The Medrad Phased Array 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 Phased Array Neurovascular Coil is a receive only, phased array coil designed to enhance the MR Imaging of the head and neck anatomy.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Medrad 1.5T Phased Array Neurovascular Coil. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than comprehensive clinical performance studies typical for novel devices.

Therefore, many of the requested categories regarding acceptance criteria, sample sizes, expert ground truth, and AI performance studies are not applicable or explicitly mentioned in detail in this document. The submission primarily addresses technical comparisons and basic performance characteristics relevant to an MRI coil.

Here's the breakdown of available information based on your request:

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in the way one might expect for a new diagnostic algorithm (e.g., a specific sensitivity or specificity threshold). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices. The performance tests conducted aim to show that the new coil's performance is comparable to or better than the predicate in key areas relevant to MRI coils.

Acceptance Criteria (Implied)	Reported Device Performance
Signal-to-Noise Ratio (SNR)	Conducted: "A Signal to Noise Ratio(SNR) study was conducted to generate a Signal -To-Noise ratio of the proposed Medrad 1.5T PHASED ARRAY NEUROVASCULAR Coil and the predicate Neurovascular device." (No specific numerical results are provided in this summary, but the study was performed presumably to show comparable or improved SNR).
Image Uniformity	Evaluated: "The Medrad PHASED ARRAY NEUROVASCULAR coil was evaluated using NEMA Standards to characterize the uniformity of the proposed coil. Contours of the images obtained with the coil were constructed for the axial image, sagittal image and coronal images." (No specific numerical results are provided, but evaluation using NEMA standards implies meeting accepted uniformity characteristics).
Geometric Distortion	Observed: "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	Demonstrated (by analysis): "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."
Clinical Effectiveness	Provided: "Clinical images for the proposed 1.5T PHASED ARRAY NEUROVASCULAR have been provided with this submission to demonstrate the clinical effectiveness of the PHASED ARRAY Neurovascular." (No detailed study description or quantitative results are included in this summary).
Substantial Equivalence	Concluded: "The proposed device is deemed by Medrad to be substantially equivalent." (FDA concurred with this conclusion).

2. Sample size used for the test set and the data provenance

Sample size: Not explicitly stated. The "Clinical images" were provided, but the number of cases or subjects is not mentioned.
Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not mentioned. The study involves demonstrating technical performance characteristics of an MRI coil and clinical effectiveness through imaging, not a diagnostic decision validated by experts in the context of classification or detection. Clinical effectiveness is demonstrated by the quality of the clinical images themselves.

4. Adjudication method for the test set

Not applicable/Not mentioned. This is not a study requiring adjudication of diagnostic outcomes.

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

Not applicable. This device is an MRI coil, not an AI-powered diagnostic algorithm.

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

Not applicable. This is hardware (an MRI coil), not an algorithm.

7. The type of ground truth used

For technical performance criteria like SNR, image uniformity, and geometric distortion, the "ground truth" is established through physical measurements and NEMA standards.
For "Clinical Evaluation," the ground truth is implicitly the quality and diagnostic utility of the images produced by the coil, observed by qualified personnel (though not explicitly detailed as expert consensus in this summary).

8. The sample size for the training set

Not applicable. This is hardware, not an AI model requiring a training set.

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

Not applicable.

Summary

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K984257

510(k) SUMMARY MEDRAD 1.5T PHASED ARRAY NEUROVASCULAR COIL

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 Phased Array Neurovascular Coil
PREDICATE DEVICES:	Medrad Neurovascular CoilMedrad Phased Array Shoulder Coil

DEVICE DESCRIPTION:

The Medrad Phased Array Neurovascular Coil is a receive only, phased array coil designed to enhance the MR Imaging of the head and neck anatomy.

INTENDED USE:

The Medrad Quadrature CTL Coil is a receive only coil intended to be used with the General Electric Superconducting MRI Scanners. This coil will facilitate complete MR imaging of the intracranial/extracranial Neurovascular, skull base and C-Spine without need for repositioning the coil on the patient.

