NeuroOne Cortical Electrode

K192764 · Neuroone, Inc. · GYC · Nov 26, 2019 · Neurology

Device Facts

• Record ID: K192764
• Device Name: NeuroOne Cortical Electrode
• Applicant: Neuroone, Inc.
• Product Code: GYC · Neurology
• Decision Date: Nov 26, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1310
• Device Class: Class 2

Intended Use

The NeuroOne Cortical Electrodes are intended for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals on the surface of the brain.

Device Story

NeuroOne Cortical Electrode is a sterile, single-use electrical conductor placed on the brain surface for <30 days. Device consists of platinum contacts mounted on thin polyimide film strips or grids. It functions as an interface between the brain surface and external, commercially available recording, monitoring, or stimulation instrumentation. Used in intraoperative and neurological monitoring settings by clinicians. Device records/monitors electrical activity or delivers stimulation to the brain. Benefits include temporary monitoring/stimulation capabilities for neurological assessment. Output is raw electrical signal data processed by external equipment; clinicians use this data to inform clinical decision-making regarding brain function.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included design verification (dimensional measurements, durability, mapping/stimulation, reliability), electrical testing per IEC 60601, biocompatibility per ISO 10993-1 and ASTM F756, packaging/shelf life per ASTM standards (D4169-16, F1980-16, 2096-11, F88-15), and sterilization validation per ISO 11135.

Technological Characteristics

Sterile, single-use cortical electrode. Contacts: Platinum. Film: Polyimide. Thickness: 0.0127 mm. Configuration: 2-16 contacts per electrode. Sensing/Actuation: Electrical signal recording and stimulation. Connectivity: Passive interface to external instrumentation. Sterilization: ISO 11135 validated.

Indications for Use

Indicated for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals on the surface of the brain.

Regulatory Classification

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.

Predicate Devices

• PMT Subdural Cortical Electrode (K082474)

Submission Summary (Full Text)

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

| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> 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.<br>10901 Red Circle Dr., Suite 150<br>Minnetonka, MN 55343<br>Email: [e-mail]<br>Website: www.NeuroOneinc.com |
| Contact Person: | Debra Kridner<br>President, Debra J Kridner Consulting, LLC<br>10901 Red Circle Dr., Suite 150<br>Minnetonka, MN 55343<br>Email: [e-mail] |
| 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 (< 30 days) on the surface of the brain. The electrodes are designed to record and/or monitor the brain's electrical activity as well as stimulate the brain. It consists of a series of contacts mounted in thin plastic strips, or in a square/rectangular grid to cover larger surface areas. The device is connected to recording, monitoring, or stimulation/response instrumentation currently commercially available for use with other cortical electrodes, including the predicate device.

There are Similarities and Differences between the subject and predicate devices. The NeuroOne and PMT electrodes have the identical indications for use and intended use. The devices both have platinum contacts (PMT also has platinum/iridium contacts as an option). Both devices have the identical principles of operation. PMT uses silicone and NeuroOne uses polyimide film both are biocompatible for their intended use. Overall the configurations, dimensions/surface area of the electrodes are similar: with the NeuroOne electrode having a slightly smaller footprint. The NeuroOne device has undergone electrical, bench, and biocompatibility testing to demonstrate the differences in material and size of the contacts/electrodes do not raise questions of safety or efficacy.

#### INDICATIONS FOR USE (For the Device Subject to This 510(k) Notification)

The NeuroOne Cortical Electrodes are intended for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals on the surface of the brain.

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# INDICATIONS FOR USE AND DEVICE CLASSIFICATION COMPARISON

The following tables provide a side-by-side comparison of the Cortical Electrode to the predicate device to support this pre-market notification.

