Evo sEEG System

{0}------------------------------------------------ September 1, 2021 Image /page/0/Picture/1 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. NeuroOne Medical Technologies Corp. % Joseph Ostendorf Manager and Principal Consultant Ostendorf Consulting, LLC 23879 Blue Spruce Road Sauk Centre, Minnesota 56378 ## Re: K211367 Trade/Device Name: Evo sEEG System Regulation Number: 21 CFR 882.1330 Regulation Name: Depth Electrode Regulatory Class: Class II Product Code: GZL Dated: July 30, 2021 Received: August 2, 2021 ## Dear Joseph Ostendorf: 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 {1}------------------------------------------------ 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 (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, 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) K211367 Device Name Evo sEEG System Indications for Use (Describe) 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. 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}------------------------------------------------ # NeuroOne # 510(k) Summary 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: | K211367 | |-----------------|----------------------------------------------------------------------------------------------------------------------------------------| | Date Prepared: | September 01, 2021 | | Applicant: | NeuroOne Medical Technologies Corp.<br>7599 Anagram Drive<br>Eden Prairie, MN 55344<br>Phone: (952) 426-1383<br>E-mail: info@n1mtc.com | | Contact Person: | Joseph Ostendorf<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§882.1330 | | Device / Regulation Name: | Electrode, Depth | | Regulation Description /<br>Common Name: | Depth electrode | | Product Code: | GZL | | Device Class / Regulation<br>Classification: | Class II | {4}------------------------------------------------ #### 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 are temporarily placed (less than 24 hours) at the subsurface level of the brain. The system is designed to be used in stereoelectroencephalography (sEG) procedures. The sEEG electrodes, by way of the accompanying cable assemblies, are connected to recording, monitoring, or stimulation/response instrumentation currently commercially available for use with other sEEG electrodes, including the predicate device. The sEEG electrodes are a 0.8 mm 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 80 mm. The contact height is 2.0 mm and spacing is 1.5-3.2 mm apart. The Evo Anchor Bolts are available in 20 mm, 25 mm, 30 mm, and 35 mm lengths, can only be used and placed through a small 2.1 mm burr hole drilled in the skull, and should be used only when sEEG depth electrodes are warranted. #### INDICATIONS FOR USE (For the Device Subject to this 510(k) Premarket Notification) 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. #### DEVICE CLASSIFICATION, INTENDED USE/INDICATIONS FOR USE, AND TECHNOLOGICAL AND PERFORMANCE CHARACTERISTICS COMPARISONS 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>K211367 | Predicate Device<br>K170959 | | Trade/Device Name: | Evo sEEG System | DIXI Medical Microdeep Depth<br>Electrode | | Device Regulation Number: | 21 CFR§882.1330 | 21 CFR§882.1330 | | Device / Regulation Name: | Electrode, Depth | Electrode, Depth | | Regulation Description /<br>Common Name: | Depth electrode | Depth electrode | | Product Code: | GZL | GZL | | Device Class / Regulation<br>Classification: | Class II | Class II | {5}------------------------------------------------ | Intended Use/Indications for Use Comparison | | | |---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Subject Device<br>K211367 | Predicate Device<br>K170959 | | Intended<br>Use | A depth electrode is an electrode used for<br>temporary stimulation of, or recording<br>electrical signals at, subsurface levels of the<br>brain. | A depth electrode is an electrode used for<br>temporary stimulation of, or recording<br>electrical signals at, subsurface levels of the<br>brain. | | Indications<br>for Use | The Evo sEEG System is intended for<br>temporary (less than 24 hours) use with<br>recording, monitoring, and stimulation<br>equipment for the recording, monitoring, and<br>stimulation of electrical signals at the<br>subsurface level of the brain. | The DIXI Medical Microdeep Depth<br>Electrodes are intended for temporary (<30<br>day) use with recording, monitoring