UroNav (Version 3.0)

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October 19, 2018 Invivo Corporation % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW BUFFALO, MN 55313 Re: K182561 Trade/Device Name: UroNav 3 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: October 15, 2018 Received: October 16, 2018 Dear c/o Mark Job: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 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. Hole 2. Mild Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) ### K182561 Device Name UroNav 3 ### Indications for Use (Describe) 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 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 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 projected future path of the interventional instrument taking into account patient movement. Other software features include patient data 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 diaical 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) | | |----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------| | <div> <span> X Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # () Invivo # 510(k) Summary | Submitted by: | Invivo Corporation<br>3545 SW 47th Avenue<br>Gainesville, FL 32608 | |---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Establishment Name: | Invivo Corporation | | Establishment<br>Registration Number: | 1056069 | | Contact Person: | Kenneth Revennaugh<br>Director, Quality and Regulatory<br>Invivo Corporation<br>3545 SW 47th Avenue<br>Gainesville, FL 32608<br>Phone: (352) 384-8590<br>Email: ken.revennaugh@philips.com | | Date Prepared: | October 11, 2018 | | Trade Name: | UroNav 3 | | Common Name: | Medical Image Processing Workstation | | Classification Name: | Picture archiving and communications system | | Classification<br>Regulation Number: | 892.2050 | | Classification: | Class II | | Classification Panel: | Radiology | | Product Code: | LLZ | {4}------------------------------------------------ ### Device Description UroNav 3 is a medical image processing system that provides image-guided intervention and diagnostic information, which guides interventional instrumentation to targets that have been defined by the physician. The target can be indicated either pre-procedurally or intra-procedurally using images or relative to an indicated position on the patient. As a diagnostic system, it combines pre-procedural and intra-procedural imaging to assist in locating areas of interest detected on one set of images on the other. The system provides fusion between Ultrasound (US) and different imaging modalities such as Magnetic Resonance Imaging (MR), Computed Tomography (CT), etc. When used as a navigation aid, it also transforms two and three-dimensional patient images (scan sets) into dynamic representations on which a medical instrument can be navigated. The system performs spatial mapping from one image space to another image space or from image space to physical space ("registration") allowing the physician to correlate scan sets with each other and to the patient. The system facilitates minimally invasive interventional procedures. Images used by UroNav can include archived image data from a CD, PACS, etc., and live images from an ultrasound system. The UroNav system consists of an Electromagnetic Measurement System (EMMS) (including a Field Generator, System Control Unit and System Interface Unit(s)), a System Unit (including a CPU/monitor, medical-grade power supply and mobile cart), Field Generator stand, UroNav software and various instrumentation devices. The UroNav System Unit and the UroNav software utilize the keyboard, mouse and visual display to interact with the image data from a connected Ultrasound System. This interaction includes the selection of targets and associated navigation on the UroNav monitor. Targeted use areas for UroNav include hospital operating rooms, outpatient surgery centers, ultrasound suites, and procedure rooms. UroNav 3 is designed to display the 2D live video received from commercially available ultrasound machines and use this 2D video to reconstruct a 3D ultrasound image. The system has been designed to work with the clinicians' existing ultrasound machine, transrectal ultrasound (TRUS) probe, commercially available needle guides and needle gun combinations. Additional software features include patient data management, multiplanar reconstruction, segmentation, image measurement and 3D image registration. UroNav utilizes an electromagnetic measurement system (EMMS) for identifying and tracking the location of the TRUS probe (and associated needle quides, instruments, etc.) relative to the 2D and 3D images. The EMMS Field Generator is positioned near the patient and provides an electromagnetic (EM) field for detection by a proprietary electromagnetic (EM) Sensor, which is attached to the ultrasound probe and tracks probe position while the physician performs a normal ultrasound imaging procedure of the subject prostate. The Field Generator and EM Sensor are connected to the UroNav {5}------------------------------------------------ System Control Unit and the PC running the UroNav software. Control of the ultrasound probe and ultrasound system is done manually by the