(262 days)
uWS-MI 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 Oncology application is intended to provide tools to display and analyze the follow-up PET/CT data, with which users can do image registration, lesion segmentation, and statistical analysis.
The Dynamic Analysis application is intended to display PET data and anatomical data such as CT or MR, and supports to do lesion segmentation and output associated time-activity curve.
The Brain Analysis (NeuroQ™) application is intended to analyze the brain PET scan, give quantitative results of the relative activity of 240 different brain regions, and make comparison of activity of normal brain regions in AC database or between two studies from the same patient, as well as provide analysis of amyloid uptake levels in the brain.
The Cardiac Analysis (ECTb™) application is intended to provide cardiac short axis reconstruction, browsing function. And it also performs perfusion analysis, activity analysis and cardiac function analysis of the cardiac short axis.
uWS-MI is a comprehensive software solution designed to process, review and analyze PET, CT or MR Images. 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 or anatomical datasets, such as CT. 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.
This Traditional 510(k) is to request modification for the cleared Picture archiving and communications system (uWS-MI) which have been cleared by FDA via K172998 on April 5, 2018.
The modifications performed on the uWS-MI (K172998) in this submission are due to the change of the basic application (Image Fusion) and the advance applications (Oncology and Dynamic Analysis).
The modifications of Brain Analysis application (NeuroQ™ -- cleared by FDA via K180077) is that it can make comparison between two studies from the same patient, as well as provide analysis of amyloid uptake levels in the brain.
The provided text describes a 510(k) submission for the uWS-MI software solution, which is intended for viewing, manipulating, and storing medical images, with specialized applications for Oncology, Dynamic Analysis, Brain Analysis (NeuroQ™), and Cardiac Analysis (ECTb™). The submission focuses on demonstrating substantial equivalence to a predicate device (uWS-MI, K172998) and several reference devices.
Acceptance Criteria and Device Performance:
The document primarily focuses on demonstrating substantial equivalence rather than explicit acceptance criteria with numerical performance targets. However, the performance verification reports mentioned indicate that the device's algorithms were evaluated. The "Remark" column in the comparison tables serves as a qualitative acceptance criterion, stating whether a function is "Same," "New Function which will not impact safety and effectiveness," or "Modified function which will not impact safety and effectiveness."
Since no specific quantitative acceptance criteria
(e.g., minimum sensitivity, specificity, or image quality scores) are listed, the table below will summarize the functions and the qualitative assessment provided for the modified applications, which are the focus of this 510(k) submission.
| Acceptance Criteria (Stated or Implied) | Reported Device Performance (Qualitative) |
|---|---|
| New functions will not impact safety and effectiveness. | Dynamic Analysis - Percentage threshold Segmentation: New Function which will not impact safety and effectiveness. |
| New functions will not impact safety and effectiveness. | Oncology - Percentage threshold lesion segmentation: New Function which will not impact safety and effectiveness. |
| Modified functions will not impact safety and effectiveness. | Oncology - Auto registration: Modified function which will not impact safety and effectiveness. |
| All other listed functions are "Same" as predicate/reference devices, implying they meet the same safety and effectiveness standards. | All other detailed functions across Dynamic Analysis, Oncology, Brain Analysis, and Cardiac Analysis are labeled as "Same," indicating performance equivalent to the predicate/reference devices. |
| Core functionalities (Image communication, Hardware/OS, Patient Administration, Review 2D/3D, Filming, Image Fusion, Inner View, Visibility, ROI/VOI, MIP Display, Compare, Report) are "Same" as predicate. | All core functionalities are "Same" as the predicate device. |
Study Details:
The document states that no clinical studies were required. The performance evaluation was based on "Performance Verification" reports for specific algorithms.
-
Sample Size used for the test set and the data provenance:
- The document does not specify the sample sizes (number of images or cases) used for the test sets in the performance verification reports (e.g., for Lung Nodule, Lymph Nodule, Non-rigid Registration, Percentage Threshold Segmentation, PET-MR Auto Registration).
- The data provenance (e.g., country of origin, retrospective or prospective nature) is not mentioned.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided in the document, as no clinical studies are mentioned.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done, as explicitly stated that "No clinical study was required." The device is primarily a post-processing software tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies that standalone performance verification for specific algorithms (Lung Nodule and Lymph Nodule Segmentation, Non-rigid Registration, Percentage Threshold Segmentation, PET-MR Auto Registration) was conducted. However, detailed results (metrics, effect sizes, etc.) are not provided in this summary. It states "Performance Evaluation Report for..." these algorithms, suggesting the algorithms were evaluated on their own.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document does not specify the type of ground truth used for the performance verification of the algorithms.
