The PressOn™ Electrode Headset is intended for use in the recording of electroencephalogram (EEG), evoked potential (EP), or as a ground and reference in an EEG or EP recording. The device is provided sterile for single patient use only.

Device Description

The PressOn™ Electrode Headset is intended to be used in medical environments where quick EEG electrode application is required. The device provides a workflow solution where the availability of technologists or other specialty-trained EEG staff is limited for applying EEG electrodes.

The headset comprises between 2 to 48 PressOn™ Electrodes, each loaded into individual button applicators, which are positioned in predetermined locations and interconnected by elastic netting, altogether forming the headset. The predetermined electrode positions are arranged by generally referencing the 10-20 Positioning System, but with flexibility to account for various head shapes and sizes and to avoid interference with intracranial pressure monitoring, ventricular drainage, and other separate devices. Like the predicate, the subject device is minimally invasive and does not directly contact neural tissues.

The PressOn™ Electrode Headset is placed on the patient's head and is oriented and secured using a nasion marker and chinstrap. The distal end of the device contains the array of PressOn™ electrodes in predetermined locations that are placed on the scalp by minimal insertion of the micro needles into the epidermis layer of the skin for use during monitoring procedures. The PressOn™ electrodes in the subject device are inserted in an identical fashion as the predicate device (K130220). Minor material and dimensional changes have been made to the original applicator to allow for multiple applicators to be connected to form the headset.

At the proximal end of the subject device is a multipin connector where the electrode leadwires terminate. The multipin connector interfaces with color-coded extension cables (identical to those used in another previously cleared Rhythmlink device, reference device K172503) that terminate into single pin connectors, which are then connected to monitoring equipment.

The leadwires are constructed of ribbon cable arrays with electrode attachment points at various distances based on the predetermined locations. These features are designed with the intent for quick application by non-neurological based medical personnel with signal quality equivalent to predicate device [K130220].

AI/ML Overview

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a structured format that directly maps to "AI performance metrics" commonly seen in such tables (e.g., sensitivity, specificity, AUC). Instead, it discusses functional performance equivalency to a predicate device based on benchtop tests.

However, we can infer the acceptance criteria and reported performance from the "Summary of Non-Clinical Tests" section:

Acceptance Criteria (Inferred)	Reported Device Performance
Electrical Continuity (Pass/Fail)	Passed (implied as "all benchtop performance testing passed predetermined acceptance criteria")
Deployment force to eject electrode from applicator and apply to synthetic skin (Within range)	Passed (implied as "all benchtop performance testing passed predetermined acceptance criteria")
Pull force required to remove the electrode from synthetic skin (Within range)	Passed (implied as "all benchtop performance testing passed predetermined acceptance criteria")
Visual assessment of electrode insertion uniformity into synthetic skin (Acceptable)	Passed (implied as "all benchtop performance testing passed predetermined acceptance criteria")
Dimensional assessment of electrode placement on head phantom (Within tolerance)	Passed (implied as "all benchtop performance testing passed predetermined acceptance criteria")

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "No Clinical Tests were conducted as referenced in 21 CFR 807.92(b)(2)."

Therefore:

Sample size for test set: Not applicable (no clinical test set).
Data Provenance: Not applicable (benchtop testing on synthetic materials, not human data).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable, as no clinical tests were conducted and the "ground truth" was established based on engineering specifications and benchtop performance against predetermined criteria.

4. Adjudication Method for the Test Set

Not applicable, as no clinical tests were conducted involving expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "No Clinical Tests were conducted." Therefore, no MRMC study was performed, and no effect size for human readers with and without AI assistance is reported. This device is a hardware electrode headset, not an AI algorithm.

6. Standalone (Algorithm Only) Performance Study

No. The device is a physical electrode headset, not an AI algorithm. Therefore, a standalone algorithm-only performance study is not relevant and not reported.

7. Type of Ground Truth Used

The "ground truth" for evaluating the device's performance was established via:

Engineering specifications and predetermined acceptance criteria for mechanical and electrical properties.
Comparison to the predicate device (K130220) for functional equivalency, implying the predicate's established performance served as a baseline.
Benchtop measurements and visual assessments on synthetic skin and head phantoms.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device (electrode headset) and not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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July 10, 2019

Rhythmlink International, LLC Gabriel Orsinger Manager, Product Development 1140 First Street South Columbia, South Carolina 29209

Re: K190801

Trade/Device Name: PressOn Electrode Headset Regulation Number: 21 CFR 882.1350 Regulation Name: Needle Electrode Regulatory Class: Class II Product Code: GXZ Dated: June 7, 2019 Received: June 10, 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

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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 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

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) K190801

Device Name PressOn™ Electrode Headset

Indications for Use (Describe)

Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

PressOn™ Electrode Headset Rhythmlink International, LLC

Type of Use (Select one or both, as applicable)

