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.

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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the UroNav 3 device, based on the provided FDA 510(k) summary:

Note: This 510(k) summary does not contain explicit acceptance criteria tables with performance metrics or detailed results of a specific clinical study for the UroNav 3. Instead, it relies on demonstrating substantial equivalence to a predicate device (UroNav Version 2.0 and PercuNav) through comparisons of technological characteristics and confirmation of nonclinical testing.

The document states: "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."

However, the specific "predetermined acceptance criteria" themselves and the breakdown of performance against those criteria are not explicitly detailed in the provided text. The safety and effectiveness are established by showing that UroNav 3 has substantially equivalent technological characteristics to the predicate devices and passed internal V&V testing according to applicable standards.

Therefore, the table below reflects what can be inferred rather than explicit numeric acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Substantial Equivalence and V&V)	Reported Device Performance (Inferred from Substantial Equivalence and V&V)
Functional Equivalence: Device performs core intended functions similar to predicate.	UroNav 3 provides image-guided interventional planning and navigation for prostate procedures, views/captures live 2D ultrasound to reconstruct 3D images/models, fuses/registers images from other DICOM modalities, and performs viewing/image-processing functions (segmentation, registration, MPR, measurement, annotation). (Stated as similar to UroNav 2.0 and PercuNav)
Safety and Effectiveness: Does not raise new safety or effectiveness concerns.	Demonstrated through: - Instructions for use, cautions, warnings, and notes for safe/effective use. - Risk Management procedure identifying and controlling potential hazards. - Product (software and hardware) development process, verification, and validation testing. - Passing all in-house testing criteria, validating design, function, and specifications. (Explicitly stated)
Technological Equivalence: Identical or similar technological characteristics.	Nearly identical technological characteristics to predicate devices (UroNav 2.0 and PercuNav) in terms of: PC-based software, Windows OS, multi-modality support, 2D/3D review, live 2D ultrasound, gland segmentation, image registration (rigid/elastic), MPR, DICOM import/export, ultrasound video, standard image viewing/measurement/annotation/segmentation/reporting tools, video capture, image overlays, planning & navigation tools, electromagnetic navigation. (Detailed comparison table provided in K)
Compliance to Standards: Adherence to relevant medical device standards.	Complies with IEC 60601-1:2005 Ed 3.1, IEC 60601-1-2:2014 Ed 4, ISO 14971:2007, IEC 62366:2007. (Explicitly stated)
Physical Form Factor: Changes do not impact safety or effectiveness.	Differences in physical form factor (smaller enclosure, separate embedded computer vs. integrated computer/display) are stated to not impact device safety or effectiveness. (Explicitly stated)
Limited Indications (vs. PercuNav): Scope of use for prostate only (vs. multiple anatomies).	The UroNav system does not include support for all anatomical locations indicated for PercuNav (e.g., liver, lung, pancreas, etc.), but this absence does not significantly affect the use of the device, nor does it raise new or additional safety risks. (Explicitly stated)
Minor UI Variations (vs. PercuNav): Cosmetic user interface changes.	Minor user interface variations (GUI icons, screen colors, image viewing layouts) are cosmetic and do not significantly affect the use of the device, nor do they raise new or additional safety risks. (Explicitly stated)

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not specify a sample size for a test set in a clinical or performance study of the UroNav 3. The document states that "Nonclinical and performance testing has been performed by designated individuals at the manufacturer's facility." This implies internal testing rather than a formal test set of patient data from external sites.

The data provenance is not explicitly stated beyond internal nonclinical and performance testing done at Invivo Corporation. There is no mention of country of origin, nor whether it was retrospective or prospective in the context of a clinical study for UroNav 3.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The 510(k) summary does not mention a clinical study with a test set requiring expert-established ground truth for UroNav 3. The document focuses on demonstrating substantial equivalence through comparison with predicate devices and internal validation. For the predicate devices or previous versions, this information might exist, but it is not provided for UroNav 3 in this document.

4. Adjudication Method for the Test Set

Since a specific test set requiring expert ground truth and adjudication is not described in the provided document for UroNav 3, no adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in this 510(k) summary for UroNav 3. The submission focuses on substantial equivalence based on technological characteristics and nonclinical testing. Therefore, no effect size of human readers improving with AI vs. without AI assistance is reported.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The UroNav 3 is described as a "stereotaxic accessory for image-guided interventional and diagnostic procedures" and emphasizes that "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." This indicates that the device is not intended or tested for standalone (algorithm-only) performance without human-in-the-loop. Its functionality is as an aid to a physician.

7. The Type of Ground Truth Used

Given the nature of the submission (substantial equivalence based on technological characteristics and internal V&V testing), the ground truth for any internal performance testing would likely be based on engineering specifications, accuracy targets for tracking systems, and known parameters for image processing algorithms. There is no mention of clinical ground truth types such as expert consensus, pathology, or outcomes data being used in a formal study for UroNav 3 in this document.

8. The Sample Size for the Training Set

The document does not mention a training set or its sample size. The UroNav 3 is a medical image processing system that integrates various functionalities (image display, registration, segmentation, navigation aid, etc.). While such systems contain algorithms, the submission doesn't describe it as a machine learning/AI device requiring a specific training set in the common sense of statistical or deep learning models needing large datasets for training. Its equivalence is based on established technological characteristics and function.

