The uPMR 790 system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration of high resolution physiologic and anatomic information, acquired simultaneously and iso-centrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and/or PET imaging. The MR is intended to produce 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. Contrast agents may be used depending on the region of interest of the scan. The PET provides distribution information of PET radiopharmaceuticals within the human body to assist healthcare providers in assessing the metabolic and physiological functions. The combined system utilizes the MR for radiation-free attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.

Device Description

The uPMR 790 system is a combined Magnetic Resonance Diagnostic Device (MRDD) and Positron Emission Tomography (PET) scanner. It consists of components such as PET detector, 3.0T superconducting magnet. RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, vital signal module, and software etc. The uPMR 790 system provides simultaneous acquisition of high resolution metabolic and anatomic information from PET and MR. PET detectors are integrated into the MR bore for simultaneous, precisely aligned whole body MR and PET acquisition. The PET subsystem supports Time of Flight (ToF). The system software is used for patient management, data management, scan control, image reconstruction, and image archive. The uPMR 790 system is designed to conform to NEMA and DICOM standards.

AI/ML Overview

The provided text is a 510(k) summary for the uPMR 790, a combined Magnetic Resonance Diagnostic Device (MRDD) and Positron Emission Tomography (PET) scanner. This document describes the device, its intended use, and the modifications made from a previously cleared predicate device (K183014).

Based on the provided information, the 510(k) pertains to modifications of an existing device and does not describe a study involving detailed acceptance criteria and performance metrics for an AI/algorithm-driven device in the manner requested.

Here's a breakdown of why and what information is available:

1. Table of Acceptance Criteria and Reported Device Performance:

Not Applicable. The document describes a device modification and its non-clinical testing. It does not present specific acceptance criteria in terms of accuracy, sensitivity, specificity, or other performance metrics for an AI or algorithm, nor does it report the device's performance against such criteria. The testing focused on demonstrating that the modified hardware (magnet, PET gantry, coils) maintains the expected functionality and safety of the device.

Reasons for Not Applicable:

The 510(k) is for a combined MR/PET imaging system (hardware), not an AI/software diagnostic tool.
The "performance data" section focuses on hardware-related tests (e.g., NEMA NU 2 for PET, Signal to Noise Ratio, Geometric Distortion, Magnetic Field Homogeneity for MR) to ensure the modified device functions similarly to its predicate. These are engineering specifications, not clinical performance metrics for an algorithm's diagnostic accuracy.

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

Not Applicable for AI/algorithm performance. The document states, "No clinical testing was conducted on the proposed devices." The non-clinical testing involved hardware measurements and phantom studies, not a test set of patient data to evaluate an algorithm's diagnostic performance.
Data Provenance: Not applicable as there was no clinical testing on data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not Applicable. Since no clinical testing was conducted on patient data, there was no need for experts to establish ground truth for a test set.

4. Adjudication Method:

Not Applicable. No clinical test set requiring adjudication was used.

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

No. The document explicitly states: "No clinical testing was conducted on the proposed devices." Therefore, no MRMC study was performed.

6. Standalone Performance Study:

No. The document explicitly states: "No clinical testing was conducted on the proposed devices." This implies no standalone (algorithm-only) performance testing on clinical data was performed either. The focus was on hardware modifications.

7. Type of Ground Truth Used:

Not Applicable for AI/algorithm performance. As no clinical testing was performed, no ground truth from pathology, outcomes data, or expert consensus was used to evaluate an algorithm's performance. The "ground truth" in the context of the non-clinical testing would be the expected physical or electrical properties of the system, measured via phantoms and engineering tests.

8. Sample Size for the Training Set:

Not Applicable. There is no mention of an AI/machine learning algorithm within the scope of this 510(k) that would require a training set. The device is a medical imaging hardware system.

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

Not Applicable. As no training set for an AI/ML algorithm is mentioned, this information is not provided.

Summary of what the document does provide:

The document focuses on demonstrating substantial equivalence of a modified MR/PET imaging system (uPMR 790) to its predicate device (also uPMR 790, K183014) based on hardware changes. The modifications include:

Introduction of a new magnet.
Change in the PET gantry structure and RF shield.
Introduction of six new receive coils and re-categorization of existing coils.

The non-clinical testing performed ensured that these hardware changes did not negatively impact the device's fundamental safety and performance characteristics, such as:

Electrical safety (IEC 60601-1, -1-2, -2-33).
PET performance measurements (NEMA NU 2).
MR imaging quality (Signal to Noise Ratio, Geometric Distortion, Image Uniformity, Magnetic Field Homogeneity, Magnetic Field Decay).
PET/MR Attenuation Correction.
Acoustic Noise.
Surface Heating of RF Receive Coils.

