(169 days)
Not Found
No
The summary explicitly states "the software does not provide any diagnosis based on the data" and there are no mentions of AI, DNN, ML, training sets, or test sets. The analysis methods described are standard Frequency EEG analysis and EP display methods.
No.
The device is intended for the acquisition, display, and storage of brain electrical activity to aid in diagnosis, not for therapeutic intervention.
Yes
The "Intended Use / Indications for Use" states that the device is intended "to aid in diagnosis" of electrical activity of a patient's brain.
No
The device description explicitly states that the system is comprised of hardware components including an amplifier, EEG cap, subject response device, laptop computer, and charging kit, in addition to the software.
Based on the provided information, the NeuralScan System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic purposes. This examination is typically performed outside of the living organism.
- NeuralScan System's Function: The NeuralScan System acquires, displays, and stores electrical activity of the brain (EEG and ERP) by placing electrodes on the patient's head. This is a direct measurement of physiological signals from within the living body, not an examination of a specimen in vitro.
- Intended Use: The intended use is to aid in diagnosis by acquiring and analyzing electrical brain activity, which is a direct physiological measurement.
Therefore, the NeuralScan System falls under the category of devices that measure physiological signals directly from the body, rather than examining specimens outside the body.
N/A
Intended Use / Indications for Use
The NeuralScan 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.
Product codes (comma separated list FDA assigned to the subject device)
OLT, GWJ, GWQ
Device Description
The NeuralScan System is comprised of the NeuralScan Amplifier with embedded firmware for acquisition and transmission of physiological signals, an EEG cap, a Subject Response Device, a laptop computer preloaded with the NeuralScan Evoke software, and a charging kit (that consists of a USB cable, clip kit, and wall adapter).
The NeuralScan Evoke software runs in a Windows Operating System environment and controls the 23 channel (21 EEG and 2 bio channels) NeuralScan EEG amplifier via a USB cable or Wi-Fi connection. The software has a graphical user interface that allows the user to input patient information, create new records, conduct studies to collect EEG and ERP data, view live data streams of the laptop display, record data to a file, analyze resultant test data using standard Frequency EEG analysis and EP display methods and print the results. The software includes a mode to measure the cap electrode impedances which is useful for determining if the electrodes are making a good electrical connection with the scalp at each electrode location. Interpretation of the data is the responsibility of the physician as the software does not provide any diagnosis based on the data.
The patient contacting accessories are commercially sourced and used without modification. The device and the accessories are not sterile and are not intended to be sterilized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's brain (scalp)
Indicated Patient Age Range
All age groups
Intended User / Care Setting
Intended for use by qualified medical personnel only in any healthcare, medical, athletic or sports clinic, or outside of medical facilities provided they are led by qualified medical personnel.
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)
Bench testing was carried out on the following characteristics:
- Electroencephalograph (EEG)
- Measurement accuracy
- Communication, data transmission and storage
- Reliability (QoS) Wireless Quality of Service
- Electromagnetic compatibility (EMC)
- Electrical safety testing
- Wireless Coexistence Wi-Fi testing
- Software verification and validation testing
- Biocompatibility verification
In addition to the above, usability testing was also conducted.
The NeuralScan device was tested and meets the requirements of following
- IEC 60601-1- Medical Electrical Equipment Part 1: Basic safety and essential performance ● Ed3.1 2005+A1:2012
- IEC 60601-1-2:2014 - Medical electrical equipment-basic safety and essential performance-EMC
- IEC 60601-2-26:2012 Medical electrical equipment - Part 2-26: Basic safety and essential performance of electroencephalographs
- ISO 15223-1:2012 Medical devices - symbols to be used with medical device labels, labelling, and information to be supplied - part 1: general requirements
Results:
- Accuracy of signal reproduction: Pass. Test shows that NeuroScan system accurately reproduces EEG signals over the specified range.
- Input dynamic range and differential offset voltage (300mV Offset): 1.5% error: Pass. (187mV Offset): 1.5% error: Pass.
- Input Noise: Maximum noise: 3.4 µV: Pass.
- Frequency Response: 0.5 Hz: 100%: Pass; 5 Hz: 105%: Pass; 50 Hz: 76%: Pass.
