(119 days)
No
The device description and performance studies focus on the physical properties and electrical performance of the electrode, with no mention of data processing or analysis using AI/ML.
No.
The device is intended for recording, monitoring, and stimulation of biopotentials for diagnostic purposes (e.g., EEG, EMG, EP signals), not for providing therapy.
Yes
This device is an electrode intended for recording biopotentials (EEG, EMG, EP), which are used in diagnostic studies of brain and muscle activity. While the device itself is a component, its intended use is directly linked to diagnostic procedures.
No
The device is described as a physical electrode with hydrogel, leadwires, and extension cables, clearly indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is 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 involves measuring electrical signals from the patient's body, not analyzing samples outside the body.
- Device Description: The description focuses on the physical components used for skin adhesion and electrical connection to the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples in vitro (in a lab setting).
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used for direct physiological measurement on the patient.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GXY
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
Head and Muscular sites
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Functional performance equivalency was determined by benchtop testing, as follows:
- DC Offset Voltage
- AC Impedance
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.
No Clinical Tests were conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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) |
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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. |