The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T systems are whole body magnetic resonance scanners designed to support 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 of the entire body, including, but not limited to, head, neck, TMI, 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 MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T systems 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 Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. The systems feature a superconducting magnet operating at 1.5 Tesla or 3.0 Telsa. 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 (gradients) 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.

This Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, and the Optima MR450w 1.5T systems are designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).

The DV25 release is introducing new software features onto these existing MR Systems.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance criteria in the format requested.

The document is a 510(k) Premarket Notification Submission for GE Medical Systems' Discovery MR series and Optima MR series devices. It primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (K132376) for minor changes, specifically new software features (DV25 release including DISCO, MDE Plus, and Silent Suite updates) and hardware modifications for obsolescence and operating system compatibility.

Here's what can be extracted based on the provided text, and what information is not available:

1. A table of acceptance criteria and the reported device performance:

The document does not provide a table with specific, quantifiable acceptance criteria (e.g., sensitivity, specificity, accuracy for a diagnostic task) and corresponding reported device performance. It generally states that "The testing was completed with passing results per the pass/fail criteria defined in the test cases," and "The clinical results demonstrated that the Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T maintain the same imaging performance results as its predicate devices (K132376)." These are high-level statements without specific metrics or thresholds.

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

Sample Size: Not specified. The document mentions "Internal scans were conducted as part of validation for workflow and image quality," but does not provide a sample size (number of patients, cases, or images) for these internal scans.
Data Provenance: The scans were "internal," suggesting they were conducted within GE Healthcare, but the country of origin, retrospective/prospective nature, or demographic details are not provided.

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

This information is not provided. The document makes no mention of external experts or how ground truth was established for the internal validation scans. The statement "These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis" relates to the general use of MR images, not to the ground truth establishment for a specific study.

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

This information is not provided.

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:

MRMC Study: No, an MRMC comparative effectiveness study was not conducted or described. The document states, "The subject of this premarket submission... did not require external clinical studies to support substantial equivalence."
AI Assistance Effect Size: The device described is a Magnetic Resonance (MR) scanner, not an AI-based diagnostic tool for interpretation. Therefore, the concept of human readers improving with AI assistance is not applicable to the information presented. The software updates are for scanner capabilities (image acquisition, image quality, workflow), not for AI-driven diagnostic interpretation.

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

The device is an MR scanner, which generates images that are then interpreted by a trained physician. It is not an algorithm that provides a standalone diagnosis. Therefore, standalone algorithm-only performance in the context of interpretation is not applicable. The "performance" being evaluated here relates to image quality and features of the MR scanner itself.

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

This information is not provided. Given the nature of an MR scanner (image acquisition), "workflow and image quality" validation might involve assessing image metrics, artifact presence, resolution, signal-to-noise ratio, and visual assessment of anatomical detail, rather than a clinical ground truth like pathology for a specific disease.

8. The sample size for the training set:

The document does not describe the development of a model that would require a "training set" in the context of machine learning or AI. The changes are software features and hardware modifications for an existing MR system. Therefore, this question is not applicable.

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

As there is no mention of a training set, this question is not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 emblem consisting of three stylized human profiles facing to the right, stacked one behind the other. The profiles are connected by a flowing line that forms a wing-like shape above them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 26, 2014

GE Medical Systems, LLC % Ms. Jenny Wong Regulatory Affairs Leader, Magnetic Resonance 3200 N. Grandview Blvd. WAUKESHA WI 53188

Re: K142085

Trade/Device Name: Discovery MR750 3.0T. Discovery MR450 1.5T. Discovery MR750w 3.0T and Optima MR450w 1.5T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: July 28, 2014 Received: July 31, 2014

Dear Ms. Wong:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D.'Hara
for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Section 4: Indications for Use Statement

Discovery MR750 3.0T, Discovery MR450 1.5T,
Discovery MR750w 3.0T and Optima MR450w 1.5T

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Indications for Use

510(k) Number (if known)

K142085

Device Name

Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and Optima MR450w 1.5T

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined in a stylized script, enclosed within a circular frame. The logo is colored in a light blue hue, and the frame has decorative elements resembling swirls or waves.

