(162 days)
Not Found
Yes
The summary explicitly mentions "AI module in ACS" and describes the training and testing datasets used for this module.
No
The device is indicated for use as a magnetic resonance diagnostic device that produces images to assist diagnosis, not to provide therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is a "magnetic resonance diagnostic device (MRDD)" and that the images and derived physical parameters "when interpreted by a trained physician yield information that may assist the diagnosis."
No
The device description explicitly lists numerous hardware components such as magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, and vital signal module. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "magnetic resonance diagnostic device (MRDD)" that produces images of internal anatomical structure and/or function. It also mentions that the images and derived parameters, when interpreted by a trained physician, "yield information that may assist the diagnosis." This describes an imaging device used for diagnosis based on visual interpretation of internal structures and functions, not a device that performs tests on biological samples in vitro (outside the body).
- Device Description: The description details the components of an MRI system, which is an imaging modality, not an IVD.
- Input Imaging Modality: The input is Magnetic Resonance, which is an imaging technique, not a method for analyzing biological samples.
- Anatomical Site: The device is used to image the head, body, and extremities, which are parts of the patient's body, not biological samples.
IVD devices are specifically designed to perform tests on biological specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
No
The provided text does not contain any explicit language stating that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
uMR Jupiter is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces 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. These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan.
The device is intended for patients > 20 kg/44 lbs.
Product codes
LNH
Device Description
uMR Jupiter is a 5T superconducting magnetic resonance diagnostic device with a 60cm size patient bore and 8 channel RF transmit system. It consists of components such as magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, and vital signal module etc. uMR Jupiter is designed to conform to NEMA and DICOM standards.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Magnetic Resonance
Anatomical Site
head, body and extremities
Indicated Patient Age Range
patients > 20 kg/44 lbs (approximately adolescent to adult, given typical weight ranges for this age group)
Intended User / Care Setting
trained physician
Description of the training set, sample size, data source, and annotation protocol
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.
Description of the test set, sample size, data source, and annotation protocol
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 testing dataset was collected independently from the training dataset, with separated subjects and during different time periods. Therefore, the testing data is entirely independent and does not share any overlap with the training data.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Verification:
- Performance evaluation report for ACS, 3D ASL, MoCap-Monitoring, FACT, 2D Flow, CEST, T1rho, Multiband, Inline T1 mapping, Inline T2 mapping and Inline T2* mapping.
- Performance evaluation report for Spectroscopy: Liver MRS, Prostate MRS, Brain MRS
- A volunteer study was conducted to determine the nerve stimulation thresholds used to limit the gradient system output. The observed parameters were used to set the PNS (Peripheral Nerve Stimulation) threshold level which is required in IEC 60601-2-33.
- Sample clinical images for all clinical sequences and coils were reviewed by three U.S. board-certified radiologists 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 - ACS Performance:
- Performance testing: 25 subjects from different countries with diverse demographic distributions covering various genders, age groups, ethnicities, and BMI groups (Table 6 in document). Phantom test also performed.
- Key results: The ACS on uMR Jupiter was shown to perform better than CS by measuring SNR and resolution using images from various ethnicities, age groups, BMIs, and pathological variations. 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 uMR Jupiter performs equivalently to that on uMR Omega. The structure measurements on paired images verified that ACS and fully sampled images of same structures were significantly the same.
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
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
April 26, 2024
Shanghai United Imaging Healthcare Co., Ltd Xin Gao RA Manager No. 2258 Chengbei Rd., Jiading District Shanghai. 201807 China
Re: K233673
Trade/Device Name: uMR Jupiter Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: March 11, 2024 Received: March 11, 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).
1
Your device is also subject to, among other requirements, the Quality System (OS) 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,
D. G. K.
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
2
Indications for Use
| Submission Number (if known) | |
|---|---|
| ------------------------------ | -- |
Device Name
uMR Jupiter
Indications for Use (Describe)
uMR Jupiter is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces 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. These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan.
The device is intended for patients > 20 kg/44 lbs.
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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3
Image /page/3/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is in bold, dark teal font. To the right of the text is a stylized "U" shape, also in dark teal. The logo is simple and modern.
510 (k) SUMMARY
Date of Preparation 1.
