The Cortical Stimulator is intended for use in functional brain mapping procedures during treatment of patients with seizure disorder, providing stimulation via electrode pairs or a hand held bipolar probe.

Device Description

The Nicolet Cortical Stimulator supports clinician guided, intermittent electrical stimulation of the brain cortex to support diagnostic and surgical procedures. The cortical stimulation energy is applied through commercially available cortical electrodes (strip and grid electrodes) of a minimum 2.3 mm diametor and a Cardinal Health, NeuroCare stimulation probe. All stimulation is temporary and intermittent, applied in support of functional brain mapping procedures during treatment of patients with seizure disorder. The Nicolet Cortical Stimulator is a constant current stimulator. The stimulation current and frequency of stimulation is selected by the user. The Nicolet Cortical Stimulator (Cortical Stimulator) consists of two components: 1) Stimulus Switching Unit and 2) Cortical Stimulator Control Unit. The Cortical Stimulator Control Unit (CSCU) is powered by an external power supply. The CSCU provides the current stimulation source. The Stimulus Switching Unit (SSU) directs the stimulation to selected electrodes. The Cortical Stimulation Control Unit can be used in a stand-alone mode with stimulus provided through the Cardinal Health, NeuroCare stimulation probe. Alternatively the Cortical Stimulation Control Unit can be connected to the Stimulation Switching Unit. When the Stimulus Switching Unit is attached, the Stimulus Switching Unit interfaces between the Nicolet C64 Electroencephalography (EEG) amplifier and the amplifier's associated headbox. The headbox provides the interface between the amplificr and the brain contacting electrodes.

AI/ML Overview

Here's an analysis of the provided text regarding the Nicolet Cortical Stimulator, focusing on acceptance criteria and the study data:

The provided text does not contain extensive information regarding specific acceptance criteria with numerical targets for device performance or a detailed comparative study proving the device meets said criteria. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and confirmation of internal design control processes.

However, based on the information provided, we can infer some details and highlight what is not present.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a formal table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, or an effect size for human improvement. The closest information available is a comparison of technical features to predicate devices, which implicitly serves as the "acceptance criteria" in a substantial equivalence argument, where the new device should perform similarly or better within defined safety limits.

Here's a table summarizing the technical characteristics and their comparison to predicate devices, which substitutes for a direct "acceptance criteria" table in this type of submission:

Feature	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (Nicolet Cortical Stimulator)	Comments
Intended Use, Indications for Use	Functional brain mapping during treatment of seizure disorder, stimulation via electrodes/probe. (Matches predicate)	Functional brain mapping during treatment of seizure disorder, providing stimulation via electrode pairs or a hand held bipolar probe.	Equivalent
Constant Current Stimulator	Yes	Yes	Same
Maximum Stimulation Charge	20 micro-Coulomb (Predicate Ojemann Cortical Stimulator)	15 micro-Coulomb	Equivalent. Lower than predicate, implying increased safety margin.
Current Stimulation Range	0 to 10 mA (peak) Constant Current (Predicate Ojemann Cortical Stimulator)	0.1 to 15 mA (peak) Constant Current	Equivalent (Total energy applied is limited to maximum 15 micro-Coulomb, which is less than predicate's 20 micro-Coulomb)
Stimulation Frequency	5, 10, 20, 50, 75, 100 Hz (Predicate Ojemann Cortical Stimulator)	1 to 100 Hz	Equivalent (Broader range encompasses predicate)
Stimulation Pulse Width Duration	0.1 to 2.0 msec per phase (Predicate Ojemann Cortical Stimulator)	0.1 to 1.0 msec per phase	Equivalent (Within predicate's range)

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

Sample Size: The document does not mention a "test set" in the context of clinical data for performance evaluation (e.g., patient studies). The testing referred to is "Software and hardware verification and validation" and "Safety standard compliance."
Data Provenance: Not applicable, as there's no mention of a clinical test set with patient data. The "Data Summary" section refers to internal company testing and scientific literature, not a specific clinical study with patient data for this device submission.

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

This information is not provided. The submission does not detail any expert-adjudicated ground truth for a clinical test set.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set or adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study is not mentioned or suggested by the provided text. This type of study is more common for diagnostic imaging devices where human interpretation is a key factor. The device is a stimulator, and its performance is evaluated based on technical specifications and safety, not on how human readers interact with its outputs in a diagnostic context.

