The Grass MR Conditional/CT Cup Electrodes and Arrays 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 an MRI or CT environment under specific conditions.

Device Description

Grass® MR Conditional/CT Cup Electrodes are for surface monitoring EEG, electromyogenic and physiologic data signals commonly recorded on the chest, extremities, head and faces of patients. Grass® MR Conditional/CT Array Cup Electrodes are also used in electrocardiography, evoked potentials, and polysomnography. The Grass® MR Conditional/CT Array Cup Electrodes are MR conditional/CT. The included extension cables are MR/CT Unsafe.

The Operating Principle and technological characteristics of the Grass MR Conditional Cup Electrodes are identical to the predicate device (K171102), 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.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Grass® MR Conditional/CT Cup Electrodes. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria for AI/ML performance. As such, many of the requested details regarding AI/ML device performance studies (e.g., sample sizes for test/training sets, expert consensus for ground truth, MRMC studies, standalone performance) are not applicable or present in this specific regulatory submission.

The document primarily details the physical and functional characteristics of the electrodes and their compliance with safety standards and predicate device equivalency, particularly concerning MR conditional features.

However, I can extract the closest applicable information related to "acceptance criteria" and "device performance" based on the provided text, interpreting "performance" in the context of the device's electrical and physical properties as assessed for medical device regulatory submission.

Here's an attempt to fill in the table and answer the questions based on the provided non-AI/ML medical device submission:

Acceptance Criteria and Reported Device Performance (Non-AI/ML Device)

Acceptance Criteria (Target Performance)	Reported Device Performance
Electrical Resistance (Singles)	< 40Ω
< 40Ω (per FDA Guidance for Cutaneous Electrodes for Recording Purposes)	< 40Ω
Electrical Resistance (Arrays)	< 36.5Ω
< 36.5Ω (per FDA Guidance for Cutaneous Electrodes for Recording Purposes)	< 36.5Ω
Impedance (Average Value of 10-Hz for 12 electrode pairs)	2 kOhms Maximum
2 kOhms Maximum (per FDA Guidance for Cutaneous Electrodes for Recording Purposes)	2 kOhms Maximum
Impedance (Individual pair impedance)	3 kOhms Maximum
3 kOhms Maximum (per FDA Guidance for Cutaneous Electrodes for Recording Purposes)	3 kOhms Maximum
MR Conditional Conditions:	Met
- Static magnetic field: 1.5 or 3.0 Tesla	1.5 or 3.0 Tesla (Met)
- Max spatial field gradient: 3,000 gauss/cm [30 T/m]	3,000 gauss/cm [30 T/m] (Met)
- Max system reported whole-body averaged SAR: 2 W/kg	2 W/kg (Met)
- Max whole-head averaged SAR: 3.2 W/kg	3.2 W/kg (Met)
- Quadrature driven transmit body and head coil	Quadrature driven transmit body and head coil (Met)
- Normal operating mode SAR limits for 60 minutes of continuous RF	Normal operating mode SAR limits for 60 minutes of continuous RF (Met)
Electrical Safety	Compliant with IEC 60601-1 Edition 3.2 2020-08 Clause 8.5.2.3
Verified per IEC 60601-1 Edition 3.2 2020-08 Clause 8.5.2.3	Compliant (Met)
Packaging and Handling Verification	Successfully Passed
Verified per ASTM D4169	Successfully Passed (Met)
Functional and Performance Characteristics	Met internal requirements and specifications
Meets internal requirements and specifications	Met (Met)

Study Details (Based on available information for a non-AI/ML device submission):

Sample size used for the test set and the data provenance:
- The document does not specify a "test set" in the context of an AI/ML model. Instead, it refers to "non-clinical testing" and "bench verification & validation" performed on the physical device. The sample sizes for these tests (e.g., how many electrodes were tested for resistance or MR compatibility) are not explicitly stated.
- Data provenance: "Internal requirements and specifications," "accredited MR testing laboratory on behalf of Natus Medicals." The country of origin is not specified for the test data, but the applicant's address is Ireland. The tests conducted are "non-clinical" bench tests, not clinical studies, thus the retrospective/prospective distinction for patient data is not applicable.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the device is a physical medical electrode, not an AI/ML algorithm requiring expert ground truth for image or diagnostic interpretation. The "ground truth" here is established by physical measurement standards (e.g., resistance, impedance) and compliance with relevant ISO/IEC/ASTM standards. The "experts" would be the engineers and technicians performing and verifying these standard-based tests.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for physical device testing against predefined engineering and safety standards. Adjudication methods are typically employed in clinical studies or expert labeling tasks for AI/ML datasets.
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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is specifically designed for AI/ML devices that assist or replace human readers in diagnostic tasks. The Grass® MR Conditional/CT Cup Electrodes are physical electrodes for recording biosignals, not an AI/ML diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is not an algorithm. Bench testing for its physical and electrical properties was performed, which could be considered analogous to "standalone" performance for a physical device (i.e., its intrinsic properties were measured without human interaction influencing the measurement itself, beyond setup).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance validation is based on established engineering and safety standards (e.g., IEC 60601-1, ASTM D4169, FDA Guidance for Cutaneous Electrodes for Recording Purposes). Performance metrics like resistance and impedance have objectively defined acceptable ranges. For MR compatibility, the "ground truth" is determined by measurements against the specified MR environment conditions.
The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/ML model.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text.

