The uMR 780/uMR790 system is indicated for use as a magnetic 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 images when interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of the scan.

Device Description

The uMR 780 is a 3.0T superconducting magnetic resonance diagnostic device with a 65cm 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 780 Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.

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.

The modification performed on the previously cleared devices (K181370 for uMR 780 and K181371 for uMR 790) is due to the modification of magnet. The modification, which do not affect the intended use or alter the fundamental scientific technology of the device, is following:

A modify magnet with a new model number;

In addition, seven coils which have been previously cleared by FDA via K183186 (Head Coil - 12, Head Coil - 32, Carotid Coil - 8, Temporomandibular Joint Coil - 4, Infant Coil - 24, Cardiac Coil - 24, Foot & Ankle Coil - 24) are added in this submission.

AI/ML Overview

This document is a 510(k) Summary for medical device clearance, specifically for the uMR 780 and uMR 790 Magnetic Resonance Diagnostic Devices. It describes modifications to previously cleared devices (K181370 for uMR 780 and K181371 for uMR 790) and the addition of previously cleared coils.

It explicitly states that no clinical testing was conducted on the proposed devices. Therefore, the information requested regarding acceptance criteria based on clinical performance, sample sizes for test sets, expert-established ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, training set sample sizes, and ground truth establishment for training sets is not available within this document. The provided text indicates a reliance on non-clinical testing and substantial equivalence to predicate devices rather than new clinical effectiveness studies.

The acceptance criteria described in the document relate to engineering and safety standards, not clinical performance.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Non-Clinical Tests)	Reported Device Performance (as stated in the document)
Signal to Noise Ratio	Test results demonstrated that the device performs as expected.
Geometric Distortion	Test results demonstrated that the device performs as expected.
Image Uniformity	Test results demonstrated that the device performs as expected.
Magnetic Field Homogeneity	Test results demonstrated that the device performs as expected.
Magnetic Field Decay	Test results demonstrated that the device performs as expected.
IEC 60601-2-33 Ed. 3.2 B:2015 Compliance	Test results demonstrated that the device performs as expected.

2. Sample size used for the test set and the data provenance:

Not Applicable. The document states, "No clinical testing was conducted on the proposed devices." The non-clinical tests would have involved physical measurements of the devices themselves, not patient data sets.

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

Not Applicable. No clinical test set or ground truth established by experts is mentioned in this document.

4. Adjudication method for the test set:

Not Applicable. No clinical test set or adjudication process is mentioned.

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. The document explicitly states "No clinical testing was conducted on the proposed devices." This type of study would fall under clinical effectiveness.

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

No. As a Magnetic Resonance Diagnostic Device (MRDD), it is a hardware system that produces images for interpretation by a physician. There is no mention of an "algorithm only" component with standalone performance in this document. The device is not an AI-driven image analysis tool, but an imaging system.

7. The type of ground truth used:

Not Applicable. For the non-clinical tests described, the "ground truth" would be established engineering specifications and measurement standards, not medical ground truth like pathology or outcomes data.

8. The sample size for the training set:

Not Applicable. No training set is mentioned as no machine learning or AI algorithm development is described in this document.

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

Not Applicable. No training set is mentioned.

Summary

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Shanghai United Imaging Healthcare Co., Ltd. % Xin Gao Regulatory Affairs Specialist No. 2258 Chengbei Road Shanghai, Shanghai 201807 CHINA

Re: K191157

Trade/Device Name: uMR 780, uMR 790 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: April 30, 2019 Received: May 1, 2019

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

May 29, 2019

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 medical devices and radiation-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,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191157

Device Name uMR 780, 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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510 (k) SUMMARY

K191157

1. Date of Prepared

April 30, 2019

2. Sponsor Identification

Shanghai United Imaging Healthcare Co.,Ltd. No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China

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

3. Identification of Proposed Device(s)

Trade Name: uMR 780, uMR 790 Common Name: Magnetic Resonance Diagnostic Device Model(s): uMR 780, uMR 790 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: LNH

4. Identification of Predicate Device(s)

Predicate Device #1 510(k) Number: K181370 Device Name: uMR 780 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: LNH

Predicate Device #2 510(k) Number: K181371 Device Name: uMR 790 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: LNH

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Reference Device

510(k) Number: K183186 Device Name: Head Coil - 12, Head Coil - 32, Carotid Coil - 8, Temporomandibular Joint Coil - 4, Infant Coil - 24, Cardiac Coil - 24, Foot & Ankle Coil - 24 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: MOS

5. Device Description

A modify magnet with a new model number;

6. Indications for Use

The uMR 780/uMR 790 system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique

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Image /page/5/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in a bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is also in a bold font. The color of the text and the "U" shape is a dark teal.

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

The technology characteristics of the modified uMR 780 and uMR 790, reflected in this 510(k) submission, do not alter the scientific technology of the devices and are substantially equivalent to those of the predicate devices.

8. Non-Clinical Tests

The following testing was conducted on the proposed devices:

A Signal to Noise Ratio
Geometric Distortion A
A Image Uniformity
A Magnetic Field Homogeneity
A Magnetic Field Decay
IEC 60601-2-33 Ed. 3.2 B:2015, Medical Electrical Equipment - Part 2-33: Particular Requirements For The Basic Safety And Essential Performance Of Magnetic Resonance Equipment For Medical Diagnostic

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.

9. Clinical Tests

No clinical testing was conducted on the proposed devices.

10. Conclusion

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 the modified uMR 780 and uMR 790 Magnetic Resonance Diagnostic Device are substantially equivalent to the predicate devices. It does not introduce new indications for use, and has the same technological characteristics and does not introduce new potential hazards or safety risks.

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.