Evo® sEEG System

K222404 · Neuroone Medical Technologies Corp. · GZL · Oct 20, 2022 · Neurology

Device Facts

• Record ID: K222404
• Device Name: Evo® sEEG System
• Applicant: Neuroone Medical Technologies Corp.
• Product Code: GZL · Neurology
• Decision Date: Oct 20, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Evo® sEEG System consists of polyimide depth electrodes, anchor bolts, and cable assemblies; used for temporary (up to 30 days) intracranial recording, monitoring, and stimulation. Electrodes feature platinum contacts (5-16 contacts; 16-80mm exploration length). System components are sterile, single-use. Electrodes are placed via 2.1mm burr hole using anchor bolts. Device connects to external, commercially available recording/stimulation instrumentation. Used in clinical settings by neurosurgeons/neurologists to localize electrical activity in the brain; output signals assist in clinical decision-making for epilepsy or other neurological conditions. Benefits include prolonged monitoring capability compared to previous 24-hour limit.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility evaluation performed per ISO 10993-1:2018 and ISO 10993-11:2017. Testing included cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), irritation (ISO 10993-10), systemic toxicity (ISO 10993-11), implantation (ISO 10993-6, 29-day sheep study), hemolysis (ISO 10993-4), and genotoxicity (ISO 10993-3). All tests passed.

Technological Characteristics

0.8mm diameter polyimide depth electrodes with platinum contacts. Available in 5-16 contacts; 16-80mm exploration length; 2.0mm contact height; 1.5-3.2mm spacing. Includes anchor bolts (20, 30, 35mm lengths) for 2.1mm burr hole placement. Sterile, single-use. No active electronic components; passive electrode system for signal transmission to external instrumentation.

Indications for Use

Indicated for temporary (less than 30 days) recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain in patients undergoing stereoelectroencephalography (sEEG) procedures.

Regulatory Classification

Identification

A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.

Predicate Devices

• Evo® sEEG System (K211367)

Submission Summary (Full Text)

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Image /page/0/Picture/10 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

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.<br>7599 Anagram Drive<br>Eden Prairie, MN 55344<br>Phone: [phone]<br>E-mail: [e-mail] |
| Contact Person: | Debra Kridner<br>Regulatory Affairs Consultant<br>7599 Anagram Drive<br>Eden 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)

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.

### 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 Device<br>K222404 | Predicate Device<br>K211367 | 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 /<br>Common Name: | Depth electrode | Depth electrode | Identical |
| Product Code: | GZL | GZL | Identical |
| Device Class / Regulation<br>Classification: | Class II | Class II | Identical |
| Intended Use/Indications for Use Comparison | | | |
| | Subject Device<br>222404 | Predicate Device<br>K211367 | Comparison |
| Intended<br>Use | A depth electrode is an electrode<br>used for temporary stimulation of,<br>or recording electrical signals at,<br>subsurface levels of the brain. | A depth electrode is an electrode<br>used for temporary stimulation of,<br>or recording electrical signals at,<br>subsurface levels of the brain. | Identical |
| Indications<br>for Use | The Evo® sEEG System is intended<br>for temporary (less than 30 days)<br>use with recording, monitoring, and<br>stimulation equipment for the<br>recording, monitoring, and<br>stimulation of electrical signals at<br>the subsurface level of the brain. | The Evo® sEEG System is intended<br>for temporary (less than 24 hours)<br>use with recording, monitoring, and<br>stimulation equipment for the<br>recording, monitoring, and<br>stimulation of electrical signals at<br>the subsurface level of the brain. | Substantially Equivalent<br>— Modified duration of<br>use, for the subject device,<br>which is prolonged<br>duration of use (less than<br>30 days) whereas the<br>predicate device was<br>cleared with limited<br>duration of use (less than<br>24 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 ISO<br>10993-5: 2009 | Implanteda<br>Skin-contactingb | ISO MEM Elution Using Mouse Fibroblast<br>Cells - 72 Hour Extraction (GLP) | Pass - Non-cytotoxic |
| Sensitization ISO<br>10993-10: 2010 | Implanteda<br>Skin-contactingb | ISO Guinea Pig Maximization Sensitization<br>(GLP - 2 Extracts)<br>ISO Buehler Repeated Patch Test (GLP) | Pass - Non-sensitizer<br>Pass - Non-sensitizer |
| Irritation ISO<br>10993-10: 2010 | Implanteda<br>Skin-contactingb | ISO Intracutaneous Irritation Test (GLP - 2<br>Extracts)<br>ISO Primary Irritation Test (GLP) | Pass - Non-irritant<br>Pass – Non-irritant |
| Implanteda Components: | | | |
| Systemic Toxicity<br>ISO 10993-11:<br>2017 | Implanteda | ISO Acute Systemic Injection Test (GLP - 2<br>Extracts)<br>ISO Materials Mediated Rabbit Pyrogen (GLP) | Pass - Non-toxic<br>Pass - Non-pyrogenic |
| Implantation ISO<br>10993-6: 2016 | Implanteda | Chronic (29 Days) GLP Brain Tissue<br>Implantation Study (Sheep) | Pass - Minimal or no reaction |
| Hemolysis ISO<br>10993-4: 2017 | Implanteda | ASTM Hemolysis - Direct Contact and<br>Extract Method (GLP) | Pass - Non-hemolytic |
| Genotoxicity ISO<br>10993-3: 2014 | Implanteda | In Vitro Mouse Lymphoma with Extended<br>Treatment (GLP)<br>ISO Bacterial Mutagenicity Test Ames Assay<br>(GLP) | Pass - Non-mutagenic and Non-<br>clastogenic.<br>Pass - Non-mutagenic |
| Subacute Toxicity<br>ISO 10993-11: 2017 | Implanteda | Subacute (28 Day) Intraperitoneal Toxicity<br>Study in Rats: Method with 14 Dose Exposure<br>(GLP)<br>Subchronic (28 Day) Intravenous Toxicity<br>Study in Rats: Method with 28 Dose Exposure<br>(GLP) | Pass - Considered negative for signs<br>of systemic toxicity<br>Pass - Considered negative for signs<br>of 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.