(84 days)
Not Found
Yes
The summary explicitly mentions "MRAC with AI-HITS" in the "Summary of Performance Studies" section and describes a training and test set for a network training process using WFI images and CT segmentation, which is characteristic of machine learning model development.
No.
The device is a diagnostic imaging system, designed to provide information about anatomical structure, physiological functions, and metabolic activity, which assists healthcare providers in assessing conditions rather than directly treating them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device combines "magnetic resonance diagnostic devices (MRDD)" and that the combined system provides "registration of high resolution physiologic and anatomic information." It also mentions that the MR is "intended to produce sagittal, transverse, coronal, and oblique cross sectional images, and that display internal anatomical structure and/or function" and the PET provides "distribution information of PET radiopharmaceuticals within the human body to assist healthcare providers in assessing the metabolic and physiological functions." These are all functions characteristic of a diagnostic device.
No
The device description explicitly lists numerous hardware components such as PET detector, superconducting magnet, RF coils, gradient coils, patient table, etc., indicating it is a physical medical device system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Device Function: The uPMR 790 system is an imaging device that uses Magnetic Resonance (MR) and Positron Emission Tomography (PET) to acquire images of the internal structure and function of the human body. It does not analyze specimens derived from the body.
- Intended Use: The intended use describes the system as providing "registration of high resolution physiologic and anatomic information," "cross sectional images," and "distribution information of PET radiopharmaceuticals within the human body." These are all related to in-vivo imaging, not in-vitro analysis of specimens.
While the system provides information to assist healthcare providers in assessment, this information is derived from imaging the patient directly, not from testing a sample taken from the patient.
No
The provided text does not contain explicit language stating that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section is marked 'Not Found'.
Intended Use / Indications for Use
The uPMR 790 system combines magnetic resonance diagnostic devices (MRDD) and Position Tomography (PET) scanners that provide registration 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 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.
Product codes (comma separated list FDA assigned to the subject device)
OUO
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 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 Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Resonance.
The modifications performed on the uPMR 790 (K192672) in this submission are due to the following changes that include:
- (1)Addition and modification of pulse sequences:
- a) New sequences: hise, asl_3d, gre_quick_4dcemra, gre_maps.
- b) Added Associated options for certain sequences: navigator, T2* mapping, cardiac tagging, Perfusion, PSIR, Cine, cardiac T1 mapping, cardiac T2 mapping, cardiac T2* mapping, dark blood, SWI+ (multi-echo), cDWI, MicroView.
- (2) Addition of MR imaging processing methods: Phase Sensitive Inversion Recovery (PSIR), Computed DWI (cDWI), Inline T1/T2* Map, Susceptibility Weighted Imaging Plus (SWI+). Arterial Spin Labeling (ASL). Cardiac T1 Mapping. Cardiac T2 Mapping, Cardiac T2* Mapping.
- (3)Addition and modification of PET imaging processing methods:
- a) The new PET imaging processing method: Hyper Iterative.
- b) Modified MRAC method:WFI based head MRAC.
- (4)Addition VSM models: uVWMERP and uMVRX.
- (5) Addition Spectroscopy: HISE for Head Spectroscopy; Prostate Spectroscopy.
The modifications, which do not affect the intended use or alter the fundamental scientific technology of the device.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Magnetic Resonance Diagnostic Device (MRDD), Positron Emission Tomography (PET)
Anatomical Site
head, body and extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare providers
Description of the training set, sample size, data source, and annotation protocol
Training dataset for AI module (Convolution Neural Network) used for WFI based head MRAC: Gender: 76 male, 54 female; Age: 17-83; Ethnicity: Chinese. The network training process uses pairs of WFI images and three-compartment segmentation from CT images of the same person.
Description of the test set, sample size, data source, and annotation protocol
Test set for AI module (Convolution Neural Network) used for WFI based head MRAC: Gender: 17 male, 10 female; Age: 15-78; Ethnicity: Chinese. Test data from Center 2 (n=12) was initially excluded from the training set and were from completely different subjects. All the data from Center1 (n=10) was collected almost 2 years after the imaging date of the training data, also with different subjects compared with the training set. Therefore, the test data was completely independent from the training data.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Clinical performance evaluation
- Performance evaluation report for 3D ASL (asl3d sequence), Inline Mapping, Cardiac T1 Mapping, Cardiac T2 Mapping, Cardiac T2* Mapping, Hyper Iterative, MRAC with AI-HITS, brain Spectroscopy, prostate Spectroscopy, EasyScan, EasyPlan.
