Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode
Device Facts
| Record ID | K191186 |
|---|---|
| Device Name | Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode |
| Applicant | Ad-Tech Medical Instrument Corporation |
| Product Code | GYC · Neurology |
| Decision Date | Jan 25, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1310 |
| Device Class | Class 2 |
Intended Use
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.
Device Story
Subdural electrodes consist of platinum/iridium or stainless steel contacts embedded in silicone substrate; designed for temporary (< 30 days) placement on brain surface. Device functions as passive conductor for biopotential signals to external recording/monitoring equipment and stimulation energy from external equipment to brain. Operated by neurosurgeons/physicians in operating rooms or clinical settings. Variations include strip, grid, dual-sided interhemispheric, multi-strip, and split-grid configurations. Output is raw electrical signal data used by clinicians to identify epileptogenic foci and map brain function. Benefits include precise localization of brain activity for surgical planning. No active internal processing; device is purely conductive.
Clinical Evidence
No clinical data provided. Substantial equivalence supported by bench testing, including electrical resistance verification, dimensional analysis, stimulation effect testing, shelf-life/sterile barrier integrity (ASTM F88, F2096, F1980, 4169-16), and EO sterilization validation (ISO 11135:2014).
Technological Characteristics
Materials: Platinum/Iridium or Stainless Steel contacts, silicone substrate. Form factor: 2D geometric shapes (strips/grids). Connectivity: Wired interface to external equipment via 1.5 mm female connectors. Sterilization: Ethylene Oxide (EO) per ISO 11135:2014. Max stimulation charge density: ≤ 30 µC/cm². No software/firmware.
Indications for Use
Indicated for patients requiring temporary (< 30 days) recording, monitoring, and stimulation of electrical signals on the brain surface to define epileptogenic foci and perform brain mapping. Contraindicated for patients at risk for infection or where continuous stimulation is required.
Regulatory Classification
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.
Predicate Devices
- Subdural Electrode (K053363)
Reference Devices
- Surgical Nerve Stimulator (K152769)
Related Devices
- K191346 — Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) · Blackrock Microsystems · Feb 14, 2020
- K053363 — DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES · Ad-Tech Medical Instrument Corp · May 30, 2006
- K170959 — DIXI Medical Microdeep Depth Electrode · Dixi Medical · Nov 24, 2017
- K192764 — NeuroOne Cortical Electrode · Neuroone, Inc. · Nov 26, 2019
- K053358 — DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES · Ad-Tech Medical Instrument Corp · May 25, 2006
Submission Summary (Full Text)
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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)
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.
| Type of Use (Select one or both, as applicable) |
|------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
| <span> <span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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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 Corporation<br>400 West Oakview Parkway<br>Oak Creek, WI 53154<br>Phone: (262) 634-1555 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person:<br>Contact Telephone: | Suzie Towers, Director, Quality Assurance, Regulatory Affairs<br>262-634-1555 |
| Date Summary Prepared: | January 24, 2020 |
| Device Trade Name: | Subdural Electrode<br>-Strip/Intraoperative Strip,<br>-Grid/Intraoperative Grid,<br>-Dual-Sided Interhemispheric,<br>-Multi-Strip and Split Grid, and<br>-Intraoperative Mapping Grid |
| Common Name: | Subdural Electrode |
| Classification Name: | Cortical Electrode<br>21 CFR 882.1310<br>Product Code: GYC Class II |
| Predicate Devices: | K053363 Subdural Electrode<br>-Dual-Sided Interhemispheric,<br>-Grid,<br>-Intraoperative,<br>-Strip, and<br>Wyler |
### 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 for<br>Evaluating New/Different<br>Characteristics |
|---------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product<br>commercial<br>name changes | From: Strip Subdural Electrodes, To: Subdural Strip<br>From: Intraoperative Subdural Electrodes,<br>To: Intraoperative Strip Electrodes<br>From: Grid Subdural Electrodes (Wyler Electrodes),<br>To: Grid Electrode<br>From: Intraoperative Subdural Electrodes<br>To: Intraoperative Grid Electrode<br>From: Grid Subdural Electrodes, Intraoperative Subdural<br>Electrodes<br>To: Intraoperative Mapping Grid Electrodes | The naming convention<br>modifications clarify Subdural<br>Strip Electrodes can be used<br>intraoperatively. This change is<br>consistent with the predicate's<br>intended use. The predicate 510(k)<br>indicated Strip Subdural and Grid<br>Subdural electrodes could be used<br>intraoperatively.<br>This change is a renaming of the<br>Grid subdural electrodes,<br>Intraoperative Subdural Electrodes.<br>"Mapping" is a clinical term<br>applied to the use of subdural<br>electrodes for stimulation and<br>recording of locations on the brain<br>surface. This change is consistent<br>with the indications for use of<br>Subdural Electrodes, which is not<br>modified by the submission. |
