SignalNED System (Model RE)

{0}------------------------------------------------ September 4, 2024 Image /page/0/Picture/1 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. Forest Devices, Inc. % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059 Re: K242306 Trade/Device Name: SignalNED System (Model RE) Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMC, OLT, GWQ Dated: August 5, 2024 Received: August 5, 2024 Dear Dave Yungvirt: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). {2}------------------------------------------------ Sincerely, Image /page/2/Picture/3 description: The image shows the name "Patrick Antkowiak -S" in black text. The text is positioned to the right of a faded blue FDA logo. The name is split into two lines, with "Patrick" on the first line and "Antkowiak -S" on the second. for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K242306 Device Name SignalNED System (Model RE) ## Indications for Use (Describe) The SignalNED Device is intended to record and display Quantitative EEG (qEEG) (relative band power, e.g., alpha, beta, delta, theta), which is intended to help the user analyze the EEG. The SignalNED does not provide any diagnostic conclusion about the patient's condition. The device is intended to be used on adults by qualified medical and clinical professionals. The SignalNED is intended to be used in a professional healthcare environment. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------|----------------------------------------------------------------------| | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # K242306 # 510(k) Summary # Traditional 510(k) Premarket Notification Summary of Safety and Effectiveness This 510(k) summary was prepared on 5/28/2024 to provide an understanding of the basis for a determination of substantial equivalence in accordance with the requirements outlined in 21 CFR 807.92. The content is also contained with the eSTAR format within Submitter's eSTAR application. # Submitter Information (Contact Details) | Applicant Name: | Forest Devices, Inc. | |--------------------|----------------------------------------------------------------------| | Applicant Address: | 544 Miltenberger St 1st Floor, #4 Pittsburgh PA 15219 United States: | | Applicant Contact: | Telephone: 412.522.0076 | | Applicant Contact: | Email: carmelo.montalvo@forestdevices.com) | Date Prepared: September 3, 2024 ## Device Name | Device Trade Name: | SignalNED System (Model RE) | |----------------------|------------------------------------------------| | Common Name: | Electroencephalograph | | Classification Name: | Reduced-Montage Standard Electroencephalograph | | Regulation Number: | 882.1400 | | Regulatory Class: | Class II | ## Product Code(s) Primary Product Code: OMC Secondary Product Codes: OLT and GXY ## Legally Marketed Predicate Devices | Predicate | Predicate Trade Name<br>(Primary Predicate is listed first) | Product Code | |-----------|-------------------------------------------------------------|------------------------------------------------------------------------------| | K170363 | Ceribell Pocket EEG Device | OMC, Reduced-Montage Standard Electroencephalograph (Primary) | | K143487 | Lifelines iEEG 2.0 | OLT, Non-Normalizing Quantitative Electroencephalograph Software (Secondary) | | K171459 | Ceribell Instant EEG Headband | GXY, Cutaneous Electrode (Secondary) | ## Device Description Summary The SignalNED Model RE machine uses 10 patient electrodes (4 left, 4 right, 2 midh are used to form the 8 channels. The SignalNED machine requires the use of the SignalNED Sensor Cap, and the system includes the following components: - Portable EEG machine (Device) - I Battery & External Battery Charger - I SignalNED Sensor Cap - I SignalNED Sensor Cap Cable The primary function of the SignalNED Model RE is to rapidly record EEG and derive the Quantitative EEG (qEEG) measurement of Relative Band Power for multiple bands (e.g., alpha, beta, theta) at each electrode. These measurements are intended to help the user analyze the underlying EEG. The SignalNED Model RE (client) achieves its intended without relying on wireless comectivity. The SignalNED RE does not provide any diagnostic conclusion about the patient's condition. ## Intended Use/Indications for Use The SignalNED Device is intended to record and store EEG signals and display Quantitative EEG (qEEG) (relative band power, e.g., alpha, beta, delta, theta), which is intended to help the EEG. The SignalNED does not provide any diagnostic conclusion about the patient's condition. The device is intended to be used on adults by qualified medical and clinical professionals. The