The 3.0T 48CH Head Coil is a receive-only RF coil designed for use with select 3.0T MRI systems manufactured by GE Healthcare. The coil is indicated for use for head imaging. The nucleus excited is hydrogen.

Device Description

The 48CH Head Coil is a phased-array receive-only coil designed to provide optimum signal-to noise, uniform coverage and high acceleration including multiband imaging of the head and brain. It is a 48-element coil tuned to image proton nuclei and designed for use with GE 3.0T MRI Systems. Each coil element has an integrated preamplifier to improve image quality. The 48CH Head Coil has an anterior coil and a posterior coil with P-connectors. The coil has optimized pads to maximize patient comfort and image uniformity.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, specifically a 48CH Head Coil for MRI systems. The FDA letter and the 510(k) summary provided indicate that this device is being submitted as substantially equivalent to a previously cleared predicate device (48CH Head Coil, K163205).

Key takeaway: The regulatory submission explicitly states that clinical studies were not required to support substantial equivalence for this device. This means the information requested about acceptance criteria, detailed study design (sample size for test/training sets, number of experts, adjudication, MRMC, standalone performance, ground truth establishment) is largely not applicable in the context of this specific 510(k) submission.

The submission focuses on non-clinical testing to demonstrate that the device is as safe and effective and performs in a substantially equivalent manner to the predicate, despite a minor design change (decoupling circuit).

Therefore, I cannot provide the requested information about acceptance criteria for a clinical study or a detailed study description because the submission states that no clinical studies were performed or required.

Here's what can be extracted and inferred from the provided text regarding the closest equivalent to "acceptance criteria" and "study" for this specific type of submission:

Acceptance Criteria and Study for Substantial Equivalence (Non-Clinical Focus)

Since this 510(k) relies on substantial equivalence established through non-clinical testing, the "acceptance criteria" are not for clinical performance metrics (like sensitivity/specificity of an AI algorithm), but rather for demonstrating that the new device performs equivalently to the predicate in terms of safety and technical specifications.

1. Table of "Acceptance Criteria" and "Reported Device Performance" (Non-Clinical Context):

Acceptance Criterion (Implied)	Reported "Device Performance" (from 510(k) Summary)
Functional Equivalence: Device performs its intended use reliably and effectively.	"The 48CH Head Coil device performs as intended."
Safety Compliance: Device meets recognized safety standards.	"The predicate and modified devices have been subject to the same risk management testing to demonstrate substantial equivalence of safety and performance.""Testing included: AAMI/ANSI ES60601-1 IEC 60601-1-2 IEC 60601-2-33 MS6-2008 Maximum B1 Peak Blocking Network Analysis Surface Temperature Testing""The 48CH Head Coil complies with the same safety and performance testing as the predicate device."
Technical Equivalence: Core technology and operational principles are the same as the predicate.	"The 48CH Head Coil employs the same fundamental scientific technology as its predicate device.""Coil Design: The 48CH Head Coil design is the same as the predicate device but implements a design change to the decoupling circuit." (Acknowledged difference, but deemed not to raise new safety/effectiveness questions)."Operating Principles: The 48CH Head Coil operates on the same principles as the predicate device.""Materials: The 48CH Head Coil uses the same materials as the predicate device."
Intended Use Equivalence: Indications for Use are identical to the predicate.	"The 3.0T 48CH Head Coil is a receive-only RF coil designed for use with select 3.0T MRI systems manufactured by GE Healthcare. The coil is indicated for use for head imaging. The nucleus excited is hydrogen.""The intended use statements are identical [to the predicate]."

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

Not Applicable. No clinical test set data was reported as part of this 510(k) submission. The testing performed was non-clinical (e.g., electrical, thermal, mechanical bench testing).
The document explicitly states: "The subject of this premarket submission, the 48CH Head Coil, did not require clinical studies to support substantial equivalence."

3. Number of Experts Used and Qualifications:

Not Applicable. No clinical ground truth was established by experts for a test set, as no clinical study was performed or required.

4. Adjudication Method:

Not Applicable. No clinical test set to adjudicate.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not Applicable. No clinical study comparing human reader performance with or without AI assistance was conducted or reported. This device is an MRI coil, not an AI-powered diagnostic algorithm.

6. Standalone (Algorithm Only) Performance:

Not Applicable. This device is an MRI coil, not a standalone algorithm.

