(147 days)
The uPMR 790 system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and iso-centrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and/or PET imaging. The MR is intended to produce sagittal, transverse, coronal, and oblique cross sectional images, and spectroscopic images, and that display internal anatomical structure and/or function of the head, body and extremities. Contrast agents may be used depending on the reqion of interest of the scan. The PET provides distribution information of PET radiopharmaceuticals within the human body to assist healthcare providers in assessing the metabolic and physiological functions. The combined system utilizes the MR for radiation-free attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.
The uPMR 790 system is a combined Magnetic Resonance Diagnostic Device (MRDD) and Positron Emission Tomography (PET) scanner. It consists of components such as PET detector, 3.0T superconducting magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, vital signal module, and software etc.
The uPMR 790 system provides simultaneous acquisition of high resolution metabolic and anatomic information from PET and MR. PET detectors are integrated into the MR bore for simultaneous, precisely aligned whole body MR and PET acquisition. The PET subsystem supports Time of Flight (ToF). The system software is used for patient management, data management, scan control, image reconstruction, and image archive. The uPMR 790 system is designed to conform to NEMA and DICOM standards.
This traditional 510(k) is to request modifications for the cleared uPMR 790(K222540). The modifications performed on the uPMR 790 (K222540) in this submission are due to the following changes that include:
- (1) Addition of RF coils: SuperFlex Body 24, SuperFlex Large -12, SuperFlex Small -12.
- (2) Addition and modification of pulse sequences:
- (a) New sequences: gre fine, fse arms dwi, fse dwi, fse mars sle, grase, gre_bssfp_ucs, gre_fq, gre_pass, gre_quick_4dncemra, gre_snap, gre_trass, gre_rufis, epi_dwi_msh, svs_wfs, svs_stme.
- (b) Added Associated options for certain sequences: QScan, MultiBand, Silicon-Only Imaging, MoCap-Monitoring, T1rho, CEST, Inline T2 mapping, CASS, inline FACT, uCSR, FSP+, whole heart coronary angiography imaging, mPLD (Only output original control/labeling images and PDw(Proton Density weighted) images, no quantification images are output).
- (c) Name change of certain sequences: gre ute(old name: gre ute sp), svs_press(old name: press),svs_steam(old name: steam), csi_press(old name: press), csi hise(old name: hise).
- (3) Addition of MR imaging processing methods: 2D Flow, 4D Flow, SNAP, CEST, T1rho, FSP+, CASS, PASS, Inline T2 Mapping and DeepRecon.
- (4) Addition and modification of PET imaging processing methods:
- (a) The new PET imaging processing methods: Hyper DPR (also named HYPER AiR) and Digital Gating (also named Self Gating).
- (b) The modified method: HYPER Iterative.
- (5) Addition of MR image reconstruction methods: AI-assisted Compressed Sensing (ACS).
- (6) Addition and modification of workflow features:
- (a) The new workflow features: EasyCrop, MoCap-Monitoring and QGuard-Imaging.
- (b) The modified workflow feature: EasyScan.
- (7) Addition Spectroscopy: Liver Spectroscopy, Breast Spectroscopy.
- (8) Additional function: MR conditional implant mode.
The provided text does not contain detailed acceptance criteria for the uPMR 790 device in the format of a table, nor does it describe a specific study proving the device meets these criteria in a comparative effectiveness study or standalone performance study as would typically be presented for an AI/ML medical device.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with specific performance metrics against acceptance criteria.
However, based on the information available, I can extract and infer some aspects related to acceptance criteria and the performance study:
Inferred Acceptance Criteria and Reported Device Performance (based on provided text):
The device is an integrated MR-PET system. The modifications primarily involve new RF coils, pulse sequences, imaging processing methods, and workflow features. The performance data section describes non-clinical testing to verify that the proposed device met design specifications and is Substantially Equivalent (SE) to the predicate device.
While explicit quantitative acceptance criteria are not tabulated, the text implies that the performance of the modified device (uPMR 790) must be at least equivalent to, or better than, the predicate and reference devices regarding image quality and functionality.
