(220 days)
Not Found
No
The summary describes standard EEG and ERP analysis techniques and does not mention any AI or ML algorithms. The performance studies focus on comparing the software's output to a predicate device using traditional statistical methods.
No.
The device is described as a software for displaying, storing, and evaluating electrical activity of the brain (EEG and ERP), which are diagnostic functions, not therapeutic ones.
Yes
This device is used for the display and storage of electrical activity of a patient's brain and for the post-hoc statistical evaluation of the human electroencephalogram (EEG) and event-related potentials (ERP), which are all diagnostic functions. It also performs real-time and offline analysis functions and displays analysis results.
Yes
The device description explicitly states "The NeuroField Analysis Suite is Software as a Medical Device (SaMD)." While it integrates with and gets data from an EEG system (Q21 EEG system), the device itself, as described, is the software suite for analysis and display, not the hardware acquisition system.
Based on the provided information, the NeuroField Analysis Suite is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic purposes. This typically involves analyzing biological samples like blood, urine, tissue, etc.
- NeuroField Analysis Suite's Function: The NeuroField Analysis Suite analyzes electrical activity of the brain (EEG and ERP) directly from the patient. It does not analyze specimens derived from the body.
- Intended Use: The intended use is for the display, storage, and statistical evaluation of brain electrical activity, not for the analysis of biological samples.
Therefore, the NeuroField Analysis Suite falls under the category of a medical device that analyzes physiological signals directly from the patient, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NeuroField Analysis Suite is to be used by qualified clinical professionals for the display and storage of electrical activity of a patient's brain, including the post-hoc statistical evaluation of the human electroencephalogram (EEG) and event-related potentials (ERP).
Product codes (comma separated list FDA assigned to the subject device)
OLU, GWJ
Device Description
The NeuroField Analysis Suite is a Normalizing Quantitative Electroencephalograph (QEEG) Software that can (1) execute EEG analysis and (2) conduct ERP test and ERP analysis. The NeuroField Analysis Suite is Software as a Medical Device (SaMD).
The NeuroField Analysis Suite consists of two modules, the NF EEG Analysis Module and the NF ERP Module.
The NF EEG Analysis Module is a separate analysis module that integrates with the Q21 EEG system by adding "Analysis", "Report", and "Tools" menu items and toolbars. It performs real-time and offline analysis functions and displays analysis results in separate windows in the UI, which can be accessed via the "Analysis" and "Reports" menu items.
The NF ERP Module is a separate evoked response potential (ERP) module that can control and get data from the Q21 EEG system and performs typical ERP functions like stimulus presentation, EEG epoching, epoch averaging, reaction time, and ERP display. The NF ERP Module is a separate stand-alone application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Electroencephalogram (EEG), event-related potentials (ERP)
Anatomical Site
Brain
Indicated Patient Age Range
Patients of all ages.
Intended User / Care Setting
qualified clinical professionals
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)
Comparative performance evaluations showed that the same EDF file, loaded to NF-EEG and Neuroguide shows comparable signals on the EEG Plot. When the spectrums are calculated, the result from both programs shows comparable spectrum and sidelobes both for real and simulated data. Both programs show comparable Z-Scores. The visualization of headmaps in both programs also shows comparable topographies over the standard EEG bands. Therefore, NF-EEG demonstrates a comparable performance to the predicate device.
Since an ERP test requires perfect synchronization between the stimulus time recording and EEG data, comparative performance evaluations were not performed directly between the Neurofield ERP and eVox systems. Instead, a mathematical validation of NF-ERP was performed. This mathematical assessment shows that the generated averaged ERPs are mathematically correct. Moreover, the analysis of real data shows that the NF-ERP can elicit correct ERP components, the generated stimulus is reliable, and the split-half reliability measure confirms test reliability. As a result, the NF-ERP and eVox systems will both produce comparable, mathematically correct oddball ERPs, and the NF-ERP performs that task as well as the predicate device.
Clinical performance evaluations are not necessary to demonstrate substantial equivalence to the predicate device.