- Common mode rejection (With 0 DC Offset): 67.3µVpp: Pass. (With 187mV dc Offset): 68µVpp: Pass.
Software verification and validation testing were conducted following the FDA guidance document for software contained in medical devices. The software was considered to be a "moderate" level of concern since a failure or latent flaw could indirectly result in a minor injury to the patient through incorrect or delayed information or through action of the operator.
No Clinical testing was necessary to determine substantial equivalence.
Based on information obtained on the predicate device with reference to the design specification, electrical safety / EMC testing and intended use, the NeuralScan device was subjected to the same type of testing. The results support the conclusion that the NeuralScan device is substantially equivalent to the Predicate devices.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Medeia, Inc. % Daniel Lehtonen Regulatory Consultant Compliance and Regulatory Services LLC 3771 Southbrook Dr Dayton, Ohio 45430
Re: K192753
Trade/Device Name: NeuralScan System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLT, GWJ, GWQ Dated: February 19, 2020 Received: February 20, 2020
Dear Daniel Lehtonen:
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 probibitions 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting (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/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 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 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 (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).
Sincerely,
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192753
Device Name
NeuralScan System
Indications for Use (Describe)
The NeuralScan 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.
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) |
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."
3
Image /page/3/Picture/0 description: The image shows the logo for Medeia. The word "Medeia" is written in a combination of colors, with the "M" in green and yellow, the "ede" in black, and the "ia" in blue. Below the word "Medeia" is the phrase "Designed for Clinicians" in a smaller font size.
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the Requirements of Safe Medical Device Systems Act 1990 and 21 CFR Sec. 807.92
510(k) Number:
a1 APPLICANT INFORMATION:
| Date Prepared: | 26 September 2019 |
|---|---|
| Name: | Medeia, Inc. |
| Address: | 7 W. Figueroa Street |
| Suite 300 | |
| Santa Barbara, CA, 93101 |
| Contact Person: | Slav Danev |
|---|---|
| Phone Number: | +1 800 433 4609 |
| Fax Number: | +1 800 433 4609 |
| Email: | danev@medeia.com |
a2 NAME OF DEVICE:
| Trade Name: | NeuralScan System |
|---|---|
| Common Name: | EEG/EP System, EEG Amplifier |
| Classification Name: | Non-normalizing quantitative electroencephalograph software |
| 21 CFR 882.1400 (OLT); | |
| Full-montage standard electroencephalograph | |
| 21 CFR 882.1400 (GWQ); | |
| Stimulator, auditory, evoked response | |
| 21 CFR 882.1900 (GWJ) | |
| Classification Panel: | Neurology |
аЗ PREDICATE DEVICES:
| Predicate Device: | K171781; eVox System |
|---|---|
| Predicate Device: | K141316; CognisionTM |
The FDA database for recalls was searched on 15 Aug 2019 during the preparation of the 510(k) submission and no recalls for the devices noted above were found.
4
Image /page/4/Picture/1 description: The image shows the logo for Medeia. The word "Medeia" is written in a bold, sans-serif font, with the first letter "M" in green and blue gradient. Below the word "Medeia" is the phrase "Designed for Clinicians" in a smaller, sans-serif font.
a4 STATEMENT OF INTENDED USE:
The NeuralScan System is intended for the acquisition, display, analysis, 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.
a5 DESCRIPTION OF THE DEVICE:
The NeuralScan System is comprised of the NeuralScan Amplifier with embedded firmware for acquisition and transmission of physiological signals, an EEG cap, a Subject Response Device, a laptop computer preloaded with the NeuralScan Evoke software, and a charging kit (that consists of a USB cable, clip kit, and wall adapter).
The NeuralScan Evoke software runs in a Windows Operating System environment and controls the 23 channel (21 EEG and 2 bio channels) NeuralScan EEG amplifier via a USB cable or Wi-Fi connection. The software has a graphical user interface that allows the user to input patient information, create new records, conduct studies to collect EEG and ERP data, view live data streams of the laptop display, record data to a file, analyze resultant test data using standard Frequency EEG analysis and EP display methods and print the results. The software includes a mode to measure the cap electrode impedances which is useful for determining if the electrodes are making a good electrical connection with the scalp at each electrode location. Interpretation of the data is the responsibility of the physician as the software does not provide any diagnosis based on the data.