Specifically for the new or modified features related to AI/ML (DeepRecon and ACS), the implicit acceptance criteria appear to be:
- DeepRecon:
- Equivalence in performance to DeepRecon on the uMR Omega.
- Better performance than NADR (No DeepRecon) in SNR and resolution.
- Maintenance of image qualities (contrast, uniformity).
- Significantly same structural measurements between DeepRecon and NADR images.
- ACS:
- Equivalence in performance to ACS on the uMR Omega (K220332).
- Better performance than CS in SNR and resolution.
- Maintenance of image qualities (contrast, uniformity) compared to fully sampled data (golden standard).
- Significantly same structural measurements between ACS and fully sampled images.
Table of Inferred Acceptance Criteria and Reported Device Performance:
| Feature/Metric | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Overall Device | Substantial Equivalence (SE) to predicate device (K222540) in performance, safety, and effectiveness. | Found to have a safety and effectiveness profile similar to the predicate device. |
| Image Performance | Meet all design specifications; generate diagnostic quality images. | Diagnostic quality images in accordance with MR guidance. |
| DeepRecon (general) | Equivalent to DeepRecon on uMR Omega. | Performs equivalently to DeepRecon on uMR Omega. |
| DeepRecon (SNR/Resolution) | Better than NADR. | Performs better than NADR. |
| DeepRecon (Quality) | Maintain image qualities (contrast, uniformity). | Maintained image qualities (contrast, uniformity). |
| DeepRecon (Structures) | Significantly same structural measurements as NADR. | Significantly same structural measurements as NADR. |
| ACS (general) | Equivalent to ACS on uMR Omega (K220332). | Performs equivalently to ACS on uMR Omega. |
| ACS (SNR/Resolution) | Better than CS. | Performs better than CS. |
| ACS (Quality) | Maintain image qualities (contrast, uniformity) as compared to fully sampled data. | Maintained image qualities (contrast, uniformity) compared to fully sampled data. |
| ACS (Structures) | Significantly same structural measurements as fully sampled data. | Significantly same structural measurements as fully sampled images. |
Breakdown of the Study as described in the 510(k) Summary:
2. Sample size used for the test set and the data provenance:
-
DeepRecon:
- "The testing dataset for performance testing was collected independently from the training dataset, with separated subjects and during different time periods."
- The exact sample size (number of subjects/cases) for the DeepRecon test set is not specified beyond being "independent."
- Data Provenance: Implied to be from UIH MRI systems, likely from clinical or volunteer scans. No specific country of origin or retrospective/prospective nature is stated for the test datasets, but training data was "collected from 264 volunteers" and "165,837 cases" using "UIH MRI systems," which suggests internal company data, likely from China where the company is based. The testing data is independently collected.
-
ACS:
- "The training and test datasets are collected from 35 volunteers, including 24 males and 11 females, ages ranging from 18 to 60. The samples from these volunteers are distributed randomly into training and test datasets."
- "The validation dataset is collected from 15 volunteers, including 10 males and 5 females, whose ages range from 18 to 60."
- It specifies "35 volunteers" for training+test and "15 volunteers" for validation. The text states "testing dataset for performance testing was collected independently from the training dataset," which contradicts the "distributed randomly into training and test datasets" statement for the 35 volunteers. This requires clarification, but assuming the 35 volunteers contributed to both, the total number used for testing is not explicitly broken out from the 35. The "validation dataset" of 15 volunteers seems to be an additional independent test set.
- Data Provenance: Implied to be from UIH MRI systems. No specific country of origin or retrospective/prospective nature is stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Expert Review: "Sample clinical images for all clinical sequences and coils were reviewed by U.S. board-certified radiologist comparing the proposed device and predicate device."
- Number of experts: Not specified, only "radiologist" (singular or plural not clear).
- Qualifications: "U.S. board-certified radiologist." No mention of years of experience.
- Quantitative/Objective Ground Truth: For DeepRecon and ACS, ground truth was not established by experts but rather by specific technical methods:
- DeepRecon: "multiple-averaged images with high-resolution and high SNR were collected as the ground-truth images."
- ACS: "Fully-sampled k-space data were collected and transformed to image space as the ground-truth."