November 15, 2023
2. Sponsor Identification
Shanghai United Imaging Healthcare Co.,Ltd. No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China
Contact Person: Xin GAO Position: Regulatory Affair Manager Tel: +86-021-67076888-5386 Fax: +86-021-67076889 Email: xin.gao@united-imaging.com
3. Identification of Proposed Device
Trade Name: uMR Jupiter Common Name: Magnetic Resonance Imaging System Model: uMR Jupiter
Regulatory Information
Regulation Number: 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Review Panel: Radiology
4. Identification of Primary/Reference Device(s)
Predicate Device
510(k) Number: K230152 Device Name: uMR Omega Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Review Panel: Radiology
- Device Description ട.
SECTION 7 - 1 of 11
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Image /page/4/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in a bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is also in a bold, sans-serif font. The color of the text and the "U" shape is a dark gray.
uMR Jupiter is a 5T superconducting magnetic resonance diagnostic device with a 60cm size patient bore and 8 channel RF transmit system. It consists of components such as magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, and vital signal module etc. uMR Jupiter is designed to conform to NEMA and DICOM standards.
Indications for Use 6.
uMR Jupiter is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces 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. These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan.
The device is intended for patients > 20 kg/44 lbs.
7. Comparison of Technological Characteristics with the Predicate Device
The differences from the predicate device are discussed in the comparison table in this submission as below.
| ITEM | Proposed Device
uMR Jupiter | Predicate Device
uMR Omega | Remark |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| General | | | |
| Product
Code | LNH | LNH | Same |
| Regulation
No. | 21 CFR 892.1000 | 21 CFR 892.1000 | Same |
| Class | II | II | Same |
| Indications
For Use | The uMR Jupiter system is
indicated for use as a
magnetic resonance
diagnostic device (MRDD)
that produces sagittal,
transverse, coronal, and
oblique cross sectional
images, and spectroscopic
images, and that display
internal anatomical structure | The uMR Omega system is
indicated for use as a
magnetic resonance
diagnostic device (MRDD)
that produces sagittal,
transverse, coronal, and
oblique cross sectional
images, and spectroscopic
images, and that display
internal anatomical structure | Note 1 |
| Table 1 Comparison of Hardware configuration | |||
|---|---|---|---|
| ITEM | Proposed Device | ||
| uMR Jupiter | Predicate Device | ||
| uMR Omega | Remark | ||
| and/or function of the head, | |||
| body and extremities. | |||
| These images and the | |||
| physical parameters derived | |||
| from the images when | |||
| interpreted by a trained | |||
| physician yield information | |||
| that may assist the diagnosis. | |||
| Contrast agents may be used | |||
| depending on the region of | |||
| interest of the scan. | |||
| The device is intended for | |||
| patients > 20 kg/44 lbs. | and/or function of the head, | ||
| body and extremities. | |||
| These images and the | |||
| physical parameters derived | |||
| from the images when | |||
| interpreted by a trained | |||
| physician yield information | |||
| that may assist the diagnosis. | |||
| Contrast agents may be used | |||
| depending on the region of | |||
| interest of the scan. | |||
| Magnet system | |||
| Field | |||
| Strength | 5.0 Tesla | 3.0 Tesla | Note 2 |
| Type of | |||
| Magnet | Superconducting | Superconducting | Same |
| Patient- | |||
| accessible | |||
| bore | |||
| dimensions | 60 cm | 75 cm | Note 3 |
| Type of | |||
| Shielding | Actively shielded, OIS | ||
| technology | Actively shielded, OIS | ||
| technology | Same | ||
| Magnet | |||
| Homogeneity | ≤ 1.3 ppm @ 50cm DSV | ||
| ≤ 0.45 ppm @ 45cm DSV | |||
| ≤ 0.19 ppm @ 40cm DSV | |||
| ≤ 0.08 ppm @ 30cm DSV | |||
| ≤ 0.015 ppm @ 20cm DSV | |||
| ≤ 0.0009 ppm @ 10cm DSV | ≤ 2.30 ppm @ 50cm DSV | ||
| ≤ 0.80 ppm @ 45cm DSV | |||
| ≤ 0.38 ppm @ 40cm DSV | |||
| ≤ 0.08 ppm @ 30cm DSV | |||