| Addition of<br>Multi-Strip and<br>Split Grid<br>subdural<br>electrode<br>variations | The Multi-Strip and Split Grid Electrode variations<br>embody individual Strip and Grid Subdural Electrodes<br>into one assembly, combining the Tails to support ease of<br>subcutaneous tunneling, see Figure 1. The same materials<br>and manufacturing processes are applied to create these<br>electrodes as were applied in the predicate submission.<br>As a convenience to the user, the multiple tails from each<br>electrode are placed together into one tube of electrode<br>tails. | Confirmation of the electrical<br>pathway from the connector on the<br>distal end of electrode to the<br>electrode contact is verified for<br>proper resistance and no cross<br>connect to another electrode<br>contact or connector contact. |
| Intraoperative<br>Mapping Grid<br>Subdural<br>Electrode<br>contacts<br>increased from<br>5 to 6 contacts. | The Intraoperative Mapping Grid Subdural Electrode<br>variations embodies 1 to 6 single electrode contacts into<br>one assembly, see Figure 2. The electrode tail terminates<br>in a 1.5 mm, recessed female connector for interface to<br>the user's equipment. The same materials and<br>manufacturing processes are applied to create these<br>electrodes as those materials and manufacturing<br>processes that were used for the predicate device. | Confirmation of the electrical<br>pathway from the connector on the<br>distal end of electrode to each<br>electrode contact is verified for<br>proper resistance and no cross<br>connect to another electrode<br>contact or connector contact. |
| The maximum<br>number of<br>Subdural<br>Electrode<br>Contacts is<br>increased from<br>128 to 256<br>contacts. | The same electrode contact material and manufacturing<br>processes are applied to fabricate the 256 contact<br>electrode. The silicone substrate body surface area of the<br>electrode is not modified, the higher electrode contact<br>count is accomplished with the same surface area of<br>Subdural Electrode body. | Confirmation of the electrical<br>pathway from the connector on the<br>distal end of electrode to the<br>electrode contact is verified for<br>proper resistance and no cross<br>connect to another electrode<br>contact. |
| Subdural<br>Electrode<br>contact spacing | The center to center spacing between electrode contacts is<br>modified from: 1 to 10 mm, to: 1 to 20 mm. It is user | The same manufacturing processes<br>applied with application of the<br>electrodes to a build template that |
| Subdural Electrode Product Family Feature Modifications | | |
| Modification | Substantial Equivalence Discussion | Scientific Methods for<br>Evaluating New/Different<br>Characteristics |
| (center to<br>center) | preference and choice with regard to what subdural<br>electrode contact spacing is preferred. | identifies the mechanical<br>dimensions of center to center<br>contact spacing. |
| The range of<br>round (Disc)<br>Electrode<br>Contact<br>diameters. | The range of Subdural Electrode contact diameters for<br>round contacts, the dimension of the electrode disc placed<br>between the silicone materials of the electrode body, is<br>modified from: 4 to 6 mm, to: 1.96 to 6.35 mm. The<br>same materials and manufacturing processes are applied<br>to create these electrodes.<br>The Electrode contact diameter is comparable to the<br>predicate cylindrical (rectangular) minimum of 1.5 mm<br>diameter with the Subdural Strip and Intraoperative Strip<br>Electrodes. | The electrode contact to tail<br>contact electrical resistance is<br>confirmed as meeting applicable<br>specification. |
| Range of round<br>(Disc)<br>Electrode<br>Contact<br>exposure<br>diameter | The Electrode Contact is the exposed metal surface,<br>contacting the brain. Based on user preference the range<br>of electrode contact exposure diameter is modified from:<br>1.8 to 4 mm (2.54 to 12.5 mm² surface are), to: 1.17 to<br>5.00 mm (1.08 to 19.6 mm² surface area). | The potential impact to safety and<br>effectiveness could be the charge<br>the density when stimulation is<br>applied and the applied stimulation<br>affecting subdural electrode<br>resistance.<br>Charge density limits of < 30<br>$μC/cm²$ for the electrode contact<br>exposed diameter surface area are<br>discussed in the Directions for Use.<br>Confirmation of no change in<br>Subdural Electrode resistance for<br>the durations of maximum<br>stimulation charge density was<br>verified. |
| Clarification of<br>Connector<br>compatibility | Both the predicate and the Subdural Electrodes under<br>review interface with the same Ad-Tech interface cables.<br>The Intra-Operative Monitoring (IOM) and Mapping<br>Subdural Electrode tails terminate in a 1.5 mm, female<br>socket, supporting interface with the user's equipment. | The Subdural Electrode contact to<br>tail contact electrical resistance is<br>confirmed to meeting applicable<br>specification. |
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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.