SignalNED is intended to be used in a professional healthcare environment. {5}------------------------------------------------ ## Substantial Equivalence Comparison Summary | Attribute | Subject Device<br>The SignalNED Model RE System<br>K Pending | Primary Predicate Device<br>Ceribell Pocket EEG<br>K170363 | Comparison | |--------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|------------| | Intended Use | To record and store EEG signals | To record and store EEG signals | Identical. | | | Presents EEG signals in visual formats in device real-time | Presents EEG signals in visual formats in device real-time | Identical. | | | Device does not have a diagnostic claim | Device does not have a diagnostic claim | Identical. | | | Device does not provide any diagnostic conclusions about<br>the patient's condition | Device does not provide any diagnostic conclusions about<br>the patient's condition | Identical. | | | Used on Adults | Used on Adults | Identical. | | Technology | Records and stores EEG signals | Records and stores EEG signals | Identical. | | | Uses specially designed cutaneous electrodes | Uses specially designed cutaneous electrodes | Identical. | | | Uses specially designed cutaneous electrodes | Uses specially designed cutaneous electrodes | Identical. | | | Uses analog to digital converter | Uses analog to digital converter | Identical. | | | Uses frequency band of 0.5Hz - 100Hz | Uses frequency band of 0.5Hz - 100Hz | Identical. | | | Device samples at 250Hz | Device samples at 250Hz | Identical. | | | Displays calculated EEG measures | Displays calculated EEG measures | Identical. | | | Use 2.4 GHz IEEE 802.11 b/g/n WIFI frequency | Use 2.4 GHz IEEE 802.11 b/g/n WIFI frequency | Identical. | | | Uses Integrated Antenna | Uses Integrated Antenna | Identical. | | | Features surface mount PCB module | Features surface mount PCB module | Identical. | | | Battery powered | Battery powered | Identical. | # Intended Use/Indications for Use Comparison Primary Predicate: K170363 Ceribell Pocket EEG The SignalNED Model RE System (Subject Device) is identical to the Primary Predicate (Predicate) in Intended to record and store EEG signals and present them in real-time. Neither the Subject Device nor Primary Predicate provides any diagnostic conclusion about the subject's condition or automated alerts of a clinical event. Additionally, neither device has a diagnostic claim, nor do they provide any diagnostic conclusions about the patient's condition. Both the Primary Predicate are intended to be used on adults by qualified medical and clinical professionals. # Technology Comparison | Device & Predicate Device(s): | K242306 | K170363<br>OMC<br>Predicate | K143487<br>OLT<br>Predicate | K171459<br>GWQ<br>Predicate | Discussion | |-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | General Device Characteristics | | | | | | | EEG Data Acquisition | 10 electrodes to<br>form 8 recording<br>channels | 10 electrodes to<br>form 8 recording<br>channels | | | Similar | | Data Acquisition Method | Analog to digital<br>converter | Analog to digital<br>converter | | | Similar | | Frequency band | 0.5 Hz - 100 Hz | 0.5 Hz - 100 Hz | | | Similar | | Sampling rate | 250 Hz | 250 Hz | | | Similar | | Displays calculated EEG measures | Yes | Yes | | | Similar | | WIFI Frequency Standard | 2.4 GHz IEEE<br>802.11 b/g/n | 2.4 GHz IEEE<br>802.11 b/g/n | | | Similar | | Antenna Type | Integrated | Integrated | | | Similar | | Form Factor / Dimensions | Surface mount<br>PCB module | Surface mount<br>PCB module | | | Similar | | Integrated Processor and Memory | 1.8GHz Quad<br>CortexTM-A53 | STM32 ARM<br>Cortex-M3 | | | Similar; The<br>subject device | | Device & Predicate Device(s): | K242306 | K170363<br>OMC<br>Predicate | K143487<br>OLT<br>Predicate | K171459<br>GWQ<br>Predicate | Discussion | | | NXP i.MX 8M<br>Plus | processor with<br>64 KB RAM | | | includes<br>additional<br>processing and<br>memory<br>capability | | Device Power | Battery Powered | Battery Powered | | | Similar | | Battery | 100-240 V AC<br>power adapter to<br>battery charger | 100-240 V AC<br>power adapter to<br>battery charger | | | Similar | | Differential input impedance | >2 Gohm | | >20 Mohm | | Similar;<br>electrical<br>specification<br>exceeds<br>predicate device.