Emission Computed Tomography System

K193241 · Shanghai United Imaging Healthcare Co., Ltd. · KPS · Jan 26, 2020 · Radiology

Device Facts

• Record ID: K193241
• Device Name: Emission Computed Tomography System
• Applicant: Shanghai United Imaging Healthcare Co., Ltd.
• Product Code: KPS · Radiology
• Decision Date: Jan 26, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

The uMI 550 PET/CT 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 the 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, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.

Device Story

The uMI 550 is a combined PET/CT diagnostic imaging system. It acquires PET data (radiopharmaceutical distribution) and CT data (anatomical/attenuation information). The system uses a workstation for scan control, image reconstruction, and fusion. New features include 'HYPER Iterative' reconstruction, which incorporates a noise control term into the objective function to improve contrast and quantification accuracy, and 'Auto-Planbox', which uses CT scout images to automatically recognize anatomy and plan scan ranges. Operated by qualified healthcare professionals in clinical settings, the device produces fused PET/CT images. These outputs assist clinicians in disease detection, staging, and treatment planning. The system benefits patients by providing precise anatomical localization of metabolic findings and potentially reducing scan time or improving image quality through iterative reconstruction.

Clinical Evidence

No prospective clinical trials were conducted. Evidence consists of a retrospective reader study of 20 clinical cases evaluated by 3 board-certified nuclear medicine physicians. Images reconstructed with OSEM vs. HYPER Iterative were compared using a 3-point contrast scale and 5-point image quality scale. Results demonstrated that HYPER Iterative provided superior contrast for small lesion detection and sufficient image quality for clinical diagnosis.

Technological Characteristics

Combined PET/CT system. PET: LYSO scintillator, 24cm axial FOV, 84 detector rings. CT: Solid-state GOS detector, 40 rows, 80 slices/rotation, 50kW generator, 5.3MHU tube. Connectivity: DICOM 3.0. Software: HYPER Iterative (regularized iterative reconstruction) and Auto-Planbox (anatomical recognition). Biocompatibility: ISO 10993-5/10. Electrical/EMC: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-44.

Indications for Use

Indicated for diagnostic imaging in patients requiring PET/CT assessment of metabolic and physiological functions, including detection, localization, diagnosis, staging, restaging, treatment planning, and treatment response evaluation for diseases and disorders in oncology, cardiology, and neurology.

Regulatory Classification

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.

Predicate Devices

• uMI 550 (K182237)

Submission Summary (Full Text)

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Shanghai United Imaging Healthcare Co., Ltd % Shumei Wang QM & RA VP No. 2258 Chengbei Rd., Jiading Industrial District Shanghai, 201807 CHINA

January 26, 2020

Re: K193241

Trade/Device Name: uMI 550 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: KPS, JAK Dated: November 22, 2019 Received: November 25, 2019

Dear Shumei Wang:

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

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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 ([e-mail]) or phone [phone] 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) K193241

Device Name uMI 550

#### Indications for Use (Describe)

The uMI 550 PET/CT 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 the 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, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.

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

| <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|-----------------------------------------------------------------------------|
| <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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Image /page/3/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is displayed in bold, sans-serif font. To the right of the text is a stylized "U" symbol, which is dark teal in color. The logo is simple and modern in design.

# 510(k) SUMMARY

- 1. Date of Preparation: January 22, 2020
#### 2. Sponsor Identification

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

Contact Person: Shumei Wang Position: QM&RA VP Tel: [phone]-6776 Fax: [phone] Email: [e-mail]

#### 3. Identification of Proposed Device

Trade Name: uMI 550 Common Name: Emission Computed Tomography System

Model(s): uMI 550

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 Device(s)

Predicate Device

510(k) Number: K182237 Device Name: uMI 550 Model(s): uMI 550

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

## 5. Device Description

The uMI 550 PET/CT system is a combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanner. This system is intended

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to be operated by qualified healthcare professionals for performing diagnostic imaging examinations. The spatial alignment and precise image registration between PET and CT ensure the PET and CT images of the same region can be fused accurately for reading. PET measures the distribution of PET radiopharmaceuticals inside the human body quantitatively. CT produces the anatomical information of the same scanned region, and provides accurate localization for the findings in the PET images. The attenuation information contained in the CT images can be utilized in the PET image reconstruction to ensure quantitation accuracy.

The uMI 550 PET/CT system also includes a patient table, a workstation with associated software installed. The software is used for patient management, data management, scan control, image reconstruction and image reading. All patient images produced by the system conform to the DICOM 3.0 standard.

The uMI 550 PET/CT has been previously cleared by FDA via K182237. The modifications performed on the uMI 550 PET/CT (K182237) in this submission are due to the addition of HYPER Iterative and Auto-Planbox function. Meanwhile the sensitivity specification has been updated. HYPER Iterative allows more iterations while remains the image noise at an acceptable level by incorporating a noise control term into the objective function. HYPER Iterative can achieve high image contrast and quantification accuracy. Auto-Planbox plan the scan range by recognizing body parts on CT scout image. It locates the different body parts based on anatomy characteristic. The scan range is generated to cover the whole body parts according to protocol selection. This function will simplify scanning process, which will be convenient for user operation.