The patient contacting accessories are commercially sourced and used without modification. The device and the accessories are not sterile and are not intended to be sterilized.
The NeuralScan System is intended for prescription use in any healthcare, medical, athletic or sports clinic, or outside of medical facilities provided they are led by qualified medical personnel.
The device is intended for use by qualified medical personnel only and qualifies for exemption per 21 CFR 801 Subpart D Prescription devices.
TECHNOLOGICAL CHARACTERISTIC COMPARISON: аб
NeuralScan product share similar device characteristics, intended use, performance, specifications, sensors and is the same in design, function, and application to the predicate devices.
The comparison table, beginning on page 5, demonstrates that the NeuralScan device is substantially equivalent to the predicate devices. The nonclinical data support the safety of the device and the hardware and software verification and validation demonstrate that the NeuralScan device should perform as intended in the specified use conditions.
Based on comparisons of device technological characteristics, features, materials, intended use and performance the NeuralScan has been shown to be substantially equivalent to the commercially available predicate devices.
5
Image /page/5/Picture/1 description: The image shows the logo for Medeia. The logo has the word "Medeia" in a sans-serif font, with the first letter "M" in green and blue, and the rest of the letters in black. Below the word "Medeia" is the phrase "Designed for Clinicians" in a smaller font.
b1 NON-CLINICAL TESTING:
Bench testing was carried out on the following characteristics:
- . Electroencephalograph (EEG)
- Measurement accuracy
- Communication, data transmission and storage
- Reliability (QoS) Wireless Quality of Service
- Electromagnetic compatibility (EMC)
- Electrical safety testing
- . Wireless Coexistence Wi-Fi testing
- . Software verification and validation testing
- Biocompatibility verification
In addition to the above, usability testing was also conducted.
Referenced Standards and Performance Testing:
The NeuralScan device was tested and meets the requirements of following
- IEC 60601-1- Medical Electrical Equipment Part 1: Basic safety and essential performance ● Ed3.1 2005+A1:2012
- IEC 60601-1-2:2014 - Medical electrical equipment-basic safety and essential performance-EMC
- . IEC 60601-2-26:2012 Medical electrical equipment - Part 2-26: Basic safety and essential performance of electroencephalographs
- ISO 15223-1:2012 Medical devices - symbols to be used with medical device labels, labelling, and information to be supplied - part 1: general requirements
| Test | Test Method Summary | Results / P or F
(per IEC 60601-2-26
performance limits) |
|------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Accuracy of signal
reproduction
Purpose: verify signal is
accurately reproduced over
a range of amplitudes. | Test circuit and method per IEC 60601-2-26
clause 201.12.1.101.1. Amplitude of 2Hz
Triangle wave varied from 50μV to 500μV.
IEC 60601-2-26 Pass-Fail Limit: error 71%, 200 ΜΩ | > 10 ΜΩ | > 60 ΜΩ | Performance testing per IEC 60601-
2-26:2012 confirmed 10 ΜΩ is
sufficient to eliminate distortion in the
measured signal. | |
| Analog to Digital
Conversion | 24 Bit | 24 Bit | 16 Bit | | |
| Sampling Rate | 200, 500, 1000 Hz | 250 Hz | 125/250 Hz | Clinically relevant human
electrophysiology does not exceed
100 Hz and therefore there is no
technical need to sample above 250
Hz. | |
| Common mode
rejection | >110 dB | >110 dB | >90dB | | |
| Analysis Software | Embedded, commercially
available, and user defined. | Embedded, commercially
available, and user defined. | Embedded, commercially
available, and user defined. | | |
| Resolution | 24 bits | 24 bits | 16 bits | | |
| Band Pass | 0.1 to 50 Hz | 0.1 to 50 Hz | 0.4 to 40 Hz | | |
| Noise | 2-3 μVp-p | 2-3 μVp-p | ≤1μV RMS | | |
| Audio Type | Burst (White Noise) | Burst (White Noise) | Unknown | The NeuroScan system uses a burst
type noise stimulus to evoke and