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document implies a technical assessment for AI performance (SNR, resolution, structural measurements). For the "U.S. board-certified radiologist" review, no specific adjudication method (e.g., 2+1 consensus) is mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study involving human readers and AI assistance is described. The performance evaluation focuses on the technical imaging characteristics and comparison to the predicate device or baseline (NADR/CS). The "U.S. board-certified radiologist" review seems to be a qualitative assessment of diagnostic image quality rather than a structured MRMC study with quantitative outcomes.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance tests for DeepRecon and ACS are described as standalone evaluations of the algorithms' effects on image quality (SNR, resolution, contrast, uniformity, structural measurements) by comparing them to NA (No Algorithm) or baseline (CS) methods.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- DeepRecon: "multiple-averaged images with high-resolution and high SNR" (objective, technical ground truth representing optimal image quality).
- ACS: "Fully-sampled k-space data" (objective, technical ground truth representing complete data).
- For the qualitative review by the radiologist, the "diagnostic quality images" from the predicate device implicitly served as a reference or ground truth for comparison.
8. The sample size for the training set:
- DeepRecon: "264 volunteers" resulting in "165,837 cases."
- ACS: "35 volunteers" (randomly distributed into training and test datasets). The exact split for training is not specified but is part of this 35.
9. How the ground truth for the training set was established:
- DeepRecon: "the multiple-averaged images with high-resolution and high SNR were collected as the ground-truth images." "All data were manually quality controlled before included for training."
- ACS: "Fully-sampled k-space data were collected and transformed to image space as the ground-truth." "All data were manually quality controlled before included for training."
In summary, the provided document focuses on demonstrating technical equivalence and improved image characteristics for the AI components (DeepRecon, ACS) through non-clinical testing against technically derived ground truths, rather than a clinical multi-reader study with expert consensus ground truth or outcomes data. The human reader involvement seems to be a qualitative review of diagnostic image quality rather than a formal MRMC study.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text.
May 24, 2024
Shanghai United Imaging Healthcare Co., Ltd. Xin Gao RA Manager No. 2258 Chengbei Rd. Jiading District Shanghai, 201807 China
Re: K234154
Trade/Device Name: uPMR 790 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: OUO, MOS Dated: April 30, 2024 Received: April 30, 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) | |
|---|---|
| ------------------------------ | -- |
Device Name
uPMR 790
Indications for Use (Describe)
The uPMR 790 system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and iso-centrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and/or PET imaging. The MR is intended to produce sagittal, transverse, coronal, and oblique cross sectional images, and spectroscopic images, and that display internal anatomical structure and/or function of the head, body and extremities. Contrast agents may be used depending on the reqion of interest of the scan. The PET provides distribution information of PET radiopharmaceuticals within the human body to assist healthcare providers in assessing the metabolic and physiological functions. The combined system utilizes the MR for radiation-free attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.
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 text "K234154" at the top. Below that is the logo for UNITED IMAGING. The logo consists of the word "UNITED" on top of the word "IMAGING". To the right of the words is a stylized letter "U".
510 (k) SUMMARY
Date of Preparation 1.
December 28, 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 Affairs Specialist Tel: +86-021-67076888-5386 Fax: +86-021-67076889 Email: xin.gao@united-imaging.com
3. Identification of Proposed Device
Trade Name: uPMR 790 Common Name: Positron Emission Tomography and Magnetic Resonance Imaging System Model: uPMR 790
Regulatory Information Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: OUO, MOS Review Panel: Radiology
4. Identification of Primary/Reference Device(s)
Predicate Device
510(k) Number: K222540 Device Name: uPMR 790 Regulation Name: Emission Computed Tomography System Regulatory Class: II Product Code: OUO 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 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 also in a bold font. The color of the text and the "U" shape is a dark gray.
Reference Device#1
510(k) Number: K220332, K230152 Device Name: uMR Omega Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: LNH Review Panel: Radiology
Reference Device#2
510(k) Number: K210001 Device Name: HYPER AiR Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Review Panel: Radiology
Reference Device#3
510(k) Number: K193241 Device Name: uMI 550 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS, JAK Review Panel: Radiology
5. Device Description
The uPMR 790 system is a combined Magnetic Resonance Diagnostic Device (MRDD) and Positron Emission Tomography (PET) scanner. It consists of components such as PET detector, 3.0T superconducting magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, vital signal module, and software etc.
