(265 days)
The uMR Omega system is indicated for use as a magnetic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional 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.
u WS-MR is a software solution intended to be used for viewing, manipulation, and storage of medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications:
The MR Stitching is intended to create full-format images from overlapping MR volume data sets acquired at multiple stages.
The Dynamic application is intended to provide a general post-processing tool for time course studies.
The Image Fusion application is intended to combine two different image series so that the displayed anatomical structures match in both series.
MRS (MR Spectroscopy) is intended to evaluate the molecule constitution and spatial distribution of cell metabolism. It provides a set of tools to view, process, and analyze the complex MRS data. This application supports the analysis for both SVS (Single Voxel Spectroscopy) and CSI (Chemical Shift Imaging) data.
The MAPs application is intended to provide a number of arithmetic and statistical functions for evaluating dynamic processes and images. These functions are applied to the grayscale values of medical images.
The MR Breast Evaluation application provides the user a tool to calculate parameter maps from contrast-enhanced timecourse images.
The Brain Perfusion application is intended to allow the visualizations in the dynamic susceptibility time series of MR datasets.
MR Vessel Analysis is intended to provide a tool for viewing, and evaluating MR vascular images.
The Inner view application is intended to perform a virtual camera view through hollow structures (cavities), such as vessels.
The DCE analysis is intended to view, manipulate, and evaluate dynamic contrast-enhanced MRI images.
The United Neuro is intended to view, manipulate, and evaluate MR neurological images.
The MR Cardiac Analysis application is intended to be used for viewing, post-processing and quantitative evaluation of cardiac magnetic resonance data.
The uMR Omega is a 3.0T superconducting magnetic resonance diagnostic device with a 75cm size patient bore. 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. The uMR Omega Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.
uWS-MR is a comprehensive software solution designed to process, review and analyze MR (Magnetic Resonance Imaging) studies. It can be used as a stand-alone SaMD or a post processing application option for cleared UIH (Shanghai United Imaging Healthcare Co.,Ltd.) MR Scanners.
The uMR 780 is a 3.0T superconducting magnetic resonance diagnostic device with a 65cm size patient bore. 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. The uMR 780 Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.
The document describes the performance testing for the "DeepRecon" feature, an artificial intelligence (AI)-assisted image processing algorithm, of the uMR Omega with uWS-MR-MRS device.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Evaluation Item | Acceptance Criteria | Reported Device Performance (Test Result) | Results |
|---|---|---|---|
| Image SNR | DeepRecon images achieve higher SNR compared to the images without DeepRecon (NADR) | NADR: 209.41±1.08, DeepRecon: 302.48±0.78 | PASS |
| Image uniformity | Uniformity difference between DeepRecon images and NADR images under 5% | 0.15% | PASS |
| Image contrast | Intensity difference between DeepRecon images and NADR images under 5% | 0.9% | PASS |
| Structure Measurements | Measurements on NADR and DeepRecon images of same structures, measurement difference under 5% | 0% | PASS |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: 77 US subjects.
- Data Provenance: The testing data was collected from various clinical sites in the US, ensuring diverse demographic distributions covering various genders, age groups, ethnicities, and BMI groups. The data was collected during separated time periods and on subjects different from the training data, making it completely independent and having no overlap with the training data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not explicitly stated, but the document mentions "American Board of Radiologists certificated physicians" evaluated the DeepRecon images. This implies a group of such experts.
- Qualifications of Experts: American Board of Radiologists certificated physicians.
4. Adjudication method for the test set
- The document states that "All DeepRecon images were rated with equivalent or higher scores in terms of diagnosis quality" by the radiologists. This suggests a consensus or rating process, but the specific adjudication method (e.g., majority vote, sequential review) is not detailed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance
- The document implies a human-in-the-loop evaluation as "DeepRecon images were evaluated by American Board of Radiologists certificated physicians," and they "verified that DeepRecon meets the requirements of clinical diagnosis." It also states "All DeepRecon images were rated with equivalent or higher scores in terms of diagnosis quality." However, this is not explicitly described as a formal MRMC comparative effectiveness study designed to quantify human reader improvement with vs. without AI assistance. The focus seems to be on the diagnostic quality of the DeepRecon images themselves. No specific effect size is provided for human reader improvement with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, a standalone (algorithm only) performance evaluation was conducted based on objective metrics like Image SNR, Image Uniformity, Image Contrast, and Structure Measurements, as detailed in Table b. The radiologist evaluation appears to be a subsequent step to confirm clinical utility.
