(169 days)
The iSR'obot MRI-US Fusion is a software application to be used by Clinicians in the clinic or hospital for 2-D and 3-D visualization, image registration, and fusion of Magnetic Resonance and Ultrasound images for mapping planning information of the prostate gland and region of interest. The software features also include multi-modality data communication, surface and volume rendering, segmentation, multi-planar reconstruction, organ delineation, region of interest delineation, landmark selection, measurements and data reporting.
The iSR'obot MRI-US Fusion (UroFusion) is a software application intended for use by Clinicians or Radiologist for 2-D and 3-D visualization, image registration and fusion of Magnetic Resonance and Ultrasound images for mapping planning of the prostate gland and region of interest, such as lesions, to provide "MRI-3D model" imaqe information. The "MRI-3D model" image information produced by this software acts as inputs to the iSR'obot Mona Lisa which allows the import of this "MRI-3D model" image information; and fusion of this model information together with the live ultrasound 3D-model image information.
Leveraging on the information available from both Magnetic Resonance (MRI) & Ultrasound modalities concurrently, the fusion results enable the clinicians to visualize the prostate and the region of interest (lesions); thus enabling fewer and more accurate targeted prostate biopsies to be taken as compared with "blind" saturated biopsies with ultrasound guidance alone.
UroFusion software system includes the following features:
- Access and display medical imaging studies from MRI DICOM data. .
- Provide for 2D contouring /3D modelling of the prostate gland. .
- Provide for 2D contouring / 3D modelling of tumour / lesions within the . gland.
- Provide for saving of patient "MRI-3D model" information together with ● the patient's MRI DICOM data.
- Provide for importing of patient "MRI-3D model" information together with relevant MRI DICOM data.
- Provide for the fusion of "MRI-3D model" information with the live . ultrasound 3D- model information for subsequent operations to be executed in iSR'obot Mona Lisa.
UroFusion can be deployed and utilized in commercially available computer platforms and operating systems; or as a standalone system.
Here's an analysis of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly define a table of acceptance criteria with numerical targets. Instead, it relies on demonstrating substantial equivalence to a predicate device (Multi-Modality Image Fusion, K120187) and performing verification and validation activities, including non-clinical performance evaluation and clinical evaluation through literature review.
The "reported device performance" is primarily qualitative, focusing on whether the UroFusion successfully fulfills its intended functions and is comparable to the predicate. The key performance demonstrated in the non-clinical testing is the measurement of "Hausdorff distance," which is a metric for comparing two point sets or shapes, indicating how far two surfaces are from each other. However, a specific acceptance criterion for Hausdorff distance (e.g., "Hausdorff distance < X mm") is not provided.
Therefore, a direct table of acceptance criteria and reported performance with quantitative metrics cannot be fully populated from this document in the traditional sense of a performance study with pre-defined thresholds.
| Acceptance Criteria (Inferred) | Reported Device Performance (from "Non-Clinical Testing") |
|---|---|
| Ability to register and fuse MRI and Ultrasound images | "The performance evaluation testing used 2 phantoms, measurement of Hausdorff distance and statistical analysis to demonstrate that UroFusion performance was successfully verified and substantiated." (Specific values for Hausdorff distance are not provided, only that it was measured and proved successful.) |
| Accuracy of 2D/3D visualization, segmentation, organ/ROI delineation | (Implicitly demonstrated by successful verification and substantiation of performance, including Hausdorff distance measurement.) |
| Functionality of listed software features (e.g., multi-modality data communication, rendering, landmark selection, data reporting) | "UroFusion complies with voluntary standards as detailed in this premarket notification submission. It also successfully completed all testing per our quality system..." (Verification and validation activities listed, implying successful functionality.) |
| Safety and Effectiveness comparable to predicate device | "Biobot believes UroFusion is of comparable type and substantially equivalent to the predicate device... Biobot believes that the UroFusion is safe and effective, and performs in a substantially equivalent manner to the predicate device." |
2. Sample Size Used for the Test Set and the Data Provenance:
-
Non-Clinical Testing:
- Sample Size: "2 phantoms" were used.
- Data Provenance: Not explicitly stated, but phantoms are simulated-use objects.
-
Clinical Testing: The document does not describe a clinical study with a specific test set of patients or medical images in the traditional sense. Instead, it relies on a literature review.
- Sample Size:
- "6 relevant papers" were evaluated.
