(119 days)
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 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).
This document describes the regulatory approval for a medical device (MR Conditional Sticky Pad Electrode), not an AI/ML-based device. Therefore, many of the requested criteria, such as those related to AI model training, ground truth establishment, expert review, and MRMC studies, are not applicable.
However, I can extract and present the information available regarding the device's acceptance criteria and the study that proves it meets them, focusing on the non-clinical performance data provided.
Understanding the Device:
The Rhythmlink MR Conditional Sticky Pad Electrode is a cutaneous electrode designed for use with recording, monitoring, and stimulation equipment for biopotentials (EEG, EMG, EP). Its key feature is its ability to remain on a patient in an MRI environment under specific conditions, a modification from its predicate device. This MRI compatibility is a primary focus of its testing and acceptance criteria.
Acceptance Criteria and Device Performance (Non-Clinical):
The acceptance criteria for this device are based on demonstrating substantial equivalence to a predicate device (K052188 - Rhythmlink Cutaneous Electrode) and ensuring MRI compatibility and functional performance. The "study" proving this involves a series of non-clinical, benchtop tests.
Acceptance Criteria Table and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Functional Performance | Equivalent DC Offset Voltage to predicate | All benchtop performance testing passed predetermined acceptance criteria. |
| Equivalent AC Impedance to predicate | All benchtop performance testing passed predetermined acceptance criteria. | |
| MR Safety Evaluation | Acceptable SAR Distribution (worst-case determination) | All benchtop performance testing passed predetermined acceptance criteria. |
| Acceptable RF Induced Heating in 1.5T & 3T systems | All benchtop performance testing passed predetermined acceptance criteria. | |
| Acceptable Magnetically Induced Displacement Force | All benchtop performance testing passed predetermined acceptance criteria. | |
| Acceptable Magnetically Induced Torque | All benchtop performance testing passed predetermined acceptance criteria. | |
| Acceptable MR Image Artifact levels | All benchtop performance testing passed predetermined acceptance criteria. | |
| Material/Design Equivalence | Carbon fiber leadwire performance vs. copper leadwire | Assessed to be substantially equivalent;Do not affect safety or effectiveness. |
| In-line disconnect feature performance | Assessed to be substantially equivalent;Do not affect safety or effectiveness. | |
| General | No new questions of safety or effectiveness raised by modifications | Concluded that the device is substantially equivalent to the predicate. |
Detailed Study Information (Non-Clinical, as applicable):
-
Sample sizes used for the test set and the data provenance:
- The document does not specify the exact number of electrodes or test runs used in the benchtop testing. It refers to "benchtop testing" and "MR Safety evaluation."
- Data Provenance: The tests were conducted internally by the manufacturer, Rhythmlink International, LLC. The testing appears to be prospective in nature, as it was performed to support the 510(k) submission for this new device. No geographical origin of data (e.g., country) is specified beyond the manufacturer's location in Columbia, South Carolina, USA.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a hardware device undergoing physical, electrical, and MRI compatibility testing, not an AI/ML system requiring expert interpretation of medical images or data. Ground truth here refers to validated engineering measurements and compliance with established standards for medical device safety and performance.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. As this is non-clinical benchtop testing, there is no "adjudication method" in the sense of reconciling different expert opinions. Test results are presumably directly measured and compared against pre-defined engineering and regulatory limits.
-
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:
- Not Applicable. This is not an AI/ML-based device, and no MRMC study was conducted. The assessment focused on the device's intrinsic function and safety, particularly in an MRI environment.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical device, not a standalone algorithm. Its "performance" is its physical and electrical characteristics.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is based on established engineering standards, physical measurements, and regulatory requirements for cutaneous electrodes and MRI compatibility (e.g., ASTM standards for MRI safety of medical devices). This includes:
- Electrical performance parameters (DC Offset Voltage, AC Impedance)
- Magnetic field interactions (displacement force, torque)
- Radiofrequency heating (SAR distribution, temperature rise)
- Image artifact evaluation in MRI
- Biocompatibility
- The "ground truth" for this device's performance is based on established engineering standards, physical measurements, and regulatory requirements for cutaneous electrodes and MRI compatibility (e.g., ASTM standards for MRI safety of medical devices). This includes:
-
The sample size for the training set:
- Not Applicable. No AI/ML training set was used.
-
How the ground truth for the training set was established:
- Not Applicable. No AI/ML training set was used.