The uPMR 790 system provides simultaneous acquisition of high resolution metabolic and anatomic information from PET and MR. PET detectors are integrated into the MR bore for simultaneous, precisely aligned whole body MR and PET acquisition. The PET subsystem supports Time of Flight (ToF). The system software is used for
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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 "U" shape, which is also in bold. The color of the logo is a dark teal.
patient management, data management, scan control, image reconstruction, and image archive. The uPMR 790 system is designed to conform to NEMA and DICOM standards.
This traditional 510(k) is to request modifications for the cleared uPMR 790(K222540). The modifications performed on the uPMR 790 (K222540) in this submission are due to the following changes that include:
- (1) Addition of RF coils: SuperFlex Body 24, SuperFlex Large -12, SuperFlex Small -12.
- (2) Addition and modification of pulse sequences:
- (a) New sequences: gre fine, fse arms dwi, fse dwi, fse mars sle, grase, gre_bssfp_ucs, gre_fq, gre_pass, gre_quick_4dncemra, gre_snap, gre_trass, gre_rufis, epi_dwi_msh, svs_wfs, svs_stme.
- (b) Added Associated options for certain sequences: QScan, MultiBand, Silicon-Only Imaging, MoCap-Monitoring, T1rho, CEST, Inline T2 mapping, CASS, inline FACT, uCSR, FSP+, whole heart coronary angiography imaging, mPLD (Only output original control/labeling images and PDw(Proton Density weighted) images, no quantification images are output).
- (c) Name change of certain sequences: gre ute(old name: gre ute sp), svs_press(old name: press),svs_steam(old name: steam), csi_press(old name: press), csi hise(old name: hise).
- (3) Addition of MR imaging processing methods: 2D Flow, 4D Flow, SNAP, CEST, T1rho, FSP+, CASS, PASS, Inline T2 Mapping and DeepRecon.
- (4) Addition and modification of PET imaging processing methods:
- (a) The new PET imaging processing methods: Hyper DPR (also named HYPER AiR) and Digital Gating (also named Self Gating).
- (b) The modified method: HYPER Iterative.
- (5) Addition of MR image reconstruction methods: AI-assisted Compressed Sensing (ACS).
- (6) Addition and modification of workflow features:
- (a) The new workflow features: EasyCrop, MoCap-Monitoring and QGuard-Imaging.
- (b) The modified workflow feature: EasyScan.
- (7) Addition Spectroscopy: Liver Spectroscopy, Breast Spectroscopy.
- (8) Additional function: MR conditional implant mode.
6. Indications for Use
The uPMR 790 system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and
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Image /page/6/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 "U" shape, 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.
fusion of high resolution physiologic and anatomic information, acquired simultaneously and iso-centrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and/or PET imaging. The MR is intended to produce sagittal, transverse, coronal, and oblique cross sectional images, and spectroscopic images, and that display internal anatomical structure and/or function of the head, body and extremities. Contrast agents may be used depending on the region of interest of the scan. The PET provides distribution information of PET radiopharmaceuticals within the human body to assist healthcare providers in assessing the metabolic and physiological functions. The combined system utilizes the MR for radiation-free attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.
-
- Comparison of Technological Characteristics with the Predicate Device uPMR 790 employs the same basic operating principles and fundamental technologies, and has the same indications for use as the predicate device. A comparison between the technological characteristics of proposed and predicate devices is provided as below.
