(101 days)
Not Found
No
The summary describes a standard EEG device and software for acquiring and displaying brain activity. There is no mention of AI, ML, or any features that would suggest the use of such technologies for analysis or interpretation. The performance studies focus on electrical safety, EMC, and software validation, not on the performance of an AI/ML algorithm.
No
The device is described as an electroencephalograph for acquiring and displaying electrical brain activity; it does not provide any treatment or therapy.
No
The device description states, "This device does not provide any diagnostic conclusion about a subject's condition. The generated data serves as an assessment aid..." This indicates it is not a diagnostic device.
No
The device description explicitly states it is a "16-lead electroencephalograph" and a "portable... electroencephalogram (EEG) device" that works with a PC and transfers signals wirelessly. This indicates the device includes hardware components for acquiring the EEG signals, not just software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens from the human body. The description clearly states that NeuroEEG acquires, records, transmits, and displays electrical brain activity directly from the patient. It does not analyze blood, urine, tissue, or other biological specimens.
- The intended use is to measure electrical brain activity. This is a physiological measurement, not an analysis of a biological sample.
- The device is an electroencephalograph (EEG). EEGs are used to measure electrical activity in the brain, which is a direct physiological measurement, not an in vitro test.
Therefore, NeuroEEG falls under the category of a medical device that measures physiological signals, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
NeuroEEG is intended for prescription use to acquire, record, transmit, and display electrical brain activity of patients of all ages.
Product codes (comma separated list FDA assigned to the subject device)
GWQ
Device Description
"NeuroEEG" is a 16-lead electroencephalograph. Electrodes correspond to the international 10-20 standard. It is a portable, non-sterile, non-invasive, non-radiation emitting electroencephalogram (EEG) device that works with a stationary PC with uninterruptible power supply (UPS) or a laptop with an internal battery.
Signal transfer occurs between NeuroEEG and PC via wireless Bluetooth channel. The accompanying MemoryMD software runs on the Windows operating system (OS) Windows 8.1 and later.
This device will be used "By Prescription" pursuant to 21 CFR 801 Subpart D. The medical use of data acquired by "NeuroEEG" is to be performed under the direction and interpretation of a licensed medical professional. This device does not provide any diagnostic conclusion about a subject's condition.
The generated data serves as an assessment aid at medical practices, rehabilitation institutions, diagnostic centers, neurosurgical clinics, OR, ICU, ER, and clinical research institutes.
The device consists of the following components:
- Registration Module: ●
- Bluetooth Adapter
- Charger and USB Cable
- Connection cable of electrode system NeuroCap ●
- Connection cable of electrode system StatNet
- Cuff;
- Flash Card;
- Flash Card Reading Device; ●
- Software Flash Disk with Software Description
- . User's Guide
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Brain
Indicated Patient Age Range
all ages
Intended User / Care Setting
medical practices, rehabilitation institutions, diagnostic centers, neurosurgical clinics, OR, ICU, ER, and clinical research institutes.
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)
Electrical safety and electromagnetic compatibility (EMC) tests have been performed by the accredited laboratories and show full compliance with the standards below. The device under consideration has passed the tests according to (FDA recognition number - standard designation number):
- 19-4 AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And . A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
- . 19-12 - IEC 60601-1-2 Edition 4.0 2014-02, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
- 5-89 IEC 60601-1-6 Edition 3.1 2013-10, Medical Electrical Equipment Part 1-6: . General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usabilitv
- 19-16 IEC 60601-1-11 Edition 2.0 2015-01, Medical Electrical Equipment Part 1-11: . General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment
- IEC 60601-2-26:2012 (Third Edition): Particular requirements for the basic safety and ● essential performance of electroencephalographs
- FCC Part 15: 2015 Subpart B .
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "General Principles of Software Validation". Verification and Validation activities have been successfully performed on the software package, including assurance that functions work as designed, performance requirements and specifications have been met, and that all hazard mitigations have been fully implemented. All testing has met the predetermined acceptance values. Traceability of the requirements specified in the requirement specifications and functional specifications is ensured during component integration, software validation and system testing.
The device under consideration has passed the test according to (Recognition Number standard):
- . 13-79: IEC 62304 Edition 1.1 2015-06, Medical Device Software - Software Life Cycle Processes.
