(174 days)
The MR Conditional PressOn™ Electrode is 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 provided 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 PressOn electrode is identical to the existing PressOn electrodes used to record neurological activity during electroencephalograph (EEG) and evoked potential (EP) procedures.
The device consists of a disk shaped electrode with three sets of flat tyne or micro needles made from Nitinol. The Electrode is permanently attached to a leadwire which is 10cm (100mm) in length. An accessory cable is supplied to attach to the 10cm electrode leadwire to create a 1.0, 1.5, 2.0 or 2.5 meter traditional lengths during the Monitoring procedure. This accessory cable is labeled "MR Unsafe" and is NOT intended to be in the MR environment at any time. A significantly shorter lead wire of 10cm is permanently attached to the electrode and reduces the effects of matching the electrode leadwire length to the wave length of the RF component. This condition reduces the probability of matching the RF wave length to the leadwire length and reduces the likely hood of an increase in the heating effect. This will enable users to leave the electrodes in place during magnetic resonance imaging (MRI) procedures.
The provided text describes a 510(k) summary for a medical device, the "MR Conditional PressOn™ Electrode." This submission focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering and simulated testing related to MRI compatibility, rather than clinical efficacy studies. Therefore, many of the requested details regarding clinical study design, ground truth establishment, expert adjudication, and MRMC studies related to AI performance are not applicable to the information provided.
Based on the information given, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The primary acceptance criterion for this device, as stated, is related to temperature rise during MRI exposure, with the performance being compared against the IEC 60601-1-1 §11.1.2 standard.
| Acceptance Criteria (IEC 60601-1-1 §11.1.2) | Reported Device Performance (Simulation & Real-time MRI Testing) |
|---|---|
| Maximum temperature at applied parts not to exceed 43°C. | Temperature rise of 0.4°C at the area where electrodes are attached to the skin, measured directly under the electrode. |
| (Implicit) Minimal effect from magnetic torque. | Materials are minimally affected by the magnetic field. |
| (Implicit) Reduced likelihood of heating effect from RF component due to leadwire length. | Reduced lead length showed a minimal heating effect from the radio frequency "E" field. |
2. Sample size used for the test set and the data provenance
The "test set" in this context primarily refers to the conditions simulated and tested for MRI compatibility, not a clinical patient dataset for evaluating diagnostic accuracy.
- Sample Size:
- Simulation (SIMCAD X with FDTD modeling): Three different electrode types were simulated: Cup Electrodes, WEBB Electrodes, and PressOn™ Electrode. The PressOn™ electrode was determined to be the "worst-case configuration." The simulation data was then compared to actual MRI testing, using field strengths of 1.5T and 3.0T, and 68 MHZ and 128 MHZ respectively.
- Real-time MRI Physical Testing: This testing was conducted using the "known worst-case configuration" (the PressOn electrode). The exact number of physical tests or specimens is not specified beyond this.
- Data Provenance: Not specified regarding country of origin. The studies were non-clinical (bench and simulation testing) and prospective in the sense that they were specifically conducted for this submission to evaluate the redesigned device's MRI compatibility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device submission focuses on the physical properties and safety during MRI exposure, not on diagnostic accuracy requiring expert interpretation or ground truth derived from clinical experts for image analysis. The "ground truth" here is the physical measurement of temperature and torque under defined MRI conditions.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used in clinical studies involving human interpretation (e.g., radiologist reads) to establish consensus on challenging cases. For physical testing (temperature, torque), the results are objective measurements.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This submission is for a neurological electrode, not an AI-powered diagnostic device. No human reader studies (MRMC) were conducted as part of this submission. The device's function is to record EEG/EP signals and remain safe in an MRI environment, not to assist human interpretation of medical images or data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device. Performance was evaluated for the physical device itself (its interaction with the MRI environment).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used was objective physical measurements and simulations based on established engineering principles and standards (e.g., temperature measurements, torque measurements, and FDTD modeling). The performance was compared against a defined safety standard (IEC 60601-1-1 §11.1.2 for temperature).
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As noted above, this is not an AI/ML device requiring a training set with established ground truth in the context of expert labels or outcomes.
