The Optima™ MR450w 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 Optima™ MR450w 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 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 Optima MR450w is proposed to be marketed with an added XP Gradient configuration compatible with systems that have the GEM Coil Suite option. 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 magnetic resonance diagnostic device and does not have specific computational acceptance criteria like an AI-powered diagnostic tool. Instead, the "acceptance criteria" are based on compliance with voluntary standards and the satisfactory performance across a range of technical and safety tests.

Here's a breakdown of the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Non-Clinical Tests)	Reported Device Performance
Risk Analysis	Complies
Requirements Reviews	Complies
Design Reviews	Complies
Performance testing:
Signal-to-noise ratio (SNR)	Tested
Geometric distortion	Tested
Image uniformity	Tested
Slice thickness	Tested
Spatial resolution	Tested
Component, Subsystem and System Testing (Verification)	Complies
Simulated use testing (Validation)	Complies
Safety Testing:
Static Field Strength	Tested
Acoustic noise	Tested
DB/dt	Tested
RF heating (SAR)	Tested
Biocompatibility	Tested

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

The document explicitly states: "The subject of this premarket submission, Optima MR450w did not require external clinical studies to support substantial equivalence. Internal scans for workflow and image quality data were used for clinical validation."

This indicates that internal, retrospective data was used, but no specific sample size for a "test set" in the context of clinical performance evaluation is mentioned. The focus was on engineering verification and validation rather than a clinical trial.

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

Not applicable. The document does not describe a process of establishing ground truth for a clinical test set with expert adjudicators. Clinical validation was based on "internal scans for workflow and image quality data," implying internal review by presumably qualified GE personnel rather than a formal expert consensus process as seen in clinical AI studies.

4. Adjudication Method for the Test Set:

Not applicable. No formal adjudication method is described, as the device did not undergo external clinical studies requiring expert consensus on a clinical test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. The document explicitly states: "The subject of this premarket submission, Optima MR450w did not require external clinical studies to support substantial equivalence." Therefore, no MRMC study comparing human readers with and without AI assistance was performed.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. The Optima MR450w is a diagnostic imaging device, not an AI algorithm. Its performance is inherent in the image quality it produces, which is then interpreted by a trained physician. The "standalone" performance is the image quality itself, which was validated through the non-clinical tests listed.

7. Type of Ground Truth Used:

For the non-clinical performance tests (SNR, geometric distortion, etc.), the "ground truth" would be established by validated measurement standards and engineering specifications. For the "internal scans for workflow and image quality data," the ground truth would be based on established imaging protocols and subjective expert evaluation of image characteristics by internal GE staff. No pathology or outcomes data is mentioned as ground truth for this submission.

8. Sample Size for the Training Set:

Not applicable. The Optima MR450w is a hardware device (MRI scanner) with associated pulse sequences and reconstruction algorithms. It is not an AI algorithm that requires a "training set" in the conventional machine learning sense. Its design and algorithms are based on established physics and engineering principles, not statistical learning from a dataset.

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

Not applicable, as there is no "training set" in the machine learning context for this device.

Summary

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GE Healthcare

510(k) Premarket Notification Submission

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

November 22, 2011 Date:

Optima MR450w

892.1000

GE Healthcare (GE Medical Systems, LLC) Submitter: 3200 N. Grandview Blvd. Waukesha, WI 53188

Primary Contact Person:

Robin Martin Regulatory Affairs Leader GE Healthcare (GE Medical Systems, LLC) Ph: (262) 312-1120 Fax: (262) 364-2785

Secondary Contact Person:

Glen Sabin Regulatory Affairs Director GE Healthcare (GE Medical Systems, LLC) Ph: (262) 521-6848 Fax: (262) 364-2785

Magnetic Resonance Diagnostic Device

Optima MR450w (K091536)

Device: Trade Name: Common/Usual Name:

Classification Names:

LNH Product Code:

Predicate Device(s):

Device Description:

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GE Healthcare 510(k) Premarket Notification Submission

Intended Use:

The Optima MR450w employs the same fundamental scientific technology as its predicate device, the Optima MR450w. Refer to Section 12 for details of the System, Technical and Application Comparison Charts.

Technology:

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GE Healthcare

510(k) Premarket Notification Submission

Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

The Optima MR450w and its applications comply with voluntary standards as detailed in Section 9 of this premarket submission. The following quality assurance measures were applied to the development of the system:

. Risk Analvsis
Requirements Reviews .
Design Reviews �
Performance testing: .
- Signal-to-noise ratio (SNR) -
- Geometric distortion -
- Image uniformity -
- Slice thickness -
- Spatial resolution -
Component, Subsystem and System Testing (Verification) .
Simulated use testing (Validation) .

In accordance with voluntary standards identified in Section 9 and FDA's November 14, 1998 guidance entitled 'Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices', the following safety tests were completed:

Safety Testing .
- Static Field Strength -
- Acoustic noise -
- DB/dt -
- RF heating (SAR) -
- Biocompatibility -

Summary of Clinical Tests:

The subject of this premarket submission, Optima MR450w did not require external clinical studies to support substantial equivalence. Internal scans for workflow and image quality data were used for clinical validation.

Conclusion:

GE Healthcare considers the Optima MR450w to be as safe, as effective, and performance is substantially equivalent to the predicate device.

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Public Health Service

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

Ms. Robin Martin Regulatory Affairs Leader GE Medical Systems, LLC. 3200 N. Grandview Blvd. WAUKESHA WI 53188

Re: K113490

Trade/Device Name: Optima MR450w Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: November 22, 2011 Received: November 25, 2011

Dear Ms. Martin:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

JAN 1 3 2012

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Mary S Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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K 113490 510fk) Number (if known):

Device Name: Optima MR450w

Indications for Use:

The Optima™ MR450w 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 Optima™ MR450w reflect the spatial distribution or molecular environment of nucle oxhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S Posth

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Saf 510(k)

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.