The uMI Panvivo is a PET/CT system designed for providing anatomical and functional images. The PET provides the distribution of specific radiopharmaceuticals. CT provides diagnostic tomographic anatomical information as well as photon attenuation information for the scanned region. PET and CT scans can be performed separately. The system is intended for assessing metabolic (molecular) and physiologic functions in various parts of the body. When used with radiopharmaceuticals approved by the requlatory authority in the country of use, the uMI Panvivo system generates images depicting the distribution of these radiopharmaceuticals. The images produced by the uMI Panvivo are intended for analysis and interpretation by qualified medical professionals. They can serve as an aid in detection, evaluation, diagnosis, staging, re-staging, monitoring, and/ or follow-up of abnormalities, lesions, tumors, inflammation, infection, disorders, and/ or diseases, in several clinical areas such as oncology, infection and inflammation, neurology. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.

The CT system can be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society. *

Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

Device Description

The proposed device uMI Panvivo combines a 295 mm axial field of view (FOV) PET and 160-slice CT system to provide high quality functional and anatomical images, fast PET/CT imaging and better patient experience. The system includes PET system, CT system, patient table, power distribution unit, control and reconstruction system (host, monitor, and reconstruction computer, system software, reconstruction software), vital signal module and other accessories.

The PET system features the following specification and technologies.

700 mm patient bore size. ●
. LYSO detector with Axial Field of Views (AFOV) of 295 mm and corresponding imaging performances.
. 250 kg maximum table load capacity allows flexible positioning and access for all patients.
. HYPER Iterative (cleared in K193241), uses a regularized iterative reconstruction algorithm, which allows for more iterations while keeping the image noise at an acceptable level by incorporating a noise penalty term into the objective function.
. AIEFOV is an extended field of view algorithm incorporating extrapolation and Deep Learning(DL). In this algorithm, Project domain extrapolation ensures the normal processing in convolution filter in scan field of view to reduce truncation artifact. DL technology using polar coordinate conversion in extending region can enhance the processing efficiency of deep networks and accelerate training test processing. Overall, AIEFOV does not affect the CT values accuracy inside of SFOV, and also increases the accuracy of CT values in the extended region.

The control and reconstruction system contains image acquisition and reconstruction, image display and post processing, data and patient management, CT dose display, networking, filming, etc.

AI/ML Overview

This document is an FDA 510(k) clearance letter and summary for the uMI Panvivo PET/CT system. It does not contain specific acceptance criteria or a dedicated study section detailing how the device meets such criteria in the manner typically found for an AI/ML medical device.

The "Performance Data" section primarily focuses on non-clinical testing for compliance with standards (electrical safety, EMC, software, biocompatibility, risk management) and describes performance evaluations for specific features (HYPER Iterative and AI EFOV) rather than a comprehensive clinical study to prove general acceptance criteria.

However, I can extract the relevant information that is present and highlight what is missing.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific quantitative acceptance criteria for image quality or clinical performance are not explicitly stated in a table format, nor are explicit numerical performance values against such criteria. The document states:

"Image performance test was conducted for uMI Panvivo to verify that the proposed device met all design specifications as it is Substantially Equivalent (SE) to the predicate device."

For the AI-specific features, it notes:

Feature	Indication/Description	Performance (as reported)
HYPER Iterative	Uses a regularized iterative reconstruction algorithm, which allows for more iterations while keeping the image noise at an acceptable level by incorporating a noise penalty term into the objective function.	Performance evaluation report for HYPER Iterative. "Sample clinical images for HYPER Iterative and AI EFOV were reviewed by U.S. board-certified radiologist. It was shown that the proposed device can generate images as intended and the image quality is sufficient for diagnostic use."
AIEFOV (AI-based)	An extended field of view algorithm incorporating extrapolation and Deep Learning (DL). Project domain extrapolation ensures normal processing in convolution filter in scan field of view to reduce truncation artifact. DL technology using polar coordinate conversion in the extending region can enhance processing efficiency of deep networks and accelerate training test processing. Overall, AIEFOV does not affect CT values accuracy inside SFOV, and also increases the accuracy of CT values in the extended region.	Performance evaluation report for AI EFOV. "Sample clinical images for HYPER Iterative and AI EFOV were reviewed by U.S. board-certified radiologist. It was shown that the proposed device can generate images as intended and the image quality is sufficient for diagnostic use." "AIEFOV does not affect the CT values accuracy inside of SFOV, and also increases the accuracy of CT values in the extended region."

Missing Information Regarding Acceptance Criteria and Quantified Performance:
The document does not provide specific quantitative acceptance criteria for image quality (e.g., contrast-to-noise ratio, spatial resolution, lesion detectability thresholds) or clinical outcomes. It relies on the qualitative statement that "image quality is sufficient for diagnostic use" and "met all design specifications" in comparison to a predicate device.

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

Test Set Sample Size: Not explicitly stated. The document mentions "Sample clinical images for HYPER Iterative and AI EFOV were reviewed." The exact number of images, cases, or patients in this "sample" is not provided.
Data Provenance: Not explicitly stated. The document does not mention the country of origin of the data or whether the data was retrospective or prospective.