7. The type of ground truth used
- For the objective performance metrics (SNR, uniformity, contrast, structure measurements), the ground truth for comparison appears to be the images "without DeepRecon (NADR)".
- For the expert evaluation, the ground truth is implicitly based on the expert consensus of the American Board of Radiologists certificated physicians regarding the diagnostic quality of the images.
- For the training data ground truth (see point 9), it was established using "multiple-averaged images with high-resolution and high SNR."
8. The sample size for the training set
- The training data for DeepRecon was collected from 264 volunteers.
9. How the ground truth for the training set was established
- The ground truth for the training dataset was established by collecting "multiple-averaged images with high-resolution and high SNR" from each subject. The input images for training were then generated by sequentially reducing the SNR and resolution of these high-quality ground-truth images. All data used for training underwent manual quality control.
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Image /page/0/Picture/0 description: The image contains 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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
October 27, 2022
Shanghai United Imaging Healthcare Co., Ltd. % Xin Gao Regulatory Affairs Specialist NO. 2258 Chengbei Road, Jiading District Shanghai, Shanghai 201807 CHINA
Re: K220332
Trade/Device Name: uMR Omega with uWS-MR-MRS Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LLZ, QIH Dated: September 23, 2022 Received: September 26, 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
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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,
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
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Indications for Use
510(k) Number (if known) K220332
Device Name uMR Omega, uWS-MR-MRS
Indications for Use (Describe)
The uMR Omega system is indicated for use as a magnetic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional 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.
u WS-MR is a software solution intended to be used for viewing, manipulation, and storage of medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications:
The MR Stitching is intended to create full-format images from overlapping MR volume data sets acquired at multiple stages.
The Dynamic application is intended to provide a general post-processing tool for time course studies.
The Image Fusion application is intended to combine two different image series so that the displayed anatomical structures match in both series.
MRS (MR Spectroscopy) is intended to evaluate the molecule constitution and spatial distribution of cell metabolism. It provides a set of tools to view, process, and analyze the complex MRS data. This application supports the analysis for both SVS (Single Voxel Spectroscopy) and CSI (Chemical Shift Imaging) data.
The MAPs application is intended to provide a number of arithmetic and statistical functions for evaluating dynamic processes and images. These functions are applied to the grayscale values of medical images.
The MR Breast Evaluation application provides the user a tool to calculate parameter maps from contrast-enhanced timecourse images.
The Brain Perfusion application is intended to allow the visualizations in the dynamic susceptibility time series of MR datasets.
MR Vessel Analysis is intended to provide a tool for viewing, and evaluating MR vascular images.
The Inner view application is intended to perform a virtual camera view through hollow structures (cavities), such as vessels.
The DCE analysis is intended to view, manipulate, and evaluate dynamic contrast-enhanced MRI images.
The United Neuro is intended to view, manipulate, and evaluate MR neurological images.
The MR Cardiac Analysis application is intended to be used for viewing, post-processing and quantitative evaluation of cardiac magnetic resonance data.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/4/Picture/1 description: The image shows the logo for United Imaging. The text "UNITED IMAGING" is in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized letter "U" that is also in bold. The logo is simple and modern.
510 (k) SUMMARY
1. Date of Prepared
October 19, 2022
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: uMR Omega with uWS-MR-MRS Common Name: Magnetic Resonance Diagnostic Device Model: uMR Omega, uWS-MR Product Code: LNH, LLZ, QIH Regulation Number: 21 CFR 892.1000 Device Class: II
4. Identification of Predicate Devices(s)
Predicate Device 510(k) Number: K193200 Device Name: uMR Omega Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: LNH
Reference Device #1
510(k) Number: K192601 Device Name: uWS-MR Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: II Product Code: LLZ, OIH
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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 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 logo is a dark gray.
Reference Device #2
510(k) Number: K193176 Device Name: uMR 780 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: LNH
5. Device Description
The uMR Omega is a 3.0T superconducting magnetic resonance diagnostic device with a 75cm size patient bore. 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. The uMR Omega Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.
uWS-MR is a comprehensive software solution designed to process, review and analyze MR (Magnetic Resonance Imaging) studies. It can be used as a stand-alone SaMD or a post processing application option for cleared UIH (Shanghai United Imaging Healthcare Co.,Ltd.) MR Scanners.
