(540 days)
Not Found
No
The summary explicitly states that the device does not provide automated event marking or diagnostic conclusions, and there is no mention of AI, ML, or related terms in the description of its functions (recording, processing, display, averaging, qEEG metrics).
No.
The device is intended for recording, processing, and display of biopotential signals, not for treatment. The "Intended Use" explicitly states that it does not provide diagnostic conclusions and is for use in diagnostic centers and laboratories.
No
The "Intended Use / Indications for Use" section explicitly states, "The devices ... do not provide to the user any diagnostic conclusion about the patient's condition." While they record and process biopotential signals that would be used in a diagnostic process, the devices themselves do not offer a diagnosis.
No
The device description explicitly mentions "digital systems" and their ability to "register" various biopotential channels, indicating the presence of hardware components for signal acquisition. While software is a key part of the system, it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The Neuron-Spectrum systems record, process, and display biopotential signals like EEG and EP. These are electrical signals measured directly from the body, not from samples taken from the body.
- Intended Use: The intended use describes the device as a "digital neurophysiological system" for recording and displaying biopotential signals. It explicitly states that the devices "do not provide to the user any diagnostic conclusion about the patient's condition."
Therefore, the device falls under the category of a medical device for physiological monitoring and analysis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The digital systems Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P with Neuron-Spectrum.NET software are intended for use as digital neurophysiological systems intended for recording, processing and display biopotential signals such as Electroencephalography (EEG) and long-latency Evoked Potential (EP). Polysomnography (PSG) derives from Electroencephalography (EEG) by the means of a dedicated software module and dedicated electrodes.
The devices are portable and can register up to 8 (Neuron-Spectrum-1), 16 (Neuron-Spectrum-2), 19 (Neuron-Spectrum-3), 21 (Neuron-Spectrum-4, Neuron-Spectrum-4/P) EEG channels, 1 (Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3 and Neuron-Spectrum-4) or up to 4 polygraphic channels (Neuron-Spectrum-4/P: ECG, EOG), 1 breath channel and 2 direct current channels (Neuron-Spectrum-4/P).
Neuron-Spectrum.NET includes the Evoked potentials averaging function and Quantitative electroencephalography (qEEG) , including specific parameters such as Rhythmicity, FFT power ratio and amplitude metrics.
The devices do not provide alarms, do not provide automated event marking and do not provide to the user any diagnostic conclusion about the patient's condition. They are intended for use in the patient care institutions, diagnostics centers, neurosurgical hospitals experimental laboratories and sleep laboratories.The patient group includes all ages and sexes.
Product codes (comma separated list FDA assigned to the subject device)
OLT, OLV, GWQ
Device Description
The digital systems Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P with Neuron-Spectrum.NET software are intended for use as digital neurophysiological systems intended for recording, processing and display biopotential signals such as Electroencephalography (EEG) and long-latency Evoked Potential (EP). Polysomnography (PSG) derives from Electroencephalography (EEG) by the means of a dedicated software module and dedicated electrodes.
The devices are portable and can register up to 8 (Neuron-Spectrum-1), 16 (Neuron-Spectrum-2), 19 (Neuron-Spectrum-3), 21 (Neuron-Spectrum-4, Neuron-Spectrum-4/P) EEG channels, 1 (Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3 and Neuron-Spectrum-4) or up to 4 polygraphic channels (Neuron-Spectrum-4/P: ECG, EOG), 1 breath channel and 2 direct current channels (Neuron-Spectrum-4/P).
Neuron-Spectrum.NET includes the Evoked potentials averaging function and Quantitative electroencephalography (qEEG) , including specific parameters such as Rhythmicity, FFT power ratio and amplitude metrics.
The devices do not provide alarms, do not provide automated event marking and do not provide to the user any diagnostic conclusion about the patient's condition. They are intended for use in the patient care institutions, diagnostics centers, neurosurgical hospitals experimental laboratories and sleep laboratories-The patient group includes all ages and sexes
The operation of the device in the video EEG monitoring mode is possible for not more than 30 days.
