(406 days)
No
The summary describes standard image processing and analysis tools for MR data, with no mention of AI, ML, or related concepts.
No.
The device is a software solution for viewing, manipulating, and analyzing medical images, and for various post-processing tasks, not for directly treating a condition or disease.
Yes
Explanation: The device is intended for "interpretation and evaluations within healthcare institutions" and supports various applications like "MR Spectroscopy is intended to evaluate the molecule constitution and spatial distribution of cell metabolism," which directly relate to diagnosing medical conditions. The mention of "A trained, licensed physician can interpret these displayed images as well as the statistics as per standard practice" further indicates its use in the diagnostic process.
Yes
The device description explicitly states "uWS-MR is a comprehensive software solution". The intended use and device description focus solely on software functionalities for viewing, manipulating, and analyzing medical images. There is no mention of accompanying hardware components that are part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that uWS-MR is a software solution for viewing, manipulating, and storing medical images, specifically MR images. It provides tools for post-processing, analysis, and visualization of these images.
- Lack of Biological Sample Analysis: There is no mention of the software analyzing biological samples or performing tests on bodily fluids or tissues. Its function is solely focused on the interpretation and analysis of medical images acquired from an MR scanner.
While the software aids in the interpretation and evaluation of medical conditions based on imaging data, this is distinct from the analysis of biological samples that defines an IVD.
N/A
Intended Use / Indications for Use
uWS-MR is a software solution intended to be used for viewing, manipulation, and storage of medical images. It supports interpretation and evaluations 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, manipulating MR vascular images. The Inner view application is intended to perform a virtual camera view through hollow structures (cavities), such as vessels.
Product codes
LLZ
Device Description
uWS-MR is a comprehensive software solution designed to process, review and analyze MR (Magnetic Resonance Imaging) studies. It can transfer images in DICOM 3.0 format over a medical imaging network or import images from external storage devices such as CD/DVDs or flash drives. These images can be functional data, as well as anatomical datasets. It can be at one or more time-points or include one or more time-frames. Multiple display formats including MIP and volume rendering and multiple statistical analysis including mean, maximum and minimum over a user-defined region is supported. A trained, licensed physician can interpret these displayed images as well as the statistics as per standard practice.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR (Magnetic Resonance Imaging)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained, licensed physician, within healthcare institutions.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software verification and validation testing was provided to demonstrate safety and efficacy of the proposed device. This includes a hazard analysis, and the potential hazards have been classified as a moderate level of concern (LOC). These documentations include:
- Software description
- Hazard Analysis
- Software requirements specification (SRS)
- Software Architecture Description
- Software Development Environment Description
- Software Verification and Validation
- Cyber security Documents
Performance Evaluation:
- Performance Evaluation For MR Dynamic
- Performance Evaluation For MR Breast
- Performance Evaluation For MR Stitching
- Performance Evaluation For MR Brain Perfusion
- Performance Evaluation For MR Spectroscopy
- Performance Evaluation For MR Fusion
- Performance Evaluation For MR Inner View
- Performance Evaluation For MR Vessel
- Performance Evaluation For MR Maps
The features described in this premarket submission are supported with the results of the testing mentioned above, the uWS-MR was found to have a safety and effectiveness profile that is similar to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K151353, K130749, K120315, K133401, K960265, K090546, K081985
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
November 7, 2018
Shanghai United Imaging Healthcare Co., Ltd. % Shumei Wang QM&RA VP No.2258 Chengbei Road, Jiading District Shanghai, 201807 CHINA
Re: K172999
Trade/Device Name: uWS-MR Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: October 9, 2018 Received: October 10, 2018
Dear Shumei Wang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Hol 2. Nils
for Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172999
Device Name uWS-MR
Indications for Use (Describe)
uWS-MR is a software solution intended to be used for viewing, manipulation, and storage of medical images. It supports interpretation and evaluations 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, manipulating MR vascular images. The Inner view application is intended to perform a virtual camera view through hollow structures (cavities), such as vessels.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" symbol, which is dark gray and has a white horizontal line through the middle. The overall design is clean and modern.
