Who is the manufacturer of MR Conditional Sticky Pad Electrode?

Rhythmlink International, LLC filed the 510(k) submission for MR Conditional Sticky Pad Electrode (K203079).

What is the FDA product code for MR Conditional Sticky Pad Electrode?

GXY. It is classified under 21 CFR 882.1320 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for MR Conditional Sticky Pad Electrode?

510(k) clearance (submission type: Traditional).

What are the predicate devices for MR Conditional Sticky Pad Electrode?

Rhythmlink Cutaneous Electrode (K052188).

Who can help prepare an FDA 510(k) submission like MR Conditional Sticky Pad Electrode?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MR Conditional Sticky Pad Electrode

K203079 · Rhythmlink International, LLC · GXY · Feb 9, 2021 · Neurology

Device Facts

Record ID	K203079
Device Name	MR Conditional Sticky Pad Electrode
Applicant	Rhythmlink International, LLC
Product Code	GXY · Neurology
Decision Date	Feb 9, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1320
Device Class	Class 2

Intended Use

The Rhythmlink MR Conditional Sticky Pad Electrode is intended for use with recording, monitoring, and stimulation equipment in the study of biopotentials such as Electroencephalograph (EEG), Surface Electromyography (EMG), or Nerve Conduction Evoked Potential Signals (EP). This device is non-sterile, single-use only, and may remain on the patient in a MRI environment under specific conditions.

Device Story

Device consists of hydrogel-based cutaneous electrodes with carbon fiber leadwires; pairs with MR-unsafe extension cables via quick-disconnect feature. Used in hospital settings for EEG, EMG, and EP signal acquisition/stimulation. Electrodes remain on patient during 1.5T or 3.0T MRI scans; extension cables are disconnected prior to imaging. Enables continuous monitoring without electrode removal. Benefits include reduced skin preparation time and workflow efficiency in MR environments. Healthcare providers apply electrodes to head or muscular sites; output is processed by standard monitoring/stimulation equipment to inform clinical diagnosis of neurological or muscular conditions.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing and MR safety evaluation (RF heating, displacement force, torque, image artifact assessment) in 1.5T and 3.0T systems.

Technological Characteristics

Materials: non-woven fabric, conductive vinyl, hydrogel. Leadwire: PVC-jacketed carbon fiber (electrode) and copper (extension). Connectors: DIN 42802, 1.5mm touchproof. MR Conditional at 1.5T/3.0T. Single-use, non-sterile. Dimensions: 15x20mm to 35x45mm.

Indications for Use

Indicated for patients requiring biopotential recording, monitoring, or stimulation (EEG, EMG, EP). Non-sterile, single-use, for use in hospital environments including MRI (1.5T or 3.0T).

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

Rhythmlink Cutaneous Electrode (K052188)

Reference Devices

Rhythmlink MR Conditional Cup & Webb Electrodes (K130287)

