CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY

K122196 · Blackrock Neuromed, LLC · GWQ · May 2, 2013 · Neurology

Device Facts

• Record ID: K122196
• Device Name: CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY
• Applicant: Blackrock Neuromed, LLC
• Product Code: GWQ · Neurology
• Decision Date: May 2, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: Pediatric

Intended 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 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.

Device Story

Cervello Bio-Potential Signal Acquisition System is a multi-channel, multi-modal physiological monitoring platform. It acquires bio-potential signals (EEG, PSG, ECoG, EMG, ECG, EOG, EP) via user-supplied electrodes. The system consists of hardware amplifiers (Cervello or NeuroPort) and software (Cervello/Central). Inputs are digitized and stored in RAM/memory cards or PC-based systems for later review. Used in clinics, hospitals, ORs, and sleep labs by trained professionals. The device provides raw signal display and storage; it does not perform automated analysis, diagnostic interpretation, or physiologic alarming. Healthcare providers use the displayed data to support clinical decision-making. The system benefits patients by enabling high-fidelity recording of neurological and physiological signals for expert review.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included third-party IEC 60601 compliance, shipping validation, and internal cart tipping requirements. Software verification and validation were performed to support the integration of Cervello software with NeuroPort hardware.

Technological Characteristics

Multi-channel bio-potential acquisition system. Hardware: Cervello Amplifier or NeuroPort system. Connectivity: PC-based (Windows XP/7/Server 2008 R2). A/D conversion: 16-bit. Sampling rate: up to 30,000 Hz. Input impedance: 1000 Megohm. Frequency response: 0.3-7.5 kHz (Elite) or 0.15-220 Hz (Ambulatory/Basic). CMRR: >90 dB. Power: 120 VAC or battery-powered (Ambulatory). Sterilization: N/A (non-invasive). Software: Cervello/Central for signal display and storage.

Indications for Use

Indicated for acquisition, storage, and display of physiological signals (EEG, PSG, ECoG, EMG, ECG, EOG, EP) in adults and pediatrics. Intended for use by trained physicians, technicians, or medical professionals in clinics, hospitals, ORs, epilepsy units, and sleep labs. Not for automated diagnosis or physiologic alarming.

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

• Blackrock NeuroPort Bio-potential Signal Processing System (K090957)
• Micromed Brain Spy Plus, Micromed Morpheus, Embla Titanium Devices (K071782)
• Da Vinchi EEG and EMG/EP Systems (K000963)

Submission Summary (Full Text)

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### 2 2013 MAY

### 510(k) Summary

- Applicant Name: Blackrock NeuroMed, LLC, . 1. 675 Arapeen Dr., Suite 105 Salt Lake City, UT 84108 Phone: [phone] 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):

8. 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):

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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

10. 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

- 11. 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.

12. Technological Characteristics

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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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13. Comparison to Predicates

