(56 days)
Not Found
No
The provided text describes a standard PET/CT imaging system and its components. There is no mention of AI, ML, deep learning, or any related technologies in the intended use, device description, or performance studies sections. The software functions described are standard for image acquisition, reconstruction, and management.
No
The device is described as a "diagnostic imaging system" intended to "assist in the detection, diagnosis, staging, restaging, treatment response evaluation" of diseases, which indicates a diagnostic rather than therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "a diagnostic imaging system" and is intended "to assist in the detection, diagnosis, staging, restaging, treatment response evaluation for diseases and disorders".
No
The device description explicitly states that the uEXPLORER PET/CT system is a combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanner, which are hardware components. While it includes software for various functions, it is not solely software.
Based on the provided text, the uEXPLORER PET/CT device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body). The uEXPLORER PET/CT is an in vivo imaging system that directly scans the patient's body.
- The intended use and device description clearly state that the system is used for diagnostic imaging of the patient's body. It measures the distribution of radiopharmaceuticals within the patient and provides anatomical information through CT.
- There is no mention of analyzing biological specimens.
Therefore, the uEXPLORER PET/CT is a diagnostic imaging system, not an IVD.
N/A
Intended Use / Indications for Use
The uEXPLORER 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, diagnosis, staging, restaging, treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.
Product codes
KPS, JAK
Device Description
The uEXPLORER 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 430ps. It has a 1940mm-long axial field of view (FOV) and the system sensitivity is 191 cps/kBq.
The uEXPLORER 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
PET, CT
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing: Non-clinical testing including dosimetry and system performance tests were conducted for the uEXPLORER during the product development.
Clinical Testing: No Clinical Study is included in this submission.
Key Results: The features described in this premarket submission are supported with the results of the testing mentioned above, the uEXPLORER was found to have a safety and effectiveness profile that is similar to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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December 18, 2018
Shanghai United Imaging Healthcare Co., Ltd. % Shumei Wang Om & RA VP No. 2258 Chengbei Rd., Jiading Industrial District SHANGHAI 201807 CHINA
Re: K182938
Trade/Device Name: uEXPLORER Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: Class II Product Code: KPS, JAK Dated: October 17, 2018 Received: October 23, 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.
1
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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 medical devices and radiation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Hole 2. Mils
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name uEXPLORER
Indications for Use (Describe)
The uEXPLORER 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, diagnosis, staging, restaging, 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" and "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 that is divided into three sections by two vertical lines. The logo is simple and modern, and the use of bold fonts and clean lines gives it a professional look.
510(k) SUMMARY
1. Date of Preparation: October 17, 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: +86-021-67076888-6776 Fax: +86-021-67076889 Email: shumei.wang@united-imaging.com
3. Identification of Proposed Device
Trade Name: uEXPLORER Common Name: Emission Computed Tomography System
Model(s): uEXPLORER
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)
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
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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" and "IMAGING" stacked on top of each other in a bold, sans-serif font. To the right of the words is a stylized letter "U" that is made up of two vertical lines and a horizontal line in the middle.
5. Device Description
The uEXPLORER 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 430ps. It has a 1940mm-long axial field of view (FOV) and the system sensitivity is 191 cps/kBq.
The uEXPLORER 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 uEXPLORER 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
5
Image /page/5/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, which is dark teal in color and has a white vertical line running through the center of it. The overall design is clean and modern.
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 uEXPLORER 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 uEXPLORER | |
| 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. | The uMI 780 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. | 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. | ||
| PET Specification | ||
| Sensitivity | >/=170cps/kBq | >/=15cps/kBq |
| NECR Peak | ||
| Value | >/=1400 | |
| kcps@16kBq/cc | >/=165kcps@16kBq/cc | |
| Peak True Count | ||
| Rate | >/=4500kcps@28kBq/cc | >/=500kcps@30kBq/cc |
| PET Scatter | ||
| Fraction | =0.44 IEC 60601-1-3 Edition 2.1 2013-04 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
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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 61223-3-5 First edition 2004-08 Evaluation and routine testing in medical A imaging departments - Part 3-5: Acceptance tests -Imaging performance of computed tomography X-ray equipment [Including: Technical Corrigendum 1 (2006)]
-
NEMA XR 25-2010: Computed Tomography Dose Check
-
NEMA XR 28-2013 Supplemental Requirements for User Information and System Function Related to Dose in CT
-
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
- A Extended Performance Test Report for performance study;
- Clinical Evaluation for sample clinical images evaluation; >
-
AEC Test Report for AEC performance study.
Software
- NEMA PS 3.1-3.20(2011): Digital Imaging and Communications in Medicine A (DICOM)
-
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
- A 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
9
Image /page/9/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 words is a stylized "U" symbol, which is also in a bold font. The logo is simple and modern, and the use of bold fonts gives it a strong and confident look.
- 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)
- A 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.
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.
Summarv
The features described in this premarket submission are supported with the results of the testing mentioned above, the uEXPLORER 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.