The uMR 780 is a 3.0T superconducting magnetic resonance diagnostic device with a 65cm size patient bore. 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. The uMR 780 Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.
uMR Omega , uWS-MR and uMR 780 have been previously cleared by FDA via K193200 , K192601 and K193176.
The modification performed on the uMR Omega (K193200). uWS-MR (K192601) and uMR 780 (K193176) in this submission is due to the following changes that include: (1). Addition of Radio Frequency Coils: Head & Neck Coil - 48, Spine Coil - 48, Head Coil - 64, SuperFlex Body - 24, SuperFlex Large - 12, SuperFlex Small -12. (2). Addition and modification of pulse sequences
a) New sequences: gre_fact, asl_3d, gre_maps, fse_mars_sle, grase, fse_dwi, fse arms dwi, gre fq, gre bssfp fi, epi dwi msh, gre senc spiral, gre bssfp ucs, gre_rufis.
b) Broadened application scope of Contrast characteristic for certain sequences: T1 mapping, T2 mapping, T2* mapping.
c) Added Associated options for certain sequences: QuietScan, Parallel imaging, MultiBand, Inversion Recovery.
d) Added Reconstruction method for certain sequences: AI-assisted Compressed Sensing, Compressed sensing.
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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" symbol, which is also in a bold font. The logo is simple and modern.
e) Added Additional accessory equipment required for certain sequences: respiratory, cardiac gating.
f) Deletion of pulse sequence: fse mx mars.
(3). Addition of Imaging processing methods: Fat Analysis and Calculation Technique (FACT), Inline T1/T2* Map, Inline T2 Map, Arterial Spin Labeling (ASL), Flow Quantification (FQ), Cardiac T1 Mapping, Cardiac T2 Mapping, Cardiac T2* Mapping, DeepRecon.
(4). Addition of Spectroscopy Sequences and Post Processing Features: Liver, Prostate, Breast.
(5). Addition of New function: Remote Assistance, MR conditional implant mode. (6). Addition of Support body parts for EasyScan: Shoulder, Abdomen, L-spine, Tspine.
These modifications do not affect the intended use or alter the fundamental scientific technology of the device.
6. Intended Use
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 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.
uWS-MR is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications:
-
The MR Stitching is intended to create full-format images from overlapping MR volume data sets acquired at multiple stages.
-
The Dynamic application is intended to provide a general post-processing tool for time course studies.
-
The Image Fusion application is intended to combine two different image series so that the displayed anatomical structures match in both series.
- A MRS (MR Spectroscopy) is intended to evaluate the molecule constitution and spatial distribution of cell metabolism. It provides a set of tools to view, process, and analyze the complex MRS data. This application supports the analysis for both SVS (Single Voxel Spectroscopy) and CSI (Chemical Shift Imaging) data.
-
The MAPs application is intended to provide a number of arithmetic and statistical functions for evaluating dynamic processes and images. These functions are applied to the grayscale values of medical images.
Page 3 of 16
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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" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, also in a bold font. The logo is simple and modern in design.
- A The MR Breast Evaluation application provides the user a tool to calculate parameter maps from contrast-enhanced time-course images.
- A The Brain Perfusion application is intended to allow the visualization of temporal variations in the dynamic susceptibility time series of MR datasets.
-
MR Vessel Analysis is intended to provide a tool for viewing, manipulating, and evaluating MR vascular images.
-
The Inner view application is intended to perform a virtual camera view through hollow structures (cavities), such as vessels.
-
The DCE analysis is intended to view, manipulate, and evaluate dynamic contrastenhanced MRI images.
-
The United Neuro is intended to view, manipulate, and evaluate MR neurological images.
-
The MR Cardiac Analysis application is intended to be used for viewing, postprocessing and quantitative evaluation of cardiac magnetic resonance data.
The uMR 780 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 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.