- PET/MR image quality test report
The acceptance criteria for the AI module (WFI based head MRAC) was that average SUVmean error (CTAC as reference) in major brain regions cross the test patient cohort is within 10%. The test results fulfilled this criteria, with most brain regions having average error below 3%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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November 14, 2022
Shanghai United Imaging Healthcare Co., Ltd. % Xin Gao Regulatory Affairs Specialist NO. 2258 Chengbei Road, Jiading District Shanghai, Shanghai 201807 CHINA
Re: K222540
Trade/Device Name: uPMR 790 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: OUO Dated: October 21, 2022 Received: October 21, 2022
Dear Xin Gao:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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 (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Signature
Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222540
Device Name uPMR 790
Indications for Use (Describe)
The uPMR 790 system combines magnetic resonance diagnostic devices (MRDD) and Position Tomography (PET) scanners that provide registration 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 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.
| 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 text is a stylized "U" shape, which is dark blue with a white line running vertically through the center. The logo is simple and modern, and the use of bold text and a strong color palette makes it easily recognizable.
510 (k) SUMMARY
-
- Date of Prepared
October 21, 2022
- Date of Prepared
2. Sponsor Identification
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(s)
Trade Name: uPMR 790 Common Name: Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Resonance Model: uPMR 790 Product Code: OUO Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system
Device Class: II
4. Identification of Predicate Device(s)
Predicate Device 510(k) Number: K192672 Device Name: uPMR 790 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: OUO
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
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Image /page/4/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the word "UNITED" stacked on top of the word "IMAGING", both in a bold, sans-serif font. To the right of the text is a stylized "U" shape, which is also in a bold, sans-serif font. The color of the logo is a dark gray.
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 Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Resonance.
The modifications performed on the uPMR 790 (K192672) in this submission are due to the following changes that include:
- (1)Addition and modification of pulse sequences:
- a) New sequences: hise, asl_3d, gre_quick_4dcemra, gre_maps.
- b) Added Associated options for certain sequences: navigator, T2* mapping, cardiac tagging, Perfusion, PSIR, Cine, cardiac T1 mapping, cardiac T2 mapping, cardiac T2* mapping, dark blood, SWI+ (multi-echo), cDWI, MicroView.
- (2) Addition of MR imaging processing methods: Phase Sensitive Inversion Recovery (PSIR), Computed DWI (cDWI), Inline T1/T2* Map, Susceptibility Weighted Imaging Plus (SWI+). Arterial Spin Labeling (ASL). Cardiac T1 Mapping. Cardiac T2 Mapping, Cardiac T2* Mapping.
- (3)Addition and modification of PET imaging processing methods:
- a) The new PET imaging processing method: Hyper Iterative.
- b) Modified MRAC method:WFI based head MRAC.
- (4)Addition VSM models: uVWMERP and uMVRX.
- (5) Addition Spectroscopy: HISE for Head Spectroscopy; Prostate Spectroscopy.
The modifications, which do not affect the intended use or alter the fundamental scientific technology of the device.
6. Indications for Use
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
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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" stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized "U" symbol, which is also in a bold, sans-serif font. The color of the logo is a dark teal.
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.
7. Technological Characteristic
The differences from the predicate device are discussed in the comparison table in this submission as below.
| ITEM | This Submission
uPMR 790 | Predicate Device
uPMR 790(K192672) | Remark | | |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| 510(K) No. | K192672 | | | | |
| Product Code | OUO | OUO | Same | | |
| Regulation No. | 21 CFR 892.1200 | 21 CFR 892.1200 | Same | | |
| Class | II | II | Same | | |
| Indications For
Use | 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 | 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 | Same | | |
| | and/or function of the | and/or function of the | | | |
| | head, body and
extremities. Contrast | head, body and
extremities. Contrast | | | |
| | agents may be used | agents may be used | | | |