-
The sample size for the training set:
- This information is not provided in the document.
-
How the ground truth for the training set was established:
- This information is not provided in the document.
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Shanghai United Imaging Healthcare Co., Ltd. Jiading District % Xin Gao Regulatory Affairs Manager NO. 2258 Chengbei Road Shanghai, Shanghai 201807 CHINA
Re: K192630
Trade/Device Name: uWS-MI Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: May 9, 2020 Received: May 13, 2020
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
June 11, 2020
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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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/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,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and 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) K192630
Device Name uWS-MI
Indications for Use (Describe)
uWS-MI 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 Oncology application is intended to provide tools to display and analyze the follow-up PET/CT data, with which users can do image registration, lesion segmentation, and statistical analysis.
The Dynamic Analysis application is intended to display PET data and anatomical data such as CT or MR, and supports to do lesion segmentation and output associated time-activity curve.
The Brain Analysis (NeuroQ™) application is intended to analyze the brain PET scan, give quantitative results of the relative activity of 240 different brain regions, and make comparison of activity of normal brain regions in AC database or between two studies from the same patient, as well as provide analysis of amyloid uptake levels in the brain.
The Cardiac Analysis (ECTb™) application is intended to provide cardiac short axis reconstruction, browsing function. And it also performs perfusion analysis, activity analysis and cardiac function analysis of the cardiac short axis.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is formed by two vertical lines and a horizontal line in the middle. The logo is simple and modern, and the colors are muted.
SECTION 3
510(k) Summary
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510 (k) SUMMARY
1. Date of Preparation:
May 9, 2020
2. Sponsor Identification
Shanghai United Imaging Healthcare Co.,Ltd. No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China
Establishment Registration Number: 3011015597
Contact Person: Xin GAO Position: Regulatory Affairs Manager Tel: +86-021-67076888-5386 Fax: +86-021-67076889 Email: xin.gao@united-imaging.com
3. Identification of Proposed Device
Trade Name: uWS-MI Common Name: Image Post Processing Software Model(s): uWS-MI
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: K172998 Device Name: uWS-MI
Reference Device#1 510(k) Number: K183170 Device Name: uWS-CT
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Image /page/5/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized "U" shape, which is formed by two vertical lines and a curved line at the bottom. The logo is simple and modern, and the use of bold text and a clean design gives it a professional look.
Reference device#2 510(k) Number: K173897 Device Name: syngo.via MI Workflows
Reference device#3 510(k) Number: K180077 Device Name: NeuroQTM3.8
Reference device#4 510(k) Number: K123646 Device Name: Emory Cardiac Toolbox™4.0
5. Device Description
uWS-MI is a comprehensive software solution designed to process, review and analyze PET, CT or MR Images. 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 or anatomical datasets, such as CT. 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.
This Traditional 510(k) is to request modification for the cleared Picture archiving and communications system (uWS-MI) which have been cleared by FDA via K172998 on April 5, 2018.
The modifications performed on the uWS-MI (K172998) in this submission are due to the change of the basic application (Image Fusion) and the advance applications (Oncology and Dynamic Analysis).
The modifications of Brain Analysis application (NeuroQ™ -- cleared by FDA via K180077) is that it can make comparison between two studies from the same patient, as well as provide analysis of amyloid uptake levels in the brain.
6. Indications for use
uWS-MI is a software solution intended to be used for viewing, manipulation,
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Image /page/6/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 icon that resembles a shield with a white cross-like shape in the center. The overall design is clean and modern.
communication, and storage of medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications:
The Oncology application is intended to provide tools to display and analyze the followup PET/CT data, with which users can do image registration, lesion segmentation, and statistical analysis.
The Dynamic Analysis application is intended to display PET data and anatomical data such as CT or MR, and supports to do lesion segmentation and output associated timeactivity curve.
The Brain Analysis (NeuroQ™) application is intended to analyze the brain PET scan, give quantitative results of the relative activity of 240 different brain regions, and make comparison of activity of normal brain regions in AC database or between two studies from the same patient, as well as provide analysis of amyloid uptake levels in the brain.
The Cardiac Analysis (ECT6TM) application is intended to provide cardiac short axis reconstruction, browsing function. And it also performs perfusion analysis, activity analysis and cardiac function analysis of the cardiac short axis.
7. Technological Characteristic
The technology characteristics of the modified uWS-MI, reflected in this 510(k) submission, do not alter the scientific technology of the devices and are substantially equivalent to those of the predicate and reference devices.