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

This concept is not directly applicable to a cortical stimulator in the sense of an "algorithm" making a standalone decision. The device's "performance" is its ability to deliver specified electrical stimulation accurately and safely. The document states "Testing of the Nicolet System with the Cortical Stimulator was performed in compliance with the Cardinal Health, Inc. NeuroCare design control process. Testing included: 1. Software and hardware verification and validation, and 2. Safety standard compliance." This implies a form of standalone technical testing to ensure the device functions as intended without direct human intervention in the delivery of the stimulation, but not in terms of AI algorithm performance.

7. The Type of Ground Truth Used

The "ground truth" for this device, as inferred from the submission, is based on:

Technical Specifications: The device's ability to precisely deliver current, frequency, and pulse width as specified.
Safety Standards: Compliance with relevant electrical safety and medical device standards.
Predicate Device Equivalence: The understanding that if the new device operates within the established safe and effective parameters of legally marketed predicate devices, it is considered safe and effective.

No specific pathology, outcomes data, or expert consensus on clinical cases is provided as "ground truth" for this device.

8. The Sample Size for the Training Set

Not applicable. The device is not an AI/ML algorithm that requires a "training set" of data. Its development involved traditional engineering design, verification, and validation processes.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for an AI/ML algorithm.

Summary

{0}------------------------------------------------

XO7296Y

510(k) Summary

DEC 3 0 2008

Company Name:	Cardinal Health, Inc.NeuroCare5225 Verona Road, Building 2Madison, WI 53711
Device Name:	Nicolet Cortical Stimulator
510(k) Sponsor, Contact:	Cardinal Health, Inc.NeuroCare5225 Verona RoadMadison, WI 53711Robert BurdgeDirector Quality Assurance and Regulatory AffairsPhone: (608) 441-153Fax: (608) 426-5172
Summary Date:	January 2, 2009
Common Name:	Cortical Stimulator
Classification Name:	Cortical Electrode, CFR 882.1310, Product Code: GYC, Class II
Predicate Device(s):	K924226 Ojemann Cortical StimulatorK040360 XLTEK EMU128 Switch Matrix

1.0 Description of Device

The Nicolet Cortical Stimulator is a constant current stimulator. The stimulation current and frequency of stimulation is selected by the user. The Nicolet Cortical Stimulator (Cortical Stimulator) consists of two components:

1. Stimulus Switching Unit and
1. Cortical Stimulator Control Unit.

{1}------------------------------------------------

The Cortical Stimulator Control Unit (CSCU) is powered by an external power supply. The CSCU provides the current stimulation source. The Stimulus Switching Unit (SSU) directs the stimulation to selected electrodes.

The Cortical Stimulation Control Unit can be used in a stand-alone mode with stimulus provided through the Cardinal Health, NeuroCare stimulation probe. Alternatively the Cortical Stimulation Control Unit can be connected to the Stimulation Switching Unit. When the Stimulus Switching Unit is attached, the Stimulus Switching Unit interfaces between the Nicolet C64 Electroencephalography (EEG) amplifier and the amplifier's associated headbox. The headbox provides the interface between the amplificr and the brain contacting electrodes.

1.1 Clinical Application

Prior to and during a surgical procedure to remove epileptic foci or a tumor of the brain, a cortical mapping procedure may be applied. Cortical stimulation may be applied to determine epileptic scizure foci that need to be surgically removed, tissue excised, as the foci are not managed with medications. The cortical stimulator is used with intra cranial cortical electrodes in the form of strips and/or grids temporarily placed on the surface of the patient's cerebral cortex. Having established a "focus" for the patient's epilepsy, the physician performs a number of procedures to establish if surgery is a viable option. Cortical mapping is one of those procedures. Cortical stimulation in support of cortical mapping may be applied during the monitoring period, in the patient epileptic monitoring area.

During cortical mapping electrical stimulation of the patient's cortex is performed through pairs of electrodes temporarily placed on the surface of the brain or by a hand held bipolar stimulator probe. The electroencephalograph (EEG) is recorded during the procedure and the patient is observed in person and through video so as to note and document clinical signs, bchavioral changes and other possible effects, such as speech changes. Thus, the surgeon is able to identify eloquent brain areas and can avoid these if resection of brain tissue is performed.

File: Cortcal Stun 510k reply 1-2-2009

{2}------------------------------------------------

The Cortical Stimulator is used in hospitals and clinical environments such as operating rooms, Neurology Clinics and Epilepsy Labs to support clinical evaluation of brain function.