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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 PressOn™ Electrode(Trade name has not been finalized at this time)Generic Device Name: MR Conditional PressOn ElectrodeRegulatory Class: Class IIClassification Name: 21 CFR §882.1350, Neurological ElectrodeProduct Code: GXZ |
| 807.92(a)(3)Predicate Device(s): | K103103Persyst PressOn™ ElectrodesK121347Rhythmlink PressOn™ Electrode |
| 807.92 (a)(4)Device Description: | The design of the Rhythmlink Disposable MR Conditional PressOnelectrode is identical to the existing PressOn electrodes used to recordneurological activity during electroencephalograph (EEG) and evokedpotential (EP) procedures.The device consists of a disk shaped electrode with three sets of flat tyneor micro needles made from Nitinol. The Electrode is permanentlyattached to a leadwire which is 10cm (100mm) in length. An accessorycable is supplied to attach to the 10cm electrode leadwire to create a 1.0,1.5, 2.0 or 2.5 meter traditional lengths during the Monitoring procedure.This accessory cable is labeled "MR Unsafe" and is NOT intended to be inthe MR environment at any time. A significantly shorter lead wire of10cm is permanently attached to the electrode and reduces the effects ofmatching the electrode leadwire length to the wave length of the RFcomponent. This condition reduces the probability of matching the RFwave length to the leadwire length and reduces the likely hood of anincrease in the heating effect. This will enable users to leave theelectrodes in place during magnetic resonance imaging (MRI) procedures. |
| 807.92(a)(5)Intended Use /Indications for Use: | The MR Conditional PressOn™ Electrode is intended for use in therecording of the Electroencephalogram (EEG), the evoked potential(EP), or as a ground and reference in an EEG or EP recording. Thisdevice is provided sterile for Single Patient Use Only and mayremain on the patient in a MRI environment under specificconditions. |
| 807.92(a)(6)TechnologicalCharacteristics | The main source of heating within the magnetic resonant imaging comesfrom the matching of the RF (radio frequency) wave length to the lengthof the electrode's leadwire. The reduction of the proposed device'sleadwire length permanently attached to the electrode is the onlyphysical change from the predicate device. This reduction in the cablelength is to reduce the likely hood of heating effect from the RFcomponent. The other issue is the torque produced by the magnetic fieldin the MR environment. The materials used in the PressOn EEG Electrodeare minimally affected by the magnetic field and the reduced lead lengthhas shown a minimal heating effect from the radio frequency "E" field.The manufacturing processes, materials and the sterility process areidentical to the predicate device {K121347 and K103103}, the PersystPressOn Electrodes. |
| 807.92(b)(1) | In summary even though the manufacturing processes are identical to |
| Summary of Non-Clinical Tests | validate no changes had occurred and the performance remained thesame as the predicate devices.. There have been no design changes to thMR Conditional PressOn Electrodes other than the length of the leadwirepermanently connected to the electrode. These tests consisted of thefollowing tests;➤ Pull Tests of the leadwire to the electrodes' connection.➤ Resistance testing of the completed assemblyBench Testing did not raise any additional questions of safety andefficacy. |
| 807.92(b)(2)Clinical Tests | In summary the clinical testing was conducted in two phases. Phase onewas to determine which electrode and modality would be the worst caseconfiguration. This was completed by using the SIMCAD X validatedsoftware with FDTD (Finite-Difference Time-Domain) modeling. Thesimulation plan consisted of three different electrode types;➤ Cup Electrodes➤ WEBB Electrodes➤ PressOn™ ElectrodeThe simulation testing showed the PressOn™ electrode to be the worstcase configuration of the three types. All the simulation data was takenand then compared to the actual MRI testing using the same fieldstrengths of 1.5T and 3.0T and 68 MHZ and 128MHZ respectfully. Thesecond phase was to perform actual MRI physical testing for real worldapplication. The physical testing also included Torque and Artifact testingand measuring. |
| 807.92(b)(3)Clinical Summary | Once both the bench testing and simulation testing were completed theMR Conditional PressOn electrodes were subjected to real time MRItesting. These physical testing was completed using the known worstcase configuration from the three types. (Cups, WEBBs and PressOn) ThePressOn Electrode was found to be the worst case electrode.The bench testing confirmed that the materials used and the currentmanufacturing processes being used are the same and did not raise anyadditional questions of safety or efficacy.The simulation testing and the real time MRI testing were shown to bethe same. Our test results were then compared to the IEC 60601-1-1§11.1.2 - Temperature for Applied Parts, stated that the maximumtemperature is not to exceed 43C° at any time. The temperatures in boththe simulations and the real time tests only indicated a raise of 0.4C° atthe area the electrodes are attached to the skin as measured directlyunder the electrode. The simulation indicated that the "Z" axis with two |
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| and temperature. Additional simulations and testing were completed to show the results of the complete leadwire (10cm) within the E filed. |
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| In summary all testing indicated that the proposed MR Conditional PressOn Electrodes performed as expected and did not raise any |
| additional questions of safety or efficacy. |
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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 consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
July 22, 2013
Rhythmlink International, LLC c/o Mr. James M. Mewborne 1140 First Street, South Columbia, SC 29209
Re: K130220
Trade/Device Name: MR Conditional PressOn Electrode Regulation Number: 21 CFR 882.1350 Regulation Name: Needle Electrode Regulatory Class: Class II Product Code: GXZ Dated: June 3, 2013 Received: June 5, 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 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.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
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Page 2 - Mr. James M. Mewborne
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
hup://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. 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
hup://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometries/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Victor Krauthamer -S
Victor Krauthamer, Ph.D. Acting 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):
Device Name: MR Conditional PressOn™ Electrode
Indications For Use:
The MR Conditional PressOn™ Electrode is 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 provided sterile for Single Patient Use Only and may remain on the patient in a MRI environment under specific conditions.
Prescription Use X (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)
Victor Krauthamer -S 2013.07.22 15:58:30 -04'00'
(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)
510(k) Number K130220
Page 1 of 1
§ 882.1350 Needle electrode.
(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).