The general properties, when carrying out EEG or EP study using EEG channels:
-
•8 (Neuron-Spectrum-1), 16 (Neuron-Spectrum-2), 19 (Neuron-Spectrum-3), 21 (Neuron-Spectrum-4, Neuron-Spectrum-4/P) channels EEG/EP recording in any unshielded room;
•up to 2 direct current channels recording (Neuron-Spectrum-4/P); -
·photic, auditory stimulation and stimulation carrying out with the use of reversal checkerboard pattern (Neuron-Spectrum-1,Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P);
-
·synchronous long-term recording of EEG and video from one, two or three video cameras and recording of audio information from one or two microphones performed using Neuron-Spectrum-Video.NET (Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P);
-
•long-latency EP recording using EEG channels: flash and reversal pattern visual, auditory and cognitive (P300, MMN, CNV) performed using Neuron-Spectrum-LEP.NET software (Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P);
-
•amplitude, spectral, exam report generation, export and import of files in the standard European data format (EDF) (Neuron-Spectrum-1,Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P);
-
•review, store and print of the recorded traces, results of their analysis and exam reports (Neuron-Spectrum-1,Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum-4/P);
-
·respiratory analysis, heart rate analysis, (Neuron-Spectrum-1,Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P);
-
·snoring analysis, limb movement analysis during sleep (Neuron-Spectrum- 4/P);
-
•body position analysis (Neuron-Spectrum- 4/P ), eye movement trends (Neuron-Spectrum-1,Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P);
-
•EMG amplitude trends and CPAP pressure trends (Neuron-Spectrum-1,Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P).
A patient stimulation can be performed with the use of stimulatorsbuilt in the device.
The main condition for using the digital EEG systems is the good professional skills of the medical staff.
Digital EEG system mode of operation is based on the acquisition and input of brain biopotentials and other physiological signals into PC for the analysis of brain electrical activity taking into account the influence of the other physiological signals.
Digital EEG system operates under control of PC (IBM PC type) with the mouse, keyboard, laser or ink jet printer and installed licensed Windows XP/Vista/7/8 operational system.Signal processing, displaying and presentation in different modes after mathematical analysis, storing of the EEG traces on the hard disc, exam report generation and their printing is done with the use of PC.
All the operation of displaying, and reporting the biopotentials and other physiological signals are demanded to the software Neuron-Spectrum.NET that runs in the PC connected to Neuron-Spectrum device.
Exactly the main operations provided by Neuron-Spectrum.NET software are:
- EEG Acquisition
- EEG Review, Editing, Storing, Exporting. ●
- EEG Analysis ●
- . Creation of Exam Reports
- . Program Setup
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
all ages and sexes
Intended User / Care Setting
patient care institutions, diagnostics centers, neurosurgical hospitals experimental laboratories and sleep laboratories.
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)
The performance data (IEC e ISO tests attached in Section and Validation tests (Section 16.3), the Software Requirements Specifications (Section 16.4) indicate that the Neuron-Spectrum-1.2.3.4.4/P with Neuron-Spectrum.NET software device meets all specified requirements and that it is substantially equivalent to the predicate devices.
All the necessary electromagnetic compatibility and electrical safety tests were performed.
The results demonstrate that Neuron-Spectrum-1,2,3,4, 4/P with Neuron-Spectrum.NET is in compliance with both the standards IEC 60601-1-2 and IEC 60601-1 and is safe as the predicate device.
All the necessary performance tests in support of substantial equivalence determination were conducted and documented in section 18 "Performance testing". The tests demonstrate that the Neuron-Spectrum-1,2,3,4,4/P with Neuron-Spectrum.NET is effective and performs as well as 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.
K122196, K132306, K040595, K102610, K011204
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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with the profiles overlapping each other. The profiles are connected by a flowing line that forms the shape of a bird. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 19, 2015
Neurosoft Ltd. c/o Enrico Bisson Studio d'Ingegneria Enrico Bisson Via Marzia n. 9 Abano Terme, Padova 35031 Italy
Re: K133995
Trade/Device Name: Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P with Neuron-Spectrum.NET software Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLT, OLV, GWO Dated: May 11, 2015
Received: May 20, 2015
Dear Mr. Bisson:
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
1
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Felipe Aquel -S Carlos L. Peña, PhD, MS for 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) K133995
Device Name
Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-4 and Neuron-Spectrum-4 and Neuron-Spectrum-4/P digital systems with Neuron-Spectrum.NET
Indications for Use (Describe)
The digital systems Neuron-Spectrum-1, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P with Neuron-Spectrum.NET software are intended for use as digital neurophysiological systems intended for recording, processing and display biopotential signals such as Electroencephalography (EEG) and long-latency Evoked Potential (EP). Polysomnography (PSG) derives from Electroencephy (EEG) by the means of a dedicated software module and dedicated electrodes.
