uMI Panorama

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. July 26, 2023 Shanghai United Imaging Healthcare Co., Ltd. % Xin GAO Regulatory Affairs Manager No. 2258 Chengbei Rd., Jiading Industrial District Shanghai, Shanghai 201807 CHINA Re: K231572 Trade/Device Name: uMI Panorama Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: Class II Product Code: KPS, JAK Dated: May 31, 2023 Received: May 31, 2023 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 {1}------------------------------------------------ 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 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 medical devices and radiation-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, D. R. Califf 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 Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) k231572 Device Name uMI Panorama ### Indications for Use (Describe) The uMI Panorama is a diagnostic imaging system that combines two existing imaging modalities PET and CT. The quantitative distribution information of PET radiopharmaceuticals within the patient body measured by PET can assist healthcare providers in assessing metabolic and physiological functions. CT provides diagnostic tomographic anatomical information as well as photon attenuation for the scanned region. The accurate registration and fusion of PET and CT images provides anatomical reference for the findings in the PET images. This system is intended to be operated by qualified healthcare professionals to assist in the detection, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases, inflammation, infection and disorders in, but not limited to oncology, cardiology and neurology. The system maintains independent functionality of the CT device, allowing for single modality CT diagnostic imaging. This 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. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------| | <span> <b> Prescription Use (Part 21 CFR 801 Subpart D) </b> </span> | <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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 word "UNITED" stacked on top of the word "IMAGING" in a bold, sans-serif font. To the right of the text is a stylized "U" shape, which is also in a bold, sans-serif font. The color of the text and the "U" shape is a dark teal. # 510 (K) SUMMARY K231572 - 1. Date of Preparation May 18, 2023 #### 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 Panorama Common Name: Positron Emission Tomography and Computed Tomography Systems Model(s): uMI Panorama GS 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 Predicate/Reference Device(s) Predicate Device 510(k) Number: K223325 Device Name: uMI Panorama Model(s): uMI Panorama 35 Regulation Name: Emission Computed Tomography System Regulatory Class: II Product Code: KPS, JAK Review Panel: Radiology - 5. Device Description: {4}------------------------------------------------ Image /page/4/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 text is a stylized letter "U" that is split in half by a vertical white line. The logo is simple and modern, and the use of bold font and a strong color gives it a sense of authority. The proposed device uMI Panorama GS combines a 148 cm axial field of view (FOV) PET and multi-slice CT system to provide high quality functional and anatomical images, fast PET/CT imaging and better patient experience. The system includes PET gantry, CT gantry, patient table, power supply cabinet, console and reconstruction system, chiller, vital signal module. The uMI Panorama GS is an extended Field of View scanner based on uMI Panorama 35. The PET system uses the detector elements that is same with the predicate device. The gantry has been designed to extend the PET detector to 504 rings, which is different from 120 rings of the uMI Panorama 35. The CT system is UIH's commercially available uCT ATLAS Astound (K223028) with 40 mm detector, which can also be used for standalone, diagnostic CT imaging. The patient table has 250 kg maximum load capacity which allows flexible positioning and access for all patients. The PSC and chiller provide higher capacity to meet the extended PET system power supply and cooling requirement, compared to uMI Panorama 35. The control and reconstruction system contains image acquisition and reconstruction, image display and post processing analysis, data and patient management, CT dose display, networking, filming, etc. Vital signal module is identical to those of the predicate device uMI Panorama 35. ## 6. Indications for Use The uMI Panorama is a diagnostic imaging system that combines two existing imaging modalities PET and CT. The quantitative distribution information of PET radiopharmaceuticals within the patient body measured by PET can assist healthcare providers in assessing metabolic and physiological functions. CT provides diagnostic tomographic anatomical information as well as photon attenuation information for the scanned region. The accurate registration and fusion of PET and CT images provides anatomical reference for the findings in the PET images. This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, treatment planning and treatment response evaluation for diseases, inflammation, infection and disorders in, but not limited to oncology, cardiology and neurology. The system maintains independent functionality of the CT device, allowing for single modality CT diagnostic imaging. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for United Imaging. The text "UNITED" is stacked on top of the text "IMAGING" in a bold, sans-serif font. To the right of the text is a stylized "U" shape, which is divided into two halves by a horizontal line in the middle. This 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. #### 7. Comparison of Technological Characteristics with the Predicate Device The uMI Panorama GS employs the same basic operating principles and fundamental technologies, and has the same indications for use as the predicate device uMI Panorama 35. A comparison between the technological characteristics of proposed and predicate devices is provided as below. | ITEM | Proposed Device | Predicate Device | |--------------------|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------| | | uMI Panorama GS | uMI Panorama 35 (K223325) | | Gantry | 760 mm bore | 760 mm bore | | PET system | Scintillator material: LYSO<br>Number of detector rings: 504<br>Axial FOV: 148 cm | Scintillator material: LYSO<br>Number of detector rings: 120<br>Axial FOV: 35 cm | | CT System | uCT ATLAS Astound | uCT ATLAS Astound | | Maximum table load | 250 kg | 318 kg | uMI Panorama's technological characteristics do not raise new safety and effectiveness concerns. #### 8. Performance Data The following performance data was provided in support of the substantial equivalence determination. ## Non-Clinical Testing Image performance test was conducted for uMI Panorama GS 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) {6}------------------------------------------------ Image /page/6/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, with a white line running vertically through the center and a horizontal line across the top, creating a cross-like shape within the "U". The logo is in a dark gray color. - ANSI/AAMIES60601-1: 2005/ (R) 2012+A1:2012+C1: A 2009/(R)2012+A2:2010/(R)2012)[IncludingAmendment2(2021)]Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - A IEC60601-1-2: 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. - A IEC 60601-2-44: 2009+A1:2012+A2:2016 Medical electrical equipment - Part 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. - A IEC 60601-1-6: 2010+A1:2013+A2:2020, Edition 3.2, Medical electrical 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 - A NEMA NU 2-2018, Performance Measurements of Positron Emission Tomographs ## Software - A NEMA PS 3.1-3.20(2022d): Digital Imaging and Communications in Medicine (DICOM) - A Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - A Content of Premarket Submissions for Management of Cybersecurity in Medical Devices # Biocompatibility - ISO 10993-1: 2018, Edition 5.0, Biological evaluation of medical devices Part A 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 - A Code of Federal Regulations, Title 21, Part 820 - Quality System Regulation {7}------------------------------------------------ Image /page/7/Picture/1 description: The image contains the logo for United Imaging. The words "UNITED IMAGING" are stacked on top of each other 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 logo is a dark gray color. #### Code of Federal Regulations, Title 21, Subchapter J - Radiological Health > ### Summary The items described in this premarket submission are supported with the results of the testing mentioned above, the uMI Panorama was found to have a safety and effectiveness profile that is similar 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 no issues are raised regarding to safety and effectiveness. The proposed device is determined to be Substantially Equivalent (SE) to the predicate device.