The following tables compare the main features, principles of operation, fundamental scientific technology and intended use of uWS-MI when compared to the predicate devices.
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| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| uWS-MI | uWS-MI (K172998) | ||
| Device ClassificationName | Picture Archiving and CommunicationsSystem | Picture Archiving and CommunicationsSystem | 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 |
| Advanced Application | Yes | Yes | Same |
| Indications for use | uWS-MI is a software solution intendedto be used for viewing, manipulation,communication, and storage of medicalimages. It supports interpretation andevaluation of examinations withinhealthcare institutions. It has thefollowing additional indications:The Oncology application is intended toprovide tools to display and analyze thefollow-up PET/CT data, with which userscan do image registration, lesionsegmentation, and statistical analysis.The Dynamic Analysis application isintended to display PET data andanatomical data such as CT or MR, andsupports to do lesion segmentation andoutput associated time-activity curve. | uWS-MI is a software solution intendedto be used for viewing, manipulation,communication, and storage of medicalimages. It supports interpretation andevaluation of examinations withinhealthcare institutions. It has thefollowing additional indications:The PET/CT Oncology application isintended to provide tools to display andanalyze the follow-up PET/CT data, withwhich users can do image registration,lesion segmentation, and statisticalanalysis.The PET/CT Dynamic Analysisapplication is intended to display thedynamic PET image data and itsassociated time-activity curve. | The indication for use ofthe proposed device isexpanded and replenished.The proposed deviceincludes more functionsunder each sameapplication as the predicatedevice. This differencewill not affect the safetyand effectiveness. |
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Image /page/8/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" symbol. The symbol is dark gray and has a white vertical line running through the center, creating a negative space effect.
| The Brain Analysis (NeuroQTM)application is intended to analyze thebrain PET scan, give quantitative resultsof the relative activity of 240 differentbrain regions, and make comparison ofactivity of normal brain regions in ACdatabase or between two studies from thesame patient, as well as provide analysisof amyloid uptake levels in the brain.The Cardiac Analysis (ECTbTM)application is intended to provide cardiacshort axis reconstruction, browsingfunction. And it also performs perfusionanalysis, activity analysis and cardiacfunction analysis of the cardiac shortaxis. | The PET/CT Brain Analysis (NeuroQTM)application is intended to analyze thebrain PET scan, give quantitative resultsof the relative activity of 240 differentbrain regions, and make comparison ofactivity of normal brain regions in ACdatabase.The PET/CT Cardiac Analysis (ECTbTM)application is intended to provide cardiacshort axis reconstruction, browsingfunction. And it also performs perfusionanalysis, activity analysis and cardiacfunction analysis of the cardiac shortaxis. | |||||
|---|---|---|---|---|---|---|
| Specification | ||||||
| Image communication | Yes | Yes | Same | |||
| Hardware /OS | Yes | Yes | Same | |||
| Patient Administration | Yes | Yes | Same | |||
| Review 2D | Yes | Yes | Same | |||
| Review 3D | Yes | Yes | Same | |||
| Filming | Yes | Yes | Same | |||
| Image Fusion | Yes | Yes | Modify a function underthis Application | |||
| Inner View | Yes | Yes | Same |
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| Visibility | Yes | Yes | Same |
|---|---|---|---|
| ROI/VOI | Yes | Yes | Same |
| MIP Display | Yes | Yes | Same |
| Compare | Yes | Yes | Same |
| Report | Yes | Yes | Same |
SE Discussion for Modified Advanced Applications 1.
| Application | Function name | Proposed deviceuWS-MI | Predicate DeviceuWS-MI(K172998) | Remark |
|---|---|---|---|---|
| DynamicAnalysis | Reframe/Rebin | Yes | Yes | Same |
| ROI Analysis | Yes | Yes | Same | |
| Pseudo color | Yes | Yes | Same | |
| Automatic cine | Yes | Yes | Same | |
| Curve Analysis | Yes | Yes | Same | |
| Table Statistics | Yes | Yes | Same | |
| Save | Yes | Yes | Same | |
| Filming | Yes | Yes | Same | |
| Manual registration | Yes | Yes | Same | |
| Auto registration | Yes | Yes | Same | |
| Dot registration | Yes | Yes | Same | |
| Fix threshold Segmentation | Yes | Yes | Same | |
| Adaptive thresholdSegmentation | Yes | Yes | Same | |
| Percentage thresholdsegmentation | Yes | NO | New Function which will notimpact safety andeffectiveness. |
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Image /page/10/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" symbol, which is also in a bold font. The color of the logo is a dark teal.