- "3 of them were original clinical studies" (implies these studies had their own patient cohorts, but the size of those cohorts is not specified in this document).
- The other 3 papers were review papers.
- "2 statements were made by physicians who had experiences with our devices." (These are anecdotal endorsements, not a structured clinical test set).
- Data Provenance: The literature search would likely encompass data from various countries based on the publications. It is implicitly retrospective as it reviews existing published data.
- Sample Size:
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Non-Clinical Testing (Phantoms):
- Ground truth for phantoms is typically inherent in their design or established through precise physical measurements, not by expert consensus in the same way as biological data. The document does not specify experts for establishing ground truth for the phantoms.
- Clinical Testing (Literature Review):
- For the reviewed clinical studies, the ground truth would have been established by the authors of those individual studies. The document does not provide details on the number or qualifications of experts involved in those studies.
- For the 2 statements from physicians, their qualifications are "physicians who had experiences with our devices," but no further details are given about their experience level or the method by which their "statements" constituted ground truth.
4. Adjudication Method for the Test Set:
- Non-Clinical Testing (Phantoms): Not applicable for phantom-based technical performance testing as described.
- Clinical Testing (Literature Review): No formal adjudication method is mentioned. The "evaluation" of the papers was done by the manufacturer, Biobot Surgical Pte Ltd, as part of their submission strategy.
5. 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. The document explicitly states: "The clinical evaluation of UroFusion was carried out using the literature search route... no clinical trials are required." Therefore, no MRMC comparative effectiveness study was performed or described in this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The non-clinical testing, particularly the measurement of Hausdorff distance on phantoms, is generally a form of standalone technical performance testing of the algorithm's accuracy in tasks like image registration and segmentation. While humans would operate the software, the measurement of performance metrics like Hausdorff distance is an objective assessment of the algorithm's output against a known ground truth (the phantom's design).
- However, the document does not explicitly present a dedicated "standalone performance" study that would typically involve a specific dataset processed solely by the algorithm and evaluated against ground truth. The focus is on the device as a "software application to be used by Clinicians."
7. The Type of Ground Truth Used:
- Non-Clinical Testing: For the phantom studies, the ground truth would have been the known physical properties and dimensions of the phantoms.
- Clinical Testing (Literature Review): The ground truth in the reviewed clinical studies would vary depending on the study design, but for prostate lesion detection and biopsy guidance, it often includes pathology reports from biopsies as the gold standard, and potentially expert consensus on imaging in some cases. The document does not specify the ground truth types for the individual studies reviewed.
8. The Sample Size for the Training Set:
The document does not provide information about a training set or its sample size. This is typical for a 510(k) submission for certain types of software, especially those that primarily focus on image processing and fusion and are seeking substantial equivalence to a predicate, rather than developing novel diagnostic algorithms that require extensive training. The device's technological basis is described as "employing the same fundamental scientific technology as that of its predicate device," suggesting it might not involve a machine learning model that requires a distinct "training set."
9. How the Ground Truth for the Training Set Was Established:
Since no training set is described, the method for establishing its ground truth is not provided.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 6, 2016
Biobot Surgical Pte Ltd % Ms. Lai Chee Liew Head of Quality, Regulatory Affairs 2 Woodlands Spectrum I #03-10 Woodlands Sector 1 SINGAPORE 738068
Re: K161109
Trade/Device Name: iSR'obot MRI-US Fusion Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 25, 2016 Received: September 8, 2016
Dear Ms. Liew:
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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Robert Oals
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K161109
Device Name
iSR'obot MRI-US Fusion
Tyne of I lea (Select one or hoth, as annlicable)
Indications for Use (Describe)
The iSR'obot MRI-US Fusion is a software application to be used by Clinicians in the clinic or hospital for 2-D and 3-D visualization, image registration, and fusion of Magnetic Resonance and Ultrasound images for mapping planning information of the prostate gland and region of interest. The software features also include multi-modality data communication, surface and volume rendering, segmentation, multi-planar reconstruction, organ delineation, region of interest delineation, landmark selection, measurements and data reporting.
| 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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510(k) Premarket Notification Submission - iSR'obot MRI-US fusion
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirement of 21 CFR Part 807.87(h).