PSC Publishing Services (301) 443-6740

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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	July 9, 2019
807.92(a)(2)DeviceIdentification	Device Trade Name:Common/Classification Name:Product Code:Classification:Classification Panel:	PressOn™ Electrode HeadsetNeedle ElectrodeGXZ21 CFR 882.1350 Class IINeurology
807.92(a)(3)PredicateDevice	K130220 - MR Conditional PressOn Electrode
807.92(a)(4)DeviceDescription	The PressOn™ Electrode Headset is intended to be used in medical environmentswhere quick EEG electrode application is required. The device provides aworkflow solution where the availability of technologists or other specialty-trainedEEG staff is limited for applying EEG electrodes.The headset comprises between 2 to 48 PressOn™ Electrodes, each loaded intoindividual button applicators, which are positioned in predetermined locations andinterconnected by elastic netting, altogether forming the headset. Thepredetermined electrode positions are arranged by generally referencing the 10-20Positioning System, but with flexibility to account for various head shapes andsizes and to avoid interference with intracranial pressure monitoring, ventriculardrainage, and other separate devices. Like the predicate, the subject device isminimally invasive and does not directly contact neural tissues.
	The PressOn™ Electrode Headset is placed on the patient's head and is orientedand secured using a nasion marker and chinstrap. The distal end of the devicecontains the array of PressOn™ electrodes in predetermined locations that areplaced on the scalp by minimal insertion of the micro needles into the epidermislayer of the skin for use during monitoring procedures. The PressOn™ electrodesin the subject device are inserted in an identical fashion as the predicate device(K130220). Minor material and dimensional changes have been made to theoriginal applicator to allow for multiple applicators to be connected to form theheadset.
	At the proximal end of the subject device is a multipin connector where theelectrode leadwires terminate. The multipin connector interfaces with color-codedextension cables (identical to those used in another previously cleared Rhythmlink

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device, reference device K172503) that terminate into single pin connectors, which are then connected to monitoring equipment.

The PressOn™ Electrode Headset is intended for use in the recording of 807.92(a)(5) electroencephalogram (EEG), evoked potential (EP), or as a ground and reference Intended Use in an EEG or EP recording. The device is provided sterile for single patient use only.

807.92(a)(6) Technological Characteristics

The technological characteristics of the PressOn™ Electrode Headset are identical to the predicate device (K130220), 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). All test methods were identical to those used to assess the predicate device.

Characteristic	Subject Device:PressOn™ Electrode Headset	Predicate Device:MR PressOn™ Electrodes
	PressOn™ Electrode Headset	MR PressOn™ Electrodes
510(k) Number	K190801	K130220
Manufacturer	Rhythmlink International, LLC	Rhythmlink International, LLC
Device Class	Class II	Class II
Product Code	GXZ	GXZ
Regulatory Name	Subdermal Needle	Subdermal Needle
Device Type	PressOn™ Electrodes	PressOn™ Electrodes
Regulation #	21 CFR 882.1350	21 CFR 882.1350
Intended Use	The PressOn Electrode Headset isintended for use in the recordingof Electroencephalogram (EEG),evoked potential (EP), or as aground and reference in an EEGor EP recording. This device isprovided sterile for Single PatientUse Only.	The MR PressOn Electrode isintended for use in the recordingof the Electroencephalogram(EEG), the evoked potential (EP),or as a ground and reference in anEEG or EP recording. This deviceis provided sterile for SinglePatient Use Only.
Single PatientUse	YES - disposable	YES - disposable
SterilizationMethod	Supplied EtO Sterile	Supplied EtO Sterile
AnatomicalSite(s)	Head and Muscular sites	Head and Muscular sites
Environmentusage	Hospital	Hospital
TargetedProcedures	EEG, EP	EEG, EP
ElectrodeMaterial	Nitinol	Nitinol
Size of Electrode	≈ 7 mm	≈ 7 mm
Number ofElectrodes perDevice	2 to 48	1
ElectrodeApplicatorDimensions	1.5cm x 2.1cm x 2.1cm	4.5cm x 3.0cm x 1.6cm
ElectrodeApplicatorMaterials	ABS, Polycarbonate, Silicone,Stainless Steel	ABS, Polycarbonate

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Use of Headset	Yes	No
ElectrodeApplication	Apply positioning headset, thenthen insert electrodes into thedermis layer with applicators	Insert electrodes into the dermislayer with an applicator
Leadwire	Multi-conductor ribbon cable,PVC-jacketed copper	Single conductor cable, PVC-jacketed copper
Electrode CableLength	Multiple cables 50 to 500 mm	240mm
Extension CableLength	Multiple cables 1.0 to 3.0 m,sheathed	Single cable 1.0 to 3.0 m
Connector	1.5mm touchproof DIN 42-802and multipin touchproofconnectors	1.5mm touchproof DIN 42-802connector
Compatibilitywith OtherDevices	Interfaces with a 1.5mm DIN 42-802 touchproof connector	Interfaces with a 1.5mm DIN 42-802 touchproof connector
MR Safety	MR Unsafe	MR Conditional
Electrical Safety	Connectors comply with IEC60601-1 (1988) sub clause56.3(c) per CFR 898.12 (Both theElectrode Cable and theExtension Cable)	Connectors comply with IEC60601-1 (1988) sub clause 56.3(c)per CFR 898.12 (Both theElectrode Cable and the ExtensionCable)
Duration of Use	Electrode: For the length of theprocedure, but not more than 30days. Positioning Headset: usedto apply electrodes and thenremoved.	Electrode: For the length of theprocedure, but not more than 30days
Biocompatible	Yes	Yes

807.92(b)(1) Summary of Non-Clinical Tests

The PressOn™ Electrode Headset is substantially equivalent in technology, safety, and effectiveness as the predicate device (K130220), as demonstrated by the test results.

Functional performance equivalency was determined by dimensional characterization, mechanical, and electrical benchtop testing, as follows:

Electrical Continuity testing of the completed assembly
. Deployment force to eject electrode from applicator and apply to synthetic skin
Pull force required to remove the electrode from synthetic skin
Visual assessment of electrode insertion uniformity into synthetic skin ●
Dimensional assessment of electrode placement on head phantom .

All benchtop performance testing passed predetermined acceptance criteria, demonstrating the PressOn™ Electrode Headset is equivalent to the predicate device in functionality, safety, and effectiveness.

No Clinical Tests were conducted as referenced in 21 CFR 807.92(b)(2). 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

§ 882.1350 Needle electrode.

(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).