(110 days)
No
The description focuses on image fusion, tracking, and basic image processing algorithms, but does not mention AI or ML. The "image state algorithms" described appear to be rule-based or deterministic rather than learned.
No
The device is described as an "adjunctive tool" for visualization, guidance, and planning for diagnostic and interventional procedures. It assists physicians by providing orientation, 3D models, and tracking, but it does not directly perform any therapeutic action or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "Navigo is intended for treatment planning and guidance for clinical, interventional and/or diagnostic procedures." It also mentions "image fusion for diagnostic clinical examinations and procedures." Additionally, the "Description of the training set, sample size, data source, and annotation protocol" refers to prostate phantoms used for "CT Compatibility test" and "Navigo Fusion Accuracy testing" which are diagnostic procedures.
No
The device description explicitly states that the Navigo Workstation Version 2.0 "connects to the video output of the ultrasound system" and "is equipped with tools to manipulate (rotate, pan, zoom) the model, and to archive and retrieve the information". While the core functionality is software-based image processing and fusion, it requires a physical connection to an ultrasound system and includes hardware components (the workstation itself) for display, manipulation, and storage. It is not solely software running on general-purpose computing hardware.
Based on the provided information, the UC-Care Navigo Workstation is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Navigo Workstation's Function: The Navigo Workstation is a tool for image guidance and planning during medical procedures. It processes and displays medical images (ultrasound, MRI, CT) and assists physicians in visualizing anatomical structures and guiding instruments. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's an "adjunctive tool for ultrasound guided procedures" and for "treatment planning and guidance for clinical, interventional and/or diagnostic procedures." This focuses on image-based guidance and planning, not the analysis of biological samples.
- Device Description: The description details how it processes and displays images, tracks instruments, and manages patient data related to imaging and procedures. It does not mention any analysis of biological specimens.
Therefore, the Navigo Workstation falls under the category of medical imaging and surgical guidance devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The UC-Care Navigo Workstation is an adjunctive tool for ultrasound guided procedures and is intended to be used by physicians in the clinic or hospital for 2-D and 3-D visualization of ultrasound images of the prostate gland. The Navigo Workstation offers the ability to fuse DICOM originated information (e.g. MRI, CT) with the ultrasound images and thus superimposes information from one modality onto the other. It also provides the ability to display a simulated insertion tool such as a needle, guide wire, catheter, grid plate or probe on a computer monitor screen that shows iman and the current and the projected future path of the interventional instrument. taking into account patient movement. Additional software include patient data management, multiplanar reconstruction, segmentation, image measurement and 3-D image registration, as well as storage and future retrieval of this information.
Navigo is intended for treatment planning and clinical, interventional and/or diagnostic procedures. The device is intended to be used in interventional and diagnostic procedures in a clinical setting. Example procedures include, but are not limited to image fusion for diagnostic clinical examinations and procedures, soft tissue ablations and placement of fiducial markers.
Product codes
LLZ
Device Description
The Navigo Workstation Version 2.0 is an adjunctive tool in the management of prostate diagnostic and interventional procedures. The Navigo Workstation Version 2.0 allows prostate needle tracking, recording, and management solution. The Navigo Workstation Version 2.0 is designed to assist the physician in performing prostate diagnostic and interventional procedures by providing regional orientation information, displaying a 3D model with real-time tracking and recording of the needle location. The Navigo Workstation Version 2.0 offers the ability to fuse DICOM originated information (e.g. MRI, CT) with the ultrasound images and thus superimposes information from one modality onto the . The device includes means to compensate for patient body and prostate motion at any time during the procedure.
The Navigo Workstation Version 2.0 is designed to work with standard trans-rectal / transperineal ultrasound systems and biopsy setup without changing or interfering with the physician's existing workflow. The Navigo Workstation Version 2.0 connects to the video output of the ultrasound system and by tracking the ultrasound probe's position, the recorded 2D ultrasound images are transferred to the Navigo Workstation Version 2.0 for viewing and creation of a 3D model. As with any other procedure, the US probe is used together with a standard disposable cover sheath supplied by the user.
Two dimensional (2D) images and the 3D model of the prostate are displayed on the Navigo Workstation Version 2.0's screen. The Navigo Workstation Version 2.0 is equipped with tools to manipulate (rotate, pan, zoom) the model, and to archive and retrieve the information for further use.
The tracking and recording enables display of an accurate 3D model of the prostate and to record needle locations on the model. Pathology diagnosis results may be updated on the 3D model and a color display representation provides a visual display of the pathology results.
