The uMR 790 system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, and that display internal anatomical structure and/or function of the head, body and extremities.

These images and the physical parameters derived from the interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan.

Device Description

The uMR 790 is a 3.0T superconducting magnetic resonance diagnostic device with a 60cm size patient bore. It consists of components such as magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, and vital signal module etc. The uMR 790 Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.

AI/ML Overview

This document describes the uMR 790 MRI system, and the studies mentioned are for the general safety and performance of the device itself (like signal-to-noise ratio, geometric distortion, image uniformity, etc.), not for a specific AI algorithm within the device for a particular diagnostic task. Therefore, the standard AI acceptance criteria and study components you've requested are not directly applicable in this context.

However, I can extract information regarding the general performance testing and safety studies conducted for the uMR 790, which are somewhat analogous to "acceptance criteria" for an MRI system.

Here's the information based on the provided text, adapted to the closest relevant categories:

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

For the uMR 790, the "acceptance criteria" are implied by adherence to various NEMA and ISO standards for MRI performance. The document states that the device "conforms to NEMA and DICOM standards" and lists specific NEMA MS standards against which tests were conducted. The "reported device performance" is summarized by the statement: "The test results demonstrated that the device performs as expected and thus, it is substantially equivalent to the predicate devices to which it has been compared."

Acceptance Criteria Category	Specific Standard Met / Performance Claim
Signal-to-Noise Ratio (SNR)	Adherence to MS 1-2008(R2014) for SNR in Diagnostic MR Images
Geometric Distortion	Adherence to MS 2-2008(R2014) for 2D Geometric Distortion in Diagnostic MR Images
Image Uniformity	Adherence to MS 3-2008(R2014) for Image Uniformity in Diagnostic MR Images
Acoustic Noise	Adherence to MS 4-2010 for Acoustic Noise Measurement Procedure
Slice Thickness	Adherence to MS 5-2010 for Determination of Slice Thickness
SNR and Uniformity (Non-Volume Coils)	Adherence to MS 6-2008(R2014) for SNR and Image Uniformity in Single-Channel Non-Volume Coils
Specific Absorption Rate (SAR)	Adherence to MS 8-2008 for Characterization of SAR for MRI Systems
Phased Array Coils Characterization	Adherence to MS 9-2008(R2014) for Characterization of Phased Array Coils
General Safety (Electrical)	Adherence to ES60601-1:2005/(R)2012 (Basic Safety & Essential Performance)
Electromagnetic Disturbances	Adherence to IEC 60601-1-2 Ed 3.0 2007-03 (EM Disturbances)
MRI Specific Safety	Adherence to 60601-2-33 Ed 3.1:2013 (MR Equipment Safety & Performance)
Biological Evaluation (Cytotoxicity)	Adherence to ISO 10993-5 (Tests For In Vitro Cytotoxicity)
Biological Evaluation (Irritation/Sensitization)	Adherence to ISO 10993-10 (Tests For Irritation And Skin Sensitization)
Diagnostic Image Quality	Sample clinical images provided to support ability to generate diagnostic quality images
Gradient-induced Nerve Stimulation	Volunteer study performed to determine associated safety limits

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 for Test Set: The document mentions "Sample clinical images" and "A volunteer study" without specifying the exact number of images or volunteers.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The volunteer study would be prospective in nature.

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

The document states that images produce information "when interpreted by a trained physician." However, it does not specify the number or qualifications of experts used to establish ground truth for the "sample clinical images" or the volunteer study evaluation.

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

No specific adjudication method is mentioned for the evaluation of the sample clinical images or the volunteer study.

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

No MRMC comparative effectiveness study was done. This device is a general MRI system, not an AI-powered diagnostic algorithm.

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

Not applicable as this is an MRI system, not a standalone algorithm.

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

For the "sample clinical images," the ground truth is implicitly based on the ability of "trained physicians" to interpret the images for diagnosis.
For the volunteer study, the ground truth relates to physiological responses to gradient stimulation.

8. The sample size for the training set

Not applicable. This is not an AI algorithm requiring a training set in the conventional sense. The "training" for the device's design and operation would come from engineering principles and existing MRI technology.

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

Not applicable for a device like an MRI scanner.

