Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the device's function as a stimulator and its integration with a biopotential acquisition system, with no mention of AI or ML capabilities for data analysis, interpretation, or control beyond basic parameter setting.

Therapeutic

No.
The document states that the device is intended for cortical stimulation during electroencephalography examinations and for recording brain potentials. It serves an accessory function for the Cervello® Basic Biopotential Signal Acquisition System. Its primary intended use is diagnostic in nature, not therapeutic.

Diagnostic

No
The device is described as a stimulator used during electroencephalography examinations and an accessory to a biopotential signal acquisition system. Its primary function is to apply stimulation and not to diagnose conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the Cervello® STIM is a "cortical stimulator" and a "low power, constant current, bi-phasic stimulator." It also mentions that it applies stimulation to the brain using third-party probes. This indicates a physical hardware component responsible for delivering electrical stimulation, not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Cervello® STIM cortical stimulator is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Cervello® STIM Function: The Cervello® STIM is a device that stimulates the brain and records electrical potentials from the brain. It interacts directly with the patient's body (in vivo) rather than analyzing samples taken from the body (in vitro).
Intended Use: The intended use clearly states it's for "cortical stimulation during electroencephalography examinations (i.e. stereoEEG)." This is a procedure performed directly on the patient.

Therefore, the Cervello® STIM falls under the category of a medical device used for in vivo procedures, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications 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).

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.

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.

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

GYC

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Brain

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K072964, K924226, K110410, K082629

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

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

1

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

2

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.

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.

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 and
essential performance
IEC 60601-1-1:2000	Medical electrical equipment - Part 1-1: General requirements for safety - Collateral
standard: Safety requirements for medical electrical systems
IEC 60601-1-4:1996
+A1:1999	Medical electrical equipment - Part 1-4: General requirements for safety - Collateral
Standard: Programmable electrical medical systems
IEC 60601-2-26:2012	Medical electrical equipment - Part 2-26: Particular requirements for the basic safety
and essential performance of electroencephalographs
IEC 60601-2-40:1998	Medical electrical equipment - Part 2-40: Particular requirements for the safety of
electromyographs and evoked response equipment
IEC 60601-1-2:2007	Medical electrical equipment - Part 1-2: General requirements for basic safety and
essential 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).

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.