Related Devices

K172503 — MR Conditional Cup Electrode, MR Conditional Webb Electrode · Rhythmlink International, LLC · Dec 1, 2017
K122376 — PMT TRUSCAN SURFACE ELECTRODE · Pmt Corp. · Dec 19, 2012
K171102 — Ives MR Conditional Cup Electrode · Ives Egg Solutions · Dec 21, 2017
K130220 — MR CONDITIONAL PRESSON ELECTRODE · Rhythmlink International, LLC · Jul 22, 2013
K130287 — MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE · Rhythmlink International, LLC · May 30, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 9, 2021 Rhythmlink International, LLC Gabriel Orsinger Vice President of Engineering and R&D 1140 First Street South Columbia, South Carolina 29209 Re: K203079 Trade/Device Name: MR Conditional Sticky Pad Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: October 12, 2020 Received: October 13, 2020 Dear Gabriel Orsinger: We have reviewed vour 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/cdrb/offomn.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 {1}------------------------------------------------ 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-devices/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). Sincerelv. # Heather L. Dean -S Heather Dean, PhD Assistant Director, Acute Injurv 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K203079 Device Name MR Conditional Sticky Pad Electrode Indications for Use (Describe) The Rhythmlink MR Conditional Sticky Pad Electrode is intended for use with recording, monitoring, and stimulation equipment in the study of biopotentials such as Electroencephalograph (EEG), Surface Electromyography (EMG), or Nerve Conduction Evoked Potential Signals (EP). This device is non-sterile, single-use only, and may remain on the patient in a MRI environment under specific conditions. 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) | #### 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." {3}------------------------------------------------ ### 510(k) Summary | 807.92(a)(1) Submitter Information | Rhythmlink International, LLC 1140 First Street South Columbia, SC 29209 Phone: 803-252-1222 FDA Registration #: 1067162 | | |-------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------| | Official Correspondent | Gabriel Orsinger, PhD Vice President of Engineering and R&D Email: gorsinger@rhythmlink.com Phone: 803-365-9664 | | | Summary Date | February 02, 2021 | | | 807.92(a)(2) Device Identification | Device Trade Name: Device 510(k) Number: Common/Classification Name: Product Code: Classification: Classification Panel: | MR Conditional Sticky Pad Electrode K203079 Cutaneous Electrode GXY 21 CFR 882.1320 Class II Neurology | | 807.92(a)(3) Predicate Device | K052188 - Rhythmlink Cutaneous Electrode | | | 807.92(a)(4) Device Description | The MR Conditional Sticky Pad Electrode is intended to be used in medical environments where quick electrode application is required with minimal skin preparation. The device provides an easy-to-apply solution by combining conductive material used to record biosignals with a hydrogel designed for patient skin adhesion. This combination of materials, with an electrically conductive leadwire designed to fit with patient monitoring and stimulation equipment, provides a fast and easy way to record brain and muscle activity, provide stimulation for evoked potentials, and serve as a ground or reference electrode during monitoring. The MR Conditional Sticky Pad Electrodes have been specifically engineered to remain safely on a patient during MR imaging under the conditions specified in the labeling. Each MR Conditional Sticky Pad Electrode comprises the hydrogel electrode attached to a 240mm long leadwire (MR Conditional Electrode Assembly), which pairs with and connects to a 1.0m to 2.5m long, MR Unsafe Extension Cable. The extension cable provides a quick disconnect function to allow patient to be quickly moved into MR imaging without removing the hydrogel electrodes from the patient. Between 2 and 48 total MR Conditional Electrode Assemblies may remain on the patient during MR imaging in either 1.5T or 3.0T systems. The MR Conditional Electrode Assemblies are marked with yellow "MR Conditional" symbols, and the MR Unsafe Extension Cables are marked in duplicate (one at each end) with red "MR Unsafe" symbols to ensure proper use). | | | 807.92(a)(5) Indications for Use 807.92(a)(6) Technological | The Rhythmlink MR Conditional Sticky Pad Electrode is intended for use with recording, monitoring, and stimulation equipment in the study of biopotentials such as Electroencephalograph (EEG), Surface Electromyography (EMG), or Nerve Conduction Evoked Potential Signals (EP). This device is non-sterile, single-use only, and may remain on the patient in a MRI environment under specific conditions. The technological characteristics of the MR Conditional Sticky Pad Electrode are identical to the predicate device (K052188), with a few dimensional and material | | {4}------------------------------------------------ modifications include the use of carbon fiber leadwire rather than