Summary

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Shanghai United Imaging Healthcare Co., Ltd. Xin GAO Regulatory Affairs Specialist No. 2258 Chengbei Rd., Jiading Industrial District SHANGHAI, CHINA 201807

October 3, 2018

Re: K181371

Trade/Device Name: uMR 790 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: May 21, 2018 Received: May 23, 2018

Dear Xin GAO:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara

For

Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181371

Device Name uMR 790

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED" is stacked on top of the text "IMAGING". To the right of the text is a stylized logo that appears to be a "U" with a horizontal line through the middle.

510 (k) SUMMARY

K181371

1. Date Prepared [21 CFR 807.92(a)(1)] May 21, 2018

2. General Information [21 CFR 807.92(a)(1)]

Manufacturer:	Shanghai United Imaging Healthcare Co., Ltd2258 Chengbei Rd., Jiading District, Shanghai, 201807
---------------	------------------------------------------------------------------------------------------------------

Contact Person:	Xin GAO
	Regulatory Affairs Specialist
	Tel: +86 (21) 67076888-5386
	Fax: +86-021-67076889
	Email: xin.gao@united-imaging.com

3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

Trade Name:	uMR 790
Common Name:	Magnetic Resonance Diagnostic Device
Model:	uMR 790
Product Code:	LNH
Regulation Number:	892.1000
Device Class:	II

4. Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)]

The identification of predicates device within this submission is as follow:

Predicate Device Manufacturer: SIEMENS AG Device Name: MAGNETOM Prisma Product Code: LNH Device Class: II Regulation Number: 21 CFR 892.1000 FDA 510 (k) #: K132119

1. Device Description [21 CFR 807.92(a)(4)]
  The uMR 790 is a 3.0T superconducting magnetic resonance diagnostic device with a

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Image /page/4/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is dark blue with a white vertical line running through the center. The overall design is clean and modern.

60cm size patient bore. It consists of components such as magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, and vital signal module etc. The uMR 790 Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.

6. Intended Use [21 CFR 807.92(a)(5)]

The uMR 790 system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, and spectroscopic images, and that display internal anatomical structure and/or function of the head, body and extremities.

These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan.

7. Technological Characteristic [21 CFR 807.92(a)(6)]

The uMR 790 has the same major technological characteristics as the predicate device. The differences from the predicate device including high order shimming configuration, interventional usage, RFPA power and external triggering function are discussed in the comparison table in this submission. The same scientific technology theory, similar physical design, same coil applications and functionalities are applied to both the uMR 790 and predicate device. The technical characteristic differences do not affect the safety and effectiveness of the uMR 790 for intended use.

8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)]

Summary of Non-Clinical Tests:

The following testing was conducted on the uMR 790 Magnetic Resonance Diagnostic Device as the predicate device:

A ES60601-1:2005/(R)2012, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
A IEC 60601-1-2 Edition 3.0 2007-03, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
A 60601-2-33 Ed. 3.1:2013, Medical Electrical Equipment - Part 2-33: Particular Requirements For The Basic Safety And Essential Performance Of Magnetic Resonance Equipment For Medical Diagnostic
A IEC 60825-1 Edition 2.0 2007-03, Safety Of Laser Products - Part 1: Equipment Classification, And Requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]

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Image /page/5/Picture/1 description: The image shows the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, dark blue letters, stacked on top of each other. To the right of the words is a stylized "U" shape, also in dark blue, with a white vertical line running through the center of the "U".

ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical A Devices - Part 5: Tests For In Vitro Cytotoxicity
A ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
A MS 1-2008(R2014), Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Images
A MS 2-2008(R2014), Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images
A MS 3-2008(R2014), Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
A MS 4-2010, Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices
MS 5-2010, Determination of Slice Thickness in Diagnostic Magnetic A Resonance Imaging
A MS 6-2008(R2014), Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging
MS 8-2008, Characterization Of The Specific Absorption Rate For Magnetic Resonance Imaging Systems
A MS 9-2008(R2014), Standards Publication Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images

The test results demonstrated that the device performs as expected and thus, it is substantially equivalent to the predicate devices to which it has been compared.

Summary of Clinical Tests:

A volunteer study was used to determine the safety limits associated with A gradient-induced nerve stimulation.
A Sample clinical images were provided to support the ability of uMR 790 to generate diagnostic quality images in accordance with the MR guidance on premarket notification submissions.

9. Conclusion [21 CFR 807.92(b)(3)]

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, we concludes that uMR 790 Magnetic Resonance Diagnostic Device is substantially equivalent to the predicate device. It does not introduce new indications for use, and has the same technological characteristics and does not introduce new potential hazards or safety risks.

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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.