(114 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 design of the Rhythmlink Disposable MR Conditional Cup and Webb electrodes are identical to the existing Cup and Webb electrodes used to record neurological activity during electroencephalograph (EEG) and evoked potential (EP) procedures. The device consists of a disk shaped electrode with a Cup or Webb shape ABS molded plastic and coated with Ag/AgCl. The Electrode is permanently attached to a leadwire using a validated crimp process and is covered with a biocompatible heat shrink material. The Cup and Webb electrodes are connected to a 10cm (100mm) long multi-strand copper cable with PVC insulation over the tinned copper conductors. An accessory cable is supplied to attach to the 10cm electrode leadwire to create 1.0 to 3.0 meter traditional lengths to attach to the monitoring equipment. This accessory cable is labeled "MR Unsafe" and is NOT intended to be in the MR environment. The significantly shorter 10cm lead wire is permanently attached to the electrode and reduces the effects of matching the electrode leadwire length to the wave length and reduces the likelihood of an increase in the heating effect. This will enable users to leave the electrodes in place during magnetic resonance imaging (MRI) procedures.
This is a 510(k) summary for a medical device: MR Conditional Cup Electrode and MR Conditional Webb Electrode. Note that 510(k) clearances are for demonstrating substantial equivalence to a predicate device, not necessarily for proving absolute safety and effectiveness through extensive clinical trials. Therefore, the details provided often focus on bench testing and comparisons to established devices rather than large-scale clinical studies.
Here's an analysis of the provided information:
Acceptance Criteria and Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format typical for performance studies. Instead, it describes various tests and concludes that the device performs "equal to the predicate devices" and "did not raise any additional questions of safety and efficacy."
However, we can infer some criteria and reported performance from the "Summary of Non-Clinical Tests":
| Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Leadwire Pull Strength | Confirmed to perform equal to predicate devices. |
| Electrical Performance: | |
| Resistance of Completed Assembly | Confirmed to perform equal to predicate devices. |
| MR Safety (Heating Effect): | |
| Max Temperature Increase (worst-case scenario) at electrode-skin interface | 0.4°C |
| MR Safety (Torque and Artifact): | Minimally affected by the magnetic field; torque and artifact testing and measuring were performed and results were acceptable. |
| Manufacturing Consistency: | No changes in manufacturing processes affecting performance were found compared to predicate devices. |
Study Information
-
Sample Size used for the test set and data provenance:
- Test Set Sample Size: The document does not specify a distinct "test set" in terms of patient samples. Instead, it refers to numerical simulations and non-simulated physical testing using phantoms.
- Numerical Simulations: Involved three different electrode types (Cup, Webb, PressOn™) with various configurations (e.g., "Z" axis with two electrodes, different head sizes and populations) and field strengths (1.5T [68 MHZ] and 3.0T [128MHZ]). The exact number of simulation runs or parameters is not quantified as a "sample size" in the traditional sense, but it was comprehensive enough to determine a "worst-case configuration."
- Physical Testing: Used phantoms "in accordance with appropriate ASTM Standards." The number of phantoms or individual tests performed is not explicitly stated.
- Data Provenance: The data is from bench testing and numerical simulations (conducted by MR:comp Services on behalf of Rhythmlink International), not human or animal subjects. Therefore, there is no direct country of origin for patient data, nor is it retrospective or prospective in the clinical sense.
- Test Set Sample Size: The document does not specify a distinct "test set" in terms of patient samples. Instead, it refers to numerical simulations and non-simulated physical testing using phantoms.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided as there was no "ground truth" derived from expert consensus on clinical data for a test set. The study relies on engineering and physics principles, simulation software (SIMCAD X with FDTD modeling), and ASTM standards for physical phantom testing.
-
Adjudication method for the test set:
- Not applicable. There was no human expert adjudication of results for a test set derived from clinical images or data, as this was a bench and simulation study.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. An MRMC comparative effectiveness study was not performed. This type of study involves multiple human readers evaluating cases with and without AI assistance, which is not relevant to the magnetic resonance compatibility testing of an electrode.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable in the typical sense of an "algorithm." The "device" being evaluated is a physical electrode, not a diagnostic algorithm. The safety evaluation was performed in a standalone manner on the device itself through simulations and physical tests, without a human-in-the-loop interacting with the device for performance measurement.
-
The type of ground truth used:
- The "ground truth" for the MR safety evaluation was based on physical measurements (temperature, torque, artifact) and validated numerical simulation models (SIMCAD X with FDTD modeling, referencing ASTM Standards for phantoms) that predict the behavior of the electrode in an MRI environment. It's an engineering and physics-based ground truth.
-
The sample size for the training set:
- Not applicable for this device and study type. There was no "training set" in the context of machine learning or AI algorithms, as this is a physical medical device.
-
How the ground truth for the training set was established:
- Not applicable. See point 7.
