(57 days)
Not Found
No
The description focuses on the physical characteristics and function of the electrodes for recording and stimulating electrical signals. There is no mention of AI/ML in the device description, intended use, or performance studies.
No.
The device's stated intended use is for "recording, monitoring, and stimulation of electrical signals on the surface of the brain," which are diagnostic and investigative functions, not direct therapeutic treatments. While stimulation could potentially be part of a therapy, the primary indicated purpose here is signal analysis and monitoring.
Yes
The device is intended for "recording, monitoring, and stimulation of electrical signals on the surface of the brain," which directly points to its use in assessing brain activity for diagnostic or monitoring purposes alongside stimulation capabilities.
No
The device description explicitly states it is a "sterile, single use electrical conductor" consisting of "contacts mounted in thin plastic strips, or in a square/rectangular grid." This describes a physical hardware component, not software. The performance studies also detail testing related to physical properties like dimensions, durability, electrical characteristics, biocompatibility, packaging, and sterilization, all indicative of a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body ("in vitro").
- Device Function: The NeuroOne Cortical Electrodes are placed directly on the surface of the brain to record, monitor, and stimulate electrical signals. This is an in vivo (within the living body) procedure, not an in vitro test.
- Intended Use: The intended use clearly states recording, monitoring, and stimulation of electrical signals on the surface of the brain. This is a direct interaction with the patient's body.
Therefore, the NeuroOne Cortical Electrodes fall under the category of implantable or externally applied medical devices used for physiological monitoring and stimulation, not in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The NeuroOne Cortical Electrodes are intended for temporary (less than 30 days) use with recording, and stimulation equipment for the recording, and stimulation of electrical signals on the surface of the brain.
Product codes (comma separated list FDA assigned to the subject device)
GYC
Device Description
The NeuroOne Cortical Electrode is a sterile, single use electrical conductor that is temporarily placed (
§ 882.1310 Cortical electrode.
(a)
Identification. A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity.(b)
Classification. Class II (performance standards).
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NeuroOne, Inc. % Debra Kridner President, Debra J Kridner LLC, Regulatory Consultant Debra J Kridner 10901 Red Circle Dr., Suite 150 Minnetonka. Minnesota 55343
Re: K192764
Trade/Device Name: NeuroOne Cortical Electrode Regulation Number: 21 CFR 882.1310 Regulation Name: Cortical Electrode Regulatory Class: Class II Product Code: GYC Dated: September 28, 2019 Received: September 30, 2019
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 Actinclude 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
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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 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-devices/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 (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
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Indications for Use
510(k) Number (if known) K192764
Device Name
NeuroOne Cortical Electrode
Indications for Use (Describe)
The NeuroOne Cortical Electrodes are intended for temporary (less than 30 days) use with recording, and stimulation equipment for the recording, and stimulation of electrical signals on the surface of the brain.
Type of Use (Select one or both, as applicable)
| 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/1 description: The image shows the word "Neuroone" in a stylized font. The "Neuro" part of the word is in gray, while the "one" part is in blue. There is a circular graphic between the two words that is divided into four sections, colored red, light pink, light blue, and dark blue. The logo appears to be for a company or organization called 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: | |
|---|---|
| Date Prepared: | September 28, 2019 |
| Applicant: | NeuroOne, Inc. |
| 10901 Red Circle Dr., Suite 150 | |
| Minnetonka, MN 55343 | |
| Email: info@NeuroOneinc.com | |
| Website: www.NeuroOneinc.com | |
| Contact Person: | Debra Kridner |
| President, Debra J Kridner Consulting, LLC | |
| 10901 Red Circle Dr., Suite 150 | |
| Minnetonka, MN 55343 | |
| Email: info@NeuroOneinc.com | |
| SUBJECT DEVICE | |
| Trade Name: | NeuroOne Cortical Electrode |
| Common Name: | Cortical Electrode |
|---|---|
| Classification Name: | Cortical electrode (21 CFR§882.1310) |
| Device Class: | Class 2 |
| Product Code | GYC |
DEVICE DESCRIPTION (For the Device Subject to This 510(k) Notification)
The NeuroOne Cortical Electrode is a sterile, single use electrical conductor that is temporarily placed (