The uMR 580/uMR 588 system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, 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.

Device Description

The uMR 580/uMR 588 is a 1.5T 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 580/uMR 588 Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.

AI/ML Overview

The provided text is a 510(k) summary for the uMR 580/uMR 588 Magnetic Resonance Diagnostic Device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the context of a clinical performance study for an AI/ML medical device.

Therefore, much of the requested information (acceptance criteria table, sample sizes for test/training sets, expert details, adjudication methods, MRMC study details, ground truth types, etc.) is not present in this document.

However, based on the information provided, here's what can be extracted:

Acceptance Criteria and Device Performance (Limited Information)

The document states that a series of non-clinical tests were conducted, and these tests demonstrated that the device performs as expected and is substantially equivalent to the predicate. The "acceptance criteria" here are implied to be conformance to established standards and the successful achievement of certain measurement outcomes in those tests. The "reported device performance" is a general statement of success rather than specific quantitative metrics against a defined threshold.

Acceptance Criterion (Implied)	Reported Device Performance
Conformance to various IEC/ISO standards for medical electrical equipment, safety, and biological evaluation.	"The test results demonstrated that the device performs as expected."
Conformance to NEMA and DICOM standards.	"The uMR 580/uMR 588 Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards."
Ability to generate diagnostic quality images (Clinical Image Review).	"Sample clinical images were provided to support the ability of uMR 580/uMR 588 to generate diagnostic quality images in accordance with the MR guidance on premarket notification submissions."
Measurement of SNR (Signal-to-Noise Ratio) in MR images.	"The test results demonstrated that the device performs as expected." (Implied success based on MS 1-2008(R2014) standard)
Measurement of 2D Geometric Distortion in MR images.	"The test results demonstrated that the device performs as expected." (Implied success based on MS 2-2008(R2014) standard)
Measurement of Image Uniformity in MR images.	"The test results demonstrated that the device performs as expected." (Implied success based on MS 3-2008(R2014) standard)
Acoustic Noise Measurement.	"The test results demonstrated that the device performs as expected." (Implied success based on MS 4-2010 standard)
Determination of Slice Thickness in MR Imaging.	"The test results demonstrated that the device performs as expected." (Implied success based on MS 5-2010 standard)
Determination of SNR and Image Uniformity for Single-Channel Non-Volume Coils.	"The test results demonstrated that the device performs as expected." (Implied success based on MS 6-2008(R2014) standard)
Characterization of SAR (Specific Absorption Rate).	"The test results demonstrated that the device performs as expected." (Implied success based on MS 8-2008 standard)
Characterization of Phased Array Coils.	"The test results demonstrated that the device performs as expected." (Implied success based on MS 9-2008(R2014) standard)

Missing Information (Not Available in the Document):

Sample sized used for the test set and the data provenance: Not specified. The document mentions "sample clinical images were provided," but no details on quantity, origin, or retrospective/prospective nature.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified.
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: Not conducted or reported. This device is a Magnetic Resonance Diagnostic Device (hardware), not an AI/ML algorithm designed to assist readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the "sample clinical images," the ground truth is implicitly "diagnostic quality images" as interpreted by a trained physician, but no formal ground truth establishment process is described.
The sample size for the training set: Not applicable, as this is a hardware device submission, not an AI/ML algorithm, and thus doesn't have a "training set" in that context.
How the ground truth for the training set was established: Not applicable.

Summary of the Study type:

The study described is a series of non-clinical bench tests (conformance to various safety, performance, and measurement standards for MRI devices) and a limited clinical image review (assessment of diagnostic quality of sample images). It is a substantial equivalence demonstration for a hardware medical device (MRI scanner), not a performance study for an AI/ML algorithm. Therefore, many of the questions asked, which are typical for AI/ML device submissions, are not relevant or answered by this document.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K183137

Trade/Device Name: uMR 580, uMR 588 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: November 12, 2018 Received: November 13, 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

January 11, 2019

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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 (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 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,

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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Image /page/3/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, also in a bold font, with a vertical line running through the center of the "U". The color of the logo is a dark teal.

510 (k) SUMMARY

K183137

1. Date Prepared [21 CFR 807.92(a)(1)] November 12, 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 GAORegulatory Affairs SpecialistTel: +86 (21) 67076888-5386

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 580, uMR 588
Common Name:	Magnetic Resonance Diagnostic Device
Model:	uMR 580, uMR 588
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: Shanghai United Imaging Healthcare Co., Ltd Device Name: uMR 560 Product Code: LNH Device Class: II Regulation Number: 21 CFR 892.1000 FDA 510 (k) #: K180926

Reference Device Manufacturer: Shanghai United Imaging Healthcare Co., Ltd Device Name: uMR 570

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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 formed by two vertical lines and a horizontal line in the middle. The logo is simple and modern, and the colors are muted.

Product Code: LNH Device Class: II Regulation Number: 21 CFR 892.1000 FDA 510 (k) #: K180925

5. Device Description [21 CFR 807.92(a)(4)]

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

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

The uMR 580/uMR 588 has the same major technological characteristics as the predicate device. The difference from the predicate device is gradient performance which is 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 580/uMR 588 and predicate device. The technical characteristic differences do not affect the safety and effectiveness of the uMR 580/uMR 588 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 580/uMR 588 Magnetic Resonance Diagnostic Device as the predicate device:

A ES 60601-1:2005/(R)2012, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance

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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" and "IMAGING" stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized icon that resembles the letter "U" with a horizontal line through the middle. The logo is simple and modern in design.

A IEC 60601-1-2 Edition 4.0 2014-02, 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)]
ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
MS 1-2008(R2014), Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Images
MS 2-2008(R2014), Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images
MS 3-2008(R2014), Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
MS 4-2010, Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices
MS 5-2010, Determination of Slice Thickness in Diagnostic Magnetic 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
MS 9-2008(R2014), Standards Publication Characterization of Phased Array A 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:

Sample clinical images were provided to support the ability of uMR 580/uMR 588 A 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 580/uMR 588 Magnetic Resonance Diagnostic Device is substantially equivalent to the predicate device. It does not introduce new indications for use, and has the same

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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.