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

AI/ML Overview

The Blackrock NeuroMed Cervello Bio-Potential Signal Acquisition System is a multi-channel, multi-modal physiological monitoring system with three configurations: Cervello Ambulatory, Cervello Basic, and Cervello Elite. The submission for this device is a consolidation/modification of existing devices, and its acceptance criteria and the study proving it meets these criteria are based on its substantial equivalence to predicate devices. The device is not intended to make any judgment of normality or abnormality of the displayed signals, nor is it a monitoring system with physiological alarms. Its purpose is to acquire, display, store, and archive bio-potential signals for interpretation and use by clinicians.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Cervello Bio-Potential Signal Acquisition System are generally aligned with the performance characteristics of its predicate devices, as the submission aims to demonstrate "substantial equivalence." The performance is deemed acceptable if it matches or is comparable to the predicate devices.

Feature	Acceptance Criteria (from Predicate Devices)	Reported Device Performance (Blackrock NeuroMed Cervello)	Justification for Equivalence
Intended Use Environment	Clinics, hospitals, operating rooms, epilepsy evaluation unit environments, sleep laboratories, medical facility, physician's office, laboratory, clinic or nursing home.	Same/equivalent clinical environments.	Same/equivalent clinical environments. Therefore, Substantially Equivalent.
Target Patient Population	All patient populations (or not stated, implying general applicability).	Adults and pediatrics / The device will be available on all patient populations as determined by a trained professional.	Same/equivalent patient populations. Therefore, Substantially Equivalent.
Use Limitations	Not a monitoring system, no physiologic alarms, no judgment of normality/abnormality, acquisition and display for clinician interpretation.	Same limitations.	Same/equivalent use limitations. Therefore, Substantially Equivalent.
Bio-Potential Signals Recorded	EEG, ECoG, ECG, EMG, EOG, EP, Video EEG, Respiration, Heart rate, SPO₂.	All listed signals, plus Respiration, Heart rate, SPO₂ for some configurations.	Same/equivalent bio-potential recordings. Therefore, Substantially Equivalent.
Clinical Applications	Bio-potential signal amplification, recording, display, digitization, retrieval and display. Acquisition of bioelectric signals for neurophysiological exams.	Same applications.	Same/equivalent clinical applications. Therefore, Substantially Equivalent.
Number of Signal Recording Channels	Up to 128 (one device) / Up to 256 (cascading).	Up to 128 (one device) / Up to 256 (cascading) (Elite); 64 or 128 (Basic); 64 (Ambulatory).	Equivalent number of channels obtained via daisy-chaining. Therefore, Substantially Equivalent.
Analog Input Channels (per unit)	16 or 24.	16 (Elite); 24 (Basic/Ambulatory).	Same/equivalent number of analog channels per unit. Therefore, Substantially Equivalent.
Amplifier Input Impedance	1000 Megohm or >10⁸ Ω (diff); >5*10⁸ Ω (CMII).	1000 Megohm or >10⁸ Ω (diff); >5*10⁸ Ω (CMII).	Collectively, identical to predicates; therefore, Substantially Equivalent.
Amplifier DC Signal Range	± 500 mV or 1V (15µV/digit).	± 500 mV or 1V (15µV/digit).	Collectively, identical to predicates; therefore, Substantially Equivalent.
Amplifier Frequency Response	0.3 to 7.5 kHz or 0.15 - 220 Hz.	0.3 to 7.5 kHz or 0.15 - 220 Hz.	Collectively, identical to predicates; therefore, Substantially Equivalent.
A/D Conversion	16 bit.	16 bit.	Collectively identical to predicates; therefore, Substantially Equivalent.
Sampling Rate	Up to 30,000 Hz or 8192 Hz per channel.	Up to 30,000 Hz or 8192 Hz per channel.	Collectively, identical to predicates; therefore, Substantially Equivalent.
CMRR	> 90 dB or >100dB@20Hz.	> 90 dB or >100dB@20Hz.	Collectively, identical to predicates; therefore, Substantially Equivalent.
Noise	< 3 µVrms or < 0.5µV r.m.s.@256Hz sampling rate.	< 3 µVrms or < 0.5µV r.m.s.@256Hz sampling rate.	Collectively, identical to predicates; therefore, Substantially Equivalent.
Power Source	120 VAC or 2x 1.5V DC AA alkaline batteries.	120 VAC or 2x 1.5V DC AA alkaline batteries.	Collectively, identical to predicates; therefore, Substantially Equivalent.
Software	Central, Cervello, or equivalent.	Cervello and Central.	Uses same software as the predicate devices; therefore substantially equivalent.
Video Camera	Available (or not stated).	Available.	Uses same video camera running through the Cervello software; therefore substantially equivalent.
Alarms	No.	No.	Collectively, identical to predicates; therefore, Substantially Equivalent.
Operating System	Windows XP, 7, Server 2008 R2, 150 MHz or 2 GHz processor.	Windows XP, 7, Server 2008 R2, Dual Core 2 GHz Processor.	PC Environment updated per new standard operating systems; therefore, Substantially Equivalent.
Safety Standards Compliance	IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26.	IEC 60601-1:1998, IEC 60601-1-2:2007, IEC 60601-2-26: 2002.	Same/equivalent safety standards. Therefore, Substantially Equivalent.

