The Discovery MR450 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions 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. Depending on the region of interest being imaged, contrast agents may be used.

The images produced by the Discovery MR450 reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

Device Description

The GE Discovery MR450 is a new MR system that is substantially equivalent to previously cleared 1.5T /3.0T MR systems. All utilize superconducting magnets, gradients, and radio frequency coils and electronics to acquire data in single voxel, two dimensional, or three dimensional datasets. The 1.5T GE Discovery MR450 features a superconductina magnet operating at 1.5 Tesla. The data acquisition system accommodates up to 32 independent receive channels in various increments, and multiple independent coil elements per channel during a single acquisition series. The system uses a combination of time-varying magnetic fields (aradients) and RF transmissions to obtain information regarding the density and position of elements exhibiting magnetic resonance. The system can image in the sagittal, coronal, axial, oblique and double oblique planes, using various pulse sequences and reconstruction algorithms.. The 1.5T GE Discovery MR450 is designed to conform to NEMA DICOM standards (Diaital Imagina and Communications in Medicine).

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the GE Discovery MR450. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the typical format of a clinical or performance study evaluating an AI/diagnostic algorithm's accuracy, sensitivity, or specificity.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices. The "performance" section refers to technical specifications and compliance with standards rather than clinical performance metrics against a defined ground truth.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for a diagnostic performance study, nor does it report specific "device performance" in terms of clinical accuracy, sensitivity, or specificity in the context of disease detection or diagnosis.

The "Performance" section outlines parameters that have been measured and documented through testing to NEMA, IEC, or ISO standards, suggesting the acceptance criteria are adherence to these technical standards.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Compliance with NEMA standards	Measured and documented performance (Signal-to-noise ratio, Geometric distortion, Image uniformity, Slice thickness, Spatial resolution) to NEMA, IEC, or ISO standards.
Compliance with IEC standards	Designed to comply with applicable IEC standards. Shall be certified by a Nationally Recognized Testing Laboratory to conform to IEC, UL, and CSA standards prior to commercialization.
Compliance with UL and CSA standards	Shall be certified by a Nationally Recognized Testing Laboratory to conform to IEC, UL, and CSA standards prior to commercialization.
(Safety standards)	Tested for Static field strength, Acoustic noise, dB/dt, RF heating (SAR), Biocompatibility.

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

This information is not provided in the document. The document refers to testing "to NEMA, IEC or ISO standards" for technical parameters, not a clinical test set with patient data.

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

This information is not provided. The document does not describe a test set that would require expert-established ground truth in a diagnostic context.

4. Adjudication Method for the Test Set

This information is not provided. An adjudication method is not applicable given the type of testing described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done or described in this submission. The submission focuses on substantial equivalence based on technical specifications and indications for use, not on improving human reader performance with AI assistance.

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

This document describes a medical imaging device (MRI scanner), not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable and was not done.

7. The Type of Ground Truth Used

The concept of "ground truth" as pathology, outcomes data, or expert consensus is not applicable to the type of technical performance testing described for an MRI scanner in this submission. The ground truth for parameters like "Signal-to-noise ratio" or "Geometric distortion" would be defined by the measurement standards themselves (e.g., specific phantoms and procedures).

8. The Sample Size for the Training Set

This information is not provided. The document describes an MRI system, not a device incorporating a machine learning or AI component that would have a "training set."

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

This information is not provided and is not applicable as there is no mention of a training set for a machine learning model.

Summary of the Study for Substantial Equivalence:

The "study" described in the 510(k) is a comparison to predicate devices and technical testing to established industry standards (NEMA, IEC, ISO). The document states:

"As stated in the FDA document 'Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices' the following parameters have been measured and documented through testing to NEMA, IEC or ISO standards..." (Section 3)

The parameters tested include:

Performance: Signal-to-noise ratio (SNR), Geometric distortion, Image uniformity, Slice thickness, Spatial resolution
Safety: Static field strength, Acoustic noise, dB/dt, RF heating (SAR), Biocompatibility

The conclusion is that the GE Discovery MR450 is substantially equivalent to the predicate GE 1.5T Signa® HDx MR System and GE Signa® MR750, based on similar indications for use, technical specifications, and compliance with relevant industry and safety standards. There is no mention of clinical accuracy or diagnostic performance studies involving patients or human readers.