| ITEM | Proposed DeviceuPMR 790 | Predicate DeviceuPMR 790(K222540) | Remark |
|---|---|---|---|
| Magnet system | |||
| Field Strength | 3.0 Tesla | 3.0 Tesla | |
| Type of Magnet | Superconducting | Superconducting | |
| Patient-accessiblebore dimensions | 60 cm | 60 cm | |
| Type of Shielding | Actively shielded, OIStechnology | ||
| MagnetHomogeneity | $\leq$ 2.400 ppm @ 50 cm DSV | $\leq$ 2.400 ppm @ 50 cm DSV | |
| $\leq$ 0.800 ppm @ 45cm DSV | $\leq$ 0.800 ppm @ 45cm DSV | ||
| $\leq$ 0.390 ppm @ 40 cm DSV | $\leq$ 0.390 ppm @ 40 cm DSV | ||
| $\leq$ 0.110 ppm @ 30 cm DSV | $\leq$ 0.110 ppm @ 30 cm DSV | ||
| $\leq$ 0.038 ppm @ 20 cm DSV | $\leq$ 0.038 ppm @ 20 cm DSV | ||
| $\leq$ 0.020 ppm @ 10 cm DSV | $\leq$ 0.020 ppm @ 10 cm DSV | ||
| Gradient system | |||
| Max gradientamplitude | 45 mT/m | 45 mT/m | |
| Max slew rate | 200 T/m/s | 200 T/m/s | |
| Shielding | active | active | |
| Cooling | water | water | |
| RF system | |||
| Resonantfrequencies | 128.23 MHz | 128.23 MHz | |
| Number of transmitchannels | 2 | 2 | |
| Number of receive | 48 | 48 | Same |
| channels | |||
| Amplifier peak | 18 kW | 18 kW | Same |
| power per channel | |||
| RF Coils | |||
| Volume TransmitCoil | Yes | Yes | Same |
| Head & Neck Coil -24 | Yes | Yes | Same |
| Body Array Coil -12 | Yes | Yes | Same |
| Breast Coil - 10 | Yes | Yes | Same |
| Flex Coil Large - 8 | Yes | Yes | Same |
| Flex Coil Small - 8 | Yes | Yes | Same |
| Knee Coil - 12 | Yes | Yes | Same |
| Lower ExtremityCoil - 36 | Yes | Yes | Same |
| Shoulder Coil - 12 | Yes | Yes | Same |
| Small Loop Coil | Yes | Yes | Same |
| Spine Coil - 32 | Yes | Yes | Same |
| Wrist Coil - 12 | Yes | Yes | Same |
| Head Coil - 32 | Yes | Yes | Same |
| Foot & Ankle Coil -24 | Yes | Yes | Same |
| Cardiac Coil - 24 | Yes | Yes | Same |
| TemporomandibularJoint Coil - 4 | Yes | Yes | Same |
| Carotid Coil - 8 | Yes | Yes | Same |
| Infant Coil - 24 | Yes | Yes | Same |
| Patient table | |||
| W $\times$ H $\times$ L: 640 mm $\times$ 890 | W $\times$ H $\times$ L: 640 mm $\times$ 890 mm | Same | |
| Dimensions | mm $\times$ 2620 mm | $\times$ 2620 mm | |
| Maximum supportedpatient weight | 250 kg | 250 kg | Same |
| Accessories | |||
| Wireless UIH Gating UnitREF 453564324621 | Wireless UIH Gating UnitREF 453564324621 | Same | |
| ECG module Ref989803163121 | ECG module Ref989803163121 | ||
| Vital Signal Gating | SpO2 module Ref989803163111(alternative) | SpO2 module Ref989803163111(alternative) | |
| uVWMERPuMVRX(alternative) | uVWMERPuMVRX(alternative) | ||
| PET | |||
| 1 cm: FWMH $\leq$ 3.2 mm | 1 cm: FWMH $\leq$ 3.2 mm | Same | |
| Resolution | 10 cm: FWHM $\leq$ 3.6 mm | 10 cm: FWHM $\leq$ 3.6 mm | |
| 20 cm: FWHM $\leq$ 4.8 mm | 20cm: FWHM $\leq$ 4.8 mm | ||
| Sensitivity | 0 cm: ≥14 cps/kBq10 cm: ≥14 cps/kBq | 0 cm: ≥14 cps/kBq10 cm: ≥14 cps/kBq | Same |
| Scatter fraction,count losses andrandomsmeasurement | NECR peak: ≥110 kcpsTrue peak: ≥300 kcpsScatter Fraction: ≤0.46 | NECR peak: ≥110 kcpsTrue peak: ≥300 kcpsScatter Fraction: ≤0.46 | Same |
| Accuracy | maximum value of the bias ator below necr peak activityvalue: ≤10% | maximum value of the bias ator below necr peak activityvalue: ≤10% | Same |
| Image quality | Contrast Recovery coefficient:10 mm: ≥45.0%13 mm: ≥55.0%17 mm: ≥55.0%22 mm: ≥65.0%28 mm: ≥65.0%37 mm: ≥70.0%Noise:10 mm: ≤9.0%13 mm: ≤8.0%17 mm: ≤7.0%22 mm: ≤7.0%28 mm: ≤7.0%37 mm: ≤7.0%Relative lung error: ≤10% | Contrast Recovery coefficient:10 mm: ≥45.0%13 mm: ≥55.0%17 mm: ≥65.0%22 mm: ≥65.0%28 mm: ≥65.0%37 mm: ≥70.0%Noise:10 mm: ≤9.0%13 mm: ≤8.0%17 mm: ≤7.0%22 mm: ≤7.0%28 mm: ≤7.0%37 mm: ≤7.0%Relative lung error: ≤10% | Note 1 |
| Time of Fly(TOF)resolution | ≤560 ps | ≤560 ps | |
| MR Image Processing Features | |||
| CASS | Yes | No | Note 2 |
| PASS | Yes | No | Note 3 |
| HYPER Iterative | Yes | Yes | Note 4 |
| Workflow Features | |||
| EasyScan | Yes | Yes | Note 5 |
| QGuard-Imaging | Yes | No | Note 6 |
| EasyCrop | Yes | No | Note 7 |