2. Sample Size Used for the Test Set and the Data Provenance

The provided document does not detail specific sample sizes for test sets in clinical studies. The performance testing primarily focused on demonstrating substantial equivalence to predicate devices through technical specifications and compliance with standards.

Sample Size for Test Set: Not explicitly mentioned in terms of patient data. The evaluation appears to be based on engineering and performance testing against established standards and comparison to predicate devices, rather than a clinical trial with a specific patient test set.
Data Provenance: The document does not mention data provenance in terms of country of origin or whether studies were retrospective or prospective, as the device's approval is based on substantial equivalence and technical performance, not new clinical data generation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

No information regarding experts establishing ground truth for a test set is provided. The submission relies on technical comparisons to predicate devices and adherence to regulatory standards (e.g., IEC 60601) to support its claims of safety and effectiveness.

4. Adjudication Method for the Test Set

Not applicable, as no dedicated test set requiring clinical adjudication is described in the provided information.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The device is a bio-potential signal acquisition system, not an AI-assisted diagnostic tool that would typically be evaluated with an MRMC study for human reader performance improvement. It does not provide automatic analysis or diagnostic judgments.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a hardware and software system for acquiring and displaying bio-potential signals; it does not contain an AI algorithm that operates standalone for diagnostic purposes. The software is explicitly stated "not intended to do automatic analysis of the recorded signals" and "not intended for use as an automated apnea monitor."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the device's performance is established by its adherence to internationally recognized electrical safety and performance standards (e.g., IEC 60601 series) and by demonstrating that its technical specifications and intended use are equivalent to existing, legally marketed predicate devices. This is a regulatory "ground truth" rather than a clinical one derived from patient outcomes or expert consensus on a specific diagnostic task.

8. The sample size for the training set

Not applicable. The device is not a machine learning or AI model, so there is no "training set" in the conventional sense. Its design and validation are based on engineering principles and regulatory compliance.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for an AI/ML model. The evaluation of this device is based on comparing its specified performance characteristics and safety profiles to those of legally marketed predicate devices.

Summary

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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

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

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.

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.

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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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