| | depending on the region | depending on the region | | | |
| | of interest of the scan. The | of interest of the scan. The | | | |
| | PET provides distribution | PET provides distribution | | | |
| | information of PET | information of PET | | | |
| | radiopharmaceuticals | radiopharmaceuticals | | | |
| | within the human body to | within the human body to | | | |
| | assist healthcare providers | assist healthcare providers | | | |
| | in assessing the metabolic | in assessing the metabolic | | | |
| | and physiological | and physiological | | | |
| | functions. The combined | functions. The combined | | | |
| | system utilizes the MR for | system utilizes the MR for | | | |
| | radiation-free attenuation | radiation-free attenuation | | | |
| | correction maps for PET | correction maps for PET | | | |
| | studies. The system | studies. The system | | | |
| | provides inherent | provides inherent | | | |
| | anatomical reference for | anatomical reference for | | | |
| | the fused PET and MR | the fused PET and MR | | | |
| | images due to precisely | images due to precisely | | | |
| | aligned MR and PET | aligned MR and PET | | | |
| | image coordinate systems. | image coordinate systems. | | | |
| Field Strength | 3.0 Tesla | 3.0 Tesla | Same | | |
| Type of Magnet | Superconducting | Superconducting | Same | | |
| Patient-accessible
bore dimensions | 60cm | 60cm | Same | | |
| Type of Shielding | Actively shielded, OIS
technology | Actively shielded, OIS
technology | Same | | |
| Magnet
Homogeneity | 2.400ppm @ 50cm DSV
0.800ppm @ 45cm DSV
0.390ppm @ 40cm DSV
0.110ppm @ 30cm DSV
0.038ppm @ 20cm DSV
0.020ppm @ 10cm DSV | 2.400ppm @ 50cm DSV
0.800ppm @ 45cm DSV
0.390ppm @ 40cm DSV
0.110ppm @ 30cm DSV
0.038ppm @ 20cm DSV
0.020ppm @ 10cm DSV | Same | | |
| Max gradient
amplitude | 45mT/m | 45mT/m | Same | | |
| Max slew rate | 200T/m/s | 200T/m/s | Same | | |
| Shielding | active | active | Same | | |
| Cooling | water | water | Same | | |
| Resonant
frequencies | 128.23MHz | 128.23MHz | Same | | |
| Number of
transmit channels | 2 | 2 | Same | | |
| Number of receive channels | 48 | 48 | Same | | |
| Amplifier peak power per channel | 18kW | 18kW | Same | | |
| Dimensions | width 640mm, height 890mm, length 2620mm | width 640mm, height 890mm, length 2620mm | Same | | |
| Maximum supported patient weight | 250kg | 250kg | Same | | |
| Vital Signal Gating | Wireless UIH Gating
Unit REF 453564324621
ECG module Ref 989803163121
SpO2 module Ref 989803163111 | Wireless UIH Gating
Unit REF 453564324621
ECG module Ref 989803163121
SpO2 module Ref 989803163111
(alternative)
uVWMERP
uMVRX
(alternative) | Note 1 | | |
| | PET | | | | |
| | Resolution | 1cm:FWMH≤3.2mm
10cm:FWHM≤3.6mm
20cm:FWHM≤4.8mm | 1cm:FWMH≤3.2mm
10cm:FWHM≤3.6mm
20cm:FWHM≤4.8mm | Same | |
| | | Sensitivity | 0cm: ≥14cps/kBq
10cm: ≥14cps/kBq | 0cm: ≥15cps/kBq
10cm: ≥15cps/kBq | Note 2 |
| | | | Scatter fraction, count losses and randoms measurement | NECR peak:≥110kcps
True peak: ≥300kcps
Scatter Fraction: ≤0.46 | NECR peak:≥110kcps
True peak: ≥360kcps
Scatter Fraction: ≤0.46 |
| Accuracy | maximum value of the bias at or below necr peak activity value:≤10% | maximum value of the bias at or below necr peak activity value:≤12% | | Note 4 | |
| | Image quality | Contrast Recovery coefficient:
10mm: ≥45.0%
13mm: ≥55.0%
17mm: ≥55.0%
22mm: ≥65.0%
28mm: ≥65.0%
37mm: ≥70.0%
Noise:
10mm: ≤9.0%
13mm: ≤8.0% | | Contrast Recovery coefficient:
10mm: ≥45.0%
13mm: ≥55.0%
17mm: ≥55.0%
22mm: ≥65.0%
28mm: ≥65.0%
37mm: ≥70.0%
Noise:
10mm: ≤9.0%
13mm: ≤8.0% | Note 5 |
| | | | | 17mm: ≤7.0% | 17mm: ≤7.0% |
| | | 22mm: ≤7.0% | 22mm: ≤7.0% | | |
| | | 28mm: ≤7.0% | 28mm: ≤7.0% | | |
| | | 37mm: ≤7.0% | 37mm: ≤7.0% | | |
| | | Relative lung error:≤10% | Relative lung error:≤16% | | |
| | | ≤560ps | N.A. | Note 6 | |
| Time of Fly(TOF) | | | | | |
| resolution | | | | | |
| | | | | | |
| Safety | | | | | |
| Electrical Safety | IEC 60601-1 | IEC 60601-1 | Same | | |
| EMC | IEC60601-1-2 | IEC60601-1-2 | Same | | |
| Max SAR for
Transmit Coil | IEC 60601-2-33 | IEC 60601-2-33 | Same | | |
| Max dB/dt | IEC 60601-2-33 | IEC 60601-2-33 | Same | | |
| | Patient Contact Materials
were tested and
demonstrated no | Patient Contact Materials
were tested and
demonstrated no | | | |
| | cytotoxicity (ISO 10993-
5), no evidence for
irritation and sensitization
(ISO 10993-10). | cytotoxicity (ISO 10993-
5), no evidence for
irritation and sensitization
(ISO 10993-10). | | | |
| Biocompatibility | | | Same | | |
| Surface Heating | NEMA MS 14 | ES 60601-1 | Note 7 | | |
Table 1 Comparison of Hardware configuration
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Image /page/6/Picture/1 description: The image shows the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the words is a stylized "U" symbol, which is a rounded square with a vertical line through the center.
