The Medrad Quad C-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 area superior to the sella turcica and inferior to the third thoracic vertabrae. Included is the brachial plexus region, nerve roots and CSF.

The Medrad Quad C-Spine Coil is a receive only coil intended to be used MRI Scanner Systems for imaging of the Area superior to the top of the sella turcica and inferior to the third thoracic vertebra

The Medrad Quad C-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 C-Spine Coil is a receive only coil designed to enhance the MR lmaging of the area superior to the top of the sella turcica and inferior to the third thoracic vertabrae. Included is the brachial plexus region, nerve roots and CSF.

Receive-only Quadrature coil.

The Quad C-Spine coil is compatible with all GE Signa System pulse sequences and appropriate imaging options.

No external tuning, or matching, is necessary since the coil is matched to the recommended anatomy of interest.

The coil plugs into a common slip connector.

The housing material is made from Royalite ABS, Fire Rated UL 94V-0

Comfort pad material is made of Unifoam S82N, Fire Rated UL 94 HF-1 with a PVC Film vinyl film fire rated cover.

AI/ML Overview

Here's an analysis of the provided text regarding the Medrad Quad C-Spine Coils, focusing on acceptance criteria and supporting studies:

This submission details a medical device, the Medrad Quad C-Spine Coil, which is an enhancement (a receive-only coil) for existing Magnetic Resonance Imaging (MRI) systems. The core of this 510(k) summary is to demonstrate substantial equivalence to predicate devices, rather than proving efficacy from first principles. Therefore, the "acceptance criteria" and "study" described are primarily focused on showing that the new device performs comparably to or better than existing, legally marketed coils.

1. Table of Acceptance Criteria and Reported Device Performance

Because this is a 510(k) submission for a device component (an MR coil) that enhances existing systems, the "acceptance criteria" are implied by a comparison to predicate devices, particularly in performance parameters relevant to image quality and safety. There isn't a single, explicit table of acceptance criteria with numerical targets in the provided text. Instead, the performance is evaluated relative to the predicate devices.

Acceptance Criteria (Implied by Predicate Comparison)	Reported Device Performance (Medrad Quad C-Spine Coil)
Similar Signal to Noise Ratio (SNR) compared to predicate devices.	A Signal to Noise Ratio (SNR) study was conducted to generate a comparison between the proposed Medrad Quad C-Spine coil and the predicate Hitachi Quad C-Spine (K954952) and the General Electric Linear C-Spine (K884369). (Explicit results of this comparison are not provided in this summary, but the study was performed implying favorable or equivalent results for substantial equivalence.)
Acceptable Image Uniformity (relative to NEMA standards and predicate experience).	Evaluated using NEMA Standards to characterize non-uniformity. Contours of the axial and sagittal images were constructed. (Explicit results of this evaluation are not provided, but the method was applied.)
No observable Geometric Distortion.	None. Device contains slightly magnetic materials, but positioned so "no observable distortion of the static magnetic field is present."
No 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.
Resolution, Slice Thickness, and Contrast unaffected.	These parameters are "not affected by the use of a surface coil and were not separately tested."
Demonstrated safety (e.g., material biocompatibility, electrical safety).	Patient contacting materials are identical to predicate devices: Royalite ABS (housing), Unifoam S82N with PVC Film (comfort pad), all fire rated. "Extensive safety, verification, durability and clinical testing was conducted on the predicate devices." Implies the new device, being substantially equivalent in design and materials, shares this safety profile.
Clinical image quality comparable to predicate devices.	"Clinical Evaluation - Images were obtained for the proposed Medrad Shoulder Coil. The clinical images of the predicate devices may be found in their respective 510(k) submissions." (Implied positive outcome for substantial equivalence.)

Study Proving Device Meets Criteria:

The primary study conducted is a comparative performance evaluation against two predicate devices: the GE Linear C-Spine Coil (K884369) and the Hitachi Quad C-Spine Coil (K954952). The goal is to demonstrate "substantial equivalence" to these legally marketed devices, rather than showing de novo efficacy.

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

The text does not explicitly state the sample size used for the test set in the SNR study, image uniformity and distortion tests, or the clinical evaluation.

Data Provenance: The studies were conducted by Medrad, Inc. in the context of a 510(k) submission to the US FDA. The source of the data is internal testing and evaluation. The nature of these tests (e.g., phantom studies for SNR, uniformity, distortion; clinical imaging of volunteers/patients) implies prospective data collection specifically for this regulatory submission. Country of origin for the data is implicitly the United States, given the company's location and FDA submission.

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

The document does not specify the number or qualifications of experts used to establish ground truth.

For technical parameters like SNR, uniformity, and distortion, ground truth is typically established through quantitative measurements using phantoms and standardized protocols (e.g., NEMA standards) rather than expert human interpretation in the same way clinical diagnostic studies might.
For the "Clinical Evaluation," while images were obtained, the ground truth for "images of the proposed Medrad Shoulder Coil" would be the direct images themselves. If a comparison was made for diagnostic quality, this would typically involve radiologists. However, this level of detail is not provided. The phrase "The clinical images of the predicate devices may be found in their respective 510(k) submissions" suggests a qualitative comparison rather than a formal, blinded, multi-reader study with independent ground truth.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the test set. Given the technical nature of much of the testing (SNR, uniformity, distortion) and the lack of explicit detail on the "Clinical Evaluation," formal adjudication (like 2+1 or 3+1 consensus) is unlikely to have been a component of these specific tests as 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, an MRMC comparative effectiveness study was not done.
This device is an MR coil, not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable. The goal is to produce high-quality MR images for human readers to interpret, not to assist those readers with AI.