7. Technological Characteristic
The differences from the predicate device are discussed in the comparison table in this submission is added below.
| ITEM | Proposed DeviceuMR Omega | Predicate DeviceuMR Omega (K193200) | Remark |
|---|---|---|---|
| General | |||
| Product Code | LNH | LNH | Same |
| Regulation No. | 21 CFR 892.1000 | 21 CFR 892.1000 | Same |
| Class | II | II | Same |
| Indications ForUse | The uMR Omega system isindicated for use as amagneticresonancediagnostic device (MRDD) thatproduces sagittal,transverse, coronal, andoblique cross sectionalimages, and spectroscopic | The uMR Omegasystem is indicated foruse as a magneticresonance diagnosticdevice (MRDD) thatproduces sagittal,transverse, coronal, andoblique cross sectional | Same |
| ITEM | Proposed DeviceuMR Omega | Predicate DeviceuMR Omega (K193200) | Remark |
| images, and that displayinternal anatomicalstructure and/or function ofthe head, body andextremities.These images and thephysical parametersderived from the imageswhen interpreted by atrained physician yieldinformation that mayassist the diagnosis.Contrast agents may beused depending on theregion of interest of thescan. | images, andspectroscopic images,and that display internalanatomical structureand/or function of thehead, body andextremities.These images and thephysical parametersderived from theimages wheninterpreted by a trainedphysician yieldinformation that mayassist the diagnosis.Contrast agents may beused depending on theregion of interest of thescan. | ||
| Magnet system | |||
| Field Strength | 3.0 Tesla | 3.0 Tesla | Same |
| Type of Magnet | Superconducting | Superconducting | Same |
| Patient-accessible boredimensions | 75cm | 75cm | Same |
| Type ofShielding | Actively shielded, OIStechnology | Actively shielded, OIStechnology | Same |
| MagnetHomogeneity | 2.30ppm @ 50cm DSV0.80ppm @ 45cm DSV0.38ppm @ 40cm DSV0.08ppm @ 30cm DSV0.02ppm @ 20cm DSV0.002ppm @ 10cm DSV | 2.30ppm @ 50cm DSV0.80ppm @ 45cm DSV0.38ppm @ 40cm DSV0.08ppm @ 30cm DSV0.02ppm @ 20cm DSV0.002ppm @ 10cmDSV | Same |
| Gradient system | |||
| Max gradientamplitude | 45mT/m | 45mT/m | Same |
| Max slew rate | 200T/m/s | 200T/m/s | Same |
| Shielding | active | active | Same |
| Cooling | water | water | Same |
| RF system | |||
| ITEM | Proposed DeviceuMR Omega | Predicate DeviceuMR Omega (K193200) | Remark |
| Resonantfrequencies | 128.23 MHz | 128.23 MHz | Same |
| Number oftransmitchannels | 2 | 2 | Same |
| Number ofreceive channels | Up to 96 | Up to 96 | Same |
| Amplifier peakpower perchannel | 18 kW | 18 kW | Same |
| RF Coils | |||
| VolumeTransmit Coil | Yes | Yes | Same |
| Head & NeckCoil -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 |
| Cardiac Coil -24 | Yes | Yes | Same |
| Temporomandibular Joint Coil -4 | Yes | Yes | Same |
| Foot & AnkleCoil - 24 | Yes | Yes | Same |
| Head Coil - 32 | Yes | Yes | Same |
| Head Coil - 12 | Yes | Yes | Same |
| Carotid Coil - 8 | Yes | Yes | Same |
| Infant Coil - 24 | Yes | Yes | Same |
| Body Array Coil- 24 | Yes | Yes | Same |
| ITEM | Proposed DeviceuMR Omega | Predicate DeviceuMR Omega (K193200) | Remark |
| Head & Neck -48 | Yes | No | The intended use of Head & Neck Coil - 48 is equivalent to previously cleared Head & Neck Coil - 24. More coil elements in the new coil can better cover the scanning parts. |
| Spine Coil - 48 | Yes | No | The intended use of Spine Coil - 48 is equivalent to previously cleared Spine Coil - 32. More coil elements in the new coil can better cover the scanning parts. |
| Head Coil - 64 | Yes | No | The intended use of Head Coil - 64 is equivalent to previously cleared Head Coil - 32. More coil elements in the new coil can better cover the scanning parts. |
| SuperFlex Body - 24 | Yes | No | The intended use of SuperFlex Body - 24 is essentially identical to previously cleared Body Array Coil - 12. The differences are the number of channels of the coil and the material used on the surface of the coil. More coil elements in the new coil can better cover the scanning parts and the flexible material is beneficial to wrap the scanning parts. |
| SuperFlex Large - 12 | Yes | No | The intended use of SuperFlex Large - 12 is essentially identical to previously cleared Flex Coil Large - 8. The differences are the number of channels of the coil and the material used on the surface of the coil. More coil elements in the new coil can better cover the scanning parts and the |
| ITEM | Proposed DeviceuMR Omega | Predicate DeviceuMR Omega (K193200) | Remark |
