The Ad-Tech Subdural Electrodes (Strip/Intraoperative Strip, Grid/Intraoperative Grid, Dual-Sided Interhemissheric, Multi-Strip and Split Grid, Intraoperative Mapping Grid) are intended for temporary (< 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals on the surface of the brain. The recording of electrical activity supports definition of epileptogenic foci and brain mapping.

Device Description

The device under review is a family of Subdural Electrodes. These electrodes provide surface brain contact to support recording, monitoring and stimulation from user supplied equipment.

The family of Subdural Electrodes under review are used under the direction of neurosurgeons and other skilled physicians to support their clinical needs for subdural electrodes on the brain. Based upon the needs of their clinical practice and particular patients, various 2-dimensional geometric shapes (length and width) resulting in variations of Subdural Electrode body shapes and orientation configurations are necessary.

All variations of Subdural Electrodes under review consist of the same materials and fundamental design as the predicate Subdural Electrodes. Either round discs or rectangular electrode contact material are sandwiched between two layers of silicone substrate electrode body material. The brain contacting side of the silicone substrate body has material removed to expose an amount of electrode contact surface area. The subdural electrode wires between the electrode contact and connector contacts at the most distal end of the subdural electrode tail pass through a tube for interface with the user's equipment.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Ad-Tech Subdural Electrodes based on the provided document:

This document is a 510(k) summary for a medical device, which typically aims to demonstrate substantial equivalence to a predicate device rather than providing extensive clinical study data that would be found in a PMA (Premarket Approval) application. Therefore, you will find information related to design and performance verification rather than large-scale clinical trials.

1. Table of Acceptance Criteria and Reported Device Performance

Device: Ad-Tech Subdural Electrodes (Strip/Intraoperative Strip, Grid/Intraoperative Grid, Dual-Sided Interhemispheric, Multi-Strip and Split Grid, Intraoperative Mapping Grid)

Acceptance Criteria / Performance Requirement	Reported Device Performance
Electrical Resistance: Measure electrical resistance from the electrode contact to connector. Verification of electrical resistance from electrode contact to connector meet specification, no electrical contact or connector cross connects to another electrode contact or connector.	Pass: Verification of electrical resistance from electrode contact to connector meet specification, no electrical contact or connector cross connects to another electrode contact or connector. (The specific resistance values/specifications are not provided in this summary but are implied to be met).
Dimensional Characteristics: Dimensional requirements are met by manufacturing. Verification of the dimensional characteristics, electrode contact placement is confirmed using the same manufacturing methods and processes as the predicate electrodes.	Pass: Verification of the dimensional characteristics, electrode contact placement is confirmed using the same manufacturing methods and processes as the predicate electrodes. (The specific dimensional requirements are not provided, but the document mentions modifications like range of contact spacing (1-20mm) and range of round electrode contact diameters (1.96-6.35mm), and exposed surface area (1.08-19.6 mm²), all confirmed through manufacturing methods.)
Stimulation Effect: Stimulation at 30 µC/cm² does not affect the electrodes. Verification that under the anticipated duration of electrical stimulation at the maximum limit does not affect the electrode resistance.	Pass: Verification that under the anticipated duration of electrical stimulation at the maximum limit does not affect the electrode resistance. (Confirmed that charge density limits of < 30 µC/cm² for the electrode contact exposed diameter surface area are discussed in the Directions for Use, and that no change in Subdural Electrode resistance was verified for durations of maximum stimulation charge density.)
Shelf Life: Confirmation of subdural electrode functional performance and sterile barrier pouch integrity (seal peel per ASTM F88 and bubble leak per ASTM F2096) after 2-year aging and simulated distribution per ASTM 4169-16 and bubble leak (ASTM F2096) after accelerated aging (ASTM F1980) and real-following time aging of two years and after simulated distribution by ASTM 4169-16.	Pass: Verified by application of referenced standards and conformance with specifications. (Specific test results are not detailed, but adherence to ASTM F88, F2096, F4169-16, and F1980 is claimed, demonstrating 2-year shelf life and barrier integrity.)
Sterility: EO sterilization of the subject device was validated according to ISO 11135:2014 to demonstrate that it is provided with a minimum sterility assumed level (SAL) of 10-6.	Pass: EO sterilization of the subject device was validated according to ISO 11135:2014 to demonstrate that it is provided with a minimum sterility assumed level (SAL) of 10-6.
Biocompatibility: (Not changed from predicate device, therefore no new testing required for this submission.)	N/A: Biocompatibility was not provided to support a determination of substantial equivalence for this submission because material and manufacturing processes have not been changed from those were cleared with the predicate device.