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
§ 882.1400 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 20, 2024
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NeuroField Inc. % Tom Renner Quality, Efficiency & Regulatory Affairs Consultant Vision28 915 SW Rimrock Way Ste 201 Pmb 402 Redmond, Oregon 97756
Re: K240420
Trade/Device Name: NeuroField Analysis Suite Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLU, GWJ Dated: February 13, 2024 Received: February 13, 2024
Dear Tom Renner:
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"
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(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).
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 Rue"). 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).
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Sincerely,
Image /page/2/Picture/3 description: The image shows the text "Patrick Antkowiak -S" to the right of the letters "FDA". The letters "FDA" are in a light blue color. The text "Patrick Antkowiak -S" is in black.
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) K240420
Device Name NeuroField Analysis Suite
Indications for Use (Describe)
The NeuroField Analysis Suite is to be used by qualified clinical professionals for the display and storage of electrical activity of a patient's brain, including the post-hoc statistical evaluation of the human electroencephalogram (EEG) and event-related potentials (ERP).
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| Research Use (Per 21 CFR 201.26(a) and (b)) Over-The-Counter Use (21 CFR 201.66) | Research Use (Per 21 CFR 201.26(a) and (b)) | Over-The-Counter Use (21 CFR 201.66) |
| Research Use (Per 21 CFR 201.26(a) and (b)) | ||
| Over-The-Counter Use (21 CFR 201.66) |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Contact Details
| Applicant Name: | NeuroField Inc. |
|---|---|
| 1836 State Street | |
| Santa Barbara, CA 93101 | |
| Contact Name: | Tom Renner |
| Quality, Efficiency & Regulatory Affairs Consultant | |
| Vision28 | |
| tom@vision28.com | |
| 541 359 5939 | |
| Date Prepared: | September 19, 2023 |
Device Name
| Trade Name: | NeuroField Analysis Suite |
|---|---|
| Product Code: | OLU, GWJ |
| Common and Classification Name: | Electroencephalograph |
| Classification Regulation: | 21 CFR 882.1400 |
| Product Class: | Class II |
Legally Marketed Predicate Device
| 510(k) | Product Code | Trade Name | Applicant |
|---|---|---|---|
| K041263 | OLU | NeuroGuide | |
| Analysis System | Applied Neuroscience, Inc. | ||
| 228 176th Terrace Drive | |||
| St. Petersburg, Florida 33708 |
Legally Marketed Secondary Predicate Device
| 510(k) | Product Code | Trade Name | Applicant |
|---|---|---|---|
| K171781 | GWJ | eVox System | Evoke Neuroscience, Inc. |
| 200 Valencia Dr. Suite 109 | |||
| Jacksonville, North Carolina 28546 |
Device Description
I. Overview
5
The NeuroField Analysis Suite is a Normalizing Quantitative Electroencephalograph (QEEG) Software that can (1) execute EEG analysis and (2) conduct ERP test and ERP analysis. The NeuroField Analysis Suite is Software as a Medical Device (SaMD).
II. Major Components
The NeuroField Analysis Suite consists of two modules, the NF EEG Analysis Module and the NF ERP Module.
The NF EEG Analysis Module is a separate analysis module that integrates with the Q21 EEG system by adding "Analysis", "Report", and "Tools" menu items and toolbars. It performs real-time and offline analysis functions and displays analysis results in separate windows in the UI, which can be accessed via the "Analysis" and "Reports" menu items.
The NF ERP Module is a separate evoked response potential (ERP) module that can control and get data from the Q21 EEG system and performs typical ERP functions like stimulus presentation, EEG epoching, epoch averaging, reaction time, and ERP display. The NF ERP Module is a separate stand-alone application.
Intended Use/Indications for use
The NeuroField Analysis Suite is to be used by qualified medical and qualified clinical professionals for the display and storage of electrical activity of a patient's brain, including the post-hoc statistical evaluation of the human electroencephalogram (EEG) and eventrelated potentials (ERP).
Substantial Equivalence Comparison
Based upon comparisons of regulatory parameters, features, and performance evaluations, the NeuroField EEG Analysis module of the NeuroField Analysis Suite is substantially equivalent to the primary predicate device, NeuroGuide Analysis System (K041263), and the NeuroField ERP functions are substantially equivalent to the secondary predicate device, eVox System (K171781).