August 29, 2024

Natus Manufacturing Limited % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K242346

Trade/Device Name: Grass® MR Conditional/CT Cup Electrodes, Single and Array Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: August 7, 2024 Received: August 7, 2024

Dear Prithul Bom:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Heather L. Dean -S

Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices

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OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K242346

Device Name

Grass® MR Conditional/CT Cup Electrodes Single

Grass® MR Conditional/CT Cup Electrodes, Array

ndications for Use (Describe)

This device is non-sterile for Single Patient Use Only and may remain on the patient in an MRI or CT environment under specific conditions.

Intended Patient Population:2 Years and Older.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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510K Summary

Preparation date: August 7, 2024

Applicant:

Address: Natus Manufacturing Limited, IDA Business Park Gort, Co. Galway, Ireland Contact Person: Sanjay Mehta, Director, Global Regulatory Affairs Natus Manufacturing Limited Tel.: (905) 829-5300 Fax .: (905) 829-5304 E-mail: sanjay.mehta(@natus.com

Device:

Proprietary Name: Grass® MR Conditional/CT Cup Electrodes ,Single, Grass® MR Conditional/CT Cup Electrodes, Array Classification Name: Cutaneous Electrode Regulation Number: 21 CFR 882.1320 Product code: GXY Device Class: II,

Predicate Device:

510K Number: K172503 MR Conditional Cup Electrode, MR Conditional Webb Electrode

Reference Device:

510K Number: K171102 Ives MR Conditional Cup Electrode

Indications for Use:

This device is non-sterile for Single Patient Use Only and may remain on the patient in an MRI or CT environment under specific conditions.

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Device Description:

Overview: Grass® MR Conditional/CT Cup Electrodes

Operating Principle of the Grass® MR Conditional/CT Cup Electrodes

System Setup Overview

Use a cotton tip applicator to apply a small amount of skin prep gel such as NuPrep® to the site of the electrode application scrubbing gently.

Fill the electrode cup with a conductive paste or gel such as Ten20®. Do not overfill the cup. Excessive amount of paste or gel can result in asymmetric signals.

Fix the cup to the patient with a small amount of pressure.

Use a small pre-cut gauze square or piece of paper tape to help secure the cup electrode to the application site.

Check that clear, strong signals are being transmitted.

When ready to remove the electrode cup, carefully remove gauze square or tape and remove any gel or paste with soap and water.

After use, discard the electrodes.

Device-patient interaction Accessories List:

Cup Electrodes are applied on the patient's skin, including but not limited to, the head (scalp). Only the cup portion of the Grass MR/CT Conditional Electrodes, which has contact with the patient (see the portion highlighted in green in Figure 2), is categorized as B - Prolonged (>24

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hours but <30 days). When accounting that up to 30 electrodes are used on the scalp of the patient at one time, the total contacting surface area corresponds to 14.4 cm².

Figure 1. Patient contacting part of the cups.

Image /page/6/Picture/3 description: The image shows a 3D rendering of a gray object with a green ring around the top. The object has a circular hole in the center. The text in the image states that the area is 48.1234 mm^2 and the perimeter is 117.218 mm.

The rest of the device (everything except the cups) is either contacting the hair of the patient or has very brief (transient contact) with the patient and caretaker during placement.

Grass® MR Conditional/CT Cup Electrodes does not have any accessory.

Intended User:

Grass® MR Conditional/CT Cup Electrodes and Arrays are for professional use only and should be used in compliance with accepted industry standards.