510 (k) SUMMARY
-
- Date of Preparation: March 26, 2018
2. Sponsor Identification
Shanghai United Imaging Healthcare Co.,Ltd. No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China
Establishment Registration Number: Not yet registered or the Number
Contact Person: Shumei Wang Position: QM&RA VP Tel: +86-021-67076888-6776 Fax: +86-021-67076889 Email: shumei.wang@united-imaging.com
3. Identification of Proposed Device
Trade Name: uWS-MR Common Name: MR Image Post-Processing Software Model(s): uWS-MR
Regulatory Information Classification Name: Picture archiving and communications system Classification: II Product Code: LLZ Regulation Number: 21 CFR 892.2050 Review Panel: Radiology
4. Identification of Predicate Device(s)
Predicate Device 510(k) Number: K123920 Device Name: syngo.via
Reference Device#1 510(k) Number: K151353 Device Name: Syngo.MR Neurology, Syngo.MR Oncology
Reference Device#2 510(k) Number: K130749 Device Name: syngo.MR General, syngo.MR Cardiology and syngo.MR Vascular
SECTION 2 - 2 of 11
4
Reference Device#3 510(k) Number: K120315 Device Name: syngo.MR Spectroscopy
Reference Device#4
510(k) Number: K133401 Device Name: syngo.MR Neurology, syngo.MR Oncology, syngo.MR BreVis and syngo.mMR General
Reference Device#5 510(k) Number: K960265 Device Name: Advantage Windows with FuncTool Option
Reference Device#6 510(k) Number: K090546 Device Name: Nordic Image Control and Evaluation (nordicICE) Software
Reference Device#7 510(k) Number: K081985 Device Name: AW Server
5. Device Description
uWS-MR is a comprehensive software solution designed to process, review and analyze MR (Magnetic Resonance Imaging) studies. It can transfer images in DICOM 3.0 format over a medical imaging network or import images from external storage devices such as CD/DVDs or flash drives. These images can be functional data, as well as anatomical datasets. It can be at one or more time-points or include one or more time-frames. Multiple display formats including MIP and volume rendering and multiple statistical analysis including mean, maximum and minimum over a user-defined region is supported. A trained, licensed physician can interpret these displayed images as well as the statistics as per standard practice.
6. Indications for use
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.
SECTION 2 - 3 of 11
5
- . 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.
7. Summary of Technological Characteristics
uWS-MR comprises the post-processing applications for viewing, manipulation, 3D visualization, post-processing and comparison of MR images. After importing the DICOM image data into the system, the operator is able to perform image browsing and processing and can further obtain advanced information. This is identical to the predicate device.
The following tables compare the main features, principles of operation, fundamental scientific technology and intended use of uWS-MR when compared to the predicate devices.
8. Substantially Equivalent (SE) Comparison
The proposed device has similar indications for use and overall function and performs in a similar manner with respect to, display, review and processing applications with predicate device and reference devices.
SECTION 2 - 4 of 11
6
Image /page/6/Picture/1 description: The image contains the logo for United Imaging. The words "UNITED" and "IMAGING" are stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized "U" shape, which is also in a bold font. The logo is simple and modern.
| Item | Proposed Device
uWS-MR | Predicate Device
syngo.via(K123920) | Remark |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| General | | | |
| Device
Classification
Name | Picture Archiving and
Communications System | Picture Archiving and
Communications System | Same |
| Product Code | LLZ | LLZ | Same |
| Regulation
Number | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |
| Device Class | II | II | Same |
| Classification
Panel | Radiology | Radiology | Same |
| Specification | | | |
| Image
communication | Standard network protocols like
TCP/IP and standard
communication protocol
DICOM. Additional fast image. | Standard network protocols
like TCP/IP and standard
communication protocol
DICOM. Additional fast
image. | Same |
| Hardware /OS | Windows 7 | Windows 7 | Same |
| Patient
Administration | Display and manage the image
data information of all patients
stored in the database. | Display and manage the image
data information of all patients
stored in the database. | Same |
| Review 2D | 2D Review consists of basic
processing of the 2D images,
e.g. rotation, scaling,
translation, windowing, and
measurements. | 2D Review consists of basic
processing of the 2D images,
e.g. rotation, scaling,
translation, windowing, and
measurements. | Same |
| Review 3D | 3D Review consist of
functionalities for displaying
and processing image in the 3D
form, e.g. VR, CPR, MPR,
MIP, etc. The module also
includes tools for VOI analysis. | 3D Review consist of
functionalities for displaying
and processing image in the 3D
form, e.g. VR, CPR, MPR,
MIP, etc. The module also
includes tools for VOI analysis. | Same |
| Filming | Filming is a module dedicated
for image printing. The print
tools provide layout editing for
both single images and series. | Filming is a module dedicated
for image printing. The print
tools provide layout editing for
both single images and series. | Same |
| Fusion | Including Auto registration,
Manual registration, Spot
registration | Including Auto registration,
Manual registration, Spot
registration | Same |
| Inner View | Inner view the vessel , colon ,
trachea | Inner view the vessel , colon ,
trachea | Same |
| Visibility | User-defined the display
property of fused image:
Adjustment of preset of T/B
value; Adjustment of the fused | User-defined the display
property of fused image:
Adjustment of preset of T/B
value; Adjustment of the fused | Same |
| Item | Proposed Device
uWS-MR | Predicate Device
syngo.via(K123920) | Remark |
| ROI/VOI | Plotting ROI or VOI, and
obtaining the maximum activity
value, the minimum activity
value, mean activity value, the
volume/area of region, and the
maximum diameter of volume,
peak activity value; | Plotting ROI or VOI, and
obtaining the maximum
activity value, the minimum
activity value, mean activity
value, the volume/area of
region, and the maximum
diameter of volume, peak
activity value; | Same |
| MIP Display | The image can be displayed as
MIP and rotating play | The image can be displayed as
MIP and rotating play | Same |
| Compare | Load two studies to compare. | Load two studies to compare. | Same |
SECTION 2 - 5 of 11
7
Image /page/7/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED" is stacked on top of the text "IMAGING" in a bold, sans-serif font. To the right of the text is a stylized, dark teal-colored symbol that resembles a shield or a stylized letter "U" with a vertical line running through the center.
