The Medrad Neurovascular Coil is a quadrature transmit/receive coil intended to be used MRI Scanner Systems for imaging of the brain, skull base, and soft tissues of the neck and upper chest, including the carotid arteries and attendant vascular system.

The Medrad Neurovascular 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 Neurovascular Coil is quadrature transmit / receive coil designed to enhance the MR Imaging of the head and neck anatomy.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Medrad Neurovascular Coil:

This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific performance criteria against predefined numerical targets. The "acceptance criteria" are implied by the need to show performance that is at least equivalent to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for an MRI coil, the acceptance criteria are not explicitly stated as numerical thresholds for a new measurement or diagnostic claim. Instead, the "acceptance criteria" are implicitly met by demonstrating performance equivalent to the predicate devices in established MRI coil metrics.

Performance Parameter	Implicit Acceptance Criteria (vs. Predicate)	Reported Device Performance
Signal-to-Noise Ratio (SNR)	SNR of the Medrad Neurovascular Coil should be comparable to or better than: - GE Head Coil (in head position) - GE Anterior Neck Coil (in neck position)	A Signal-to-Noise Ratio (SNR) study was conducted to generate an SNR comparison between the proposed Medrad Neurovascular Coil and the predicate GE Head Coil (head position) and the GE Anterior Neck Coil (neck location). The conclusion states "increased SNR" which implies it met or exceeded the predicate.
Image Uniformity	Non-uniformity should be characterized and acceptable according to NEMA Standards.	The Medrad Neurovascular Coil was evaluated using NEMA Standards to characterize non-uniformity. Contours of images were constructed for axial, sagittal, and coronal views. (No explicit performance value given, but implied as acceptable).
Specific Absorption Rate (SAR)	SAR levels should be acceptable for different loading cases according to NEMA Standards and not exceed limits.	An SAR analysis was conducted per NEMA Standards for: - Lossless phantom (minimum load) - Neck (heavy load) - Head (light load). (No explicit values given, but implied as acceptable).
Geometric Distortion	No observable distortion of the static magnetic field should be present.	The device contains slightly magnetic materials, but they are positioned such that "no observable distortion of the static magnetic field is present."
Transmit RF Field [B1] Distortion	No significant currents induced; no artifacts observed during imaging.	Analysis of electrical design showed no significant currents induced. "No artifacts of any type were observed during imaging."
Clinical Evaluation (Morphological Detail)	Morphological detail should be equivalent to predicate devices.	Images obtained for the Medrad Neurovascular Coil were compared with the predicate GE Head Coil and GE Anterior Neck Coil. The results were compared "to substantiate equivalency with regards to morphological detail." The conclusion states "morphological detail" is achieved.
Clinical Evaluation (Image Clarity)	Image clarity should be equivalent to predicate devices.	Images obtained for the Medrad Neurovascular Coil were compared with the predicate GE Head Coil and GE Anterior Neck Coil. The conclusion states "image clarity" is achieved.
Safety and Durability	Device meets safety and durability standards.	"Extensive safety, verification, durability... testing was conducted." (Implied successful).

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

The document does not specify a numerical sample size for the "test set" (i.e., the number of patients or phantoms used for the SNR, SAR, image uniformity, and clinical evaluations).

Data Provenance: The document does not explicitly state the country of origin. Given Medrad, Inc. is located in Indianola, PA, USA, it's highly probable the studies were conducted in the United States. The text states "Clinical Evaluation - Images were obtained..." and "A Signal to Noise Ratio(SNR) study was conducted...", implying these were prospective evaluations rather than retrospective data analysis. However, details are scarce.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The "Clinical Evaluation" section mentions "results were compared to substantiate equivalency with regards to morphological detail and SNR." This implies expert review, likely by radiologists, but no details are provided.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

The document does not describe any specific adjudication method for evaluating the clinical images. The comparison was qualitative to "substantiate equivalency with regards to morphological detail and SNR."