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

The document does not specify a "test set" in the context of clinical data for algorithmic performance. Instead, it details performance tests conducted on the device hardware.

Sample Size for Performance Tests: The document does not explicitly state the number of devices or samples used for each performance test (Electrical Resistance, Dimensional Characteristics, Stimulation Effect, Shelf Life, Sterility). It implies that sufficient samples were tested to demonstrate compliance.
Data Provenance: The data provenance is laboratory testing and manufacturing verification of the device's physical and electrical characteristics, adhering to industry standards (e.g., ASTM, ISO). This is not retrospective or prospective clinical data from human subjects.

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

This information is not applicable as the submission is for a hardware device (electrodes) and focuses on engineering/performance verification rather than a diagnostic algorithm requiring ground truth established by medical experts. The "ground truth" for these tests would be the established engineering specifications and international standards.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (like 2+1 or 3+1) is relevant for clinical studies where multiple human readers assess cases and their disagreements are resolved. This is not applicable to the performance verification tests described for these physical electrodes. The "adjudication" in this context is the comparison of test results against predefined specifications and industry standards.

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

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical data was not provided to support a determination of substantial equivalence." This type of study would be for evaluating the performance of a diagnostic or assistive AI algorithm, which is not the subject of this 510(k).

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

No, a standalone algorithm study was not done. This submission is for physical medical electrodes, not an algorithm.

7. The Type of Ground Truth Used

For the performance tests described, the "ground truth" is based on:

Established engineering specifications for electrical resistance and dimensional characteristics.
Recognized international standards (e.g., ISO 11135:2014 for sterilization, ASTM F88, F2096, F4169-16, F1980 for shelf life and packaging).
Clinically established physiological limits (e.g., charge density limits of < 30 µC/cm² for brain tissue).

8. The Sample Size for the Training Set

This information is not applicable as this 510(k) submission is for a physical medical device (electrodes) and does not involve an AI algorithm with a training set.

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

This information is not applicable as this 510(k) submission is for a physical medical device (electrodes) and does not involve an AI algorithm with a training set.

Summary

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January 25, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Ad-Tech Medical Instrument Corporation Gary Syring Compliance Manager/Regulatory Specialist 400 West Oakview Parkway Oak Creek, Wisconsin 53154

Re: K191186

Trade/Device Name: 1) Subdural Strip/Intraoperative Strip Electrode, 2) Subdural Grid/Intraoperative Grid Electrode, 3) Dual-Sided Interhemispheric Subdural Electrode, 4) Multi-Strip and Split Grid Subdural Electrode, 5) Intraoperative Mapping Grid Subdural Electrode Regulation Number: 21 CFR 882.1310 Regulation Name: Cortical Electrode Regulatory Class: Class II Product Code: GYC Dated: December 23, 2019 Received: December 27, 2019

Dear Gary 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 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191186

Device Name

Subdural Strip/Intraoperative Strip Electrode, Subdural Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Split Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for AD-TECH Medical Instrument Corporation. The logo features the text "AD-TECH" in a bold, sans-serif font, followed by the words "MEDICAL INSTRUMENT CORPORATION" in a smaller, lighter font. To the left of the text is a stylized graphic of three curved lines, resembling sound waves or a stylized tree.

Traditional 510(k) Summary - K191186

This 510(k) summary was prepared to provide an understanding of the basis for the determination of substantial equivalence in accordance with the requirements 21 CFR 807.92.

Submitter's Name:	Ad-Tech Medical Instrument Corporation400 West Oakview ParkwayOak Creek, WI 53154Phone: (262) 634-1555
Contact Person:Contact Telephone:	Suzie Towers, Director, Quality Assurance, Regulatory Affairs262-634-1555
Date Summary Prepared:	January 24, 2020
Device Trade Name:	Subdural Electrode-Strip/Intraoperative Strip,-Grid/Intraoperative Grid,-Dual-Sided Interhemispheric,-Multi-Strip and Split Grid, and-Intraoperative Mapping Grid
Common Name:	Subdural Electrode
Classification Name:	Cortical Electrode21 CFR 882.1310Product Code: GYC Class II
Predicate Devices:	K053363 Subdural Electrode-Dual-Sided Interhemispheric,-Grid,-Intraoperative,-Strip, andWyler

Purpose of Submission

Both the predicate Subdural Electrodes and the Subdural Electrodes under review are characterized by physical features that describe the characteristics of the variations. Modification of available Subdural Electrode Product Family features addressed by this 510(k) submission are summarized in the table below.