| Date: | August 24, 2016 |
|---|---|
| Submitter: | Biobot Surgical Pte Ltd2 Woodlands Spectrum I,#03-10 Woodlands Sector 1,Singapore 738068 |
| Primary Contact: | Lai Chee LiewHead of Quality, Regulatory AffairsBiobot Surgical Pte LtdTelephone: +65 63511868E-mail: laichee@zicomgroup.com |
| Secondary Contact: | Thum Ee LinAssistant Manager, Regulatory AffairsBiobot Surgical Pte LtdTelephone: +65 63511868E-mail: eelin@zicomgroup.com |
Product Identification
| Device Trade Name: | iSR'obot MRI-US Fusion |
|---|---|
| Common / Usual Name: | Picture Archiving and Communication System |
| Classification Names: | 21 CFR 892.2050, System, Image Processing, Radiological |
| Product Code: | LLZ |
| Manufacturer / DesignLocation: | Biobot Surgical Pte Ltd2 Woodlands Spectrum I, #03-10 Woodlands Sector 1,Singapore 738068 |
| Manufacturing Location(s): | Biobot Surgical Pte Ltd2 Woodlands Spectrum I, #03-10 Woodlands Sector 1,Singapore 738068 |
| Distributor: | Biobot Surgical Pte Ltd2 Woodlands Spectrum I, #03-10 Woodlands Sector 1,Singapore 738068 |
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Device Description
The iSR'obot MRI-US Fusion (UroFusion) is a software application intended for use by Clinicians or Radiologist for 2-D and 3-D visualization, image registration and fusion of Magnetic Resonance and Ultrasound images for mapping planning of the prostate gland and region of interest, such as lesions, to provide "MRI-3D model" imaqe information. The "MRI-3D model" image information produced by this software acts as inputs to the iSR'obot Mona Lisa which allows the import of this "MRI-3D model" image information; and fusion of this model information together with the live ultrasound 3D-model image information.
Leveraging on the information available from both Magnetic Resonance (MRI) & Ultrasound modalities concurrently, the fusion results enable the clinicians to visualize the prostate and the region of interest (lesions); thus enabling fewer and more accurate targeted prostate biopsies to be taken as compared with "blind" saturated biopsies with ultrasound guidance alone.
UroFusion software system includes the following features:
- Access and display medical imaging studies from MRI DICOM data. .
- Provide for 2D contouring /3D modelling of the prostate gland. .
- Provide for 2D contouring / 3D modelling of tumour / lesions within the . gland.
- Provide for saving of patient "MRI-3D model" information together with ● the patient's MRI DICOM data.
- Provide for importing of patient "MRI-3D model" information together with relevant MRI DICOM data.
- Provide for the fusion of "MRI-3D model" information with the live . ultrasound 3D- model information for subsequent operations to be executed in iSR'obot Mona Lisa.
UroFusion can be deployed and utilized in commercially available computer platforms and operating systems; or as a standalone system.
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510(k) Premarket Notification Submission - iSR'obot MRI-US fusion
The system does not produce any original medical images. All images located on the UroFusion system have been received from DICOM compliant modalities and/or image acquisition systems.
The system allows trained professionals to access and display DICOM images for the purpose of modelling and planning clinical procedures. These trained professionals includes radiologists, urologists, radiology oncologists and interventional oncologists.
Hardware Description
The UroFusion is a software-only device that runs on off-the-shelf computer systems. The hardware platform that the device runs on is as follows:
| HardwarePlatform | CPU Type | CPU Frequency | Disk Space | Memory | Others |
|---|---|---|---|---|---|
| Desktop orLaptopComputers | 32-bit or 64-bit | 1 GHz and above | ≥ 15 GBHard diskspace | ≥ 8 GB | USB 2.0interface orCD/DVD Rom |
The components external to UroFusion software are:
| Mona Lisa UltrasoundScanning & Modelling | This module is part of the iSR'obot Mona Lisasystem that will provide the ultrasoundinformation needed to generate the US-3Dmodel information |
|---|---|
| Mona Lisa Biopsy Planning | This module is part of Mona Lisa system that willprovide for planning and execution of prostatebiopsies |
The UroFusion is designed and verified to work with iSR'obot Mona Lisa (K130944).
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510(k) Premarket Notification Submission - iSR'obot MRI-US fusion
Intended Use
The iSR'obot MRI-US Fusion is a software application to be used by Clinicians in the clinic or hospital for 2-D and 3-D visualisation, image registration, and fusion of Magnetic Resonance and Ultrasound images for mapping planning information of the prostate gland and region of interest.
