Navigo Workstation Version 2.0

K173054 · UC-CARE , Ltd. · LLZ · Jan 16, 2018 · Radiology

Device Facts

• Record ID: K173054
• Device Name: Navigo Workstation Version 2.0
• Applicant: UC-CARE , Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Jan 16, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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 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.

Device Story

Navigo Workstation Version 2.0 is an adjunctive image-guided system for prostate procedures. It inputs live 2D ultrasound video and pre-operative DICOM images (MRI/CT). The system tracks the ultrasound probe and interventional tools (needle, catheter, grid plate) using electromagnetic tracking. It transforms these inputs by fusing DICOM data with real-time ultrasound, creating a 3D prostate model, and calculating tool trajectories relative to defined Regions of Interest (ROIs). The physician operates the workstation in a clinical setting to visualize the target organ, projected tool paths, and patient movement compensation. Output is displayed on a monitor, allowing the physician to guide needles into targets. The device aids in treatment planning and interventional accuracy, potentially improving biopsy and ablation outcomes. It supports manual adjustments for fusion and model alignment.

Clinical Evidence

Bench testing only. Evaluated 2D-to-3D manual correction, CT compatibility, and MRI fusion accuracy using prostate phantoms. Accuracy defined as location error between targeted and actual needle position (measured via post-procedure CT). All results met the <3mm location error requirement.

Technological Characteristics

Workstation-based system; electromagnetic tracking; DICOM connectivity (PACS/intranet); Windows OS; supports trans-rectal and trans-perineal ultrasound probes. Features include 3D model reconstruction, multiplanar reconstruction (MPR), image fusion, and manual motion compensation. Software includes image state algorithms for parameter detection.

Indications for Use

Indicated for physicians in clinical or hospital settings for 2D/3D visualization of prostate ultrasound images, image fusion (MRI/CT), and guidance of interventional tools (needles, catheters, probes) during diagnostic and interventional procedures including biopsies, ablations, and fiducial marker placement.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Navigo Workstation (K160934)
• Uronav (Version 2.0) (K153073)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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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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# 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: [phone] ext. 656 Facsimile: [phone] 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

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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

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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.

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## 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.

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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<br>Version 2.0 | Navigo Workstation<br>(K160934) | Uronav (Version<br>2.0) (K153073) |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The UC-Care Navigo<br>Workstation is an<br>adjunctive tool for<br>ultrasound guided<br>procedures and is<br>intended to be used by<br>physicians in the clinic<br>or hospital for 2-D and<br>3-D visualization of<br>ultrasound images of<br>the prostate gland. The<br>Navigo Workstation<br>offers the ability to fuse<br>DICOM originated<br>information (e.g. MRI,<br>CT) with the ultrasound<br>images and thus<br>superimposes<br>information from one<br>modality onto the other.<br>It also provides the<br>ability to display a<br>simulated image of a<br>tracked insertion tool<br>such as a needle, guide<br>wire, catheter, grid plate<br>or probe on a computer<br>monitor screen that<br>shows images of the<br>target organ and the<br>current and the<br>projected future path of<br>the interventional<br>instrument taking into<br>account patient<br>movement. Additional<br>software features<br>include patient data | The UC-Care Navigo<br>Workstation is an<br>adjunctive tool for<br>ultrasound guided<br>procedures and is<br>intended to be used by<br>physicians in the<br>clinic or hospital for 2-<br>D and 3-D<br>visualization of<br>ultrasound images of<br>the prostate gland.<br>The Navigo<br>Workstation offers the<br>ability to fuse DICOM<br>originated information<br>(e.g. MRI) with the<br>ultrasound images<br>and thus<br>superimpose<br>information from one<br>modality onto the<br>other. Additional<br>software features<br>include patient data<br>management, multi-<br>planar reconstruction,<br>segmentation, image<br>measurement and 3-<br>D image registration.<br>The device is<br>specifically indicated<br>to provide information<br>on regional<br>orientation within the<br>prostate to assist<br>needle targeted<br>procedures (e.g. | UroNav is a<br>stereotaxic accessory<br>for image-guided<br>interventional and<br>diagnostic procedures<br>of the prostate gland.<br>It provides 2D and 3D<br>visualization of<br>Ultrasound (US)<br>images and the ability<br>to fuse and register<br>these images with<br>those from other<br>imaging modalities<br>such as Magnetic<br>Resonance (MR),<br>Computed<br>Tomography, etc.<br>It also provides the<br>ability to display a<br>simulated image of a<br>tracked insertion tool<br>such as a biopsy<br>needle, guidewire,<br>gridplate or probe on<br>a computer monitor<br>screen that shows<br>images of the target<br>organ and the current<br>and the projected<br>future path of the<br>interventional<br>instrument taking into<br>account patient<br>movement. Other<br>software features<br>include patient data |
| | management,<br>multiplanar<br>reconstruction,<br>segmentation, image<br>measurement and 3-D<br>image registration, as<br>well as storage and<br>future retrieval of this<br>information<br><br>Navigo is intended for<br>treatment planning and<br>guidance for clinical,<br>interventional and/or<br>diagnostic procedures.<br>The device is intended<br>to be used in<br>interventional and<br>diagnostic procedures in<br>a clinical setting.<br>Example procedures<br>include, but are not<br>limited to image fusion<br>for diagnostic clinical<br>examinations and<br>procedures, soft tissue<br>biopsies, soft tissue<br>ablations and placement<br>of fiducial markers. | biopsy) regions of<br>interest display,<br>procedures planning<br>and, reconstruction of<br>a 3D rendered<br>surface model of the<br>prostate display<br>needle locations that<br>have been selected<br>by the physician, as<br>well as storage and<br>future retrieval of this<br>information. | management, multi-<br>planar reconstruction,<br>segmentation, image<br>measurements and<br>2D/3D image<br>registration.<br><br>UroNav is intended<br>for treatment planning<br>and guidance for<br>clinical, interventional<br>and/or diagnostic<br>procedures.<br>The device is intended to<br>be used in<br>interventional and<br>diagnostic procedures<br>in a clinical setting.<br>Example procedures<br>include, but are not<br>limited to image<br>fusion for diagnostic<br>clinical examinations<br>and procedures, soft<br>tissue biopsies, soft<br>tissue ablations and<br>placement of fiducial<br>markers. |
| Product Code | LLZ | LLZ | LLZ |
| Device Classification | System, Image<br>Processing,<br>Radiological | System, Image<br>Processing,<br>Radiological | System, Image<br>Processing,<br>Radiological |
| Target Anatomy | prostate | prostate | prostate |
| Anatomical Access | Transrectal & Trans-<br>perineal | Transrectal | Transrectal & Trans-<br>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<br>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<br>(MPR) | Yes | Yes | Yes |
| Motion Compensation | | | |
| Reference sensor | Yes | Yes | No |
| Connectivity | |…