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

No, a standalone (algorithm-only) performance study was not done.
Again, this is a physical medical device (an MR coil), not a software algorithm. Its "performance" is in its ability to acquire high-quality images, which are then interpreted by a human (the radiologist).

7. The Type of Ground Truth Used

For SNR, Image Uniformity, and Geometric Distortion: Ground truth is established through quantitative physical measurements using phantoms and NEMA standards.
For Resolution, Slice Thickness, and Contrast: The statement that these are "not affected by the use of a surface coil" implies that the fundamental physics of MRI and the system's capabilities (which are part of the predicate device's established performance) form the basis of this 'ground truth'.
For the Clinical Evaluation: The "clinical images" themselves serve as the primary data. While not explicitly stated, "ground truth" for diagnostic quality in such a comparison would implicitly rely on expert radiologist interpretation of the images, comparing them to those obtained with predicate devices, likely in a qualitative or semi-quantitative manner. There is no mention of pathology or outcomes data being used as ground truth for the coil's performance.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device. This is a physical, passive receive coil, not a machine learning model.

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

This question is not applicable as there is no training set for this type of device.

Summary

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510(k) SUMMARY MEDRAD 1.0T, 1.5T QUAD C-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 C-Spine Coil
PREDICATE DEVICES:	General Electric (GE) Linear C-SpineHitachi Quad C-Spine Coil
DEVICE DESCRIPTION:

INTENDED USE:

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 area superior to the sella turcica and inferior to the third thoracic vertabrae. Included is the brachial plexus region, nerve roots and CSF

Anatomical Region:	The area superior to the top of the sella turcicaand inferior to the third thoracic vertabrae.Included is the brachial plexus region, nerveroots and CSF
Nuclei Excited:	Hydrogen
Diagnostic Uses:	2D and 3D Imaging

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Proposed Medrad Quad C-Spine Coil Technical Comparison To Predicate Devices:

The following table compares the predicate GE Linear C-Spine Coil, the Hitachi 1.5T Quad C-Spine Coil and the proposed Medrad Quad C-Spine Coil.

GE Linear C-Spine Coil(K884369)	Hitachi Quad C-Spine Coil(K954952)	Medrad Quad C-Spine Coil
Receive-only linear coil.	Receive-only Quadrature coil	Receive-only Quadraturecoil.
Region of interest includesthe area superior to the topof the sella turcica andinferior to the third thoracicvertebrae. Included is thebrachial plexus region, nerveroots and CSF.	Region of interest includesthe area superior to the topof the sella turcica andinferior to the third thoracicvertebrae. Included is thebrachial plexus region, nerveroots and CSF.	Region of interest includesthe area superior to the topof the sella turcica andinferior to the third thoracicvertebrae. Included is thebrachial plexus region, nerveroots and CSF.
The linear C-Spine coil iscompatible with all GE SignaSystem pulse sequences andappropriate imaging options.	The Quad C-Spine Coil iscompatible with the MRH-1500 and Stratis systempulse sequences andimaging options.	The Quad C-Spine coil iscompatible with all GE SignaSystem pulse sequences andappropriate imaging options.
No external tuning, ormatching, is necessary sincethe coil is matched to therecommended anatomy ofinterest.	No external tuning, ormatching, is necessary sincethe coil is matched to therecommended anatomy ofinterest.	No external tuning, ormatching, is necessary sincethe coil is matched to therecommended anatomy ofinterest.
The coil plugs into a commonslip connector.	The coil plugs into thesystem via three BNCconnectors	The coil plugs into a commonslip connector.

Proposed Medrad Quad C-Spine Coil Technical Comparison to Predicate Devices (Cont.):

Patient contacting materials comparison information
GE Linear C-Spine Coil	Hitachi Quad C-Spine Coil	Medrad Quad C-Spine Coil
The housing material is made from Royalite ABS, Fire Rated UL 94V-0	The housing material is made from Royalite ABS, Fire Rated UL 94V-0	The housing material is made from Royalite ABS, Fire Rated UL 94V-0
Comfort pad material is made of Unifoam S82N, Fire Rated UL 94 HF-1 with a PVC Film vinyl film fire rated cover.	Comfort pad material is made of Unifoam S82N, Fire Rated UL 94 HF-1 with a PVC Film vinyl film fire rated cover.	Comfort pad material is made of Unifoam S82N, Fire Rated UL 94 HF-1 with a PVC Film vinyl film fire rated cover.

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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 C-Spine coil and the predicate Hitachi Quad C-Spine (K954952) and the General Electric Linear C-Spine (K884369).

IMAGE UNIFORMITY - The Medrad Quad C-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 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 maqnetic 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 - Images were obtained for the proposed Medrad Shoulder Coil. The clinical images of the predicate devices may be found in their respective 510(k) submissions.

CONCLUSION - Extensive safety, verification, durability and clinical testing was conducted on the predicate devices. (K884369 and K954952). The proposed device is deemed by Medrad to be substantially equivalent.

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Image /page/3/Picture/0 description: The image shows a logo and the words "DEPARTMENT OF". The logo is on the left side of the image and consists of three curved lines. The text is on the right side of the image and is in a bold, sans-serif font. The text is aligned to the left and is in all capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 1998 NOV

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

K982959

Re:

Medrad Quad C-Spine Coil Dated: August 21, 1998 Received: August 24, 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 probibitions 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 (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/cdrividsmarcain.html"

Sincerely yours,

Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive 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): K98 2959

DEVICE NAME: ______________________________________________________________________________________________________________________________________________________________________________

INDICATIONS FOR USE:

The Medrad Quad C-Spine Coil is intended for use only under the supervision of a physician who is trained in the field of Diagnostic Magnetic Resonance Imaging.

本

(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) OR

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

David b. Srymm

(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.