Ives MR Conditional Cup Electrode

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December 21, 2017 Ives EGG Solutions John Ives Design Engineer 25 Storey Avenue, #118 Newburyport, Massachusetts 01950 Re: K171102 Trade/Device Name: Ives MR Conditional Cup Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: Not Dated Received: November 29, 2017 Dear John Ives: 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) K171102 Device Name Ives MR Conditional Cup Electrode #### Indications for Use (Describe) The Ives MR Conditional Cup Electrodes are intended for use in the general recording and monitoring of the electroencephalography (EEG), evoked potential (EP) as well as ground and reference related to the EEG and EP recording. The Cup Electrodes are intended to be left in place during MR imaging at 1.5T and 3T as well as during CT scanning. The extension cable must be disconnected from the Ives MR Conditional Cup Electrodes before scanning and MUST remain disconnected throughout the entire MR scan. EEG or EP should not be recorded throughout the entire the CT and MR imaging. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------|------------------------------------------------------------------------------| | <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | 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}------------------------------------------------ # 010_510(k) Summary ## Ives MR Conditional Cup Electrode (K171102) | Company Name: | Ives EEG Solutions, Inc. | | |--------------------------|----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------| | Contact: | Mr. John Ives | | | Phone: | 978-358-8006 | | | Fax: | 978-358-7825 | | | Email: | johnrives@gmail.com | | | Summary Date: | December 8, 2017 | | | Trade Name: | Ives MR Conditional Cup Electrode | | | Model Number: | CPE (Conductive Plastic Electrode) | | | Common Name: | Surface Electrode, Cutaneous electrode | | | Classification Name: | 21 CFR 882.1350, Cutaneous Electrode GXY | | | Main Predicate Device: | 510(k) Number:<br>Manufacture:<br>Trade Name:<br>Product Code: | K071118<br>Ives EEG Solutions, LLC<br>EEG Surface Electrode System<br>GXY | | Other Predicate Devices: | 510(k) Number:<br>Manufacture:<br>Name:<br>Product Code: | K130287<br>Rythmlink International, LLC Trade<br>MR Conditional Cup Electrode, MR Conditional Webb Electrode<br>GXY | | Other Predicate Devices: | 510(k) Number:<br>Manufacture:<br>Name:<br>Product Code: | K122376<br>TruScan® Surface Electrodes<br>TruScan® Surface Electrodes<br>GXY | #### Description of Electrodes: The cutaneous surface electrode (CPE) are electrodes that are all applied to the surface of the patient's skin, they are non-invasive. These electrodes are used for the recording of electroencephalography (EEG), evoked potential (EP) as well as the ground and reference associated with the recording. They consist of a disc or cup made from a variety of materials, which include, conductive plastic and Ag-Ag/Cl, materials that have long been used for this intended purpose throughout the industry and compatible to the MR environment. The conductive cup electrode is permanently connected to a PVC insulated copper lead wire varying in length from 6" to 9". This joint is then covered in a heatshrink tube to provide a strain relief. The lead wires are staggered in length (6" to 9") and terminate in a small mass connector that conforms to DIN 42-802 for electrical safety. A blue sponge is provided to locate the lead wire termination off of the scalp and {4}------------------------------------------------ #### 010 4 510(k) Summary at the top of the patient's head. To permit EEG monitoring, this small mass connector mates with a harness system as per K062880 (an Ives EEG Solutions 510K describing a Subdermal Wire Electrode System) which connects to the EEG recording instrument using molded "touch-proof" connectors which also conform to DIN 42-802. The Harness is disconnected for imaging. The electrode lead length is as short as possible to connect directly with the 10-20 EEG scalp site. This prevents coiling of the lead wires and as short as possible lead length to reduce or eliminate the RF heating antenna effect during MR scanning sequences. Electrode and lead materials are selected to avoid use of any magnetic ferrous metals. #### Indications for Use The Ives MR Conditional Cup Electrodes are intended for use in the general recording and monitoring of the electroencephalography (EEG), evoked potential (EP) as well as ground and reference related to the EEG and EP recording. The Cup Electrodes are intended to be left in place during MR imaging