The Medrad Anterior Neck 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 area superior to the oral pharynx and inferior to the brachial plexus. This area includes the pharynx, throat, tongue, larynx and thyroid regions anatomy.

The Medrad Anterior Neck Coil is a receive only coil intended to be used in MRI Scanner Systems for imaging of the area superior to the oral pharynx and inferior to the brachial plexus.

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

Device Description

The Medrad Anterior Neck Coil is a receive only coil designed to enhance the MR Imaging of the area superior to the oral pharynx and inferior to the brachial plexus. This area includes the pharynx, throat, tongue, larynx and thyroid regions.

AI/ML Overview

The provided text describes a 510(k) submission for the Medrad Anterior Neck Coil, which is an MR Imaging Surface Coil. The submission focuses on demonstrating substantial equivalence to a predicate device, the General Electric (GE) Anterior Neck Coil, rather than presenting a study proving a specific performance claim against acceptance criteria for a new clinical indication.

Here's a breakdown of the requested information based on the provided text:

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

For a substantial equivalence submission, acceptance criteria are generally met by demonstrating that the new device is as safe and effective as the predicate device. The performance data primarily focuses on comparing physical and technical characteristics.

Acceptance Criteria (Implied by Substantial Equivalence to Predicate)	Reported Medrad Anterior Neck Coil Performance (Comparison to Predicate)
Signal-to-Noise Ratio (SNR) equivalent to predicate device	A Signal-to-Noise Ratio (SNR) study was conducted to generate a Signal-To-Noise ratio comparison between the proposed Medrad Anterior Neck coil and the predicate GE Anterior Neck Coil. (No specific numerical values or acceptance thresholds are provided, but the conclusion implies performance is acceptable for substantial equivalence).
Image Uniformity acceptable/equivalent to predicate device	The Medrad Anterior Neck 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. (No specific thresholds or quantitative results are provided, but the implied conclusion is positive).
No significant Geometric Distortion	None. "No observable distortion of the static magnetic field is present."
No significant Transmit RF Field B1 Distortion / artifacts	"No significant currents are induced. No artifacts of any type were observed during imaging."
Resolution, Slice Thickness, and Contrast unaffected by coil use	"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 Anterior Neck Coil." (This is a statement of expectation rather than a direct test result for the new device).
Clinical effectiveness similar to predicate device	Clinical images for the proposed 1.5T Anterior Neck Coil have been provided with this submission to demonstrate the clinical effectiveness of the Anterior Neck coils. Based on these results, and the SNR results for the 1.0T Anterior Neck Coil, Medrad concludes that the proposed 1.0T Anterior Neck Coil will produce similar clinical image results.
Patient contacting materials are safe and equivalent to predicate device	"All materials used are the same as the GE Anterior Neck coil. (Predicate device)." "Medrad, Inc. certifies that the patient contacting materials and formulations for the proposed Medrad Anterior Neck Coils are unchanged from currently marketed devices."

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

The document does not specify the sample size for any test sets beyond stating "clinical images" were provided. The provenance of the data (country of origin, retrospective/prospective) is 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)

No information is provided regarding the number or qualifications of experts used for any evaluation.

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

No adjudication method is described.

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 MRMC study was conducted. This device is an MRI coil, not an AI or software device. The focus is on the coil's physical and imaging characteristics.

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

Not applicable. This is not an AI algorithm.

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

For the clinical evaluation, the "clinical effectiveness" was demonstrated using "clinical images," implying that the visual assessment of these images by unspecified individuals, presumably radiologists or medical professionals, served as the basis for concluding their effectiveness. This is akin to expert opinion/visual assessment of image quality for diagnostic adequacy. For technical parameters like SNR, image uniformity, and geometric distortion, the ground truth would be quantitative measurements against established engineering standards (e.g., NEMA standards for uniformity).

8. The sample size for the training set

Not applicable. This is not an AI algorithm.

