(30 days)
No
The summary describes a device that records and processes EEG data to calculate quantitative EEG (qEEG) measurements (relative band power). There is no mention of AI, ML, or any algorithms that learn from data to perform tasks or make predictions. The performance studies focus on standard electrical and signal processing accuracy, not on the performance of a learning algorithm.
No
The device is intended to record and display qEEG to help the user analyze the EEG; it does not provide diagnostic conclusions or treatment.
No
The "Intended Use / Indications for Use" section explicitly states, "The SignalNED does not provide any diagnostic conclusion about the patient's condition." Its purpose is to record and display qEEG to "help the user analyze the EEG."
No
The device description explicitly lists hardware components such as a portable EEG machine, battery, charger, sensor cap, and cable, indicating it is not software-only.
Based on the provided information, the SignalNED Device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The SignalNED Device records electrical activity on the human body (EEG).
- The intended use is to record and display qEEG to help analyze the EEG. This is a measurement and analysis tool for physiological signals, not for analyzing biological samples like blood, urine, or tissue.
- The device description focuses on EEG acquisition and processing. It describes electrodes, a sensor cap, and the calculation of relative band power from the EEG signal.
- There is no mention of analyzing biological samples.
Therefore, the SignalNED Device falls under the category of a medical device that measures and processes physiological signals, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
OMC, OLT, GWQ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Head
Indicated Patient Age Range
Adults
Intended User / Care Setting
Qualified medical and clinical professionals in a professional healthcare environment.
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
- Lead Off Detection: Test designed to validate the ability to detect disconnected electrodes. All testing passed acceptance criteria.
- Signal Acquisition Noise Levels: Test designed to assess noise levels in signal acquisition. All testing passed acceptance criteria.
- Software ADC Conversion Accuracy: Test designed to verify accuracy of software in ADC conversion. All testing passed acceptance criteria.
- Quantitative Electroencephalogram (QEEG): Test designed to ensure accuracy of the QEEG Relative Band Power calculation. All testing passed acceptance criteria.
- EC12:2020 Electrical Performance: Test designed to confirm compliance with EC12:2020 electrical standards. All testing passed acceptance criteria.
- Essential Performance Tests (IEC 80601-2-26): Test designed to verify compliance with IEC 80601-2-26 essential performance requirements. All testing passed acceptance criteria.
Electrical Performance: Electrical testing conducted on the subject device complies with IEC 60601-1, IEC 60601-1-2. All testing passed.
Biocompatible Performance: 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. End points tested according to EN-ISO-10993-1:2020 include ISO 10993-1: Risk Management, ISO 10993-5: Cytotoxicity, ISO 10993-10: Sensitization, and ISO 10993-23: Irritation or intracutaneous reactivity. All testing passed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).
0
September 4, 2024
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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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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
(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
The SignalNED Model RE System
K Pending | Primary Predicate Device
Ceribell Pocket EEG
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
the patient's condition | Device does not provide any diagnostic conclusions about
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
OMC
Predicate | K143487
OLT
Predicate | K171459
GWQ
Predicate | Discussion |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Device Characteristics | | | | | |
| EEG Data Acquisition | 10 electrodes to
form 8 recording
channels | 10 electrodes to
form 8 recording
channels | | | Similar |
| Data Acquisition Method | Analog to digital
converter | Analog to digital
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
802.11 b/g/n | 2.4 GHz IEEE
802.11 b/g/n | | | Similar |
| Antenna Type | Integrated | Integrated | | | Similar |
| Form Factor / Dimensions | Surface mount
PCB module | Surface mount
PCB module | | | Similar |
| Integrated Processor and Memory | 1.8GHz Quad
CortexTM-A53 | STM32 ARM
Cortex-M3 | | | Similar; The
subject device |
| Device & Predicate Device(s): | K242306 | K170363
OMC
Predicate | K143487
OLT
Predicate | K171459
GWQ
Predicate | Discussion |
| | NXP i.MX 8M
Plus | processor with
64 KB RAM | | | includes
additional
processing and
memory
capability |
| Device Power | Battery Powered | Battery Powered | | | Similar |
| Battery | 100-240 V AC
power adapter to
battery charger | 100-240 V AC
power adapter to
battery charger | | | Similar |
| Differential input impedance | >2 Gohm | | >20 Mohm | | Similar;
electrical
specification
exceeds
predicate device.
This difference
does not impact
safety and
effectiveness. |
| Common mode input impedance | >1 Gohm | | >100 Mohm | | Similar:
electrical
specification
exceeds
predicate
device. This
difference does
not impact safety
and
effectiveness. |
| Channel equivalent input noise | 1.97 μVpp | |