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Image /page/7/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED" is stacked on top of the text "IMAGING" in a bold, sans-serif font. To the right of the text is a stylized logo that resembles the letter "U" with a horizontal line through the top portion. The logo and text are in a dark teal color.
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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" 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 dark blue. The logo is simple and modern, and the use of bold text and a strong color makes it easily recognizable.
| Note 1 | Compared to the predicate device, the proposed device add an alternative VSM model
(include uVWMERP and uMVRX). The trigger method, principle, connection mode,
installation position and other aspects of this model are completely consistent with the
original model. |
|--------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Note 2 | Comparing to the previous submission, the calibration factor of well-counter has been
updated according to well-counter vendor's notice. The measured activity will be different
based on the new factor. So the sensitivity specification, which depends on activity, shall
be updated accordingly. |
| Note 3 | The true peak value is updated to a wider criterion. It will not affected the system
effectiveness, operator can achieve the equivalent counts by adjusting acquisition time. |
| Note 4 | The accuracy specification update to a better criterion due to physical correction
optimization. The superior specification will not affect the effectiveness and safety. |
| Note 5 | The relative lung error specification update to a better criterion due to verification, it is
reasonable to claim a better criterion. The superior specification will not affect the
effectiveness and safety. |
| Note 6 | The Time of Fly resolution is added according to the NEMA NU2-2018 standard. Time of
Fly resolution improve the image signal noise ratio, it will not affect the effectiveness and
safety. |
| Note 7 | The NEMA standards publication MS 14-2019 describes the procedure for heating RF coil
heating under worst-case normal operating conditions. The results for the surface heating
test showed that proposed devices perform as well as or better than predicate devices. |
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Image /page/9/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 a bold, sans-serif font. The color of the logo is a dark teal.
Table 2 provides the new application software features of the proposed device in comparison to the predicate device.
Table 2 Comparison of the new Application Software Features
| ITEM | This
Submission
uPMR 790 | Predicate
Device
uPMR
790(K192672) | Remark | |
|---------------------------------------------------|--------------------------------|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MR Image Processing Features | | | | |
| Phase Sensitive
Inversion Recovery
(PSIR) | Yes | No | PSIR is substantially equivalent to FFT reconstruction and acquire real image from two TI (time-inversion) images which is benefit for more stable contrast. | |
| Computed DWI
(cDWI) | Yes | No | cDWI is substantially equivalent to DWI and generates fitting b-value from multiple acquisition b values. | |
| Inline T1/T2* Map | Yes | No | Inline T1/T2* Map is substantially equivalent to T1/T2* Map processed by post-processing module. The map result displays inline without extra operation by post-processing module. | |
| Susceptibility
Weighted Imaging
Plus (SWI+) | Yes | No | SWI+ is substantially equivalent to SWI and acquires multi-echo to achieve more information than SWI. | |
| Arterial Spin
Labeling (ASL) | Yes | No | ASL is substantially equivalent to FSE and uses extra arterial spin labeling preparation and imaging processing for cerebral blood flow (CBF) imaging without contrast agent. | |
| Cardiac T1
Mapping | Yes | No | Cardiac T1 mapping is substantially equivalent to GRE and uses multiple TI acquisitions with IR preparation and imaging processing for cardiac T1 mapping. | |
| Cardiac T2
Mapping | Yes | No | Cardiac T2 mapping is substantially equivalent to | |
| Cardiac
Mapping | T2* | Yes | No | GRE and uses multiple T2-
prep duration preparation
acquisitions and imaging
processing for cardiac T2
mapping.
Cardiac T2* mapping is
substantially equivalent to
GRE and uses multiple TE
acquisitions and imaging
processing for cardiac T2*
mapping. |
| PET Image Processing Features | | | | |
| Hyper Iterative | Yes | No | HYPER Iterative is a
regularized iterative
reconstruction algorithm
which incorporates a noise
control term into the iterative
process. It allows more
iterations while remains the
image noise at an acceptable
level. HYPER Iterative can
achieve high image contrast
and quantification accuracy
compared with OSEM
algorithm.
