The Cervello® STIM cortical stimulator is a low power, constant current, bi-phasic stimulator intended for cortical stimulation during electroencephalography examinations (i.e. stereoEEG).

The stimulation is applied to the brain using third-party stimulation probes (including cortical or intracranial electrodes) and the resulting cortical or deep brain potentials themselves are recorded using third-party cortical or intracranial electrodes.

The Cervello® STIM itself is an accessory to the Cervello® Basic Biopotential Signal Acquisition System. The stimulation parameters, the election and the activation of the stimulation current are all set-up and controlled from it. The Cervello® STIM can operate only when so connected and with the Cervello software; it cannot serve as a stand-alone cortical stimulator.

Device Description

The Cervello® STIM cortical stimulator is a low power, constant current, bi-phasic stimulator intended for cortical stimulation during electroencephalography examinations (i.e. stereoEEG). The stimulation is applied to the brain using third-party stimulation probes (including cortical or intracranial electrodes) and the resulting cortical or deep brain potentials themselves are recorded using third-party cortical or intracranial electrodes. The Cervello® STIM itself is an accessory to the Cervello® Basic Biopotential Signal Acquisition System. The stimulation parameters, the election and the activation of the stimulation current are all set-up and controlled from it. The Cervello® STIM can operate only when so connected and with the Cervello software; it cannot serve as a stand-alone cortical stimulator.

AI/ML Overview

I am sorry, but the provided text is a 510(k) summary for the Cervello® STIM cortical stimulator. It focuses on demonstrating substantial equivalence to predicate devices, but does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The document primarily provides a comparison of technological characteristics between the Cervello® STIM and other predicate devices, along with adherence to recognized consensus standards. It does not detail specific clinical or performance studies with acceptance criteria and results.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the information given.

Summary

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

January 27, 2016

Blackrock Neuromed % John Ziobro Principal Spectramedex 117 West South Street Oconomowo, Wisconsin 53066

Re: K151354

Trade/Device Name: Cervello Stim Regulation Number: 21 CFR 882.1310 Regulation Name: Cortical Electrode Regulatory Class: Class II Product Code: GYC Dated: December 22, 2015 Received: December 29, 2015

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

William J. Heetderks -S

for Carlos L. Peña, PhD, MS 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) K151354

Device Name Cervello® STIM

Indications for Use (Describe)

The Cervello® STIM cortical stimulator is a low power, constant current, bi-phasic stimulator intended for cortical stimulation during electroencephalography examinations (i.e. stereoEEG).

The stimulation is applied to the brain using third-party stimulation cortical or intracranial electrodes) and the resulting cortical or deep brain potentials themselves are recorded using third-party cortical or intracranial electrodes.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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CERVELLO® STIM Traditional 510(k) Summary

SECTION 3

Traditional 510(k) Summary

Blackrock NeuroMed, LLC 1. Applicant Name: 630 Komas DR, Suite 200 Salt Lake City, UT 84108 USA Establishment Registration Number: 3009161142
Submission Correspondent: On behalf of Blackrock Neuromed, the following consultant is assigned the 2. responsibility of submission correspondence:

John F. Ziobro Principal Consultant SpectraMedEx, LLC 117 W. South Street Oconomowoc. WI 53066 262.719.8922

1. Trade Name: CERVELLO® STIM
1. Common Name: Cortical stimulator
న్. Description: Cortical Electrode (Per FDA Classification)
MICROMED S.P.A. 6. Manufacturing Site: (Hardware & Software) Via giotto 2 Mogliano veneto Treviso, ITALY 31021 Establishment Registration Number: 3005994236
1. Sterilization Site: N/A, The device is not provided sterile, nor does it need to be sterilized for its intended use
1. Suggested Classification Regulation, Class & Product Code & Panel: 21 CFR 882.1310Neurology Class II Product Code: GYC Panel: Neurology
9 Reason for Traditional 510(k): New submission
1. Predicate Device(s): 510(k) Number: K072964 Manufacturer: Cardinal Health (Natus) Trade Name: Nicolet Cortical Stimulator Product Code: GYC (cortical electrodes) Classification: 21 CFR 882.1310
- Predicate Device(s): 510(k) Number: K924226 Manufacturer: Integra Life Sciences Trade Name: Ojemann Cortical Stimulator OCS2 Product Code: GYC (cortical electrodes) Classification: 21 CFR 882.1310
- Predicate Device(s): 510(k) Number: K110410 Manufacturer: Nihon Khoden

CERVELLO® STIM Traditional 510(k) Submission

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CERVELLO® STIM

Traditional 510(k) Summary

VOLUME 2

SECTION 3

Trade Name: MS-120-BK Product Code: GYC (cortical electrodes), GWF (evoked response, electrical) Classification: 21 CFR 882.1310

Predicate Device(s):	510(k) Number:	K082629
	Manufacture:	Grass Telefactor (Astromed)
	Trade Name:	S12X
	Product Code:	GYC (cortical electrodes)
	Classification:	21 CFR 882.1310

1. Compliance to Special Controls / Performance Standards: Compliance to the following recognized consensus standards is declared:

Harmonized standard	Title :
IEC 60601-1:2005 +/A1:2012	Medical electrical equipment - Part 1: General requirements for basic safety andessential performance
IEC 60601-1-1:2000	Medical electrical equipment - Part 1-1: General requirements for safety - Collateralstandard: Safety requirements for medical electrical systems
IEC 60601-1-4:1996+A1:1999	Medical electrical equipment - Part 1-4: General requirements for safety - CollateralStandard: Programmable electrical medical systems
IEC 60601-2-26:2012	Medical electrical equipment - Part 2-26: Particular requirements for the basic safetyand essential performance of electroencephalographs
IEC 60601-2-40:1998	Medical electrical equipment - Part 2-40: Particular requirements for the safety ofelectromyographs and evoked response equipment
IEC 60601-1-2:2007	Medical electrical equipment - Part 1-2: General requirements for basic safety andessential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests
IEC 62304:2006	Medical device software - Software life-cycle processes

12. Summary Date: May 15, 2015

1. Indication for Use
  The Cervello® STIM cortical stimulator is a low power, constant current, bi-phasic stimulator intended for cortical stimulation during electroencephalography examinations (i.e. stereoEEG).

14. Technological Characteristics

The hardware and software is very similar to other products on the market and does not differ significantly in any respect. This system is combines the hardware and software platforms of the predicates and as such has it has identical technological characteristics.

15. Comparison to Predicates

The main differences between the CERVELLO® STIM device under review and the predicate(s) (Namely the Nicolet Cortical Stimulator as the primary predicate) are as follows:

Physical size (the proposed device is smaller)

CERVELLO® STIMTraditional 510(k) Submission	VOL_002/003_Traditional 510(k) Summary.docxConfidential	Page 002/003-2
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SECTION 3

. Stand-alone versus component (The primary predicate is equivalent to the proposed device in terms that both are "accessories" to their parent systems)
. Required components (The proposed device MUST be used in concert with the CERVELLO® amplifier. The predicates may be used as stand-alone devices).
. User interface (The proposed device does not have any display – it's information is conveyed to the user via the software interface that is part of the EEG amplifier system. The predicate devices may include displayed information on the physical devices themselves).
Stimulation parameters. Some of the parameters of the proposed device are at the low end of the predicates (e.g. the train length of the proposed device = 1-15 seconds while predicates extend to 20 or 30 seconds), while some of the stimulation parameters exceed the range of the pulse width duration of the proposed device is 3 msec, while the predicate(s) do not exceed 2 msee). However, these differences do not impact the overall design intent of the device (it is still intended for the same intended user and intended use environment).

A comparison of their stimulators and their parameters are shown in the following table:

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						VOLUME 2
						SECTION 3
Feature	NicoletCortical Stimulator(K072964)	Integra Life SciencesOjemann Cortical StimulatorOCS2(K924226)	Nihon KohdenMS-120 BK(K110410)	Grass-TelefactorS12X(K082629)	CERVELLO® STIMSD LTM STIM(New - Under Review)	SubstantialEquivalenceComments
StimulationOutputMethod	Constant Current	Constant Current	Constant Current	Constant Current	Constant Current	Identicalspecification.Therefore,SubstantiallyEquivalent
MaximumStimulationCharge	15μC	20μC	4.5μC	20μC	20μC	Within therange of thepredicates.Therefore,SubstantiallyEquivalent
CurrentStimulationRange	0.1 to 15mA (peak)	0 to 10 mA (peak)	0 to 15 mA (peak)	0.2 to 15 mA, except at 2ms whencurrent is limited to 10 mA	0 to 15 mA (peak; up to 2KΩload) in steps of 0.1 mA	Within therange of thepredicates.Therefore,SubstantiallyEquivalent
StimulationFrequency	1 to 100HzSingle pulse or continuous	5,10,20,50,75,100Hz	0.1 to 50Hz	2 to 100Hz except at pulse widthsof 1 or 2 ms when the frequency islimited to 50Hz	Single pulse; continuous: from 0.1Hz to 100 Hz in steps of 0.1 Hz	Within theboundaries ofthe predicates.Therefore,SubstantiallyEquivalent
StimulationPulseWidthDuration	0.1 to 1.0 msec per phase	0.1 to 2.0 ms per phase	0.05 to 0.3 msec per phase	0.1 to 2.0 ms	50 μs to 1000 μs in steps of 1 μs(Equivalent to 0.1 to 1.0 msec)	Within theboundaries ofthe predicates,Therefore,SubstantiallyEquivalent
StimulationTrainLength	User specified 0.1-30 seconds	Unknown	Unknown	0.2 to 20 sec in 7 steps	User specified 1-15 seconds	Within therange of thepredicates.Therefore,SubstantiallyEquivalent
OutputTrigger	Trigger Out permitssynchronizing externalequipment	Unknown	Trigger input and output on theconnected acquisition systemME1000-A	Unknown	Trigger on single pulse forstimulation rate up to 20 Hz,trigger on train start for higher	Triggercapabilitysimilar to
		CERVELLO®STIM				VOLUME 2
		Traditional 510(k) Summary				SECTION 3
	NicoletCortical Stimulator	Integra Life SciencesOjemann Cortical StimulatorOCS2	Nihon KohdenMS-120 BK	Grass-TelefactorS12X	CERVELLO® STIMSD LTM STIM	SubstantialEquivalence
Feature	(K072964)	(K924226)	(K110410)	(K082629)	(New - Under Review)	Comments
					stimulation rates	predicates.Therefore,SubstantiallyEquivalent
Pulse shape	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular	Identicalspecification.Therefore,SubstantiallyEquivalent
StimulationMode	Biphasic	Biphasic	Biphasic (high output mode; notspecified for the low outputmode)	Selectable positive, negative, oralternating on successive pulsesBiphasic	Biphasic (with independentlycontrollable main & reversephases)	All devices arebiphasicTherefore,SubstantiallyEquivalent
StimulatorfeaturesAs peradvertisingmaterials	The Nicolet Cortical Stimulatorinterfaces with the NicOne· Stand alone unit orseamlessly integrates withNicOne EEG applicationsoftware	The Model OCS2 OjemannCortical Stimulator is a portable,battery-operated, bipolar stimulatordesigned according to thespecifications of Dr. GeorgeOjemann of the University ofWashington, Seattle. It is especiallyuseful for cortical stimulation priorto epilepsy surgery and forintraoperative cortical mappingbefore cortical incision orplacement of depth electrodes inpatients with seizure disorders.	The high and low setting.stimulation current andfrequency of stimulation isselected by the user. The NihonKohden MS-120BK isconnected to the MEE 1000Athrough the JB-116BK or JB-132BK amplifier.In the Low output setting theNihon Kohden MS-120BKapplies cortical stimulationenergy through the NihonKohden stimulation pod (JS-102B) which is connected tocommercially available corticalelectrodes (strip and gridelectrodes).In the High output setting, theMS-120BK outputselectrostimulation pulse throughthe Nihon Kohden extensioncord (BM-121B) which isconnected to commerciallyavailable stimulationelectrode(s)	Stimulation can be via a traditionalhand-held electrode probe forintraoperative stimulation, or viaintracranial electrodes using theGrass ESAx Electrode SwitchingArray option in conjunction withGrass Technologies' BeehiveVideo/EEG monitoring systems.	• It works in conjunction withMicromed amplifier models SDLTM 64 EXPRESS (i.e. Cervello64)· Direct connection to theamplifier inputs, connection to thepatient through the standardamplifier jackbox andcommercially available electrodes(strip, grid or depth electrodes).	EquivalentFeatures.Differences arefor marketingpurposes and donot impact thedesign intent /Intended use.Therefore,SubstantiallyEquivalent
Image: BLACKROCK NEUROMED logo		CERVELLO®STIM				VOLUME 2
		Traditional 510(k) Summary				SECTION 3
	Feature	Integra Life SciencesOjemann Cortical StimulatorOCS2	Nihon KohdenMS-120 BK	Grass-TelefactorS12X	CERVELLO® STIMSD LTM STIM	SubstantialEquivalenceComments
		(K924226)	(K110410)	(K082629)	(New - Under Review)
Number ofChannelsCapable ofBeingSelected	NicoletCortical Stimulator(K072964)
	• Two Stimulus SwitchingUnits may be used toelectronically select 128electrodes, 64 electrode pairs• Stimulates "user selectable"electrode pairs or bipolar probe			• Direct Connect up to 128channels for electrode selection andEEG recording• Two ESAx switching units can bedaisy chained for up to 128channels• ESAx connects any combinationof 64 electrodes to the plus andminus stimulus output of the S12X	• Number of Stimulators: 1electrical stimulators, positive andnegative electrode can beswitched to any of the 64available output channels	Within therange of thepredicates.Therefore,SubstantiallyEquivalent

CERVELLO®

CERVELLO® STIM Traditional 510(k) Submission

Confidential

VOLUME 2

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Confidential

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Image /page/9/Picture/0 description: The image shows the logo for Blackrock Neuromed. The logo consists of a stylized penguin-like figure on the left, followed by the word "BLACKROCK" in black, bold letters. Below "BLACKROCK" is the word "NEUROMED" in a lighter blue color. The logo is clean and modern, with a focus on the company name and a simple, recognizable symbol.

CERVELLO® STIM Traditional 510(k) Summary

SECTION 3

16. Conclusions

Blackrock Neuromed, believes the proposed CERVELLO® STIM (Model SD LTM STIM) and its predicates, the Nicolet Cortical Stimulator, the Integra Ojemann Cortical Stimulator, The Nihon Kohden MS-120 BK Cortical Stimulator and the Grass-Telefactor Model S12X System, are substantially equivalent in their intended use, intended users, intended use environment and indications for use. Furthermore, both systems have the same/equivalent technological characteristics, physical characteristics and safety standards. The differences that exist between the devices, relating to their physical size, the interconnectiveness with the other common components, their user interface, and minor differences in the stimulation parameters do not affect the relative safety and/or effectiveness.

Regulation Number and Section

§ 882.1310 Cortical electrode.

(a)
Identification. A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity.(b)
Classification. Class II (performance standards).