The Evo® sEEG System is intended for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.

Device Description

The NeuroOne Evo® sEEG System is comprised of the Evo® sEEG Electrodes (which includes Anchor Bolt Cap and Stylet) accompanying Cable Assemblies, and the Evo® Anchor Bolts. The Evo® sEEG System components are provided sterile and are single use only. The Evo® sEEG Electrodes and Anchor Bolts are temporarily placed (less than 30 days) at the subsurface level of the brain. The system is designed to be used in stereoelectroencephalography (sEEG) procedures.

The sEEG electrodes, by way of the accompanying cable assemblies, are connected to recording, monitoring, or stimulation/response instrumentation commercially available for use with other sEEG electrodes, including the predicate device.

The sEEG electrodes are a 0.8mm diameter polyimide electrode with platinum contacts and are available in varying numbers of contacts: 5 to 16 contacts, with an exploration length (recording depth) from 16 to 80mm. The contact height is 2.0mm and spacing is 1.5-3.2mm apart.

The Evo® Anchor Bolts are available in 20mm, 30mm, and 35mm lengths, can only be used and placed through a small 2.1mm burr hole drilled in the skull, and should be used only when sEEG depth electrodes are warranted.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Evo® sEEG System, focusing on its substantial equivalence to a predicate device, particularly regarding an extended duration of use. The core of the information revolves around biocompatibility testing to support this extended use.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are implicitly derived from the ISO standards for biocompatibility testing, where "Pass" indicates meeting the acceptance criteria according to the standard. The reported device performance aligns with these "Pass" conclusions.

Test/Standard	Acceptance Criteria (Implicit from "Pass")	Reported Device Performance
Cytotoxicity ISO 10993-5: 2009	Non-cytotoxic	Pass - Non-cytotoxic
Sensitization ISO 10993-10: 2010	Non-sensitizer	Pass - Non-sensitizer
Irritation ISO 10993-10: 2010	Non-irritant	Pass - Non-irritant
Systemic Toxicity ISO 10993-11: 2017	Non-toxic	Pass - Non-toxic
Material Mediated Pyrogenicity (ISO 10993-11: 2017)	Non-pyrogenic	Pass - Non-pyrogenic
Implantation ISO 10993-6: 2016	Minimal or no reaction	Pass - Minimal or no reaction
Hemolysis ISO 10993-4: 2017	Non-hemolytic	Pass - Non-hemolytic
Genotoxicity ISO 10993-3: 2014	Non-mutagenic and Non-clastogenic	Pass - Non-mutagenic and Non-clastogenic; Pass - Non-mutagenic
Subacute Toxicity ISO 10993-11: 2017 (Intraperitoneal)	Negative for signs of systemic toxicity	Pass - Considered negative for signs of systemic toxicity
Subacute Toxicity ISO 10993-11: 2017 (Intravenous)	Negative for signs of systemic toxicity	Pass - Considered negative for signs of systemic toxicity

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions specific tests, some of which imply sample sizes (e.g., "ISO Guinea Pig Maximization Sensitization" and "Chronic (29 Days) GLP Brain Tissue Implantation Study (Sheep)"), but it does not explicitly state the numerical sample sizes for each test. The data provenance (country of origin, retrospective/prospective) is also not explicitly provided in the given text. These were "performance evaluations... conducted to address the proposed extended duration of use" and "biocompatibility testing ... as part of this 510(k)", implying they were conducted for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable to the provided document. The study described is a series of biocompatibility tests, not a clinical study involving expert interpretation of medical images or patient outcomes to establish a "ground truth" for a diagnostic device. The "ground truth" here is the biological reaction or material property as determined by standardized laboratory methods (e.g., cytotoxicity, sensitization, implantation response).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable. Adjudication methods are typically used in clinical trials or studies where human readers independently assess data and then resolve disagreements. The biocompatibility tests are laboratory-based and follow established protocols.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. The device is an sEEG electrode system, not an AI-powered diagnostic tool. The performance studies detailed are physical and biological evaluations of the device material and function, not its interpretative assistance capabilities for human readers.

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

This section is not applicable. As stated above, the device is an sEEG electrode system, not an algorithm, and therefore, an "algorithm only" performance evaluation is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is the biological and material reaction observed and measured through standardized laboratory tests (e.g., presence/absence of cytotoxicity, level of irritation, tissue response from implantation). This is derived directly from the results of the specific ISO-standardized tests rather than a clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

This section is not applicable. The provided document describes device performance testing for regulatory submission, not the development or training of an AI algorithm. Therefore, there is no "training set" in the context of this submission.