Image /page/3/Picture/6 description: The image shows the logo and contact information for AD-TECH MEDICAL INSTRUMENT CORPORATION. The address is 400 WEST OAKVIEW PARKWAY, OAK CREEK, WI 53154 U.S.A. The phone number is 262-634-1555, the fax number is 262-634-5668, and the toll-free number is 800-776-1555. The email address is sales@adtechmedical.com, and the website is www.adtechmedical.com.

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Modification	Substantial Equivalence Discussion	Scientific Methods forEvaluating New/DifferentCharacteristics
Productcommercialname changes	From: Strip Subdural Electrodes, To: Subdural StripFrom: Intraoperative Subdural Electrodes,To: Intraoperative Strip ElectrodesFrom: Grid Subdural Electrodes (Wyler Electrodes),To: Grid ElectrodeFrom: Intraoperative Subdural ElectrodesTo: Intraoperative Grid ElectrodeFrom: Grid Subdural Electrodes, Intraoperative SubduralElectrodesTo: Intraoperative Mapping Grid Electrodes	The naming conventionmodifications clarify SubduralStrip Electrodes can be usedintraoperatively. This change isconsistent with the predicate'sintended use. The predicate 510(k)indicated Strip Subdural and GridSubdural electrodes could be usedintraoperatively.This change is a renaming of theGrid subdural electrodes,Intraoperative Subdural Electrodes."Mapping" is a clinical termapplied to the use of subduralelectrodes for stimulation andrecording of locations on the brainsurface. This change is consistentwith the indications for use ofSubdural Electrodes, which is notmodified by the submission.
Addition ofMulti-Strip andSplit Gridsubduralelectrodevariations	The Multi-Strip and Split Grid Electrode variationsembody individual Strip and Grid Subdural Electrodesinto one assembly, combining the Tails to support ease ofsubcutaneous tunneling, see Figure 1. The same materialsand manufacturing processes are applied to create theseelectrodes as were applied in the predicate submission.As a convenience to the user, the multiple tails from eachelectrode are placed together into one tube of electrodetails.	Confirmation of the electricalpathway from the connector on thedistal end of electrode to theelectrode contact is verified forproper resistance and no crossconnect to another electrodecontact or connector contact.
IntraoperativeMapping GridSubduralElectrodecontactsincreased from5 to 6 contacts.	The Intraoperative Mapping Grid Subdural Electrodevariations embodies 1 to 6 single electrode contacts intoone assembly, see Figure 2. The electrode tail terminatesin a 1.5 mm, recessed female connector for interface tothe user's equipment. The same materials andmanufacturing processes are applied to create theseelectrodes as those materials and manufacturingprocesses that were used for the predicate device.	Confirmation of the electricalpathway from the connector on thedistal end of electrode to eachelectrode contact is verified forproper resistance and no crossconnect to another electrodecontact or connector contact.
The maximumnumber ofSubduralElectrodeContacts isincreased from128 to 256contacts.	The same electrode contact material and manufacturingprocesses are applied to fabricate the 256 contactelectrode. The silicone substrate body surface area of theelectrode is not modified, the higher electrode contactcount is accomplished with the same surface area ofSubdural Electrode body.	Confirmation of the electricalpathway from the connector on thedistal end of electrode to theelectrode contact is verified forproper resistance and no crossconnect to another electrodecontact.
SubduralElectrodecontact spacing	The center to center spacing between electrode contacts ismodified from: 1 to 10 mm, to: 1 to 20 mm. It is user	The same manufacturing processesapplied with application of theelectrodes to a build template that
Subdural Electrode Product Family Feature Modifications
Modification	Substantial Equivalence Discussion	Scientific Methods forEvaluating New/DifferentCharacteristics
(center tocenter)	preference and choice with regard to what subduralelectrode contact spacing is preferred.	identifies the mechanicaldimensions of center to centercontact spacing.
The range ofround (Disc)ElectrodeContactdiameters.	The range of Subdural Electrode contact diameters forround contacts, the dimension of the electrode disc placedbetween the silicone materials of the electrode body, ismodified from: 4 to 6 mm, to: 1.96 to 6.35 mm. Thesame materials and manufacturing processes are appliedto create these electrodes.The Electrode contact diameter is comparable to thepredicate cylindrical (rectangular) minimum of 1.5 mmdiameter with the Subdural Strip and Intraoperative StripElectrodes.	The electrode contact to tailcontact electrical resistance isconfirmed as meeting applicablespecification.
Range of round(Disc)ElectrodeContactexposurediameter	The Electrode Contact is the exposed metal surface,contacting the brain. Based on user preference the rangeof electrode contact exposure diameter is modified from:1.8 to 4 mm (2.54 to 12.5 mm² surface are), to: 1.17 to5.00 mm (1.08 to 19.6 mm² surface area).	The potential impact to safety andeffectiveness could be the chargethe density when stimulation isapplied and the applied stimulationaffecting subdural electroderesistance.Charge density limits of < 30$μC/cm²$ for the electrode contactexposed diameter surface area arediscussed in the Directions for Use.Confirmation of no change inSubdural Electrode resistance forthe durations of maximumstimulation charge density wasverified.
Clarification ofConnectorcompatibility	Both the predicate and the Subdural Electrodes underreview interface with the same Ad-Tech interface cables.The Intra-Operative Monitoring (IOM) and MappingSubdural Electrode tails terminate in a 1.5 mm, femalesocket, supporting interface with the user's equipment.	The Subdural Electrode contact totail contact electrical resistance isconfirmed to meeting applicablespecification.