The Navigo Workstation Version 2.0 supports the display of ROIs on the 3D model and displays visual indication when the needle trajectory intersects with an ROI (Region Of Interest) is defined by the physician by segmenting a portion of the prostate on a 2D image and displaying its location on the 3D model, thereby defining a portion of the prostate as a target to direct a needle within. The 2D images for segmentation of the ROI can be either a frozen Ultrasound image or a DICOM compliant image from another imaging study completed prior to the Ultrasound procedure (e.g. MR,CT).The ROls are clearly numbered and labeled by a letter symbolizing its origin (Ultrasound or DICOM). On each image, more than one ROI may be defined (segmented).
The live 2D ultrasound image is superimposed in real-time with the 2D ROI boundaries thus allowing the physician to see the real-time advancement of the needle on the live ultrasound image with reference to ROI boundaries. The 3D model is displayed on a separate window alongside the ultrasound's live continuous images display, allowing prostate 3D orientation.
Regardless of the type of ultrasound probe used for the procedure (side-fire or end-fire) a cannula for a needle is built within the outer shell of the probe and therefore a needle can be inserted through the designated cannula. The designated cannula defines the needle path along its trajectory. The needle trajectory is displayed on the 3D model representing the potential needle route to allow the physician to direct the needle in real time into the target. When the projected path intersects with an ROI, the ROI will change indicating the needle can be directed inside the ROI if the physician ensures that the needle is inserted deep enough. In trans-perineal procedures the grid-plate sensor is placed on the grid base via a fixator; the sensor tracks the grid location during the procedure and enables the Navigo Workstation Version 2.0 to present in real time the optional trajectories locations. During the procedure, the physician may change some of the parameters on the US system or perform different actions that require the Navigo Workstation Version 2.0 to adjust. A physician may wish to freeze an image and perform measurements, label the image and save it to the report, switch between transversal and longitudinal view, or change the view of the ultrasound image. The Navigo Workstation Version 2.0 is equipped with image state algorithms to automatically detect the change in parameters and adjust itself to the new parameters. For example, if the physician freezes the US image, the Navigo Workstation Version 2.0 will automatically present additional menu option for a frozen image like measurements tools and labeling. The image state algorithm was developed to support generic ultrasound parameters and is specifically tested for each new ultrasound system model the Navigo Workstation Version 2.0 is required to support. In case of auto-detection failure, the user is informed and asked to confirm or manually change the detected parameters In order to continue.
In off-line mode, the Navigo Workstation Version 2.0 software further enables the physician to analyze previous procedures using the prostate model, update the 3D model if necessary. update the recorded biopsies' locations, generate reports, and provides a DICOM (MRI/CT) interface for ROI definition, 3D model display, and data communication.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound, MRI, CT
Anatomical Site
prostate gland
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians in the 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)
The performance characteristics of the Navigo Workstation Version 2.0 and its compliance with the applicable recognized standards were evaluated through the following testing:
- Software verification and validation testing
- Electrical safety testing
- EMC testing
Bench Testing:
- 2D to 3D Correction (Manual adjustment): Testing performed using a prostate phantom. A simulated shift was performed with the phantom, and the Navigo software was used to correct the shift. The location error of fusion ROIs in the model relative to their location in the US image were evaluated by measuring the distance between the US lesion center and ROI overlay center (i.e. location error). For all working scenarios (simple procedure, fusion and alignment with historic procedures), the manual adjustment enabled to overcome deviations in model location during procedure and return the model to the correct location within the required 3mm accuracy level.
- CT Compatibility: Testing performed using prostate phantom. Phantoms were scanned both on MRI and on CT. For each phantom the DICOM CT series and MRI (T2) series were loaded in Navigo Fusion studio. Images from apex to base were selected and segmented. The 3D models generated by Navigo based on MRI and CT images were compared to evaluate volumes of the two models, the average gap between the surfaces (RMSE) and the maximum distance (local maximum). The results establish that the 3D models created from MRI data are equal to the equivalent 3D models created from the CT data within the acceptance criteria. It can be concluded that the Navigo Workstation Version 2.0 is compatible with CT DICOM data.
