1.5T Brivo MR355 and 1.5T Optima MR360 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 1.5T Brivo MR355 and 1.5T Optima MR360 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

1.5T Brivo MR355 and 1.5T Optima MR360 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The 1.5T Brivo MR355 and 1.5T Optima MR360 features a superconducting magnet operating at 1.5 Tesla. The system uses a combination of time-varying magnetic fields (gradients) and RF transmissions to obtain information regarding the density and position of nuclei exhibiting magnetic resonance. The data acquisition system accommodates 16 independent receive channels and multiple independent coil elements per channel during a single acquisition series.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Safety & Effectiveness comparable to predicate device	The device is considered "as safe, as effective, and performance is substantially equivalent to the predicate device(s)."
Compliance with voluntary standards	Complies with IEC60601-1, IEC60601-2-33, IEC60601-1-1, IEC60601-1-2, IEC60601-1-4, IEC60601-1-6, ISO14971, ISO10993-1, and IEC62304.
Production of high-resolution, high signal-to-noise ratio, and short scan times	Device designed to support these characteristics.
Ability to produce various image types (axial, sagittal, coronal, oblique, spectroscopic, parametric maps, spectra, dynamic)	Indicated for use to produce these image types.
Imaging capabilities for various body regions (head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, musculoskeletal)	Indicated for imaging these body regions.
Images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis	Device's intended use statement includes this.

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

Test Set Sample Size: The document states, "Internal scans were conducted as part of validation for workflow and image quality, and sample clinical images are included in the submission." However, a specific number for a "test set" (i.e., a dataset used for independent evaluation of the device's performance against ground truth) is not provided. The term "internal scans" and "sample clinical images" suggest internal testing rather than a formal test set with defined sample size.
Data Provenance: Not explicitly stated. The company is GE Healthcare, with a submitter address in Beijing, China, but the origin of the "internal scans" and "sample clinical images" is not specified. It's safe to assume it's retrospective data gathered for internal validation.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/not described. This submission did not involve a formal clinical study with a test set requiring expert adjudication.

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 and is not mentioned.
Effect Size: Not applicable.

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

Standalone Study: No, this device is a Magnetic Resonance Imaging System, not an AI algorithm. Its performance is inherent to its hardware and software specifications for image acquisition, not for an independent diagnostic algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: For the "internal scans" for workflow and image quality, the ground truth would likely be based on technical specifications, image quality metrics, and potentially visual assessment by technical experts or radiologists comparing against established benchmarks or the predicate device's performance. There's no mention of expert consensus for diagnostic accuracy, pathology, or outcomes data in specific clinical scenarios.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device is an MRI system, not an AI algorithm that requires a "training set" in the machine learning sense. The development and validation involved standard engineering processes, not machine learning model training.

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

Ground Truth Establishment for Training Set: Not applicable, as there was no training set for an AI algorithm. The device's "ground truth" for its development would be based on engineering specifications, physical principles of MRI, and comparison to existing, cleared MRI systems.

Summary of the Study:

The submission explicitly states: "The subject of this premarket submission, 1.5T Brivo MR355 and 1.5T Optima MR360 did not require clinical studies to support substantial equivalence. Internal scans were conducted as part of validation for workflow and image quality, and sample clinical images are included in the submission."

Therefore, the "study" proving the device meets acceptance criteria was primarily a non-clinical validation process (risk analysis, requirements, design reviews, module verification, system verification, performance testing, safety testing, simulated use testing) demonstrating compliance with voluntary standards and substantial equivalence to a predicate device (1.5T Brivo MR355 and 1.5T Optima MR360 K103330). The "acceptance criteria" were implied to be the device's ability to produce high-quality MRI images across various body parts, consistent with its intended use and comparable to the predicate device's performance, as verified through internal testing and compliance with relevant standards. No formal clinical efficacy or diagnostic accuracy studies involving patient outcomes or expert adjudication were conducted or deemed necessary for this 510(k) clearance.