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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
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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-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
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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) |
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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, PhDVice President of Engineering and R&DEmail: gorsinger@rhythmlink.comPhone: 803-365-9664 | |
| Summary Date | February 02, 2021 | |
| 807.92(a)(2)DeviceIdentification | Device Trade Name:Device 510(k) Number:Common/Classification Name:Product Code:Classification:Classification Panel: | MR Conditional Sticky Pad ElectrodeK203079Cutaneous ElectrodeGXY21 CFR 882.1320 Class IINeurology |
| 807.92(a)(3)PredicateDevice | K052188 - Rhythmlink Cutaneous Electrode | |
| 807.92(a)(4)DeviceDescription | The MR Conditional Sticky Pad Electrode is intended to be used in medical environmentswhere quick electrode application is required with minimal skin preparation. The deviceprovides an easy-to-apply solution by combining conductive material used to recordbiosignals with a hydrogel designed for patient skin adhesion. This combination ofmaterials, with an electrically conductive leadwire designed to fit with patient monitoringand stimulation equipment, provides a fast and easy way to record brain and muscleactivity, provide stimulation for evoked potentials, and serve as a ground or referenceelectrode during monitoring. The MR Conditional Sticky Pad Electrodes have beenspecifically engineered to remain safely on a patient during MR imaging under theconditions specified in the labeling.Each MR Conditional Sticky Pad Electrode comprises the hydrogel electrode attached toa 240mm long leadwire (MR Conditional Electrode Assembly), which pairs with andconnects to a 1.0m to 2.5m long, MR Unsafe Extension Cable. The extension cableprovides a quick disconnect function to allow patient to be quickly moved into MRimaging without removing the hydrogel electrodes from the patient. Between 2 and 48total MR Conditional Electrode Assemblies may remain on the patient during MRimaging 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 forUse807.92(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 asElectroencephalograph (EEG), Surface Electromyography (EMG), or Nerve ConductionEvoked Potential Signals (EP). This device is non-sterile, single-use only, and mayremain on the patient in a MRI environment under specific conditions.The technological characteristics of the MR Conditional Sticky Pad Electrode areidentical to the predicate device (K052188), with a few dimensional and material |
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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 DeviceMR Conditional Sticky PadElectrode | 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 ConditionalSticky Pad Electrode is intendedfor use with recording,monitoring, and stimulationequipment in the study ofbiopotentials such asElectroencephalograph (EEG),Surface Electromyography(EMG), or Nerve ConductionEvoked Potential Signals (EP).This device is non-sterile, single-use only, and may remain on thepatient in a MRI environmentunder specific conditions. | Intended for use withrecording, monitoring andstimulation equipment for thepurpose of stimulating/recording of biopotentialsignals. Electrodes areapplied in the study ofbiopotentials such asElectroencephalograph(EEG), surfaceElectromyography (EMG),nerve conduction Evokedpotential signals (EP).Electrodes are non-invasiveas they are applied to thepatient's skin using a self-adhesive solid-gel surface.The electrodes are non-sterileand for single patient useonly. |
| 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 Conditionalat 1.5T or 3.0T | Hospital; Non-MR |
| Targeted Procedures | EEG, EMG, EP | EEG, EMG, EP |
| Electrode Material | Non-woven fabric, conductivevinyl, 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 (MRConditional Electrode) & Copper(Extension Cable) | PVC-jacketed Copper |
| Leadwire Length* | 240mm (MR ConditionalElectrode) + 1.0m to 2.5mExtension Cable | 1.0m to 2.5m |
| Connectors | DIN 42802, 1.5mm Touchproof | DIN 42802, 1.5mmTouchproof |
| Electrode Application | Applied directly to skin surface | Applied directly to skinsurface |
| Single Patient Use | Yes, disposable | Yes, disposable |
| Duration of Use | ≤ 24 hours | ≤ 24 hours |
| Biocompatible | Yes | Yes |
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- 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)ClinicalSummary | 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 thepredicate device. The only changes made to the subject device include (1) a carbon fiberleadwire attached to the electrode, and (2) the addition of an extension leadwire, enablingMR Conditionality. None of these changes raise new questions of safety or effectiveness.and the Submitter has provided applicable performance information to demonstrate thatthe changes do not adversely impact safety or effectiveness. The Submitter thereforeconcludes that its MR Conditional Sticky Pad Electrode is substantially equivalent to theCutaneous Electrode device. |
§ 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).