The comparison between the NeuroField Analysis Suite, the primary predicate NeuroGuide Analysis System (K041263) and the secondary predicate eVox System (K171781) below consists of a series of tables followed by explanations of the similarities and differences described in each table.
III. Comparison of Regulatory Parameters
| Comparison | NeuroField Analysis Suite | Primary Predicate:
NeuroGuide Analysis
System (K041263) | Secondary Predicate:
eVox System (K171781) |
| ------------ | --------------------------- | --------------------------------------------------------------- | ----------------------------------------------- |
|---|
6
| Indications
for use | The NeuroField Analysis
Suite is to be used by
qualified medical and
qualified clinical
professionals for the
display and storage of
electrical activity of a
patient's brain, including
the post-hoc statistical
evaluation of the human
electroencephalogram
(EEG) and event-related
potentials (ERP). | The NeuroGuide
Analysis system is to be
used by qualified
medical and qualified
clinical professionals for
the post-hoc statistical
evaluation of the
human
electroencephalogram
(EEG). | The eVox System is
intended for the
acquisition, display, and
storage, of electrical
activity of a patient's
brain including
electroencephalograph
(EEG) and event-related
potentials (ERP) obtained
by placing two or more
electrodes on the head
to aid in diagnosis. |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
population | Patients of all ages. | Patients of all ages (“2
months to 82 years”). | All age groups. |
| Common or
usual name | Normalizing Quantitative
Electroencephalograph
Software
Stimulator, Auditory,
Evoked Response | Normalizing Quantitative
Electroencephalograph
Software | Full Montage
Electroencephalograph
Stimulator, Auditory,
Evoked Response |
| Regulatory
Class | Class II | Class II | Class II |
| Classification
name and
product code | 882.1400
Electroencephalograph
OLU
882.1900 Evoked response
auditory stimulator GWJ | 882.1400
Electroencephalograph
OLU | 882.1400
Electroencephalograph
GWQ
882.1900 Evoked
response auditory
stimulator
GWJ |
Discussion of Similarities and Differences
The NeuroField Analysis Suite and the primary predicate are materially the same in regulatory parameters:
- Both are Normalizing Quantitative Electroencephalograph Software that can be ● used with all ages of patients
- Both are for statistical evaluation of the human electroencephalogram (EEG)
- Both have the same classification name, primary product code, and regulatory class
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The Indications for Use of the NeuroField Analysis Suite consist of a combination of the Indications for use of the predicate ("The NeuroGuide Analysis system is to be used by qualified medical and qualified clinical professionals for the post-hoc statistical evaluation of the human electroencephalogram (EEG).") and the relevant section of the Indications for Use of the secondary predicate ("display, and storage, of electrical activity of a patient's brain including electroencephalograph (EEG) and event-related potentials (ERP)".
The secondary predicate is provided because of its event-related potentials (ERP) features, compared below.
| IV. Comparison of Features – EEG Analysis (OLU) | |||
|---|---|---|---|
| Category | Comparison | NeuroField Analysis Suite | Primary Predicate: |
| NeuroGuide Analysis System (K041263) | |||
| General | Default File Format | Proprietary nfx format | Proprietary ng format |
| Supported Open File Standards | EDF, EDF+, XDF | EDF, EDF+ | |
| Supported Device and Vendors | Neurofield Q21 | Neurofield Q21 and various other vendors | |
| Re-montaging | Yes | Yes | |
| IIR Filtering | Yes | Yes | |
| Notch Filtering | Yes | Yes | |
| Add Event Markers | Yes | Yes | |
| Analyze Whole Data | Yes | Yes | |
| Analyze Selected Interval | Yes | Yes | |
| Analyze Selected Markers only | Yes | No | |
| Power | |||
| Analysis | Absolute Power | ||
| Raw/Z-Scores | Yes | Yes | |
| Relative Power Raw / Z-Scores | Yes | Yes | |
| Power Ratios Raw / Z-Scores | Yes | Yes | |
| Head Maps | Yes | Yes | |
| FFT Spectrum | Yes | Yes | |
| Frequency | |||
| Resolution | 0.5 Hz | 0.5 Hz | |
| Single Frequency | |||
| Side-Lobe |