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Image /page/5/Figure/1 description: This image shows two different types of medical devices, labeled as "Multi-Strip" and "Split Grid". The "Multi-Strip" device has a central shaft that splits into multiple strips at one end, each containing several small dots. The "Split Grid" device also has a central shaft, but it splits into two branches, each connected to a rectangular grid with multiple dots arranged in rows and columns.

Figure 1: Multi-Strip and Split Grid Electrode

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Image /page/6/Figure/0 description: The image shows a schematic diagram of a structure that resembles a nerve cell or a branching network. On the left side, there are four circular structures, each with three extensions, connected to a central, thicker line. This line extends horizontally, and on the right side, it branches out into four lines, each ending with a rectangular shape. The overall impression is that of a system with multiple inputs on one end converging into a central pathway and then diverging into multiple outputs on the other end.

Figure 2: Intraoperative Mapping Grid Subdural Electrode

Device Description

The device under review is a family of Subdural Electrodes. These electrodes provide surface brain contact to support recording, monitoring and stimulation from user supplied equipment.

Intended Use of the Device

The Ad-Tech Subdural Electrodes (Strip/Intraoperative Strip, Grid/Intraoperative Grid, Dual- Sided Interhemispheric, Multi-Strip and Split Grid, Intraoperative Mapping Grid) are intended for temporary (< 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals on the surface of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.

Ad-Tech's Subdural Electrode intended use is modified the current trade names of the Subdural Electrodes. This is the only information in the intended use modified by this 510(k) submission. This modification has no impact on the actual intended use of the device.

Summary of Technological Characteristics

The fundamental technical characteristics of the Subdural Electrodes are not affected by this submission. Fundamentally the Subdural Electrodes are a conductor of the biopotential signals from the surface of the brain to the user's equipment and as applicable, conductors of the stimulation energy from the user's equipment to the surface of the brain.

The following table provides a side-by-side comparison of the Subdural Electrodes to the predicate devices applied to support this pre-market notification.