and<br>stimulation equipment for the recording,<br>monitoring and stimulation of electrical<br>signals at the subsurface level of the brain. | | Electrode Technological and Performance Characteristics Comparison | | | | | |--------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--|--| | | Subject Device<br>K211367 | Predicate Device<br>K170959 | | | | Manufacturer | NeuroOne Medical Technologies<br>Corp. | DIXI Medical | | | | Electrode Diameter | 0.8 mm | 0.8 mm | | | | Electrode Material | Polyimide | Polyamide | | | | Number of Contacts | 5 - 16 | 5 - 18 | | | | Contact Height/Length | 2 mm | 2 mm | | | | Contact Spacing | 1.5 – 3.2 mm | 1.5 - 11 mm | | | | Contact Material(s) | Platinum | Platinum/iridium | | | | Exploration Length<br>(Recording Depth) | 16 - 80 mm | 16 - 80.5 mm | | | | Single patient use, Disposable | Yes | Yes | | | | Provided Sterile | Yes | Yes | | | | Environment of Use | Intraoperative and Neurological<br>monitoring locations at subsurface<br>levels of the brain | Intraoperative and Neurological<br>monitoring locations at subsurface<br>levels of the brain | | | | Duration of Use | Less than 24 hours | Less than 30 days | | | | Principles of Operation | Depth electrodes are temporarily<br>placed at subsurface levels of the<br>brain to record, monitor, and<br>stimulate electrical signals | Depth electrodes are temporarily<br>placed at subsurface levels of the<br>brain to record, monitor, and<br>stimulate electrical signals | | | {6}------------------------------------------------ | Anchor Bolt Technological and Performance Characteristics Comparison | | | |----------------------------------------------------------------------|---------------------------------------------------------|---------------------------------------------------------| | | Subject Device<br>K211367 | Predicate Device<br>K170959 | | Manufacturer | NeuroOne Medical Technologies<br>Corp. | DIXI Medical | | Depth Electrode Diameter<br>Compatibility | 0.8 mm | 0.8 mm | | Material(s) | Titanium | Titanium | | Lengths Offered | 20 - 35 mm | 15 - 35 mm | | Anchor Bolt ID | 0.9 mm | 0.9 mm | | Single patient use, Disposable | Yes | Yes | | Provided Sterile | Yes | Yes | | Environment of Use | Intraoperative and Neurological<br>monitoring locations | Intraoperative and Neurological<br>monitoring locations | | Duration of Use | Less than 24 hours | Less than 30 days | | Principles of Operation | Threaded into a pre-drilled hole in<br>the skull. | Threaded into a pre-drilled hole in<br>the skull. | {7}------------------------------------------------ #### SIMILIARITIES AND DIFFERENCES TO THE PREDICATE (For the Device Subject to this 510(k) Premarket Notification) There are similarities and differences between the subject and predicate devices. The NeuroOne Evo sEEG System and the DIXI Medical Microdeep Depth Electrode devices have the same Device Regulation Numbers, Device / Regulation Names, Regulation / Common Names, Product Codes, and Device Class / Regulation Classifications. Both devices have identical Intended Uses and similar Indications for Use. The devices further possess the same Electrode Diameters. The NeuroOne Evo sEEG System has a similar material as the DIXI Medical Microdeep Depth Electrode as both utilize polymer materials for the electrode body and for their insulative properties. The NeuroOne Evo sEEG System has a similar Number of Contacts and is within the range of contacts offered for the DIXI Medical Microdeep Depth Electrodes. Both devices share the same electrode Contact Height/Length. The NeuroOne Evo sEEG System has similar Contact Spacing and utilizes variable contact spacing across the device size configurations whereas the DIXI Medical Microdeep Depth Electrodes utilizes the same Contact Spacing across all device size configurations. The devices are similar in both utilizing platinum contacts, although the DIXI Medical Microdeep Depth Electrodes have platinum/iridium contacts. The NeuroOne Evo sEEG System has a similar Exploration Length (Recording Depth) and is within the range of Exploration Length (Recording Depth) offered for the DIXI Medical Microdeep Depth Electrodes. Both devices are Single Patient Use, Disposable devices, which are provided Sterile. They both are used in the same Environment of Use and share similar Durations of Use. And finally, they both have the very same principles of operation. The NeuroOne