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

There is no mention of an MRMC comparative effectiveness study or any AI component in this submission. This device is an MRI coil, a hardware component, not an AI-powered diagnostic tool.

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

This question is not applicable as the device is an MRI coil, not an algorithm.

7. The Type of Ground Truth Used

For the performance parameters, the "ground truth" is established through:

Physical Measurements and Standards: For SNR, Image Uniformity (NEMA Standards), and SAR (NEMA Standards), the ground truth is derived from established physics principles and industry standards applied to physical phantoms or models.
Visual Comparison with Predicate Device: For Geometric Distortion, Transmit RF Field [B1] Distortion, and Clinical Evaluation (morphological detail, image clarity), the "ground truth" or reference is the performance of the predicate GE Head Coil and GE Anterior Neck Coil. The goal is to show the new coil performs equivalently.

8. The Sample Size for the Training Set

This question is not applicable as the device is an MRI coil, not an AI model that requires a training set.

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

This question is not applicable as the device is an MRI coil, not an AI model.

Summary of the Study:

The study was primarily a comparative performance evaluation focusing on demonstrating substantial equivalence of the Medrad Neurovascular Coil to two predicate devices: the GE Head Coil and the GE Anterior Neck Coil.

Key Tests Conducted:
- Signal-to-Noise Ratio (SNR) Study: Compared Medrad coil to GE Head Coil (head) and GE Anterior Neck Coil (neck).
- Image Uniformity: Evaluated using NEMA Standards.
- Specific Absorption Rate (SAR) Analysis: Conducted per NEMA Standards for various load cases (lossless phantom, neck, head).
- Geometric Distortion Analysis: Assessed for observable distortion.
- Transmit RF Field [B1] Distortion Analysis: Evaluated for induced currents and artifacts during imaging.
- Clinical Evaluation: Qualitative comparison of images obtained with the Medrad coil against predicate coils regarding morphological detail and SNR.
- Safety, Verification, Durability Testing: General statement of these tests being conducted.
Conclusion: The studies aimed to show that the Medrad Neurovascular Coil is "substantially equivalent" to predicate devices, noting improvements like "increased SNR" and achieving "image clarity" and "morphological detail." The overall intent was to prove the device's safety and effectiveness for its intended use through comparison with already-marketed and accepted devices.

Summary

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JUN 1 8 1998

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

OFFICIAL CONTACT: Rodney J. Rylands Regulatory Affairs Manager Medrad, Inc. One Medrad Drive Indianola, PA 15051 (412) 767-2400 Ext. 3778

CLASSIFICATION NAME: Magnetic Resonance Diagnostic Accessory[21 CFR 892.1000]

COMMON/USUAL NAME: MR Imaging Surface Coil

PROPRIETARY NAME: Medrad Neurovascular Coil

PREDICATE DEVICES:

General Electric (GE) Quadrature Head Coil and GE Anterior Neck Coil

DEVICE DESCRIPTION: The Medrad Neurovascular Coil is quadrature transmit / receive coil designed to enhance the MR Imaging of the head and neck anatomy. Reference FIGURE 1 Below:

Image /page/0/Picture/10 description: The image is a black and white line drawing of a mechanical component. The component has a cylindrical section with square cutouts, connected to a broader, flatter base. The drawing style is technical, emphasizing the component's structure and form.

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510(k) Summary Medrad Neurovascular Coil Device Page 2 of 4

INTENDED USE:

The Medrad Neurovascular Coil is a quadrature transmit / receive coil intended to frome mountin the General Electric Superconducting MRI Scanners. This coil is intended to facilitate complete MR imaging of the intracranial/extracranial neurovasculature and skull base.

Head and Neck, from the top of the cranium to Anatomical Region: the arch of the aorta.

Hydrogen Nuclei Excited:

2D and 3D Imaging Diagnostic Uses:

PROPOSED MEDRAD NEUROVASCULAR COIL TECHNICAL COMPARISON TO PREDICATE DEVICES:

The following table compares claims made in regard to the GE Head Coil, the GE Anterior Neck Coil, and the Neurovascular Coil.

