The GE Signa® 3.0T with Excite is a whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa® 3.0T with Excite MR System is indicated for use as a diagnostic imaging device to produce transverse, saqittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa® 3.0T with Excite MR systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic These images and/or spectra when interpreted by a trained physician yield resonance. information that may assist in diagnosis.

Device Description

The GE Signa 3.0T with Excite Magnetic Resonance System is a modification to the Signa® 3.0T Magnetic Resonance System (K022397) which utilizes a superconducting magnet to acquire 2D single-slice and multi-slice, and 3D volume images. The GE Signa® 3.0T with Excite Magnetic Resonance System features a superconducting magnet operating at 3.0T. The system can image in the sagittal, coronal, axial, oblique and double oblique planes, using various pulse sequences. Images are acquired and reconstructed using 2D and 3D Fourier transformation techniques. The system is intended for high-resolution anatomical applications, short scan times, and multinuclear spectroscopy.

AI/ML Overview

The provided 510(k) summary for the GE Signa® 3.0T with Excite Magnetic Resonance System (K040444) does not contain the detailed information requested regarding acceptance criteria, device performance metrics, or specific study designs with sample sizes, ground truth establishment, or expert involvement.

This submission is a "Substantially Equivalent" determination for a modification to an existing device (Signa® 3.0T MR system, K022397). The primary difference is the addition of eight independent receive channels as part of a system upgrade.

Here's what can be extracted based on the provided document and why other information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "The Signa® 3.0T with Excite MR System was evaluated to the appropriate NEMA performance standards as well as the IEC 601-1 International Medical Equipment Safety standard and IEC 601-2-33 Particular Requirements for Safety of Magnetic Resonance Equipment for Medical Diagnosis."

Acceptance Criteria: While the standards are named (NEMA, IEC 601-1, IEC 601-2-33), the specific acceptance criteria values (e.g., minimum signal-to-noise ratio, maximum image distortion) are not listed in this 510(k) summary. These standards define various performance metrics for MR systems, and the device would have to meet the specified thresholds within those standards.
Reported Device Performance: The document only makes a general statement: "The Signa® 3.0T with Excite MR System is comparable to the currently marketed Signa® 3.0T Magnetic Resonance System." It does not provide specific numerical performance results from the evaluations against NEMA or IEC standards.

Therefore, a table with specific acceptance criteria and reported numerical performance cannot be constructed from this document.

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

Sample Size: The document does not specify a sample size for a "test set" in the context of clinical or image-based performance evaluation. The evaluation appears to be primarily technical validation against engineering standards rather than diagnostic accuracy studies involving patient data.
Data Provenance: Not applicable, as human data for a test set is not described.

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

Number of Experts: Not applicable, as there is no mention of a test set with human-interpreted ground truth.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

Not applicable, as there is no mention of a test set requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

MRMC Study: The document does not describe any MRMC comparative effectiveness study. This type of study would typically compare diagnostic performance with and without the new feature (e.g., the 8 independent receive channels) and involve multiple human readers.
Effect Size: Not applicable, as no MRMC study is reported.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The GE Signa® 3.0T with Excite is a Magnetic Resonance Diagnostic System, not an AI algorithm. Standalone performance, in the context of AI, refers to the algorithm's performance without human input. This concept does not apply directly to an MR imaging system. The "performance" described would be technical image quality and safety assessments.

7. The Type of Ground Truth Used:

Based on the statement, "The Signa® 3.0T with Excite MR System was evaluated to the appropriate NEMA performance standards as well as the IEC 601-1 International Medical Equipment Safety standard and IEC 601-2-33 Particular Requirements for Safety of Magnetic Resonance Equipment for Medical Diagnosis," the "ground truth" for the evaluation would be engineering and technical specifications and measurement protocols defined by these international standards. This would involve phantom studies and technical measurements rather than clinical ground truth (like pathology or outcomes data).

8. The Sample Size for the Training Set:

Not applicable. This is an MR imaging device, not an AI algorithm that requires a "training set" of data in the machine learning sense. The development and testing would involve engineering and physics principles.

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

Not applicable, as there is no training set for an AI algorithm.

In summary, the 510(k) K040444 is a substantial equivalence submission for a hardware modification to an existing MR system. The evaluation primarily relies on demonstrating compliance with established engineering and safety standards (NEMA, IEC) rather than clinical performance studies involving patient data, expert interpretation, or AI algorithm validation.

Summary

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K040444

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GE Medical Systems

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

APR 1 4 2004

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:	February 19, 2004

Device Name:

GE Signa® 3.0T with Excite Magnetic Resonance System Magnetic Resonance Diagnostic System, 21 CFR 892.1000, 90-LNH

Marketed Device:

The GE Signa 3.0T with Excite Magnetic Resonance System is substantially equivalent to the currently marketed Signa® 3.0T MR system (K022397) with the main differences being an addition of eight independent receive channels as part of a system upgrade.

Device Description:

Indications for Use:

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

Comparison with Predicate Device:

The Signa® 3.0T with Excite MR System is a modification of the Signa® 3.0T MR system (K022397) with the main differences being the addition of eight independent receive channels.

Summary of Studies:

The Signa® 3.0T with Excite MR System was evaluated to the appropriate NEMA performance standards as well as the IEC 601-1 International Medical Equipment Safety standard and IEC 601-2-33 Particular Requirements for Safety of Magnetic Resonance Equipment for Medical Diagnosis. The Signa® 3.0T with Excite MR System is comparable to the currently marketed Signa® 3.0T Magnetic Resonance System.

Conclusion:

It is the opinion of GE that the Signa® 3.0T with Excite MR System is substantially equivalent to the Signa® 3.0T Magnetic Resonance System. Usage of the Signa® 3.0T with Excite MR System does not result in any new potential hazards.

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APR 1 4 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K040444 Trade/Device Name: GE Signa® 3.0T with EXCITE Magnetic Resonance System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Product Code: 90 LNH Dated: January 19, 2004 Received: February 17, 2004

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 cither class II (Special Controls) or class III (PMA), 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 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 Brydon

Nancv 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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GE Medical Systems

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

STATEMENT OF INTENDED USE

510(k) Number (if known):

Device Name: GE Signa® 3.0T with Excite MR System

Indications for Use

The GE Signa® 3.0T with Excite is a whole body magnetic resonance scanners designed to The GE Signa 3.01 with Excite is a where body magnot scan times. The Signal 3.0T with support figh resolution, filgh signal to more ratio imaging device to produce transverse, Excite MR System is indicated for use as a alagnotic maging mages of f
sagittal, coronal and oblique images, spectroscopic images, and/or spectra, coak sagillal, coronal and oblique images, spool occopic including, but not limited to, head, neck, neck, neck, neck, the Internal Structures and organs of the entire of the sposts and musculoskeletal TMJ, spine, breast, neart, abdomen, pervis, jointe, prosulto, at with Excite MR systems reflect
regions of the body. The images produced by the Signal 3.0T with Excite Mr. S regions of the body. The images produced by the eight.
the spatial distribution of protons (hydrogen nuclei) exhibiting magnetice that may a the spatial distribution of profots (hydrogen nuder) exhibiting magnetic on that may assist in diagnosis.

(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)

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Over-The-Counter Use

David h. hyman

E-2 and Radiological Devi 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.