2.0 Intended use of Device

The intended use of the Cortical Stimulator Unit is:

3.0 Technological Characteristics

The technical characteristics of the Cortical Stimulator are equivalent to those of the predicate devices. The following table summarizes equivalence.

Feature	CorticalStimulatorUnder Review	PredicateOjemann CorticalStimulator(K924226)	PredicateXLTEK EMU128Switch Matrix(K040360)	Comments
Intended Use,Indications for Use	The CorticalStimulator isintended for use infunctional brainmapping proceduresduring treatment ofpatients with seizuredisorder, providingstimulation viaelectrode pairs or ahand held bipolarprobe.	The OCS-I isintended for useduring surgicalprocedures such asplacement ofelectrodes and brainmapping duringtreatment of patientswith seizure disorder.	The EMU128 SwitchBox used with theEMU128Selectroencephalograph system to supportelectrode switchingfor brain mappingstudies.	EquivalentThe predicateOjemann CorticalStimulator is aconstant currentstimulation source.The predicateEMU128 Switch Boxprovides switching ofan externalstimulation source toelectrodes.
Constant CurrentStimulator	Yes	Yes	Not ApplicableAn externalstimulator is appliedto this switchingdevice to supportstimulation.	Same
MaximumStimulation Charge	15 micro-Coulomb	20 micro-Coulomb	Not ApplicableAn externalstimulator is appliedto this switchingdevice to supportstimulation.	EquivalentThe maximumstimulation chargeapplied is lower thanthe predicateOjemann CorticalStimulator

{3}------------------------------------------------

Feature	CorticalStimulatorUnder Review	PredicateOjemann CorticalStimulator(K924226)	PredicateXLTEK EMU128Switch Matrix(K040360)	Comments
Current StimulationRange	0.1 to 15 mA (peak)Constant Current	0 to 10 mA (peak)Constant Current	Not ApplicableAn externalstimulator is appliedto this switchingdevice to supportstimulation.	EquivalentThe total stimulationenergy applied islimited to amaximum of 15micro-Coulomb (15mA at 1 msec). Thisis less than thepredicate OjemannCortical Stimulator20 micro-Coulomb(10 mA at 2 msec).
StimulationFrequency	1 to 100 Hz	5, 10, 20, 50, 75, 100Hz	Not ApplicableAn externalstimulator is appliedto this switchingdevice to supportstimulation.	Equivalent
Stimulation PulseWidth Duration	0.1 to 1.0 msec perphase	0.1 to 2.0 msec perphase	Not ApplicableAn externalstimulator is appliedto this switchingdevice to supportstimulation.	Equivalent

4.0 Data Summary

Testing of the Nicolet System with the Cortical Stimulator was performed in compliance with the Cardinal Health, Inc. NeuroCare design control process. Testing included:

I. Software and hardware verification and validation, and
1. Safety standard compliance.

A summary of scientific literature supporting the safety of the Nicolet Cortical Stimulator was provided.

5.0 Conclusions

The safety and effectiveness of the Nicolet Cortical Stimulator was demonstrated by testing in compliance with the Design Control process. The intended use and technology of the Nicolet Cortical Stimulator is the same as the predicate devices. No new questions of safety or effectiveness are raised.

File: Cortical Stim 510k reply 1-2-2009

{4}------------------------------------------------

Image /page/4/Picture/12 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized emblem that resembles a caduceus or a staff with a serpent entwined around it. The emblem is rendered in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cardinal Health, Inc. % Quality & Regulatory Associates, Inc. Mr. Gary Syring 800 Levanger Lane Stoughton, Wisconsin 53589

Re: K072964

Trade/Device Name: Nicolet Cortical Stimulator Regulation Number: 21 CFR 882.1310 Regulation Name: Cortical electrode. Regulatory Class: Class II Product Code: GYC, ETN Dated: December 23, 2008 Received: December 29, 2008

DEC 3 0 2008

Dear Mr. Syring:

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 includions 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 provisiopp of the 1.0. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misburanti, isamd adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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, TDAcova 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); 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.

{5}------------------------------------------------

Page 2 - Mr. Gary Syring

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicated device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket survillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmanlet Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet oddress http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark H. Wilkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Indications for Use

510(k) Number (if known): ____________________________

Device Name: Nicolet Cortical Stimulator

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Signature of Sign Off

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K072964

Page F-1

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).