9. How the ground truth for the training set was established

This section is not applicable for the same reasons as point 8.

Summary

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NeuroOne Medical Technologies Corp. Debra Kridner Regulatory Affairs Consultant 7599 Anagram Drive Eden Prairie, MN 55344

Re: K222404

Trade/Device Name: Evo® sEEG System Regulation Number: 21 CFR 882.1330 Regulation Name: Depth Electrode Regulatory Class: Class II Product Code: GZL Dated: August 8, 2022 Received: August 9, 2022

Dear Debra Kridner:

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.

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

October 20, 2022

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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 (QS) 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) K222404

Device Name Evo® sEEG System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X 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/2 description: The image shows the logo for Neuroone, followed by the text "510(k) Summary". The Neuroone logo consists of the company name in a stylized font, with a circular graphic to the right of the name. The circular graphic is divided into four colored sections: red, light red, light blue, and blue. The text "510(k) Summary" is in a bold font and is located directly below the logo.

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number:	K222404
Date Prepared:	October 18, 2022
Applicant:	NeuroOne Medical Technologies Corp.7599 Anagram DriveEden Prairie, MN 55344Phone: (952) 426-1383E-mail: info@n1mtc.com
Contact Person:	Debra KridnerRegulatory Affairs Consultant7599 Anagram DriveEden Prairie, MN 55344
SUBJECT DEVICE

Trade/Device Name:	Evo® sEEG System
Device Regulation Number:	21 CFR § 882.133
Device/Regulation Name:	Electrode, Depth
Regulation Description/ Common Name:	Depth electrode
Product Code:	GZL
Device Class/ Regulation Classification:	Class II

DEVICE DESCRIPTION (For the Device Subject to this 510(k) Premarket Notification)

INDICATIONS FOR USE

The Evo® System is intended for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.

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The following tables provide a side-by-side comparison of the Evo® sEEG System to the predicate device to support this pre-market notification.

Device Classification Comparison
	Subject DeviceK222404	Predicate DeviceK211367	Comparison
Trade/Device Name:	Evo® sEEG System	Evo® sEEG System	Identical
Device Regulation Number:	21 CFR § 882.1330	21 CFR § 882.1330	Identical
Device / Regulation Name:	Electrode, Depth	Electrode, Depth	Identical
Regulation Description /Common Name:	Depth electrode	Depth electrode	Identical
Product Code:	GZL	GZL	Identical
Device Class / RegulationClassification:	Class II	Class II	Identical
Intended Use/Indications for Use Comparison
	Subject Device222404	Predicate DeviceK211367	Comparison
IntendedUse	A depth electrode is an electrodeused for temporary stimulation of,or recording electrical signals at,subsurface levels of the brain.	A depth electrode is an electrodeused for temporary stimulation of,or recording electrical signals at,subsurface levels of the brain.	Identical
Indicationsfor Use	The Evo® sEEG System is intendedfor temporary (less than 30 days)use with recording, monitoring, andstimulation equipment for therecording, monitoring, andstimulation of electrical signals atthe subsurface level of the brain.	The Evo® sEEG System is intendedfor temporary (less than 24 hours)use with recording, monitoring, andstimulation equipment for therecording, monitoring, andstimulation of electrical signals atthe subsurface level of the brain.	Substantially Equivalent— Modified duration ofuse, for the subject device,which is prolongedduration of use (less than30 days) whereas thepredicate device wascleared with limitedduration of use (less than24 hours).

SIMILIARITIES AND DIFFERENCES TO THE PREDICATE

There is only one difference between the predicate device. The subject device has the same Indications for Use with the only modification being the extend duration of use. The subject device is indicated for prolonged duration of use (less than 30 days) whereas the predicate device was cleared with limited duration of use (less than 24 hours). With the exception of the indicated duration of use, the subject and predicate device are identical.

SUMMARY OF PERFORMANCE TESTING AND STANDARDS

Performance evaluations were conducted to address the proposed extended duration of use in accordance with ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process and ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for Systemic Toxicity process to evaluate and characterize the performance of the device to support a determination of substantial equivalence to the predicate device

The Evo® sEG System has undergone additional biocompatibility testing to support a prolonged duration of use (less than 30

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K222404

days) and demonstrated that the results of the extension of use of the device do not raise new questions of safety or efficacy. Biocompatibility testing was conducted to evaluate and characterize the performance of the device to support a determination of substantial equivalence to the predicate device where changes were made, as part of this 510(k).