| Mocap-Monitoring | Yes | No | Note 8 |
Table 1 Comparison to 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" 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 formed by two vertical lines connected by a horizontal line at the top. The logo is simple and modern in design.
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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" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized symbol that resembles the letter "U" with a vertical line running through the center and a horizontal line connecting the two sides near the top. The color of the text and symbol is a dark teal.
Table 2 Comparison to Reference device#1
| ITEM | Proposed DeviceuPMR 790 | uMR Omega(K220332) | Remark |
|---|---|---|---|
| SuperFlex Body - 24 | Yes | Yes | Same |
| SuperFlex Large - 12 | Yes | Yes | Same |
| SuperFlex Small - 12 | Yes | Yes | Same |
| MR Image Processing Features | |||
| 2D Flow | Yes | Yes | Same |
| DeepRecon | Yes | Yes | Same |
| Inline T2 Mapping | Yes | Yes | Same |
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Image /page/9/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 logo consisting of a dark blue square with rounded corners and a white "H" shape inside. The logo is simple and modern.
| Spectroscopy Features | |||
|---|---|---|---|
| Liver Spectroscopy | Yes | Yes | Same |
| Breast Spectroscopy | Yes | Yes | Same |
| MR Image Reconstruction Features | |||
| ACS | Yes | Yes | Same |
| Function | |||
| MR conditional implantmode | Yes | Yes | Same |
| ITEM | Proposed DeviceuPMR 790 | uMR Omega(K230152) | Remark |
| MR Image Processing Features | |||
| 4D Flow | Yes | Yes | Same |
| SNAP | Yes | Yes | Same |
| CEST | Yes | Yes | Same |
| T1rho | Yes | Yes | Same |
Table 3 Comparison to Reference device#2
| ITEM | Proposed DeviceuPMR 790 | Reference Device#2HYPER AiR(K210001) | Remark |
|---|---|---|---|
| HYPER DPR | Yes | Yes | Same |
Table 4 Comparison to Reference device#3
| ITEM | Proposed DeviceuPMR 790 | Reference Device#3uMI 550(K193241) | Remark |
|---|---|---|---|
| Digital Gating | Yes | Yes | Same |
| Note 1 | The contrast recovery coefficient of 17mm spheres is updated from 55% to 65%, whilehistorical test data shows the test results can meet 65% requirement. |
|---|---|
| The difference did not raise new safety and effectiveness concerns. | |
| Note 2 | CASS is substantially equivalent to BSSFP and acquires two different phase cycling angleimages and combine them by MIP operation to reduce dark band artifact.The difference did not raise new safety and effectiveness concerns. |
| Note 3 | PASS is substantially equivalent to GRE and acquires two different type (SSFP_FID andSSFP_SE) echoes image and combine them to achieve hybrid contrast image. |
| Note 4 | In this submission, the noise control term was changed from total variation regularizationto smoothed total variation regularization.The difference did not raise new safety and effectiveness concerns. |
| Note 5 | EasyScan of the proposed device supports more body part than that of the predicatedevice. In this submission, shoulder and abdomen are included.The difference did not raise new safety and effectiveness concerns. |
| Note 6 | QGuard-Imaging is expected for automatic monitoring of MR images for motion artifactsand providing real-time prompts to assist technicians in image quality control.The difference did not raise new safety and effectiveness concerns. |
| Note 7 | EasyCrop is a function that enables automatic cropping of vascular images scanned withthe TOF_3D protocol to simplify the workflow, which allows users to obtain interference-free vascular MIP images and automatically rotated MIP images with different angles |
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Image /page/10/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 formed by two vertical lines and a horizontal line connecting them at the top. The logo is simple and modern in design.
