(105 days)
No
The document describes a passive electrode device for recording electrical signals and its MR compatibility, with no mention of data processing or analysis capabilities that would involve AI/ML.
No.
The device is described as being used for recording physiological signals (EEG, EP), not for treating a condition.
Yes
Explanation: The device is used for "recording of the Electroencephalogram (EEG), the evoked potential (EP)," which are diagnostic tests to assess neurological function.
No
The device description explicitly details physical hardware components (electrodes, leadwires, connectors, cables) and the performance studies focus on mechanical, electrical, and MR safety testing of these physical components. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for recording physiological signals (EEG and EP) from the body. This is a direct measurement of electrical activity within the patient, not an analysis of samples taken from the body (like blood, urine, or tissue).
- Device Description: The device is a set of electrodes designed to be placed on the skin. This is consistent with a device used for physiological monitoring, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of reagents, assays, sample preparation, or any other components or processes typically associated with in vitro diagnostics.
IVD devices are specifically designed to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device directly interacts with the patient's body to record electrical signals.
N/A
Intended Use / Indications for Use
The MR Conditional Cup and Webb Electrodes are intended for use in the recording of the Electroencephalogram (EEG), the evoked potential (EP), or as a ground and reference in an EEG or EP recording. This device is non-sterile for Single Patient Use Only and may remain on the patient in a MRI environment under specific conditions.
Product codes
GXY
Device Description
The fundamental scientific technology of Rhythmlink's MR Conditional Cup and Webb Electrodes is identical to the predicate device. The device consists of ABS molded disk-shaped Cup or Webb style cutaneous electrodes coated with Ag/AgCl. The electrodes are affixed to 18cm long conductive leadwires. Up to 10 leadwires are connected to a multipin touch proof connector to form an electrode array assembly, which is labeled "MR Conditional." Up to 4 electrode arrays can be used simultaneously on a patient. The device design and leadwire length have been engineered for both 1.5T (64MHz) and 3.0T (128 MHz) MRI environments. An extension cable, 1.0 to 3.0m long, is included to attach the electrode array to monitoring equipment. The extension cable is clearly labeled with "MR Unsafe" symbols on both ends, and is NOT intended to be in the MR environment. This enables users to quickly disconnect the MR Unsafe extension cable and leave the MR Conditional electrodes in place on the patient for MRI procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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Summary of Performance Studies
The MR Conditional Cup and Webb Electrodes exhibit the same fundamental scientific technology, safety, and effectiveness as the predicate device (K130287), as demonstrated by the test results. The functional performance equivalency was determined by mechanical and electrical benchtop testing, as follows: Tensile testing Continuity testing Signal quality testing The MR safety and performance equivalency of the MR Conditional Cup and Webb Electrodes were determined using the same test methodology as the predicate device, summarized below: Worst-case device configuration was established through multiple SAR computational simulations The established worst-case configuration of the finished device was tested to the applicable ASTM standards: RF-Induced Heating MR Image Artifact Magnetically Induced Torque Magnetically Induced Displacement Force The results of these MR safety and functional tests verified the computational analysis, and determined the MR conditionality and device labeling information for both 1.5 T and 3.0 T MR environments. All MR testing was performed by an accredited MR testing laboratory on behalf of Rhythmlink International, LLC. In summary, the non-clinical testing concluded that the MR Conditional Cup and Webb Electrodes demonstrated equivalent functionality, safety, and effectiveness as the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 1, 2017
Rhythmlink International, LLC Daniel McCoy Vice President of Engineering and R&D 1140 First Street South Columbia, South Carolina 29209
Re: K172503
Trade/Device Name: MR Conditional Cup Electrode, MR Conditional Webb Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: September 7, 2017 Received: September 11, 2017
Dear Mr. McCoy:
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Vivek J. Pinto -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172503
Device Name
MR Conditional Cup Electrode, MR Conditional Webb Electrode
Indications for Use (Describe)
The MR Conditional Cup and Webb Electrodes are intended for use in the recording of the Electroencephalogram (EEG), the evoked potential (EP), or as a ground and reference in an EEG or EP recording. This device is non-sterile for Single Patient 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 | Daniel McCoy
Vice President Engineering and R&D
Email: dmccoy@rhythmlink.com
Phone: 803-365-9660 | | |
| Summary Date | December 1, 2017 | | |
| 807.92(a)(2)
Device
Identification | Device Trade Name:
Common/Classification Name: Cutaneous Electrode
Product Code:
Classification:
Classification Panel: | MR Conditional Cup and Webb Electrode
GXY
21 CFR 882.1320 Class II
Neurology | |
| 807.92(a)(3)
Predicate Device | K130287 - MR Conditional Cup and Webb Electrode | | |
| 807.92(a)(4)
Device Description | The fundamental scientific technology of Rhythmlink's MR Conditional Cup
and Webb Electrodes is identical to the predicate device.
The device consists of ABS molded disk-shaped Cup or Webb style
cutaneous electrodes coated with Ag/AgCl. The electrodes are affixed to
18cm long conductive leadwires. Up to 10 leadwires are connected to a
multipin touch proof connector to form an electrode array assembly, which is
labeled "MR Conditional." Up to 4 electrode arrays can be used
simultaneously on a patient. The device design and leadwire length have
been engineered for both 1.5T (64MHz) and 3.0T (128 MHz) MRI
environments.
