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iSR'obot Mona Lisa 2.0 is a user-controlled, stereotaxic accessory intended to guide physicians in the planning and positioning of insertion tools, such as a third-party needle or a probe, during image-guided diagnostic and interventional procedures in conjunction with the guidance of transrectal ultrasound involving the prostate gland in a clinical setting. Examples of such procedures include, but are not limited to, image fusion for diagnostic clinical examinations and procedures, soft tissue biopsies, and soft tissue ablations.

The iSR'obot Mona Lisa 2.0 system consists of a workstation, robotic navigation module (comprising of a motorized mechanical robotic arm, bed rail stabilizer or floor stand stabilizer) and disposables. The workstation is installed with application software that provides functions for image processing, image segmentation, 2D/3D visualization to support urologists or physicians in planning needle positions for procedures. The application software (UroBiopsy / UroTherapy) interfaces and controls the robotic arm to position its needle guidance mechanism at a trajectory to allow needle insertion by the physician. Another application software (UroFusion) provides an interface for users to perform contouring of the prostate gland and marking of suspected lesion regions, which can be imported into UroBiopsy or UroTherapy for image fusion during the procedure. The physician is able to review procedural data such as prostate information and model, needle positioning plan and trajectories, number of needles executed, etc., using a utility software (UroReview). A utility software (UroConnect) provides the connectivity solution to a picture archiving and communication system (PACS) server for downloading/uploading DICOM-compatible data. The bed rail stabilizer and floor stand stabilizer provide support for the robotic arm. They are to be attached to the bed rail or mounted on the floor respectively. Sterile disposables are used with iSR'obot Mona Lisa 2.0 during prostate procedures. The system is compatible with commercially available ultrasound systems, transrectal ultrasound bi-plane probes, and commercially available needle devices.

iSR'obot Mona Lisa 2.0 is a user-controlled, stereotaxic accessory intended to guide physicians in the planning and positioning of insertion tools, such as a third-party needle or a probe, during image-guided diagnostic and interventional procedures in conjunction with the guidance of transrectal ultrasound involving the prostate gland in a clinical setting. Examples of such procedures include, but are not limited to, image fusion for diagnostic clinical examinations and procedures, soft tissue biopsies, and soft tissue ablations. The iSR'obot Mona Lisa 2.0 provides 2D and 3D visualization of Ultrasound images and the ability to fuse and register these images with those from other imaging modalities such as Magnetic Resonance, etc. It also provides the ability to display a simulated image of an insertion tool on a computer monitor screen, the target organ, and the current and projected future path of the insertion tool taking into account patient movement. Other software features include multiplanar reconstruction, segmentation, image measurements, 2D/3D image registration, and reporting.

The iSR'obot Mona Lisa 2.0 is user-controlled, stereotaxic accessory intended to guide physicians in the planning and positioning of insertion tools, such as a needle or a probe, during image-guided diagnostic and interventional procedures involving the prostate gland in a clinical setting. The device displays the 2D live image feeds from commercially available ultrasound systems and constructs 3D ultrasound image stacks. The system allows the importation of an MRI image to create a model of patient prostate by providing fusion between Ultrasound and Magnetic Resonance Imaging (MRI). The system is compatible with commercially available ultrasound systems, transrectal ultrasound bi-plane probes, and commercially available needle devices. Other software features include multi-planar reconstruction, segmentation, image measurements and 2D/3D image registration.

iSR'obot Mona Lisa 1.0 is intended for use by a trained urologist or physician to perform the computer-assisted transperineal prostate biopsy under transrectal ultrasound guidance. The device serves as a biopsy needle guide only. It shall be used in conjunction with a third- party ultrasound machine and endorectal probe that supports B-Mode, and a thirdparty prostate biopsy gun and needle. The insertion of biopsy needle will be done by urologist. The patient is administered general anesthesia and placed in a lithotomy position.

The iSR'obot Mona Lisa 1.0 is able to display the 2D live image feeds from commercially available ultrasound systems and also construct 3D ultrasound image stacks. The system allows the importation of an MRI image to create a model of patient prostate by providing fusion between Ultrasound and Magnetic Resonance Imaging (MRI). The system is compatible with commercially available ultrasound systems, transrectal ultrasound bi-plane probes, and commercially available needle devices. Other software features include multi-planar reconstruction, segmentation, image measurements, and 2D/3D image registration. The device is a user-controlled, stereotaxic accessory intended to guide the urologist or physician in the planning and positioning of a needle during ultrasound-guided transperineal prostate procedures such as biopsies in the operating room. The iSR'obot Mona Lisa 1.0 comprises a workstation, robotic navigation module (comprising of robotic arm and bed rail stabilizer), and disposables.

The iSR'obot Biopsy Kit (consisting of a needle guide, a probe sheath and a drape) is intended to be used with the iSR'obot Mona Lisa (K130944) for performing image guided transperineal biopsies of the prostate.