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

Not applicable. This is not an AI algorithm.

Summary of the Study and Conclusion:

The "study" described is a technical comparison and performance evaluation for a 510(k) premarket notification. The core of the submission is to demonstrate that the Medrad Anterior Neck Coil is substantially equivalent to the predicate GE Anterior Neck Coil. The key finding is that Medrad was the original designer and manufacturer of the GE predicate device, and the proposed Medrad device is "exactly the same as the proposed device except for the labeling."

The performance data includes:

Signal to Noise Ratio (SNR) study: Conducted to compare the proposed coil to the predicate.
Image Uniformity evaluation: Using NEMA Standards.
Geometric Distortion assessment: Concluding "none" due to careful placement of slightly magnetic materials.
Transmit RF Field B1 Distortion analysis: Concluding "no significant currents are induced" and "no artifacts of any type."
Resolution, Slice Thickness, and Contrast: Stated to be unaffected by the use of a surface coil and not re-tested.
Clinical Evaluation: Clinical images were provided for the 1.5T coil to demonstrate effectiveness, with the conclusion that the 1.0T coil would produce similar results based on this and SNR data.

The overarching conclusion is that due to the device being essentially identical to the predicate (manufactured by the same company) and undergoing safety, verification, durability, and clinical testing as the predicate, the proposed device is substantially equivalent.

Summary

{0}------------------------------------------------

NOV 2 1998

510(k) SUMMARY MEDRAD 1.0T, 1.5T ANTERIOR NECK 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 Anterior Neck Coil
PREDICATE DEVICES:	General Electric (GE) Anterior Neck Coil

DEVICE DESCRIPTION:

INTENDED USE:

Anatomical Region:	The area superior to the oral pharynx andinferior to the brachial plexus. This areaincludes the pharynx, throat, tongue, larynx andthyroid regions anatomy.
Nuclei Excited:	Hydrogen
Diagnostic Uses:	2D and 3D Imaging

{1}------------------------------------------------

510(k) Summary Medrad Anterior Neck Coil Page 2 of 3

PROPOSED MEDRAD ANTERIOR NECK COIL TECHNICAL COMPARISON TO PREDICATE DEVICES:

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

GE Anterior Neck Coil(PMA P830074)	Medrad Anterior Neck 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 ANTERIOR NECK TECHNICAL COMPARISON TO PREDICATE DEVICES

Patient contacting materials comparison information
GE Anterior Neck Coil	Medrad Anterior Neck Coil
Reference PMA P830074for material information	All materials used are thesame as the GE Anterior Neck coil. (Predicatedevice)
Certification: Medrad, Inc. certifies that the patientcontacting materials and formulations forthe proposed Medrad Anterior Neck Coilsare unchanged from currently marketeddevices.

{2}------------------------------------------------

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 Anterior Neck coil and the predicate GE Anterior Neck Coil.

IMAGE UNIFORMITY - The Medrad Anterior Neck 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 IB11 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 Anterior Neck Coil.

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

CONCLUSION - Extensive safety, verification, durability and clinical testing was conducted on the predicate GE device (PMA P830074). This device is exactly the same as the proposed device except for the labeling. The proposed device is deemed by Medrad to be substantially equivalent.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

Re: ·

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 1998

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

K982932 Medrad Anterior Neck Coil Dated: August 19, 1998 Received: August 20, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH

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 (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 ritto 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 Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

510(k) NUMBER (IF KNOWN): K982932

Medrad Anterior Neck Coil DEVICE NAME:

INDICATIONS FOR USE:

The Medrad Anterior Neck Coil is a receive only coil intended to be used in MRI Scanner Systems for imaging of the area superior to the oral pharynx and inferior to the brachial plexus.

The Medrad Anterior Neck Coil is intended for use only under the supervision of a physician who is trained in the field of Diagnostic Magnetic 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)

Vivid G. Segura

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological D

510(k) Number K982432

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.