- Navigo Fusion Accuracy testing – Trans-perineal Approach: Testing performed using two phantoms each containing randomly located isoechoic lesions. MRI scanning of the phantom was performed and loaded into the Navigo fusion studio, contours of the prostate and the lesions were marked. Trans-perineal Ultrasound (BK Flex focus, 8848) scan was then performed using the Navigo Workstation Version 2.0. 3 biopsy needles were then targeted into each lesion by inserting the needle to the suggested trajectories. A 1 mm CT scan was performed post procedure to visualize the inserted needles within the isoechoic lesions. Accuracy was defined as the difference between the actual needle location as measured on CT and the targeted location as measured on the real time US images. All obtained results demonstrate that the accuracy of the MRI fusion performed by the Navigo Workstation Version 2.0 when used with the trans-perineal approach meets the requirements of a location error
§ 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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 16, 2018
UC-Care Ltd. % John Smith, M.D., J.D. Partner Hogan Lovells US LLP 555 13th Street NW WASHINGTON DC 20004
Re: K173054
Trade/Device Name: Navigo Workstation Version 2.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 19, 2017 Received: December 19, 2017
Dear Dr. Smith:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
For
Robert Ochs, Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
510(k) Number (if known) K173054
Device Name
Navigo Workstation Version 2.0.
Indications for Use (Describe)
The UC-Care Navigo Workstation is an adjunctive tool for ultrasound guided procedures and is intended to be used by physicians in the clinic or hospital for 2-D and 3-D visualization of ultrasound images of the Navigo Workstation offers the ablity to fuse DICOM originated information (e.g. MRI, CT) with the ultrasound images and thus superimposes information from one modality onto the other. It also provides the ability to display a simulated insertion tool such as a needle, guide wire, catheter, grid plate or probe on a computer monitor screen that shows iman and the current and the projected future path of the interventional instrument. taking into account patient movement. Additional software include patient data management, multiplanar reconstruction, segmentation, image measurement and 3-D image registration, as well as storage and future retrieval of this information.
Navigo is intended for treatment planning and clinical, interventional and/or diagnostic procedures. The device is intended to be used in interventional and diagnostic procedures in a clinical setting. Example procedures include, but are not limited to image fusion for diagnostic clinical examinations and procedures, soft tissue ablations and placement of fiducial markers.
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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3
510(k) SUMMARY UC-Care Ltd.'s Navigo Workstation Version 2.0
Submitter
UC-Care Ltd. Apollo Bldg., New Industrial Zone P.O.Box 67 Yokneam 20692, Israel Phone: +972-4-909-7427 ext. 656 Facsimile: +972-4-993-7323 Contact Person: Hadas Sheynise
Date Prepared: 29 September 2017
Name of Device: Navigo Workstation Version 2.0
Common or Usual Name: Navigo Workstation Version 2.0
Classification Name: Picture archiving and communications system
Regulatory Class: Il
Regulation Number: 21 CFR 892.2050
Product Code: LLZ
Predicate Devices
UC-Care Ltd.'s Navigo Workstation K160934
InVivo Corporation's Uronav (Version 2.0) K153073
Device Description
The Navigo Workstation Version 2.0 is an adjunctive tool in the management of prostate diagnostic and interventional procedures. The Navigo Workstation Version 2.0 allows prostate needle tracking, recording, and management solution. The Navigo Workstation Version 2.0 is designed to assist the physician in performing prostate diagnostic and interventional procedures by providing regional orientation information, displaying a 3D model with real-time tracking and recording of the needle location. The Navigo Workstation Version 2.0 offers the ability to fuse DICOM originated information (e.g. MRI, CT) with the ultrasound images and thus superimposes information from one modality onto the . The
4
device includes means to compensate for patient body and prostate motion at any time during the procedure.
The Navigo Workstation Version 2.0 is designed to work with standard trans-rectal / transperineal ultrasound systems and biopsy setup without changing or interfering with the physician's existing workflow. The Navigo Workstation Version 2.0 connects to the video output of the ultrasound system and by tracking the ultrasound probe's position, the recorded 2D ultrasound images are transferred to the Navigo Workstation Version 2.0 for viewing and creation of a 3D model. As with any other procedure, the US probe is used together with a standard disposable cover sheath supplied by the user.
Two dimensional (2D) images and the 3D model of the prostate are displayed on the Navigo Workstation Version 2.0's screen. The Navigo Workstation Version 2.0 is equipped with tools to manipulate (rotate, pan, zoom) the model, and to archive and retrieve the information for further use.
The tracking and recording enables display of an accurate 3D model of the prostate and to record needle locations on the model. Pathology diagnosis results may be updated on the 3D model and a color display representation provides a visual display of the pathology results.