| when the scan is completed and images are generated. After enabling the EasyCrop | |
|---|---|
| function, the original images of TOF_3D will still be saved. | |
| The difference did not raise new safety and effectiveness concerns. | |
| Note 8 | MoCap-Monitoring is a motion monitoring module which is periodic and is inserted into |
| a pulse sequence. It can realize real-time motion monitoring in imaging scanning and | |
| provides an alert when motion occurs. | |
| The difference did 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
Non-clinical testing including surface heating and image performance tests were conducted for the uPMR 790 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)
- ANSI/AAMIES60601-1: 2005/ (R) A 2012+A1:2012+C1:2009/(R)2012+A2:2010/(R)2012) [IncludingAmendment2(2021)]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 60601-2-33 Ed. 4.0:2022 Medical Electrical Equipment - Part 2-33: Particular Requirements for The Basic Safety and Essential Performance of Magnetic Resonance Equipment for Medical Diagnostic
-
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.
-
IEC 62304:2006+AMD1:2015 CSV Consolidated version, Medical device software - Software life cycle processes
-
IEC 62464-1 Edition 2.0: 2018-12, Magnetic resonance equipment for medical imaging Part 1: Determination of essential image quality parameters.
- A NEMA MS 1-2008(R2020), Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Images
- A NEMA MS 2-2008(R2020), Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images
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Image /page/11/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 words is a stylized "U" symbol, which is dark gray. The logo is simple and modern in design.
- NEMA MS 3-2008(R2020), Determination of Image Uniformity in Diagnostic A Magnetic Resonance Images
- A NEMA MS 4-2010, Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices
- A NEMA MS 5-2018, Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging
-
NEMA MS 6-2008(R2014, R2020), Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging
- NEMA MS 8-2016, Characterization of the Specific Absorption Rate (SAR) for > Magnetic Resonance Imaging Systems
- NEMA MS 9-2008(R2020), Standards Publication Characterization of Phased A Array Coils for Diagnostic Magnetic Resonance Images
- NEMA MS 14-2019, Characterization of Radiofrequency (RF) Coil Heating in A Magnetic Resonance Imaging Systems
- A IEC /TR 60601-4-2: 2016, Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
- A NEMA NU 2-2018, Performance Measurements of Positron Emission Tomography
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
- A ISO 10993-5: 2009, Edition 3.0, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
-
ISO 10993-10: 2021, Edition 4.0. Biological evaluation of medical devices - Part 10: Tests for skin sensitization.
- ISO 10993-23: 2021, Edition 1.0, Biological evaluation of medical devices Part A 10: Tests for irritation.
- A Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
Other Standards and Guidance
- ISO 14971: 2019, Edition 3.0, Medical Devices Application of risk A management to medical devices
- A Code of Federal Regulations, Title 21, Part 820 - Quality System Regulation
- Code of Federal Regulations, Title 21, Subchapter J Radiological Health A
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Image /page/12/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 dark gray. The logo is clean and modern in appearance.
Performance Verification
Non-clinical testing was conducted to verify the features described in this premarket submission.
