uMI 550 PET/CT System

K182237 · Shanghai United Imaging Healthcare Co., Ltd. · KPS · Oct 12, 2018 · Radiology

Device Facts

• Record ID: K182237
• Device Name: uMI 550 PET/CT System
• Applicant: Shanghai United Imaging Healthcare Co., Ltd.
• Product Code: KPS · Radiology
• Decision Date: Oct 12, 2018
• 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

uMI 550 PET/CT system combines multi-slice X-ray CT and PET scanners; inputs include PET radiopharmaceutical distribution data and CT tomographic anatomical/attenuation data. System performs spatial alignment and image registration to fuse PET and CT images for clinical reading. PET system features time-of-flight capability (395ps timing resolution), 240mm axial FOV, and ~11cps/kBq sensitivity. Operated by qualified healthcare professionals in clinical settings. Software manages patient data, scan control, image reconstruction, and reading. Fused images provide anatomical reference for PET findings; CT data used for PET attenuation correction. Benefits include improved localization and metabolic/physiological assessment for oncology, cardiology, and neurology patients.

Clinical Evidence

No clinical study included. Substantial equivalence supported by bench testing, including dosimetry, image performance (NEMA NU 2-2012), electrical safety (ANSI AAMI ES60601-1), EMC (IEC 60601-1-2), and software verification/validation.

Technological Characteristics

Combined PET/CT scanner. PET: 240mm axial FOV, 395ps timing resolution. CT: 40 detector rows, 22mm Z-plane coverage, 0.55mm min slice thickness, 0.5s rotation speed. Materials comply with ISO 10993-5/10. Connectivity: DICOM 3.0. Software: Moderate level of concern. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-44, NEMA XR 25/28/29, NEMA NU 2-2012.

Indications for Use

Indicated for diagnostic imaging in patients requiring PET/CT scans for detection, localization, diagnosis, staging, restaging, treatment planning, and treatment response evaluation of diseases, including 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 780 (K172143)

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 Cn

October 12, 2018

Re: K182237

Trade/Device Name: uMI 550 PET/CT System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: Class II Product Code: KPS, JAK Dated: August 16, 2018 Received: August 17, 2018

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara 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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#### Indications for Use

510(k) Number (if known)

K182237

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) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X 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 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 logo that appears to be a combination of the letters "U" and "I". The logo is a dark color, possibly dark blue or gray, and the background is white.

### 510(k) SUMMARY

#### 1. Date of Preparation: August 16, 2018

#### 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: K172143 Device Name: uMI 780 Model(s): uMI 780

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
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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 a 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 font. The logo is simple and modern, and the use of a bold font gives it a strong and confident look.

The uMI 550 PET/CT system is a combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanner. This system is intended 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 PET system has time-of-flight capability with a timing resolution of 395ps. It has a 240mm-long axial field of view (FOV) and a system sensitivity ~11cps/kBq.

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.

#### 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

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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 IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized symbol that resembles a shield or a stylized letter "U" with a white line running vertically through the center, creating a negative space that looks like the letter "I".

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 uMI 550 PET/CT has the same indications for use as the predicate device uMI 780 PET/CT. The fundamental scientific technology of the proposed device is same as the predicate device.