| SuperFlex Small - 12 | Yes | No | flexible material isbeneficial to wrap thescanning parts.The intended use ofSuperFlex Small - 12 isessentially identical topreviously cleared FlexCoil Small - 8. Thedifferences are thenumber of channels of thecoil and the material usedon the surface of the coil.More coil elements in thenew coil can better coverthe scanning parts and theflexible material isbeneficial to wrap thescanning parts. |
| Patient table | |||
| Dimensions | width 640mm, height880mm, length 2620mm | width 640mm, height880mm, length2620mm | Same |
| Maximumsupportedpatient weight | 310 kg | 310 kg | Same |
| Accessories | |||
| Vital SignalGating | ECG, Peripheral Pulse Gating,Respiratory Gating | ECG, Peripheral PulseGating, Respiratory Gating | Same |
| Safety | |||
| Electrical Safety | Comply with ES60601-1 | Comply with ES60601-1 | Same |
| EMC | Comply with IEC60601-1-2 | Comply withIEC60601-1-2 | Same |
| Max SAR forTransmit Coil | Comply with IEC 60601-2-33 | Comply with IEC60601-2-33 | Same |
| Max dB/dt | Comply with IEC 60601-2-33 | Comply with IEC60601-2-33 | Same |
| Biocompatibility | Patient Contact Materialswere tested anddemonstrated nocytotoxicity (ISO 10993-5), no evidence forirritation and sensitization | Patient ContactMaterials were testedand demonstrated nocytotoxicity (ISO10993-5), no evidencefor irritation and | Same |
| ITEM | Proposed DeviceuMR Omega | Predicate DeviceuMR Omega (K193200) | Remark |
| sensitization (ISO 10993-10). | |||
| Surface Heating | NEMA MS 14 | ES 60601-1 | 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. |
Table 1 Comparison of Hardware configuration
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Image /page/8/Picture/1 description: The image shows the logo for United Imaging. The words "UNITED IMAGING" are stacked on top of each other in a bold, sans-serif font. To the right of the words is a stylized "U" symbol, which is dark blue and has a white line running vertically through the center. The logo is simple and modern, and the use of bold font and a strong color makes it easily recognizable.
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Image /page/9/Picture/1 description: The image contains the logo for United Imaging. The words "UNITED" and "IMAGING" are stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized "U" shape, which is likely a graphical representation of the company's name. The logo is simple and modern, with a focus on clarity and readability.
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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" 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.
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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" stacked on top of "IMAGING" 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 color of the text and symbol is a dark teal.
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Image /page/12/Picture/1 description: The image shows 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 font.
Table 2 provides the new application software features of the proposed device in comparison to the predicate device.
| ITEM | ProposedDeviceuMR Omega | PredicateDeviceuMR Omega(K193200) | Remark |
|---|---|---|---|
| Imaging Features | |||
| Fat AnalysisandCalculationTechnique(FACT) | Yes | No | FACT is short for fat analysis and calculationtechnique and substantially equivalent to WFI.It not only separates water and fat signal andquantifies fat fraction and R2* mappingaccording to chemical shift effect and T2*effect. |
| Inline T1/T2*Mapping | Yes | No | Inline T1/T2* Mapping is substantially equivalent toT1/T2* Mapping processed by post-processingmodule. The map result displays inline without extraoperation by post-processing module. |
| Inline T2Mapping | Yes | No | Inline T2 Map is substantially equivalent to T2 Mapprocessed by post-processing module. The map resultdisplays inline without extra operation by post-processing module. |
| Arterial SpinLabeling(ASL) | Yes | No | ASL is substantially equivalent to FSE and uses extraarterial spin labeling preparation and imagingprocessing for cerebral blood flow (CBF) imagingwithout contrast agent. |
| FlowQuantification(FQ) | Yes | No | FQ is substantially equivalent to GRE and uses extraflow encoding and imaging processing for flowquantification. |
Table 2 Comparison of the new Application Software Features
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Image /page/13/Picture/1 description: The image contains the logo for United Imaging. The words "UNITED" and "IMAGING" are stacked on top of each other in a bold, sans-serif font. To the right of the words is a stylized "U" symbol, which is dark gray in color. The logo is simple and modern in design.