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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 UseEnvironment	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 PatientPopulation	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-PotentialSignals 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
ClinicalApplications	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 ofSignal RecordingChannels	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 InputChannels (perunit)	16	16	N/A	N/A	Same/equivalent number of analog channels per unit.Therefore, Substantially Equivalent
Amplifier InputImpedance	1000 Megohm	1000 Megohm	>10° Ω (diff); >5*108 Ω (CMII)	N/A	Collectively, identical to predicates; therefore, Substantially Equivalent
Amplifier DCSignal Range	+ 500 mV	+ 500 mV	1V (15µV/digit)	N/A	Collectively, identical to predicates; therefore, Substantially Equivalent
AmplifierFrequencyResponse	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 SignalProcessing System(K090957)	Micromed Morpheus, etc.(K071782)	Airsep Corporation(K000963)	Substantial EquivalenceComments
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 andall other inputs	N/A	Collectively, identical topredicates; therefore,Substantially Equivalent
Noise	< 3 µVrms	< 3 µVrms	$< 0.5µV r.m.s.@256Hz sampling$rate	N/A	Collectively, identical topredicates; therefore,Substantially Equivalent
Power Source	120 VAC	120 VAC	2x 1,5V DC AA, alkalinebatteries	120 VAC	Collectively, identical topredicates; therefore,Substantially Equivalent
Software	Cervello and Central	Central	Equivalent to Cervello	Equivalent to Cervello	Collectively, identical topredicates; therefore,Substantially EquivalentUses same software as thepredicate devices; thereforesubstantially equivalent
Video Camera	Available	Not Stated	Available	Available	Uses same video camera runningthrough the Cervello software:therefore substantiallyequivalent
Alarms	No	No	No	No	Collectively, identical topredicates; therefore,Substantially Equivalent
OperatingSystem	Windows XP, 7, Server 2008 R2, DualCore 2 GHz Processor	Windows XP	N/A	Windows, 150 MHz	PC Environment updated pernew standard operating systems;therefore, SubstantiallyEquivalent
Safety StandardsCompliance	IEC 60601-1:1998IEC 60601-1-2:2007IEC 60601-2-26: 2002	IEC 60601-1:1998IEC 60601-1-2:2001IEC 60601-2-26	IEC 60601-1 (1988)+ A1:1991 +A2:1995 (2nd edition); IEC60601-1-1 2000-12;IEC 60601-1-2:2001-09; IEC60601-2-26:2002-11; IEC 60601-1-2:2001-09	N/A	Same/equivalent safetystandards.Therefore, SubstantiallyEquivalent
FeatureIndications forUse		Blackrock NeuroMed Cervello BasicUp to 64 channels with one Cervellohardware device (Amplifier) using theCervello software. The device isintended to acquire and storephysiological signals for EEG and/orPSG, and to transfer the data to separatepolysomnographic analysis software.The devices are intended to be used byphysicians, technicians and other medicalprofessions that are trained in EEGand/or PSG.The Cervello Ambulatory System doesnot make any judgment of normality orabnormality of the displayed signals orthe results of an analysis. In no way areany of the functions represented as beingin and of themselves diagnostic.	Blackrock Neuroport Bio-potentialSignal Processing System(K090957) ReferenceSupports recording,processing and display of biopotentialsignals from user supplied electrodes.Biopotentialsignals include: Electrocorticography(ECOG), electroencephalography(EEG),electromyography (EMG),electrocardiography (ECG),electrooculography (EOG) andEvoked Potential (EP).	Micromed Morpheus, etc.(K071782)	Airsep Corporation(K000963)	Substantial EquivalenceComments
Intended Use		Acquire, display, store, and archiveelectroencephalographic signals from thebrain using a full montage array (i.е., 16or more electrodes) and user-specifiedlocations.	Bio-potential signal amplification,recording, display, digitization,retrieval and display.	Acquire and store physiologicalsignals for EEG and SleepStudies, and to transfer the data toseparate polysomnographicanalysis software.	DA VINCHI EEG Systems are used forthe acquisition, display and storage ofbiologic signals relating principally to,cortical surface potentials with additionalcapabilities of collecting polygraphicsignals such as EKG, muscle tone,respiration effort-etc. Signals arecollected and processed as per traditionaltechniques of EEG interpretation.Computer and digital techniquesenhance the physician's capability ofworking with acquired trace data duringthe interpretation process.The system is a computer basedinstrument for the acquisition, display,review and storage of electromygraphic,electroneurographic and evoked potentialsignals. The instrument displays signals,aids in specific measurements but doesnot perform any interpretation or attemptto evaluate any signals for theirpathologic relevance. All datainterpretation is performed by thephysician.This submission covers only thecomputer software used in the system. Itdoes not include any hardware. It doesnot involve any patient monitoring ordiagnosis.	Same/equivalent intended use.Therefore, SubstantiallyEquivalent
Intended User		Physicians, technicians, or other medicalprofessionals that are trained in EEGand/or PSG	Trained clinicians working in researchinstitutions, clinics, hospitals, operatingrooms, epilepsy evaluation unitenvironments, sleep laboratories.	Physicians, technicians, or othermedical professionals that aretrained in EEG and/or PSG	Acquisition, display and storage ofbiologic signals relating principally tocortical surface potentials with additionalcapabilities of collecting polygraphicsignals such as EKG, muscletone,respiration effort cic.	Same/equivalent intended use.Identical to K071782.Therefore, SubstantiallyEquivalent
Intended UseEnvironment		Medical facility, physician's office,laboratory, clinic or nursing home oroutside of a medical facility undersupervision of a medical professional	Research institution, clinic, hospital,operating room, epilepsy evaluationunit environments, sleep laboratory.	Medical facility, physician'soffice, laboratory, clinic ornursing home or outside of amedical facility under supervisionof a medical professional	Qualified personnel (doctors ortechnicians of the Neuro-physiopathological departments)	Same/equivalent intendedusers. Identical to K071782.Therefore, SubstantiallyEquivalent
Target PatientPopulation		The device will be available on allpatient populations as determined by a	Not stated	The device will be available on allpatient populations as determined	Medical facilities	Same/equivalent clinicalenvironments. Identical toK071782.Therefore, SubstantiallyEquivalentSame/equivalent patientpopulations. Identical toPage 8 of 13