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

Number of Experts: "a U.S. board-certified radiologist". This implies one radiologist, although it's possible it refers to a group and uses "radiologist" generically.
Qualifications of Experts: "U.S. board-certified radiologist". No information on years of experience or specialization is provided.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable or not described. With a single "U.S. board-certified radiologist" reviewing images, an adjudication method (like 2+1 or 3+1 for consensus) would not be performed. The radiologist's assessment served as the evaluation.

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

MRMC Study: No, an MRMC comparative effectiveness study is not explicitly mentioned as having been done or used to demonstrate performance. The document describes a review by a single U.S. board-certified radiologist. Therefore, there is no information on the effect size of how much human readers improve with AI vs. without AI assistance.

6. Standalone Performance Study

Standalone Performance Study: The document implies a form of standalone performance evaluation for the AI EFOV and HYPER Iterative features through "Performance evaluation report for HYPER Iterative and AI EFOV" and the review by a radiologist. However, this is presented as an evaluation of image quality generated by the device, not necessarily a quantitative standalone diagnostic performance study (e.g., sensitivity, specificity) of the AI algorithm itself in a diagnostic task. The AI EFOV is described as an algorithm that improves image quality, specifically accuracy of CT values in the extended region and reduction of truncation artifacts. The evaluation focuses on whether the generated images are "sufficient for diagnostic use" and if CT values outside the SFOV are more accurate.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for the review of "sample clinical images" appears to be the expert opinion of the "U.S. board-certified radiologist" that the images were "sufficient for diagnostic use." For the AIEFOV's claim of increased accuracy of CT values in the extended region, the method for establishing this accuracy (e.g., comparison to a phantom with known values or a gold standard imaging technique) is not detailed.

8. Sample Size for the Training Set

Training Set Sample Size: Not explicitly stated. The document mentions "Deep Learning(DL) technology" for AIEFOV and says it can "accelerate training test processing," implying a training phase. However, the size of the dataset used for training the DL model is not provided.

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

Training Set Ground Truth Establishment: Not explicitly stated. While DL is mentioned, the methodology for creating the ground truth used to train the DL model for the AIEFOV feature is not described in this document.

Summary

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Image /page/0/Picture/0 description: The image contains 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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

August 15, 2024

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

Re: K241596

Trade/Device Name: uMI Panvivo Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: Class II Product Code: KPS, JAK Dated: June 3, 2024 Received: June 3, 2024

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

FDA

Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

Submission Number (if known)

K241596

Device Name

uMI Panvivo

Indications for Use (Describe)

Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

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 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 logo is simple and modern in design.

510 (K) SUMMARY

K241596

Date of Preparation 1. June 3, 2024

Sponsor Identification 2.

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

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

3. Identification of Proposed Device

Device Name: uMI Panvivo Common Name: Positron Emission Tomography and Computed Tomography Svstem Model(s): uMI Panvivo

Regulatory Information Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: II Product Code: KPS, JAK Review Panel: Radiology

4. Identification of Primary/Reference Device(s)

Predicate Device

510(k) Number: K172143 Device Name: uMI 780 Regulation Name: Emission Computed Tomography System Regulatory Class: II Product Code: KPS, JAK Review Panel: Radiology

Reference Device#1

510(k) Number: K230162 Device Name: uCT 760, uCT 780

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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 vertical line running through the center, creating a negative space "I" shape. The logo is simple and modern in design.

Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK Review Panel: Radiology

Reference Device#2

510(k) Number: K193241 Device Name: uMI 550 Regulation Name: Emission Computed Tomography System Regulatory Class: II Product Code: KPS, JAK Review Panel: Radiology

ನ. Device Description:

The PET system features the following specification and technologies.

700 mm patient bore size. ●
. LYSO detector with Axial Field of Views (AFOV) of 295 mm and corresponding imaging performances.
. 250 kg maximum table load capacity allows flexible positioning and access for all patients.
. HYPER Iterative (cleared in K193241), uses a regularized iterative reconstruction algorithm, which allows for more iterations while keeping the image noise at an acceptable level by incorporating a noise penalty term into the objective function.
. AIEFOV is an extended field of view algorithm incorporating extrapolation and Deep Learning(DL). In this algorithm, Project domain extrapolation ensures the normal processing in convolution filter in scan field of view to reduce truncation artifact. DL technology using polar coordinate conversion in extending region can enhance the processing efficiency of deep networks and accelerate training test processing. Overall, AIEFOV does not affect the CT values accuracy inside of SFOV, and also increases the accuracy of CT values in the extended region.

The control and reconstruction system contains image acquisition and reconstruction, image display and post processing, data and patient management, CT dose display, networking, filming, etc.

6. Indications for Use

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Image /page/5/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 text is a stylized "U" shape, which is dark blue with a white horizontal line through the middle. The overall design is clean and modern.