Evo Anchor Bolts and the DIXI Medical Microdeep Depth Electrode anchor bolts have the same Depth Electrode Diameter Compatibility and Material(s). The anchor bolts Lengths Offered with the NeuroOne Evo Anchor Bolts are similar to the DIXI Medical Microdeen Depth Electrode anchor bolts and are within the range offered by the DIXI Medical Microdeep Depth Electrode anchor bolts. The Evo Anchor Bolts have the same Anchor Bolt IDs as the DIXI Medical Microdeep Depth Electrode anchor bolts. Both devices are Single Patient use, Disposable devices, which are provided Sterile. They both are used in the same Environment of Use and share similar Durations of Use. And finally, they both have the very same Principles of Operation. Performance testing was conducted to evaluate and characterize the performance of the device to support a determination of substantial equivalence to the predicate device. A comparison was made against the predicate where data was available. The Evo sEEG System has undergone bench, electrical, biocompatibility, packaging, and sterilization testing to demonstrate the differences in the sizes and materials do not raise questions of safety or efficacy. {8}------------------------------------------------ #### SUMMARY OF PERFORMANCE TESTING AND STANDARDS Performance testing was conducted to evaluate and characterize the performance of the device to support a determination of substantial equivalence to the predicate device. A comparison was made against the predicate where data was available. The Evo sEEG System has undergone non-clinical performance, biocompatibility, sterility, shelf-life, and packaging to demonstrate that the results do not raise questions of safety or efficacy. | Non-Clinical Performance Tests | | | |------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------| | Test | Test Method Summary | Results and Conclusions | | Dimensional | Electrode Outer Diameter | Pass – All samples passed the<br>acceptance criteria | | | Electrode Working Length | Pass – All samples passed the<br>acceptance criteria | | | Electrode Recording Depth | Pass – All samples passed the<br>acceptance criteria | | | Electrode Contact Spacing | Pass – All samples passed the<br>acceptance criteria | | | Electrode Contact Size | Pass – All samples passed the<br>acceptance criteria | | | Electrode Tail | Pass - All samples passed the<br>acceptance criteria | | | Anchor Bolt Compatibility –<br>Outer Diameter | Pass – All samples passed the<br>acceptance criteria | | Mechanical Performance -<br>Implantation | Anchor Bolt Placement Torque | Pass – All samples passed the<br>acceptance criteria | | | Anchor Bolt Removal Torque | Pass – All samples passed the<br>acceptance criteria | | | Electrode Depth Setting | Pass – All samples passed the<br>acceptance criteria | | | Electrode Depth Setting - Sliding<br>Force | Pass – All samples passed the<br>acceptance criteria | | | Electrode Through Anchor Bolt | Pass – All samples passed the<br>acceptance criteria | | | Electrode Stylet Removal | Pass – All samples passed the<br>acceptance criteria | | | Anchor Bolt Cap Torque | Pass – All samples passed the<br>acceptance criteria | | | Anchor Bolt Cap Torque<br>Movement | Pass – All samples passed the<br>acceptance criteria | | | Electrode Migration | Pass – All samples passed the<br>acceptance criteria | | Electrochemical Performance | Impedance | Pass – All samples passed the<br>acceptance criteria | | | Reliability | Pass - All samples passed the<br>acceptance criteria | | | Stimulation | Pass - All samples passed the<br>acceptance criteria | | | Detection | Pass - All samples passed the<br>acceptance criteria | | | Kink Resistance | Pass - All samples passed the<br>acceptance criteria | | Mechanical Performance –<br>Monitoring | Electrode Rigidity | Pass – All samples passed the<br>acceptance criteria | | | Anchor Bolt Cap Torque | Pass – All samples passed the<br>acceptance criteria | | | Anchor Bolt Cap Sealing | Pass – All samples passed the<br>acceptance criteria | | | Electrode Flexibility | Pass – All samples passed the<br>acceptance criteria | | Mechanical Integrity | Anchor Bolt Compatibility –<br>Torque | Pass – All samples passed the<br>acceptance criteria | | | Anchor Bolt Retention | Pass – All samples passed the<br>acceptance criteria | | | Electrode Integrity | Pass – All samples passed the<br>acceptance criteria | | | Anchor