The devices are portable and can register up to 8 (Neuron-Spectrum-1), 16 (Neuron-Spectrum-2), 19 (Neuron-Spectrum-3), 21 (Neuron-Spectrum-4, Neuron-Spectrum-4/P) EEG channels, 1 (Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3 and Neuron-Spectrum-4) or up to 4 polygraphic channels (Neuron-Spectrum-4/P: ECG, EOG),1 breath channel and 2 direct current channels (Neuron-Spectrum-4/P).
Neuron-Spectrum.NET includes the Evoked potentials averaging function and Quantitative electroencephalography (qEEG), including specific parameters such as Rhythmicity, FFT power ratio and amplitude metrics
The devices do not provide alarms, do not provide automated event marking and do not provide to the user any diagnostic conclusion about the patient's condition. They are in the patient care institutions, diagnostics centers, neurosurgical hospitals experimental laboratories. The patient group includes all ages and sexes.
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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3
Section 05 510K Summary
APPLICANT
| Company Name: | Neurosoft Ltd |
|---|---|
| Company Address: | 5, Voroninstr. |
| 153032, Ivanovo | |
| Russian Federation | |
| Manufacturing Address: | Neurosoft Ltd. |
| 5, Voroninstr. | |
| 153032, Ivanovo | |
| Russian Federation | |
| Company Phone: | +7 4932 24-04-34 |
| Company Fax: | +7 4932 24-04-35 |
| Contact Person: | Eugene Polezhaev |
| Director of quality and information technologies | |
| E-mail: polezhaev@neurosoft.ru | |
| Official Contact for Correspondence: | Enrico Bisson (Consultant) |
| Studio di Ingegneria Enrico Bisson | |
| Via Marzia, 9 - 35031 Abano Terme (PD) - ITALY | |
| Phone: +39 049 8630080 | |
| Fax: +39 049 8630080 | |
| E-mail: enrico.bisson@isoplan.org | |
| Date Summary Prepared: | June. 11 2015 |
DEVICE IDENTIFICATION
| Generic Device Name: | Bio-Potential Signal Acquisition System |
|---|---|
| Trade/Proprietary Name: | Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P with Neuron-Spectrum.NET |
| software | |
| Classification Name: | 21 CFR 882.1400 Electroencephalograph |
| Class.II | |
| Product Code: OLT, OLV, GWQ. | |
| Panel: | Neurology |
4
LEGALLY MARKETED DEVICES (PREDICATE DEVICES)
| Predicate Devices | 510(K) Holder/Applicant | 510(k) No. | Reason. |
|---|---|---|---|
| CERVELLO™ BIO- | |||
| POTENTIAL | |||
| SIGNAL | |||
| ACQUISITION | |||
| SYSTEM | Blackrock Neuromed, LLC | K122196 | Overall functions |
| Persyst 12 Eeg Review | |||
| And Analysis | |||
| Software | Persyst Development Corp | K132306 | Software functions |
| Alice 5 System | Respironics , INC. | K040595 | Polysomnographyfunction |
| Focus EMG Device | TELEEMG, LLC | K102610 | Auditory stimulator |
| Neurofax m EEG-9100 | Nihon Kohden Corporation | K011204 | Photic Stimulator |
DEVICE DESCRIPTION
The digital systems Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P with Neuron-Spectrum.NET software are intended for use as digital neurophysiological systems intended for recording, processing and display biopotential signals such as Electroencephalography (EEG) and long-latency Evoked Potential (EP). Polysomnography (PSG) derives from Electroencephalography (EEG) by the means of a dedicated software module and dedicated electrodes.
The devices are portable and can register up to 8 (Neuron-Spectrum-1), 16 (Neuron-Spectrum-2), 19 (Neuron-Spectrum-3), 21 (Neuron-Spectrum-4, Neuron-Spectrum-4/P) EEG channels, 1 (Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3 and Neuron-Spectrum-4) or up to 4 polygraphic channels (Neuron-Spectrum-4/P: ECG, EOG), 1 breath channel and 2 direct current channels (Neuron-Spectrum-4/P).
Neuron-Spectrum.NET includes the Evoked potentials averaging function and Quantitative electroencephalography (qEEG) , including specific parameters such as Rhythmicity, FFT power ratio and amplitude metrics.
The devices do not provide alarms, do not provide automated event marking and do not provide to the user any diagnostic conclusion about the patient's condition. They are intended for use in the patient care institutions, diagnostics centers, neurosurgical hospitals experimental laboratories and sleep laboratories-The patient group includes all ages and sexes
5
The operation of the device in the video EEG monitoring mode is possible for not more than 30 days.
