(169 days)
No
The summary describes standard image processing techniques like registration, fusion, segmentation, and rendering, but does not mention AI, ML, or any related concepts like deep learning or neural networks. The performance studies also focus on traditional metrics and phantom testing, not AI/ML validation methods.
No.
This device is a software application designed for image visualization, registration, and fusion to aid in planning prostate biopsies, not to directly treat a medical condition.
No
The device is described as a software application for visualization, image registration, and fusion of medical images to assist in planning procedures, specifically targeted biopsies. It does not provide a diagnosis itself.
Yes
The device description explicitly states that the iSR'obot MRI-US Fusion is a "software application" and can be deployed on "commercially available computer platforms." While it interacts with imaging modalities and another device (iSR'obot Mona Lisa), its core function and description are solely focused on the software processing and fusion of image data.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The iSR'obot MRI-US Fusion software processes and fuses medical images (MRI and Ultrasound) taken from the body. It does not analyze specimens taken from the body.
- Intended Use: The intended use is for visualization, image registration, and fusion of images for mapping planning information of the prostate gland and region of interest. This is an image processing and planning tool, not a diagnostic test performed on a biological sample.
- Device Description: The description focuses on image processing, 3D modeling, and fusion of image data. It does not mention any analysis of biological specimens.
- Mentions image processing: The mention of "21 CFR 892.2050, System, Image Processing, Radiological" further reinforces that this device falls under the category of radiological image processing systems, not IVDs.
Therefore, the iSR'obot MRI-US Fusion is a medical device used for image processing and planning, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance, Ultrasound
Anatomical Site
prostate gland
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinicians, Radiologist / clinic or hospital
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)
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.
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. There were also no adverse complications noted in the 6 papers.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, formed by three overlapping human profiles.
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.
1
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
2
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) |
|---|---|
| ------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
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 Ltd |
| 2 Woodlands Spectrum I, | |
| #03-10 Woodlands Sector 1, | |
| Singapore 738068 | |
| Primary Contact: | Lai Chee Liew |
| Head of Quality, Regulatory Affairs | |
| Biobot Surgical Pte Ltd | |
| Telephone: +65 63511868 | |
| E-mail: laichee@zicomgroup.com | |
| Secondary Contact: | Thum Ee Lin |
| Assistant Manager, Regulatory Affairs | |
| Biobot Surgical Pte Ltd | |
| Telephone: +65 63511868 | |
| E-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 / Design | |
| Location: | Biobot Surgical Pte Ltd |
| 2 Woodlands Spectrum I, #03-10 Woodlands Sector 1, | |
| Singapore 738068 | |
| Manufacturing Location(s): | Biobot Surgical Pte Ltd |
| 2 Woodlands Spectrum I, #03-10 Woodlands Sector 1, | |
| Singapore 738068 | |
| Distributor: | Biobot Surgical Pte Ltd |
| 2 Woodlands Spectrum I, #03-10 Woodlands Sector 1, | |
| Singapore 738068 |
4
Image /page/4/Picture/1 description: The image shows the text "510(k) Premarket Notification Submission - iSR'obot MRI-US fusion". The text appears to be the title or heading of a document or presentation. The text is black and is on a white background. The text is centered on the image.
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.
5
Image /page/5/Picture/1 description: The image shows the logo for Biobot. The word "biobot" is written in a sans-serif font. The "bio" part of the word is in orange, and the "bot" part is in blue. There is a small black dot above the "i" in "bio."
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:
| Hardware
| Platform | CPU Type | CPU Frequency | Disk Space | Memory | Others |
|---|---|---|---|---|---|
| Desktop or | |||||
| Laptop | |||||
| Computers | 32-bit or 64- | ||||
| bit | 1 GHz and above | ≥ 15 GB | |||
| Hard disk | |||||
| space | ≥ 8 GB | USB 2.0 | |||
| interface or | |||||
| CD/DVD Rom |
The components external to UroFusion software are:
| Mona Lisa Ultrasound
Scanning & Modelling | This module is part of the iSR'obot Mona Lisa
system that will provide the ultrasound
information needed to generate the US-3D
model information |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Mona Lisa Biopsy Planning | This module is part of Mona Lisa system that will
provide for planning and execution of prostate
biopsies |
The UroFusion is designed and verified to work with iSR'obot Mona Lisa (K130944).