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K130287
MAY 3 0 2013
5. Traditional 510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR§807.92(a).
| 807.92(a)(1)Submitter Information: | Rhythmlink International, LLC1140 First Street SouthColumbia, SC 29209Phone: 803-252-1222FDA Registration #: 1067162Owner Operator #: 9052354 |
|---|---|
| Official Correspondent: | James M. MewborneManager of Regulatory AffairsRhythmlink International, LLC1140 First Street SouthColumbia, SC 29209Phone: 803-252-1222 ext. 101Email: jmewborne@rhythmlink.com |
| Summary Date: | January 22, 2013 |
| 807.92(a)(2)Device Identification: | Proprietary Device Name:MR Conditional Cup ElectrodeMR Conditional Webb Electrode(Trade name has not been finalized at this time)Regulation Description: Cutaneous ElectrodeReview Panel: NeurologyProduct Code: GXYRegulation Number: 21 CFR §882.1320, Cutaneous ElectrodeRegulatory Class: Class 2 |
| 807.92(a)(3)Predicate Device(s): | K061148 Rhythmlink Cup Electrode |
| 807.92 (a)(4)Device Description: | The design of the Rhythmlink Disposable MR Conditional Cup and Webb electrodes are identical to the existing Cup and Webb electrodes used to record neurological activity during electroencephalograph (EEG) and evoked potential (EP) procedures.The device consists of a disk shaped electrode with a Cup or Webb shape ABS molded plastic and coated with Ag/AgCl. The Electrode is permanently attached to a leadwire using a validated crimp process and is covered with a biocompatible heat shrink material. The Cup and Webb electrodes are connected to a10cm (100mm) long multi-strand copper cable with PVC insulation over the tinned copper conductors. An accessory cable is supplied to attach to the 10cm electrode leadwire to create 1.0 to 3.0 meter traditional lengths to attach to the monitoring equipment. This accessory cable is labeled "MR Unsafe" and is NOT intended to be in the MR environment. The significantly shorter 10cm lead wire is permanently attached to the electrode and reduces the effects of matching the electrode leadwire length to the wave length and reduces the likelihood of an increase in the heating effect. This will enable users to leave the electrodes in place during magnetic resonance imaging (MRI) procedures. |
| 807.92(a)(5)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. |
| 807.92(a)(6)TechnologicalCharacteristics | The main source of heating within the magnetic resonant imaging comes from the matching of the RF (radio frequency) wave lengths to the length of the electrode's leadwire. The reduction of the proposed device's leadwire length permanently attached to the electrode is the only physical change from the predicate device. This reduction in the cable length is to reduce the likelihood of heating effect from the RF component. The other issue is the torque produced by the magnetic field in the MR environment. The materials used in the MR Conditional Cup and Webb Electrodes are minimally affected by the magnetic field and the reduced leadwire length has shown a minimal heating effect from the radio frequency "E" field. The materials and manufacturing processes are identical to the predicate device [K061148] Rhythmlink Disc Electrodes. |
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| 807.92(b)(1) | |
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| Summary of Non-Clinical Tests | In summary the MR Conditional Cup and Webb Electrodes are identical to the Predicate device Cup and Webb electrodes in materials, manufacturing. processes and electrical performance. Bench tests where performed to determine if any changes had occurred in the manufacturing processes that would affect performance and they were found to predicate devices. There have been no design changes to the MR Conditional Cup and Webb Electrodes other than the length of the leadwire permanently connected to the electrode. These tests consisted of the following tests: ➤ Pull Tests of the leadwire to the electrodes' connection. ➤ Resistance testing of the completed assembly The mechanical and electrical bench testing confirmed the MR Conditional Cup and Web Electrode performs equal to the predicate devices and did not raise any additional questions of safety and efficacy. Additional testing was conducted by MR:comp Services on behalf of Rhythmlink International to determine the safety and efficacy of the proposed device within the magnetic resonance environment. In summary the numerical simulations were conducted in two phases. Phase one was to determine which of the three electrodes and modality would be the worst case configuration. The numerical simulations where completed using the SIMCAD X validated software with FDTD (Finite-Difference Time- Domain) modeling. The simulation plan consisted of three different electrode types: ➤ Cup Electrodes ➤ Webb Electrodes ➤ PressOn™ Electrode The numerical simulation tested all configurations of the three electrodes and found the PressOn™ electrode with two opposing leadwires to be the worst case configuration of the three types. All of the simulations used the same field strengths of 1.5T [68 MHZ] and 3.0T [128MHZ] for the final results. The second phase performed non-simulated physical testing within the MR equipment to replicate real world application as physically and economically feasible. The phantoms used for the physical testing where in accordance with appropriate ASTM Standards. The non-simulated physical testing also included Torque and Artifact testing and measuring. The simulation testing and the non-simulation MRI testing were shown to produce equivalent results. The temperatures in both the simulations and |
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| Clinical Summary | |
|---|---|
| 807.92(b){3} | No Clinical Tests where conducted as referenced in 21 CFR 807.92(b){3}. |
| Clinical Tests | |
| 807.92(b)(2) | No Clinical Tests where conducted as referenced in 21 CFR 807.92(b)(2). |
| additional questions of safety or efficacy. | |
| Webb Electrodes performed as expected and did not raise any new or | |
| In summary all testing concluded that the proposed MR Conditional Cup and | |
| populations. | |
| Additional simulations and testing were completed to show the results ofthe complete leadwire (10cm) within the E field, different head sizes and | |
| in the "E" field which created the highest SAR and temperature change. | |
| simulation indicated that the "Z" axis with two electrodes is the worst case | |
| are attached to the skin as measured directly under the electrode. The | |
| the real time tests only indicated a raise of 0.4C° at the area the electrodes |
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and the state of the states of the
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the caduceus.
May 30,2013
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Rhythmlink International, LLC Attn: James M. Mewborne Manager of Regulatory Affairs 1140 First Street South Columbia, SC 29209
Re: K130287
Trade Name: MR Conditional Cup Electrode, MR Conditional Web Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: February 2, 2013 Received: March 4, 2013
Dear Mr. Mewborne:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 – Mr. James M. Mewborne
Enclosure
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to: http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address:
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joyce MEWhang -S
for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): K130287
Device Name: MR Conditional Cup Electrode, MR Conditional Webb Electrode
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.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ovee
(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)
510(k) Number K130287
Page 1 of 1
§ 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).