Note 8 | |
| WFI based head
MRAC | Yes | No | Note 8 | |
| Spectroscopy Features | | | | |
| HISE of Head
Spectroscopy | Yes | No | HISE technique is added in
Head spectroscopy and has no
change of spectroscopy
principle. It is short for High
SNR and high bandwidth and
have better performance than
general technique. | |
| Prostate
Spectroscopy | Yes | No | Prostate spectroscopy is
substantially equivalent to
spectroscopy and uses
characteristic metabolites
detection post processing for
prostate spectroscopy. | |
| Workflow Features | | | | |
| Easy Scan | Yes | No | Easy Scan feature allows
automatic slice positioning
for cardiac, c-spine and knee
imaging. The positioning can | |
| | | | also be adjusted manually by
user. The final positioning
effect is equivalent to manual
operation without Easy Scan
feature. | |
| Easy Plan | Yes | No | With the built-in planning
rules, Easy Plan feature
allows automatic whole-body
bed position planning for
different size of patient. The
final positioning effect is
equivalent to manual
operation without Easy Plan
feature. | |
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Image /page/10/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is stacked on top of each other and is 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.
11
Image /page/11/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" symbol, which is also in a bold font. The logo is simple and modern, and the colors are muted.
| Note 8 | The new Water Fat Imaging (WFI) based PET head attenuation correction is an
improvement over the previous UTE (Ultra short Time-to-Echo) based method. |
|--------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The new method is based on DIXON Water and Fat Imaging (WFI technique and
Quick3d (Also termed fast low angle shot, FLASH) MR sequence. In this |
| | method, an AI module, which essentially is a Convolution Neural Network
(CNN) was used to generate three masks of air, cortical bone and a mixed |
| | compartment containing soft tissue and fat, then the mixed compartment was |
| | separated into soft tissue and fat using an image intensity threshold. The network |
| | training process uses pairs of WFI images and three-compartment segmentation
from CT images of the same person. |
| | Information about training and validation dataset is shown below. |
| | Training dataset: Gender, 76 male 54 female, Age 17-83; Ethnicity, Chinese; |
| | Test set: Gender, 17 male, 10 female; Age: 15-78; Ethnicity: Chinese |
| | Test data from Center 2 (n=12) was initially excluded from the training set and |
| | were from completely different subjects. All the data from Center1 (n=10) was |
| | collected almost 2 years after the imaging date of the training data, also with |
| | different subjects compared with the training set. Therefore, the test data was |
| | completely independent from the training data. |
| | The acceptance criteria is that average SUVmean error (CTAC as reference) in |
| | major brain regions cross the test patient cohort is within 10%, which is |
| | consistent with previous literatures using similar evaluation methodology. The |
| | test results fulfills this criteria, with most brain regions having average error |
| | below 3%. |
8. Performance Data
The following testing was performed as described in the guidance /standards:
- ES 60601-1 Medical electrical equipment Part 1: General requirements for basic A safety and essential performance
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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" 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 a bold font gives it a strong and confident look.
- IEC 60601-1-2 Medical electrical equipment Part 1-2: General Requirements for A basic safety and essential Performance
- IEC 60601-2-33 Ed. 3.1:2013. Medical Electrical Equipment Part 2-33: A Particular Requirements For The Basic Safety And Essential Performance Of Magnetic Resonance Equipment For Medical Diagnostic
- A ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
- A ISO 10993-10 Third Edition 2010-08-01. Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
- A MS 1-2008(R2020), Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Images
- A MS 3-2008(R2020), Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
- A MS 6-2008(R2014), Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging
-
MS 9-2008(R2020), Standards Publication Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images
- A MS 14-2019, Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems
- A NEMA NU 2 Performance Measurements of Positron Emission Tomography
Non-clinical testing were conducted to verify the features described in this premarket submission.
- A Clinical performance evaluation
- A Performance evaluation report for 3D ASL (asl3d sequence), Inline Mapping, Cardiac T1 Mapping, Cardiac T2 Mapping, Cardiac T2* Mapping, Hyper Iterative, MRAC with AI-HITS, brain Spectroscopy, prostate Spectroscopy, EasyScan, EasyPlan.
- A PET/MR image quality test report
The test results demonstrated that the device performs as expected and thus, it is substantially equivalent to the predicate devices to which it has been compared.
9. Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, we concludes that uPMR 790 Magnetic Resonance Diagnostic Device is substantially equivalent to the predicate device. It does not introduce new indications for use, and has the same technological characteristics and does not introduce new potential hazards or safety risks.