The 3.0T 16ch AIR AA is a receive-only RF coil designed for use with GE 3.0T MRI systems to produce diagnostic images of general human anatomy, including extremities. The nucleus detected is hydrogen.

Device Description

The 3.0T 16ch AIR AA is a receive-only coil designed to provide optimum signal-to noise and uniform coverage of general human anatomy including extremities. The coil has 16 elements tuned to image proton nuclei. Each coil element has an integrated preamplifier to improve image quality. The 3.0T 16ch AIR AA is provided with a P-connector that is compatible with GE Healthcare 3.0T MR systems. The coils have a soft material to conforms to the patient's anatomy and maximize patient comfort.

AI/ML Overview

This document describes a 510(k) premarket notification for the GE Healthcare 3.0T 16ch AIR AA, a receive-only RF coil for MRI systems. The submission asserts substantial equivalence to a predicate device (1.5T 16ch AIR AA, K182590) based on non-clinical and clinical testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Defined in FDA Guidance Document "Magnetic Resonance (MR) Receive-only Coil - Performance Criteria for Safety and Performance Based Pathway")	Reported Device Performance (Summary from submission)
Image Quality:	Met:
Image Signal-to-Noise Ratio (SNR) in accordance with NEMA MS-9	Satisfied performance criteria.
Image Uniformity in accordance with NEMA MS-9	Satisfied performance criteria.
Diagnostic Quality Images for various anatomies and pulse sequences	Determined to be of diagnostic quality by a U.S. Board Certified Radiologist.
Safety:	Met:
Surface heating in accordance with NEMA MS-14	Satisfied performance criteria.
Inspection of decoupling circuitry	Satisfied performance criteria.
EMC testing for immunity from electrostatic discharge in accordance with applicable portions of IEC 60601-1-2	Satisfied performance criteria.
General electrical and mechanical safety in accordance with applicable portions of AAMI/ANSI ES 60601-1 and IEC 60601-2-33	Satisfied performance criteria.
Biocompatibility assessment in accordance with the ISO 10993 series of standards	Satisfied performance criteria.

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

Non-Clinical Testing: The document does not specify a "sample size" in terms of number of patients or cases for the non-clinical tests (SNR, Uniformity, Heating, etc.). These tests are typically performed on the device itself under controlled laboratory conditions. The data provenance is implied to be from GE Healthcare's testing facilities.
Clinical Testing: The document states "sample clinical images have been obtained from various anatomies and using various pulse sequences." The exact number of images, patients, or cases is not specified. The provenance of this data (e.g., country of origin, retrospective or prospective) is also not specified.

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

Non-Clinical Testing: Ground truth for non-clinical tests is based on established engineering standards (NEMA, IEC, AAMI/ANSI, ISO). No human experts are explicitly mentioned for establishing ground truth in this context, as measurements are objective.
Clinical Testing: The diagnostic quality of the sample clinical images was "assessed by a U.S. Board Certified Radiologist." This indicates one expert was used. Their qualification is a "U.S. Board Certified Radiologist." The exact experience level (e.g., 10 years) is not specified.

4. Adjudication Method for the Test Set

Non-Clinical Testing: Not applicable, as objective standards are used.
Clinical Testing: Inferred as none, as only one radiologist assessed the images for diagnostic quality. There is no mention of multiple readers or an adjudication process.

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

No, an MRMC comparative effectiveness study was NOT done. The document explicitly states "sample clinical images have been obtained... and determined to be of diagnostic quality" by a single radiologist. There is no mention of comparing human readers with and without AI assistance, or any effect size. This device is a hardware component (MRI coil), not an AI algorithm designed to assist human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not directly applicable as the device is an MRI receive coil, which is a hardware component, not an AI algorithm. The performance being evaluated is the image quality and safety of the coil itself. The clinical testing focuses on whether the images produced by the coil are diagnostically acceptable.

7. The Type of Ground Truth Used

Non-Clinical Testing: Ground truth is based on engineering standards and direct physical measurements (e.g., SNR values, temperature readings, electrical parameters).
Clinical Testing: Ground truth for image diagnostic quality is based on expert consensus (specifically, the assessment of a U.S. Board Certified Radiologist).

8. The Sample Size for the Training Set

Not Applicable. This document describes the clearance of a hardware device (an MRI coil), not an AI algorithm that requires a training set.

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

Not Applicable. As mentioned above, this is a hardware device approval, not an AI algorithm.