The general properties, when carrying out EEG or EP study using EEG channels:
-
•8 (Neuron-Spectrum-1), 16 (Neuron-Spectrum-2), 19 (Neuron-Spectrum-3), 21 (Neuron-Spectrum-4, Neuron-Spectrum-4/P) channels EEG/EP recording in any unshielded room;
•up to 2 direct current channels recording (Neuron-Spectrum-4/P); -
·photic, auditory stimulation and stimulation carrying out with the use of reversal checkerboard pattern (Neuron-Spectrum-1,Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P);
-
·synchronous long-term recording of EEG and video from one, two or three video cameras and recording of audio information from one or two microphones performed using Neuron-Spectrum-Video.NET (Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P);
-
•long-latency EP recording using EEG channels: flash and reversal pattern visual, auditory and cognitive (P300, MMN, CNV) performed using Neuron-Spectrum-LEP.NET software (Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P);
-
•amplitude, spectral, exam report generation, export and import of files in the standard European data format (EDF) (Neuron-Spectrum-1,Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P);
-
•review, store and print of the recorded traces, results of their analysis and exam reports (Neuron-Spectrum-1,Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum-4/P);
-
·respiratory analysis, heart rate analysis, (Neuron-Spectrum-1,Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P);
-
·snoring analysis, limb movement analysis during sleep (Neuron-Spectrum- 4/P);
-
•body position analysis (Neuron-Spectrum- 4/P ), eye movement trends (Neuron-Spectrum-1,Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P);
-
•EMG amplitude trends and CPAP pressure trends (Neuron-Spectrum-1,Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P).
A patient stimulation can be performed with the use of stimulatorsbuilt in the device.
The main condition for using the digital EEG systems is the good professional skills of the medical staff.
Digital EEG system mode of operation is based on the acquisition and input of brain biopotentials and
6
other physiological signals into PC for the analysis of brain electrical activity taking into account the influence of the other physiological signals.
Digital EEG system operates under control of PC (IBM PC type) with the mouse, keyboard, laser or ink jet printer and installed licensed Windows XP/Vista/7/8 operational system.Signal processing, displaying and presentation in different modes after mathematical analysis, storing of the EEG traces on the hard disc, exam report generation and their printing is done with the use of PC.
The typical schematics of the equipment location when connecting to the desktop PC is given on the Fia. 1
Image /page/6/Figure/3 description: This image shows a diagram of an EEG (electroencephalogram) setup. The diagram includes a computer system unit connected via USB to an EEG electronic unit. Various components are connected to the EEG unit, including EEG electrodes, ear electrodes, an electrode cap, a breath sensor, a ground electrode, a pattern-stimulator, a pattern-stimulator adapter, a photic stimulator, and an auditory stimulator.
Fig.1 Connection scheme.
All the operation of displaying, and reporting the biopotentials and other physiological signals are demanded to the software Neuron-Spectrum.NET that runs in the PC connected to Neuron-Spectrum device.
Exactly the main operations provided by Neuron-Spectrum.NET software are:
- EEG Acquisition
- EEG Review, Editing, Storing, Exporting. ●
- EEG Analysis ●
- . Creation of Exam Reports
- . Program Setup
There are then additional software packages:
7
| Optional Software | |
|---|---|
| Neuron-Spectrum-PSG | This software allows performing comprehensive polysomnography |
| studies (manual sleep stage analysis, analysis of sleep-disordered | |
| breathing) on digital EEG system Neuron-Spectrum-4/P. All the rest | |
| models of Neuron-Spectrum series provide only manual sleep stage | |
| analysis. | |
| Neuron-Spectrum-Video | This software allows performing the long-term synchronous EEG and |
| video recording from one or two video cameras controlled from the | |
| computer and audio information from one or two microphones. There | |
| are wide possibilities to review, edit and store the recorded data | |
| Neuron-Spectrum-LEP | This software allows recording long-latency auditory, visual (on flash |
| and pattern), somatosensory and cognitive (P300, MMN, CNV) EP | |
| using EEG channels (up to 21 ones) with brain mapping with theuse | |
| both built-in stimulators. |
INTENDED USE /INDICATIONS FOR USE
The digital systems Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P with Neuron-Spectrum.NET software are intended for use as digital neurophysiological systems intended for recording, processing and display biopotential signals such as Electroencephalography (EEG) and long-latency Evoked Potential (EP). Polysomnography (PSG) derives from Electroencephalography (EEG) by the means of a dedicated software module and dedicated electrodes.