| Application | Function name | ProposeddeviceuWS-MI | PredicateDeviceuWS-MI(K172998) | Referencedevice#1:uWS-CT(K183170) | Referencedevice#2:syngo.via MIWorkflows(K173897) | Remark |
|---|---|---|---|---|---|---|
| Oncology | Compare display | Yes | Yes | / | / | Same |
| Auto registration | Yes | Yes | / | / | Modified functionwhich will not impactsafety andeffectiveness. | |
| Manual registration | Yes | Yes | / | / | Same | |
| Spread | Yes | Yes | / | / | Same | |
| Statistical Analysis | Yes | Yes | / | / | Same | |
| Save | Yes | Yes | / | / | Same | |
| Fix Segmentation | Yes | Yes | / | / | Same | |
| Adaptive Segmentation | Yes | Yes | / | / | Same | |
| Percentage thresholdlesion segmentation | Yes | No | / | / | New Function whichwill not impact safetyand effectiveness. | |
| Lung NoduleSegmentation | Yes | / | Yes | / | Same | |
| Liver TumorSegmentation | Yes | / | Yes | / | Same | |
| Lymph NodeSegmentation | Yes | / | Yes | Same |
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Image /page/11/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the words is a stylized "U" symbol, which is also in a bold, sans-serif font. The logo is in a dark gray color.
| Application | Function name | Proposed deviceuWS-MI | Reference device#3:NeuroqTM(K180077) | Remark |
|---|---|---|---|---|
| BrainAnalysis(NeuroqTM) | Reformat | Yes | Yes | Same |
| Quality Control | Yes | Yes | Same | |
| Slice Display | Yes | Yes | Same | |
| Compare | Yes | Yes | Same | |
| PET/CT Fusion | Yes | Yes | Same | |
| EQuAL analysis | Yes | Yes | Same | |
| AmyQ | Yes | Yes | Same | |
| Save results, Captureregion/display, Exit | Yes | Yes | Same | |
| 3D Display | Yes | Yes | Same |
| Application | Function name | Proposed deviceuWS-MI | Reference device#4Syntermed Emory CardiacToolboxTM (K123646) | Remark |
|---|---|---|---|---|
| CardiacAnalysis(EmoryCardiacToolboxTM) | Reconstruction | Yes | Yes | Same |
| SSS | Yes | Yes | Same | |
| Polor Maps | Yes | Yes | Same | |
| Perfusion Analysis | Yes | Yes | Same | |
| Viability Analysis | Yes | Yes | Same | |
| Functional Analysis | Yes | Yes | Same | |
| Save results, Capture region/display , Exit | Yes | Yes | Same |
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Image /page/12/Picture/1 description: The image contains the logo for United Imaging. The words "UNITED" and "IMAGING" are stacked on top of each other in bold, sans-serif font. To the right of the text is a stylized "U" symbol, which is also in bold and appears to be a solid color. The logo is simple and modern in design.
| How1001 | I AD | CI W | Same |
|---|---|---|---|
| ﻟ | हr UD | ન તાલુﺗﺄﺳﻴﺴﺎﺕ ﺳﻨﺔ 1999 ﻓﻲ ﺇﺳﺒﺎﻧﻴﺎ، ﻭﻳﺘﺤﺪ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ | Same |
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Image /page/13/Picture/1 description: The image contains the logo for United Imaging. The words "UNITED IMAGING" are stacked on top of each other and are in a bold, sans-serif font. To the right of the words is a stylized "U" shape that is dark gray. The logo is simple and modern.
8. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
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). Those documentations include:
- Software description
- Device Hazard Analysis
- · Software requirements specification (SRS)
- · Software Architecture Design Chart
- · Software Development Environment Description
- · Software Verification and Validation
- · Cybersecurity Documents
Animal Study
No animal study was required.
Clinical Studies
No clinical study was required.
Performance Verification
- . Performance Evaluation Report for Lung Nodule and Lymph Nodule Segmentation Algorithms
- Performance Evaluation Report for Non-rigid Registration Algorithm
- . Performance Evaluation Report for Percentage Threshold Segmentation Algorithm
- . Performance Evaluation Report for PET-MR Auto Registration Image Fusion
Other Standards and Guidance
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Image /page/14/Picture/1 description: The image contains the logo for United Imaging. The words "UNITED IMAGING" are stacked on top of each other and are 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 initial. The logo is simple, modern, and professional in appearance.
- 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).
- . 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-MI was found to have a safety and effectiveness profile that is similar to the predicate device and reference devices.
9. Substantial Equivalent 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 Substantial Equivalent to the predicate device and reference devices.
§ 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).