The Medrad Breast Coil is a receive only coil intended to be used with the General Electric Superconducting MRI Scanners. This coil is intended to facilitate complete MR imaging of the breast anatomy.

The Medrad Breast Coil is a receive only coil intended to be used MRI Scanner Systems for imaging of the breast anatomy.

The Medrad Breast Coil is intended for use only under the supervision of a physician who is trained in the field of Diagnostic Resonance Imaging.

Device Description

The Medrad Breast Coil is a receive only coil designed to enhance the MR lmaging of the breast anatomy. This coil is designed to be used optimally with either a conventional Signa 1.5T system, or a system including the Phased Array upgrade.

AI/ML Overview

Here's an analysis of the provided text regarding the Medrad Breast Coil, focusing on acceptance criteria and the supporting study:

The provided document, a 510(k) summary (K982921), describes a medical device, the Medrad Breast Coil, and its comparison to a predicate device for regulatory clearance. It does not contain a typical "acceptance criteria" table with specific thresholds for performance metrics. Instead, the "acceptance criteria" appear to be implicit in demonstrating substantial equivalence to a legally marketed predicate device (GE Breast Coil) by showing that the new device performs as well as or better than the predicate, or that any differences do not raise new questions of safety or effectiveness.

The "study" conducted to "prove the device meets the acceptance criteria" is primarily a technical comparison and performance evaluation against the predicate device, rather than a standalone clinical trial with pre-defined success metrics.

Here's the information broken down:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Substantial Equivalence to Predicate Device	Conclusion: The proposed device is deemed substantially equivalent to the predicate GE Breast Coil (K923025). "Mechanically and electrically the devices are identical. This labeling change is the only change to the device."
Signal-to-Noise Ratio (SNR) Comparable to Predicate	SNR Study Conducted: A Signal to Noise Ratio (SNR) study was conducted to generate a comparison between the proposed Medrad Breast coil and the predicate GE Breast Coil. The summary implies the results were favorable or at least non-inferior to support substantial equivalence. (Specific numerical results are not provided in this summary.)
Image Uniformity Acceptable per NEMA Standards	Evaluated using NEMA Standards: The Medrad Breast Coil was evaluated using NEMA Standards to characterize the non-uniformity of the proposed coil. Contours of the images obtained were constructed for axial and sagittal views. (Specific results or acceptance thresholds are not provided, but the conclusion implies satisfactory uniformity.)
No Geometric Distortion	Geometric Distortion: "None." The device contains slightly magnetic materials, but they are positioned "so that no observable distortion of the static magnetic field is present."
No Transmit RF Field [B1] Distortion / No Artifacts	Transmit RF Field [B1] Distortion: Analysis of electrical design and blocking network demonstrates "no significant currents are induced." "No artifacts of any type were observed during imaging."
Preservation of Resolution, Slice Thickness, and Contrast	Resolution, Slice Thickness, and Contrast: "These performance parameters are not affected by the use of a surface coil and were not separately tested in the performance evaluation of the proposed Medrad Breast Coil." (This is an assertion based on the coil type, rather than a direct measurement that met a criterion).
Clinical Effectiveness Demonstrated	Clinical Evaluation: "Clinical images for the proposed 1.5T Breast Coil have been provided with this submission to demonstrate the clinical effectiveness of the breast coils." Based on these, and SNR for .5T/1.0T coils, Medrad concludes that the .5T/1.0T coils will produce "similar clinical image results." (Specific clinical metrics are not provided).
Patient-Contacting Materials are Safe and Identical to Predicate	Material Comparison: "All materials used are the same as the GE Breast coil (Predicate device)." Medrad certifies materials for the proposed device are "unchanged from currently marketed devices."

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

Test Set Sample Size: Not explicitly stated for any of the performance tests (SNR, Image Uniformity, Clinical Evaluation).
Data Provenance: Not explicitly stated (e.g., country of origin). The document describes general performance evaluations and clinical images. It doesn't specify if these were from a particular study population or retrospective/prospective collection. Given the context of a 510(k) summary for a component (coil), this evaluation would likely be conducted in a controlled environment (e.g., lab, imaging facility) rather than a broad clinical trial.

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

This type of detail is not provided in the 510(k) summary. The evaluation focuses on technical performance and image characteristics rather than interpretation-based "ground truth" established by experts for a diagnostic output. The "clinical images" were provided to "demonstrate clinical effectiveness," implying review by qualified personnel, but details are absent.

4. Adjudication Method for the Test Set

Not applicable as the evaluation described is primarily technical performance testing and image characteristic assessment, not diagnosis or interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document describes technical evaluations and a submission of "clinical images" to demonstrate effectiveness, but not a study comparing human readers with and without AI assistance, or comparing human reader performance using different coils in an MRMC design.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is an MRI breast coil, which is a hardware component. It does not involve an algorithm or AI that would have "standalone" performance in the sense of a software-as-a-medical-device (SaMD). Its performance is directly tied to the image acquisition process.

7. The Type of Ground Truth Used

The term "ground truth" in the diagnostic sense (e.g., pathology, outcomes) is not applicable here. The "truth" for the performance tests would be the established engineering and imaging physics standards (e.g., NEMA standards for image uniformity, physical measurements for distortion, electrical design analysis). For the "clinical images," their "effectiveness" would be judged by their ability to clearly depict breast anatomy, which is a qualitative assessment by imaging professionals.