at 1.5T and 3T as well as during CT scanning. The extension cable must be disconnected from the Ives MR Conditional Cup Electrodes before scanning and MUST remain disconnected throughout the entire MR scan. EEG or EP should not be recorded throughout the entire the CT and MR imaging. ### Substantial Equivalent to Predicate Devices | | Ives Surface EEG<br>Electrodes Model:<br>GCE<br>SCE, SCES CPES | Rhythmlink International<br>Model: Cup Electrode | TruScan® Surface<br>Electrodes | |-------------|----------------------------------------------------------------|--------------------------------------------------|--------------------------------| | 510K number | K171102 | K130287 | K122376 | {5}------------------------------------------------ # 010_4 510(k) Summary | IFU | The Ives MR Conditional | The MR Conditional Cup and | The PMT® TruScan® | | | | | | | | | | | | | | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|----------------------------------|-----------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--| | | Cup Electrodes are | Webb Electrodes are intended | Surface Electrodes are | | | | | | | | | | | | | | | | | intended for use in the | for use in the recording of the | indicated for cutaneous | | | | | | | | | | | | | | | | | general recording and | Electroencephalogram (EEG), | use in the general | | | | | | | | | | | | | | | | | monitoring of the | the evoked potential (EP), or as | recording and monitoring | | | | | | | | | | | | | | | | | electroencephalography | a ground and reference in an | of the | | | | | | | | | | | | | | | | | (EEG), evoked potential | EEG or EP recording. This | Electroencephalograph | | | | | | | | | | | | | | | | | (EP) as well as ground and | device is non-sterile for Single | (EEG) and Evoked | | | | | | | | | | | | | | | | | reference related to the | Patient Use Only and may | Potential (EP). | | | | | | | | | | | | | | | | | EEG and EP recording. | remain on the patient in a MRI | The PMT® TruScan® | | | | | | | | | | | | | | | | | | environment under specific | Surface Electrodes are CT | | | | | | | | | | | | | | | | | The Cup Electrodes are | conditions. | compatible and MR | | | | | | | | | | | | | | | | | intended to be left in place | | Conditional under the | | | | | | | | | | | | | | | | | during MR imaging at | | following conditions: | | | | | | | | | | | | | | | | | 1.5T and 3T as well as | | * Static magnetic field | | | | | | | | | | | | | | | | | during CT scanning. | | strength of 1.5-T only | | | | | | | | | | | | | | | | | | | * Maximum spatial | | | | | | | | | | | | | | | | | The extension cable must | | gradient magnetic field of | | | | | | | | | | | | | | | | | be disconnected from the | | 5,000 Gauss/cm (5OT/in) | | | | | | | | | | | | | | | | | Ives MR Conditional Cup | | or less | | | | | | | | | | | | | | | | | Electrodes before | | * The connector hub must | | | | | | | | | | | | | | | | | scanning and MUST | | be placed near the center | | | | | | | | | | | | | | | | | remain disconnected | | MR system's bore, and | | | | | | | | | | | | | | | | | throughout the entire MR | | must be at least 20-cm | | | | | | | | | | | | | | | | | scan. EEG or EP should | | from the wall of the MR | | | | | | | | | | | | | | | | | not be recorded | | system's bore at all times. | | | | | | | | | | | | | | | | | throughout the entire the | | * The extension cable | | | | | | | | | | | | | | | | | CT and MR imaging. | | must be disconnected from | | | | | | | | | | | | | | | | | | | the PMT TruScan Surface | | | | | | | | | | | | | | | | | | | Electrode before scanning | | | | | | | | | | | | | | | | | | | and MUST remain | | | | | | | | | | | | | | | | | | | disconnected throughout | | | | | | | | | | | | | | | | | | | the entire MR scan. | | | | | | | | | | | | | | | | | | | * Normal Operating Mode | | | | | | | | | | | | | | | | | | | of operation for the MR | | | | | | | | | | | | | | | | | | | system with a maximum | | | | | | | | | | | | | | | | | | | whole body averaged | | | | | | | | | | | | | | | | | | | specific absorption rate | | | | | | | | | | | | | | | | | | | (SAR) of 2.0-W/kg for 15 | | | | | | | | | | | | | | | | | | | minutes of scanning (i.e., | | | | | | | | | | | | | | | | | | | per pulse sequence) | | | | | | | | | | | | | | | | Classification<br>Product CodeGXYGXYGXYIndications For<br>UseRecording of the<br>EEG, EP, GND, REFRecording of the EEG,<br>EP, GND, REFRecording of the<br>EEG, EP, GND,Target<br>PopulationAdultAdultAdultAge Range>21>21>21 | | | | | | | | | | | | | | | | | | {6}------------------------------------------------ | 010_4 510(k) Summary | | | | |----------------------|-----------------------------------------|---------------------------------|---------------------------| | Length of | temporary | temporary | temporary | | Recording | | | | | | | | | | Supervision | EEG Technologist | EEG Technologist | EEG Technologist | | Size of electrode | 1cm | 1cm | 1cm | | Design | Cup electrode with | Cup electrode with hole for gel | Cup electrode with hole | | | hole for gel | | for gel | | Materials | ABS molded plastic | ABS molded plastic with Ag- | Silver/silver chloride | | | with Ag- Ag/Cl | Ag/Cl coating | | | Lead Design | Tinseled copper wire | Copper wire with Vinyl (PVC) | Nichrome | | | with silver coat with | insulation | | | Lead Length | Tested at 6" to 11" as | Tested at 3.9" but marketed at | Tested and marketed at | | See below 1: | well as marketed | 9.5" | 9" | | Performance | High quality EEG | High quality EEG | | | | | | | | Biocompatibility | Long History | Long History | - | | | | | | | Mechanical | Ideal | Ideal | | | Safety | | | | | Chemical Safety | OK | OK | | | | | | | | Anatomical Sites | Surface, scalp, skin | Surface, scalp, skin | Surface, scalp, skin | | | | | | | Human Factors | Easily Placed by | Easily Placed by traditional | Easily Placed by | | | traditional means | means | traditional means | | Energy Used | Record EEG | Record EEG Biopotential Only | Record EEG Biopotential | | and/or Delivered | Biopotential Only | | Only | | Compatibility | Connects to any | Connects to any Standard | Connects to any Standard | | | Standard Recording | Recording Device | Recording Device | | Interconnection | 48" lead connects | 48" lead connects from EEG | 48" lead connects from | | | between electrode from EEG electrode to | electrode to standard 1.5mm | EEG electrode to | | lead and | standard 1.5mm Safe- | Safe-Lead ("Touch-Proof") | standard 1.5mm | | Connection | NO other connection | NO other connection to | | | during imaging | to electrode set during | electrode set during imaging | | | Where Used | Hospital, ICU, | Hospital, ICU, inpatient | | | | inpatient | | | | Packaging | Non-sterile in plastic | Non-sterile in plastic bag | Non-sterile, sealed in PE | | | bag | | pouch | | Electrical Safety | Connects with Safe- | Connects with Safe-Lead | 1.5mm | | | Lead | | Brass/Polypropylene IEC | | | | | 60601-1 subclause | | | | | 56.3(c) compliant | | Static MRI field | 1.5T and 3T | 1.5T and 3T | 1.5T only | | strength tested | | | | | Connector | Located at top of head | Not specified | Must be at least 20cm | | placement | using supplied sponge, | | from the wall of the MR | | | thus near center of | | bore at all times | | Maximum SAR | 3.2W/Kg | Not specified | 2.0W/Kg | | | | | | {7}------------------------------------------------ ## 010_4 510(k) Summary DIFFERENCE RATIONALE: There are essentially no major differences between our device and the predicate device except as noted below. 1: There is a significant lead length difference between Rhythmlink as tested and Ives as tested (3.9" vs. 6"-11"); however, as marketed the difference is 9.5" vs. 6" to 11"). Testing showed that the leads connected to the subject device supported the safe and effective use of the device for the indications for use stated. Ives EEG Solutions found that the EEG technologist needs at least 6" to allow easy application of the electrode and also to allow for staggered lead lengths to extend from the 10-20 site to the connector at the top of the head, thus the longest lead is 11". #### Non-Clinical Testing Non-clinical testing has demonstrated that the Ives MR Conditional Cup Electrodes is MR Conditional and can safely remain on the patient during an MR scan under the following conditions: - Static magnetic fields strength of 1.5 T and 3.0 T - Maximum spatial gradient magnetic fields of 2,000 gauss/cm (20T/m) or less - Transmit body and head coil, quadrature driven - 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 - The extension cable must be disconnected from the Ives MR Conditional Cup Electrodes before scanning and must remain disconnected throughout the entire MR scan. Under the scan conditions defined above, the Ives MR Conditional Cup Electrodes is expected to produce a maximum temperature rise of less than 5℃ after 15 minutes of continuous scanning. In clinical testing, the image artifact caused by the device extends approximately 3 mm from the Ives MR Conditional Cup Electrodes when imaged with a gradient echo pulse sequence in a 1.5 T and 3.0 T MRI system. #### CONCLUSION: Ives MR Conditional Cup electrodes are substantially equivalent to the predicate MRI Conditional EEG cutaneous electrode.