Table 2 SE Discussion for advanced applications
| Application | Function name | Proposed
device
uWS-MR | Reference
Device#1
Syngo.MR
Neurology,
Syngo.MR
Oncology
(K151353) | Reference
Device#6
Nordic Image
Control and
Evaluation
(nordicICE)
Software
(K090546) | Remark |
|-----------------------|-------------------------------------------------------------------------------|-------------------------------|--------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|--------|
| MR Brain
Perfusion | Type of imaging
scans | MRI | MRI | / | Same |
| | Intended Body part | MR
neurological
images. | MR
neurological
images. | / | Same |
| | Rectify motion | Yes | Yes | / | Same |
| | Remove background | Yes | Yes | / | Same |
| | Arterial Select:
Automatically or
manually select
arterial location. | Yes | Yes | / | Same |
| | Parametric Mapping
Calculation | Yes | / | Yes | Same |
| | TIC Analysis | Yes | Yes | / | Same |
| | Save Image Data | Yes | Yes | / | Same |
| | Print Image Data | Yes | Yes | / | Same |
| | Report | Yes | Yes | / | Same |
SECTION 2 - 6 of 11
8
Image /page/8/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, with 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.
| Application | Function name | Proposed device | Reference Device#4 | Reference Device#5 | Remark |
|---|---|---|---|---|---|
| MR Breast Evaluation | Type of imaging scans | MRI | MRI | MRI | Same |
| Intended Body part | Breast | Breast | Breast | Same | |
| Automatic Subtraction | Yes | Yes | Yes | Same | |
| Motion Correction | Yes | Yes | Yes | Same | |
| TIC Analysis | Yes | Yes | Yes | Same | |
| Background Removal | Yes | Yes | Yes | Same | |
| TIC Analysis | Yes | Yes | Yes | Same | |
| Automatic Parameter Map Calculation | Yes | Yes | Yes | Same | |
| Save Image Data | Yes | Yes | Yes | Same | |
| Print Image Data | Yes | Yes | Yes | Same | |
| Report | Yes | Yes | Yes | Same | |
| syngo.MR | |||||
| Neurology, | |||||
| syngo.MR | |||||
| Oncology, | |||||
| syngo.MR | |||||
| BreVis and | |||||
| syngo.mMR | |||||
| General | |||||
| (K133401) | Advantage | ||||
| Windows | |||||
| with | |||||
| FuncTool | |||||
| Option | |||||
| (K960265) |
| Application | Function name | Proposed
device
uWS-MR | Reference Device#2
syngo.MR General,
syngo.MR Cardiology and
syngo.MR Vascular(K130749) | Remark |
|--------------|----------------------------|------------------------------|--------------------------------------------------------------------------------------------------|--------|
| MR Stitching | Type of imaging
scans | MRI | MRI | Same |
| | Intended Body
part | WholeBody | WholeBody | Same |
| | Automatic Stitching | Yes | Yes | Same |
| | Manual Stitching | Yes | Yes | Same |
| | Homogenous
Modification | Yes | Yes | Same |
| | Sharp/Smooth | Yes | Yes | Same |
| | Save Image Data | Yes | Yes | Same |
| | Print Image Data | Yes | Yes | Same |
| | Report | Yes | Yes | Same |
SECTION 2 - 7 of 11
9
Image /page/9/Picture/1 description: The image shows 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 words is a stylized "U" shape, which is also in a bold font. The logo is simple and modern, and it is likely used to represent the company's brand.