An extension cable, 1.0 to 3.0m long, is included to attach the electrode array
to monitoring equipment. The extension cable is clearly labeled with "MR
Unsafe" symbols on both ends, and is NOT intended to be in the MR
environment. This enables users to quickly disconnect the MR Unsafe
extension cable and leave the MR Conditional electrodes in place on the
patient for MRI procedures. | | |
| 807.92(a)(5)
Intended Use | The MR Conditional Cup and Webb Electrodes are intended for use in the
recording of the Electroencephalogram (EEG), the evoked potential (EP), or
as a ground and reference in an EEG or EP recording. This device is non-
sterile for Single Patient Use Only and may remain on the patient in a MRI
environment under specific conditions. | | |
| 807.92(a)(6)
Technological
Characteristics | The technological characteristics of the MR Conditional Cup and Webb
Electrodes are identical to the predicate device (K130287), with a few
dimensional and material modifications that have been assessed to be
equivalent to the predicate and therefore do not affect the fundamental
scientific technology, safety, or effectiveness of the device (reference
Substantial Equivalence of Technological Characteristics table, below). The
test methods were identical to those used to assess the predicate device. | | |
| 807.92(b)(1)
Summary of Non-
Clinical Tests | The MR Conditional Cup and Webb Electrodes exhibit the same fundamental
scientific technology, safety, and effectiveness as the predicate device
(K130287), as demonstrated by the test results.
The functional performance equivalency was determined by mechanical and
electrical benchtop testing, as follows:
Tensile testing Continuity testing Signal quality testing
The MR safety and performance equivalency of the MR Conditional Cup and
Webb Electrodes were determined using the same test methodology as the
predicate device, summarized below:
Worst-case device configuration was established through multiple
SAR computational simulations The established worst-case configuration of the finished device was
tested to the applicable ASTM standards:
RF-Induced Heating MR Image Artifact Magnetically Induced Torque Magnetically Induced Displacement Force
The results of these MR safety and functional tests verified the computational
analysis, and determined the MR conditionality and device labeling
information for both 1.5 T and 3.0 T MR environments. All MR testing was
performed by an accredited MR testing laboratory on behalf of Rhythmlink
International, LLC.
In summary, the non-clinical testing concluded that the MR Conditional Cup
and Webb Electrodes demonstrated equivalent functionality, safety, and
effectiveness as the predicate device. | | |
| 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). | | |
| Characteristic | Modified Device | Predicate Device | Equivalency |
| Indications
for Use | The MR Conditional Cup and
Webb Electrodes are intended
for use in the recording of the
Electroencephalogram (EEG),
the evoked potential (EP), or as
a ground and reference in an
EEG or EP recording. This
device is non-sterile for Single
Patient Use Only and may
remain on the patient in a MRI
environment under specific
conditions. | The MR Conditional Cup and
Webb Electrodes are intended
for use in the recording of the
Electroencephalogram (EEG),
the evoked potential (EP), or
as a ground and reference in an
EEG or EP recording. This
device is non-sterile for Single
Patient Use Only and may
remain on the patient in a MRI
environment under specific
conditions. | Identical |
| MR
Conditions | Non-clinical testing has demonstrated
that the MR Conditional Cup and Webb
Electrode array is MR Conditional in
configurations of 2 to 40 electrodes,
using 1 to 4 arrays. These electrodes
can safely remain on a patient during an
MR scan meeting the following
conditions:
• Static magnetic field of 1.5 and 3.0
Tesla
• Maximum spatial field gradient of
4,000 gauss/cm [40 T/m]
• Maximum MR system reported
whole-body averaged specific
absorption rate (SAR) of 2 W/kg and
whole-head averaged SAR of 3.2 W/kg
• Quadrature driven transmit body coil
only
• Maximum active scan time of 15
minutes | Non-clinical testing has demonstrated
that the MR Conditional Cup and
Webb Electrode is MR Conditional in
configurations of 2 to 48 electrodes.
These electrodes can safely remain on
a patient during an MR scan under the
following conditions:
• Static magnetic field of 1.5 or 3.0
Tesla.
• Maximum spatial gradient field of
4,000 gauss/cm (40T/m) or less
• Maximum whole-body averaged
specific absorption rate of 2 W/kg in
the Normal Operating Mode
• Remove extension cables before
entering an MR environment. They
are MR Unsafe. | Equivalent |
| Electrode
Material | ABS 20% glass filled,
Ag/AgCl coated | ABS 20% glass filled,
Ag/AgCl coated | Identical |
| Electrode
Diameter | ~10mm | ~10mm | Identical |
| Wire | Conductive cable, PVC coated | Conductive cable, PVC coated | Equivalent |
| Electrode
Cable Length | 18cm | 10cm | Equivalent |
| Connector | Touch proof multipin
connector(s) | Touch proof single pin
connector(s) | Equivalent |
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5
Substantial Equivalence of Technological Characteristics Table