The Navigo Workstation Version 2.0 supports the display of ROIs on the 3D model and displays visual indication when the needle trajectory intersects with an ROI (Region Of Interest) is defined by the physician by segmenting a portion of the prostate on a 2D image and displaying its location on the 3D model, thereby defining a portion of the prostate as a target to direct a needle within. The 2D images for segmentation of the ROI can be either a frozen Ultrasound image or a DICOM compliant image from another imaging study completed prior to the Ultrasound procedure (e.g. MR,CT).The ROls are clearly numbered and labeled by a letter symbolizing its origin (Ultrasound or DICOM). On each image, more than one ROI may be defined (segmented).
The live 2D ultrasound image is superimposed in real-time with the 2D ROI boundaries thus allowing the physician to see the real-time advancement of the needle on the live ultrasound image with reference to ROI boundaries. The 3D model is displayed on a separate window alongside the ultrasound's live continuous images display, allowing prostate 3D orientation.
Regardless of the type of ultrasound probe used for the procedure (side-fire or end-fire) a cannula for a needle is built within the outer shell of the probe and therefore a needle can be inserted through the designated cannula. The designated cannula defines the needle path along its trajectory. The needle trajectory is displayed on the 3D model representing the potential needle route to allow the physician to direct the needle in real time into the target. When the projected path intersects with an ROI, the ROI will change indicating the needle can be directed inside the ROI if the physician ensures that the needle is inserted deep enough. In trans-perineal procedures the grid-plate sensor is placed on the grid base via a fixator; the sensor tracks the grid location during the procedure and enables the Navigo Workstation Version 2.0 to present in real time the optional trajectories locations. During the procedure, the physician may change some of the parameters on the US system or perform
5
different actions that require the Navigo Workstation Version 2.0 to adjust. A physician may wish to freeze an image and perform measurements, label the image and save it to the report, switch between transversal and longitudinal view, or change the view of the ultrasound image. The Navigo Workstation Version 2.0 is equipped with image state algorithms to automatically detect the change in parameters and adjust itself to the new parameters. For example, if the physician freezes the US image, the Navigo Workstation Version 2.0 will automatically present additional menu option for a frozen image like measurements tools and labeling. The image state algorithm was developed to support generic ultrasound parameters and is specifically tested for each new ultrasound system model the Navigo Workstation Version 2.0 is required to support. In case of auto-detection failure, the user is informed and asked to confirm or manually change the detected parameters In order to continue.
In off-line mode, the Navigo Workstation Version 2.0 software further enables the physician to analyze previous procedures using the prostate model, update the 3D model if necessary. update the recorded biopsies' locations, generate reports, and provides a DICOM (MRI/CT) interface for ROI definition, 3D model display, and data communication.
Intended Use / Indications for Use
The UC-Care Navigo Workstation is an adjunctive tool for ultrasound guided procedures and is intended to be used by physicians in the clinic or hospital for 2-D and 3-D visualization of ultrasound images of the prostate gland. The Navigo Workstation offers the ability to fuse DICOM originated information (e.g. MRI, CT) with the ultrasound images and thus superimposes information from one modality onto the other.
It also provides the ability to display a simulated image of a tracked insertion tool such as a needle, guide wire, catheter, grid plate or probe on a computer monitor screen that shows images of the target organ and the current and the projected future path of the interventional instrument taking into account patient movement. Additional software features include patient data management, multiplanar reconstruction, segmentation, image measurement and 3-D image registration, as well as storage and future retrieval of this information.
Navigo is intended for treatment planning and quidance for clinical, interventional and/or diagnostic procedures. The device is intended to be used in interventional and diagnostic procedures in a clinical setting. Example procedures include, but are not limited to image fusion for diagnostic clinical examinations and procedures, soft tissue biopsies, soft tissue ablations and placement of fiducial markers.
6
Summary of Technological Characteristics
The subject NaviGo™ Workstation Version 2.0 and the primary predicate, the NaviGo™ Workstation have the same general intended use, namely visualization of the prostate during an ultrasound procedure. The indications for use language has been updated for consistency with the UroNav predicate.
The NaviGo Workstation Version 2.0 is substantially similar to cleared Navigo in terms of technological characteristics and principles of operation. Both devices have the same following technological characteristics::
- To assist the physician by transfer and display of ultrasound images on the workstation screen
- . To provide regional orientation information during prostate procedures
- To build, display and manipulate a 3D model of the prostate on screen .