| Application | Function name | Proposed
device
uWS-MR | Reference Device#2
syngo.MR General,
syngo.MR
Cardiology and
syngo.MR Vascular
(K130749) | Reference
Device#7
AW
SERVER(K
081985) | Remark |
|-----------------------|------------------------------------------------------|------------------------------|---------------------------------------------------------------------------------------------------------|----------------------------------------------------|--------|
| MR Vessel
Analysis | Type of imaging
scans | MRI | MRI | / | Same |
| | Intended Body
part | WholeBody | WholeBody | / | Same |
| | Automatic blood
vessel center lines
extraction | Yes | Yes | / | Same |
| | Vascular stenosis
analysis: | Yes | / | Yes | Same |
| | Vascular display
with
MPR\CPR\VR\MIP | Yes | Yes | / | Same |
| | Save Image Data | Yes | Yes | / | Same |
| | Print Image Data | Yes | Yes | / | Same |
| | Report | Yes | Yes | / | Same |
| Application | Function name | Proposed
device | Reference Device#3
syngo.MR Spectroscopy | Remark |
|-------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|-----------------------------------------------------------------|--------|
| | | uWS-MR | (K120315) | |
| MRS | Type of imaging scans | MRI | MRI | Same |
| | Intended Body part | Brain | Brain | Same |
| | Single-voxel Spectrum Data Analysis | Yes | Yes | Same |
| | Chemical Shift Imaging Data | Yes | Yes | Same |
| | Protocol Management: | Yes | Yes | Same |
| | Statistics Analysis | 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 |
| | | uWS-MR | Advantage
Windows
with
FuncTool
Option
(K960265) | |
| MR | ADC and eADC Calculate | Yes | Yes | Same |
| Dynamic | T1, T2, T2*/R2* Calculate | Yes | Yes | Same |
| MR MAPS | Background Removal | Yes | Yes | Same |
| | ROI Curves Analysis: Plot interested region,
including correlated or non-correlated,
symmetric or asymmetric, and get mean time-
intensity curve | Yes | Yes | Same |
| | Statistic Table: Produce statistical table for
parameters, and freely select to display items
in demand. | Yes | Yes | Same |
| | DCE (Dynamic Contrast Enhance)
customizes background pixel range
calculation (Support to modify manually), and
automatically provides parameter value, end-
stage scanning value (Support to modify by
need). The relative Parameter Maps includes
PEI (Positive Enhanced Integration), TTP
(Time to Peak), MSI (Maximum Slope of
Increasing) and MTE (Mean Time to
Enhance). | Yes | Yes | Same |
| | DSC (Dynamic Susceptibility Contrast-
enhance) customizes background pixel range
calculation (Support to modify manually), and
automatically provides parameter value, end-
stage scanning value (Support to modify by
need). The relative Parameter Maps includes
NEI (Negative Enhanced Integration), TTP
(Time to Peak), MSD (Maximum Slop of
Descending) and MTE (Mean Time to
Enhance) | Yes | Yes | Same |
| | Save Image Data | Yes | Yes | Same |
| | Print Image Data | Yes | Yes | Same |
| | Report | Yes | Yes | Same |
| Application | Function name | Proposed device | Reference Device#5 | Remark |
|---|---|---|---|---|
| ------------- | --------------- | ----------------- | -------------------- | -------- |
SECTION 2 - 8 of 11
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Image /page/10/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 "U" symbol, which is made up of two vertical bars and a horizontal bar in the middle.
9. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
SECTION 2 - 9 of 11
11
Biocompatibility
Not Applicable to the proposed device, because the device is stand-alone software.
Electrical Safety and Electromagnetic Compatibility (EMC)
Not Applicable to the proposed device, because the device is stand-alone software.
Software Verification and Validation
Software verification and validation testing was provided to demonstrate safety and efficacy of the proposed device. This includes a hazard analysis, and the potential hazards have been classified as a moderate level of concern (LOC). These documentations include:
- Software description
- · Hazard Analysis
- · Software requirements specification (SRS)
- · Software Architecture Description
- · Software Development Environment Description
- · Software Verification and Validation
- · Cyber security Documents
Animal Study
No animal study was required.
Clinical Studies
No clinical study was required.
Performance Verification
- . Performance Evaluation For MR Dynamic
- Performance Evaluation For MR Breast
- Performance Evaluation For MR Stitching
- Performance Evaluation For MR Brain Perfusion
- . Performance Evaluation For MR Spectroscopy
- . Performance Evaluation For MR Fusion
- . Performance Evaluation For MR Inner View
- Performance Evaluation For MR Vessel
- . Performance Evaluation For MR Maps
Product Standards and Guidance
- NEMA PS 3.1 - 3.20 Digital Imaging and Communications in Medicine (DICOM) Set (2016).
- ISO 14971 Medical devices - Application of risk management to medical devices (Edition 2.0, corrected version, 2007).
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12
- IEC 62304 Medical device software Software life cycle processes (Edition 1.1, ● 2015).
Summary
The features described in this premarket submission are supported with the results of the testing mentioned above, the uWS-MR was found to have a safety and effectiveness profile that is similar to the predicate device.
10. Substantially Equivalent (SE) Conclusion
The proposed device is equivalent to the predicate device with regard to safety and efficacy. This conclusion is based upon a comparison of intended use, technological characteristics, performance specification, device hazards as well as verification and validation results.
In summary, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.