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	ONEUROME
r		PredicateTable 4.0	Table Comparison - Basi	. ·
Feature	lackrock NeuroMed Cervello Br	Blackrock Neuroport Bio-potentia	icromed Morpheus, etc. (K071782)	irsep Corporation. (K000963)	Substantial EquivalenComment
	ained professiona		a trained professiona		Therefore, SubstantiEquivalent6071782
se limitation		The System is not a monitoring system No physiologic alarms are provided The acquisitions and display of bideo potential signals issues and therpretation and use of the clini	hese devices do not provide arms and is not is not interaction first arms and is not interactions and links and and is not mort missioners and submissions mormality of t	he device] does not involve any patienonitoring or diagnosi	Therefore, SubstantialSame/equivalent useimitationsEquivalent
Bio-Potential Signals Recorded		Electroencephalography (EEG) Electro conticography (ECCoC) Electrocardiography (ECGO) Electrocardiography (ECCG) Electrocardiograph myography (EMCG) Electrooculography (EOG)	Electrocardiography (EEG) Electrocardiography (ECG) Video EEG, Respiration, Heart Rate,SPO	Polygraphic signals such as EKG. muscle tone, respiration effort-etc. and	Same/equivalent bio-potentecordings. Therefore, SubstantialEquivalen
Clinical Application	quisition of bio-electrical signaluding EEG and Video Elecording	Bio-potential signal amplification, recording, display, digitization, retrieval and display.	The device function is the acquisition of bioelectric sign: as is typical for Editor amplifical as is typical for Editor amplifical 32 channels	System 98 software is intendedsed to perform neurophysiologi	Same/equivalent clinicapplications. Therefore, SubstantialEquivalent
Number of Signal Recording Channels	4 channels with one device.	Up to 128 with one device; Up to 23 by cascading two devices		N/A	Equivalent number of channels obtained via daisy-chaining. Therefore, Substantially Equivalent
Analog Inpul Channels (perunit)	24 per uni	l (	24	N/A	Same/equivalent number analog channels per unit. Therefore, SubstantiallyEquivalent
Amplificr Input Impedance	>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, SubstantiallyEquivalent
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	<0.5µV r.m.s.@256Hz sampling rate	<3 µVrms	<0.5µV r.m.s.@256Hz sampling rate	N/A	predicates; therefore, Substantially Equivalent
Power Source	Acquisition unit, 2x 1,5V DC AA, alkaline batteries, computer (for software), 120 VAC	120 VAC	2x 1,5V DC AA, alkaline batteries	120 VAC	Collectively, identical to predicates; therefore, Substantially Equivalent
Software	Cervello	Central	Equivalent to Cervello	Equivalent to Cervello	Collectively, identical to predicates; therefore, Substantially Equivalent
Video Camera	Available	Not Stated	Available	Available	Uses same software as the predicate devices; therefore substantially equivalent
Alarms	No	No	No	No	Uses same video camera running through the Cervello software; therefore substantially equivalent
Operating System	Windows XP, 7, Server 2008 R2,, Dual Core 2 GHz Processor	Windows XP	N/A	Windows, 150 MHz	PC Environment updated per new standard operating systems; therefore, Substantially Equivalent
Safety Standards compliance	IEC 60601-1:1998IEC 60601-1-2:2007IEC 60601-2-26: 2002	IEC 60601-1:1998IEC 60601-1-2:2001IEC 60601-2-26	IEC 60601-1 (1988)+ A1:1991 + A2:1995 (2nd edition); IEC 60601-1-1 2000-12;IEC 60601-1-2:2001-09; IEC 60601-2-26:2002-11; IEC 60601-1-2:2001-09	N/A	Same/equivalent safety standards.Therefore, Substantially Equivalent
FeatureIndications forUse	Blackrock NeuroMed CervelloAmbulatory	Blackrock Neuroport Bio-potentialSignal Processing System(K090957) Reference	Micromed Morpheus, etc.(K071782)	Airsep Corporation(K000963)	Substantial EquivalenceComments