Intended Patient Population:

2 Years and Older.

Clinical Benefits:

Facilitates obtaining the recording of an EEG study to detect any irregularities indicative of various brain disorders.

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Comparison to Predicate Device

Feature	Subject DeviceGrass® MRConditional/CTCup Electrodes	PREDICATEDEVICERythmlink(K172503)	PREDICATEDEVICEIVES Electrode(K171102)	Similarities
IntendedUse/Indicationsfor Use	The MRConditional/CT cupelectrodes areintended for use inthe recording of theElectroencephalogram (EEG), theevoked potential(EP), or as a groundand reference in anEEG or EPrecording.This device is non-sterile for SinglePatient Use Onlyand may remain onthe patient in anMRI/CTenvironment underspecific conditions.	The MR ConditionalCup Electrodes areintended for use inthe recording of theElectroencephalogram (EEG), theevoked potential(EP), or as a groundand reference in anEEG or EPrecording. Thisdevice is non-sterile for SinglePatient Use Onlyand may remain onthe patient in anMRI environmentunder specificconditions.	The Ives MRConditional CupElectrodes are intendedfor use in the generalrecording andmonitoring of theelectroencephalography (EEG), evokedpotential (EP) as wellas ground andreference related to theEEG and EP recording.The Cup Electrodes areintended to be left inplace during MRimaging at 1.5T and 3Tas well as during CTscanning. Theextension cable mustbe disconnected fromthe Ives MRConditional CupElectrodes beforescanning and MUSTremain disconnectedthroughout the entireMR scan. EEG or EPshould not be recordedthroughout the entirethe CT and MRimaging.	Same as predicate
Configuratio ns	Single and Array	Single and Array	Not Available	Same as predicate
Feature	Subject Device	PREDICATEDEVICE	PREDICATEDEVICE	Similarities
	Grass® MRConditional/CTCup Electrodes	Rythmlink(K172503)	IVES Electrode(K171102)
MRConditions	Non-clinical testinghas demonstratedthat the MRConditional /CT Cupand Electrodes Arrayis MR Conditionalin configurations of1to 30 electrodes,using 5 to 9 arrays.These electrodescan safely remainon a patient during aMR scan meetingthe followingconditions:• Static magneticfield of 1.5 or 3.0Tesla Maximumspatial fieldgradient of 3,000gauss/cm [30 T/m]• Maximum MRsystem reportedwhole-bodyaveraged specificabsorption rate[SAR] of 2 W/kgand whole-headaveraged SAR of3.2 W/kg.• Quadrature driventransmit body andhead coil.• Normal operatingmode SAR limitsfor 60 minutes ofcontinuous RF	Non-clinical testinghas demonstratedthat the MRConditional CupElectrode array isMR Conditional inconfigurations of 2to 40 electrodes,using 1 to 4 arrays.These electrodes cansafely remain on apatient during anMR scan meetingthe followingconditions:• Static magneticfield of 1.5 and 3.0Tesla• Maximum spatialfield gradient of4,000 gauss/cm [40T/m]• Maximum MRsystem reportedwhole-bodyaveraged specificabsorption rate(SAR) of 2 W/kgand whole-headaveraged SAR of3.2 W/kg• Quadrature driventransmit body coilonly• Maximum activescan time of 15Minutes	MR Conditional andcan safely remain onthe patient during anMR scan under thefollowing conditions:• Static magnetic fieldsstrength of 1.5 T and3.0 T• Maximum spatialgradient magneticfields of 2,000gauss/cm (20T/m) orless• Transmit body andhead coil, quadraturedriven• Maximum MRSystem reported whole-body averaged specificabsorption rate (SAR)of 2 W/kg and whole-head averaged SAR of3.2 W/kg• The extension cablemust be disconnectedfrom the Ives MRConditional CupElectrodes beforescanning and mustremain disconnectedthroughout the entireMR scan.	Same as predicate
Feature	Subject DeviceGrass® MRConditional/CTCup Electrodes	PREDICATEDEVICERythmlink(K172503)	PREDICATEDEVICEIVES Electrode(K171102)	Similarities
ElectrodeMaterial	ABS 20% glassfilled, Ag/AgClcoated	ABS 20% glassfilled, Ag/AgClcoated	ABS molded plasticwith Ag- Ag/Cl	Same as predicate
ElectrodeDiameter	10mm	10mm	10 mm	Same as predicate
Wire	Carbon conductivecable, PVC coated	Conductive cable,PVC coated	Tinseled copper withsilver coat with	Equivalent in safetyand effectiveness
ElectrodeCable LengthSingles (Leadwire)	282 mm	28.2 cm (282mm)	Not Available	Similar to predicate
Electrode Cable 270 mmLength Arrays(Lead wire)	270 mm	18 cm	Tested at 15.24 cm(152.4 mm) to 27.94cm (279.4 mm) as well asmarketed	Equivalent in safetyand effectiveness;Non-clinical MRItesting and allperformance testingwas performed on270mm lengtharrays. Increase inlength doesn't affectsafety and effectivityof the device.
Connector	Touch proofmultipinconnector(s)	Touch proofmultipinconnector(s)	Touch proof multipinconnector(s)	Same as predicate
Feature	Subject DeviceGrass® MRConditional/CTCup Electrodes	PREDICATEDEVICERythmlink(K172503)	PREDICATEDEVICEIVES Electrode(K171102)	Similarities
MaxresistanceSingles	$< 40Ω$	Not available	Not available	Meets theperformance criteriaper FDA Guidancefor CutaneousElectrodes forRecording Purposes– PerformanceCriteria for Safetyand PerformanceBased Pathway.
MaxresistanceArrays	$< 36.5Ω$	Not available	Not available	Meets theperformance criteriaper FDA Guidancefor CutaneousElectrodes forRecording Purposes– PerformanceCriteria for Safetyand PerformanceBased Pathway.
Impedance	2 kOhmsMaximum(Average Value of10-Hz impedancefor 12electrode pairs), 3kOhms Maximum(Individual pairimpedance)	Not available	Not available	Meets theperformance criteriaper FDA Guidancefor CutaneousElectrodes forRecording Purposes– PerformanceCriteria for Safetyand PerformanceBased Pathway.

