(120 days)
Not Found
No
The summary describes a system of electrodes, cables, and anchor bolts for recording 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 physical characteristics and implantation accuracy, not algorithmic performance.
No.
The device is described as being used for "recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain," which are diagnostic and monitoring functions, not therapeutic.
Yes
The device is intended for the "recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain," which are actions typically performed to gather information used in diagnosis or to guide treatment. The description further states it's for "stereoelectroencephalography (sEG) procedures," which are diagnostic procedures to pinpoint epileptic foci.
No
The device description explicitly lists hardware components: Evo sEEG Electrodes, Cable Assemblies, and Evo Anchor Bolts. These are physical components implanted in the brain.
Based on the provided information, the Evo sEEG System is not an In Vitro Diagnostic (IVD) device.
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 involves directly interacting with the patient's body to measure electrical activity.
- Device Description: The device consists of electrodes, cables, and anchor bolts that are surgically placed within the brain. This is an invasive procedure.
- Anatomical Site: The device is used within the "subsurface level of the brain."
- Mechanism of Action: The device works by detecting and potentially stimulating electrical signals within the brain tissue.
In Vitro Diagnostic devices, as defined by regulatory bodies like the FDA, are used to examine specimens (like blood, urine, or tissue) that are taken from the human body. They are used to provide information for the diagnosis, treatment, or prevention of disease.
The Evo sEEG System operates within the body to directly interact with and measure physiological signals, which is characteristic of an in vivo device, not an in vitro device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
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 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.
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
Intraoperative and Neurological monitoring locations
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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)
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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. |
| 7599 Anagram Drive | |
| Eden Prairie, MN 55344 | |
| Phone: (952) 426-1383 | |
| E-mail: info@n1mtc.com | |
| Contact Person: | Joseph Ostendorf |
| Regulatory Affairs Consultant | |
| 7599 Anagram Drive | |
| 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 / | |
| Common Name: | Depth electrode |
| Product Code: | GZL |
| Device Class / Regulation | |
| 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 | ||
| K211367 | Predicate Device | |
| K170959 | ||
| Trade/Device Name: | Evo sEEG System | DIXI Medical Microdeep Depth |
| Electrode | ||
| Device Regulation Number: | 21 CFR§882.1330 | 21 CFR§882.1330 |
| Device / Regulation Name: | Electrode, Depth | Electrode, Depth |
| Regulation Description / | ||
| Common Name: | Depth electrode | Depth electrode |
| Product Code: | GZL | GZL |
| Device Class / Regulation | ||
| Classification: | Class II | Class II |
5
| Intended Use/Indications for Use Comparison | ||
|---|---|---|
| Subject Device | ||
| K211367 | Predicate Device | |
| K170959 | ||
| 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. | ||
| Indications | ||
| for Use | 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. | The DIXI Medical Microdeep Depth | |
| Electrodes are intended for temporary ( |