Test/Standard	Tested Components	Summary	Conclusion
Implanteda and Skin-contactingb Components:
Cytotoxicity ISO10993-5: 2009	ImplantedaSkin-contactingb	ISO MEM Elution Using Mouse FibroblastCells - 72 Hour Extraction (GLP)	Pass - Non-cytotoxic
Sensitization ISO10993-10: 2010	ImplantedaSkin-contactingb	ISO Guinea Pig Maximization Sensitization(GLP - 2 Extracts)ISO Buehler Repeated Patch Test (GLP)	Pass - Non-sensitizerPass - Non-sensitizer
Irritation ISO10993-10: 2010	ImplantedaSkin-contactingb	ISO Intracutaneous Irritation Test (GLP - 2Extracts)ISO Primary Irritation Test (GLP)	Pass - Non-irritantPass – Non-irritant
Implanteda Components:
Systemic ToxicityISO 10993-11:2017	Implanteda	ISO Acute Systemic Injection Test (GLP - 2Extracts)ISO Materials Mediated Rabbit Pyrogen (GLP)	Pass - Non-toxicPass - Non-pyrogenic
Implantation ISO10993-6: 2016	Implanteda	Chronic (29 Days) GLP Brain TissueImplantation Study (Sheep)	Pass - Minimal or no reaction
Hemolysis ISO10993-4: 2017	Implanteda	ASTM Hemolysis - Direct Contact andExtract Method (GLP)	Pass - Non-hemolytic
Genotoxicity ISO10993-3: 2014	Implanteda	In Vitro Mouse Lymphoma with ExtendedTreatment (GLP)ISO Bacterial Mutagenicity Test Ames Assay(GLP)	Pass - Non-mutagenic and Non-clastogenic.Pass - Non-mutagenic
Subacute ToxicityISO 10993-11: 2017	Implanteda	Subacute (28 Day) Intraperitoneal ToxicityStudy in Rats: Method with 14 Dose Exposure(GLP)Subchronic (28 Day) Intravenous ToxicityStudy in Rats: Method with 28 Dose Exposure(GLP)	Pass - Considered negative for signsof systemic toxicityPass - Considered negative for signsof systemic toxicity

3 Components tested: Electrode, Anchor Bolt, Cap with prolonged (>24 hours to 30 days) contact with tissue/bone *Components tested: Strain Relief, Lock Band, Stylet Assembly, Electrode Connector with limited <24 hours) contact with intact skin

Other non-clinical performance tests, including dimension, mechanical testing, electrochemical testing, electrical safety testing, packaging testing, shelf-life testing and sterilization were not needed as the differences in duration of use do not affect these device properties and the results of these non-clinical tests were provided in the predicate submission.

BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The Intended Use, Fundamental Scientific Technology, and Principles of Operation for the Evo® sEEG System, which has biocompatibility testing to support prolonged duration of use are the same as those described for the predicate device. The Evo® sEEG System which has biocompatibility testing to support prolonged duration of use does not raise new questions regarding safety and effectiveness when compared to the predicate device and has been determined by NeuroOne Medical Technologies Corp. to be substantially equivalent.

In summary, the subject device Evo® sEEG System has the following similarities to the predicate device which are relevant to the

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K222404

conclusion that they are substantially equivalent:

. Has the identical intended use
Has substantially equivalent indications for use (<30 days vs. < 24 hours for predicate)
. Has the identical technological characteristics
. Performance Testing demonstrates it is biocompatible for new indication (< 30 days)

Therefore, the conclusions drawn from the additional biocompatibility tests demonstrate the device can be used for less than 30 days, is as safe, as effective, and performs as well as the legally marketed predicate device, per 21 CFR 807.92(b)(3). The Evo® sEEG System with prolonged duration of use is substantially equivalent to the predicate device.

SUBSTANTIAL EQUIVALENCE CONCLUSIONS

Through comparison of technological and performance characteristics, the prolonged duration of use is determined to be substantially equivalent to the predicate device.

Regulation Number and Section

§ 882.1330 Depth electrode.

(a)
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.(b)
Classification. Class II (performance standards).