MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL by MEDRAD, INC.

The Medrad Phased Array Neurovascular coil is a receive-only coil intended to be used with the General Electric Superconducting MRI scanners. The coil will facilitate complete MR imaging of the intracranial/extracranial Neurovascular, skull base and C-Spine without moving the patient or the coil, i.e., no scan room intervention.

Device Description

The Medrad 8-Receiver Phased Array Neurovascular Coil is a receive-only coil intended to be used with the General Electric Superconducting MRI scanners for MR imaging of the intracranial Neurovascular, skull base and C-Spine without moving the patient or the coil, i.e., no scan room intervention.

AI/ML Overview

The provided text describes a Special 510(k) summary for a medical device called the "Medrad 8-Receiver Phased Array Neurovascular Coil." This submission focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study with acceptance criteria and device performance metrics typical for novel AI/software devices. Therefore, much of the requested information regarding AI-specific criteria, sample sizes for test/training sets, expert involvement, and MRMC studies is not applicable or cannot be extracted from this document.

However, I can extract information related to the device's characteristics and the general approach to demonstrating its safety and effectiveness.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in the format typically seen for algorithms (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to a predicate device. The performance is reported in terms of meeting design specifications and international standards, and having comparable features and functionality to the predicate.

Feature / Acceptance Criteria (Implied by Substantial Equivalence to Predicate)	Reported Device Performance (Proposed Device)
Coil type	Phased Array Receive-Only Coil (Same as predicate)
Region of Interest	Vertex of the skull to the aortic arch (Same as predicate)
Compatibility	All phased array GEMS 1.5T Signa Excite platforms with 8-Receiver capability; All Signa System pulse sequences and appropriate imaging options. (Similar, but updated compatibility for newer platforms/capabilities compared to predicate)
Tuning	No external tuning or matching necessary (Same as predicate)
System connection	Plugs into the MRI System by way of the Phased Array quick disconnect port (Same as predicate)
Imaging configurations	High resolution Head, Parallel imaging Fast Brain, Neurovascular, C-Spine (user optional), Volume Neck (user optional), High resolution Head and C-Spine (user optional) (Similar, with addition of "Parallel imaging" mention)
Housing Material	Polyurethane; Fire Rated UL 94V-0 (Similar to predicate's housing materials)
Comfort Pad Material	Cotton material embedded with urethane and is fire rated to CAL 117 (Same as predicate)
Safety and Effectiveness	Met design specifications, meets applicable requirements of international standards, risk analysis performed, design verification and validation testing conducted.

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

This information is not applicable to this type of device submission. This is a hardware device (an MRI coil), not an AI/software product, and its evaluation focuses on engineering specifications, material compatibility, and functional equivalence, not on processing a "test set" of data for diagnostic performance. No data provenance is mentioned as there's no data analysis in this context.

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

This information is not applicable. There is no "ground truth" establishment in the context of an MRI coil's engineering and functional evaluation.

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

This information is not applicable. There is no "test set" or adjudication process described for this hardware device.

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 MRI coil, not an AI system. Therefore, there is no AI assistance to measure improvement for human readers.

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

No, a standalone algorithm performance study was not done. This device is an MRI coil, a hardware component, not an algorithm.

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

This information is not applicable. The evaluation of this MRI coil focuses on adherence to engineering specifications, safety standards, and functional equivalence to a predicate device, rather than diagnostic accuracy against a clinical ground truth.

8. The sample size for the training set

This information is not applicable. This is a hardware device submission, not an AI/machine learning device that would involve a training set.

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

This information is not applicable. As there is no training set mentioned, there is no ground truth establishment for it.

Summary of the Study for Substantial Equivalence:

The study proving the device meets the acceptance criteria (which, in this case, is primarily demonstrating substantial equivalence to a predicate device) is documented through the application of Medrad's design controls as part of its Quality System, compliant with FDA's Quality System Regulations (QSRs).

Risk Analysis: A risk analysis was performed.
Design Verification and Validation Testing: This testing was conducted to support the conclusions drawn from the risk analysis and to demonstrate that the device met its design specifications and applicable international standards. While specific test results are not detailed in this summary, the document states: "Test results demonstrate that the design specifications for the Medrad 8-Receiver Phased Array Neurovascular Coil were met and that the Medrad 8-Receiver Phased Array Neurovascular Coil meets the applicable requirements of the international standards cited."
Comparison to Predicate Device: A detailed comparison of features and principles of operation to the legally marketed "Medrad 1.5T Phased Array Neurovascular Coil" (K984257) was provided. The comparison focuses on:
- Coil type
- Region of Interest
- Compatibility (with specific MRI scanners)
- Tuning
- System connection
- Imaging configurations
- Patient-contacting materials (housing and comfort pad)

The conclusion is that the proposed device is "substantially equivalent" to the predicate, maintaining the same intended use, similar operational parameters, similar labeling, and used in a similar manner.