| ≤ 0.02 ppm @ 20cm DSV | |||
| ≤ 0.002 ppm @ 10cm DSV | Note 4 | ||
| Gradient system | |||
| Max | |||
| gradient | |||
| amplitude | 120 mT/m | 45 mT/m | Note 5 |
| Max slew | |||
| rate | 200 T/m/s | 200 T/m/s | Same |
| Shielding | active | active | Same |
| Cooling | water | water | Same |
| RF system | |||
| Resonant | |||
| frequencies | 210.794 MHz | 128.23 MHz | Note 6 |
| Number of | |||
| transmit | |||
| channels | 8 | 2 | |
| Amplifier | |||
| peak power | |||
| per channel | 8 kW | 18 kW or 20 kW | Note 7 |
| ITEM | Proposed Device | ||
| uMR Jupiter | Predicate Device | ||
| uMR Omega | Remark | ||
| Number of | |||
| receive | |||
| channels | 96 | Up to 96 | Note 8 |
| RF Coils | |||
| SuperFlex | |||
| Small-24 | Yes | SuperFlex Small-12 | Note 9 |
| Tx/Rx Head | |||
| Coil -48 | Yes | Head Coil -32 | Note 10 |
| Tx/Rx Knee | |||
| Coil - 24 | Yes | Yes | Note 11 |
| SuperFlex | |||
| Body - 24 | Yes | Yes | |
| Head & | |||
| Neck Coil - | |||
| 48 | Yes | Yes | |
| Spine Coil - | |||
| 48 | Yes | Yes | |
| Patient table | |||
| Note 12 | |||
| Dimensions | W×H×L: 640 mm×1025 | ||
| mm×2620 mm | W×H×L: 640 mm×880 mm× | ||
| 2620 mm | |||
| Maximum | |||
| supported | |||
| patient | |||
| weight | 310 kg | 310 kg | Same |
| Accessories | |||
| Vital Signal | |||
| Gating | Support | ||
| ECG/Respiratory/Pulse | Support | ||
| ECG/Respiratory/Pulse | Same |
SECTION 7 - 2 of 11
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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 words is a stylized "U" symbol, which is also in bold. The color of the logo is a dark teal.
SECTION 7 - 3 of 11
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Image /page/6/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is in bold, dark blue font. To the right of the text is a dark blue icon that resembles the letter "U" with a vertical line through the center.
Table 2 Comparison of the Application Software Features
| ITEM | Proposed Device
uMR Jupiter | Predicate Device
uMR Omega | Remark |
|-------------------------------------------------------------------------|--------------------------------|-------------------------------|---------|
| Imaging Features | | | |
| Non-uniformity Correction | Yes | Yes | Same |
| Distortion Correction | Yes | Yes | Same |
| Image Filter | Yes | Yes | Same |
| SWI (Susceptibility
Weighted Imaging) | Yes | Yes | Same |
| PC (2D/3D Phase Contrast) | Yes | Yes | Same |
| GETI (Gradient Echo Train Imaging) | Yes | Yes | Same |
| ADC (Apparent Diffusion Coefficient) | Yes | Yes | Same |
| FACT (Fat Analysis and Calculation Technique) | Yes | Yes | Same |
| PSIR (Phase Sensitive Inversion Recovery) | Yes | Yes | Same |
| cDWI (Computed DWI) | Yes | Yes | Same |
| Inline T1 Mapping | Yes | Yes | Same |
| Inline T2* Mapping | Yes | Yes | Same |
| Inline T2 Mapping using SEME | Yes | Yes | Same |
| Inline T2 Mapping using MASS | Yes | No | Note 13 |
| SWI+ (Susceptibility Weighted Imaging Plus) | Yes | Yes | Same |
| 3D ASL (Arterial Spin Labeling) | Yes | Yes | Same |
| 2D Flow (2D Flow Quantification) | Yes | Yes | Same |
| CEST (3D Chemical Exchange Saturation Transfer) | Yes | Yes | Same |
| T1rho (T1rho Quantitative Mapping Imaging) | Yes | Yes | Same |
| FSP+ (Fast Spoiled Gradient Echo Plus) | Yes | Yes | Same |
| CASS (Constructive Acquisition of Steady State) | Yes | No | Note 14 |
| PASS (Pair-Echo Acquisition of Steady State) | Yes | No | Note 15 |
| SNAP (Simultaneous Non-contrast Angiography and Intraplaque Hemorrhage) | Yes | Yes | Same |
| MultiBand | Yes | Yes | Same |
| Function | | | |
| Remote Assistance | Yes | Yes | Same |
| Spectroscopy Sequences | | | |
| Brain MRS | Yes | Yes | Same |
| Liver MRS | Yes | Yes | Same |
| Prostate MRS | Yes | Yes | Same |
| Workflow Features | | | |
| MoCap-Monitoring (Motion Capture Monitoring) | Yes | No | Note 16 |
| Image Reconstruction Features | | | |
| ACS (AI-assisted
Compressed Sensing) | Yes | Yes | Same |
| uCS (united Compressed
Sensing) | Yes | Yes | Same |
SECTION 7 - 4 of 11
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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" symbol, which is also in a bold, sans-serif font. The color of the logo is a dark teal.
