The Optima MR450w is a whole body magnetic resonance scanner designed to support high resolution and high signal-to-noise ratio images in short exam times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique anatomical images, spectroscopic data, parametric maps, or dynamic images of the structures or functions of the entire body. The indication for use includes, but is 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 Optima MR450w reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and spectra, when interpreted by a trained physician yield information that may assist in diagnosis.

Device Description

The 1.5T GE Optima MR450w features a superconducting 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 (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 1.5T GE Optima MR450w is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).

AI/ML Overview

The GE Optima MR450w is a whole-body magnetic resonance scanner. The provided text, a 510(k) summary, outlines its safety and performance characteristics in comparison to a predicate device, the GE Discovery® MR450 System (K083147).

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria or a direct "reported device performance" table in the format usually seen for diagnostic algorithms. Instead, it refers to compliance with established standards (NEMA, IEC, ISO) and states that performance parameters were "measured and documented through testing to NEMA, IEC or ISO standards."

However, based on the Summary of Studies section, the performance parameters evaluated and implicitly deemed acceptable are:

Acceptance Criteria (Parameter Evaluated)	Reported Device Performance (Implicitly Met)
Signal-to-noise ratio (SNR)	Complies with NEMA, IEC, or ISO standards
Geometric distortion	Complies with NEMA, IEC, or ISO standards
Image uniformity	Complies with NEMA, IEC, or ISO standards
Slice thickness	Complies with NEMA, IEC, or ISO standards
Spatial resolution	Complies with NEMA, IEC, or ISO standards
Static field strength	Complies with NEMA, IEC, or ISO standards
Acoustic noise	Complies with NEMA, IEC, or ISO standards
RF heating (SAR)	Complies with NEMA, IEC, or ISO standards
Biocompatibility	Complies with NEMA, IEC, or ISO standards

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

The document does not specify a "test set" in the context of an algorithm or AI model evaluation. The studies described are physical performance and safety tests of the MR scanner itself. Therefore, sample sizes for medical images or patient data are not relevant or provided here. The tests are in accordance with NEMA, IEC, or ISO standards, which dictate the procedures and specifications for evaluating MR system performance and safety.

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

This information is not applicable. The studies concern the fundamental physical and electrical performance of the MR scanner, not the diagnostic accuracy of interpretations based on images from the device. Ground truth, in this context, would be established by validated measurement equipment and adherence to engineering and safety standards, rather than expert interpretation of medical images.

4. Adjudication Method for the Test Set:

Not applicable, as there's no "test set" of medical images or diagnostic interpretations being adjudicated. The tests are objective measurements against published standards.

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

No, an MRMC comparative effectiveness study was not done. This document describes the substantial equivalence of a new MR scanner model to a predicate device, focusing on its physical and safety performance. It does not involve human readers interpreting images with or without AI assistance, nor does it measure the effect size of AI on human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:

No, a standalone algorithm performance study was not done. The device is an MR imaging hardware system, not an AI algorithm.

7. The Type of Ground Truth Used:

The ground truth for the evaluations described is based on established engineering, safety, and performance standards as defined by organizations like NEMA, IEC, and ISO. These standards dictate acceptable ranges and methodologies for measuring parameters such as SNR, geometric distortion, SAR, and acoustic noise. The "truth" is whether the device's measured performance falls within the specified limits of these standards.

8. The Sample Size for the Training Set:

Not applicable. The document is about the hardware and core functionality of an MR scanner, not an AI or machine learning model. Therefore, there is no "training set."

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

Not applicable, for the same reasons as above.

Summary

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K091536

Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters are stylized and connected, and there are decorative flourishes at the top and bottom of the circle.

JUL 1 7 2009

GE Healthcare

3200 N. Grandview Blvd. Waukesha, WI 53188 USA

Section 5 - 510(k) Summary

This 510lk summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.92cl.

Submitter:	GE Healthcare3200 N. Grandview Blvd.Waukesha, WI 53188
Contact Person:	Mark StaufferRegulatory Affairs Leader
Telephone:	262 - 521 - 6891
Fax:	262 - 521 - 6439
Email:	mark.x.stauffer@ge.com
Date Prepared:	15 May 2009

Device Name:

Proprietary Name: Optima MR450w Classification Name: Magnetic Resonance Diagnostic System, 21 CFR 892.1000, 90-LNH

Predicate Device: GE Discovery® MR450 System (K083147)

Device Description:

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Indications for Use:

The Optima MR450w is a whole body magnetic resonance scanner designed to support high resolution and high signal-to-noise ratio images in short exam times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique anatomical images, spectroscopic data, parametric maps, , or dynamic images of the structures or functions of the entire body. The indication for use includes, but is 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.

Comparison with Predicate Devices:

The indications for use for the Optima MR450w System are similar to those for the GE Discovery® MR450 System,

Comparison statement between Optima MR450w and Discovery MR450 System :

The GE Optima MR450w is a new device design that is similar to the previously cleared 1.5T HDx MR system (K052293) with the main difference being the static magnet physical dimensions, which reflect the design objective of creating a larger diameter patient enclosure (bore). Both systems utilize superconducting magnets, gradients, and radio frequency coils and electronics to acquire data in single voxel, two-dimensional, or threedimensional datasets. The operating software is common to both systems, as are the user applications provided with the system or offered as options.

Summary of Studies:

As stated in the FDA document "Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices" the following parameters have been measured

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and documented through testing to NEMA, IEC or ISO standards (as referenced throughout this submission and listed in Section 9:

Performance:

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

Safety

Static field strength Acoustic noise വ്വവ RF heating (SAR) Biocompatibility

The Optima MR450w has been designed to comply with applicable IEC standards. It shall be certified by a Nationally Recognized Testing Laboratory to conform to IEC, NL and CSA standards prior to commercialization of the system.

Conclusion:

It is the opinion of GE that the GE Optima MR450w 1.5T system is substantially equivalent to the Discovery MR450 1.5T system.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GE Medical Systems LLC % Mr. Daniel W. Lehtonen Senior Staff Engineer-Medical Devices Intertek Testing Services NA, Inc. 2307 E. Aurora Rd., Unit B7 TWINSBURG OH 44087

JUL 1 7 2009

Re: K091536

Trade/Device Name: Optima MR 450w Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: July 2, 2009 Received: July 6, 2009

Dear Mr. Lehtonen:

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. Ilsting 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); medical device reporting of medical

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrl/mdr/ 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 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 yours ull Janine M. Morris

Acting 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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Indications for Use

510(k) Number (if known):

Device Name:

Optima MR450w

1091536

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)

AND/OR

Arza Kutz
(Division Sign-off)

Division of Reproductive, Abdominal and 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.