(72 days)
No
The summary describes a system of electrodes, cables, and anchor bolts for recording, monitoring, and stimulating electrical signals in the brain. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on biocompatibility and safety, not algorithmic performance.
No.
The device is used for recording, monitoring, and stimulation of electrical signals for diagnostic purposes in sEEG procedures, not for therapeutic intervention.
Yes
The device is intended for "recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain," which directly relates to gathering information about a patient's condition to aid in diagnosis or understanding of brain activity.
No
The device description explicitly lists hardware components: Evo® sEEG Electrodes (including Anchor Bolt Cap and Stylet), accompanying Cable Assemblies, and Evo® Anchor Bolts. These are physical components intended for implantation and connection to external equipment.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain." This is a direct interaction with the patient's body for physiological measurement and intervention.
- Device Description: The device is comprised of electrodes and anchor bolts that are "temporarily placed (less than 30 days) at the subsurface level of the brain." This describes an invasive medical device used for in-vivo procedures.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This device does not perform tests on samples taken from the body.
The Evo® sEEG System is clearly designed for direct interaction with the patient's brain for diagnostic and potentially therapeutic (stimulation) purposes, which falls under the category of an in-vivo medical device, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
GZL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subsurface level of the brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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).
Tested Components: Implanted (Electrode, Anchor Bolt, Cap) and Skin-contacting (Strain Relief, Lock Band, Stylet Assembly, Electrode Connector).
Tests performed:
- Cytotoxicity ISO 10993-5: 2009: ISO MEM Elution Using Mouse Fibroblast Cells - 72 Hour Extraction (GLP). Conclusion: Pass - Non-cytotoxic.
- Sensitization ISO 10993-10: 2010: ISO Guinea Pig Maximization Sensitization (GLP - 2 Extracts), ISO Buehler Repeated Patch Test (GLP). Conclusion: Pass - Non-sensitizer.
- Irritation ISO 10993-10: 2010: ISO Intracutaneous Irritation Test (GLP - 2 Extracts), ISO Primary Irritation Test (GLP). Conclusion: Pass - Non-irritant.
- Systemic Toxicity ISO 10993-11: 2017: ISO Acute Systemic Injection Test (GLP - 2 Extracts), ISO Materials Mediated Rabbit Pyrogen (GLP). Conclusion: Pass - Non-toxic, Pass - Non-pyrogenic.
- Implantation ISO 10993-6: 2016: Chronic (29 Days) GLP Brain Tissue Implantation Study (Sheep). Conclusion: Pass - Minimal or no reaction.
- Hemolysis ISO 10993-4: 2017: ASTM Hemolysis - Direct Contact and Extract Method (GLP). Conclusion: Pass - Non-hemolytic.
- Genotoxicity ISO 10993-3: 2014: In Vitro Mouse Lymphoma with Extended Treatment (GLP), ISO Bacterial Mutagenicity Test Ames Assay (GLP). Conclusion: Pass - Non-mutagenic and Non-clastogenic, Pass - Non-mutagenic.
- Subacute Toxicity ISO 10993-11: 2017: Subacute (28 Day) Intraperitoneal Toxicity Study in Rats: Method with 14 Dose Exposure (GLP), Subchronic (28 Day) Intravenous Toxicity Study in Rats: Method with 28 Dose Exposure (GLP). Conclusion: Pass - Considered negative for signs of systemic toxicity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 Drive | |
| Eden Prairie, MN 55344 | |
| Phone: (952) 426-1383 | |
| E-mail: info@n1mtc.com | |
| Contact Person: | Debra Kridner |
| Regulatory Affairs Consultant | |
| 7599 Anagram Drive | |
| 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.
4
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 | |||
| K222404 | Predicate Device | ||
| 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 / | |||
| Common Name: | Depth electrode | Depth electrode | Identical |
| Product Code: | GZL | GZL | Identical |
| Device Class / Regulation | |||
| Classification: | Class II | Class II | Identical |
| Intended Use/Indications for Use Comparison | |||
| Subject Device | |||
| 222404 | Predicate Device | ||
| K211367 | Comparison | ||
| Intended | |||
| Use | A depth electrode is an electrode | ||
| used for temporary stimulation of, | |||
| or recording electrical signals at, | |||
| subsurface levels of the brain. | A depth electrode is an electrode | ||
| used for temporary stimulation of, | |||
| or recording electrical signals at, | |||
| subsurface levels of the brain. | Identical | ||
| Indications | |||
| for 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. | The Evo® sEEG System is intended | ||
| for temporary (less than 24 hours) | |||
| use with recording, monitoring, and | |||
| stimulation equipment for the | |||
| recording, monitoring, and | |||
| stimulation of electrical signals at | |||
| the subsurface level of the brain. | Substantially Equivalent | ||
| — Modified duration of | |||
| use, for the subject device, | |||
| which is prolonged | |||
| duration of use (less than | |||
| 30 days) whereas the | |||
| predicate device was | |||
| cleared with limited | |||
| duration of use (less than | |||
| 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
5
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 | |||
| 10993-5: 2009 | Implanteda | ||
| Skin-contactingb | ISO MEM Elution Using Mouse Fibroblast | ||
| Cells - 72 Hour Extraction (GLP) | Pass - Non-cytotoxic | ||
| Sensitization ISO | |||
| 10993-10: 2010 | Implanteda | ||
| Skin-contactingb | ISO Guinea Pig Maximization Sensitization | ||
| (GLP - 2 Extracts) | |||
| ISO Buehler Repeated Patch Test (GLP) | Pass - Non-sensitizer | ||
| Pass - Non-sensitizer | |||
| Irritation ISO | |||
| 10993-10: 2010 | Implanteda | ||
| Skin-contactingb | ISO Intracutaneous Irritation Test (GLP - 2 | ||
| Extracts) | |||
| ISO Primary Irritation Test (GLP) | Pass - Non-irritant | ||
| Pass – Non-irritant | |||
| Implanteda Components: | |||
| Systemic Toxicity | |||
| ISO 10993-11: | |||
| 2017 | Implanteda | ISO Acute Systemic Injection Test (GLP - 2 | |
| Extracts) | |||
| ISO Materials Mediated Rabbit Pyrogen (GLP) | Pass - Non-toxic | ||
| Pass - Non-pyrogenic | |||
| Implantation ISO | |||
| 10993-6: 2016 | Implanteda | Chronic (29 Days) GLP Brain Tissue | |
| Implantation Study (Sheep) | Pass - Minimal or no reaction | ||
| Hemolysis ISO | |||
| 10993-4: 2017 | Implanteda | ASTM Hemolysis - Direct Contact and | |
| Extract Method (GLP) | Pass - Non-hemolytic | ||
| Genotoxicity ISO | |||
| 10993-3: 2014 | Implanteda | In Vitro Mouse Lymphoma with Extended | |
| Treatment (GLP) | |||
| ISO Bacterial Mutagenicity Test Ames Assay | |||
| (GLP) | Pass - Non-mutagenic and Non- | ||
| clastogenic. | |||
| Pass - Non-mutagenic | |||
| Subacute Toxicity | |||
| ISO 10993-11: 2017 | Implanteda | Subacute (28 Day) Intraperitoneal Toxicity | |
| Study in Rats: Method with 14 Dose Exposure | |||
| (GLP) | |||
| Subchronic (28 Day) Intravenous Toxicity | |||
| Study in Rats: Method with 28 Dose Exposure | |||
| (GLP) | Pass - Considered negative for signs | ||
| of systemic toxicity | |||
| Pass - Considered negative for signs | |||
| 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