Who is the manufacturer of NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE?

Neurosoft , Ltd. filed the 510(k) submission for NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE (K133995).

What is the FDA product code for NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE?

OLT. It is classified under 21 CFR 882.1400 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE

Q: What are the predicate devices for NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE?

CERVELLO™ BIO-POTENTIAL SIGNAL ACQUISITION SYSTEM (K122196); Persyst 12 Eeg Review And Analysis Software (K132306); Alice 5 System (K040595); Focus EMG Device (K102610); Neurofax m EEG-9100 (K011204).

K133995 · Neurosoft , Ltd. · OLT · Jun 19, 2015 · Neurology

Device Facts

Record ID	K133995
Device Name	NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE
Applicant	Neurosoft , Ltd.
Product Code	OLT · Neurology
Decision Date	Jun 19, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1400
Device Class	Class 2
Attributes	Software as a Medical Device, Pediatric

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 laboratories. The patient group includes all ages and sexes.

Device Story

Digital neurophysiological systems (Neuron-Spectrum series) acquire, process, and display biopotential signals (EEG, EP, PSG). Inputs include EEG electrodes, polygraphic channels (ECG, EOG), breath sensors, and DC channels. The system operates via a PC-based software (Neuron-Spectrum.NET) which performs signal processing, averaging for EPs, and qEEG analysis (Rhythmicity, FFT power ratio, amplitude metrics). Used in hospitals, diagnostic centers, and sleep labs by trained medical professionals. The device provides no alarms, no automated event marking, and no diagnostic conclusions; output is raw or processed waveform data for clinician review. Benefits include standardized neurophysiological data acquisition and analysis to support clinical assessment of neurological and sleep disorders.

Clinical Evidence

Bench testing only. Performance validated through electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and software verification/validation testing. No clinical data presented.

Technological Characteristics

Portable digital EEG/EP/PSG systems. PC-based architecture (Windows XP/Vista/7/8). Connectivity via USB. 16-bit ADC. Sampling rates 100-5000 Hz. Input impedance >400 MΩ. Includes photic and auditory stimulators. Software performs FFT-based spectral analysis and averaging. Sterilization not applicable (uses patient-contact electrodes).

Indications for Use

Indicated for recording, processing, and displaying biopotential signals (EEG, long-latency EP, and PSG) in patients of all ages and sexes. Used in clinical, diagnostic, neurosurgical, and sleep laboratory settings.

Regulatory Classification

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.

Predicate Devices

CERVELLO™ BIO-POTENTIAL SIGNAL ACQUISITION SYSTEM (K122196)
Persyst 12 Eeg Review And Analysis Software (K132306)
Alice 5 System (K040595)
Focus EMG Device (K102610)
Neurofax m EEG-9100 (K011204)

Related Devices

K171384 — Micromed BRAIN QUICK system · Micromed S.P.A. · Feb 1, 2018
K122196 — CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY · Blackrock Neuromed, LLC · May 2, 2013
K062533 — BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524 · Neurovirtual USA, Inc. · Dec 22, 2006
K112107 — BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS · Neurovirtual USA, Inc. · Oct 28, 2011
K180290 — Natus Brain Monitor Amplifier · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · Jun 14, 2018

Submission Summary (Full Text)

{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) | |----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------| |----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------| #### 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}------------------------------------------------ # 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 {9}------------------------------------------------ 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 {10}------------------------------------------------ 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). {11}------------------------------------------------ 12.3Table . Hardware Comparison with the Predicate Device Cervello™ Bio-Potential Signal Acquisition System {12}------------------------------------------------ | 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)…