The EEG Electrode Template is intended to be used in medical environments where EEG electrode placement is required. The device provides a workflow solution to support application of EEG electrodes. The EEG Electrode Template is made from elastic webbing to conform to various head shapes and sizes. The device has between 16 to 21 holes in predetermined locations that are arranged by generally referencing the 10-20 Positioning System. The EEG Electrode Template is placed on the patient's head and is oriented with its nasion marker and secured with its chinstrap to support positioning of EEG electrodes. The elasticity of the device enables flexibility to account for various head shapes and sizes and to avoid interference with intracranial pressure monitoring, ventricular drainage, or other separate devices. Identical to the predicate (K043009), the subject device is non-invasive, non-sterile, and for single patient use.

AI/ML Overview

The provided text describes information about the Rhythmlink International, LLC EEG Electrode Template (K191225). Based on the text, here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Hole-to-hole spacing	All hole-to-hole spacing was within 5 mm of specifications.

2. Sample size used for the test set and the data provenance

Sample size: Not explicitly stated. The text mentions "dimensional characterization of the EEG Electrode Template," implying that the testing was performed on a sample of the manufactured device.
Data provenance: The data is from non-clinical performance testing of the subject device (EEG Electrode Template) itself. No information about country of origin, retrospective or prospective study is provided as it's not a clinical study involving patients or human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The ground truth for the non-clinical dimensional characterization was based on the device's specifications, not on expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This was a non-clinical dimensional test, not a clinical study requiring adjudication of expert opinions.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an EEG electrode template, not an AI-powered diagnostic tool, and the study was a non-clinical performance test.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, this question is not applicable. The device is a physical template for electrode placement, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for the performance testing was the device's own specifications for hole-to-hole spacing.

8. The sample size for the training set

Not applicable. This is a physical device, not a machine learning model, so there is no training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)SubmitterInformation	Rhythmlink International, LLC1140 First Street SouthColumbia, SC 29209Phone: 803-252-1222FDA Registration #: 1067162
OfficialCorrespondent	Gabriel Orsinger, PhDDirector of EngineeringEmail: gorsinger@rhythmlink.comPhone: 803-365-9664
Summary Date	August 5, 2019
807.92(a)(2)DeviceIdentification	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)PredicateDevice	K043009 – Brainet Kit
807.92(a)(4)DeviceDescription	The EEG Electrode Template is intended to be used in medical environmentswhere EEG electrode placement is required. The device provides a workflowsolution to support application of EEG electrodes.
	The EEG Electrode Template is made from elastic webbing to conform to varioushead shapes and sizes. The device has between 16 to 21 holes in predeterminedlocations that are arranged by generally referencing the 10-20 Positioning System.The EEG Electrode Template is placed on the patient's head and is oriented withits nasion marker and secured with its chinstrap to support positioning of EEGelectrodes. The elasticity of the device enables flexibility to account for varioushead shapes and sizes and to avoid interference with intracranial pressuremonitoring, ventricular drainage, or other separate devices. Identical to thepredicate (K043009), the subject device is non-invasive, non-sterile, and for singlepatient use.
807.92(a)(5)Intended Use	The EEG Electrode Template is intended for use as an accessory to support theplacement 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 isintended for use as an accessoryto support placement ofelectroencephalograph (EEG)electrodes.	The Brainet® template isplaced on the scalp to supportelectroencephalograph(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 ElectrodePositions	16 to 21	Up to 21
Electrode PositionIdentifier	Number and text	Color
Template Materials	Elastic, polyester thread, screen-printed ink, Velcro/Veltex	Elastic, Velcro (othermaterials 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

Regulation Number and Section

§ 882.1320 Cutaneous electrode.

(a)
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.(b)
Classification. Class II (performance standards).