physician, just as it would be in the absence of UroNav 3. However, by tracking the position and orientation of the ultrasound probe while capturing the video image, UroNav is able to reconstruct and display a 3D image and 3D rendered surface model of the prostate. The reconstructed 3D image can be further processed to perform various measurements including volume estimation and can be examined for abnormalities by the physician. Patient information, notes and images may be stored for future retrieval. Locations for biopsies, needles, markers, and other devices may be selected by the physician, displayed in the 3D image and 3D rendered surface model, and stored. Previously created 3D models may be recalled and may be aligned or registered to the current live display of the prostate. The 3D model used for co-reqistration may be based on another series of ultrasound images or DICOM images. The physician may also attach a commercially available biopsy needle guide to the TRUS probe and use the probe and biopsy needle to perform tissue biopsy. Whenever the ultrasound machine is turned on by the physician, the live 2D ultrasound image is displayed on the UroNav display during the biopsy. As the TRUS probe with attached needle guide is maneuvered by the physician, the position and orientation of the probe is tracked. UroNav 3 is able to add, display and edit plans for target locations (e.g., biopsy sites) as well as an estimate of the probe position and needle trajectory relative to the 3D image and 3D rendered surface model of the prostate and the planned target locations. UroNav 3 offers the physician additional 3D information for assessing prostate abnormalities, planning and implementing biopsy procedures. The additional image processing features are generated with minimal changes to previous TRUS probe based procedures, and the physician always has access to the live 2D ultrasound image during prostate assessment or biopsy procedure. In addition to standard transrectal procedures, UroNav 3 also supports transperineal access and commercially available gridplates normally used for performing such procedures. When using transperineal mode, the UroNav EM Sensors are attached to both the TRUS probe and the transperineal gridplate within a mechanical stepper assembly. Procedure planning, segmentation, registration and navigation are performed the same as the standard transrectal procedure except that a computer rendering of the transperineal gridplate is displayed on the UroNav 3 display. UroNav provides an indication of the gridplate coordinates that correspond to the identified target location. {6}------------------------------------------------ ### Intended Use UroNav is a stereotaxic accessory for image-quided 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, quidewire, 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, 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. | Predicate Devices Name | Predicate 510(k) Submission<br>References | |------------------------|-------------------------------------------| | UroNav (Version 2.0) | K153073 (Primary) | | PercuNav | K121498 (Reference) | # Predicate Device Information & Comparison The design, function, and specifications of UroNav 3 are similar to the identified legally marketed predicate devices. Similar to UroNav (Version 2.0) and PercuNav, UroNav 3 provides image-guided interventional planning and navigation for prostate procedures, the ability to view and capture live 2D ultrasound data to create reconstructed 3D ultrasound images/models and the ability to fuse and register these images with those acquired and imported from other DICOM-based imaging devices. Similar to all of the above listed predicate devices, UroNav also performs other viewing and imageprocessing functions such as image registration, multi-planar reformats and includes tools to segment, measure and annotate images. Each of the devices can also output selected image views, processed data and user-defined reports. UroNav 3, UroNav (Version 2.0) and PercuNav utilize the identical commercially available Electromagnetic Measurement System (EMMS) for procedure navigation and tracking. UroNav and PercuNav also share common software source code for basic system functionality such as multi-modality image viewing, segmentation, registration, {7}------------------------------------------------ EM navigation, and annotation and DICOM functionality. Both UroNav 3 and PercuNav can also be enabled as a software option on compatible ultrasound machines. UroNav 3 and PercuNav utilize the identical commercially available Electromagnetic Measurement System (EMMS) for procedure navigation and tracking. UroNav 3 and PercuNav also share common software source code for basic system functionality such as multi-modality image viewing, segmentation, registration, EM navigation, and annotation and DICOM functionality. The differences between UroNav 3 and UroNav (Version 2.0) are mainly changes to the physical form factor of the submitted device. The submitted device utilizes a smaller mechanical enclosure, which enhances device portability. Also, the submitted device includes a separate, embedded computer that can be used with commercially-available display monitors versus the