- . To define the physician's ROIs (Regions Of Interest) and display them on the 3D model
- . To archive procedure data and report generating
- . To provide data management solutions
- To track, display and record trajectories
- . To display the scanning history, including pathology analyses
- . To retrieve and display DICOM compliant information
- . To fuse DICOM compliant originated regions of interest with the ultrasound 2D and 3D information
Several modifications have been made from the primary predicate device, including the following:
The physician can now upload MR and CT DICOM studies from PACS and also from the hospital intranet file server to the Navigo workstation. . No modification of the original source documents on the intranet server is possible. Also, with this change it is possible to backup data from the Navigo workstation to the hospital intranet file server.
Addition of optional automatic segmentation and as a result the removal of the illustration model option.
Real-time prostate model overlay on the live US image with the ability to perform manual adjustments.
Addition of a Fusion review option which allows the physician to inspect the fusion result and make manual adjustments if needed.
Display of the US image parameters with manual setting capability.
7
The Navigo Workstation Version 2.0 includes a support to trans-perineal biopsy and an option for manual compensation procedure when it is not possible to use the reference sensor (e.g. Lithotomic position).
A table comparing the key features of the subject and predicate devices is provided below.
| | Navigo Workstation
Version 2.0 | Navigo Workstation
(K160934) | Uronav (Version
2.0) (K153073) |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The UC-Care Navigo
Workstation is an
adjunctive tool for
ultrasound guided
procedures and is
intended to be used by
physicians in the clinic
or hospital for 2-D and
3-D visualization of
ultrasound images of
the prostate gland. The
Navigo Workstation
offers the ability to fuse
DICOM originated
information (e.g. MRI,
CT) with the ultrasound
images and thus
superimposes
information from one
modality onto the other.
It also provides the
ability to display a
simulated image of a
tracked insertion tool
such as a needle, guide
wire, catheter, grid plate
or probe on a computer
monitor screen that
shows images of the
target organ and the
current and the
projected future path of
the interventional
instrument taking into
account patient
movement. Additional
software features
include patient data | The UC-Care Navigo
Workstation is an
adjunctive tool for
ultrasound guided
procedures and is
intended to be used by
physicians in the
clinic or hospital for 2-
D and 3-D
visualization of
ultrasound images of
the prostate gland.
The Navigo
Workstation offers the
ability to fuse DICOM
originated information
(e.g. MRI) with the
ultrasound images
and thus
superimpose
information from one
modality onto the
other. Additional
software features
include patient data
management, multi-
planar reconstruction,
segmentation, image
measurement and 3-
D image registration.
The device is
specifically indicated
to provide information
on regional
orientation within the
prostate to assist
needle targeted
procedures (e.g. | UroNav is a
stereotaxic accessory
for image-guided
interventional and
diagnostic procedures
of the prostate gland.
It provides 2D and 3D
visualization of
Ultrasound (US)
images and the ability
to fuse and register
these images with
those from other
imaging modalities
such as Magnetic
Resonance (MR),
Computed
Tomography, etc.
It also provides the
ability to display a
simulated image of a
tracked insertion tool
such as a biopsy
needle, guidewire,
gridplate or probe on
a computer monitor
screen that shows
images of the target
organ and the current
and the projected
future path of the
interventional
instrument taking into
account patient
movement. Other
software features
include patient data |
| | management,
multiplanar
reconstruction,
segmentation, image
measurement and 3-D
image registration, as
well as storage and
future retrieval of this
information
Navigo is intended for
treatment planning and
guidance for clinical,
interventional and/or
diagnostic procedures.
The device is intended
to be used in
interventional and
diagnostic procedures in
a clinical setting.
Example procedures
include, but are not
limited to image fusion
for diagnostic clinical
examinations and
procedures, soft tissue
biopsies, soft tissue
ablations and placement
of fiducial markers. | biopsy) regions of
interest display,
procedures planning
and, reconstruction of
a 3D rendered
surface model of the
prostate display
needle locations that
have been selected
by the physician, as
well as storage and
future retrieval of this
information. | management, multi-
planar reconstruction,
segmentation, image
measurements and
2D/3D image
registration.
UroNav is intended
for treatment planning
and guidance for
clinical, interventional
and/or diagnostic
procedures.
The device is intended to
be used in
interventional and
diagnostic procedures
in a clinical setting.
