K Number
K122196
Device Name
CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY
Date Cleared
2013-05-02

(282 days)

Product Code
Regulation Number
882.1400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Blackrock NeuroMed Cervello Bio-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 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 judgment 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, technicians and other medical professions that are trained in EEG and/or PSG. The Cervello Basic system does not make any judgment 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. 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 biopotential signals from user-supplied electrodes. Bio-potential signals include: Electrocorticography (ECGG), electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electrooculography (EOG) and Evoked Potential (EP). Intended users include Physicians, clinicians or other medical professionals that are trained in bio-potential and/or EEG recording. The Cervello Elite system does not make any judgment 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.
Device Description
Multi-Channel, Multi-Modal Physiological Monitoring System Cervello Ambulatory - This system uses the Cervello Amplifier in the ambulatory environment and provides up to 64 input channels for EEG and PSG studies. The Amplifier is battery powered during recording; the internal microcontroller stores the data in a RAM buffer and memory card where it can be downloaded later for review by a physician. Cervello Basic - This is a PC-based clinician-oriented EEG and/or PSG monitoring system that provides between up to 128 channels for EEG recording using the Cervello Amplifier. Data is displayed on a monitor using the Cervello Basic software program and video capabilities are available. Cervello Elite -- This is a PC-based clinician-oriented monitoring system that provides up to 256 channels for recording bio-potentials such as electroencephalography (EEG), electromyography (EMG), electroencephalography (ECG), electrooculography (EOG), electrocorticography (ECoG) and evoked potential (EP) using the NeuroPort Bio-Potential System Hardware and operates both the Cervello (Basic) and the Central Software. Video capabilities are available. In all cases, and as with the predicate devices, the Cervello Basic, Ambulatory and Elite Systems are not monitoring systems. No physiologic alarms are provided. The acquisition and display of bio-potential 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 and the software is not intended to do automatic analysis of the recorded signals
More Information

Not Found

No
The document explicitly states that the device "does not make any judgment of normality of the displayed signals or the results of an analysis" and "the software is not intended to do automatic analysis of the recorded signals," which are key functions often associated with AI/ML in this context. There are no mentions of AI, ML, or related concepts like training or test sets.

No
The device is described as an acquisition and monitoring system for physiological signals (EEG, PSG, etc.) and explicitly states that it does not make judgments of normality, is not diagnostic, and provides no physiological alarms. Its function is to acquire and store data for interpretation by a clinician, not to provide therapy.

No

The intended use/indications for use section explicitly states for all configurations (Ambulatory, Basic, and Elite): "In no way are any of the functions represented as being in and of themselves diagnostic." The device descriptions also state that the systems "do not make any judgment of normality or abnormality of the displayed signals and the software is not intended to do automatic analysis of the recorded signals."

No

The device description explicitly mentions and describes hardware components (Cervello Amplifier, Neuroport Bio-Potential Recording Systems) that are integral to the function of the device configurations. While software is used, it is part of a larger system that includes hardware for signal acquisition and storage.

Based on the provided text, the Blackrock NeuroMed Cervello Bio-Potential Signal Acquisition Product Family is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • Definition of IVD: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic purposes. This typically involves analyzing biological samples like blood, urine, tissue, etc.
  • Device Function: The Cervello system acquires and stores physiological signals (EEG, PSG, ECoG, EMG, ECG, EOG, EP) directly from the patient's body using electrodes. It does not analyze biological specimens.
  • Intended Use: The intended use is to acquire and store these signals for interpretation by trained medical professionals. The text explicitly states that the devices "do not make any judgment of normality of the displayed signals or the results of an analysis" and are "in no way are any of the functions represented as being in and of themselves diagnostic."
  • Device Description: The description reinforces that it's a "Multi-Channel, Multi-Modal Physiological Monitoring System" and emphasizes that the acquisition and display of signals are "for the interpretation and use of the clinician."

Therefore, the Cervello system falls under the category of a physiological signal acquisition and monitoring system, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The Blackrock NeuroMed Cervello Bio-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 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 judgment 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, 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.

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, clinicians or other medical professionals that are trained in bio-potential and/or EEG recording.

The Cervello Elite 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.

Product codes (comma separated list FDA assigned to the subject device)

GWQ, OLV, GWL, GWL, GWK

Device Description

Multi-Channel, Multi-Modal Physiological Monitoring System

Cervello Ambulatory - This system uses the Cervello Amplifier in the ambulatory environment and provides up to 64 input channels for EEG and PSG studies. The Amplifier is battery powered during recording; the internal microcontroller stores the data in a RAM buffer and memory card where it can be downloaded later for review by a physician.