integrated computer/display included with UroNav (Version 2.0). These differences between UroNav 3 and UroNav (Version 2.0) do not impact device safety or effectiveness. The differences between UroNav 3 and PercuNav include a limited number of indications, options and features of the predicate device, which are not included in the submitted device. These two (2) minor differences are described as follows. - a) While both devices support interventional and diagnostic procedures of the prostate gland, the UroNav system does not include support for all of the anatomic locations indicated for PercuNav (e.g., liver, lung, pancreas, etc.). The absence of these anatomic locations does not significantly affect the use of the device, nor does it raise new or additional safety risks. This difference between UroNav 3 and the PercuNav device does not impact device safety or effectiveness. - b) Other differences between UroNav 3 and PercuNav include minor user interface variations such as GUI icons, screen colors and image viewing layouts. These differences are cosmetic in nature do not significantly affect the use of the device, nor do they raise new or additional safety risks. These differences between UroNav 3 and the legally marketed predicate device do not impact device safety or effectiveness. {8}------------------------------------------------ ### Safety and Effectiveness The UroNav 3 labeling contains instructions for use and necessary cautions, warnings and notes to provide for safe and effective use of the device. Risk Management is ensured via Invivo's Risk Management procedure, which is used to identify potential hazards. These potential hazards are controlled via the product (software and hardware) development process, verification and validation testing. ### Nonclinical Testing and Performance Information Nonclinical and performance testing has been performed by designated individuals as required by Invivo Corporation's quality procedures. Verification & Validation Test Plans were designed to evaluate all input functions, output functions, and actions performed by UroNav in each operational mode. UroNav 3 has been assessed and tested at the manufacturer's facility and has passed all in-house testing criteria including validating design, function and specifications. Nonclinical and performance testing results are provided in the 510(k) and demonstrate that the predetermined acceptance criteria are met. The UroNav 3 has been designed to comply with the applicable standards: - IEC 60601-1:2005 Ed 3.1 - IEC 60601-1-2:2014 Ed 4 - ISO 14971:2007 - IEC 62366:2007 # Technological Characteristics UroNav 3 is a diagnostic and interventional software accessory, which can be combined with an optional mobile computer workstation and commercially-available navigation devices and includes functions that are commonly found in various medical imaging software applications. It provides convenient options for visualizing diagnostic and interventional information in support of routine clinical procedures of the prostate gland. The device does not directly contact the patient, nor does it control any life sustaining devices. Diagnosis is not performed by the UroNav system but by Radiologists, Urologists, Clinicians and referring Physicians. A physician, providing ample opportunity for competent human intervention interprets the images and information being displayed and maintains control of the clinical procedure at all times. The UroNav 3 utilizes the same technological characteristics as the predicate devices. {9}------------------------------------------------ Both: - are PC based software applications that provide 2D and 3D medical image acquisition including ultrasound video image acquisition arid visualization of the prostate gland - use Windows operating systems - allow co-registration of live ultrasound images to previously created 3-0 image sets based on previously collected live ultrasound image sets or DICOM images sets - include image enhancements such as contrast and brightness, zoom and pan capabilities - provide patient and clinical data management features - deal with live ultrasound images received from commercially available imaging devices - use graphic overlays to define segmentations - calibrate ultrasound video images - create a report - allow for image measurements such as volume, length, and angle measurements - allow multi-planar reformatting - allow manual planning of instrument positioning including biopsy needle placement and planning - allow the user to plan and mark the reached positions of the biopsies and instruments - do not steer or in any way control the positioning of the instruments used or of any treatment process what so ever - are only intended for use on the prostate gland Following is the comparison of technological characteristics between UroNav 3 and predicate devices: | Product | Submitted Device:<br>Invivo<br>UroNav 3 | Predicate Device:<br>Invivo<br>UroNav (Version 2.0)<br>K153073 | Predicate Device:<br>Philips Healthcare<br>PercuNav<br>K121406 | |---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | UroNav is a stereotaxic accessory<br>for image-guided interventional and<br>diagnostic procedures of the<br>prostate gland. It provides 2D and<br>3D visualization of Ultrasound (US)<br>images and the ability to fuse and<br>register these images with those<br>from other imaging modalities such<br>as Magnetic Resonance (MR),<br>Computed Tomography, etc. It also<br>provides the ability to display a<br>simulated image of a tracked<br>insertion tool such as a biopsy<br>needle, guidewire, gridplate or<br>probe on a computer monitor<br>screen that shows images of the<br>target organ and the current and<br>the projected future path of the<br>interventional instrument taking<br>into account patient movement.