| Cardiac T1Mapping | Yes | No | Cardiac T1 mapping is substantially equivalent toGRE and uses multiple TI acquisitions with IRpreparation and imaging processing for cardiac T1mapping. |
|---|---|---|---|
| Cardiac T2Mapping | Yes | No | Cardiac T2 mapping is substantially equivalent toGRE and uses multiple T2-prep duration preparationacquisitions and imaging processing for cardiac T2mapping. |
| Cardiac T2*Mapping | Yes | No | Cardiac T2* mapping is substantially equivalent toGRE and uses multiple TE acquisitions and imagingprocessing for cardiac T2* mapping. |
| DeepRecon | Yes | No | Note 1 |
| Workflow Features | |||
| Easy Scan | Yes | No | Easy Scan feature allows automatic slice positioningfor Shoulder, Abdomen, L-spine and T-spineimaging. The positioning can also be adjustedmanually by user. The final positioning effect isequivalent to manual operation without Easy Scanfeature. |
| Function | |||
| MRconditionalimplant mode | Yes | No | In MR conditional implant mode, user can set thesafety conditions of the MR conditional implant, anduMR Omega system ensure the scanning complieswith the conditions. |
| RemoteAssistance | Yes | No | Remote Assistance intends for remote support andservice. |
| Spectroscopy Sequences | |||
| LiverSpectroscopy | Yes | No | Liver spectroscopy is substantially equivalent toSpectroscopy and uses multi-echo acquisition andpost-processing instead of single echo for fatquantification of liver. |
| ProstateSpectroscopy | Yes | No | Prostate spectroscopy is substantially equivalent toSpectroscopy and uses characteristic metabolitesdetection post processing for prostate spectroscopy. |
| BreastSpectroscopy | Yes | No | Breast spectroscopy is substantially equivalent toSpectroscopy and uses characteristic metabolitesdetection post processing for breast spectroscopy. |
| Note 1 | DeepRecon is a deep-learning based image processing algorithm for intelligentimage de-noising and K-space-interpolation based image super-resolution. |
|---|---|
| Note 1 | The training data of DeepRecon were collected from 264 volunteers. Each subjectwas 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 intraining dataset, the multiple-averaged images with high-resolution and high SNRwere collected as the ground-truth images. The input images were generated from theground-truth images by sequentially reducing the SNR and resolution of the ground-truth images. All data were manually quality controlled before included for training. |
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Image /page/14/Picture/1 description: The image shows the logo for United Imaging. The words "UNITED IMAGING" are stacked on top of each other in bold, sans-serif font. To the right of the words is a stylized letter "U" that is also in bold. The logo is a dark teal color.
The DeepRecon has undergone performance testing on 77 US subjects with diverse demographic distributions covering various genders, age groups, ethnicities, and BMI groups (Table a).
| Table a. DeepRecon American Volunteers' Demographic Distribution | |
|---|---|
| Subjects' Characteristics | Total(N=77) |
| Gender | |
| Male | 37 |
| Female | 40 |
| Age | |
| 18-29 | 14 |
| 30-44 | 30 |
| 45-64 | 24 |
| >=65 | 9 |
| Ethnicity | |
| White | 36 |
| Black | 19 |
| Asian | 5 |
| Hispanic (of any race) | 17 |
| Body Mass Index (BMI) | |
| Underweight (<18.5) | 1 |
| Healthy weight (18.5-24.9) | 18 |
| Overweight (25.0-29.9) | 28 |
| Class1 Obesity (30.0-34.9) | 14 |
| Class2 Obesity (35-39.9) | 8 |
| Class3 Obesity (>=40) | 8 |
The independence of these testing datasets were ensured by collecting testing data from various clinical sites and during separated time periods and on subjects different from the training data. Thus, the testing data have no overlap with the training data and are completely independent. The acceptance criteria for performance testing and the corresponding testing results can be found in Table b.
| EvaluationItem | Acceptance Criteria | Test Result | Results |
|---|---|---|---|
| Image SNR | DeepRecon images achieve higher SNR compared to the images without DeepRecon (NADR) | NADR:209.41±1.08DeepRecon:302.48±0.78 | PASS |
| Image uniformity | Uniformity difference between DeepRecon images and NADR images under 5% | 0.15% | PASS |
| Image contrast | Intensity difference between DeepRecon images and NADR images under 5% | 0.9% | PASS |
Table b. The performance evaluation report criteria of DeepRecon
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Image /page/15/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" shape, which is dark gray with a white vertical line running through the center. The logo is simple and modern, and the use of bold font and a strong color palette makes it easily recognizable.