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.
## 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<br>(Under Review) | Subdural Electrodes<br>(Primary Predicate<br>K053363) | Comment |
| Indications for Use | The Ad-Tech Subdural<br>Electrodes<br>(Strip/Intraoperative Strip,<br>Grid/Intraoperative Grid,<br>Dual-Sided<br>Interhemispheric, Multi-<br>Strip and Split Grid,<br>Intraoperative Mapping<br>Grid) are intended for<br>temporary (< 30 days) use<br>with recording,<br>monitoring, and<br>stimulation equipment for<br>the recording, monitoring,<br>and stimulation of<br>electrical signals on the<br>surface of the brain. The<br>recording of electrical<br>activity supports definition<br>of the location of<br>epileptogenic foci and<br>brain mapping. | The Ad-Tech Subdural<br>Electrodes (Dual-Sided<br>Interhemispheric, Grid,<br>Intraoperative, Strip,<br>Wyler) are intended for<br>temporary (< 30 days) use<br>with recording,<br>monitoring, and<br>stimulation equipment for<br>the recording, monitoring,<br>and stimulation of<br>electrical signals on the<br>surface of the brain. The<br>recording of electrical<br>activity supports definition<br>of the location of<br>epileptogenic foci and<br>brain mapping. | Update list of trade names. |
| Clinical Application | Placed on the surface of<br>the brain to support<br>recording, monitoring,<br>and stimulation. | Placed on the surface of<br>the brain to support<br>recording, monitoring,<br>and stimulation. | Same |
| Contraindications | The subdural electrodes<br>should not be used on any<br>patient whom the<br>physician/surgeon<br>considers at risk for<br>infection. The subdural<br>electrodes are not<br>intended for continuous<br>stimulation. Stimulation<br>should only be applied to<br>support the brain<br>mapping purpose of the<br>electrodes. | The subdural electrodes<br>should not be used on any<br>patient whom the<br>physician/surgeon<br>considers at risk for<br>infection. The subdural<br>electrodes are not<br>intended for continuous<br>stimulation. Stimulation<br>should only be applied to<br>support the brain<br>mapping purpose of the<br>electrodes. | Same |
| Single patient use,<br>Disposable | Yes | Yes | Same |
| Provided Sterile | Yes | Yes | Same |
| Provided Non-Sterile<br>(to be sterilized by the<br>user) | No | Yes | Only sterilized electrodes<br>are available. |
| Environment of | Operating rooms and<br>temporary | Operating rooms and<br>temporary | Same |
| Substantial Equivalence Technical Characteristics | | | |
| Feature | Subdural Electrodes<br>(Under Review) | Subdural Electrodes<br>(Primary Predicate<br>K053363) | Comment |
| Use | monitoring | monitoring | |
| Duration of Use | < 30 days | < 30 days | Same |
| Electrode Body surface<br>area | ≤ 138 cm² | ≤ 138 cm² | Same<br>The subdural electrodes<br>consist of an electrode<br>contact between two layers<br>of silicone material. The<br>silicone material defines<br>Electrode Body surface<br>area. |
| Electrode Contact<br>Material | Platinum/Iridium or<br>Stainless Steel | Platinum/Iridium or<br>Stainless Steel | Same |
| Maximum Stimulation<br>Charge Density | ≤ 30 µC/cm² | Not indicated in<br>labeling | Clarification of stimulation<br>charge density limits for<br>brain tissue, as established<br>in K152769 (Surgical Nerve<br>Stimulator). |
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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 |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Electrical<br>Resistance | Measure electrical resistance from the electrode contact to connector.<br>Verification of electrical resistance from electrode contact to connector meet<br>specification, no electrical contact or connector cross connects to another electrode<br>contact or connector. | Pass |
| Dimensional<br>Characteristics | Dimensional requirements are met by manufacturing.<br>Verification of the dimensional characteristics, electrode contact placement is<br>confirmed using the same manufacturing methods and processes as the predicate<br>electrodes. | Pass |
| Stimulation<br>effect | Stimulation at 30 $µC/cm2$ does not affect the electrodes.<br>Verification that under the anticipated duration of electrical stimulation at the<br>maximum limit does not affect the electrode resistance. | Pass |
| Shelf Life | Confirmation of subdural electrode functional performance and sterile barrier pouch<br>integrity (seal peel per ASTM F88 and bubble leak per ASTM F2096) after 2-year<br>aging and simulated distribution per ASTM 4169-16 and bubble leak (ASTM F2096)<br>after accelerated aging (ASTM F1980) and real-following time aging of two years<br>and after simulated distribution by ASTM 4169-16.<br>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 to<br>demonstrate 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 substantial<br>equivalence for this submission because material and manufacturing processes have<br>not 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.