Summary

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January 3, 2023

GE Healthcare Coils (USA Instruments, Inc.) % Lauren Ross Regulatory Affairs Leader 1515 Danner Drive Aurora, Ohio 44202

Re: K223378

Trade/Device Name: 3.0T 16ch AIR AA Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: MOS Dated: November 4, 2022 Received: November 7, 2022

Dear Lauren Ross:

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. 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 located 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.

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

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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) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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,

Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K223378

Device Name 3.0T 16ch AIR AA

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)X 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:	January 3, 2022
Submitter:	GE Healthcare Coils (USA Instruments, Inc.)1515 Danner DriveAurora, OH 44202USA
Primary Contact Person:	Lauren RossRegulatory Affairs LeaderGE HealthcarePhone: 262-399-5721
Secondary Contact Person:	Andrew MendenRegulatory Affairs LeaderGE HealthcarePhone: 262-399-5721
Device Trade Name:	3.0T 16ch AIR AA
Common/Usual Name:	Coil, Magnetic Resonance, Specialty
Product Classification:
Classification Name:	Magnetic Resonance Diagnostic Device
Regulation Number:	21 CFR 892.1000
Product Code:	MOS
Predicate Device:	1.5T 16ch AIR AA (K182590)

Device Description:

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Indications Use:

Comparison of the Indications for Use:

Both the 3.0T 16ch AIR AA and the predicate device are classified as coils for magnetic resonance imaging devices and are intended for diagnostic use. Both indications for use statements are functional in nature, and do not list specific diseases or conditions. The 3.0T 16ch AIR AA and the predicate device are indicated for the same patient population, and for the same clinical setting.

Therefore, GE Healthcare believes that the 3.0T 16ch AIR AA has the same intended use as the predicate device in accordance with the FDA's quidance document "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]", dated 28 July 2014.

Comparison of Technological Characteristics:

The most notable technological difference between the 3.0T 16ch AIR AA and the predicate device is that the 3.0T 16ch AIR AA is tuned to the frequency for imaging hydrogen nuclei (protons) at 3.0T. while the predicate device is intended for 1.5T. This technological difference does not raise any different questions of safety and effectiveness. Both devices must address questions of whether they provide appropriate mitigations for electrical, mechanical, thermal, and biocompatibility risks, and provide an adequate level of image quality for diagnostic use.

Summary of Non-Clinical Tests:

The 3.0T 16ch AIR AA has undergone the following testing:

. Image Signal-to-Noise Ratio (SNR) in accordance with NEMA MS-9
. Image Uniformity in accordance with NEMA MS-9
. Surface heating in accordance with NEMA MS-14
Inspection of decoupling circuitry
. EMC testing for immunity from electrostatic discharge in accordance with applicable portions of IEC 60601-1-2
. General electrical and mechanical safety in accordance with applicable portions of AAMI/ANSI ES 60601-1 and IEC 60601-2-33
. Biocompatibility assessment in accordance with the ISO 10993 series of standards

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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. There are three white flourishes or droplets surrounding the circle, positioned at roughly equal intervals. The logo is simple and recognizable, representing the multinational conglomerate.

The results of the non-clinical tests satisfy the performance criteria defined in the FDA guidance document Magnetic Resonance (MR) Receive-only Coil - Performance Criteria for Safety and Performance Based Pathway.

Summary of Clinical Tests:

In accordance with the FDA guidance document Magnetic Resonance (MR) Receiveonly Coil - Performance Criteria for Safety and Performance Based Pathway, sample clinical images have been obtained with the 3.0T 16ch AIR AA from various anatomies and using various pulse sequences. The sample images have been assessed by a U.S. Board Certified Radiologist and determined to be of diagnostic quality.

Substantial Equivalence Conclusion:

The indications for use of the proposed devices are comparable to the claimed predicate devices. The 3.0T 16ch AIR AA employs equivalent technology to the claimed predicate devices. Additionally, the results from the above non-clinical tests demonstrate that the devices perform as intended. Thus, the 3.0T 16ch AIR AA are substantially equivalent to the predicate device to which they have been compared.

Conclusion:

Based on the results of the non-clinical testing, GE Healthcare concludes that the 3.0T 16ch AIR AA is as safe, as effective, and performs as well as or better than the predicate device. The 3.0T 16ch AIR AA also meets the performance criteria outlined in the Magnetic Resonance (MR) Receive-only Coil - Performance Criteria for Safety and Performance Based Pathway guidance.

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.