The uMI Panvivo is a PET/CT system designed for providing anatomical and functional images. The PET provides the distribution of specific radiopharmaceuticals. CT provides diagnostic tomographic anatomical information as well as photon attenuation information for the scanned region. PET and CT scans can be performed separately. The system is intended for assessing metabolic (molecular) and physiologic functions in various parts of the body. When used with radiopharmaceuticals approved by the regulatory authority in the country of use, the uMI Panvivo system generates images depicting the distribution of these radiopharmaceuticals. The images produced by the uMI Panvivo are intended for analysis and interpretation by qualified medical professionals. They can serve as an aid in detection, localization, evaluation, diagnosis, staging, re-staging, monitoring, and/or follow-up of abnormalities, lesions, tumors, inflammation, infection, organ function, disorders, and/or diseases, in several clinical areas such as oncology, infection and inflammation, neurology. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.

Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

7. Comparison of Technological Characteristics with the Predicate Device

uMI Panvivo employs the same basic operating principles and fundamental technologies, and has the similar indications for use as the predicate device uMI 780. A comparison between the technological characteristics of proposed and predicate devices is provided as below.

ITEM	Proposed DeviceuMI Panvivo	Predicate DeviceuMI 780 (K172143)
Patient bore size	700mm	700mm
PET System	Scintillator material: LYSONumber of detector rings: 100Axial FOV: 295 mm	Scintillator material: LYSONumber of detector rings: 112Axial FOV: 300 mm

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Image /page/6/Picture/1 description: The image contains the logo for United Imaging. The words "UNITED IMAGING" are in bold, sans-serif font, stacked on top of each other. To the right of the words is a stylized "U" shape, which is also in bold. The logo is simple and modern.

CT System	uCT 780	uCT 780
Maximum table load	250kg	250kg

uMI Panvivo's technological characteristics do not raise new safety and effectiveness concerns.

8. Performance Data

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

Non-Clinical Testing

Image performance test was conducted for uMI Panvivo to verify that the proposed device met all design specifications as it is Substantially Equivalent (SE) to the predicate device.

UNITED IMAGING HEALTHCARE claims conformance to the following standards and guidance:

Electrical Safety and Electromagnetic Compatibility (EMC)

A ANSI/AAMI ES60601-1: 2005/ (R) 2012+A1:2012+C1:2009/(R)2012+A2:2010/(R)2012)[IncludingAmendment2(2 021)]Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
A IEC 60601-1-2:2014+A1:2020, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
A IEC 60601-1-3:2008+AMD1:2013+A2:2021, Edition 2.2, Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment.
IEC 60601-2-44:2009+A1:2012+A2:2016 Medical electrical equipment Part A 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
A IEC 60825-1: 2014, Edition 3.0, Safety of laser products - Part 1: Equipment classification and requirements.
IEC 60601-1-6:2010+A1:2013+A2:2020, Edition 3.2, Medical electrical A equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.
A IEC 62304:2006+AMD1:2015 CSV Consolidated version, Medical device software - Software life cycle processes
NEMA NU 2-2018, Performance Measurements of Positron Emission Tomographs
A IEC TR 60601-4-2:2016, Edition 1.0, Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of

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Image /page/7/Picture/1 description: The image shows 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 words is a stylized letter "U" that is dark blue. The logo is simple and modern.

medical electrical equipment and medical electrical systems

Software

A NEMA PS 3.1-3.20(2016): Digital Imaging and Communications in Medicine (DICOM)
Guidance for the Content of Premarket Submissions for Software Contained in A Medical Devices
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices

Biocompatibility

A ISO 10993-1:2018, Edition 5.0, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
A ISO 10993-5: 2009, Edition 3.0, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
A ISO 10993-10: 2010, Edition 3.0, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.

Other Standards and Guidance

A ISO 14971: 2019, Edition 3.0, Medical Devices - Application of risk management to medical devices
Code of Federal Regulations, Title 21, Part 820 Quality System Regulation >
Code of Federal Regulations, Title 21, Subchapter J Radiological Health A

Performance Verification

Non-clinical testing was conducted to verify the features described in this premarket submission.

Performance evaluation report for HYPER Iterative and AI EFOV. A
A Sample clinical images for HYPER Iterative and AI EFOV were reviewed by U.S. board-certified radiologist. It was shown that the proposed device can generate images as intended and the image quality is sufficient for diagnostic use.

Summary

The features described in this premarket submission are supported with the results of the testing mentioned above, the uMI Panvivo was found to have a safety and effectiveness profile that is substantially equivalent to the predicate device.

9. Conclusions

Based on the comparison and analysis above, the proposed device has similar intended use, performance, safety equivalence, and effectiveness as the predicate device. The differences above between the proposed device and predicate device do not affect the intended use, technology characteristics, safety, and effectiveness. And

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Image /page/8/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 dark blue with a white line running vertically through the center. The logo is simple and modern, and the use of blue and white gives it a clean and professional look.

no issues are raised regarding to safety and effectiveness. The proposed device is determined to be Substantially Equivalent (SE) to the predicate device.

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.