Cervello Basic - This is a PC-based clinician-oriented EEG and/or PSG monitoring system that provides between up to 128 channels for EEG recording using the Cervello Amplifier. Data is displayed on a monitor using the Cervello Basic software program and video capabilities are available.

Cervello Elite -- This is a PC-based clinician-oriented monitoring system that provides up to 256 channels for recording bio-potentials such as electroencephalography (EEG), electromyography (EMG), electroencephalography (ECG), electrooculography (EOG), electrocorticography (ECoG) and evoked potential (EP) using the NeuroPort Bio-Potential System Hardware and operates both the Cervello (Basic) and the Central Software. Video capabilities are available.

In all cases, and as with the predicate devices, the Cervello Basic, Ambulatory and Elite Systems are not monitoring systems. No physiologic alarms are provided. The acquisition and display of bio-potential 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 and the software is not intended to do automatic analysis of the recorded signals

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

brain, cortical surface

Indicated Patient Age Range

Adults and pediatrics

Intended User / Care Setting

Physicians, technicians, or other medical professions that are trained in EEG and/or PSG; Physicians, clinicians or other medical professionals that are trained in bio-potential and/or EEG recording.

Clinics, hospitals, operating rooms, epilepsy evaluation unit environments, sleep laboratories; Medical facility, physician's office, laboratory, clinic or nursing home or outside of a medical facility under supervision of a medical professional.

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)

Performance testing included:

  • Third-party testing for compliance with IEC 60601
  • Shipping Validation for both cart based systems (Elite and Basic) using the required packaging
  • Internal testing to ensure the cart meets tipping requirements
  • Additional Software Testing Documentation

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.

K090957, K071782, K000963

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

2 2013 MAY

510(k) Summary

  • Applicant Name: Blackrock NeuroMed, LLC, . 1. 675 Arapeen Dr., Suite 105 Salt Lake City, UT 84108 Phone: 801.994.5662 Contact: Andy Gotshalk
    Cervello™ Bio-Potential Signal Acquisition System 2. Trade Name:

Bio-Potential Signal Acquisition System 3. Common Name:

  • Manufacturing Site: Blackrock NeuroMed, LLC 4. 675 Arapeen Dr., Suite 105 Salt Lake City, UT 84108 Establishment Registration Number: 3007323246
    Summary Date: March 15, 2013 5.

  • Classification Name: 21 CFR 882.1400 Electroencephalograph 6.
    Class .II Product Code: GWQ, OLV, GWL, GWK Panel: Neurology

Consolidation/Modification of existing devices 7. Reason for 510(k):

  1. Description: Multi-Channel, Multi-Modal Physiological Monitoring System

Cervello Ambulatory - This system uses the Cervello Amplifier in the ambulatory environment and provides up to 64 input channels for EEG and PSG studies. The Amplifier is battery powered during recording; the internal microcontroller stores the data in a RAM buffer and memory card where it can be downloaded later for review by a physician.

Cervello Basic - This is a PC-based clinician-oriented EEG and/or PSG monitoring system that provides between up to 128 channels for EEG recording using the Cervello Amplifier. Data is displayed on a monitor using the Cervello Basic software program and video capabilities are available.

Cervello Elite -- This is a PC-based clinician-oriented monitoring system that provides up to 256 channels for recording bio-potentials such as electroencephalography (EEG), electromyography (EMG), electroencephalography (ECG), electrooculography (EOG), electrocorticography (ECoG) and evoked potential (EP) using the NeuroPort Bio-Potential System Hardware and operates both the Cervello (Basic) and the Central Software. Video capabilities are available.

In all cases, and as with the predicate devices, the Cervello Basic, Ambulatory and Elite Systems are not monitoring systems. No physiologic alarms are provided. The acquisition and display of bio-potential 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 and the software is not intended to do automatic analysis of the recorded signals

  • The Company does not sell any of the following accessories: EEG electrodes, accessory cables, oximeter sensors, 9. cannulae and respiratory effort sensors. Predicate Device(s):

1

K090957 Manufacture: Trade Name: Product Code: GWL Classification: 882.1835

I2S Micro Implantable Systems, LLC d/b/a Blackrock Microsystems Blackrock NeuroPort Bio-potential Signal Processing System

510(k) Number: K071782 Manufacture: Micromed S.P.A. Micromed Brain Spy Plus, Micromed Morpheus, Embla Titanium Devices Trade Name: Product Code: GWO Classification: 866.3740

510(k) Number: Manufacture: Trade Name: Product Code: Classification:

K000963 Airsep Corp. (Marketed by Embla) Da Vinchi EEG and EMG/EP Systems GWO 866.3740

  1. Intended Use of Device

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, digitize, retrieval, store and display bio-potential signals

    1. Indication for Use
      The Blackrock NeuroMed Cervello Bio-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 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 judgment 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, technicians and other medical professions that are trained in EEG and/or PSG. The Cervello Basic system does not make any judgment 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.