Anatomical Region:	intracranial/extracranialNeurovascular, skullbase and C-Spine
Nuclei Excited:	Hydrogen
Diagnostic Uses:	2D and 3D Imaging

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510(k) Summary Medrad PHASED ARRAY NEUROVASCULAR Page 2 of 3

Proposed Medrad 1.5T Neurovascular Array Coil Technical Comparison To Predicate Device:

The following table compares claims made in regard to the Medrad 1.5T Neurovascular Coil to the Medrad 1.5T Neurovascular Array Coil

Medrad 1.5TNeurovascular Coil(K981094)	Medrad Phased ArrayShoulder Coil (K960901)	Medrad 1.5T NeurovascularArray Coil
Quadrature Transmit-Receive Coil	Phased Array Receive-OnlyCoil	Phased Array Receive-onlyQuadrature coil.
Region of interest coversthe top of the brain to theaortic arch.	*N/A	Region of interest covers thetop of the brain to the aorticarch.
The Neurovascular coil iscompatible with all SignaSystem pulse sequencesand appropriate imagingoptions.	*N/A	The Neurovascular Array coil iscompatible with all SignaSystem pulse sequences andappropriate imaging options.
No external tuning, ormatching, is necessarysince the coil is matched tothe recommended anatomyof interest.	*N/A	No external tuning, ormatching, is necessary sincethe coil is matched to therecommended anatomy ofinterest.
The coil plugs into the MRISystem by way of the HeadCoil quick disconnect port	*N/A	The coil plugs into the MRISystem by way of the PhasedArray quick disconnect port

This predicate device is being used to substantiate the technology equivalence to the proposed device only.

Proposed Medrad 1.5T Neurovascular Array Coil Technical Comparison to Predicate Devices (Cont.):

Patient contacting materials comparison information
Medrad 1.5T Neurovascular Coil	Medrad 1.5T Neurovascular Array Coil
The housing material is made from GlassFilled Polyester; Fire Rated UL 94V-0	The housing material is made from GlassFilled Polyester; Fire Rated UL 94V-0 andKydex, Fire Rated UL 94V-0
Comfort pad material is made with aBuellidyne coating and are fire rated UL-94HFI.	Comfort Pad material is made with a cottonmaterial embedded with urethane and is firerated to CAL 117

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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 of the proposed Medrad 1.5T PHASED ARRAY NEUROVASCULAR Coil and the predicate Neurovascular device.

IMAGE UNIFORMITY - The Medrad PHASED ARRAY NEUROVASCULAR coil was evaluated using NEMA Standards to characterize the uniformity of the proposed coil. Contours of the images obtained with the coil were constructed for the axial image, sagittal image and coronal images.

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 PHASED ARRAY NEUROVASCULAR.

CLINICAL EVALUATION - Clinical images for the proposed 1.5T PHASED ARRAY NEUROVASCULAR have been provided with this submission to demonstrate the clinical effectiveness of the PHASED ARRAY Neurovascular.

CONCLUSION - Extensive safety, verification, durability and clinical testing was conducted on the predicate Medrad devices. (K960901, K981094) The proposed device is deemed by Medrad to be substantially equivalent.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 25 1999

Jim Ferguson, Jr. Sr. Regulatory Affairs Associate Medrad, Inc. One Medrad Drive Indianola, PA 15051-0780

Re:

K984257

Medrad 1.5T Phased Array Neurovascular Coil Dated: November 25, 1998 Received: November 30, 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 legally marketed predicate 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). 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.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATION FOR USE

510(k) Number:_ K984257

Medrad 1.5T Phased Array Neurovascular Coil Device Name:

Indications for Use/Intended Use:

The Medrad Phased Array Neurovascular Coil is a receive only, phased array coil designed to enhance the MR Imaging of the head and neck anatomy.

The Medrad Phased Array 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)

David C. Seggern

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

510(k) Number K984257

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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.