<br>This difference<br>does not impact<br>safety and<br>effectiveness. | | Common mode input impedance | >1 Gohm | | >100 Mohm | | Similar:<br>electrical<br>specification<br>exceeds<br>predicate<br>device. This<br>difference does<br>not impact safety<br>and<br>effectiveness. | | Channel equivalent input noise | 1.97 μVpp | | <3.5 µVpp | | Similar;<br>electrical<br>specification<br>exceeds<br>predicate<br>device. This<br>difference does<br>not impact safety<br>and<br>effectiveness. | | Frequency band | 0.5 Hz - 30 Hz | | 0.16 Hz - 70 Hz<br>(-6 dB) | | Similar; within<br>range of<br>predicate. This<br>difference does<br>not impact safety<br>and<br>effectiveness. | | Low filter | 0.5 Hz | | 0.5 Hz | | Same | | High filter | 30 Hz | | 10 Hz - 100 Hz | | Similar; within<br>range of<br>predicate. This<br>difference does<br>not impact safety<br>and<br>effectiveness. | | Sampling rate | 1 kHz | | 200,256 Hz | | Similar; | | Device & Predicate Device(s): | K242306 | K170363<br>OMC<br>Predicate | K143487<br>OLT<br>Predicate | K171459<br>GWQ<br>Predicate | Discussion | | | | | | | specification<br>exceeds<br>predicate<br>device. This<br>difference does<br>not impact safety<br>and<br>effectiveness. | | Displays calculated EEG measures | Yes | | Yes | | Same | | Calculated EEG measures displayed | Power Spectrum<br>Density | | Spectrum, Power<br>Spectrum,<br>Density, band<br>power, spectral<br>edge, peak<br>frequency | | Similar; subject<br>device is a<br>subset to the<br>predicate<br>device. | | WIFI Frequency Standard | 2.4 GHz IEEE<br>802.11 b/g/n | | 2.4 GHz IEEE<br>802.11 b/g/n | | Similar | | Antenna Type | Integrated | | Integrated | | Similar | | Where used | On the head | | | On the head | Similar | | Means of Connection | A cable<br>attached to the<br>Sensor Cap to<br>allow<br>connection to<br>SignalNED<br>Model RE device | | | A cable<br>attached to<br>the headband<br>to allow<br>connection<br>to an EEG<br>acquisition/recor<br>ding device | Similar | | Electrode Type | Silver/silver-<br>chloride<br>(Ag/AgCl)<br>electrodes | | | Silver/silver-<br>chloride<br>(Ag/AgCl)<br>electrodes | Similar | | Number of Electrodes | 10 electrodes | | | 10 electrodes | Similar | | Electrode Form | Reservoir is<br>filled with<br>conductive<br>electrolyte gel<br>by separate<br>dispensing<br>container | | | Reservoir is<br>filled with<br>conductive<br>electrolyte gel<br>by separate<br>dispensing<br>container | Similar | | Electrode Locations | The placement of<br>the electrodes is<br>according to the<br>International 10-<br>20 system of<br>electrode<br>placement or the<br>American<br>Electroencephalo<br>graphic Society<br>positioning<br>system. | | | The placement<br>of the electrodes<br>is according to<br>the International<br>10- 20 system of<br>electrode<br>placement or the<br>American<br>Electroencephal<br>ographic Society<br>positioning<br>system. The<br>number of the<br>electrodes in use<br>is according to | Similar; both<br>use the<br>International<br>10-20 system of<br>electrode<br>placement or<br>the American<br>Electroencephal<br>ographic<br>Society<br>positioning<br>system. The<br>Subject device<br>uses 10<br>electrodes | | Device & Predicate Device(s): | K242306 | K170363<br>OMC<br>Predicate | K143487<br>OLT<br>Predicate | K171459<br>GWQ<br>Predicate | Discussion | | | | | | whereas the<br>Predicate device<br>has<br>configuration<br>option from 9-<br>19<br>electrodes. | | | Electrode Mounts | Thermoplastic<br>Elastomer | | | Thermoplastic<br>Elastomer | Same | | Available Sizes | Various sizes<br>(overall head<br>size range 26 cm<br>–<br>66 cm) | | | Various sizes<br>(overall head<br>size range 26<br>cm –<br>66 cm) | Same | | Cap Material | Spandex blend:<br>Nylon Knitted<br>Fabric, 82%<br>Nylon and 18%<br>Spandex | | | Spandex blend:<br>Nylon Knitted<br>Fabric, 82%<br>Nylon and 18%<br>Spandex | Same | | Type of Connector | Custom Touch-<br>proof safety<br>socket | | | Touch-proof<br>safety socket<br>DIN 42- 802 | Similar; the<br>electrical<br>performance<br>testing completed<br>for both Subject<br>and Predicate met<br>the same<br>requirements per<br>FDA guidance.<br>document<br>"Cutaneous<br>Electrodes for<br>Recording<br>Purposes-<br>Performance<br>Criteria for Safety<br>and Performance<br>Based Pathway,"<br>August 2020. | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ # Intended Use/Indications for Use Comparison # Secondary Predicate: K143487 Lifelines iEEG 2.0 The Subject is identical to the Secondary Predicate (K143487, Lifelines iEEG 2.0) in Intended to acquire, display, and store EEG signals, using cutaneous electrodes. Neither the Subject Device nor Secondary Predicate provides any diagnostic conclusion about the subject's condition or automated alerts of a clinical event. Additionally, neither device claim, nor do they provide any diagnostic conclusions about the patient's condition. # Technology Comparison ## Secondary Predicate: K143487 Lifelines iEEG 2.0 Both the Subject Device and Secondary Predicate (K143487) are identical in that