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The Grass® MR Conditional/CT Cup Electrodes and the predicate device are equivalent in features and technical characteristics. There are no major differences that alter the intended use or raise new issues of safety or effectiveness.

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Brief Summary of Performance Testing

Electrical Safety	The Grass® MR Conditional/CT Cup Electrodes was verified forperformance in accordance with the following standard:
	○ IEC 60601-1 Edition 3.2 2020-08 Clause 8.5.2.3 - Medical electricalequipment - Part 1: General requirements for basic safety and essentialperformance
Packaging andHandlingVerification	The packaged Natus Grass® MR Conditional/CT Cup Electrodes componentshave successfully passed packaging and handling verification per ASTMD4169
PerformanceTesting – BenchVerification &Validation	The Natus Grass® MR Conditional/CT Cup Electrodes has successfullypassed performance verification and validation in accordance with internalrequirements and specifications at the system level.The Bench testing verification and validation was performed to confirmdevice meets the functional and performance characteristics.
	Additionally, Natus Grass® MR Conditional/CT have been tested internallyand met defined acceptance criteria. The tests included:
	○ Functional Test○ Mechanical design Test○ Electrical Safety Test○ Biocompatibility Test○ Packaging○ FDA Guidance for Cutaneous Electrodes for Recording Purposes -Performance Criteria for Safety and Performance Based PathwayResults indicate that the Grass® MR Conditional/CT Cup Electrodessystem complies with its predetermined specifications and the applicable

Non-Clinical Testing:

The MR safety and performance equivalency of the Natus Grass® MR Conditional/CT Electrodes were determined using the same test methodology as the predicate device, summarized below:

Worst-case device configuration was established through feasibility testing. .
The established worst-case configuration of the finished device was tested to the applicable . ASTM standards:

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RF-Induced Heating O
o MR Image Artifact
Magnetically Induced Torque o
o Magnetically Induced Displacement Force

The results of these MR safety and functional tests determined the MR conditionality and device labelling 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 Natus Medicals. In summary, the non-clinical testing concluded that the Natus Grass® MR Conditional/CT Electrodes demonstrated equivalent functionality, safety, and effectiveness as the predicate device.

Clinical Tests:

No Clinical Tests were conducted as referenced in 21 CFR 807.92(b)(2).

Conclusions

The substantial equivalence of the Grass® MR Conditional/CT Cup Electrodes with the predicate device(s) was demonstrated by testing in compliance with the Design Control process. The intended use and technology of the Grass® MR Conditional/CT Cup Electrodes is similar to that of the predicate device(s). Verification and Validation were performed to ensure no new questions of safety or effectiveness are raised. The results of these activities demonstrate that the Gras® MR Conditional/CT Cup Electrodes is as safe, as effective, and performs as well as or better than the predicate device.

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).