- Performance evaluation report for ACS, DeepRecon, ImageGuard, MoCap-A Monitoring, EasyCrop, EasyScan, Oscan, ASL 3D, Multiband, Silicon-Only Imaging, MARS+, 2D Flow, 4D Flow, Inline CEST, Inline Fact, T1rho, Inline T2 mapping, HYPER DPR, Digital Gating, HYPER Iterative and Inline T2 mapping.
- A Performance evaluation report for Spectroscopy: Liver MRS, Breast MRS
- A Sample clinical images for all clinical sequences and coils were reviewed by U.S. board-certified radiologist comparing the proposed device and predicate device. It was shown that the proposed device can generate diagnostic quality images in accordance with the MR guidance on premarket notification submissions.
Summary of the Machine Learning Algorithm
- DeepRecon
DeepRecon is a deep-learning based image processing algorithm for image denoising and K-space-interpolation based image super-resolution.
The training data of DeepRecon were collected from 264 volunteers. Each subject was scanned by UIH MRI systems for multiple body parts and clinical protocols, resulted in a total of 165,837 cases. In terms of the ground truth and input images in training dataset, the multiple-averaged images with high-resolution and high SNR were collected as the ground-truth images. The input images were generated from the ground-truth images by sequentially reducing the SNR and resolution of the groundtruth images. All data were manually quality controlled before included for training.
DeepRecon has undergone performance testing and phantom test to verify its performance. The testing dataset for performance testing was collected independently from the training dataset, with separated subjects and during different time periods. Therefore, the testing data for performance testing is entirely independent and does not share any overlap with the training data.
The test results demonstrate that DeepRecon on uPMR 790 performs equivalently to that on uMR Omega. The DeepRecon on uPMR 790 was shown to perform better than NADR (No DeepRecon) by measuring SNR and resolution. Meanwhile, results from the tests also demonstrated that DeepRecon maintained image qualities, such as
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Image /page/13/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 gray with a white line running vertically through the center, creating a negative space effect.
contrast and uniformity. The structure measurements on paired images verified that DeepRecon and NADR images of same structures were significantly the same.
. ACS
ACS is an acceleration reconstruction technique. By adding one more regularization term from AI module, ACS is a slight extension of CS (Compressed Sensing).
The training dataset of AI module in ACS was collected from a variety of anatomies, image contrasts, and acceleration factors. Each subject was scanned by UIH MRI systems for multiple body parts and clinical protocols, resulting in a large number of cases. Fully-sampled k-space data were collected and transformed to image space as the ground-truth. The input data were generated by sub-sampling the fully-sampled kspace data with different parallel imaging acceleration factors and partial Fourier factors. All data were manually quality controlled before included for training.
The training and test datasets are collected from 35 volunteers, including 24 males and 11 females, ages ranging from 18 to 60. The samples from these volunteers are distributed randomly into training and test datasets. The validation dataset is collected from 15 volunteers, including 10 males and 5 females, whose ages range from 18 to 60.
ACS has undergone the same tests as the predicate device uMR Omega to verify its performance. The testing dataset for performance testing was collected independently from the training dataset, with separated subjects and during different time periods. Therefore, the testing data for performance testing is entirely independent and does not share any overlap with the training data. In addition, comparison tests were conducted between ACS on uPMR 790 and uMR Omega.
The ACS on uPMR 790 was shown to perform better than CS by measuring SNR and resolution. Meanwhile, results from the tests also demonstrated that ACS maintained image qualities, such as contrast and uniformity, as compared against fully sampled data as golden standards. The test results demonstrate that ACS on uPMR 790 performs equivalently to that on uMR Omega via K220332. The structure measurements on paired images verified that ACS and fully sampled images of same structures were significantly the same.
Summary
The features described in this premarket submission are supported with the results of the testing mentioned above, the uPMR 790 was found to have a safety and effectiveness profile that is similar to the predicate device.
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Image /page/14/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 "U" shape, which is formed by two vertical lines and a horizontal line in the middle. The logo is simple and modern, and the use of bold font makes it easily readable.
Conclusion 9.
Based on the comparison and analysis above, the proposed device has similar indications for 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.
§ 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.