Example procedures
include, but are not
limited to image
fusion for diagnostic
clinical examinations
and procedures, soft
tissue biopsies, soft
tissue ablations and
placement of fiducial
markers. |
| Product Code | LLZ | LLZ | LLZ |
| Device Classification | System, Image
Processing,
Radiological | System, Image
Processing,
Radiological | System, Image
Processing,
Radiological |
| Target Anatomy | prostate | prostate | prostate |
| Anatomical Access | Transrectal & Trans-
perineal | Transrectal | Transrectal & Trans-
perineal |
| Software | | | |
| Windows O.S. | Yes | Yes | Yes |
| Medical Imaging Software | Yes | Yes | Yes |
| Image Display | | | |
| Multi-Modality Support | Yes | Yes | Yes |
| General Image 2D/3D
Review | Yes | Yes | Yes |
| 3D Rendering View | Yes | Yes | Yes |
| Live 2D Ultrasound | Yes | Yes | Yes |
| Image Processing | | | |
| Gland Segmentation | Yes | Yes | Yes |
| Image Registration | Yes | Yes | Yes |
| Rigid Registration | Yes | Yes | Yes |
| Elastic Registration | No | No | Yes |
| Multi-Planar Reformatting
(MPR) | Yes | Yes | Yes |
| Motion Compensation | | | |
| Reference sensor | Yes | Yes | No |
| Connectivity | | | |
| DICOM | Yes | Yes | Yes |
| Ultrasound video | Yes | Yes | Yes |
| Review tools | | | |
| Standard Image Viewing
Tools | Yes | Yes | Yes |
| Measurement Tools | Yes | Yes | Yes |
| Annotation Tools | Yes | Yes | Yes |
| Segmentation Tools | Yes | Yes | Yes |
| Reporting Tools | Yes | Yes | Yes |
| Video Capture | Yes | Yes | Yes |
| Image Overlays | Yes | Yes | Yes |
| Planning & Navigation | | | |
| Import Prior Plans | Yes | Yes | Yes |
| Import / Add Targets | Yes | Yes | Yes |
| Plan / Mark Locations | Yes | Yes | Yes |
| Navigation Type | Electromagnetic | Electromagnetic | Electromagnetic |
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Performance Data
The performance characteristics of the Navigo Workstation Version 2.0 and its compliance with the applicable recognized standards were evaluated through the following testing:
- Software verification and validation testing .
- . Electrical safety testing
- EMC testing
Bench Testing
The following bench studies were performed in order to demonstrate that the Navigo Workstation Version 2.0 meets its specifications and its updated indications for use:
- 2D to 3D Correction (Manual adjustment): In order to validate that the correction defined by moving the model contour on the 2D image enables the user to correct the 3D model location in respect to the real time US image, the following testing was performed using a prostate phantom. A simulated shift was performed with the phantom, and the Navigo software was used to correct the shift. The location error of fusion ROIs in the model relative to their location in the US image were evaluated by measuring the distance between the US lesion center and ROI overlay center (i.e. location error). For all working scenarios (simple procedure, fusion and alignment with historic procedures), the manual adjustment enabled to overcome deviations in model location during procedure and return the model to the correct location within the required 3mm accuracy level.
- . CT Compatibility: In order to validate that the Navigo Workstation Version 2.0 can read correctly the CT data to create a CT 3D model, testing was performed using prostate phantom. Phantoms were scanned both on MRI and on CT. For each phantom the DICOM CT series and MRI (T2) series were loaded in Navigo Fusion studio. Images from apex to base were selected and segmented. The 3D models generated by Navigo based on MRI and CT images were compared to evaluate volumes of the two models, the average gap between the surfaces (RMSE) and the maximum distance (local maximum). The results establish that the 3D models created from MRI data are equal to the equivalent 3D models created from the CT data within the acceptance criteria. Therefore, it can be concluded that the Navigo Workstation Version 2.0 is compatible with CT DICOM data.
- . Navigo Fusion Accuracy testing – Trans-perineal Approach:_To validate the Navigo Workstation Version 2.0 MRI fusion accuracy when used with the trans-perineal approach, testing was performed using two phantoms each containing randomly located isoechoic lesions. MRI scanning of the phantom was performed and loaded into the Navigo fusion studio, contours of the prostate and the lesions were marked. Trans-perineal Ultrasound (BK Flex focus, 8848) scan was then performed using the Navigo Workstation Version 2.0. 3 biopsy needles were then targeted into each
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lesion by inserting the needle to the suggested trajectories. A 1 mm CT scan was performed post procedure to visualize the inserted needles within the isoechoic lesions. Accuracy was defined as the difference between the actual needle location as measured on CT and the targeted location as measured on the real time US images. All obtained results demonstrate that the accuracy of the MRI fusion performed by the Navigo Workstation Version 2.0 when used with the trans-perineal approach meets the requirements of a location error