	Up to 64 channels with one Cervellohardware device (Amplifier) using theCervello software. The device isintended to acquire and storephysiological signals for EEG and/orPSG, and to transfer the data to separatepolysomnographic analysis software.The devices are intended to be used byphysicians, technicians and other medicalprofessions that are trained in EEGand/or PSG.The Cervello Ambulatory system doesnot make any judgment of normality orabnormality of the displayed signals orthe results of an analysis. In no way are	Supports recording,processing and display of biopotentialsignals from user supplied electrodes.Biopotential signals include:Electrocorticography (ECOG),electroencephalography (EEG),electromyography (EMG),electrocardiography (ECG),electrooculography (EOG) andEvoked Potential (EP).	Acquire and store physiologicalsignals for EEG and SleepStudies, and to transfer the data toseparate polysomnographicanalysis software.	DA VINCHI EEG Systems are used forthe acquisition, display and storage ofbiologic signals relating principally to,cortical surface potentials with additionalcapabilities of collecting polygraphicsignals such as EKG, muscle tone,respiration effort-etc. Signals arecollected and processed as per traditionaltechniques of EEG interpretation.Computer and 'digital techniquesenhance the physician's capability ofworking with acquired trace data duringthe interpretation process.The system is a computer basedinstrument for the acquisition, display,review and storage of electromygraphic,eiectroneurographic and evoked potentialsignals. The instrument displays signals,aids in specific measurements but doesnot perform any interpretation or attemptto evaluate any signals for theirpathologic relevance. All datainterpretation is performed by thephysician.This submission covers only thecomputer software used in the system. Itdoes not include any hardware. It doesnot involve any patient monitoring ordiagnosis..	Same/equivalent indicationsfor Use. Therefore,Substantially Equivalent.
Intended Use	Acquire, display, store, and archiveelectroencephalographic signals from thebrain	Bio-potential signal amplification,recording, display, digitization,retrieval and display.	Acquire, display, store, andarchive electroencephalographicsignals from the brain using a fullmontage array (i.e., 16 or moreelectrodes) and user-specifiedlocations.	Acquisition, display and storage ofbiologic signals relating principally tocortical surface potentials with additionalcapabilities of collecting polygraphicsignals such as EKG, muscletone,respiration effort etc.	Same/equivalent intended use.Therefore, SubstantiallyEquivalent
Intended User	Physicians, technicians, or other medicalprofessionals that are trained in EEGand/or PSG	Trained clinicians working in researchinstitutions, clinics, hospitals, operatingrooms, epilepsy evaluation unitenvironments, sleep laboratories.	Physicians, technicians, or othermedical professionals that aretrained in EEG and/or PSG	Qualified personnel (doctors ortechnicians of theNeurophysiopathological departments)	Same/equivalent intendedusers. Identical to K071782.Therefore, SubstantiallyEquivalent
Intended UseEnvironment	Medical facility, physician's office,laboratory, clinic or nursing home oroutside of a medical facility undersupervision of a medical professional	Research institution, clinic, hospital,operating room, epilepsy evaluationunit environments, sleep laboratory.	Medical facility, physician'soffice, laboratory, clinic ornursing home or outside of amedical facility under supervisionof a medical professional	Medical facilities	Same/equivalent clinicalenvironments. Identical toK071782.Therefore, SubstantiallyEquivalent
Target PatientPopulation	The device will be available on allpatient populations as determined by a	The device will be available on allpatient populations as determined by a	The device will be available on allpatient populations as determined by a	Not stated	Same/equivalent patientpopulations. Identical to

