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.

Device Description

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 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.

AI/ML Overview

The provided document describes the FDA 510(k) premarket notification for the Ives MR Conditional Cup Electrode, focusing on its substantial equivalence to predicate devices and its MR Conditional properties.

Here's an analysis of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formal "acceptance criteria" table with corresponding "reported device performance" in the way one might expect in a detailed study report. However, it implicitly defines acceptance criteria through its claims of MR Conditional compatibility and the supporting non-clinical testing.

Here's a reconstruction of the implicit acceptance criteria and the device's performance based on the non-clinical testing section:

Acceptance Criteria Category	Specific Criterion (Implicit)	Reported Device Performance
MR Conditional Environmental Compatibility
Static Magnetic Field Strength	Safe at specified static magnetic field strengths.	Safe at 1.5 T and 3.0 T.
Spatial Gradient Magnetic Fields	Safe at specified maximum spatial gradient magnetic fields.	Safe at maximum 2,000 gauss/cm (20T/m) or less.
RF Transmit Coil Type	Compatibility with common RF transmit coil types.	Compatible with transmit body and head coil, quadrature driven.
Whole-Body Averaged SAR (WB-SAR)	Safe within specified WB-SAR limits.	Safe at maximum MR System reported WB-SAR of 2 W/kg.
Whole-Head Averaged SAR (WH-SAR)	Safe within specified WH-SAR limits.	Safe at maximum MR System reported WH-SAR of 3.2 W/kg.
Extension Cable Status	Must be disconnected during MRI.	Extension cable must be disconnected from the Ives MR Conditional Cup Electrodes before scanning and must remain disconnected throughout the entire MR scan.
Thermal Performance (Heating)
Maximum Temperature Rise (Imaging)	Maximum temperature rise below a critical threshold during continuous scanning.	Expected to produce a maximum temperature rise of less than 5℃ after 15 minutes of continuous scanning (under defined scan conditions).
Imaging Artifact
Size of Image Artifact (Clinical)	Image artifact size within acceptable limits.	Image artifact 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 (in clinical testing).
Material Composition	Materials selected to avoid magnetic ferrous metals.	Electrode and lead materials are selected to avoid use of any magnetic ferrous metals. (This is a design criterion that inherently supports MR compatibility rather than a direct performance metric from testing, though its outcome is reflected in the MR Conditional claims).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document mentions "clinical testing" for image artifact, but does not specify the sample size (e.g., number of electrodes, number of subjects/patients) used for this testing.
Data Provenance: The document does not explicitly state the country of origin. Given the FDA submission and the company name ("Ives EEG Solutions, Inc." and "Newburyport, Massachusetts"), it is highly probable the testing was conducted in the United States. The document is a regulatory submission, not a research paper, so detailed provenance is not typically included here unless specifically requested by the FDA for certain study types. The testing described is non-clinical (thermal, electromagnetic compatibility) and clinical (image artifact assessment), implicitly making it prospective for the purpose of this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The testing described focuses on physical properties (heating, artifact) rather than diagnostic accuracy or interpretation requiring ground truth established by medical experts for a test set. The "clinical testing" mentioned for image artifact would typically be assessed by radiologists, but the number and qualifications are not stated.

4. Adjudication Method for the Test Set

This information is not provided in the document. This type of adjudication method (e.g., 2+1) is relevant for studies involving human interpretation of data, such as diagnostic accuracy studies, which is not the primary focus of the non-clinical and basic clinical compatibility testing described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done and is not applicable here. This document is about the MR compatibility and basic safety of an EEG electrode, not about the diagnostic effectiveness of an AI algorithm or human readers. The device itself is an electrode, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

No, a standalone study of an algorithm performance was not done. The device is an electrode, not an algorithm.

7. Type of Ground Truth Used

For the non-clinical testing (thermal, magnetic compatibility), the "ground truth" is established by:

Physical measurements and scientific principles: Temperature rise is directly measured. Magnetic field interactions are assessed based on material properties and measured forces/torques.
Established MR safety standards: Testing methods and thresholds are derived from recognized industry standards and regulatory guidance for MR compatibility.

For the "clinical testing" of image artifact, the "ground truth" implicitly refers to the direct observation and measurement of the artifact on MR images by qualified personnel (likely radiologists or MR physicists), compared against a baseline expectation or standard for acceptable artifact. It's not ground truth in the sense of a disease diagnosis but rather a direct physical effect.

8. Sample Size for the Training Set

Not Applicable. This device is a physical medical instrument (an electrode), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The non-clinical and clinical testing performed relates to the physical safety and compatibility of the device.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no AI algorithm and no training set, there is no ground truth to be established for a training set.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

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

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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) K171102

Device Name Ives MR Conditional Cup Electrode

Indications for Use (Describe)

The Cup Electrodes are intended to be left in place during MR imaging at 1.5T and 3T as well as during CT scanning.

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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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:Manufacture:Trade Name:Product Code:	K071118Ives EEG Solutions, LLCEEG Surface Electrode SystemGXY
Other Predicate Devices:	510(k) Number:Manufacture:Name:Product Code:	K130287Rythmlink International, LLC TradeMR Conditional Cup Electrode, MR Conditional Webb ElectrodeGXY
Other Predicate Devices:	510(k) Number:Manufacture:Name:Product Code:	K122376TruScan® Surface ElectrodesTruScan® Surface ElectrodesGXY

Description of Electrodes:

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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 Cup Electrodes are intended to be left in place during MR imaging at 1.5T and 3T as well as during CT scanning.

Substantial Equivalent to Predicate Devices

	Ives Surface EEGElectrodes Model:GCESCE, SCES CPES	Rhythmlink InternationalModel: Cup Electrode	TruScan® SurfaceElectrodes
510K number	K171102	K130287	K122376

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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)
ClassificationProduct CodeGXYGXYGXYIndications ForUseRecording of theEEG, EP, GND, REFRecording of the EEG,EP, GND, REFRecording of theEEG, EP, GND,TargetPopulationAdultAdultAdultAge Range>21>21>21

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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

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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.

Regulation Number and Section

§ 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).