they display Quantitative Electroencephalograph (qEEG) measures that are derived from the acquired EEG. They are similar in differential input impedance, common mode input impedance, channel equivalent input noise, frequency band, low filter, sampling rate. The Subject exceeds the predicate in electrical specifications or is within the specified range of the Predicate. ## Intended Use/Indications for Use Comparison {9}------------------------------------------------ # Secondary Predicates: K171459 Ceribell Instant EEG Headband The Intended Use of the Subject Device and the Secondary Predicate (K171459, Cerbell Instant EEG Headband) is identical. Both use a disposable headpiece with an integrated array of 10 passive cutaneous electrodes that are applied to the patient's head to record EEG signals when connected to an EEG recording device. ## Technology Comparison ## Secondary Predicates: K171459 Ceribell Instant EEG Headband The technology of the Subject Device and the Secondary Predicate (K171459, Cerbell Instant EEG Headband) is identical in type of patient contact, where used, means of connection, electrodes and electrode form. The Subject and Secondary Predicate both follow placement of the electrodes is according to the International 10-20 system of the American Electroencephalographic Society positioning system. The Subject uses 10 electrodes, and the Seconder 9-19 electrodes. The electrode mounts, sizes electrode cap materials. performance requirement, electrical compliance, designation for use are identical. Both are packaged non-sterile. Both demonstrate conformance to ISO 10993-1, ISO 10993-5, and ISO 10993-10. | Testing | Objective and Outcome | |-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Lead Off Detection | ■ Test is designed to validate the ability to detect disconnected electrodes.<br>■ All testing passed acceptance criteria and details are contained in the test report. | | Signal Acquisition Noise Levels | ■ Test is designed to assess noise levels in signal acquisition.<br>■ All testing passed acceptance criteria and details are contained in the test report | | Software ADC Conversion Accuracy | ■ Test is designed to verify accuracy of software in ADC conversion.<br>■ All testing passed acceptance criteria and details are contained in the test report. | | Quantitative Electroencephalogram<br>(QEEG) | ■ Test is designed to ensure accuracy of the QEEG Relative Band Power calculation.<br>■ All testing passed acceptance criteria and details are contained in the test report. | | EC12:2020 Electrical Performance | ■ Test is designed to confirm compliance with EC12:2020 electrical standards.<br>■ All testing passed acceptance criteria and details are contained in the test report. | | Essential Performance Tests<br>(IEC 80601-2-26) | ■ Test is designed to verify compliance with IEC 80601-2-26 essential performance requirements.<br>■ All testing passed acceptance criteria and details are contained in the test report. | #### Summary of Non-clinical Performance Testing ## Electrical Performance Electrical testing was conducted on the subject device complies with IEC 60601-1, IEC 60601-1-2. All testing passed. # Biocompatible Performance The Forest SignalNED System is an EEG device used by trained medical professionals. The EEG machine datient, but the Sensor Cap, which is part of the system, is placed on the patient's head (Limited Exposure less than 24 hours, Surface Contacting Medical Device that contacts intacts ). The SignalNED was assessed for biocompatibility under the requirements of ISO 10993 for the Biological Evaluation of Medical Devices for cytotoxicity, irritation within the Limited Contact duration (A), for Surface Medical Device for Intact Skin scope. EN-ISO-10993-1:2020 the following test are the end points for our biocompatibility testing: - I ISO 10993-1: Risk Management - ISO 10993-5: Cytotoxicity - 트 ISO 10993-10: Sensitization - I ISO 10993-23: Irritation or intracutaneous reactivity All testing passed. # Conclusion In conclusion, Forest Devices, Inc. has successfully demonstrated that the SignalNED is equivalent in safety and efficacy to the predicate in the intended use, technological characteristics and performance testing. The Forest Devices SignalNED Model RE System raises no additional questions of safety or effectiveness and is substantially equivalent to the cleared with the ences in the Subject Device and predicates do not raise additional questions of safety or effectiveness or exceeds all conditions that are required for establishing substantial equivalence and obtaining FDA clearance to market our medical device, the SignalNED Model RE System.