SECTION 7 - 5 of 11
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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" symbol, which is dark blue. The logo is simple and modern in design.
| Note 1 | The proposed device includes enhancements to the software that controls Specific Absorption Rate (SAR) based on simulations for human at least 20kg. Therefore, it is used for patient > 20 kg/44 lbs.
The difference did not raise new safety and effectiveness concerns. |
|---------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Note 2 | The static field strength of the proposed device is different from the predicate device, but the basic imaging characteristics are consistent.
The difference did not raise new safety and effectiveness concerns. |
| Note 3 | The patient-accessible bore dimension of the proposed device is smaller than that of the predicate device, which satisfies the clinical applications. The difference did not raise new safety and effectiveness concerns. |
| Note 4 | Magnet Homogeneity of the proposed device is better than that of the predicate device. Magnet homogeneity contributes to image quality. The proposed device with better magnet homogeneity is benefit for image quality.
The difference did not raise new safety and effectiveness concerns. |
| Note 5 | The max gradient amplitude of the proposed device is larger than that of the predicate device. Peripheral nerve stimulation and cardiac stimulation was controlled according to IEC 60601-2-33.
The difference did not raise new safety and effectiveness concerns. |
| Note 6 | The difference in the resonant frequencies of the proposed device and the predicate device is due to the difference in field strength.
The difference did not raise new safety and effectiveness concerns. |
| Note 7 | The transmit channel number of the proposed device is more than that of the predicate device. More transmit channels, better B1 uniformity. The local SAR was monitored to ensure patients' safety.
The difference did not raise new safety and effectiveness concerns. |
| Note 8 | The number of receive channels of proposed device is 96. The number of receive channels of predicate device is 48 or 96. The number of receive channels of proposed device is the same as one configuration of uMR Omega.
The difference did not raise new safety and effectiveness concerns. |
| Note 9 | The intended use of SuperFlex Small-24 is equivalent to previously cleared SuperFlex Small-12. The difference between them is the number of channels of the receiver coil.
The difference did not raise new safety and effectiveness concerns. |
| Note 10 | The intended use of Tx/Rx Head Coil -48 is equivalent to previously cleared Head Coil -32. There are two differences between them. One is that Tx/Rx Head Coil -48 can be used as a transmitter coil and SAR is controlled. The other one is that the receiver channel number of Tx/Rx Head Coil -48 is more than that of Head Coil -32.
The difference did not raise new safety and effectiveness concerns. |
| Note 11 | These coils were modified to adapt the frequency of the proposed device.
The difference did not raise new safety and effectiveness concerns. |
| Note 12 | The height of the patient table of the proposed device is higher than that of the predicate device, which can satisfy clinical application.
The difference did not raise new safety and effectiveness concerns |
| Note 13 | MASS is substantially equivalent to GRE and acquires three different types
(lower order SSFP_FID, SSFP_SE and higher order SSFP_FID) of echo images
and achieves T2 mapping image by an iteration and search method.
The difference did not raise new safety and effectiveness concerns. |
| Note 14 | CASS is substantially equivalent to BSSFP and acquires two different phase
cycling angle images and combines them by MIP operation to reduce dark band
artifacts.
The difference did not raise new safety and effectiveness concerns. |
| Note 15 | PASS is substantially equivalent to GRE and acquires two different type
(SSFP_FID and SSFP_SE) of echo image and combines them to achieve hybrid
contrast image.
The difference did not raise new safety and effectiveness concerns. |
| Note 16 | 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. |
SECTION 7 - 6 of 11
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Image /page/9/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is in bold, sans-serif font. To the right of the text is a stylized "U" symbol, which is also in a bold font. The logo appears to be a dark teal color.