The devices are portable and can register up to 8 (Neuron-Spectrum-1), 16 (Neuron-Spectrum-2), 19 (Neuron-Spectrum-3), 21 (Neuron-Spectrum-4, Neuron-Spectrum-4/P) EEG channels, 1 (Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3 and Neuron-Spectrum-4) or up to 4 polygraphic channels (Neuron-Spectrum-4/P: ECG, EOG), 1 breath channel and 2 direct current channels (Neuron-Spectrum-4/P).
Neuron-Spectrum.NET includes the Evoked potentials averaging function and Quantitative electroencephalography (qEEG) , including specific parameters such as Rhythmicity, FFT power ratio and amplitude metrics.
The devices do not provide alarms, do not provide automated event marking and do not provide to the user any diagnostic conclusion about the patient's condition. They are intended for use in the patient care institutions, diagnostics centers, neurosurgical hospitals experimental laboratories and sleep laboratories.The patient group includes all ages and sexes.
8
The Neuron-Spectrum devices with Neuron-Spectrum.NET software bring together similar
functions from a previously cleared for market device; namely CERVELLO™ BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM (K122196). Persyst 12 Eeg Review And Analysis Software(K132306), Alice 5 System (K040595) , Focus EMG Device (K102610) and Neurofax m EEG-9100 (K011204)
SUBSTANTIAL EQUIVALENCE
The Neuron-Spectrum devices with Neuron-Spectrum.NET software are of comparable type and are substantially equivalent to the following predicate device:
| Predicate Device | 510(K) Holder | 510(k) No. | Date Cleared |
|---|---|---|---|
| CERVELLO™ BIO- | |||
| POTENTIAL SIGNAL | |||
| ACQUISTION SYSTEM | Blackrock Neuromed, | ||
| LLC | K122196 | 05/02/2013 | |
| Persyst 12 Eeg Review And | |||
| Analysis | |||
| Software | Persyst Development | ||
| Corp | K132306 | 11/21/2013 | |
| Alice 5 System | Respironics , INC. | K040595 | 03/18/2004 |
| Focus EMG Device | TELEEMG, LLC | K102610 | 03/04/2011 |
| Neurofax m EEG-9100 | Nihon Kohden Corporation | K011204 | 05/08/2001 |
The substantial equivalence determination is discussed in Section 12 Substantial Equivalence Discussion.
Predicate devices indications for use
K122196:The Blackrock NeuroMedCervello™ Bio-Potential Signal Acquisition System contains the following configurations:
Ambulatory: Up to 64 channels with one Cervello hardware device (Amplifier) using the Cervello software. The device is intended to acquire and store physiological signals for EEG and to transfer the data to separate polysomnographic analysis software. The devices are intended to be used by physicians, technicians and other medical professions that are trained in EEG and/or PSG. The Cervello Ambulatory System does not make any judgement of normality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.
Basic: Up to 64 channels with one Cervello hardware device (Amplifier) and up to 128 channels by cascading 2 Cervello devices using the Cervello software. The device is intended to acquire and store physiological signals for EEG and/or PSG, and to transfer the data to separate polysomnographic analysis software. The devices are intended to be used by physicians and other medical professions that are trained in EEG and/or PSG. The Cervello Basic System does not make any judgement of normality or abnormality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.
Elite: Up to 128 with one Neuroport Bio-Potential Recording Systems and up to 256 by cascading two Neuroport systems using the Central and/or Cervello software. The system supports recording, processing and display of bio-potential signals from user-supplied elettrodes. Bio-potential signals include: (EEG), Electrocorticography (ECoG). electroencephalography electromyography (EMG). Electrocardiography (ECG), Electroculography (EOG) and Evoked Potential (EP). Intended users include
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Physicians, technicians clinicians or other medical professionals that are trained in bio-potential and/or EEG recording. The Cervello Elite System does not make any judgement of normality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.
K132306: The Persyst Development Corp. Persyst 12 Eeg Review And Analysis Software contains the following indication for use:
1-Persyst 12 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices using scalp electrodes and to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.
2-The Seizure Detection component of Persyst 12 is intended to mark previously acquired sections of adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with a full scalp montage according to the standard 10/20 system.
