(101 days)
NeuroEEG is intended for prescription use to acquire, record, transmit, and display electrical brain activity of patients of all ages.
"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.
This is a 510(k) premarket notification for the NeuroEEG device, not a study report. Therefore, information regarding acceptance criteria and performance studies in the way you've requested is not typically found in this type of document. 510(k) submissions focus on demonstrating substantial equivalence to a predicate device.
However, based on the provided text, I can infer some aspects related to testing and "acceptance" in the context of a 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide a typical "acceptance criteria" table with specific quantitative thresholds that the device was tested against for clinical performance. Instead, it demonstrates compliance with recognized standards and successful completion of verification and validation activities.
| Feature/Aspect Tested | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And . A2:2010/(R)2012 (Consolidated Text) | Full compliance |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 Edition 4.0 2014-02 | Full compliance |
| Usability | Compliance with IEC 60601-1-6 Edition 3.1 2013-10 | Passed tests |
| Home Healthcare Environment | Compliance with IEC 60601-1-11 Edition 2.0 2015-01 | Passed tests |
| Electroencephalograph Specific | Compliance with IEC 60601-2-26:2012 (Third Edition) | Passed tests |
| FCC Compliance | Compliance with FCC Part 15: 2015 Subpart B | Passed tests |
| Software Verification & Validation | Functions work as designed, performance requirements and specifications met, all hazard mitigations fully implemented, all testing met predetermined acceptance values. | Successfully performed; met predetermined acceptance values. |
| Software Life Cycle Processes | Compliance with IEC 62304 Edition 1.1 2015-06 | Passed test |
| Input Noise | Superior or equivalent to predicate device | Less than 2 uV (Predicate: 1.5uV at input) - Note: "Less than 2 uV" is effectively comparable for a 510(k) |
| Common Mode Rejection Ratio | Superior or equivalent to predicate device | >110 dB (Predicate: >120 dB) - Note: "Similar performance" is the claim for 510(k), not necessarily superiority. |
2. Sample Size for Test Set and Data Provenance
The document does not provide information on a specific clinical "test set" for performance evaluation in terms of patient data. The testing mentioned primarily relates to hardware and software validation against technical standards. There is no mention of patient data, retrospective/prospective studies, or country of origin for such data.
3. Number of Experts and Qualifications for Ground Truth
This information is not provided as there is no specific clinical study described where expert ground truth was established for a test set. The submission focuses on technical compliance and substantial equivalence.
4. Adjudication Method
This information is not applicable/provided because no clinical test set requiring expert adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not conducted or described in this 510(k) submission. MRMC studies are typically done for diagnostic aids where human interpretation is involved, which this basic EEG acquisition device is not intended as a diagnostic tool itself but rather for data acquisition.
6. Standalone Performance Study
A standalone performance study in the sense of an algorithm-only without human-in-the-loop performance test for a diagnostic or interpretive algorithm was not conducted or described. The device, NeuroEEG, is an electroencephalograph—a medical device for acquiring and displaying physiological signals, not an interpretive algorithm. Its "standalone performance" refers to its ability to accurately acquire and transmit EEG signals according to technical specifications, which are addressed by the electrical safety and software verification/validation tests. The 510(k) summary explicitly states: "This device does not provide any diagnostic conclusion about a subject's condition."
7. Type of Ground Truth Used
The ground truth for the technical and software testing would be the specifications and requirements of the relevant industry standards (e.g., IEC, AAMI, FCC) and the device's own design specifications. For "performance" in the context of this 510(k), the "ground truth" demonstrated by testing is that the device correctly performs its intended function of acquiring, recording, transmitting, and displaying electrical brain activity in accordance with engineering and safety standards. There is no mention of pathology, outcomes data, or expert consensus on clinical diagnoses as ground truth.
8. Sample Size for Training Set
This information is not applicable/provided. The NeuroEEG is an EEG acquisition system and does not appear to involve machine learning models that would require a "training set" of data in the typical sense.
9. How Ground Truth for Training Set Was Established
This information is not applicable/provided as there is no mention of a training set for machine learning.
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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.
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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
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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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K173460
510(k) Summary
| Identification of Submitter | |
|---|---|
| Primary Contact Name | Abdus-Salaam Muwwakkil,Chief Quality OfficerMemoryMD Inc. |
| Address: | 205 E 42nd Street, 14th FloorNew York, New York 10017,USA |
| Telephone: | 215-341-6373 |
| Fax: | 646-304-1064 |
| Email: | abdus@memorymd.com |
| Name / Address ofManufacturer: | MemoryMD Inc.67 35th street, c250Brooklyn, New York 11232,USA |
| Date Prepared | 11/06/2017 |
| Identification of the subject device | |
| Device Proprietary Name: | NeuroEEG |
| Common Name: | Full-Montage StandardElectroencephalograph |
| Regulation: | 21 CFR 882.1400 |
| Review Panel: | Neurology |
| Product Code: | GWQ |
| Classification Panel: | Neurology |
| Device Class: | Class II |
| Predicate Device | ||||
|---|---|---|---|---|
| 510(k) Number | ClassificationProduct Code | Trade ofProprietary | Manufacturer | |
| K150498 | GWQ | Discovery 24 | BrainmasterTechnologies, Inc.195 Willis Street,Suite 3 Bedford, OH44146 |
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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
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- . 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 24EK150498 | "NeuroEEG" byMemoryMDK173460 | |
|---|---|---|
| MODALITIES | EEG | EEG |
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| INDICATION FOR USE | Indicated for prescriptionuse to acquire, record anddisplay physiological anddata forelectroencephalographstudies of patients of allages | NeuroEEG is intendedfor prescription use toacquire, record,transmit, and displayelectrical brain activity ofpatients of all ages. |
|---|---|---|
| SYSTEMCOMPONENTS | Hardware Module; BrainAvatar Acquisitionsoftware; Electrode cap(sold separately); USBCable w/chokes; Touch-Proof sockets that allowuse of compliant "freesensors' without a cap | Registration Module,Bluetooth adapter,Charger and USB Cable,Connection cable ofelectrode system NeuroCap connection,Connection cableelectrode system StatNet,Cuff, Flash card, FlashCard Reading Device,Software Flash Disk withSoftware 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 CHARGECURRENT | n/a | 400 mA |
| WIRELESSCONNECTIONCHANNELFREQUENCY | n/a | 2.4 GHz |
| ENVIRONMENT FORUSE | Clinical EEG | Clinical and experimentalEEG; laboratory research;Rehabilitation centers;OR, ICU, ER |
| SOFTWARE | BrainAvatar | MemoryMD |
| PATIENT ISOLATION | optical & magnetic | No connection of theproduct to the powersupply or PC during theregistration. |
| ISOLATIONVOLTAGE | >2500V | No connection of theproduct to the powersupply or PC during theregistration. |
| Connection to PC | USB, optically andmagnetically isolated | Bluetooth |
| NOTCH FILTERING | 60/50 Hz | 100/60/50 Hz |
| COMMON MODEREJECTION 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 0.01microvolts EEG, 0.4microvolts DC | 24 bits; resolution 0.1microvolts EEG, 0.1microvolts DC |
| Power | Isolated Power via USBport | Internal battery |
| Shelf Life | n/a | 5 years |
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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.
§ 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).