copper leadwire to connect to the pad electrode, and the addition of an in-line disconnect feature to remove the electrode leadwire from the extension leadwire when in an MR environment. These modifications 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).The test methods were identical to those used to assess the predicate device. | Characteristic | Subject Device MR Conditional Sticky Pad Electrode | Predicate Device: Cutaneous Pad Electrode | |-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K203079 | K052188 | | Manufacturer | Rhythmlink International, LLC | Rhythmlink International, LLC | | Device Class | Class II | Class II | | Product Code | GXY | GXY | | Classification Name | Cutaneous Electrode | Cutaneous Electrode | | Device Type | Cutaneous Electrode | Cutaneous Electrode | | Regulation # | 21 CFR 882.1320 | 21 CFR 882.1320 | | Indications For Use | The Rhythmlink MR Conditional Sticky Pad Electrode is intended for use with recording, monitoring, and stimulation equipment in the study of biopotentials such as Electroencephalograph (EEG), Surface Electromyography (EMG), or Nerve Conduction Evoked Potential Signals (EP). This device is non-sterile, single- use only, and may remain on the patient in a MRI environment under specific conditions. | Intended for use with recording, monitoring and stimulation equipment for the purpose of stimulating/ recording of biopotential signals. Electrodes are applied in the study of biopotentials such as Electroencephalograph (EEG), surface Electromyography (EMG), nerve conduction Evoked potential signals (EP). Electrodes are non-invasive as they are applied to the patient's skin using a self- adhesive solid-gel surface. The electrodes are non-sterile and for single patient use only. | | Single Patient Use | YES - disposable | YES - disposable | | Sterilization Method | Non-sterile | Non-sterile | | Shelf Life | 2 years | 2 years | | Anatomical Site(s) | Head and Muscular sites | Head and Muscular sites | | Environment usage* | Hospital; MR Conditional at 1.5T or 3.0T | Hospital; Non-MR | | Targeted Procedures | EEG, EMG, EP | EEG, EMG, EP | | Electrode Material | Non-woven fabric, conductive vinyl, hydrogel | Non-woven fabric, conductive vinyl, hydrogel | | Electrode Sizes | Small (15 x 20 mm) Large (20 x 25mm) Ground (35 x 45mm) | Small (15 x 20 mm) Large (20 x 25mm) Ground (35 x 45mm) | | Leadwire Material* | PVC-jacketed carbon fiber (MR Conditional Electrode) & Copper (Extension Cable) | PVC-jacketed Copper | | Leadwire Length* | 240mm (MR Conditional Electrode) + 1.0m to 2.5m Extension Cable | 1.0m to 2.5m | | Connectors | DIN 42802, 1.5mm Touchproof | DIN 42802, 1.5mm Touchproof | | Electrode Application | Applied directly to skin surface | Applied directly to skin surface | | Single Patient Use | Yes, disposable | Yes, disposable | | Duration of Use | ≤ 24 hours | ≤ 24 hours | | Biocompatible | Yes | Yes | {5}------------------------------------------------ * Any changes from predicate device were evaluated to be substantially equivalent through non-clinical functional performance and MR Safety testing described below. The MR Conditional Sticky Pad Electrode is substantially equivalent in technology, safety, and effectiveness as the predicate device (K052188), as demonstrated by the test results. Functional performance equivalency was determined by benchtop testing, as follows: - DC Offset Voltage - . AC Impedance 807.92(b)(1) Summary of Non-Clinical Tests Additionally, MR Safety evaluation was performed identically to reference device, Rhythmlink MR Conditional Cup & Webb Electrodes (K130287), as follows: - Numerical Evaluation of SAR Distribution (i.e., worst-case determination) - . Radiofrequency (RF) Induced Heating in 1.5T & 3T systems - . Measurement of Magnetically Induced Displacement Force - Measurement of Magnetically Induced Torque - Evaluation of MR Image Artifact ● All benchtop performance testing passed predetermined acceptance criteria, demonstrating the MR Conditional Sticky Pad Electrode is substantially equivalent to the predicate device in functionality, safety, and effectiveness. | 807.92(b)(2) Clinical Tests | No Clinical Tests were conducted as referenced in 21 CFR 807.92(b)(2). | |-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 807.92(b)(3) Clinical Summary | No Clinical Tests were conducted as referenced in 21 CFR 807.92(b)(3). | | 807.92(b)(4) Conclusion | In conclusion, the MR Conditional Sticky Pad Electrode is substantially equivalent to the predicate device. The only changes made to the subject device include (1) a carbon fiber leadwire attached to the electrode, and (2) the addition of an extension leadwire, enabling MR Conditionality. None of these changes raise new questions of safety or effectiveness. and the Submitter has provided applicable performance information to demonstrate that the changes do not adversely impact safety or effectiveness. The Submitter therefore concludes that its MR Conditional Sticky Pad Electrode is substantially equivalent to the Cutaneous Electrode device. |