Who is the manufacturer of MR Conditional Cup Electrode, MR Conditional Webb Electrode?

Rhythmlink International, LLC filed the 510(k) submission for MR Conditional Cup Electrode, MR Conditional Webb Electrode (K172503).

What is the FDA product code for MR Conditional Cup Electrode, MR Conditional Webb 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 Cup Electrode, MR Conditional Webb Electrode?

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

What are the predicate devices for MR Conditional Cup Electrode, MR Conditional Webb Electrode?

MR Conditional Cup and Webb Electrode (K130287).

Who can help prepare an FDA 510(k) submission like MR Conditional Cup Electrode, MR Conditional Webb 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 Cup Electrode, MR Conditional Webb Electrode

K172503 · Rhythmlink International, LLC · GXY · Dec 1, 2017 · Neurology

Device Facts

Record ID	K172503
Device Name	MR Conditional Cup Electrode, MR Conditional Webb Electrode
Applicant	Rhythmlink International, LLC
Product Code	GXY · Neurology
Decision Date	Dec 1, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1320
Device Class	Class 2

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.

Device Story

Device consists of ABS molded cup or webb-style cutaneous electrodes coated with Ag/AgCl; attached to 18cm conductive leadwires. Up to 10 leadwires connect to a multipin touch-proof connector forming an electrode array. Up to 4 arrays used simultaneously. Includes an MR Unsafe extension cable (1.0-3.0m) for connection to monitoring equipment; extension cable must be disconnected before entering MRI environment. Electrodes remain on patient during MRI. Used in clinical settings by healthcare professionals. Provides electrical signal input for EEG/EP monitoring; enables patient monitoring during MRI procedures without requiring electrode removal.

Clinical Evidence

No clinical data. Bench testing only. Functional performance verified via tensile, continuity, and signal quality testing. MR safety verified via computational SAR simulations and ASTM-standard testing for RF-induced heating, image artifacts, torque, and displacement force in 1.5T and 3.0T environments.

Technological Characteristics

Materials: ABS (20% glass-filled), Ag/AgCl coating. Form factor: Cup or Webb-style cutaneous electrodes (~10mm diameter), 18cm leadwires, multipin touch-proof connectors. Energy: Passive electrical signal conduction. Connectivity: Wired to monitoring equipment. Sterilization: Non-sterile. MR safety: Conditional for 1.5T/3.0T; max spatial gradient 4,000 gauss/cm; max SAR 2 W/kg (whole-body) / 3.2 W/kg (whole-head); max scan time 15 minutes.

Indications for Use

Indicated for patients requiring EEG or EP recording, including use as ground/reference electrodes. Suitable for use in 1.5T and 3.0T MRI environments under specified conditions.

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

MR Conditional Cup and Webb Electrode (K130287)

Related Devices

K122376 — PMT TRUSCAN SURFACE ELECTRODE · Pmt Corp. · Dec 19, 2012
K130287 — MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE · Rhythmlink International, LLC · May 30, 2013
K171102 — Ives MR Conditional Cup Electrode · Ives Egg Solutions · Dec 21, 2017
K203079 — MR Conditional Sticky Pad Electrode · Rhythmlink International, LLC · Feb 9, 2021
K130220 — MR CONDITIONAL PRESSON ELECTRODE · Rhythmlink International, LLC · Jul 22, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ 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) | | |-------------------------------------------------|---------------------------------------------------------| | | | | <div></div> | <div></div> | | Prescription Use (Part 21 CFR 801 Subpart D) | <div></div> 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 | 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 | {4}------------------------------------------------ {5}------------------------------------------------ Substantial Equivalence of Technological Characteristics Table