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

| ITEM | Proposed Device | Predicate Device |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | KPS, JAK | KPS, JAK |
| Regulation No. | 21 CFR 892.1200 | 21 CFR 892.1200 |
| Class | Class II | Class II |
| Intended Use | The uMI 550 PET/CT is<br>a diagnostic imaging<br>system that combines two<br>existing imaging<br>modalities - PET and CT.<br>The quantitative<br>distribution information<br>of PET<br>radiopharmaceuticals<br>within the patient body<br>measured by PET can<br>assist healthcare<br>providers in assessing the<br>metabolic and<br>physiological functions.<br>CT provides diagnostic<br>tomographic anatomical<br>information as well as<br>photon attenuation<br>information for the<br>scanned region. The<br>accurate registration and<br>fusion of PET and CT<br>images provides<br>anatomical reference for<br>the findings in the PET<br>images. | The uMI 780 PET/CT is<br>a diagnostic imaging<br>system that combines<br>two existing imaging<br>modalities - PET and<br>CT. The quantitative<br>distribution information<br>of PET<br>radiopharmaceuticals<br>within the patient body<br>measured by PET can<br>assist healthcare<br>providers in assessing<br>the metabolic and<br>physiological functions.<br>CT provides diagnostic<br>tomographic anatomical<br>information as well as<br>photon attenuation<br>information for the<br>scanned region. The<br>accurate registration and<br>fusion of PET and CT<br>images provides<br>anatomical reference for<br>the findings in the PET<br>images. |
| | This system is intended<br>to be operated by<br>qualified healthcare<br>professionals to assist in<br>the detection,<br>localization, diagnosis,<br>staging, restaging,<br>treatment planning and<br>treatment response<br>evaluation for diseases<br>and disorders in, but not<br>limit to, oncology,<br>cardiology and<br>neurology. | This system is intended<br>to be operated by<br>qualified healthcare<br>professionals to assist in<br>the detection,<br>localization, diagnosis,<br>staging, restaging,<br>treatment planning and<br>treatment response<br>evaluation for diseases<br>and disorders in, but not<br>limit to, oncology,<br>cardiology and<br>neurology. |
| PET Specification | | |
| Sensitivity | >/=10cps/kBq | >/=15cps/kBq |
| NECR Peak<br>Value | >/=90 kcps@13kBq/cc | >/=165kcps@16kBq/cc |
| Peak True Count<br>Rate | >/=300kcps@27kBq/cc | >/=500kcps@30kBq/cc |
| PET Scatter<br>Fraction | =0.44</td =0.44</td | |
| Count Rate Bias | =±5%</td =±5%</td | |
| Axial<br>FWHM@1cm | =3.5mm</td =3.5mm</td | |
| Transaxial<br>FWHM@1cm | =3.5mm</td =3.5mm</td | |
| Axial<br>FWHM@10cm | =4.0mm</td =4.0mm</td | |
| Transaxial<br>FWHM@10cm | =4.0mm</td =4.0mm</td | |
| CT Specification | | |
| Scan Regime | Continuous Rotation | Continuous Rotation |
| Scan Modes | Topo<br>Axial Scan<br>Helical Scan | Topo<br>Axial Scan<br>Helical Scan |
| Z-plane coverage | 22mm | 40mm |
| Number of<br>detector row | 40 | 80 |
| Minimum slice<br>thickness | 0.55mm | 0.5mm |
| Rotation speed | Up to 0.5 sec per 360°<br>rotation | Up to 0.3 sec for 360°<br>rotation |
| Table Maximum<br>table load | 250kg | 250kg |
| Safety | | |
| Biocompatibility | Comply with ISO 10993-5,ISO 10993-10 | Comply with ISO 10993-5,ISO 10993-10 |
| Electrical Safety | Comply with ANSI AAMI ES60601-1 | Comply with ANSI AAMI ES60601-1 |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 |

Table 1 Comparison of Technological Characteristics

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#### 8. Performance Data

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

#### Non-Clinical Testing

Non-clinical testing including dosimetry and image performance tests were conducted for the uMI 550 during the product development.

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

#### Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical Safety and Electromagnetic Compatibility (EMC) testing were conducted on the uMI 550 in accordance with the following standards:

- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- 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
- > IEC 60601-2-44 Edition 3.2: 2016 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography
- > 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)]

#### Product Particular Standards

- IEC 60601-1-3 Edition 2.1 2013-04 Medical electrical equipment Part 1-3: General A requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
- A IEC 61223-3-5 First edition 2004-08 Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests -Imaging performance of computed tomography X-ray equipment [Including: Technical Corrigendum 1 (2006)]
- A NEMA XR 25-2010: Computed Tomography Dose Check

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- A NEMA XR 28-2013 Supplemental Requirements for User Information and System Function Related to Dose in CT
- A NEMA XR 29-2013: Standard Attributes on CT Equipment Related to Dose Optimization and Management

### Performance Verification

- NEMA NU 2-2012 Performance Measurements of Positron Emission Tomographs A
- Clinical Evaluation for sample clinical images evaluation; A
- A AEC Test Report for AEC performance study.

### Software

- NEMA PS 3.1-3.20(2011): Digital Imaging and Communications in Medicine A (DICOM)
- A IEC 62304: Medical Device Software - software life cycle process
- A Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- > Content of Premarket Submissions for Management of Cybersecurity in Medical Devices

### Biocompatibility

- ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices -A Part 10: Tests for irritation and skin sensitization
- > ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity

### Other Standards and Guidances

- ISO 14971: Medical Devices Application of risk management to medical devices A
- A Code of Federal Regulations, Title 21, Part 820 - Quality System Regulation
- A Code of Federal Regulations, Title 21, Subchapter J - Radiological Health
- A Laser Products - Conformance with IEC 60825-1 and IEC 60601-2-22; Guidance for Industry and FDA Staff (Laser Notice No. 50)
- > Provision for Alternate Measure of the Computed Tomography Dose Index (CTDI) to Assure Compliance with the Dose Information Requirements of the Federal Performance Standard for Computed Tomography

#### Software Verification and Validation

Software documentation for a Moderate Level of Concern software per FDA' Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" is included as a part of this submission.

The risk analysis was completed and risk control was implemented to mitigate identified hazards. The testing results show that all the software specifications have met the acceptance criteria. Verification and validation testing of the proposed device was found acceptable to support the claim of substantial equivalence.

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UNITED IMAGING HEALTHCARE conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modification, misuse or denial of use, or unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Cybersecurity information in accordance with guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" is included in this submission.

### Clinical Testing

No Clinical Study is included in this submission.

#### Summary

The features described in this premarket submission are supported with the results of the testing mentioned above, the uMI 550 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 same intended

use, similar performance, equivalence safety and effeteness 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.

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