The conclusion is that the modified device remains substantially equivalent to the predicate, and introduces no new indications for use, technological characteristics, or potential hazards/safety risks.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and 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 in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

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

November 20, 2019

Re: K192672

Trade/Device Name: uPMR 790 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: OUO Dated: September 25, 2019 Received: September 26, 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

{1}------------------------------------------------

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K192672

Device Name uPMR 790

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized "U" shape, which is also in a bold font. The color of the logo is a dark teal.

510 (k) SUMMARY

K192672

1. Date of Prepared

September 25, 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: uPMR 790 Common Name: Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Resonance Model: uPMR 790

Product Code: OUO Regulation Number: 21 CFR 892.1200 Device Class: II

4. Identification of Predicate Device(s)

Predicate Device 510(k) Number: K183014 Device Name: uPMR 790 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: OUO

5. Device Description

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image contains the logo for United Imaging. The words "UNITED" and "IMAGING" are stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized symbol that resembles the letter "U" with a horizontal line through the middle. The logo is simple and modern in design.

spectrometer, computer, equipment cabinets, power distribution system, internal communication system, vital signal module, and software etc. The uPMR 790 system provides simultaneous acquisition of high resolution metabolic and anatomic information from PET and MR. PET detectors are integrated into the MR bore for simultaneous, precisely aligned whole body MR and PET acquisition. The PET subsystem supports Time of Flight (ToF). The system software is used for patient management, data management, scan control, image reconstruction, and image archive. The uPMR 790 system is designed to conform to NEMA and DICOM standards.

This traditional 510(k) is to request modifications for the cleared Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Resonance.

The modifications performed on the uPMR 790 (K183014) in this submission are due to the change of the magnet, volume transmit coil, receive coils and PET gantry.

The modifications, which do not affect the intended use or alter the fundamental scientific technology of the device, are following:

A Introduce a new magnet
A Change the PET gantry structure and RF shield
A Introduce six new receive coils and new categorization of coils

6. Indications for Use

The uPMR 790 system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and iso-centrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and/or PET imaging. The MR is intended to produce 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. Contrast agents may be used depending on the region of interest of the scan. The PET provides distribution information of PET radiopharmaceuticals within the human body to assist healthcare providers in assessing the metabolic and physiological functions. The combined system utilizes the MR for radiation-free attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.

7. Technological Characteristic

A new magnet model is introduced in uPMR 790 and critical specifications of the main magnet are as same as the predicate device including field strength, magnet

{5}------------------------------------------------

Image /page/5/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 also in bold. The color of the logo is a dark teal.

dimension and field homogeneity. The mechanical structure of PET gantry and RF shield are modified to provide better system integration and both PET and RF characteristics are tested and validated to show substantially equivalence to those of the predicate device.

Six new receive coils are added including: Head Coil - 32, Foot & Ankle Coil -24, Cardiac Coil- 24, Temporomandibular Joint Coil - 4, Carotid Coil - 8, Infant Coil -24. Also seven receive coils are categorized as PET/MR coils with gamma ray attenuation and scattering data characterized in uPMR 790.

Overall the technology characteristics of the uPMR 790 with modified hardware and new coils, reflected in this 510(k) submission, are fundamentally equivalent to those of the predicate device.

8. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Non-Clinical Testing

The following testing was conducted on the proposed devices:

A ES60601-1, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
A IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
A IEC 60601-2-33. Medical Electrical Equipment - Part 2-33: Particular Requirements For The Basic Safety And Essential Performance Of Magnetic Resonance Equipment For Medical Diagnostic
V NEMA NU 2 Performance Measurements of Positron Emission Tomography
A Signal to Noise Ratio
Geometric Distortion
Image Uniformity
Magnetic Field Homogeneity
Magnetic Field Decay
A PET/MR Attenuation Correction
A Acoustic Noise
A Surface Heating of RF Receive Coils

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.

Clinical Testing

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the word "UNITED" stacked on top of the word "IMAGING", both in a bold, sans-serif font. To the right of the words is a stylized "U" shape, which is also in a bold font. The color of the logo is a dark teal.

No clinical testing was conducted on the proposed devices.

9. 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 uPMR 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.

Regulation Number and Section

§ 892.1200 Emission computed tomography system.

(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.