The iSR'obot Biopsy Kit is a consumables pack consisting of three (3) separate singleuse items designed to be used with the iSR'obot Mona Lisa (K130944). Contents of the Biopsy Kit: Probe Sheath: Non-active invasive device made of medical grade TPX (polymethylpentene). The open end of the sheath is intended to be connected to the end of the probe platform of Mona Lisa and its closed end is to be inserted into the patient's rectum for transient use (< 1 hour) during the prostate biopsy process. The device functions as a sheath to an ultrasound probe providing a stabilized channel for ultrasound scanning of the prostate organ. Needle Guide (for 18G needle): Non-active non-invasive device medical grade PP (Polypropylene). It is to be mounted on the Mona Lisa, functioning as a channel for a biopsy needle. The head of the needle guide will touch the pivot point (puncture hole) on the patient's perineal skin during the biopsy process Drape: An accessory made of plastic (Low Density Polyethylene - Titanlene) with silicone rings. It is intended to be used as a cover for the iSR'obot Mona Lisa during the biopsy process for the purpose of prevention of contamination. The components are assembled into a Tyvek Film Pouch which is made up of Tyvek 1059B and a PET/PE laminated 52µm transparent film. The Tyvek 1059B is highly resistant to penetration by bacterial spores and other contaminating microorganisms. Microbial barrier test conducted on the Tyvek film pouch showed that the pouch can maintain sterility for the 3 years shelf-life of the Biopsy kit if packaging integrity is not compromised. The final kit assembled in a cleanroom is sterilized using ethylene oxide. Biopsy Papers (not considered a medical device) are included with the kit as a convenience to the user. The hospital has the option of using biopsy specimen collection products generally supplied in the hospital.

The iSR'obot MRI-US Fusion is a software application to be used by Clinicians in the clinic or hospital for 2-D and 3-D visualization, image registration, and fusion of Magnetic Resonance and Ultrasound images for mapping planning information of the prostate gland and region of interest. The software features also include multi-modality data communication, surface and volume rendering, segmentation, multi-planar reconstruction, organ delineation, region of interest delineation, landmark selection, measurements and data reporting.

The iSR'obot MRI-US Fusion (UroFusion) is a software application intended for use by Clinicians or Radiologist for 2-D and 3-D visualization, image registration and fusion of Magnetic Resonance and Ultrasound images for mapping planning of the prostate gland and region of interest, such as lesions, to provide "MRI-3D model" imaqe information. The "MRI-3D model" image information produced by this software acts as inputs to the iSR'obot Mona Lisa which allows the import of this "MRI-3D model" image information; and fusion of this model information together with the live ultrasound 3D-model image information. Leveraging on the information available from both Magnetic Resonance (MRI) & Ultrasound modalities concurrently, the fusion results enable the clinicians to visualize the prostate and the region of interest (lesions); thus enabling fewer and more accurate targeted prostate biopsies to be taken as compared with "blind" saturated biopsies with ultrasound guidance alone. UroFusion software system includes the following features: - Access and display medical imaging studies from MRI DICOM data. . - Provide for 2D contouring /3D modelling of the prostate gland. . - Provide for 2D contouring / 3D modelling of tumour / lesions within the . gland. - Provide for saving of patient "MRI-3D model" information together with ● the patient's MRI DICOM data. - Provide for importing of patient "MRI-3D model" information together with relevant MRI DICOM data. - Provide for the fusion of "MRI-3D model" information with the live . ultrasound 3D- model information for subsequent operations to be executed in iSR'obot Mona Lisa. UroFusion can be deployed and utilized in commercially available computer platforms and operating systems; or as a standalone system.

iSR'obot Mona Lisa is intended for use by a trained urologist or physician to perform the computerassisted transperineal prostate biopsy under transrectal ultrasound guidance. The device serves as a biopsy needle guide only. It shall be used in conjunction with a third party ultrasound machine and endorectal probe that supports BMode, and a third party prostate biopsy gun and needle. The insertion of biopsy needle will be done by urologist.

iSR'obot Mona Lisa is a platform-hosted motorized device integrating a probe-driving system for 3-D image collection and a precise biopsy guidance mechanism (biopsy needle platform) to control the orientation of needle insertion and depth of puncture to assist the surgeon perform targeted transperineal prostate biopsy in conjunction with the guidance of transrectal ultrasound. The device serves as a needle quide only. The device has a graphics user interface (GUI) that can provide a complete view of the 3D prostate to the physicians by hands-free image acquisition. The prostate segmentation tool allows a manual or automatic surface detection from the 3D image, based on which the prostate volume is calculated and the systematic biopsy plan is generated. This plan can be customized and the approved plan will be used to control the biopsy needle platform to guide the needle positioning for the manual puncture.

iSR'obot Mona Lisa is intended for use by a trained urologist or physician to perform the computer-assisted transperineal prostate biopsy under transrectal ultrasound guidance. The device serves as a biopsy needle guide only. It shall be used in conjunction with a third party ultrasound machine and endorectal probe that supports B-Mode, and a third party prostate biopsy gun and needle. The insertion of biopsy needle will be done by urologist.

iSR'obot Mona Lisa is a platform-hosted motorized device integrating a probe-driving system for 3-D image collection and a precise biopsy guidance mechanism (biopsy needle platform) to control the orientation of needle insertion and depth of puncture to assist the surgeon perform targeted transperineal prostate biopsy in conjunction with the guidance of transrectal ultrasound. The device serves as a needle guide only. The device has a graphics user interface (GUI) that can provide a complete view of the 3D prostate to the physicians by hands-free image acquisition. The prostate segmentation tool allows a manual or automatic surface detection from the 3D image, based on which the prostate volume is calculated and the systematic biopsy plan is generated. This plan can be customized and the approved plan will be used to control the biopsy needle platform to guide the needle positioning for the manual puncture.