3-The Spike Detection component of Persyst 12 is intended to mark previously acquired sections of the patient's EEG recordings that may correspond to spikes, in order to assist qualified clinical practitioners in the assessment of EEG traces. The Spike Detection component is intended to be used in patients at least one month old. Persyst 12 Spike Detection performance has not been assessed for intracranial recordings.
4-Persyst 12 includes the calculation and display of a set of quantitative measures intended to monitor and analyze the EEG waveform. These include FFT, Rhythmicity, Peak Envelope, Artifact Intensity, Amplitude, Relative Symmetry and Suppression Ratio. Automatic event marking is not applicable to the quantitative measures. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveforms.
5-The aEEG functionality included in Persyst 12 is intended to monitor the state of the brain. The automated event marking function of Persyst 12 is not applicabletoaEEG.
6- Persyst 12 provides notifications for seizure detection, quantitative EEG and aEEG that can be used when processing a record during acquisition. These include an on screen display and the optional sending of an email message. Delays of up to several minutes can occur between the beginning of a seizure and when the Persyst 12 notifications will be shown to a user. Persyst 12 notifications cannot be used as a substitute for real time monitoring of the underlying EEG by a trained expert.
7-Persyst AR (Artifact Reduction) is intended to reduce EMG, eye movement, and electrode artifacts in a standard 10-20 EEG recording. AR does not remove the entifact signal, and is not effective for other types of artifacts. AR may modify portions of waveforms representing cerebral activity. Waveforms must still be read by a qualified medical practitioner trained in recognizing artifact, and any interpretation or diagnosis must be made with reference to the original waveforms.
8-This device does not provide any diagnostic conclusion about the patient's condition to the user.
K040595 : TheRespironics , INC. Alice 5 Systemcontains the following indication for use:
The Alice 5 System is a Polysomnography System that is intended to record, display and print physiological information to clinicians/physicians. These parameters are presented graphically on a computer screen for diagnostic review, similar in application to the use of a traditional paper based polygraph recorder. The device will be used in hospitals, institutions, sleep centres or clinics, or other test environments where adults
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or infant patients require the documentation of various sleep or other physiological disorders.
This device does not provide alarms and, is not intended for use as an automated apnoea monitor.
K102610 :TELEEMG, LLC USA FOCUS EMG DEVICE contains the following indication for use:
The Focus is intended for use by a healthcare provider to perform nerve conductions and EMG studies as an aid in the evaluation of patients with diseases of muscle and nerves. The machine can also use electrical stimulus or sound stimulus for evoked potentials (EP) studies.
K011204: Nihon Kohden Corporation Neurofax m EEG-9100 Operator's manual contains the following information:
The EEG-9100A/G/J/K Electroencephalograph is designed for both clinical and research use. This electroencephalograph realizes the conventional EEG's functions in a GUI (graphical user interface) environment. It provides powerful data filing and easy operation. The EEG waveforms and patient information are saved in a large capacity media (hard disk, MO disk or CD-R/CD-RW disk).
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12.3Table . Hardware Comparison with the Predicate Device Cervello™ Bio-Potential Signal Acquisition System
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| ATTRIBUTE /
CHARACTERISTICS | NEURON-SPECTRUM-1,2,3,4,4/P | LEGALLY MARKETED PREDICATE DEVICES OF
Cervello™ Bio-Potential Signal Acquisition System |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | NEUROSOFT Ltd
(Submitted Product) | Blackrock NeuroMedLLC |
| 'K" numbers | K133995 | K122196 |
| Proprietary / Trade Name | Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3,
Neuron-Spectrum-4 and Neuron-Spectrum-4/P with Neuron-
Spectrum.NET Software | Cervello™Bio-PotentialSignalAcquisitionSystem |
| CFR Section | 882.1400 | 882.1400 |
| Pro-code | OLT, OLV, GWQ | GWQ, OLV, GWL, GWK |
| Classification name | Electroencephalograph | Electroencephalograph |
| Indications For Use | The digital systems Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-
Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P with
Neuron-Spectrum.NET software are intended for use as digital
neurophysiological systems intended for recording, processing and
display biopotential signals such as Electroencephalography (EEG)
and long-latency Evoked Potential (EP). Polysomnography (PSG)
derives from Electroencephalography (EEG) by the means of a
dedicated software module and dedicated electrodes. The devices are
portable and can register up to 8 (Neuron-Spectrum-1), 16 (Neuron-
Spectrum-2), 19 (Neuron-Spectrum-3), 21 (Neuron-Spectrum-4,
Neuron-Spectrum-4/P) EEG channels, 1 (Neuron-Spectrum-1,
Neuron-Spectrum-2, Neuron-Spectrum-3 and Neuron-Spectrum-4) or
up to 4 polygraphic channels (Neuron-Spectrum-4/P: ECG, EOG), 1
breath channel and 2 direct current channels (Neuron-Spectrum-4/P).
