EEG Electrode Template

K191225 · Rhythmlink International, LLC · GXY · Aug 5, 2019 · Neurology

Device Facts

• Record ID: K191225
• Device Name: EEG Electrode Template
• Applicant: Rhythmlink International, LLC
• Product Code: GXY · Neurology
• Decision Date: Aug 5, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2

Intended Use

The EEG Electrode Template is intended for use as an accessory to support the placement of electroencephalograph (EEG) electrodes.

Device Story

The EEG Electrode Template is a non-invasive, non-sterile, single-patient-use accessory designed to assist clinicians in the placement of EEG electrodes. It consists of elastic webbing with 16 to 21 holes arranged according to the 10-20 Positioning System. The device is placed on the patient's head, oriented using a nasion marker, and secured with a chinstrap. Its elastic construction allows it to conform to various head shapes and sizes while avoiding interference with other medical equipment like intracranial pressure monitors or ventricular drains. By providing a standardized template for electrode positioning, it facilitates the EEG setup process in hospital environments. It does not perform signal processing or analysis; it serves purely as a mechanical positioning aid.

Clinical Evidence

No clinical tests were conducted. Substantial equivalence was established through non-clinical bench testing, specifically dimensional characterization to ensure accurate electrode placement.

Technological Characteristics

Materials: elastic webbing, polyester thread, screen-printed ink, Velcro/Veltex. Form factor: head-worn elastic template with 16-21 holes. Positioning: 10-20 system. Sterilization: non-sterile. Shelf life: 2 years. Connectivity: none (mechanical accessory).

Indications for Use

Indicated for use as an accessory to support the placement of EEG electrodes on the head of patients requiring EEG monitoring.

Regulatory Classification

Identification

A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

Predicate Devices

• Brainet Kit (K043009)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.

August 5, 2019

Rhythmlink International, LLC Gabriel Orsinger Director of Engineering 1140 First Street South Columbia, South Carolina 29209

## Re: K191225

Trade/Device Name: EEG Electrode Template Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: May 6, 2019 Received: May 7, 2019

## Dear Gabriel Orsinger:

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

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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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for

Vivek Pinto. PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine 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) K191225

Device Name EEG Electrode Template

Indications for Use (Describe)

The EEG Electrode Template is intended for use as an accessory to support the placement of electroencephalograph (EEG) electrodes.

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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# 510(k) Summary

| 807.92(a)(1)<br>Submitter<br>Information | Rhythmlink International, LLC<br>1140 First Street South<br>Columbia, SC 29209<br>Phone: [phone]<br>FDA Registration #: 1067162 | |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Official<br>Correspondent | Gabriel Orsinger, PhD<br>Director of Engineering<br>Email: [e-mail]<br>Phone: [phone] | |
| Summary Date | August 5, 2019 | |
| 807.92(a)(2)<br>Device<br>Identification | Device Trade Name: | EEG Electrode Template |
| | Common/Classification Name: | Cutaneous Electrode |
| | Product Code: | GXY |
| | Classification: | 21 CFR 882.1320 Class II |
| | Classification Panel: | Neurology |
| 807.92(a)(3)<br>Predicate<br>Device | K043009 – Brainet Kit | |
| 807.92(a)(4)<br>Device<br>Description | The EEG Electrode Template is intended to be used in medical environments<br>where EEG electrode placement is required. The device provides a workflow<br>solution to support application of EEG electrodes. | |
| | The EEG Electrode Template is made from elastic webbing to conform to various<br>head shapes and sizes. The device has between 16 to 21 holes in predetermined<br>locations that are arranged by generally referencing the 10-20 Positioning System.<br>The EEG Electrode Template is placed on the patient's head and is oriented with<br>its nasion marker and secured with its chinstrap to support positioning of EEG<br>electrodes. The elasticity of the device enables flexibility to account for various<br>head shapes and sizes and to avoid interference with intracranial pressure<br>monitoring, ventricular drainage, or other separate devices. Identical to the<br>predicate (K043009), the subject device is non-invasive, non-sterile, and for single<br>patient use. | |
| 807.92(a)(5)<br>Intended Use | The EEG Electrode Template is intended for use as an accessory to support the<br>placement of electroencephalograph (EEG) electrodes. | |

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## 807.92(a)(6) Technological Characteristics

The technological characteristics of the EEG Electrode Template are identical to the predicate device (K043009), with several minor dimensional and material modifications which have been assessed to be substantially equivalent to the predicate and therefore do not affect the safety or effectiveness of the device (reference Technological Characteristics table, below).

| Characteristic | Subject Device: | Predicate Device: |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | EEG Electrode Template | Brainet Kit |
| Manufacturer | K191225 | K043009 |
| Device Class | Rhythmlink International, LLC | Jordan Neuroscience, Inc. |
| Product Code | Class II | Class II |
| GXY | GXY | GXZ (different model) |
| | Regulatory Name | Cutaneous electrode |
| Regulation # | 21 CFR 882.1320 | 21 CFR 882.1320 |
| Intended Use | The EEG Electrode Template is<br>intended for use as an accessory<br>to support placement of<br>electroencephalograph (EEG)<br>electrodes. | The Brainet® template is<br>placed on the scalp to support<br>electroencephalograph<br>(EEG) electrode placement. |
| Single Patient Use | YES – disposable | YES - disposable |
| Sterilization Method | Non-sterile | Non-sterile |
| Shelf Life | 2 years | N/A – not listed on device |
| Anatomical Site(s) | Head | Head |
| Environment usage | Hospital | Hospital |
| Targeted Procedures | EEG | EEG |
| Number of Electrode<br>Positions | 16 to 21 | Up to 21 |
| Electrode Position<br>Identifier | Number and text | Color |
| Template Materials | Elastic, polyester thread, screen-<br>printed ink, Velcro/Veltex | Elastic, Velcro (other<br>materials unknown) |
| Duration of Use | Short term | Short term |
| Biocompatible | Yes | Yes |

#### 807.92(b)(1) The EEG Electrode Template is substantially equivalent in technology, safety, and Summary of effectiveness as the predicate device (K043009), as demonstrated by the test Non-Clinical results. Functional performance equivalency was determined by dimensional Tests characterization of the EEG Electrode Template, which demonstrated that all holeto-hole spacing was within 5 mm of specifications. In conclusion, all non-clinical performance testing passed predetermined acceptance criteria, demonstrating the EEG Electrode Template is equivalent to the predicate device in functionality, safety, and effectiveness. 807.92(b)(2) No Clinical Tests were conducted as referenced in 21 CFR 807.92(b)(2). Clinical Tests 807.92(b)(3) No Clinical Tests were conducted as referenced in 21 CFR 807.92(b)(3). Clinical Summary