The GE 3.0T General Purpose Flex Coil is designed to facilitate MR imaging of the Brachial Plexus, Unilateral Hip and Thigh. The GE 3.0T General Purpose Flex Coil will facilitate dynamic MR imaging of the joints of lower extremity (Knee and Ankle). This coil consists of two 5" x 6.5" surface coils coupled as a Helmholtz pair in a flexible package that can be wrapped around the anatomy of interest. This flexibility allows for the coil to be applied to a wider range of patients when compared to a similar coil in a rigid package. The coil is an option to the GE Signa® 3.0T whole body MR System.

Device Description

The GE 3.0T General Purpose Flex Coil is a modification of the existing 1.5T GP Flex Coil (K923264), to increase the field strength from 1.5T to 3.0T. In addition, two passive blocking networks are added to improve reliability and patient safety.

AI/ML Overview

This GE 3.0T General Purpose Flex Coil is a magnetic resonance coil, not an AI/ML device. Therefore, the provided text does not contain information about acceptance criteria, device performance metrics (like sensitivity, specificity), sample sizes for test/training sets, expert qualifications, or ground truth establishment relevant to AI/ML device evaluation. Instead, the document discusses the substantial equivalence of the new 3.0T coil to an existing 1.5T coil.

Here's an analysis of what is provided and why the requested information is absent:

The document states: "Testing was performed to demonstrate that the design modifications to the 1.5T general Purpose Flex coil meet predetermined acceptance criteria." However, it does not detail what those "predetermined acceptance criteria" were or the specific results of that testing quantitatively.

The core of this submission is a claim of substantial equivalence to an existing cleared device (GE Medical Systems 1.5T GP Flex coil M1085GP (K923264)). This means the device is being marketed as essentially the same in terms of safety and effectiveness as a predicate device, rather than a novel device requiring extensive performance studies as would be the case for many AI/ML technologies.

Therefore, I cannot populate the requested table or answer most of the questions as they pertain to the evaluation of an AI/ML diagnostic device, which this product is not.

However, I can provide what information is available based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not explicitly stated in quantitative terms. The general criterion is that "design modifications... meet predetermined acceptance criteria."	Not explicitly stated in quantitative terms. The overall conclusion is that it is "substantially equivalent" to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This is not an AI/ML device study, so the concept of a "test set" and "data provenance" in this context is not applicable. The "testing" mentioned would likely involve engineering verification and validation (e.g., electrical safety, mechanical integrity, SAR compliance, image quality comparisons) rather than clinical performance on a dataset of patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable as this is not an AI/ML diagnostic device.

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

Not applicable.

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 is a medical device (MR coil), not an AI/ML software.

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

Not applicable; this is a hardware device.

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

Not applicable. For a device like this, "ground truth" would relate to its physical and functional specifications (e.g., signal-to-noise ratio, uniformity, SAR values) compared to engineering design requirements and the performance of the predicate device.

8. The sample size for the training set:

Not applicable; this is a hardware device, not an AI/ML algorithm.

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

Not applicable.

Summary of available information from the document:

Device Type: Magnetic Resonance Coil (hardware)
Purpose: To facilitate MR imaging of the Brachial Plexus, Unilateral Hip and Thigh, and dynamic MR imaging of the joints of the lower extremity (Knee and Ankle) at 3.0T field strength.
Key Modification: Retuning from 1.5T to 3.0T and addition of two passive blocking networks for reliability and patient safety.
Justification for Market: Substantial equivalence to an existing 1.5T GP Flex Coil (K923264).
Type of Study Performed: "Testing was performed to demonstrate that the design modifications to the 1.5T general Purpose Flex coil meet predetermined acceptance criteria." (Specific criteria and results are not detailed in this summary).
Conclusion: The device is substantially equivalent, and its usage "does not result in any new potential hazards."

Summary

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Kó 3.0953

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GE Medical Systems

Page 1 of 2

General Electric Company P.O. Box 414, Milwaukee, WI 53201

APR 1 0 2003

510(k) Summary

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.92(c).

Submitter:	GE Medical SystemsPO Box 414Milwaukee, WI 53201
Contact Person:	Larry A. Kroger Ph.D.Manager, Regulatory Programs
Telephone:	262- 544-3894
Fax:	262- 548-4768
Date Prepared:	March 24.2003

Device Name:

GE 3.0T General Purpose Flex Coil Magnetic Resonance Coil, 21 CFR 892.1000, 90-MOS

Marketed Device:

The GE 3.0T General Purpose Flex Coil is substantially equivalent to the currently marketed GE Medical Systems 1.5T GP Flex coil M1085GP (K923264)

Device Description:

Indications for Use:

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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is black and white.

General Electric Company P.O. Box 414, Milwaukee, WI 53201

Comparison with Predicate Device:

The GE 3.0T General Purpose Flex Coil is a modification of the existing cleared 1.5T General Purpose Flex Coil (K923264), with the main difference being the coil has been retuned for operation in a 3.0T magnetic field instead of a 1.5T field strength. In addition, two passive blocking networks are added to improve reliability, and patient safety.

Summary of Studies:

Testing was performed to demonstrate that the design modifications to the 1.5T general Purpose Flex coil meet predetermined acceptance criteria.

Conclusion:

It is the opinion of GE that the 3.0T General Purpose Flex Coil is substantially equivalent to the GE 1.5T general Purpose Flex coil (K923264). Usage of the GE 3.0T General Purpose Flex Coil does not result in any new potential hazards.

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Image /page/2/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 representation of a human figure with three flowing lines above it, symbolizing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the central image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 0 2003

Larry Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems P.O. Box 414 MILWAUKEE WI 53201

Re: K030953

Trade/Device Name: GE 3.0T General Purpose Flex Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: March 24, 2003 Received: March 27, 2003

Dear Dr. Kroger:

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 Section 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 the 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" (21CFR Part 807.97) you may obtain. 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

Page 2

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510(k) Number (if known): _ 大 o 3

Device Name: GE 3.0T General Purpose Flex 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)

Prescription Use
(Per 21 CFR 801.109)

OR Over-The-Counter Use(Division Sign-Off) Division of Reproductive, and Radiological Devices 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.