Neuron-Spectrum.NET includes the Evoked potentials averaging
function and Quantitative electroencephalography (qEEG), including
specific parameters such as Rhythmicity, FFT power ratio and
amplitude metrics.
The devices do not provide alarms,do not provide automated event
markingand do not provide to the user any diagnostic conclusion about
the patient's condition. They are intended for use in the patient care
institutions, diagnostics centers, neurosurgical hospitals
experimental laboratories and sleep
laboratories. The patient group includes all ages and sexes. | The Blackrock NeuroMedCervello Rio-Potential Signal Acquisition
Product Family contains the following configurations.
Ambulatory: Up to 64 channels with one Cervello hardware device
(Amplifier) using the Cervello software. The device is intended to
acquire and store physiological signals for EEG and/or PSG, and to
transfer thle data to separate polysomnographic analysis software.
The devices are intended to be used by physicians, technicians and
other medical professions that are trained in EEG and/or PSG.
The Cervello Ambulatory system does not make any judgment of
normality or abnormality of the displayed signals or the results of an
analysis. In no way are any of the functions represented as being in
and of themselves diagnostic.
Basic: Up to 64 channels with one Cervello hardware device
(Amplifier) and up to 128 channels by cascading 2 Cervello devices
using the Cervello software. The device is intended to acquire and
store physiological signals for EEG and/or PSG, and to transfer the
data to separate polysomnographic analysis software. The devices
are intended to be used by physicians, technicians and other
medical professions that are trained in EEG and/or PSG. The
Cervello Basic system does not make any judgment of normality or
abnormality of the displayed signals or the results of an analysis. In
no way are any of the functions represented as being in and of
themselves diagnostic. |
| ATTRIBUTE /
CHARACTERISTICS | NEURON-SPECTRUM-1,2,3,4,4/P
NEUROSOFT Ltd
(Submitted Product) | LEGALLY MARKETED PREDICATE DEVICES OF
Cervello™ Bio-Potential Signal Acquisition System
Blackrock NeuroMedLLC |
| | | Elite: Up to 128 with one Neuroport Bio-Potential Recording Systems and up to 256 by cascading two Neuroport systems using the Central and/or Cervello software. The system supports recording., processing and display of bio-potential signals from user-supplied electrodes. Bio-potential signals include: Electrocorticography (ECOG), Electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electrooculography (EOG) and Evoked Potential (EP). Intended users include Physicians, technicians, clinicians or other medical professionals that are trained in bio-potential and/or EEG recording. The Cervello Elite System does not make judgement of normality or abnormality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic. |
| ATTRIBUTE /
CHARACTERISTICS | NEURON-SPECTRUM-1,2,3,4,4/P
NEUROSOFT Ltd
(Submitted Product) | LEGALLY MARKETED PREDICATE DEVICES OF
Cervello™ Bio-Potential Signal Acquisition System
Blackrock NeuroMedLLC |
| Intended Use | The digital systems Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-
Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P with
Neuron-Spectrum.NET software are intended for use as digital
neurophysiological systems intended for recording, processing and
display biopotential signals such as Electroencephalography (EEG)
and long-latency Evoked Potential (EP). Polysomnography (PSG)
derives from Electroencephalography (EEG) by the means of a
dedicated software module and dedicated electrodes. The devices are
portable and can register up to 8 (Neuron-
Spectrum-1), 16 (Neuron-
Spectrum-2), 19 (Neuron-Spectrum-3), 21 (Neuron-Spectrum-4,
Neuron-Spectrum-4/P) EEG channels, 1 (Neuron-Spectrum-1,
Neuron-Spectrum-2, Neuron-Spectrum-3 and Neuron-Spectrum-4) or
up to 4 polygraphic channels (Neuron-Spectrum-4/P: ECG, EOG), 1
breath channel and 2 direct current channels (Neuron-Spectrum-4/P).
Neuron-Spectrum.NET includes the Evoked potentials averaging
function and Quantitative electroencephalography (qEEG) , including
specific parameters such as Rhythmicity, FFT power ratio and
amplitude metrics.