Performance Date 8.
The following testing was conducted on uMR Jupiter and were provided in support of the substantial determination.
Non-Clinical Testing
Non-clinical testing including image performance tests were conducted for uMR Jupiter 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)
- A ANSI/AAMIES60601-1: 2005/ (R) 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
-
IEC 60601-2-33 Ed. 3.2:2015 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 equipment - Part 1-6: General requirements for basic safety and essential
SECTION 7 - 7 of 11
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Image /page/10/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is displayed in bold, sans-serif font, stacked on two lines. To the right of the text is a stylized "U" symbol, which is dark teal in color. The symbol is a rounded shape with a vertical line running through the center, creating a negative space in the shape of a cross.
performance - Collateral standard: Usability.
- A IEC 62304:2006+AMD1:2015 CSV Consolidated version, Medical device software - Software life cycle processes
- A 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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NEMA MS 3-2008(R2020), Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
- A NEMA MS 4-2010, Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices
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NEMA MS 5-2018, Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging
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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
- A NEMA MS 8-2016, Characterization of the Specific Absorption Rate (SAR) for Magnetic Resonance Imaging Systems
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NEMA MS 9-2008(R2020), Standards Publication Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images
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NEMA MS 10-2010, Determination of Local Specific Absorption Rate (SAR) in Diagnostic Magnetic Resonance Imaging.
- A NEMA MS 14-2019, Characterization of Radiofrequency (RF) Coil Heating in 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
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
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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.
- A ISO 10993-10: 2021, Edition 4.0, Biological evaluation of medical devices - Part 10: Tests for skin sensitization.
- A ISO 10993-23: 2021, Edition 1.0, Biological evaluation of medical devices - Part
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Image /page/11/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 "U" shape, which is dark teal in color. The logo is simple and modern in design.
10: Tests for irritation.
- 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
- A ISO 14971: 2019, Edition 3.0, Medical Devices - Application of risk management to medical devices
- Code of Federal Regulations. Title 21. Part 820 Ouality System Regulation A
- Code of Federal Regulations, Title 21, Subchapter J Radiological Health A
Performance Verification
Non-clinical testing was conducted to verify the features described in this premarket submission.
- A Performance evaluation report for ACS, 3D ASL, MoCap-Monitoring, FACT, 2D Flow, CEST, T1rho, Multiband, Inline T1 mapping, Inline T2 mapping and Inline T2* mapping.
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Performance evaluation report for Spectroscopy: Liver MRS, Prostate MRS, Brain MRS
- A A volunteer study was conducted to determine the nerve stimulation thresholds used to limit the gradient system output. The observed parameters were used to set the PNS (Peripheral Nerve Stimulation) threshold level which is required in IEC 60601-2-33.
- A Sample clinical images for all clinical sequences and coils were reviewed by three U.S. board-certified radiologists 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
● 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.
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Image /page/12/Picture/1 description: The image shows 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, with a white line running horizontally through the middle of the U. The logo is a dark gray color.
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 performance testing on 25 subjects coming from different countries with diverse demographic distributions covering various genders, age groups, ethnicities, and BMI groups (Table 6). Phantom test has also been performed for ACS to verify its performance.
| Gender | |
|---|---|
| Male | 15 |
| Female | 10 |
| Age | |
| 18-28 | 5 |
| 29-40 | 7 |
| >41 | 13 |
| Ethnicity | |
| White | 4 |
| Asian | 21 |
| Body Mass Index (BMI) | |
| Underweight (24.9) | 5 |
The testing dataset was collected independently from the training dataset, with separated subjects and during different time periods. Therefore, the testing data is entirely independent and does not share any overlap with the training data.
The ACS on uMR Jupiter was shown to perform better than CS by measuring SNR and resolution using images from various ethnicities, age groups, BMIs, and pathological variations. 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 uMR Jupiter performs equivalently to that on uMR Omega. The structure measurements on paired images verified that ACS and fully sampled images of same structures were significantly the same.
Summary
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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 bold, dark blue letters, stacked on top of each other. To the right of the text is a stylized, dark blue symbol that resembles a shield or a stylized letter "U" with a vertical line running through the center. The overall design is clean and modern.
The features described in this premarket submission are supported with the results of the testing mentioned above, the uMR Jupiter was found to have a safety and effectiveness profile that is similar to the predicate device.
Conclusions 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.