| Intended Use/Indications for Use Comparison | | |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | Predicate Device<br>K082474 |
| Intended Use | A cortical electrode is an electrode which is<br>temporarily placed on the surface of the brain<br>for stimulating the brain or recording the<br>brain's electrical activity. | A cortical electrode is an electrode which is<br>temporarily placed on the surface of the brain<br>for stimulating the brain or recording the<br>brain's electrical activity. |
| Indications for<br>Use | The NeuroOne Cortical Electrodes | Catalog Numbers 21 10-XXX: The Subdural<br>Cortical Electrodes (Dual Side Macro<br>Electrodes, Dual Side Micro Electrodes,<br>Dual Side Macro-Micro Electrodes, Dual<br>Sided Hemispherical Macro Electrodes,<br>Dual Sided Hemispherical Micro Electrodes,<br>Dual Side Hemispherical Macro-Micro<br>Electrodes, Macro Grids, Macro Strip,<br>Macro-Micro Grids, Macro-Micro Strips,<br>Micro Grids, and Micro Strips.) |
| | are intended for temporary (less than 30 days)<br>use with recording, monitoring, and<br>stimulation equipment for the recording,<br>monitoring, and stimulation of electrical<br>signals on the surface of the brain. | are intended for temporary (<30 day)<br>use with recording, monitoring, and<br>stimulation equipment for the recording,<br>monitoring and stimulation of electrical<br>signals on the surface of the brain. |

| Device Classification Comparison Subject Device | | |
|-------------------------------------------------|-----------------------------|---------------------------------|
| | Subject Device | Predicate Device<br>K082474 |
| Trade/Device Name: | NeuroOne Cortical Electrode | PMT Subdural Cortical Electrode |
| Common Name: | Cortical electrode | Cortical electrode |
| Classification Number: | 21 CFR 882.1310 | 21 CFR 882.1310 |
| Classification Name: | Cortical electrode | Cortical electrode |
| Device Class: | Class 2 | Class 2 |
| Product Code: | GYC | GYC |

| Technological and Performance Characteristics Comparison | | |
|----------------------------------------------------------|----------------|-----------------------------|
| | Subject Device | Predicate Device |
| Manufacturer | NeuroOne, Inc. | PMT |
| Number of Contacts per Electrode | 2 - 16 | 2 - 64 |
| Thickness of Contact | 0.0127 mm | 0.5 - 1.01mm |
| Contact Diameter | 3 mm | 2 - 4.5mm |
| Contact Material(s) | Platinum | Platinum or stainless steel |
| Surface Area of Electrode | 1x2 469mm² | 1x2 570mm² |
| Electrode Film Material | Polyimide | Silicone |
| Electrode Film Thickness | 0.0127 mm | 0.5 - 1.01 mm |
| Thickness of Tail | 0.0127 mm | 1.40mm |

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| Technological and Performance Characteristics Comparison | | |
|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|------------------|
| | Subject Device | Predicate Device |
| Single patient use, Disposable | Yes | Same |
| Provided Sterile | Yes | Yes |
| Environment of Use | Intraoperative and Neurological<br>monitoring locations on surface of<br>brain | Same |
| Duration of Use | Less than 30 days | Same |
| Principles of Operation | Cortical electrodes are placed on<br>the surface of the brain to record,<br>monitor and stimulate brain<br>activity | Same |

### SUMMARY OF TESTING and PERFORMANCE 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 NeuroOne device has undergone electrical, bench, and biocompatibility testing to demonstrate any differences do not raise questions of safety or efficacy.

- . Design Verification Testing
- o Dimensional Measurements
- O Durability
- Mapping/Stimulation O
- Reliability o
- Electrical to IEC 60601 O
- Biocompatibility Testing to ISO 10993-1 and ASTM F756
- . Packaging/Shelf Life to ASTM D4169-16, ASTM F1980-16, ASTM 2096-11, ASTM F88-15
- Sterilization Validation to ISO 11135 ●
- Labeling to ISO 15223-1 .

The Indications for Use, Intended Use, Fundamental Scientific Technology and Principles of Operation for the Cortical Electrode are the same as those described for the predicate device. The Cortical Electrode is found to have a safety and effectiveness profile that is the same as the predicate device and is determined by NeuroOne to be substantially equivalent.

In summary, the Cortical Electrode has the following similarities to the predicate device which has previously received 510(k) clearance:

- Has the same indications for use
- Has the same intended use

.

- Used in the same anatomical site
- Uses the same technological characteristics

#### ● Uses the same principles of operation

- Uses the same sterilization methodology
- Biocompatible for its intended use
- SUBSTANTIAL EQUIVALENCE CONCLUSIONS

Through the comparison of technological and performance characteristics, the subject device is determined to be substantially equivalent to the predicate device.