<br>Other software features include | UroNav is a stereotaxic<br>accessory for image-guided<br>interventional and diagnostic<br>procedures of the prostate<br>gland. It provides 2D and 3D<br>visualization of Ultrasound<br>(US) images and the ability to<br>fuse and register these images<br>with those from other imaging<br>modalities such as Magnetic<br>Resonance (MR), Computed<br>Tomography, etc. It also<br>provides the ability to display a<br>simulated image of a tracked<br>insertion tool such as a biopsy<br>needle, guidewire, gridplate or<br>probe on a computer monitor<br>screen that shows images of<br>the target organ and the<br>current and the projected<br>future path of the interventional | PercuNav is a stereotaxic<br>accessory for Computed<br>Tomography (CT),<br>Magnetic Resonance<br>(MR), Ultrasound (US),<br>Positron Emission<br>Tomography (PET), Single<br>Photon Emission<br>Computed Tomography<br>(SPECT), Rotational<br>Fluoroscopy, Endoscopy,<br>and other imaging<br>systems. CT, Ultrasound,<br>PET, MR, and Rotational<br>Fluoroscopy may be fused<br>in various combinations,<br>such as CT with MR, MR<br>with ultrasound, etc. It may<br>include instrumentation to<br>display the simulated<br>image of a tracked | | Product | Submitted Device: | Predicate Device: | Predicate Device: | | | Invivo | Invivo | Philips Healthcare | | | UroNav 3 | UroNav (Version 2.0) | PercuNav | | | | K153073 | K121498 | | | patient data management,<br>multiplanar reconstruction,<br>segmentation, image<br>measurements and 2D/3D image<br>registration.<br>UroNav is intended for treatment<br>planning and guidance for clinical,<br>interventional and/or diagnostic<br>procedures. The device is intended<br>to be used in interventional and<br>diagnostic procedures in a clinical<br>setting. Example procedures<br>include, but are not limited to<br>image fusion for diagnostic clinical<br>examinations and procedures, soft<br>tissue biopsies, soft tissue<br>ablations and placement of fiducial<br>markers. | instrument taking into account<br>patient movement. Other<br>software features include<br>patient data management,<br>multiplanar reconstruction,<br>segmentation, image<br>measurements and 2D/3D<br>image registration.<br>UroNav is intended for<br>treatment planning and<br>guidance for clinical,<br>interventional and/or diagnostic<br>procedures. The device is<br>intended to be used in<br>interventional and diagnostic<br>procedures in a clinical setting.<br>Example procedures include,<br>but are not limited to image<br>fusion for diagnostic clinical<br>examinations and procedures,<br>soft tissue biopsies, soft tissue<br>ablations and placement of<br>fiducial markers. | insertion tool such as a<br>biopsy needle, guidewire<br>or probe on a computer<br>monitor screen that shows<br>images of the target<br>organs and the current and<br>the projected future path of<br>the interventional<br>instrument taking into<br>account patient movement.<br>This is intended for<br>treatment planning and<br>guidance for clinical,<br>interventional and/or<br>diagnostic procedures. The<br>device also supports an<br>image free mode in which<br>the proximity of the<br>interventional device is<br>displayed relative to<br>another device. The device<br>is intended to be used in<br>interventional and<br>diagnostic procedures in a<br>clinical setting. The device<br>is also intended for use in<br>clinical interventions to<br>determine the proximity of<br>one device relative to<br>another. Example<br>procedures include, but<br>are not limited to:<br>• Image fusion for<br>diagnostic clinical<br>examinations and<br>procedures<br>• Soft tissue biopsies<br>(liver, lung, kidney,<br>breast, pancreas,<br>bladder, adrenal glands,<br>lymph node, mesentery,<br>etc.)<br>• Soft tissue ablation<br>(liver, kidney, breast,<br>pancreas, lung, etc.)<br>• Bone ablation<br>• Bone biopsies<br>• Nerve Blocks & Pain<br>Management<br>• Drainage placements<br>• Hydrodissections<br>• Bladder Stimulation<br>• Fiducial placements<br>• Tumor resections<br>• Sinus procedures<br>• Intranasal procedures<br>• Transphenoidal<br>procedures | | Product | Submitted Device: | Predicate Device: | Predicate Device: | | | Invivo<br>UroNav 3 | Invivo<br>UroNav (Version 2.0)<br>K153073 | Philips Healthcare<br>PercuNav<br>K121498 | | Decision Date | Pending | 11/16/2015 | 12/14/2012 | | Product Code | LLZ | LLZ | JAK | | Class | II | II | II | | Target | Prostate | Prostate | Multiple (including<br>Prostate) | | Anatomy<br>Access | Transrectal & Transperineal | Transrectal &<br>Transperineal | Multiple (including<br>Transrectal) | | Software | | | | | Windows O.S. | Yes | Yes | Yes | | Medical<br>Imaging<br>Software | Yes | Yes | Yes | | Image Display | | |…