The devices do not provide alarms, do not provide automated event
marking and do not provide to the user any diagnostic conclusion
about the patient's condition. They are intended for use in the patient
care institutions, diagnostics centers, neurosurgical hospitals
experimental laboratories and sleep
laboratoriesThe patient group includes all ages and sexes- | Ambulatory- Acquire, display, store, and archive
electroencephalographic signals from the brain using a full
montage array and user-specified electrode locations.
Basic- Acquire, display, store, and archive
electroencephalographic signals from the brain using a full
montage array and user-specified electrode locations.
Elite- Acquire, amplify, record, display, digitize, retrieval, store
and display bio-potential signals |
| Clinical applications | Bio-potential signal amplification, recording, display, digitization,
retrieval. | Bio-potential signal amplification, recording, display,
digitization, retrieval. |
| Intended Users | Physicians and clinicians or other medical professionals that are
trained in bio-potential recording | Physicians, technicians, clinicians or other medical
professionals that are trained in bio-potential recording |
| Intended Use
Environment | Care institutions, diagnostic centres, neurosurgical hospitals
experimental laboratories and sleep laboratories of research
institutions | Clinics, hospitals, operating rooms, epilepsy evaluation unit
environments, sleep laboratories |
| ATTRIBUTE /
CHARACTERISTICS | NEURON-SPECTRUM-1,2,3,4,4/P
NEUROSOFT Ltd
(Submitted Product) | LEGALLY MARKETED PREDICATE DEVICES OF
Cervello™ Bio-Potential Signal Acquisition System
Blackrock NeuroMedLLC |
| Target
population | Adults and newborns | Adults and paediatrics |
| Use limitations | The device is not a monitoring system and no physiologic alarms are provided. The acquisition and display of biopotential signals is for the interpretation and use of the clinician. The devices do not make any judgment of normality or abnormality of the displayed signals. | The System is not a monitoring system. No physiologic alarms areprovided. The acquisition and display of biopotential signals is for the interpretation and use of the clinician. The devices do not make any judgment of normality or abnormality of the displayed signals. |
| Bio-Potential
Signals Recorded | Electroencephalography (EEG)
Electrocardiography (ECG)
Electrooculography (EOG)
Evoked potential (EP),
Video EEG, PSG
Respiration | Electroencephalography (EEG)
Electrocorticography (ECOG)
Electrocardiography (ECG)
Electromyography (EMG)
Electrooculography (EOG)
Evoked potential (EP)
Video EEG,
Respiration, Heart rate, SPO2 |
| Number of
Signal Recording
Channels | up to 8 (Neuron-Spectrum-1), 16 (Neuron-Spectrum-2), 19 (Neuron-Spectrum-3), 21 (Neuron-Spectrum-4, Neuron-Spectrum-4/P) EEG channels,
1 breath channel (Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum-4/P)
2 direct current channels (Neuron-Spectrum-4/P). | Up to 128 with one device and up to 256 by cascading two NeuroPortBiopotential devices |
| AnalogInput
Channels (per
unit) | 28 | 16 |
| Sampling rate | 100, 200, 500, 1000, 2000, 5000 Hz | 256 Hz Up to 30,000 Hz |
| ATTRIBUTE /
CHARACTERISTICS | NEURON-SPECTRUM-1,2,3,4,4/P
NEUROSOFT Ltd
(Submitted Product) | LEGALLY MARKETED PREDICATE DEVICES OF
Cervello™ Bio-Potential Signal Acquisition System
Blackrock NeuroMedLLC |
| Power source | Supply voltage:
• electronic unit: 5V DC
• desktop PC-based system: 220/230 V AC (50 Hz)
• notebook PC-based system: 220/230 V AC (50 Hz) / int. battery | Five-channel external power supply with sequencing, 120VAC / 60Hz input or 220VAC / 50Hz input |
| Software | Neuron-Spectrum.NET Software | Cervello™ and Interface to NeuroExplorer, Spike2, MATLAB, C/C++, and other 3rd-party software |
| Videocamera | available | available |
| Alarms | No | no |
| Digital resolution | 32/64 bits | 16 bits |
| Input noise EEG (rms value) | Within 0.5-200 Hz not more than 2 µV
(not more than 0.3 µV) | 100 dB | 105 dB or greater (at 60 Hz) |
| Noise | 100 MΩhm 100 MΩhm