The Medrad Quad T/L Spine Coil is a receive only coil intended to be used in MRI Scanner Systems for imaging of the thoracic and lumbar regions of the spine anatomy.

The Medrad Quad T/L Spine 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 Quad T/L Spine Coil is a receive only coil designed to enhance the MR Imaging of the thoracic and lumbar regions of the spine anatomy.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Medrad Quad T/L Spine Coil. It focuses on demonstrating substantial equivalence to a predicate device, as the proposed device is essentially identical to the predicate with a change in branding (from GE to Medrad).

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	Reported Device Performance
Signal-to-Noise Ratio (SNR)	A Signal to Noise Ratio (SNR) study was conducted to generate a comparison between the proposed Medrad Quad T/L Spine coil and the predicate GE Quad T/L Spine Coil. The document implies that the comparison showed sufficient equivalence, though specific numerical results are not provided. The conclusion states that based on SNR results, the .5T and 1.0T coils "will produce similar clinical image results."
Image Uniformity	The Medrad Quad T/L Spine 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 image. The implication is that the uniformity met acceptable standards, likely similar to the predicate.
Geometric Distortion	None. The device contains slightly magnetic materials, but they are positioned to ensure "no observable distortion of the static magnetic field is present." This implies the device meets the criterion of not introducing geometric distortion.
Transmit RF Field [B1] Distortion	Analysis of the electrical design and blocking network demonstrates that "no significant currents are induced." "No artifacts of any type were observed during imaging." This indicates the device meets the criterion of not introducing B1 distortion.
Resolution, Slice Thickness, and Contrast	These parameters "are not affected by the use of a surface coil and were not separately tested." The acceptance criterion here is that the coil should not negatively impact these inherent MRI system parameters. The assumption is that because the coil is "receive only" and mechanically/electrically identical to the predicate, these parameters remain unaffected.
Clinical Effectiveness	Clinical images for the proposed 1.5T Quad T/L Spine Coil were provided to "demonstrate the clinical effectiveness." Based on these results and the SNR results for the .5T and 1.0T coils, Medrad concludes that all proposed coils "will produce similar clinical image results." This surrogate endpoint of "similar clinical image results" combined with direct clinical images for one model serves as the criterion for clinical effectiveness.
Patient Contacting Materials	All materials used are the same as the GE Quad T/L Spine coil (Predicate device). Medrad, Inc. certifies that the patient contacting materials and formulations for the proposed Medrad Quad T/L Spine Coils are unchanged. This implies the biocompatibility and safety of materials are maintained, relying on the predicate's established safety profile.
Mechanical and Electrical Identity	The proposed device and the predicate device are stated to be "Mechanically and electrically identical." This is a fundamental acceptance criterion for demonstrating substantial equivalence based on the nature of the change (labeling/branding only).
Overall Substantial Equivalence	The ultimate acceptance criterion is that the device is substantially equivalent to a legally marketed predicate device. The conclusion explicitly states: "The proposed device is deemed by Medrad to be substantially equivalent." The FDA letter confirms the finding of substantial equivalence.

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

The document does not explicitly state the numerical "sample size" for the performance tests in terms of number of patients or scans.

SNR Study: "A Signal to Noise Ratio(SNR) study was conducted..." No specific number of acquisitions or phantoms is mentioned.
Image Uniformity: "The Medrad Quad T/L Spine Coil was evaluated using NEMA Standards..." No specific number of images or phantoms.
Clinical Evaluation: "Clinical images for the proposed 1.5T Quad T/L Spine Coil have been provided with this submission..." It does not specify how many images or from how many patients.

Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) for a branding change, it's highly probable many of these tests were conducted internally by Medrad on phantoms and potentially healthy volunteers, rather than a large-scale clinical trial. The "clinical images" for the 1.5T are likely from a limited number of cases.

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

The document does not mention the use of experts to establish ground truth in the context of radiologists or similar clinical reviewers for image quality. The assessment of image quality (SNR, uniformity, distortion) appears to be based on engineering and NEMA standards rather than expert consensus on clinical findings. The "clinical images" were simply used to "demonstrate clinical effectiveness," implying they were reviewed, but not by a panel establishing ground truth in a diagnostic sense for a new algorithm.