7. Type of Ground Truth Used:

Not Applicable for clinical ground truth. For the non-clinical testing, the "ground truth" would be established engineering specifications, safety standards (e.g., IEC 60601 series), and performance metrics of the predicate device against which the new device was compared (e.g., signal-to-noise ratio measurements, temperature limits, B1 field uniformity targets).

8. Sample Size for the Training Set:

Not Applicable. This device is an MRI coil, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

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

Not Applicable. No training set exists for this type of device.

In summary, the provided document clearly states that this 510(k) submission for the 48CH Head Coil did not require clinical studies to demonstrate substantial equivalence, relying instead on non-clinical testing. Therefore, the detailed questions related to clinical study design, data, experts, and ground truth are not applicable to the information contained within this regulatory filing.

Summary

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April 12, 2018

GE Healthcare Coils (USA Instruments, Inc.) Veronica Meridith Regulatory Affairs Leader 1515 Danner Drive Aurora, Ohio 44202

Re: K180666

Trade/Device Name: 48CH Head Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: MOS Dated: March 12, 2018 Received: March 14, 2018

Dear Veronica Meridith:

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 manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 mediation-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,

Michael D. O'Hara For

Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K180666

Device Name 48CH Head Coil

Indications for Use (Describe)

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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510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date:	March 12, 2018
Submitter:	GE Healthcare Coils (USA Instruments, Inc.)1515 Danner DriveAurora, OH 44202USA
Primary Contact Person:	Veronica MeridithRegulatory Affairs LeaderGE HealthcarePhone: 262-955-5427Fax: 414-908-9585
Secondary Contact Person:	Andrew MendenRegulatory Affairs ManagerGE HealthcarePhone: 262-521-6223Fax: 414-908-9585
Device Trade Name:	48CH Head Coil
Common/Usual Name:	Coil, Magnetic Resonance, Specialty
Classification Names:	Magnetic Resonance Diagnostic Device per 21 CFR 892.1000
Product Code:	MOS
Predicate Device(s):	48CH Head Coil (K163205)
Device Description:	The 48CH Head Coil is a phased-array receive-only coildesigned to provide optimum signal-to noise, uniform coverageand high acceleration including multiband imaging of the headand brain. It is a 48-element coil tuned to image proton nucleiand designed for use with GE 3.0T MRI Systems. Each coilelement has an integrated preamplifier to improve imagequality. The 48CH Head Coil has an anterior coil and aposterior coil with P-connectors. The coil has optimized pads tomaximize patient comfort and image uniformity.
Intended Use:	The 3.0T 48CH Head Coil is a receive-only RF coil designedfor use with select 3.0T MRI systems manufactured by GEHealthcare. The coil is indicated for use for head imaging. Thenucleus excited is hydrogen.
Comparison of Intended Use:	The intended use statements are identical.
Comparison of TechnologicalCharacteristics:	The 48CH Head Coil employs the same fundamental scientifictechnology as its predicate device.Coil Design: The 48CH Head Coil design is the same as thepredicate device but implements a design change to thedecoupling circuit.Operating Principles: The 48CH Head Coil operates on thesame principles as the predicate device.Materials: The 48CH Head Coil uses the same materials as thepredicate device.Safety and Performance Testing: The 48CH Head Coilcomplies with the same safety and performance testing as thepredicate device.These technological differences do not raise any differentquestions of safety and effectiveness.
Determination of SubstantialEquivalence:	Summary of Non-Clinical Tests:The predicate and modified devices have been subject to thesame risk management testing to demonstrate substantialequivalence of safety and performance.Testing included: AAMI/ANSI ES60601-1 IEC 60601-1-2 IEC 60601-2-33 MS6-2008 Maximum B1 Peak Blocking Network Analysis Surface Temperature Testing The predicate and modified devices use the same patient

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Summary of Clinical Tests:	The subject of this premarket submission, the 48CH Head Coil, did not require clinical studies to support substantial equivalence.
Substantial Equivalence Conclusion:	The indications for use of the proposed device are identical to the claimed predicate device. The 48CH Head Coil employs equivalent technology to the claimed predicate device. Additionally, the results from the above non-clinical tests demonstrate that the device performs as intended. Thus, the 48CH Head Coil is substantially equivalent to the predicate device to which it has been compared.
Conclusion:	GE Healthcare considers the 48CH Head Coil to be as safe and effective, and performs in a substantially equivalent manner to the predicate device.

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.