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ONEUROCK ONE UROMED

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BREACKROCK
CHEVROMED

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BLACKROCK	NEUROMED
Image: Blackrock logo

Feature	Blackrock NeuroMed Cervello Ambulatory	Blackrock Neuroport Bio-potential Signal Processing System (K090957) Reference	Micromed Morpheus, etc. (K071782)	Airsep Corporation (K000963)	Substantial Equivalence Comments
Use limitations	trained professional	trained professional	by a trained professional		K071782.Therefore, Substantially Equivalent
Bio-Potential Signals Recorded	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
Clinical Applications	Electroencephalography (EEG), Respiration, Heart Rate, SPO2	Electroencephalography (EEG) Electro- corticography (ECOG)Electrocardiography (ECG) Electro- myography (EMG) Electrooculography (EOG) Evoked potential (EP)Bio-potential signal amplification, recording, display, digitization, retrieval and display.	Electroencephalography (EEG), Respiration, Heart Rate, SPO2	Polygraphic signals such as EKG, muscle tone, respiration effort-etc. and electromygraphic, eiectroneurographic and evoked potential signals	Same/equivalent bio-potential recordings. Identical to K071782.Therefore, Substantially Equivalent
	The acquisition of bioelectric signals, as is typical for EEG amplifiers		The device function is the acquisition of bioelectric signals, as is typical for EEG amplifiers and holster recorders.	Intended to be used to perform neurophysiological exams such as EEG	Same/equivalent clinical applications.Therefore, Substantially Equivalent
Number of Signal Recording Channels	64 channels with one device.	Up to 128 with one device; Up to 256 by cascading two devices	32 channels	N/A	Equivalent number of channels obtained via daisy-chaining.Therefore, Substantially Equivalent
Analog Input Channels (per unit)	24 per unit	16	24	N/A	Same/equivalent number of analog channels per unit. Identical to K071782.Therefore, Substantially Equivalent
Amplifier Input Impedance	>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 CervelloAmbulatory	Blackrock Neuroport Bio-potentialSignal Processing System(K090957) Reference	Micromed Morpheus, etc.(K071782)	Airsep Corporation(K000963)	Substantial EquivalenceComments
Noise	<0.5µV r.m.s.@256kHz sampling rate	<3 µVrms	<0.5µV r.m.s.@256Hz sampling rate	N/A	Substantially EquivalentCollectively, identical to predicates; therefore,Substantially Equivalent
Power Source	2x 1,5V DC AA, alkaline batteries	120 VAC	2x 1,5V DC AA, alkaline batteries	120 VAC	Collectively, identical to predicates; therefore,Substantially Equivalent
Software	Cervello	Central	Equivalent to Cervello	Equivalent to Cervello	Uses same software as the predicate devices; thereforesubstantially equivalent
Video Camera	Available	Not Stated	Available	Available	Uses same video camera running through the Cervello software; thereforesubstantially equivalent
Alarms	No	No	No	No	Collectively, identical to predicates; therefore,Substantially Equivalent
Operating System	N/A	Windows XP	N/A	Windows, 150 MHz	PC Environment updated per new standard operating systems; therefore,Substantially Equivalent
Safety Standards Compliance	IEC 60601-1:1998IEC 60601-1-2:2007IEC 60601-2-26: 2002	IEC 60601-1:1998IEC 60601-1-2:2001IEC 60601-2-26	IEC 60601-1 (1988)+ A1:1991 + A2:1995 (2nd edition); IEC 60601-1-1 2000-12;IEC 60601-1-2:2001-09; IEC 60601-2-26:2002-11; IEC 60601-1-2:2001-09	N/A	Same/equivalent safety standards.Therefore, Substantially Equivalent

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ONEUROM

Based ni be petina device on neter er in eles specials, it s clartal tes ersce na ni atmei
fatina and trians in teine diferes in tres sperato al telane coperatio
de lasver ui

Conclusions 14.

The modifications to the Predicate Systems to create the Blackrock NeuroMed Cervello Basic and Cervello Ambulatory were evaluated
raise no new questions of safety or effecti

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/12/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like extensions.

May 02,2013

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Blackrock Neuromed, LLC. c/o John Ziobro SpectrMedex 117 West South Street Oconomowo, WI 53066

Re: K122196

Trade/Device Name: Cervello Bio-potential Signal Acquisition System Product Family:

Cervello Elite Cervello Basic Cervello Ambulatory Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWQ, OLV, GWL, GWL, GWK Dated: March 15, 2013 Received: April 4, 2013

Dear Mr. Ziobro:

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 comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Mr. John Ziobro

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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,

Joyce M. Whang -S

for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K122196

Device Name: Cervello Bio-Potential Signal Acquisition System

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.

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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.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joyce M. Whang -S

(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number K122196

Regulation Number and Section

§ 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).