Indications for Use
The iSR'obot MRI-US Fusion is a software application to be used by Clinicians in the clinic or hospital for 2-D and 3-D visualization, image registration, and fusion of Magnetic Resonance and Ultrasound images for mapping planning information of the prostate gland and region of interest. The software features also include multi-modality data communication, surface and volume rendering, segmentation, multi-planar reconstruction, organ delineation, region of interest delineation, landmark selection, measurements and data reporting.
Technology
UroFusion employs the same fundamental scientific technology as that of its predicate device, Multi-modality Image Fusion (K120187). The majority of the software features and functions are common between the two products.
| Predicate Device:Multi-modalityImage Fusion | Proposed Device:iSR'obot MRI-USFusion | DiscussionofSimilarities | |
|---|---|---|---|
| Manufacturer | Eigen | Biobot | |
| 510(k) number | K120187 | Pending | |
| Where Used | Office settings in clinicor hospital | Office settings in clinicor hospital | Same |
| Software Device | Yes | Yes | Same |
| Image Registration | Multi-modalityimage registration | Multi-modalityimage registration | Same |
| Systemcomposition | Offline software andonline software | Offline software andonline software | Same |
| Predicate Device:Multi-modalityImage Fusion | Proposed Device:iSR'obot MRI-USFusion | DiscussionofSimilarities | |
| Workflow | User first uses offlinesoftware to importMRI/CT DICOM datato prepare prostatecontours and markarea of interest. Thenuser uses onlinesoftware to fuseprepare MRI/CTimages to Ultrasoundimages. | User first uses offlinesoftware to importMRI DICOM data toprepare prostatecontours and markarea of interest.Then user uses onlinesoftware to fuseprepare MRI imagesto Ultrasound images. | Same |
| Data Acquisition | DICOM import forMRI images foroffline software;snapshot ofUltrasound imagesfor offline software. | DICOM import forMRI images foroffline software;snapshot ofUltrasound imagesfor offline software. | Same |
| ImageFusion/OverlayDisplay | Fused overlay ofimages from multiplemodalities | Fused overlay ofimages from multiplemodalities | Same |
| Opacity Control | Yes | Yes | Same |
| 3-D Rendering | Yes | Yes | Same |
| Surface Rendering | Yes | Yes | Same |
| Region of Interest | Yes | Yes | Same |
| ConfigurableImage Layouts | Yes | Yes | Same.User canchoose tosee differentslice ofimage stackin any viewof thetransversal,sagittal andcoronalviews. |
| Predicate Device:Multi-modalityImage Fusion | Proposed Device:iSR'obot MRI-USFusion | DiscussionofSimilarities | |
| 3-D Contoursfor Planning | Yes | Yes | Same.User candefine 3-Dcontours ofprostate andarea ofinterest,which can beused forbiopsyplanning. |
| Export of 3Dcontours forplanning | Yes | Yes | Same. |
| Image StorageandCommunication | Yes | Yes | Same. |
| Modalities | CT, MR, Ultrasound | MRI, Ultrasound | This deviceis tested forMRI andUltrasoundmodalities.Thisdifferencedid not raisenew safetyandeffectivenessconcerns. |
| ImageConstruction | Full 3-D imageconstruction fromimage slices. | Full 3-D imageconstruction fromimage slices. | Same |
| Predicate Device:Multi-Modality ImageFusion - K120187 | Proposed Device:MRI- US FusionSoftware | Discussion | |
| Intended Use | The software is intendedfor 2-D and 3-Dvisualization, imageregistration, and fusion ofMRI, CT and Ultrasoundimaging modalities. | The iSR'obot MRI-USFusion is a softwareapplication to be used byClinicians in the clinic orhospital for 2-D and 3-Dvisualization, imageregistration, and fusion ofMagnetic Resonance andUltrasound images formapping planninginformation of theprostate gland and regionof interest. | Same |
The table below outlines the major subsystem differences and similarities.