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 logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is 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.
February 16, 2018
MemoryMD Inc. Abdus-Salaam Muwwakkil Chief Quality Officer 205 East 42nd St 14th FL New York, New York 10017
Re: K173460
Trade/Device Name: NeuroEEG Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWQ Dated: November 6, 2017 Received: November 21, 2017
Dear Abdus-Salaam Muwwakkil:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Hoffmann -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173460
Device Name NeuroEEG
Indications for Use (Describe)
NeuroEEG is intended for prescription use to acquire, record, transmit, and display electrical brain activity of patients of all ages.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K173460
510(k) Summary
| Identification of Submitter | |
|---|---|
| Primary Contact Name | Abdus-Salaam Muwwakkil, |
| Chief Quality Officer | |
| MemoryMD Inc. | |
| Address: | 205 E 42nd Street, 14th Floor |
| New York, New York 10017, | |
| USA | |
| Telephone: | 215-341-6373 |
| Fax: | 646-304-1064 |
| Email: | abdus@memorymd.com |
| Name / Address of | |
| Manufacturer: | MemoryMD Inc. |
| 67 35th street, c250 | |
| Brooklyn, New York 11232, | |
| USA | |
| Date Prepared | 11/06/2017 |
| Identification of the subject device | |
| Device Proprietary Name: | NeuroEEG |
| Common Name: | Full-Montage Standard |
| Electroencephalograph | |
| Regulation: | 21 CFR 882.1400 |
| Review Panel: | Neurology |
| Product Code: | GWQ |
| Classification Panel: | Neurology |
| Device Class: | Class II |
| Predicate Device | ||||
|---|---|---|---|---|
| 510(k) Number | Classification | |||
| Product Code | Trade of | |||
| Proprietary | Manufacturer | |||
| K150498 | GWQ | Discovery 24 | Brainmaster | |
| Technologies, Inc. | ||||
| 195 Willis Street, | ||||
| Suite 3 Bedford, OH | ||||
| 44146 |
4
Device Description
"NeuroEEG" is a 16-lead electroencephalograph. Electrodes correspond to the international 10-20 standard. It is a portable, non-sterile, non-invasive, non-radiation emitting electroencephalogram (EEG) device that works with a stationary PC with uninterruptible power supply (UPS) or a laptop with an internal battery.
Signal transfer occurs between NeuroEEG and PC via wireless Bluetooth channel. The accompanying MemoryMD software runs on the Windows operating system (OS) Windows 8.1 and later.
This device will be used "By Prescription" pursuant to 21 CFR 801 Subpart D. The medical use of data acquired by "NeuroEEG" is to be performed under the direction and interpretation of a licensed medical professional. This device does not provide any diagnostic conclusion about a subject's condition.
The generated data serves as an assessment aid at medical practices, rehabilitation institutions, diagnostic centers, neurosurgical clinics, OR, ICU, ER, and clinical research institutes.
The device consists of the following components:
- Registration Module: ●
- Bluetooth Adapter
- Charger and USB Cable
- Connection cable of electrode system NeuroCap ●
- Connection cable of electrode system StatNet
- Cuff;
- Flash Card;
- Flash Card Reading Device; ●
- Software Flash Disk with Software Description
- . User's Guide
Intended Use of Device
NeuroEEG is intended for prescription use to acquire, record, transmit, and display electrical brain activity of patients of all ages.
Test Summary
Electrical safety and electromagnetic compatibility (EMC) tests have been performed by the accredited laboratories and show full compliance with the standards below. The device under consideration has passed the tests according to (FDA recognition number - standard designation number):
- 19-4 AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And . A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
5
- . 19-12 - IEC 60601-1-2 Edition 4.0 2014-02, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
- 5-89 IEC 60601-1-6 Edition 3.1 2013-10, Medical Electrical Equipment Part 1-6: . General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usabilitv
- 19-16 IEC 60601-1-11 Edition 2.0 2015-01, Medical Electrical Equipment Part 1-11: . General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment
- IEC 60601-2-26:2012 (Third Edition): Particular requirements for the basic safety and ● essential performance of electroencephalographs
- FCC Part 15: 2015 Subpart B .