ERP | |
| Audio Duration | 100ms | 100ms | 50ms | | |
| Audio Side | Both | Both | Unknown | | |
| Trade Name | NeuralScan System | eVox System | Cognision™ | Comments | |
| Audio Frequency
Range | 440Hz-16kHz | 440 Hz-16kHz | Unknown | The NeuralScan system generates a
sound with a frequency range of
440Hz-16kHz which is a sufficiently
wide enough band for human
hearing. | |
| Intensity | 0 to 85dB | 0 to 85dB | Unknown | The sound emitted by the
NeuralScan system is a flat white
noise burst, therefore the peak and
average are the same. Maximum
decibel level is 85dB, well below
125dB (no risk to user). | |
| Audio Noise
Patterns | 12.5% occurrence randomly
distributed over 10 minutes | 12.5% occurrence randomly
distributed over 10 minutes | 10% occurrence within 10-60
minutes | The balance of this pattern is best to
elicit the desired ERPs. | |
| Input Voltage
Range | ± 400 mV | ± 150 mV | Not Stated | Due to the 24x gain that is applied to
the A/D channels by the NeuralScan
the dynamic range is ± 400 mV for
the NeuralScan System which is
sufficient for its use environment. | |
| General Specifications | | | | | |
| Safety Standards
Compliance | IEC 60601-1: 2005 +
CORR. 1:2006 + CORR.
2:2007 + AM1:2012 (or IEC
60601-1: 2012 reprint)
EN 60601-1-2:2014
IEC 60601-2-26:2012 | IEC 60601-1: 2005 +
CORR. 1:2006 + CORR.
2:2007 + AM1:2012 (or IEC
60601-1: 2012 reprint)
EN 60601-1-2:2012
IEC 60601-2-26:2012 | UL 60601-1:2003
EN60601-1-2/A1:2007
EN60601-1-2/A1:2007
EN 60601-2-26
IEC 60601-2-40 | | |
| Operating
Environment | 10 to +45 °C, Relative humidity,
30% to 70% non- condensing | 0 to +45 °C, Relative humidity,
5% to 95% non- condensing | 60-90 °F | | |
| Storage
Environment | -40° to 70° C, Relative humidity,
5% to 95% non- condensing | -20° to 45° C, Relative humidity,
5% to 95% non- condensing | Not Published | | |
8
Image /page/8/Picture/0 description: The image shows the logo for Medeia. The logo has the word "Medeia" in a sans-serif font, with the "M" in green and yellow, and the rest of the letters in black. Below the word "Medeia" is the phrase "Designed for Clinicians" in a smaller, sans-serif font.
9
Image /page/9/Picture/0 description: The image shows the logo for "Medeia". The logo has a stylized "M" in green and yellow, followed by the rest of the word "edeia" in black. Below the word "Medeia" is the phrase "Designed for Clinicians" in a smaller font size.
10
Image /page/10/Picture/0 description: The image shows the logo for Medeia. The logo has the word "Medeia" in black font, with the "M" in green and blue. Below the word "Medeia" is the phrase "Designed for Clinicians" in a smaller blue font.
11
Image /page/11/Picture/0 description: The image shows the logo for Medeia. The word "Medeia" is written in a bold, sans-serif font, with the "M" in green and yellow, and the rest of the letters in black. Below the word "Medeia" is the phrase "Designed for Clinicians" in a smaller, blue font.
12
Image /page/12/Picture/0 description: The image shows the logo for Medeia. The word "Medeia" is written in a bold, sans-serif font, with the "M" in green and blue and the rest of the letters in black. Below the word "Medeia" is the phrase "Designed for Clinicians" in a smaller, sans-serif font.
| Conclusion | The comparison tabulated above demonstrates that the NeuralScan device is
substantially equivalent to the predicate devices. The nonclinical data support the
safety of the device and the hardware and software verification and validation
demonstrate that the NeuralScan device should perform as intended in the
specified use conditions. |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Declarations | • This summary includes only information that is also covered in the body of the
510(k).
• This summary does not contain any puffery or unsubstantiated labeling claims.
• This summary does not contain any raw data, i.e., contains only summary
data.
• This summary does not contain any trade secret or confidential commercial
information.
• This summary does not contain any patient identification information. |