Summary

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K083147

GE Healthcare

GE Discovery MR450 510(k) Premarket Notification

. . . . .

NOV - 4 2008

Section 5 -- 510(k) Summary

. .

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GE Healthcare

GE Discovery MR450 510(k) Premarket Notification

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).

GE Healthcare Submitter: 3200 N. Grandview Blvd. : Waukesha, WI 53188
Contact Person: Yuan Ma Regulatory Affairs Leader
Telephone: 262 - 521 - 6223 Fax: 414 - 908 - 9390 yuan.ma@med.ge.com Email:
October 20, 2008 Date Prepared:

Device Name:

Proprietary Name: Discovery MR450 Classification Name: Maqnetic Resonance Diagnostic System, 21 CFR 892.1000, 90-LNH

Predicate Devices:

GE 1.5T Signa® HDx Magnetic Resonance System (K052293) GE Signa® MR750 System (K081028)

Device Description:

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Indications for Use:

Comparison with Predicate Devices:

The indications for use for the Discovery MR450 are similar to those for the GE Signa® HDx Magnetic Resonance System and the GE Signa® MR750.

Comparison statement between Discovery MR450 and 1.5T Signa® HDx system :

The GE Discovery MR450 is a new device design that is similar to the previously cleared 1.5T HDx MR system (K052293) with the main differences being new receive chain architecture that will support up to 32 channels in various channel increments, an increase in the amplitude and slew rate of the gradient output, water-cooling of the radio frequency amplifiers, an increased patient table weight limit, faster image reconstruction, and new svstem packgaina. The new receive chain architecture supports up to 32 independent receive channels and will accommodate expansion to 128 channels through future product development. The amplitude and slew rate of the gradient output has been increased relative to the predicate Siana® HDx svstem. The patient table has been designed to support up to five hundred pounds. Electrical components have been updated to minimize obsolescence issues. Also, the system packaging has incorporated watering cooling and has been designed to support the new receive channel architecture, improved gradients, and future expandability to 128 channels.

Comparison statement between Discovery MR450 and GE Signa® MR750:

The GE Discovery MR450 is also similar to the previously cleared Signa® MR750 3T system (K081028). The primary difference is the strength of the static magnetic field and adjustments to the corresponding frequency specific components. The software and user interface, RF receive chain, patient handling, gradient performance and aesthetic specifications are common with the Signa® MR750. The RF transmit coil has been altered to be compatible with the same gradient coil as the Signa® MR750, and the transmit RF amplifier is similar to the 1.5T HDx product. There are applications improvements that

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GE Healthcare

GE Discovery MR450 510|k} Premarket Notification

resulted from developmental work done to the feature set included with the MR450, but these are significantly equivalent to the Signa® MR750.

Summary of Studies:

As stated in the FDA document "Guidance for the Submission of Premarket Notifications for Maqnetic Resonance Diagnostic Devices" the following parameters have been measured and documented through testing to NEMA, IEC or ISO standards (as referenced throughout this submission and listed in Section 9:

10000

Performance:

Signal-to-noise ratio (SNR) Geometric distortion Image uniformity Slice thickness Spatial resolution

Safety

Static field strength Acoustic noise dB/dt RF heating (SAR) Biocompatibility
The Discovery MR450 has been designed to comply with applicable IEC standards. It shall be certified by a Nationally Recognized Testing Laboratory to conform to IEC, UL and CSA standards prior to commercialization of the system.

Conclusion:

It is the opinion of GE that the GE Discovery MR450 is substantially equivalent to the 1.5T Signa® HDx MR System and GE Signa® MR750.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GE Medical Systems LLC % Mr. Jay Y. Kogoma Responsible Third Party Official Intertek Testing Services 2307 E. Aurora Rd., Unit B7 TWINSBURG OH 44087

NOV - 4 2008

Re: K083147

Trade/Device Name: Discovery MR450

Regulation Number: 21 CFR 892.1000

Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: October 23, 2008

Received: October 24, 2008

Dear Mr. Kogoma:

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 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.

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Page 2

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.

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 this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

hope M. Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

CO83147

Device Name:

Discovery MR450

Indications for Use:

Prescription Use (21 CFR 801 Subpart D)

Over-the-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Amr A. Whang
(Division Sign-Off)

જુહ

Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

AND/OR

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.