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 biopotential signals from user-supplied electrodes. Bio-potential signals include: Electrocorticography (ECGG), electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electrooculography (EOG) and Evoked Potential (EP). Intended users include Physicians, clinicians or other medical professionals that are trained in bio-potential and/or EEG recording.

The Cervello Elite system does not make any judgment 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.

  1. Technological Characteristics

2

CKROCK EUROMED

The hardware and software is very similar to other products on the market and does not differ significantly in any respect. This system combines the hardware and software platforms of the predicates and as such, it has identical technological characteristics. Software verification and hardware-related performance testing was submitted in the predicate device applications, and the V&V/performance testing necessary to support the use of the Cervello software on the NeuroPort hardware was submitted with this application.

Performance testing included:

  • Third-party testing for compliance with IEC 60601
  • Shipping Validation for both cart based systems (Elite and Basic) using the required packaging .
  • Internal testing to ensure the cart meets tipping requirements .
  • . Additional Software Testing Documentation

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  1. Comparison to Predicates

| 、.
| | Substantial Equivalent indication ame/couralent indication Ise. Therefore, Substantia quivalent | Therefore, Substantially quivaloni | herefore, Substantially quivalent
Page 5 of I |
|--------|---------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| | | | | |
| | | | nire, display, store, and ive electroencephaloging ive electroencephaloging tage array (in brancephaloging tage array (in the langus milli trodes) and user-specific | sicians, technicians, or of lical professionals that an |
| | | | ntial signal amplification, reco
3io-poter display, c | Trained clinicians working in resear |
| | | Cervello Elite System does stany judgment of memorials and many many is any i judgemanny is any i judgemanny in any in any in any in any in and of the and of the films funnis | o-potential signal amplifica fording, display, display, digitization rieval and display | sicians, lechnicians, clinici r medical professionals the |
| ﺎ | Feature | ndications fo
Usc | ntended Us | ntended Use |

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BLACKROCK NEUROMED
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FeatureBlackrock NeuroMed Cervello EliteBlackrock Neuroport Bio-potential Signal Processing System (K090957)Micromed Morpheus, etc. (K071782)Airsep Corporation (K000963)Substantial Equivalence Comments
Intended Use
EnvironmentClinics, hospitals, operating rooms, epilepsy evaluation unit environments, sleep laboratories.environments, sleep laboratories.
Research institution, clinic, hospital, operating room, epilepsy evaluation unit environments, sleep laboratory.Medical facility, physician's office, laboratory, clinic or nursing home or outside of a medical facility under supervision of a medical professionalMedical facilitiesSame/equivalent clinical environments.
Therefore, Substantially Equivalent
Target Patient
PopulationAdults and pediatricsNot statedThe device will be available on all patient populations as determined by a trained professionalNot statedSame/equivalent patient populations.
Therefore, Substantially Equivalent
Use limitationsThe System is not a monitoring system. No physiologic alarms are provided. The acquisition and display of bio-potential 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 are provided. The acquisition and display of bio-potential signals is for the interpretation and use of the clinician.These devices do not provide alarms and is not intended for use as an automated apnea monitor. The devices do not make any judgment of normality or abnormality of the displayed signals.[The device] does not involve any patient monitoring or diagnosisSame/equivalent use limitations.
Therefore, Substantially Equivalent
Bio-Potential
Signals RecordedElectroencephalography (EEG) Electro-corticography (ECOG) Electrocardiography (ECG) Electro-myography (EMG) Electrooculography (EOG) Evoked potential (EP), Video EEG, Respiration, Heart rate, SPO₂Electroencephalography (EEG) Electro-corticography (ECOG) Electrocardiography (ECG) Electro-myography (EMG) Electrooculography (EOG) Evoked potential (EP)Electroencephalography (EEG)
Electrocardiography (ECG),
Video EEG, Respiration, Heart Rate, SPO2Polygraphic signals such as EKG, muscle tone, respiration effort-etc. and electromygraphic, electroneurographic and evoked potential signalsSame/equivalent bio-potential recordings.
Therefore, Substantially Equivalent
Clinical
ApplicationsBio-potential signal amplification, recording, display, digitization, retrieval and display.Bio-potential signal amplification, recording, display, digitization, retrieval and display.The device function is the acquisition of bioelectric signals, as is typical for EEG amplifiers and holster recorders.
32 channelsThe System 98 software is intended to be used to perform neurophysiological exams such as EEG, EMG and EPSame/equivalent clinical applications.
Therefore, Substantially Equivalent
Number of
Signal Recording
ChannelsUp to 128 with one device; Up to 256 by cascading two NeuroPort Bio-potential devicesUp to 128 with one device; Up to 256 by cascading two devices24N/AEquivalent number of channels obtained via daisy-chaining.
Therefore, Substantially Equivalent
Analog Input
Channels (per
unit)1616N/AN/ASame/equivalent number of analog channels per unit.
Therefore, Substantially Equivalent
Amplifier Input
Impedance1000 Megohm1000 Megohm>10° Ω (diff); >5*108 Ω (CMII)N/ACollectively, identical to predicates; therefore, Substantially Equivalent
Amplifier DC
Signal Range+ 500 mV+ 500 mV1V (15µV/digit)N/ACollectively, identical to predicates; therefore, Substantially Equivalent
Amplifier
Frequency
Response0.3 to 7.5 kHz0.3 to 7.5 kHz0.15 - 220 HzN/ACollectively, identical to predicates; therefore, Substantially Equivalent
A/D Conversion16 bit16 bit16 bitN/ACollectively identical to predicates; therefore, Substantially Equivalent