| Structure | Measurements on NADR andDeepRecon images of samestructures, measurement differenceunder 5% | 0% | PASS |
|---|---|---|---|
| The DeepRecon has been validated to provide image de-nosing and super-resolutionprocessing using various ethnicities, age groups, BMIs, and pathological variations.In addition, DeepRecon images were evaluated by American Board of Radiologistscertificated physicians, covering a range of protocols and body parts. The evaluationreports from radiologists verified that DeepRecon meets the requirements of clinicaldiagnosis. All DeepRecon images were rated with equivalent or higher scores interms of diagnosis quality. |
Table 3 provides the new Post Processing Features of the proposed device in comparison to the Reference Device #1.
| ITEM | Function name | Proposed device uWS-MR | Reference Device #1 uWS-MR (K192601) | Remark |
|---|---|---|---|---|
| MRS | Type of imaging scans | MRI | MRI | Same |
| Intended Body part | Brain, Body | Brain | Provides spectroscopy protocol of the body including prostate, breast and liver, which does not affect safety and effectiveness. | |
| Single-voxel Spectrum Data Analysis | Yes | Yes | Same | |
| Chemical Shift Imaging Data | Yes | Yes | Same | |
| Protocol Management | Yes | Yes | Same | |
| Metabolite Pseudo-color Map | Yes | Yes | Same | |
| Curve Peak Setting | Yes | Yes | Same | |
| Save Image Data | Yes | Yes | Same | |
| Print Image Data | Yes | Yes | Same | |
| Report | Yes | Yes | Same |
Table 3 Comparison of the new Post Processing Features
Table 4 provides the new Image Processing Features of the proposed device in comparison to the reference device #2.
Table 4 Comparison of the new Image Processing Features
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Image /page/16/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 logo is simple and modern, and the use of bold fonts gives it a strong and confident look.
| ITEM | Proposed DeviceuMR Omega | Reference Device #2uMR 780 (K193176) | Remark |
|---|---|---|---|
| Image Processing Features | |||
| AI-assisted compressed sensing | Yes | Yes | Same |
| Inline T1/T2* Mapping | Yes | Yes | Same |
Table 5 provide the Basic Functions of the Proposed Device uWS-MR in comparison to the reference device #1. All basic functions of uWS-MR are same as uWS-MR (K192601) in this submission.
| Item | Proposed DeviceuWS-MR | Reference Device #1uWS-MR (K192601) | Remark |
|---|---|---|---|
| General | |||
| DeviceClassificationName | Medical image management andprocessing system | Medical image management andprocessing system | Same |
| Product Code | QIH LLZ | QIH LLZ | Same |
| RegulationNumber | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |
| Device Class | II | II | Same |
| ClassificationPanel | Radiology | Radiology | Same |
| AdvancedApplication | Yes | Yes | Same |
| Indicationsfor use | uWS-MR is a software solutionintended to be used for viewing,manipulation, communication, andstorage of medical images. Itsupports interpretation andevaluation of examinations withinhealthcare institutions. It has thefollowing additional indications:The MR Stitching is intendedto create full-format imagesfrom overlapping MR volumedata sets acquired at multiplestages.The Dynamic application isintended to provide a generalpost-processing tool for timecourse studies.The Image Fusion applicationis intended to combine two | uWS-MR is a software solutionintended to be used for viewing,manipulation, communication,and storage of medical images. Itsupports interpretationand evaluation of examinationswithin healthcare institutions. Ithas the following additionalindications:The MR Stitching isintended to create full-format images fromoverlapping MR volumedata sets acquired atmultiple stages.The Dynamic application isintended to provide ageneral post-processing toolfor time course studies. | Same |
| Item | Proposed DeviceuWS-MR | Reference Device #1uWS-MR (K192601) | Remark |
| different image series so that the displayed anatomical structures match in both series. MRS (MR Spectroscopy) is intended to evaluate the molecule constitution and spatial distribution of cell metabolism. It provides a set of tools to view, process, and analyze the complex MRS data. This application supports the analysis for both SVS (Single Voxel Spectroscopy) and CSI (Chemical Shift Imaging) data. The MAPs application is intended to provide a number of arithmetic and statistical functions for evaluating dynamic processes and images. These functions are applied to the grayscale values of medical images. The MR Breast Evaluation application provides the user a tool to calculate parameter maps from contrast-enhanced time-course images. The Brain Perfusion application is intended to allow the visualization of temporal variations in the dynamic susceptibility time series of MR datasets. MR Vessel Analysis is intended to provide a tool for viewing, manipulating, and evaluating MR vascular images. The