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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<br>Environment | Clinics, hospitals, operating rooms, epilepsy evaluation unit environments, sleep laboratories. | environments, sleep laboratories.<br>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.<br>Therefore, Substantially Equivalent |
| Target Patient<br>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.<br>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.<br>Therefore, Substantially Equivalent |
| Bio-Potential<br>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)<br>Electrocardiography (ECG),<br>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.<br>Therefore, Substantially Equivalent |
| Clinical<br>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.<br>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.<br>Therefore, Substantially Equivalent |
| Number of<br>Signal Recording<br>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.<br>Therefore, Substantially Equivalent |
| Analog Input<br>Channels (per<br>unit) | 16 | 16 | N/A | N/A | Same/equivalent number of analog channels per unit.<br>Therefore, Substantially Equivalent |
| Amplifier Input<br>Impedance | 1000 Megohm | 1000 Megohm | >10° Ω (diff); >5*108 Ω (CMII) | N/A | Collectively, identical to predicates; therefore, Substantially Equivalent |
| Amplifier DC<br>Signal Range | + 500 mV | + 500 mV | 1V (15µV/digit) | N/A | Collectively, identical to predicates; therefore, Substantially Equivalent |
| Amplifier<br>Frequency<br>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 | | | | |
|-----------------------------------|----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Blackrock NeuroMed Cervello Elite | Blackrock Neuroport Bio-potential Signal<br>Processing System<br>(K090957) | Micromed Morpheus, etc.<br>(K071782) | Airsep Corporation<br>(K000963) | Substantial Equivalence<br>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<br>all other inputs | N/A | Collectively, identical to<br>predicates; therefore,<br>Substantially Equivalent | |
| Noise | < 3 µVrms | < 3 µVrms | $< 0.5µV r.m.s.@256Hz sampling$<br>rate | N/A | Collectively, identical to<br>predicates; therefore,<br>Substantially Equivalent | |
| Power Source | 120 VAC | 120 VAC | 2x 1,5V DC AA, alkaline<br>batteries | 120 VAC | Collectively, identical to<br>predicates; therefore,<br>Substantially Equivalent | |
| Software | Cervello and Central | Central | Equivalent to Cervello | Equivalent to Cervello | Collectively, identical to<br>predicates; therefore,<br>Substantially Equivalent<br>Uses same software as the<br>predicate devices; therefore<br>substantially equivalent | |
| Video Camera | Available | Not Stated | Available | Available | Uses same video camera running<br>through the Cervello software:<br>therefore substantially<br>equivalent | |
| Alarms | No | No | No | No | Collectively, identical to<br>predicates; therefore,<br>Substantially Equivalent | |
| Operating<br>System | Windows XP, 7, Server 2008 R2, Dual<br>Core 2 GHz Processor | Windows XP | N/A | Windows, 150 MHz | PC Environment updated per<br>new standard operating systems;<br>therefore, Substantially<br>Equivalent | |
| Safety Standards<br>Compliance | IEC 60601-1:1998<br>IEC 60601-1-2:2007<br>IEC 60601-2-26: 2002 | IEC 60601-1:1998<br>IEC 60601-1-2:2001<br>IEC 60601-2-26 | IEC 60601-1 (1988)+ A1:1991 +<br>A2:1995 (2nd edition); IEC<br>60601-1-1 2000-12;<br>IEC 60601-1-2:2001-09; IEC<br>60601-2-26:2002-11; IEC 60601-<br>1-2:2001-09 | N/A | Same/equivalent safety<br>standards.<br>Therefore, Substantially<br>Equivalent | |
| Feature<br>Indications for<br>Use | | Blackrock NeuroMed Cervello Basic<br>Up to 64 channels with one Cervello<br>hardware device (Amplifier) using the<br>Cervello software. The device is<br>intended to acquire and store<br>physiological signals for EEG and/or<br>PSG, and to transfer the data to separate<br>polysomnographic analysis software.<br>The devices are intended to be used by<br>physicians, technicians and other medical<br>professions that are trained in EEG<br>and/or PSG.<br>The Cervello Ambulatory System does<br>not make any judgment of normality or<br>abnormality of the displayed signals or<br>the results of an analysis. In no way are<br>any of the functions represented as being<br>in and of themselves diagnostic. | Blackrock Neuroport Bio-potential<br>Signal Processing System<br>(K090957) Reference<br>Supports recording,<br>processing and display of biopotential<br>signals from user supplied electrodes.<br>Biopotential<br>signals include: Electrocorticography<br>(ECOG), electroencephalography<br>(EEG),<br>electromyography (EMG),<br>electrocardiography (ECG),<br>electrooculography (EOG) and<br>Evoked Potential (EP). | Micromed Morpheus, etc.<br>(K071782) | Airsep Corporation<br>(K000963) | Substantial Equivalence<br>Comments |
| Intended Use | | Acquire, display, store, and archive<br>electroencephalographic signals from the<br>brain using a full montage array (i.е., 16<br>or more electrodes) and user-specified<br>locations. | Bio-potential signal amplification,<br>recording, display, digitization,<br>retrieval and display. | Acquire and store physiological<br>signals for EEG and Sleep<br>Studies, and to transfer the data to<br>separate polysomnographic<br>analysis software. | DA VINCHI EEG Systems are used for<br>the acquisition, display and storage of<br>biologic signals relating principally to,<br>cortical surface potentials with additional<br>capabilities of collecting polygraphic<br>signals such as EKG, muscle tone,<br>respiration effort-etc. Signals are<br>collected and processed as per traditional<br>techniques of EEG interpretation.<br>Computer and digital techniques<br>enhance the physician's capability of<br>working with acquired trace data during<br>the interpretation process.<br>The system is a computer based<br>instrument for the acquisition, display,<br>review and storage of electromygraphic,<br>electroneurographic and evoked potential<br>signals. The instrument displays signals,<br>aids in specific measurements but does<br>not perform any interpretation or attempt<br>to evaluate any signals for their<br>pathologic relevance. All data<br>interpretation is performed by the<br>physician.<br>This submission covers only the<br>computer software used in the system. It<br>does not include any hardware. It does<br>not involve any patient monitoring or<br>diagnosis. | Same/equivalent intended use.<br>Therefore, Substantially<br>Equivalent |
| Intended User | | Physicians, technicians, or other medical<br>professionals that are trained in EEG<br>and/or PSG | Trained clinicians working in research<br>institutions, clinics, hospitals, operating<br>rooms, epilepsy evaluation unit<br>environments, sleep laboratories. | Physicians, technicians, or other<br>medical professionals that are<br>trained in EEG and/or PSG | Acquisition, display and storage of<br>biologic signals relating principally to<br>cortical surface potentials with additional<br>capabilities of collecting polygraphic<br>signals such as EKG, muscletone,<br>respiration effort cic. | Same/equivalent intended use.<br>Identical to K071782.<br>Therefore, Substantially<br>Equivalent |
| Intended Use<br>Environment | | Medical facility, physician's office,<br>laboratory, clinic or nursing home or<br>outside of a medical facility under<br>supervision of a medical professional | Research institution, clinic, hospital,<br>operating room, epilepsy evaluation<br>unit environments, sleep laboratory. | Medical facility, physician's<br>office, laboratory, clinic or<br>nursing home or outside of a<br>medical facility under supervision<br>of a medical professional | Qualified personnel (doctors or<br>technicians of the Neuro-<br>physiopathological departments) | Same/equivalent intended<br>users. Identical to K071782.<br>Therefore, Substantially<br>Equivalent |
| Target Patient<br>Population | | The device will be available on all<br>patient populations as determined by a | Not stated | The device will be available on all<br>patient populations as determined | Medical facilities | Same/equivalent clinical<br>environments. Identical to<br>K071782.<br>Therefore, Substantially<br>Equivalent<br>Same/equivalent patient<br>populations. Identical to<br>Page 8 of 13 |

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| r | | Predicate<br>Table 4.0 | Table Comparison - Basi | . · | |
| Feature | lackrock NeuroMed Cervello Br | Blackrock Neuroport Bio-potentia | icromed Morpheus, etc. (K071782) | irsep Corporation. (K000963) | Substantial Equivalen<br>Comment |
| | ained professiona | | a trained professiona |…