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Table 4.0 Predicate Table Comparison - Elite
FeatureBlackrock NeuroMed Cervello EliteBlackrock Neuroport Bio-potential Signal
Processing System
(K090957)Micromed Morpheus, etc.
(K071782)Airsep Corporation
(K000963)Substantial Equivalence
Comments
Sampling RateUp to 30,000 HzUp to 30,000 Hz8192 Hz per channelN/ASubstantially Equivalent
CMRR> 90 dB> 90 dB>100dB@20Hz between G1 and
all other inputsN/ACollectively, identical to
predicates; therefore,
Substantially Equivalent
Noise108 Ω (diff); >5*108 Ω (CM000 Megohm>108 Ω (diff); >5*108 Ω (CMN/ASame/equivalent number analog channels per unit. Identical to K071782. Therefore, Substantially
Equivalent
Amplifier DC Signal RangeV (15µV/digi+ 500 mVV (1 SuV/digiN/A
Amplifier Frequency Response0.15 - 220 H20.3 to 7.5 kHz0.15 - 220 HzN/A
A/D Conversio16 bit1 6 bit16 bitN/A
ampling Ratc3192 Hz per chaniJp to 30,000 Hz92 Hz per chaniN/ACollectively, identical t Substantially Equivaler
CMRR>100dB@20Hz between GI and all other> 90 dB>100dB@20Hz between G1 andN/ACollectively, identical to
FeatureBlackrock NeuroMed Cervello Basic inputsBlackrock Neuroport Bio-potential Signal Processing System (K090957) ReferenceMicromed Morpheus, etc. (K071782)Airsep Corporation (K000963)Substantial Equivalence Comments
Noise10° Ω (diff); >5*108 Ω (CMII)1000 Megohm>10° Ω (diff); >5*108 Ω (CMII)N/ACollectively, identical to predicates; therefore, Substantially Equivalent
Amplifier DC Signal Range1V (15µV/digit)+ 500 mV1V (15µV/digit)N/ACollectively, identical to predicates; therefore, Substantially Equivalent
Amplifier Frequency Response0.15-220 Hz0.3 to 7.5 kHz0.15-220 HzN/ACollectively, identical to predicates; therefore, Substantially Equivalent
A/D Conversion16 bit16 bit16 bitN/ACollectively, identical to predicates; therefore, Substantially Equivalent
Sampling Rate8192 Hz per channelUp to 30,000 Hz8192 Hz per channelN/ACollectively, identical to predicates; therefore, Substantially Equivalent
CMRR>100dB@20Hz between G1 and all other> 90 dB>100dB@20Hz between G1 and all otherN/ACollectively, identical to predicates; therefore, Substantially Equivalent
FeatureBlackrock NeuroMed Cervello
AmbulatoryBlackrock Neuroport Bio-potential
Signal Processing System
(K090957) ReferenceMicromed Morpheus, etc.
(K071782)Airsep Corporation
(K000963)Substantial Equivalence
Comments
Noise