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® STIM
Traditional 510(k) Submission | VOL_002/003_Traditional 510(k) Summary.docx
Confidential | 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	Nicolet
Cortical Stimulator
(K072964)	Integra Life Sciences
Ojemann Cortical Stimulator
OCS2
(K924226)	Nihon Kohden
MS-120 BK
(K110410)	Grass-Telefactor
S12X
(K082629)	CERVELLO® STIM
SD LTM STIM
(New - Under Review)	Substantial
Equivalence
Comments
Stimulation
Output
Method	Constant Current	Constant Current	Constant Current	Constant Current	Constant Current	Identical
specification.
Therefore,
Substantially
Equivalent
Maximum
Stimulation
Charge	15μC	20μC	4.5μC	20μC	20μC	Within the
range of the
predicates.
Therefore,
Substantially
Equivalent
Current
Stimulation
Range	0.1 to 15mA (peak)	0 to 10 mA (peak)	0 to 15 mA (peak)	0.2 to 15 mA, except at 2ms when
current is limited to 10 mA	0 to 15 mA (peak; up to 2KΩ
load) in steps of 0.1 mA	Within the
range of the
predicates.
Therefore,
Substantially
Equivalent
Stimulation
Frequency	1 to 100Hz
Single pulse or continuous	5,10,20,50,75,100Hz	0.1 to 50Hz	2 to 100Hz except at pulse widths
of 1 or 2 ms when the frequency is
limited to 50Hz	Single pulse; continuous: from 0.1
Hz to 100 Hz in steps of 0.1 Hz	Within the
boundaries of
the predicates.
Therefore,
Substantially
Equivalent
Stimulation
Pulse
Width
Duration	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 the
boundaries of
the predicates,
Therefore,
Substantially
Equivalent
Stimulation
Train
Length	User specified 0.1-30 seconds	Unknown	Unknown	0.2 to 20 sec in 7 steps	User specified 1-15 seconds	Within the
range of the
predicates.
Therefore,
Substantially
Equivalent
Output
Trigger	Trigger Out permits
synchronizing external
equipment	Unknown	Trigger input and output on the
connected acquisition system
ME1000-A	Unknown	Trigger on single pulse for
stimulation rate up to 20 Hz,
trigger on train start for higher	Trigger
capability
similar to
		CERVELLO®
STIM				VOLUME 2
		Traditional 510(k) Summary				SECTION 3
	Nicolet
Cortical Stimulator	Integra Life Sciences
Ojemann Cortical Stimulator
OCS2	Nihon Kohden
MS-120 BK	Grass-Telefactor
S12X	CERVELLO® STIM
SD LTM STIM	Substantial
Equivalence
Feature	(K072964)	(K924226)	(K110410)	(K082629)	(New - Under Review)	Comments
					stimulation rates	predicates.
Therefore,
Substantially
Equivalent
Pulse shape	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular	Identical
specification.
Therefore,
Substantially
Equivalent
Stimulation
Mode	Biphasic	Biphasic	Biphasic (high output mode; not
specified for the low output
mode)	Selectable positive, negative, or
alternating on successive pulses
Biphasic	Biphasic (with independently
controllable main & reverse
phases)	All devices are
biphasic
Therefore,
Substantially
Equivalent
Stimulator
features
As per
advertising
materials	The Nicolet Cortical Stimulator
interfaces with the NicOne
· Stand alone unit or
seamlessly integrates with
NicOne EEG application
software	The Model OCS2 Ojemann
Cortical Stimulator is a portable,
battery-operated, bipolar stimulator
designed according to the
specifications of Dr. George
Ojemann of the University of
Washington, Seattle. It is especially
useful for cortical stimulation prior
to epilepsy surgery and for
intraoperative cortical mapping
before cortical incision or
placement of depth electrodes in
patients with seizure disorders.	The high and low setting.
stimulation current and
frequency of stimulation is
selected by the user. The Nihon
Kohden MS-120BK is
connected to the MEE 1000A
through the JB-116BK or JB-
132BK amplifier.
In the Low output setting the
Nihon Kohden MS-120BK
applies cortical stimulation
energy through the Nihon
Kohden stimulation pod (JS-
102B) which is connected to
commercially available cortical
electrodes (strip and grid
electrodes).
In the High output setting, the
MS-120BK outputs
electrostimulation pulse through
the Nihon Kohden extension
cord (BM-121B) which is
connected to commercially
available stimulation
electrode(s)	Stimulation can be via a traditional
hand-held electrode probe for
intraoperative stimulation, or via
intracranial electrodes using the
Grass ESAx Electrode Switching
Array option in conjunction with
Grass Technologies' Beehive
Video/EEG monitoring systems.	• It works in conjunction with
Micromed amplifier models SD
LTM 64 EXPRESS (i.e. Cervello

· Direct connection to the
amplifier inputs, connection to the
patient through the standard
amplifier jackbox and
commercially available electrodes
(strip, grid or depth electrodes). | Equivalent
Features.
Differences are
for marketing
purposes and do
not impact the
design intent /
Intended use.
Therefore,
Substantially
Equivalent |
| Image: BLACKROCK NEUROMED logo | | CERVELLO®
STIM | | | | VOLUME 2 |
| | | Traditional 510(k) Summary | | | | SECTION 3 |
| | Feature | Integra Life Sciences
Ojemann Cortical Stimulator
OCS2 | Nihon Kohden
MS-120 BK | Grass-Telefactor
S12X | CERVELLO® STIM
SD LTM STIM | Substantial
Equivalence
Comments |
| | | (K924226) | (K110410) | (K082629) | (New - Under Review) | |
| Number of
Channels
Capable of
Being
Selected | Nicolet
Cortical Stimulator
(K072964) | | | | | |
| | • Two Stimulus Switching
Units may be used to
electronically select 128
electrodes, 64 electrode pairs
• Stimulates "user selectable"
electrode pairs or bipolar probe | | | • Direct Connect up to 128
channels for electrode selection and
EEG recording
• Two ESAx switching units can be
daisy chained for up to 128
channels
• ESAx connects any combination
of 64 electrodes to the plus and
minus stimulus output of the S12X | • Number of Stimulators: 1
electrical stimulators, positive and
negative electrode can be
switched to any of the 64
available output channels | Within the
range of the
predicates.
Therefore,
Substantially
Equivalent |

CERVELLO®

CERVELLO® STIM Traditional 510(k) Submission

Confidential

VOLUME 2

7

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Confidential

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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.