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510(k) Premarket Notification Submission - iSR'obot MRI-US fusion
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510(k) Premarket Notification Submission - iSR'obot MRI-US fusion
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510(k) Premarket Notification Submission - iSR'obot MRI-US fusion
Determination of Substantial Equivalence
The software documentation was provided at a moderate level of concern following the FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
UroFusion complies with voluntary standards as detailed in this premarket notification submission. It also successfully completed all testing per our quality system and it was designed and manufactured under the Quality System Regulations of 21 CFR 820 and ISO 13485. The following quality assurance measures were applied to the development of the system:
- Risk Analysis ●
- Requirements Reviews ●
- Design Reviews ●
- Usability Analysis ●
- Testing on unit level (Verification) ●
- . Integration testing (Verification)
- Performance testing (Verification)
- Regression testing (Verification) .
- System testing (Verification) ●
- . Simulated use testing (Validation)
Biobot believes UroFusion is of comparable type and substantially equivalent to the predicate device based on the table above (Page 5-5 to 5-7) which compares its technology similarities. Both devices' indication for use is similar except the imaging modalities to be used.
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510(k) Premarket Notification Submission - iSR'obot MRI-US fusion
| Predicate Device:Multi-Modality ImageFusion - K120187 | Proposed Device:MRI- US FusionSoftware | Discussion | |
|---|---|---|---|
| Indicationsfor Use | Multi-Modality ImageFusion is a softwareapplication to be usedby physicians in theclinic or hospital for 2- Dand 3-D visualization,image registration, andfusion of MRI, CT andUltrasound imagingmodalities for mappingplanning informationacross modalities.Additional softwarefeatures includedatabase management,data communication,surface rendering,segmentation, regionsof interest (ROI)delineation, volumetricmeasurements, anddata reporting. | The iSR'obot MRI-USFusion is a softwareapplication to be used byClinicians in the clinic orhospital for 2-D and 3-Dvisualization, imageregistration, and fusion ofMagnetic Resonance andUltrasound images formapping planninginformation of theprostate gland and regionof interest. The softwarefeatures also includemulti-modality datacommunication, surfaceand volume rendering,segmentation, multi-planar reconstruction,organ delineation, regionof interest delineation,landmark selection,measurements and datareporting | SubstantiallyEquivalentTheindication foruse of theMRI-USFusionSoftwaresystem issubstantiallyequivalent tothe predicatedevice'sindication foruse. The ROIinformation ismapped toUltrasoundmodality. |
Therefore, we believe that UroFusion is of comparable type and substantially equivalent to the currently marketed system Multi-modality Image Fusion.
Summary of Additional Testing
In addition to verification and validation activities successfully completed as required by Biobot's quality system, additional engineering (non-clinical testing) and clinical testing (through literature review) was performed to substantiate performance claims, the indications, and ultimately substantial equivalence.
Non-Clinical Testing
The performance evaluation testing used 2 phantoms, measurement of Hausdorff distance and statistical analysis to demonstrate that UroFusion performance was successfully verified and substantiated.
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510(k) Premarket Notification Submission - iSR'obot MRI-US fusion
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Clinical Testing
The clinical evaluation of UroFusion was carried out using the literature search route as the intended use and use principle of UroFusion are essentially the same as the other 3D image-processing products already in the market. These products are applied in clinical practice for several years with published data.
The search resulted in 6 relevant papers and 2 statements which were evaluated in regard to the significance and relevance concerning the characteristics of MRI-US Fusion and its clinical application. 3 of them were original clinical studies and the other 3 were review papers that comprehensively cover the publications, relevant devices and application in the market and academic area. The 2 statements were made by physicians who had experiences with our devices.
After evaluation, it is clear that overall operating principle of UroFusion is the same or very similar as those commercial products in the market. When such modelling software is not available, the urologist can only do systematic, random or blind sampling of prostate compared to having a fused MRI-ultrasound model where the urologist can execute biopsy on the planned biopsy sites.
There were also no adverse complications noted in the 6 papers.
In conclusion, given the prior clearances of similar image processing products, extensive global clinical use of MRI-ultrasound coupling, completed verification testing and engineering bench testing that have not raised new questions of safety or effectiveness, the clinical evaluation done for UroFusion is sufficient and no clinical trials are required.
Substantial Equivalence Conclusion
Comparison of the intended uses, the technological characteristics, and performance specifications demonstrates the functional equivalence of UroFusion to the predicate device, Multi-Modality Image Fusion (K120187). In addition, based on conformance to standards, development under our quality system, and the engineering and clinical testing provided, Biobot believes that the UroFusion is safe and effective, and performs in a substantially equivalent manner to the predicate device.
§ 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).