Bolt Cap Integrity | Pass – All samples passed the<br>acceptance criteria | | | Guiding Stylet Integrity | Pass – All samples passed the<br>acceptance criteria | | Electrical Safety | Product shall meet the applicable<br>requirements of the IEC 60601-1<br>standard. | Pass – All samples passed the<br>acceptance criteria | | Packaging | The packaged device and labeling<br>shall withstand the conditions of<br>ISTA 3A and ASTM D-4169;<br>DC13; AL1 without loss of<br>function, sterility, or legibility. | Pass – All samples passed the<br>acceptance criteria | | Shelf-Life | The packaged device and labeling<br>shall withstand simulated storage<br>conditions without loss of<br>function, sterility, or legibility. | Pass – All samples passed the<br>acceptance criteria | | Sterilization | The sterilization process shall be<br>validated to demonstrate a<br>minimum of SAL of 10-6 for the<br>product using Ethylene Oxide | Pass – All samples passed the<br>acceptance criteria | {9}------------------------------------------------ | Biocompatibility | | | |--------------------------------|-------------------------------------------------------------------------------|---------------------------------------------------------------------------------------| | Test | Test Summary | Conclusions | | Cytotoxicity | ISO MEM Elution Using Mouse<br>Fibroblast Cells - 72 Hour<br>Extraction (GLP) | Pass - Non-cytotoxic | | Sensitization | ISO Guinea Pig Maximization<br>Sensitization<br>(GLP - 2 Extracts) | Pass - Did not elicit a sensitization<br>response | | Irritation | ISO Intracutaneous Irritation<br>(GLP - 2 Extracts) | Pass - The requirements of the<br>ISO Intracutaneous Reactivity<br>Test have been met | | Acute Systemic Toxicity | ISO Acute Systemic Toxicity<br>(GLP - 2 Extracts) | Pass - The ISO Acute Systemic<br>Injection Test have been met | | Material Mediated Pyrogenicity | ISO Materials Mediated Rabbit<br>Pyrogen<br>(GLP) | Pass - Non-pyrogenetic | {10}------------------------------------------------ | Implantation | Provide general information on<br>the health hazards likely to arise<br>from continuous exposure of the<br>device for local tissue/bone<br>response to implantation sites in<br>both an ovine brain implantation<br>study (including assessment for<br>neurotoxicity) and rabbit tibia<br>study (Evo sEEG anchor bolt<br>only). | Pass – Minimal or no reaction | |--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------| | Hemolysis | ASTM Hemolysis - Direct<br>Contact and Extract Method<br>(GLP) | Pass - Non-hemolytic | #### Simulated Use and Implantation Accuracy Study #### Results and Conclusions A human cadaver study was conducted by NeuroOne Medical Technologies Corp. with the purpose of demonstrating the simulated use of the Evo sEEG System, and its implantation accuracy, when implanted according to its Instructions For Use (IFU). The implantation accuracy of the Evo sEEG System was compared to the implantation accuracy of the predicate DIXI Medical Microdeep Depth Electrode (K170959). The results demonstrated no significant difference between the implantation accuracy of the subject and predicate devices and therefore these devices are substantially equivalent when evaluating implantation accuracy. #### BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE The Intended Use, Fundamental Scientific Technology, and Principles of Operation for the Evo sEEG System are the same as those described for the predicate device. The Evo sEEG System 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 Evo sEEG System has the following similarities to the predicate device, which has previously received 510(k) clearance: - . Has the same device classification - Has the same intended use ● - Has the similar indications for use - Has the same environment of use ● - Uses similar technological characteristics - . Uses the same principles of operation - . Uses the same sterilization methodology - Is biocompatible for its intended use Therefore, the conclusions drawn from the non-clinical tests (biocompatibility) demonstrate the device 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 is substantially equivalent to the predicate device. #### SUBSTANTIAL EQUIVALENCE CONCLUSIONS Through the thorough comparison of technological and performance characteristics, the subject device is determined to be substantially equivalent to the predicate device.