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "General Principles of Software Validation". Verification and Validation activities have been successfully performed on the software package, including assurance that functions work as designed, performance requirements and specifications have been met, and that all hazard mitigations have been fully implemented. All testing has met the predetermined acceptance values. Traceability of the requirements specified in the requirement specifications and functional specifications is ensured during component integration, software validation and system testing.
The device under consideration has passed the test according to (Recognition Number standard):
- . 13-79: IEC 62304 Edition 1.1 2015-06, Medical Device Software - Software Life Cycle Processes.
Comparison to predicate device and conclusion
The technological characteristics. features, specifications, materials, mode of operation, and intended use of the proposed NeuroEEG is substantially equivalent to the predicate device quoted below. The differences between the subject device and predicate device does not raise new issues of safety or effectiveness.
| | Discovery 24E
K150498 | "NeuroEEG" by
MemoryMD
K173460 |
|------------|---------------------------------|---------------------------------------------|
| MODALITIES | EEG | EEG |
6
| INDICATION FOR USE | Indicated for prescription
use to acquire, record and
display physiological and
data for
electroencephalograph
studies of patients of all
ages | NeuroEEG is intended
for prescription use to
acquire, record,
transmit, and display
electrical brain activity of
patients of all ages. |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SYSTEM
COMPONENTS | Hardware Module; Brain
Avatar Acquisition
software; Electrode cap
(sold separately); USB
Cable w/chokes; Touch-
Proof sockets that allow
use of compliant "free
sensors' without a cap | Registration Module,
Bluetooth adapter,
Charger and USB Cable,
Connection cable of
electrode system Neuro
Cap connection,
Connection cable
electrode system StatNet,
Cuff, Flash card, Flash
Card Reading Device,
Software Flash Disk with
Software description,
User's Guide |
| # OF EEG CHANNELS | 24 | 16 |
| A/D RESOLUTION | 24 bit | 24 bit |
| DIGITIZATION RATE | 1024 Hz | 500 Hz |
| SAMPLING RATE | 256 Hz | 500 Hz |
| IMPEDANCE CHECK | Yes | Yes |
| BATTERY CHARGE
CURRENT | n/a | 400 mA |
| WIRELESS
CONNECTION
CHANNEL
FREQUENCY | n/a | 2.4 GHz |
| ENVIRONMENT FOR
USE | Clinical EEG | Clinical and experimental
EEG; laboratory research;
Rehabilitation centers;
OR, ICU, ER |
| SOFTWARE | BrainAvatar | MemoryMD |
| PATIENT ISOLATION | optical & magnetic | No connection of the
product to the power
supply or PC during the
registration. |
| ISOLATION
VOLTAGE | >2500V | No connection of the
product to the power
supply or PC during the
registration. |
| Connection to PC | USB, optically and
magnetically isolated | Bluetooth |
| NOTCH FILTERING | 60/50 Hz | 100/60/50 Hz |
| COMMON MODE
REJECTION RATIO | >120 dB | >110 dB |
| GAIN | 16 | 6 |
| INPUT IMPEDANCE | > 1000GOhms | min 1GOhms |
| INPUT NOISE | 1.5uV at input | Less than 2 uV |
| SELF-Calibration | Yes | Yes |
| FREQUENCY BAND | 0.5 - 70 Hz | 0 - 80 Hz |
| Input Range | 100 mV p-p | $\pm$ 0.8V |
| Amplifier bandwidth | 0.000 - 100 Hz | 0 - 125 Hz |
| A/D accuracy | 24 bits; resolution 0.01
microvolts EEG, 0.4
microvolts DC | 24 bits; resolution 0.1
microvolts EEG, 0.1
microvolts DC |
| Power | Isolated Power via USB
port | Internal battery |
| Shelf Life | n/a | 5 years |
7
The "NeuroEEG" device is similar in intended use, operating principals and fundamental scientific technology to the following predicate device: "Discovery 24" (K150498: Date of Premarket Notification Approval: January 26, 2016).
As shown in the table below, both systems have the same manner of use, being computer-based digital EEG systems with basic functions. They have similar requirements for training and expectations of user. The safety requirements and expectations are the same. The systems have comparable performance in terms of data sampling, accuracy, speed and resolution of displays. They use identical patient connectors and methodology, being standard 10-20 EEG sensor placement.