GE Head Coil	GE Anterior Neck Coil	Neurovascular Coil
Predicated Device	Predicate Device	Proposed Device
Quadrature Transmit/ReceiveBirdcage Coil	Receive-only linear coil.	Quadrature Transmit/Receivecoil.
Suggested application: Head	Anterior fossa of the skull base,the orapharynx, larynx, pharynx,and peripharyngealareas as wellas extending down through thesterno-claviculararea.	Coverage extends from the topof the head through the aorticarch.
The Head Coil is compatible withall Signa, Vectra and ContourSystem pulse sequences.	The anterior neck coil iscompatible with all Signa andContour System pulse sequencesand appropriate imaging options.	The coil is compatible with allSigna, and Contour pulsesequences and options.
Each system is tuned to theHead Coil.	No external tuning, or matching,is necessary since the coil ismatched to the recommendedanatomy of interest.	No external tuning and matchingis required.
Plugs into MRI system by way ofthe Head Coil quick disconnectport.	The coil plugs into a common slipconnector.	The coil plugs into the MRIsystem by way of the Head Coilquick disconnect port.

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510(k) Summary Medrad Neurovascular Coil Device Page 3 of 4

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

Patient contacting materials comparison information
GE Head Coil	GE Anterior Neck Coil	Neurovascular Coil
The housing material is made from Glass Filled Polyester; Fire Rated UL94-V0	The housing material is made from Closed Cell Polyetheylene Foam; Fire Rated UL94-HF-1	The housing material is made from Glass Filled Polyester; Fire Rated UL94-V0
The comfort pad is made of Denier Nylon Gray (Fire Rated)	No comfort pads	Comfort pads are included made with a Buellidyne coating and are fire rated UL-94 HFI.

Medrad, Inc. certifies that the patient contacting materials and formulations for the Certification: proposed Medrad Neurovascular Coils are unchanged from currently marketed devices.

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 Neurovascular Coil and the predicate GE Head Coil in the Head Position and between the Neurovascular Coil and the predicate Anterior Neck Coil for the Neck location.

IMAGE UNIFORMITY - The Medrad Neurovascular 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, and the coronal image.

SPECIFIC ABSORPTION RATE - An SAR analysis data has been gathered for the proposed Medrad Neurovascular Coil per the methodology of NEMA Standards for the following loading cases:

1. Lossless phantom for determination of coil losses representing a limit minimum load case.
1. Neck for determination of RF power deposition during Head and Neck imaging - representing a heavy load.
1. Head for determination of RF power deposition during Head imaging representing a light load.

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GEOMETRIC DISTORTION: The proposed Medrad Neurovascular 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 Neurovascular Coil.

CLINICAL EVALUATION - Images were obtained for the proposed Medrad Neurovascular Coil and the predicate GE Head Coil and GE Anterior Neck coil. The results wre compared to substantiate equivalency with regards to morphological detail and SNR.

CONCLUSION - Extensive safety, verification, durability, and clinical testing was conducted with the Medrad Neurovascular Coil to substantiate the claims of the proposed device and to verify that the proposed device is substantially equivalent to the predicate devices.

Image clarity, morphological detail and increased SNR demonstrate that the Medrad Neurovascular Coil will produce the required detailed resolution in surface coil imaqing .

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Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 8 1998

Rodney J. Rylands Manager, Regulatory Affairs Medrad, Inc. One Medrad Dr. Indianola, PA 15051

Re:

K981094 Medrad 0.5T, 1.0T and 1.5T Neurovascular Coils for GE Signa MRI Systems Dated: March 24, 1998 Received: March 26, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS

Dear Mr. Rylands:

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 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 equivaliation assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (2) 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/cdrb/dsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.

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

Enclosure

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1981094 510(k) NUMBER (IF KNOWN):

DEVICE NAME: Medrad Neurovascular Coil

INDICATIONS FOR USE:

The Medrad Neurovascular 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)

Elvin h. Sisson

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