The modifications are listed as follow:

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Image /page/5/Picture/1 description: The image shows 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 text is a stylized, dark teal-colored symbol that resembles a shield with a white line running horizontally through the center. The logo is simple and modern, conveying a sense of strength and innovation.

- Introduce HYPER Iterative function. >
- > Introduce Auto-Planbox function.
- > Update sensitivity specification.

| | uMI 550 PET/CT<br>previous<br>submission(K182237) | uMI 550 PET/CT this<br>submission | Remark |
|--------------------|---------------------------------------------------|---------------------------------------|------------------------------------------------|
| Sensitivity | >/=10cps/kBq @0cm<br>>/=10cps/kBq @10cm | >/=9cps/kBq @0cm<br>>/=9cps/kBq @10cm | Sensitivity specification<br>has been updated. |
| HYPER<br>Iterative | Not available | Available | New function has been<br>added |
| Auto-<br>Planbox | Not available | Available | New function has been<br>added |

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Image /page/6/Picture/1 description: The image shows the logo for United Imaging. The words "UNITED IMAGING" are stacked on top of each other in bold, dark blue font. To the right of the words is a stylized dark blue symbol that resembles the letter "U" with a vertical line through the center.

# 6. Indications for Use

The uMI 550 PET/CT 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 the 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 and disorders in, but not limit to, oncology, cardiology and neurology.

#### 7. Comparison of Technological Characteristics with the Predicate Devices

The technology characteristics of the modified uMI 550. 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.

Table 1 below provides a comparison of the technological characteristics of the proposed device in comparison to the predicate device.

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Image /page/7/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" symbol, which is also in a bold, sans-serif font. The color of the logo is a dark teal.

| ITEM | Table 1 Comparison of Technological Characteristics<br>Proposed Device<br>uMI 550 | Predicated Device<br>uMI 550(K182237) | Remark | | |
|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|------------------------|-------|
| General | | | | | |
| Product Code | KPS, JAK | KPS, JAK | Same | | |
| Regulation No. | 21 CFR 892.1200 | 21 CFR 892.1200 | Same | | |
| Class | Class II | Class II | Same | | |
| Intended Use | The uMI 550 PET/CT 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 the 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.<br>This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and | The uMI 550 PET/CT 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 the 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.<br>This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and | Same | | |
| Specifications | | | | | |
| PET Specifications | | | | | |
| Scintillator material | LYSO | LYSO | Same | | |
| Scintillator dimensions | 2.76mm×2.76mm×16.3mm | 2.76mm×2.76mm×16.3mm | Same | | |
| Number of detector rings | 84 | 84 | Same | | |
| Number of image planes | 167 | 167 | Same | | |
| Axial field of view | 24cm | 24cm | Same | | |
| Image matrix sizes | 128×128, 150×150, 192×192, 256×256, 512×512, 600×600 | 128×128, 150×150, 192×192, 256×256, 512×512, 600×600 | Same | | |
| Coincidence window | 4.0ns | 4.0ns | Same | | |
| Spatial Resolution | Axial FWHM@1 cm | </=3.5mm | </=3.5mm | Same | |
| | Transaxial FWHM@1 cm | </=3.5mm | </=3.5mm | | |
| | Axial FWHM@1 0cm | </=4.0mm | </=4.0mm | Same | |
| | Transaxial FWHM@1 0cm | </=4.0mm | </=4.0mm | | |
| Sensitivity | >/=9cps/kBq | >/=10cps/kBq | Note No.1 | | |
| NECR Peak Value | >/=90 kcps@13kBq/cc | >/=90 kcps@13kBq/cc | Same | | |
| Peak True Count Rate | >/=300kcps@27kBq/cc | >/=300kcps@27kBq/cc | Same | | |
| PET Scatter Fraction | </=0.44 | </=0.44 | Same | | |
| Count Rate Bias | </=±5% | </=±5% | Same | | |
| Image Quality | Acceptance Value | | Same | | |
| | Sphere | Contrast Recovery | | Background variability | |
| | 10 mm | >=45.0% | | <7.5% | |
| | 13 mm | >=55.0% | | <7.0% | |
| | 17 mm | >=65.0% | | <7.0% | |
| 22 mm | $\ge 72.0%$ | <7.0% | 22 mm | $\ge 72.0%$ | <7.0% |
| 28 mm | $\ge 65.0%$ | <7.0% | 28 mm | $\ge 65.0%$ | <7.0% |
| 37 mm | $\ge 70.0%$ | <7.0% | 37 mm | $\ge 70.0%$ | <7.0% |
| Lung<br>Residual | $\le 16.0%$ | <7.0% | Lung<br>Residual | $\le 16.0%$ | <7.0% |
| CT Specifications | | | | | |
| Scan Regime | Continuous Rotation | | Continuous Rotation | Same | |
| Scan…