-1: Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk management process; Fourthedition | 2-220 |
| ISO 10993-5 Third edition 2009-06-01: Biological evaluation ofmedical devices – Part 5: Tests for vitro cytotoxicity | 2-245 |
| ISO 10993-10 Third Edition 2010-08-01: Biological evaluation ofmedical 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 AlertingSystem | ||
| 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 DeviceSPEAC® System | Predicate DeviceBrain Sentinel® Monitoring and AlertingSystem | ||
| Classification | Class II21 CFR 882.1580Non-EEG physiological signal-basedseizure monitoring system | Class II21 CFR 882.1580Non-EEG physiological signal-based seizuremonitoring 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 aa proprietary algorithm to identify sustainedsEMG contraction patterns—during thetonic phase and early transition to the clonicphase—that are pathognomonic of GTCseizures. | sEMG signal, sampled at the rate of 1000 Hz,from the biceps brachii are processed by aproprietary algorithm to identify sustainedsEMG contraction patterns—during the tonicphase and early transition to the clonicphase—that are pathognomonic of GTCseizures. | 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 ButtonCancel Button | Power On/Off Button(Manual) Alarm ButtonCancel Button | Same; No change |
| Characteristic | K182180 | DEN140033 | Comment |
| Subject Device | Predicate Device | ||
| SPEAC® System | Brain Sentinel® Monitoring and AlertingSystem | ||
| sEMG sampling rate | 1,000 Hz | 1,000 Hz | Same; No change |
| sEMG Frequency Bandsof 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 extensionthat could be associated with a GTC seizure | Unilateral, appendicular, tonic extension thatcould 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 DeviceSPEAC® System | Predicate DeviceBrain Sentinel® Monitoring and AlertingSystem | ||
| Software Controls | Alert Mode (adjunctive seizure monitoringand sEMG recording),Record Only (sEMG recording) | Alert Mode (adjunctive seizure monitoringand sEMG recording) | Similar; sEMG recording waspreviously cleared but in this 510(k),the physician can now disable the alarmso that they device is recording onlyand therefore does not alarm. |
| sEMG Electrode | |||
| sEMG Electrode | sEMG Electrode | Similar; The electrode patch hasincreased in surface area to improve thecomfort to the user in wearing thedevice while maintaining patchintegrity. Electrode testing wasperformed to validate the newelectrode. | |
| Network Connection | |||
| Cellular Router | Cradlepoint Router | Cradlepoint Router | |
| Recharging Accessories | |||
| sEMG MonitorRecharging Accessories | USB - Micro-USB | USB - Micro-USB | |
| Characteristic | K182180 | DEN140033 | Comment |
| Subject DeviceSPEAC® System | Predicate DeviceBrain Sentinel® Monitoring and AlertingSystem | ||
| Laptop Base StationRecharging Accessories | 12V / 1.5A | 12V / 1.5A | Same; No change. |
| Arm Strap | |||
| sEMG Monitor ArmStrapMDDS | Black Spandex Arm Strap | Black Spandex Arm Strap | Same; No change. |
| Medical Device DataSystems | Physician Portal (SPEAC2ME®) | Physician Portal (SPEAC2ME®) | Similar; The portal has been upgradedto allow physicians to disable the alertmode for record only mode. |
| Limitations | |||
| Warnings & Limitations | The System is available byprescription only from a physician orproperly licensed practitioner. The System should not be used as astandalone monitor for monitoringseizures and is not intended to beused during physical activity. The device is not a seizure detectiondevice. | For prescription use only. The device is not a GTC seizuredetection device and should not beused to guide medical therapydecisions. The safety and effectiveness of theBrain Sentinel® Monitoring andAlerting System has not beenestablished in monitoring sEMG | Similar with modifications to alignand be consistent with the indicationsfor use (i.e., recording mode) and tobetter inform users and patients onappropriate use of the subject device. |
| Characteristic | K182180 | DEN140033 | Comment |
| Subject Device | Predicate Device | ||
| SPEAC® System | Brain Sentinel® Monitoring and AlertingSystem | ||
| The System alarms are not forstandalone use and should not beused to guide medical therapydecisions. The System has not beendemonstrated to affect any clinicaloutcome such as status epilepticus,brain damage, or death following aGTC seizure. The System does not predict sEMGsignals that may be associated withGTC seizures. The device providesan alert from -30.82 – 25.06 seconds,with an average of 5.34 seconds(SEM ± 2.86), following the onset ofSEMG activity that may beassociated with a GTC seizure. The System does not predict seizureonset. The safety and effectiveness of theSystem has not been established inpediatric populations. | signals that may be associated withseizures other than the GTCS. The safety and effectiveness of theBrain Sentinel® Monitoring andAlerting System has not beenestablished in pediatric populations. The device is not intended to be usedas a stand-alone monitoring device. The device is not intended to be usedduring physical activity. This device does not predict seizureonset. PLEASE REFER TO THELABELING FOR A MORECOMPLETE LIST OFWARNINGS, PRECAUTIONS ANDCONTRAINDICATIONS. | ||
| Characteristic | K182180 | DEN140033 | Comment |
| Subject Device | Predicate Device | ||
| SPEAC® System | Brain Sentinel® Monitoring and AlertingSystem | ||
| 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 DeviceSPEAC® Systemapplications, or alter theconfiguration or environmentvariables of this. | Predicate DeviceBrain Sentinel® Monitoring and AlertingSystem |
Table 4: Comparison of Technological Characteristics to Predicate Device
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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.).
§ 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.