Summary

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K 123417

JAN 1 7 2013

GE Healthcare 510(k) Premarket Notification Submission

510(k) Summary

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

10 October 10, 2012 Date:

GE Healthcare, (GE Hangwei Medical Systems Co., Ltd.) Submitter: No.2 Yong Chang North Road, Beijing Economic & Tech Development Area Beijing, 100176, China

Primary Contact Person:

Ruoqian Liu Regulatory Affairs Manager GE Healthcare Phone: 86-10-58068943 Fax: 86-10-67803267

Secondary Contact Person:

Glen Sabin Regulatory Affairs Director GE Healthcare Phone: 262-521-6848

Fax: 262-364-2785

1.5T Brivo MR355 and 1.5T Optima MR360 Device: Trade Name: Common/Usual Name: Magnetic Resonance Imaging System Magnetic resonance diagnostic device Classification Names: Product Code: LNH

1.5T Brivo MR355 and 1.5T Optima MR360 (K103330) Predicate Device(s):

Discovery MR750w 3.0T (K103327)

Device Description: 1.5T Brivo MR355 and 1.5T Optima MR360 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The 1.5T Brivo MR355 and 1.5T Optima MR360 features a superconducting magnet operating at 1.5 Tesla. The system uses a combination of time-varying magnetic fields (gradients) and RF transmissions to obtain information regarding the density and position of nuclei exhibiting magnetic resonance. The data acquisition system accommodates 16 independent receive channels and multiple independent coil elements per channel during a single acquisition series.

Image /page/0/Picture/15 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script. The letters are enclosed within a circular border, creating a recognizable emblem for the company.

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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The letters and the circle are black, creating a strong contrast against the white background.

GE Healthcare 510(k) Premarket Notification Submission

1.5T Brivo MR355 and 1.5T Optima MR360 is a whole body Intended Use: 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. 1.5T Brivo MR355 and 1.5T Optima MR360 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.

Proposed 1.5T Brivo MR355 and 1.5T Optima MR360 employs Technology: the same fundamental scientific technology as its predicate device 1.5T Brivo MR355 and 1.5T Optima MR360 (K103330).

Summary of Non-Clinical Tests:

1.5T Brivo MR355 and 1.5T Optima MR360 and its applications comply with voluntary standards , including IEC60601-1, IEC60601-2-33, IEC60601-1-1, IEC60601-1-2, IEC60601-1-4,

IEC60601-1-6, ISO14971, ISO10993-1 and IEC62304.

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)

Summary of Clinical Tests:

The subject of this premarket submission, 1.5T Brivo MR355 and 1.5T Optima MR360 did not require clinical studies to support

Determination of Substantial Equivalence:

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Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circle. The letters and the circle are in black, while the background is white. The logo has a vintage or classic appearance.

GE Healthcare

510(k) Premarket Notification Submission

substantial equivalence. Internal scans were conducted as part of validation for workflow and image quality, and sample clinical images are included in the submission.

Conclusion:

GE Healthcare considers the 1.5T Brivo MR355 and 1.5T Optima MR360 to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).

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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 stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

January 17, 2013

GE Hangwei Medical Systems Co., Ltd % Ruogian Liu Regulatory Affairs Manager No2 Yong Chang North Road Beijing Economic & Tech Development Area Beijing, 100176, CHINA

Re: K123417

Trade/Device Name: 1.5T Brivo MR355 and 1.5T Optima MR360 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: November 1, 2012 Received: November 6, 2012

Dear Mr. Liu:

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 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

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. . 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health 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,

Michael D. O'Hara

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

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GE Healthcare 510(k) Premarket Notification Submission

510(k) Number (if known):

1.5T Brivo MR355 and 1.5T Optima MR360 Device Name:

Indications for Use:

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 Diagnostics and Radiological Health (OIR)

Michael D. O'Hara

Divisions of Pradiological Health Page 1 of 1
Office of In Vitro Diagnostics and
Radiological Health

K123417

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.