GE Healthcare 510(k) Premarket Notification Submission

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided: Date: July 28, 2014

Submitter:	GE Healthcare, (GE Medical Systems, LLC)3200 N Grandview Blvd.Waukesha, WI 53188
Primary Contact Person:	Jenny WongRegulatory Affairs Leader, MRGE Healthcare, (GE Medical Systems, LLC)Phone: 262-548-2899Fax: 414-908-9585
Secondary Contact Person:	Glen SabinRegulatory Affairs Director, MRGE Healthcare, (GE Medical Systems, LLC)Phone: 262-521-6848Fax: 414-908-9585
Device:	Trade Name: Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w3.0T, and Optima MR450w 1.5T
Common/Usual Name:	Magnetic Resonance Diagnostic Device
Classification Names:	892.1000
Product Code:	LNH
Predicate Device(s):	Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w3.0T, and Optima MR450w 1.5T [K132376]
Device Description:	The Discovery MR750 3.0T, Discovery MR450 1.5T, DiscoveryMR750w 3.0T and the Optima MR450w 1.5T are whole body magneticresonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. The systems feature asuperconducting magnet operating at 1.5 Tesla or 3.0 Telsa. The dataacquisition system accommodates up to 32 independent receivechannels in various increments and multiple independent coil elementsper channel during a single acquisition series. The system uses a

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Image /page/5/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 blue and has a vintage or classic design.

GE Healthcare 510(k) Premarket Notification Submission

combination of time-varying magnetic fields (gradients) 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 DV25 release is introducing new software features onto these existing MR Systems.

Intended Use: The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T systems are whole body magnetic resonance scanners 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 MR750 3.0T. Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T systems 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.

The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery Technology: MR750w 3.0T, and Optima MR450w 1.5T employs the same fundamental scientific technology as its predicate devices.

The following is a summary of the differences between the proposed Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T and the predicates (Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and

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Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The logo is enclosed within a circular border, and the entire design is in a blue color.

the Optima MR450w 1.5T (K132376)).

New base software on the MR systems (version DV25) ●
Addition of new software features onto the MR scanners including DISCO, MDE Plus and Silent Suite updates)
Hardware modifications to the host computer and reconstruction engine for obsolescence and compatibility with a new operating system
Revised and updated labeling to include new features

Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T systems with the addition of the new software features complies with the following voluntary standards:

IEC 60601-1
IEC 60601-1-2 ●
IEC 60601-2-33 ●

In addition, these MR scanners are in compliance with the applicable NEMA standards, including NEMA PS3.1-3.20 for DICOM conformance.

The following quality assurance measures were applied to the development of the system:

Risk Analysis
Requirements Reviews
Design Reviews
Testing on unit level (Module verification)
. Integration testing (System verification)
. Performance testing (Verification)
. Safety testing (Verification)
. Simulated use testing (Validation)

The non-clinical tests have been summarized in the verification testing that was completed for the addition of the new software features to the compatible MR scanners. The testing was completed with passing results per the pass/fail criteria defined in the test cases. This supports substantial equivalence to its predicates because it was also developed under quality assurance Design Controls. In addition, the modified scanners are in compliance to the same Standards.

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Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. The circle is surrounded by decorative, swirling lines, also in blue, which give the logo a classic and recognizable appearance.

GE Healthcare 510(k) Premarket Notification Submission

Summary of Clinical Tests:

The subject of this premarket submission, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T, did not require external clinical studies to support substantial equivalence. Internal scans were conducted as part of validation for workflow and image quality for the addition of the new features. The clinical results demonstrated that the Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T maintain the same imaging performance results as its predicate devices (K132376). Sample clinical images are included in this submission.

Conclusion: GE Healthcare considers the Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, and Optima MR450w 1.5T to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).

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.