6
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-modality
Image Fusion | Proposed Device:
iSR'obot MRI-US
Fusion | Discussion
of
Similarities |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Eigen | Biobot | |
| 510(k) number | K120187 | Pending | |
| Where Used | Office settings in clinic
or hospital | Office settings in clinic
or hospital | Same |
| Software Device | Yes | Yes | Same |
| Image Registration | Multi-modality
image registration | Multi-modality
image registration | Same |
| System
composition | Offline software and
online software | Offline software and
online software | Same |
| | Predicate Device:
Multi-modality
Image Fusion | Proposed Device:
iSR'obot MRI-US
Fusion | Discussion
of
Similarities |
| Workflow | User first uses offline
software to import
MRI/CT DICOM data
to prepare prostate
contours and mark
area of interest. Then
user uses online
software to fuse
prepare MRI/CT
images to Ultrasound
images. | User first uses offline
software to import
MRI DICOM data to
prepare prostate
contours and mark
area of interest.
Then user uses online
software to fuse
prepare MRI images
to Ultrasound images. | Same |
| Data Acquisition | DICOM import for
MRI images for
offline software;
snapshot of
Ultrasound images
for offline software. | DICOM import for
MRI images for
offline software;
snapshot of
Ultrasound images
for offline software. | Same |
| Image
Fusion/Overlay
Display | Fused overlay of
images from multiple
modalities | Fused overlay of
images from multiple
modalities | Same |
| Opacity Control | Yes | Yes | Same |
| 3-D Rendering | Yes | Yes | Same |
| Surface Rendering | Yes | Yes | Same |
| Region of Interest | Yes | Yes | Same |
| Configurable
Image Layouts | Yes | Yes | Same.
User can
choose to
see different
slice of
image stack
in any view
of the
transversal,
sagittal and
coronal
views. |
| | Predicate Device:
Multi-modality
Image Fusion | Proposed Device:
iSR'obot MRI-US
Fusion | Discussion
of
Similarities |
| 3-D Contours
for Planning | Yes | Yes | Same.
User can
define 3-D
contours of
prostate and
area of
interest,
which can be
used for
biopsy
planning. |
| Export of 3D
contours for
planning | Yes | Yes | Same. |
| Image Storage
and
Communication | Yes | Yes | Same. |
| Modalities | CT, MR, Ultrasound | MRI, Ultrasound | This device
is tested for
MRI and
Ultrasound
modalities.
This
difference
did not raise
new safety
and
effectiveness
concerns. |
| Image
Construction | Full 3-D image
construction from
image slices. | Full 3-D image
construction from
image slices. | Same |
| | Predicate Device:
Multi-Modality Image
Fusion - K120187 | Proposed Device:
MRI- US Fusion
Software | Discussion |
| Intended Use | The software is intended
for 2-D and 3-D
visualization, image
registration, and fusion of
MRI, CT and Ultrasound
imaging modalities. | 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. | Same |
The table below outlines the major subsystem differences and similarities.
Image /page/6/Picture/11 description: The image shows the logo for Biobot Analytics. The logo consists of the word "biobot" in a sans-serif font. The "bio" portion of the word is in orange, while the "bot" portion is in blue. There is a small orange circle above the "i" in "bio".
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Image /page/7/Picture/1 description: The image shows the logo for Biobot Analytics. The logo features the word "biobot" in a sans-serif font, with the "bio" portion in a bright orange color and the "bot" portion in a dark blue color. To the left of the word "biobot" is an orange oval shape, which appears to be a stylized representation of a cell or droplet.
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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Image /page/10/Picture/1 description: The image shows the word "biobot" in a stylized font. The "bio" part of the word is in a gradient orange color, while the "bot" part is in blue. The "o" in "bio" is shaped like an oval, with the orange gradient going from light to dark from left to right.
510(k) Premarket Notification Submission - iSR'obot MRI-US fusion
| | Predicate Device:
Multi-Modality Image
Fusion - K120187 | Proposed Device:
MRI- US Fusion
Software | Discussion |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | Multi-Modality Image
Fusion is a software
application to be used
by physicians in the
clinic or hospital for 2- D
and 3-D visualization,
image registration, and
fusion of MRI, CT and
Ultrasound imaging
modalities for mapping
planning information
across modalities.
Additional software
features include
database management,
data communication,
surface rendering,
segmentation, regions
of interest (ROI)
delineation, volumetric
measurements, and
data reporting. | 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 | Substantially
Equivalent
The
indication for
use of the
MRI-US
Fusion
Software
system is
substantially
equivalent to
the predicate
device's
indication for
use. The ROI
information is
mapped to
Ultrasound
modality. |
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.
11
510(k) Premarket Notification Submission - iSR'obot MRI-US fusion
Image /page/11/Picture/2 description: The image shows the logo for Biobot. The logo features the word "biobot" in a stylized, lowercase font. The "bio" portion of the word is in blue, while the "bot" portion is in orange. A stylized orange circle is behind the word "bio".
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.