Summary

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8 2002 NOV

KO23596

Special 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Submitter's Name:	Medrad Inc.
Submitter's Address:	One Medrad Drive, Indianola, PA 15051 USA
Telephone Number:	(412) 767-2400, ext. 3326
Fax Number:	(412) 767-2475
Contact Person:	Jim Ferguson, Jr.
Date:	October 25, 2002
Proprietary Name:	Medrad 8-Receiver Phased Array Neurovascular Coil
Common Name:	MR Imaging Surface Coil
Classification:	Class II, 892.1000
Classification Name:	Magnetic Resonance Diagnostic device
Predicate Device:	Medrad 1.5T Phased Array Neurovascular CoilK984257

Substantial Equivalence: The information provided in this premarket notification demonstrates that the proposed device is substantially equivalent to a legally marketed device. The proposed 8-Receiver Phased Array Neurovascular Coil is substantially equivalent to the 1.5T Phased Array Neurovascular Coil (K984257)

The Medrad 8-Receiver Phased Array Neurovascular Coil maintains the same intended use, similar operational parameters, similar labeling and is used in a manner similar to the predicate device.

Like the Medrad 4-Receiver Neurovascular Coil, the Medrad 8-Receiver Neurovascular Coil is a receive-only coil intended to be used with the General Electric Superconducting MRI scanners for MR imaging of the intracranial Neurovascular, skull base and C-Spine without moving the patient or the coil, i.e., no scan room intervention

Medrad has established, as part of its Quality System, design controls in compliance with FDA's Quality System Regulations (QSRs). These design controls are applied to all Medrad product development processes and product design changes. These design controls were applied to the development of the Stellant CT Injector and meet the requirements of the FDA's QSRs.

As part of the design control a risk analysis was performed, and design verification and validation testing was conducted to support the conclusion drawn by the risk analysis.

Test results demonstrate that the design specifications for the Medrad 8-Receiver Phased Array Neurovascular Coil were met and that the Medrad 8-Receiver Phased Array Neurovascular Coil meets the applicable requirements of the international standards cited. Therefore, it has been determined that the Medrad 8-Receiver Phased Array Neurovascular Coil is substantially equivalent to the predicate device, its predecessor, for its intended use when used as prescribed in the User Operation Manual.

A comparison of features and principles of operation between the proposed device and predicate device is provided in the table below.

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Feature	(Proposed) Medrad 1.5T 8-Receiver Neurovascular	Medrad 1.5T NeurovascularArray Coil (Predicate)
Coil type	Phased Array Receive-Only Coil	Phased Array Receive-onlyQuadrature coil.
Region of Interest	Vertex of the skull to the aorticarch.	Vertex of the skull to the aorticarch.
Compatibility	All phased array GEMS 1.5TSigna Excite platforms with 8-Receiver capability. All SignaSystem pulse sequences andappropriate imaging options.	All phased array GEMS 1.5TSigna Horizon platforms All SignaSystem pulse sequences andappropriate imaging optionsexcluding parallel imaging.
Tuning	No external tuning, or matching,is necessary since the coil ismatched to the recommendedanatomy of interest.	No external tuning, or matching, isnecessary since the coil ismatched to the recommendedanatomy of interest.
System connection	The coil plugs into the MRISystem by way of the PhasedArray quick disconnect port	The coil plugs into the MRI Systemby way of the Phased Array quickdisconnect port
Imaging configurations	High resolution Head, Parallelimaging Fast Brain,Neurovascular, C-Spine (useroptional), Volume Neck (useroptional), High resolution Headand C-Spine (user optional)	High resolution Head, FastBrain, Neurovascular, C-Spine(user optional), Volume Neck(user optional), Highresolution Head and C-Spine(user optional)

Patient contacting materials comparison information
	Medrad 1.5T Neurovascular (Proposed)	Medrad 1.5T Neurovascular Array Coil (Predicate)
Housing	The housing material is made from Polyurethane; Fire Rated UL 94V-0	The housing material is made from Glass Filled Polyurethane; Fire Rated UL 94V-0 and Kydex, Fire Rated UL 94V-0
Comfort Pad	Comfort Pad material is made with a cotton material embedded with urethane and is fire rated to CAL 117	Comfort Pad material is made with a cotton material embedded with urethane and is fire rated to CAL 117

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Image /page/2/Picture/1 description: The image shows a partial view of the Department of Health & Human Services logo. The logo features the department's emblem, which is a stylized representation of an eagle with three lines extending from its body. The text "DEPARTMENT OF HEALTH &" is partially visible, curved along the left side of the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 2002 NOV

Re: K023596

Trade/Device Name: Medrad 8 Receiver Phased Array Neurovascular Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II

Product Code: 90 MOS Dated: October 25, 2002 Received: October 28, 2002

Dear Mr. Ferguson:

Mr. Jim Ferguson, Jr.

One Medrad Drive

Medrad, Inc.

Regulatory Affairs Analyst

INDIANOLA PA 15051

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Intended Use

Indications for Use Statement

510(k) Number:

KO23596

Device Name:

Medrad 8-Receiver Phased Array Neurovascular Coil

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David L. Simpson

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K023596

Prescription Use
/

Over-The-Counter Use _ (Per 21 CFR 801.109)

· Medrad, Inc. · Special 510(k) Premarket Submission · 8-Receiver Neurovascular · Confidential ·

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.