4. Adjudication Method for the Test Set

No adjudication method is described. This is expected given that the studies primarily focus on physical and electrical device performance (SNR, uniformity, distortion) and a direct comparison to a known predicate which is mechanically and electrically identical. The "clinical images" are for demonstration, not for a diagnostic performance study requiring adjudication of expert readings.

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

No MRMC comparative effectiveness study was done or mentioned. This is a device modification submission (branding change for an existing device), not a new diagnostic algorithm requiring an MRMC study to compare human performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a passive, receive-only MR coil. It is a hardware component, not an algorithm, and therefore does not have a "standalone" or "human-in-the-loop" performance in the context of an AI/software device.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is primarily based on:

Physical and Electrical Measurements against Engineering Standards: For SNR, Image Uniformity (NEMA Standards), Geometric Distortion, and RF Field Distortion, the "ground truth" is adherence to established engineering principles and measurement techniques to ensure the coil performs as expected and identically to the predicate.
Identity to Predicate Device: The core "ground truth" establishing substantial equivalence is the mechanical and electrical identity of the proposed device to the already-cleared predicate device.
Clinical Images: For clinical effectiveness, the "ground truth" is implied by the satisfactory appearance and interpretability of the "clinical images," demonstrating that the coil functions appropriately in a clinical setting to acquire images of the spine.

8. Sample Size for the Training Set

Not applicable. This is a hardware device (MR coil), not a machine learning model. Therefore, there is no "training set."

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

Not applicable, as there is no training set for a hardware device.

Summary

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NOV 2 1998

510(k) SUMMARY MEDRAD .5T, 1.0T, 1.5T QUAD T/L SPINE 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 Quad T/L Spine Coil
PREDICATE DEVICES:	General Electric (GE) Quad T/L Spine Coil

DEVICE DESCRIPTION:

The Medrad Quad T/L Spine Coil is a receive only coil designed to enhance the MR Imaging of the thoracic and lumbar regions of the spine anatomy.

INTENDED USE:

The Medrad Quad T/L Spine 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 Quad T/L Spine anatomy.

Anatomical Region:	thoracic and lumbar regions of the spineanatomy.
Nuclei Excited:	Hydrogen
Diagnostic Uses:	2D and 3D Imaging

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510(k) Summary Medrad Quad T/L Spine Coil Page 2 of 3

PROPOSED MEDRAD QUAD T/L SPINE COJL TECHNICAL COMPARISON TO PREDICATE DEVICES:

The following table compares the predicate GE Quad T/L Spine Coil and the proposed Medrad Quad T/L Spine Coil.

GE Quad T/L Spine Coil(K923025)	Medrad Quad T/L Spine 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 QUAD T/L SPINE TECHNICAL COMPARISON TO PREDICATE DEVICES(Cont.):

Patient contacting materials comparison information
GE Quad T/L Spine Coil	Medrad Quad T/L Spine Coil
Reference K 902663 for material information	All materials used are the same as the GE Quad T/L Spine coil. (Predicate device)
Certification: Medrad, Inc. certifies that the patient contacting materials and formulations for the proposed Medrad Quad T/L Spine Coils are unchanged from currently marketed devices.

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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 Quad T/L Spine coil and the predicate GE Quad T/L Spine Coil.

IMAGE UNIFORMITY - The Medrad Quad T/L Spine 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 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 Quad T/L Spine Coil.

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

CONCLUSION - Extensive safety, verification, durability and clinical testing was conducted on the predicate GE device. (K 902663) 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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Re:

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing to the right, stacked on top of each other. The profiles are connected by a flowing line that forms the shape of a ribbon. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the design.

Public Health Service

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

K982919 Medrad Quad T/L Spine 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 vitne 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/cdr/dsmaldsmamain.html".

Sincerely yours,

Lillian Yim, 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

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510(k) NUMBER (IF KNOWN) : K 98 19 19

DEVICE NAME: Medrad Quad T/L Spine Coil

INDICATIONS FOR USE:

The Medrad Quad T/L Spine Coil is a receive only coil intended to be used in MRI Scanner Systems for imaging of the thoracic and lumbar regions of the spine anatomy.

The Medrad Quad T/L Spine 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	V
(Per 21 CFR 801.109)

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

Vorind h. Algerson

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological De 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.