The Medrad Shoulder 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 shoulder anatomy.

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

The Medrad Shoulder 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 Shoulder Coil is a receive only coil designed to enhance the MR Imaging of the shoulder anatomy.

AI/ML Overview

This is a 510(k) premarket notification for a medical device, specifically an MRI shoulder coil. The document describes a comparison between a proposed Medrad Shoulder Coil and a predicate GE Shoulder Coil. The core of the submission is to demonstrate substantial equivalence, rather than a clinical study evaluating a novel diagnostic algorithm.

Therefore, many of the requested categories for AI/algorithm performance studies are not applicable to this document. The device is a physical MRI coil, not a diagnostic algorithm.

Here's the information that can be extracted relevant to acceptance criteria and performance, as much as possible, acknowledging the limitations for an AI-focused request:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implicit from comparison)	Reported Device Performance
Signal-to-Noise Ratio (SNR) Comparison	SNR study conducted to compare with predicate device.
Image Uniformity (NEMA Standards)	Evaluated using NEMA Standards; contours constructed for axial and sagittal images.
Geometric Distortion (Absence of)	None (observed distortion of static magnetic field). Acknowledges "slightly magnetic materials" but positioned to avoid distortion.
Transmit RF Field [B1] Distortion (Absence of)	No significant currents induced; no artifacts observed.
Resolution, Slice Thickness, Contrast (No effect)	These parameters are not affected by a surface coil. Not separately tested.
Clinical Effectiveness	Clinical images for 1.5T coil provided to demonstrate effectiveness. Conclusion drawn for 0.5T and 1.0T based on 1.5T clinical images and SNR results.
Patient-Contacting Materials (Identical to predicate)	All materials are the same as the predicate GE shoulder coil.
Design and Manufacturing Responsibility	Medrad was responsible for predicate, remains responsible for proposed device.
Labeling	GE labeling for predicate, Medrad labeling for proposed device.
Mechanical and Electrical Identity	Mechanically and electrically identical to predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not explicitly stated for each test (SNR, uniformity). For "Clinical Evaluation," it shows "clinical images for the proposed 1.5T Shoulder Coil have been provided," but the number of images or patients is not specified.
Data Provenance: Not specified. Retrospective or prospective is not mentioned. Country of origin not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This document describes the performance of a physical MRI coil, not an AI or diagnostic algorithm, so there is no "ground truth" in the traditional sense of expert interpretation for diagnostic accuracy. The "clinical effectiveness" is demonstrated through imaging, implying visual assessment by radiologists, but details about expert involvement are not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method for diagnostic accuracy is mentioned, as this is not an AI/diagnostic algorithm study.

5. 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. This is not an MRMC study and does not involve AI assistance. The comparison is between two physical MRI coils.

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

Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable for diagnostic ground truth. For the physical performance tests (SNR, uniformity, distortion), the "ground truth" would be established by physical measurements and NEMA standards, as well as visual inspection by engineers and physicists regarding the absence of distortion or artifacts. For "clinical effectiveness," the "ground truth" is implied to be the visual quality and diagnostic utility of the images as interpreted by medical professionals, but the method for establishing this is not detailed.

8. The sample size for the training set

Not applicable. This pertains to a physical device, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This pertains to a physical device, not an AI algorithm.

Summary

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982916

OCT 2 9 1998

510(k) SUMMARY MEDRAD .5T, 1.0T, 1.5T SHOULDER 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 Shoulder Coil
PREDICATE DEVICES:	General Electric (GE) Shoulder Coil

DEVICE DESCRIPTION:

The Medrad Shoulder Coil is a receive only coil designed to enhance the MR Imaging of the shoulder anatomy.

INTENDED USE:

Anatomical Region:	right or left shoulder anatomy
Nuclei Excited:	Hydrogen
Diagnostic Uses:	2D and 3D Imaging

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PROPOSED MEDRAD SHOULDER COIL TECHNICAL COMPARISON TO PREDICATE DEVICES:

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

GE Shoulder Coil(K892235)	Medrad Shoulder Coil
GE labeling	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 SHOULDER TECHNICAL COMPARISON TO PREDICATE DEVICES:

Patient contacting materials comparison information
GE Shoulder Coil	Medrad Shoulder Coil
Reference K892235 formaterial information	All materials used are thesame as the GE shouldercoil. (Predicate device)
Certification: Medrad, Inc. certifies that the patientcontacting materials and formulations forthe proposed Medrad Shoulder 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 Shoulder coil and the predicate GE Shoulder Coil.

IMAGE UNIFORMITY - The Medrad Shoulder 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 and sagittal image.

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 Shoulder Coil.

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

CONCLUSION - Extensive safety, verification, durability and clinical testing was conducted on the predicate GE device (K 892235). Mechanically and electrically the proposed device and the predicate device 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 is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 29 1998

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

Re:

K982916 Medrad Shoulder Coil 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 Federal 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 (QS) 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/dsmardsmamain.html".

Sincerely yours,

Kilian Yin

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

Enclosure

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Page 1

510(k) NUMBER (IF KNOWN) :

DEVICE NAME: Medrad Shoulder Coil

INDICATIONS FOR USE:

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

The Medrad Shoulder 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) √

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

David C. Ingram
Division Sign Off

(Division Sign-Off) Division of Reproductive, Abdominal, EN 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.