Inner view application is intended to perform a virtual camera view through hollow structures (cavities), such as vessels. | The Image Fusion application is intended to combine two different image series so that the displayed anatomical structures match in both series. MRS (MR Spectroscopy) is intended to evaluate the molecule constitution and spatial distribution of cell metabolism. It provides a set of tools to view, process, and analyze the complex MRS data. This application supports the analysis for both SVS (Single Voxel Spectroscopy) and CSI (Chemical Shift Imaging) data. The MAPs application is intended to provide a number of arithmetic and statistical functions for evaluating dynamic processes and images. These functions are applied to the grayscale values of medical images. The MR Breast Evaluation application provides the user a tool to calculate parameter maps from contrast-enhanced time-course images. The Brain Perfusion application is intended to allow the visualization of temporal variations in the dynamic susceptibility time series of MR datasets. MR Vessel Analysis is intended to provide a tool for viewing, manipulating, and evaluating MR vascular images. | ||
| Item | Proposed DeviceuWS-MR | Reference Device #1uWS-MR (K192601) | Remark |
| The DCE analysis is intended to view, manipulate, and evaluate dynamic contrast-enhanced MRI images. The United Neuro is intended to view, manipulate, and evaluate MR neurological images. The MR Cardiac Analysis application is intended to be used for viewing, post-processing and quantitative evaluation of cardiac magnetic resonance data. | The Inner view application is intended to perform a virtual camera view through hollow structures (cavities), such as vessels. The DCE analysis is intended to view, manipulate, and evaluate dynamic contrast-enhanced MRI images. The United Neuro is intended to view, manipulate, and evaluate MR neurological images. The MR Cardiac Analysis application is intended to be used for viewing, post-processing and quantitative evaluation of cardiac magnetic resonance data. |
Table 5 Comparison of the Basic Functions of uWS-MR
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Image /page/17/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 logo is a dark gray color.
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Image /page/18/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" shape, which is also in bold. The color of the logo is a dark teal.
Based on the comparison and analysis above, the proposed device has same intended use, similar performance, equivalence safety and effeteness in hardware and software 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.
8. Performance Data
The following performance data according to FDA guidances and Recognized Consensus Standards were provided in support of the substantial equivalence determination.
- A ES 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- A IEC 60601-1-2 Medical electrical equipment Part 1-2: General Requirements for basic safety and essential Performance
- A IEC 60601-2-33 Ed. 3.1:2013, Medical Electrical Equipment - Part 2-33: Particular Requirements For The Basic Safety And Essential Performance Of Magnetic Resonance Equipment For Medical Diagnostic
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ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
- ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical A
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Image /page/19/Picture/1 description: The image shows 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 font and has a white line running vertically through the center.
Devices - Part 10: Tests For Irritation And Skin Sensitization
-
MS 1-2008(R2020), Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Images
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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
- A 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
Non-clinical testing were conducted to verify the features described in this premarket submission.
- A Clinical performance evaluation
- A Performance evaluation report for SENC(sequence: gre senc spiral), 3D ASL (asl3d sequence), uCS Cine, FACT, MultiBand, Quiet Scan, 2D Flow quantification, EasyScan, Inline T1/T2* Mapping, Inline T2 Mapping, AI-assisted Compressed Sensing (ACS), DeepRecon, Metal Artifact Reduction Sequence (MARS), Cardiac T1 Mapping, Cardiac T2 Mapping, Cardiac T2* Mapping.
- A Performance testing for Spectroscopy: MRS Breast, MRS Prostate, MRS Fat Fraction.
-
System Validation report: Remote Assistance, MR conditional implant mode.
The test results demonstrated that the device performs as expected and thus, it is substantial 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 conclude that uMR Omega Magnetic Resonance Diagnostic Device with uWS-MR-MRS 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.
§ 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.