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Substantial Equivalence Technical Characteristics
Feature	Subdural Electrodes(Under Review)	Subdural Electrodes(Primary PredicateK053363)	Comment
Indications for Use	The Ad-Tech SubduralElectrodes(Strip/Intraoperative Strip,Grid/Intraoperative Grid,Dual-SidedInterhemispheric, Multi-Strip and Split Grid,Intraoperative MappingGrid) are intended fortemporary (< 30 days) usewith recording,monitoring, andstimulation equipment forthe recording, monitoring,and stimulation ofelectrical signals on thesurface of the brain. Therecording of electricalactivity supports definitionof the location ofepileptogenic foci andbrain mapping.	The Ad-Tech SubduralElectrodes (Dual-SidedInterhemispheric, Grid,Intraoperative, Strip,Wyler) are intended fortemporary (< 30 days) usewith recording,monitoring, andstimulation equipment forthe recording, monitoring,and stimulation ofelectrical signals on thesurface of the brain. Therecording of electricalactivity supports definitionof the location ofepileptogenic foci andbrain mapping.	Update list of trade names.
Clinical Application	Placed on the surface ofthe brain to supportrecording, monitoring,and stimulation.	Placed on the surface ofthe brain to supportrecording, monitoring,and stimulation.	Same
Contraindications	The subdural electrodesshould not be used on anypatient whom thephysician/surgeonconsiders at risk forinfection. The subduralelectrodes are notintended for continuousstimulation. Stimulationshould only be applied tosupport the brainmapping purpose of theelectrodes.	The subdural electrodesshould not be used on anypatient whom thephysician/surgeonconsiders at risk forinfection. The subduralelectrodes are notintended for continuousstimulation. Stimulationshould only be applied tosupport the brainmapping purpose of theelectrodes.	Same
Single patient use,Disposable	Yes	Yes	Same
Provided Sterile	Yes	Yes	Same
Provided Non-Sterile(to be sterilized by theuser)	No	Yes	Only sterilized electrodesare available.
Environment of	Operating rooms andtemporary	Operating rooms andtemporary	Same
Substantial Equivalence Technical Characteristics
Feature	Subdural Electrodes(Under Review)	Subdural Electrodes(Primary PredicateK053363)	Comment
Use	monitoring	monitoring
Duration of Use	< 30 days	< 30 days	Same
Electrode Body surfacearea	≤ 138 cm²	≤ 138 cm²	SameThe subdural electrodesconsist of an electrodecontact between two layersof silicone material. Thesilicone material definesElectrode Body surfacearea.
Electrode ContactMaterial	Platinum/Iridium orStainless Steel	Platinum/Iridium orStainless Steel	Same
Maximum StimulationCharge Density	≤ 30 µC/cm²	Not indicated inlabeling	Clarification of stimulationcharge density limits forbrain tissue, as establishedin K152769 (Surgical NerveStimulator).

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Performance Tests to Demonstrate Substantial Equivalence

To establish the technical equivalency of the Subdural Electrodes, evaluations were conducted to confirm compliance with performance requirements, including:

Test	Summary of Requirement, Evaluation	Result
ElectricalResistance	Measure electrical resistance from the electrode contact to connector.Verification of electrical resistance from electrode contact to connector meetspecification, no electrical contact or connector cross connects to another electrodecontact or connector.	Pass
DimensionalCharacteristics	Dimensional requirements are met by manufacturing.Verification of the dimensional characteristics, electrode contact placement isconfirmed using the same manufacturing methods and processes as the predicateelectrodes.	Pass
Stimulationeffect	Stimulation at 30 $µC/cm2$ does not affect the electrodes.Verification that under the anticipated duration of electrical stimulation at themaximum limit does not affect the electrode resistance.	Pass
Shelf Life	Confirmation of subdural electrode functional performance and sterile barrier pouchintegrity (seal peel per ASTM F88 and bubble leak per ASTM F2096) after 2-yearaging and simulated distribution per ASTM 4169-16 and bubble leak (ASTM F2096)after accelerated aging (ASTM F1980) and real-following time aging of two yearsand after simulated distribution by ASTM 4169-16.Verified by application of referenced standards and conformance with specifications.	Pass

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Test	Summary of Requirement, Evaluation	Result
Sterility	EO sterilization of the subject device was validated according to ISO 11135:2014 todemonstrate that it is provided with a minimum sterility assumed level (SAL) of 10-6.	Pass
Biocompatibility	N/A Biocompatibility was not provided to support a determination of substantialequivalence for this submission because material and manufacturing processes havenot been changed from those were cleared with the predicate device.	N/A

Clinical data was not provided to support a determination of substantial equivalence.

Conclusion

Based on the intended use, technological characteristics as compared to the predicate, and performance testing, the subdural electrode is substantially equivalent to the predicate device.

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).