(282 days)
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.
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):
- 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
- 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
-
- Indication for Use
The Blackrock NeuroMed Cervello Bio-Potential Signal Acquisition Product Family contains the following configurations.
- Indication for Use
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.
- Technological Characteristics
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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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- Comparison to Predicates
| 、.
| | Substantial Equivalent indication ame/couralent indication Ise. Therefore, Substantia quivalent | Therefore, Substantially quivaloni | herefore, Substantially quivalent
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Feature | Blackrock NeuroMed Cervello Elite | Blackrock Neuroport Bio-potential Signal Processing System (K090957) | Micromed Morpheus, etc. (K071782) | Airsep Corporation (K000963) | Substantial Equivalence Comments |
---|---|---|---|---|---|
Intended Use | |||||
Environment | Clinics, 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 professional | Medical facilities | Same/equivalent clinical environments. | ||
Therefore, Substantially Equivalent | |||||
Target Patient | |||||
Population | Adults and pediatrics | Not stated | The device will be available on all patient populations as determined by a trained professional | Not stated | Same/equivalent patient populations. |
Therefore, Substantially Equivalent | |||||
Use limitations | 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. 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 diagnosis | Same/equivalent use limitations. |
Therefore, Substantially Equivalent | |||||
Bio-Potential | |||||
Signals Recorded | Electroencephalography (EEG) Electro-corticography (ECOG) Electrocardiography (ECG) Electro-myography (EMG) Electrooculography (EOG) Evoked potential (EP), Video EEG, Respiration, Heart rate, SPO₂ | Electroencephalography (EEG) Electro-corticography (ECOG) Electrocardiography (ECG) Electro-myography (EMG) Electrooculography (EOG) Evoked potential (EP) | Electroencephalography (EEG) | ||
Electrocardiography (ECG), | |||||
Video EEG, Respiration, Heart Rate, SPO2 | Polygraphic signals such as EKG, muscle tone, respiration effort-etc. and electromygraphic, electroneurographic and evoked potential signals | Same/equivalent bio-potential recordings. | |||
Therefore, Substantially Equivalent | |||||
Clinical | |||||
Applications | Bio-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 channels | The System 98 software is intended to be used to perform neurophysiological exams such as EEG, EMG and EP | Same/equivalent clinical applications. | |||
Therefore, Substantially Equivalent | |||||
Number of | |||||
Signal Recording | |||||
Channels | Up to 128 with one device; Up to 256 by cascading two NeuroPort Bio-potential devices | Up to 128 with one device; Up to 256 by cascading two devices | 24 | N/A | Equivalent number of channels obtained via daisy-chaining. |
Therefore, Substantially Equivalent | |||||
Analog Input | |||||
Channels (per | |||||
unit) | 16 | 16 | N/A | N/A | Same/equivalent number of analog channels per unit. |
Therefore, Substantially Equivalent | |||||
Amplifier Input | |||||
Impedance | 1000 Megohm | 1000 Megohm | >10° Ω (diff); >5*108 Ω (CMII) | N/A | Collectively, identical to predicates; therefore, Substantially Equivalent |
Amplifier DC | |||||
Signal Range | + 500 mV | + 500 mV | 1V (15µV/digit) | N/A | Collectively, identical to predicates; therefore, Substantially Equivalent |
Amplifier | |||||
Frequency | |||||
Response | 0.3 to 7.5 kHz | 0.3 to 7.5 kHz | 0.15 - 220 Hz | N/A | Collectively, identical to predicates; therefore, Substantially Equivalent |
A/D Conversion | 16 bit | 16 bit | 16 bit | N/A | Collectively identical to predicates; therefore, Substantially Equivalent |
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Table 4.0 Predicate Table Comparison - Elite | ||||||
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Feature | Blackrock NeuroMed Cervello Elite | Blackrock Neuroport Bio-potential Signal | ||||
Processing System | ||||||
(K090957) | Micromed Morpheus, etc. | |||||
(K071782) | Airsep Corporation | |||||
(K000963) | Substantial Equivalence | |||||
Comments | ||||||
Sampling Rate | Up to 30,000 Hz | Up to 30,000 Hz | 8192 Hz per channel | N/A | Substantially Equivalent | |
CMRR | > 90 dB | > 90 dB | >100dB@20Hz between G1 and | |||
all other inputs | N/A | Collectively, identical to | ||||
predicates; therefore, | ||||||
Substantially Equivalent | ||||||
Noise | 108 Ω (diff); >5*108 Ω (CM | 000 Megohm | >108 Ω (diff); >5*108 Ω (CM | N/A | Same/equivalent number analog channels per unit. Identical to K071782. Therefore, Substantially | |
Equivalent | ||||||
Amplifier DC Signal Range | V (15µV/digi | + 500 mV | V (1 SuV/digi | N/A | ||
Amplifier Frequency Response | 0.15 - 220 H2 | 0.3 to 7.5 kHz | 0.15 - 220 Hz | N/A | ||
A/D Conversio | 16 bit | 1 6 bit | 16 bit | N/A | ||
ampling Ratc | 3192 Hz per chani | Jp to 30,000 Hz | 92 Hz per chani | N/A | Collectively, identical t Substantially Equivaler | |
CMRR | >100dB@20Hz between GI and all other | > 90 dB | >100dB@20Hz between G1 and | N/A | Collectively, identical to | |
Feature | Blackrock NeuroMed Cervello Basic inputs | Blackrock Neuroport Bio-potential Signal Processing System (K090957) Reference | Micromed Morpheus, etc. (K071782) | Airsep Corporation (K000963) | Substantial Equivalence Comments | |
Noise | 10° Ω (diff); >5*108 Ω (CMII) | 1000 Megohm | >10° Ω (diff); >5*108 Ω (CMII) | N/A | Collectively, identical to predicates; therefore, Substantially Equivalent | |
Amplifier DC Signal Range | 1V (15µV/digit) | + 500 mV | 1V (15µV/digit) | N/A | Collectively, identical to predicates; therefore, Substantially Equivalent | |
Amplifier Frequency Response | 0.15-220 Hz | 0.3 to 7.5 kHz | 0.15-220 Hz | N/A | Collectively, identical to predicates; therefore, Substantially Equivalent | |
A/D Conversion | 16 bit | 16 bit | 16 bit | N/A | Collectively, identical to predicates; therefore, Substantially Equivalent | |
Sampling Rate | 8192 Hz per channel | Up to 30,000 Hz | 8192 Hz per channel | N/A | Collectively, identical to predicates; therefore, Substantially Equivalent | |
CMRR | >100dB@20Hz between G1 and all other | > 90 dB | >100dB@20Hz between G1 and all other | N/A | Collectively, identical to predicates; therefore, Substantially Equivalent | |
Feature | Blackrock NeuroMed Cervello | |||||
Ambulatory | Blackrock Neuroport Bio-potential | |||||
Signal Processing System | ||||||
(K090957) Reference | Micromed Morpheus, etc. | |||||
(K071782) | Airsep Corporation | |||||
(K000963) | Substantial Equivalence | |||||
Comments | ||||||
Noise |