(105 days)
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 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.
The provided text is a 510(k) Pre-Market Notification for a medical device (MR Conditional Cup Electrode, MR Conditional Webb Electrode). It describes the device, its intended use, and comparative testing performed to demonstrate substantial equivalence to a predicate device.
Crucially, this document does NOT describe the acceptance criteria and study that proves a device meets acceptance criteria for an AI/ML-based medical device. Instead, it is focused on demonstrating the physical and functional safety and performance of a conventional medical electrode in an MRI environment compared to a previously approved device.
Therefore, I cannot extract the information required for a study proving an AI/ML device meets acceptance criteria from this document. The concepts of "test set," "ground truth," "expert consensus," "human readers," "AI assistance," "effect size," and "standalone performance" are not applicable to the type of device and testing described in this 510(k) summary.
The document states:
- "No Clinical Tests were conducted as referenced in 21 CFR 807.92(b)(2)."
- "The functional performance equivalency was determined by mechanical and electrical benchtop 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..."
The acceptance criteria here pertain to physical safety and functional performance (e.g., thermal limits in MRI, signal quality) as demonstrated by benchtop and computational testing, not diagnostic performance based on algorithms or human interpretation of data.
If you have a document describing the study for an AI/ML device, please provide that, and I will be happy to assist.
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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
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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
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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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510(k) Summary
| 807.92(a)(1)SubmitterInformation | Rhythmlink International, LLC.1140 First Street SouthColumbia, SC 29209Phone: 803-252-1222FDA Registration #: 1067162 | ||
|---|---|---|---|
| OfficialCorrespondent | Daniel McCoyVice President Engineering and R&DEmail: dmccoy@rhythmlink.comPhone: 803-365-9660 | ||
| Summary Date | December 1, 2017 | ||
| 807.92(a)(2)DeviceIdentification | Device Trade Name:Common/Classification Name: Cutaneous ElectrodeProduct Code:Classification:Classification Panel: | MR Conditional Cup and Webb ElectrodeGXY21 CFR 882.1320 Class IINeurology | |
| 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 Cupand Webb Electrodes is identical to the predicate device.The device consists of ABS molded disk-shaped Cup or Webb stylecutaneous electrodes coated with Ag/AgCl. The electrodes are affixed to18cm long conductive leadwires. Up to 10 leadwires are connected to amultipin touch proof connector to form an electrode array assembly, which islabeled "MR Conditional." Up to 4 electrode arrays can be usedsimultaneously on a patient. The device design and leadwire length havebeen engineered for both 1.5T (64MHz) and 3.0T (128 MHz) MRIenvironments.An extension cable, 1.0 to 3.0m long, is included to attach the electrode arrayto monitoring equipment. The extension cable is clearly labeled with "MRUnsafe" symbols on both ends, and is NOT intended to be in the MRenvironment. This enables users to quickly disconnect the MR Unsafeextension cable and leave the MR Conditional electrodes in place on thepatient for MRI procedures. | ||
| 807.92(a)(5)Intended Use | The MR Conditional Cup and Webb Electrodes are intended for use in therecording of the Electroencephalogram (EEG), the evoked potential (EP), oras 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 MRIenvironment under specific conditions. | ||
| 807.92(a)(6)TechnologicalCharacteristics | The technological characteristics of the MR Conditional Cup and WebbElectrodes are identical to the predicate device (K130287), with a fewdimensional and material modifications that have been assessed to beequivalent to the predicate and therefore do not affect the fundamentalscientific technology, safety, or effectiveness of the device (referenceSubstantial Equivalence of Technological Characteristics table, below). Thetest 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 fundamentalscientific technology, safety, and effectiveness as the predicate device(K130287), as demonstrated by the test results.The functional performance equivalency was determined by mechanical andelectrical benchtop testing, as follows:Tensile testing Continuity testing Signal quality testingThe MR safety and performance equivalency of the MR Conditional Cup andWebb Electrodes were determined using the same test methodology as thepredicate device, summarized below:Worst-case device configuration was established through multipleSAR computational simulations The established worst-case configuration of the finished device wastested to the applicable ASTM standards:RF-Induced Heating MR Image Artifact Magnetically Induced Torque Magnetically Induced Displacement ForceThe results of these MR safety and functional tests verified the computationalanalysis, and determined the MR conditionality and device labelinginformation for both 1.5 T and 3.0 T MR environments. All MR testing wasperformed by an accredited MR testing laboratory on behalf of RhythmlinkInternational, LLC.In summary, the non-clinical testing concluded that the MR Conditional Cupand Webb Electrodes demonstrated equivalent functionality, safety, andeffectiveness 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 |
| Indicationsfor Use | The MR Conditional Cup andWebb Electrodes are intendedfor use in the recording of theElectroencephalogram (EEG),the evoked potential (EP), or asa ground and reference in anEEG or EP recording. Thisdevice is non-sterile for SinglePatient Use Only and mayremain on the patient in a MRIenvironment under specificconditions. | The MR Conditional Cup andWebb Electrodes are intendedfor use in the recording of theElectroencephalogram (EEG),the evoked potential (EP), oras a ground and reference in anEEG or EP recording. Thisdevice is non-sterile for SinglePatient Use Only and mayremain on the patient in a MRIenvironment under specificconditions. | Identical |
| MRConditions | Non-clinical testing has demonstratedthat the MR Conditional Cup and WebbElectrode array is MR Conditional inconfigurations of 2 to 40 electrodes,using 1 to 4 arrays. These electrodescan safely remain on a patient during anMR scan meeting the followingconditions:• Static magnetic field of 1.5 and 3.0Tesla• Maximum spatial field gradient of4,000 gauss/cm [40 T/m]• Maximum MR system reportedwhole-body averaged specificabsorption rate (SAR) of 2 W/kg andwhole-head averaged SAR of 3.2 W/kg• Quadrature driven transmit body coilonly• Maximum active scan time of 15minutes | Non-clinical testing has demonstratedthat the MR Conditional Cup andWebb Electrode is MR Conditional inconfigurations of 2 to 48 electrodes.These electrodes can safely remain ona patient during an MR scan under thefollowing conditions:• Static magnetic field of 1.5 or 3.0Tesla.• Maximum spatial gradient field of4,000 gauss/cm (40T/m) or less• Maximum whole-body averagedspecific absorption rate of 2 W/kg inthe Normal Operating Mode• Remove extension cables beforeentering an MR environment. Theyare MR Unsafe. | Equivalent |
| ElectrodeMaterial | ABS 20% glass filled,Ag/AgCl coated | ABS 20% glass filled,Ag/AgCl coated | Identical |
| ElectrodeDiameter | ~10mm | ~10mm | Identical |
| Wire | Conductive cable, PVC coated | Conductive cable, PVC coated | Equivalent |
| ElectrodeCable Length | 18cm | 10cm | Equivalent |
| Connector | Touch proof multipinconnector(s) | Touch proof single pinconnector(s) | Equivalent |
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Substantial Equivalence of Technological Characteristics Table
§ 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).