8. The Sample Size for the Training Set

Not applicable. The Medrad Breast Coil is a hardware device (receive-only coil) and does not involve AI/machine learning algorithms that require a "training set."

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

Not applicable. As above, no training set is involved for this hardware device.

Summary

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3 1998 NOV

K982921

510(k) SUMMARY MEDRAD .5T, 1.0T, 1.5T BREAST COILS

OFFICIAL CONTACT:	Jim Ferguson, Jr.Sr. Regulatory Affairs AssociateMedrad, Inc.One Medrad DriveIndianola, PA 15051(412) 767-2400 Ext. 3326
CLASSIFICATION NAME:	Magnetic Resonance Diagnostic Accessory[21 CFR 892.1000}
COMMON/USUAL NAME:	MR Imaging Surface Coil
PROPRIETARY NAME:	Medrad Breast Coil
PREDICATE DEVICES:	General Electric (GE) Breast Coil

DEVICE DESCRIPTION:

INTENDED USE:

Anatomical Region:	Breast anatomy
Nuclei Excited:	Hydrogen
Diagnostic Uses:	2D and 3D Imaging

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510(k) Summary Medrad Breast Coil Page 2 of 3

PROPOSED MEDRAD BREAST COIL TECHNICAL COMPARISON TO PREDICATE DEVICES:

The following table compares the predicate GE Breast Coil and the proposed Medrad Breast Coil.

GE Breast Coil (K923025)	Breast Coil0 00 0 0 0 0 0 0 0 0 0 0 0
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------oo laheling	Medrad labeling

Medrad was responsible for the design and manufacturing of the predicate device, and will remain responsible for the design and manufacturing for the proposed device. The device will be labeled and marketed as "Medrad Product". This is the only change to the device.

PROPOSED MEDRAD BREAST TECHNICAL COMPARISON TO PREDICATE DEVICES(Cont.):

Patient contacting materials comparison information
GE Breast Coil	Medrad Breast Coil
Reference K 923025 formaterial information	All materials used are thesame as the GE Breast coil.(Predicate device)
Certification: Medrad, Inc. certifies that the patientcontacting materials and formulations forthe proposed Medrad Breast Coils areunchanged from currently marketeddevices.

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PERFORMANCE TEST DATA:

SIGNAL TO NOISE RATIO (SNR)

A Signal to Noise Ratio(SNR) study was conducted to generate a Signal -To-Noise ratio comparison between the proposed Medrad Breast coil and the predicate GE Breast Coil.

IMAGE UNIFORMITY - The Medrad Breast Coil was evaluated using NEMA Standards to characterize the non-uniformity of the proposed coil. Contours of the images obtained with the coil were constructed for the axial image, sagittal imaqe.

GEOMETRIC DISTORTION: None. Static magnetic field distortion results from the use of magnetic materials in the construction of a surface coil. This device contains slightly magnetic materials or components. However, such-components have been positioned within the surface coil so that no observable distortion of the static magnetic field is present.

TRANSMIT RF FIELD [B1] DISTORTION - Analysis of the electrical design of the coil and its blocking network demonstrates that no significant currents are induced. No artifacts of any type were observed during imaging.

RESOLUTION. SLICE THICKNESS. AND CONTRAST - These performance parameters are not affected by the use of a surface coil and were not separately tested in the performance evaluation of the proposed Medrad Breast Coil.

CLINICAL EVALUATION - Clinical images for the proposed 1.5T Breast Coil have been provided with this submission to demonstrate the clinical effectiveness of the breast coils. Based on these results, and the SNR results for the proposed .5T and 1.0T breast Coils, Medrad concludes that the proposed .5T and 1.0T breast Coils will produce similar clinical image results.

CONCLUSION - Extensive safety, verification, durability and clinical testing was conducted on the predicate GE device. (K 923025). Mechanically and electrically the devices are identical. This labeling change is the only change to the device. The proposed device is deemed by Medrad to be substantially equivalent.

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with its wings spread, with three human profiles superimposed on the eagle's body. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

10008 3 NOV

Jim Ferguson, Jr. Sr. Regulatory Affairs Associate Medrad, Inc. One Medrad Drive Indianola, PA 15051

Re: K982921 Medrad Breast Coil Models M21BRC, M42BRA and M64BRA Dated: August 18, 1998 Received: August 19, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS

Dear Mr. Ferguson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Fecteral Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdri/dsmadsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.

Lillian Yin, Ph.D Director, Division of Reprodu Abdominal, Ear, Nose and Thro and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) NUMBER (IF KNOWN): KUS290

Medrad Breast Coil DEVICE NAME:

INDICATIONS FOR USE:

The Medrad Breast Coil is a receive only coil intended to be used MRI Scanner Systems for imaging of the breast anatomy.

The Medrad Breast Coil is intended for use only under the supervision of a physician who is trained in the field of Diagnostic Resonance Imaging.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

くな Over-The-Counter-Use (Optional Format 1-2-96)

Division Sign Off

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dev 510(k) Number

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.