9. How the Ground Truth for the Training Set Was Established

As no training set is described, no information on how ground truth for a training set was established is provided.

Summary

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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

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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

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Indications for Use

510(k) Number (if known)

K182561

Device Name UroNav 3

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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() Invivo

510(k) Summary

Submitted by:	Invivo Corporation3545 SW 47th AvenueGainesville, FL 32608
Establishment Name:	Invivo Corporation
EstablishmentRegistration Number:	1056069
Contact Person:	Kenneth RevennaughDirector, Quality and RegulatoryInvivo Corporation3545 SW 47th AvenueGainesville, FL 32608Phone: (352) 384-8590Email: 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
ClassificationRegulation Number:	892.2050
Classification:	Class II
Classification Panel:	Radiology
Product Code:	LLZ

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Device Description

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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.

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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) SubmissionReferences
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,

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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.

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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.

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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:InvivoUroNav 3	Predicate Device:InvivoUroNav (Version 2.0)K153073	Predicate Device:Philips HealthcarePercuNavK121406
Intended Use	UroNav is a stereotaxic accessoryfor image-guided interventional anddiagnostic procedures of theprostate gland. It provides 2D and3D visualization of Ultrasound (US)images and the ability to fuse andregister these images with thosefrom other imaging modalities suchas Magnetic Resonance (MR),Computed Tomography, etc. It alsoprovides the ability to display asimulated image of a trackedinsertion tool such as a biopsyneedle, guidewire, gridplate orprobe on a computer monitorscreen that shows images of thetarget organ and the current andthe projected future path of theinterventional instrument takinginto account patient movement.Other software features include	UroNav is a stereotaxicaccessory for image-guidedinterventional and diagnosticprocedures of the prostategland. It provides 2D and 3Dvisualization of Ultrasound(US) images and the ability tofuse and register these imageswith those from other imagingmodalities such as MagneticResonance (MR), ComputedTomography, etc. It alsoprovides the ability to display asimulated image of a trackedinsertion tool such as a biopsyneedle, guidewire, gridplate orprobe on a computer monitorscreen that shows images ofthe target organ and thecurrent and the projectedfuture path of the interventional	PercuNav is a stereotaxicaccessory for ComputedTomography (CT),Magnetic Resonance(MR), Ultrasound (US),Positron EmissionTomography (PET), SinglePhoton EmissionComputed Tomography(SPECT), RotationalFluoroscopy, Endoscopy,and other imagingsystems. CT, Ultrasound,PET, MR, and RotationalFluoroscopy may be fusedin various combinations,such as CT with MR, MRwith ultrasound, etc. It mayinclude instrumentation todisplay the simulatedimage 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,multiplanar reconstruction,segmentation, imagemeasurements and 2D/3D imageregistration.UroNav is intended for treatmentplanning and guidance for clinical,interventional and/or diagnosticprocedures. The device is intendedto be used in interventional anddiagnostic procedures in a clinicalsetting. Example proceduresinclude, but are not limited toimage fusion for diagnostic clinicalexaminations and procedures, softtissue biopsies, soft tissueablations and placement of fiducialmarkers.	instrument taking into accountpatient movement. Othersoftware features includepatient data management,multiplanar reconstruction,segmentation, imagemeasurements and 2D/3Dimage registration.UroNav is intended fortreatment planning andguidance for clinical,interventional and/or diagnosticprocedures. The device isintended to be used ininterventional and diagnosticprocedures in a clinical setting.Example procedures include,but are not limited to imagefusion for diagnostic clinicalexaminations and procedures,soft tissue biopsies, soft tissueablations and placement offiducial markers.	insertion tool such as abiopsy needle, guidewireor probe on a computermonitor screen that showsimages of the targetorgans and the current andthe projected future path ofthe interventionalinstrument taking intoaccount patient movement.This is intended fortreatment planning andguidance for clinical,interventional and/ordiagnostic procedures. Thedevice also supports animage free mode in whichthe proximity of theinterventional device isdisplayed relative toanother device. The deviceis intended to be used ininterventional anddiagnostic procedures in aclinical setting. The deviceis also intended for use inclinical interventions todetermine the proximity ofone device relative toanother. Exampleprocedures include, butare not limited to:• Image fusion fordiagnostic clinicalexaminations andprocedures• Soft tissue biopsies(liver, lung, kidney,breast, pancreas,bladder, adrenal glands,lymph node, mesentery,etc.)• Soft tissue ablation(liver, kidney, breast,pancreas, lung, etc.)• Bone ablation• Bone biopsies• Nerve Blocks & PainManagement• Drainage placements• Hydrodissections• Bladder Stimulation• Fiducial placements• Tumor resections• Sinus procedures• Intranasal procedures• Transphenoidalprocedures
Product	Submitted Device:	Predicate Device:	Predicate Device:
	InvivoUroNav 3	InvivoUroNav (Version 2.0)K153073	Philips HealthcarePercuNavK121498
Decision Date	Pending	11/16/2015	12/14/2012
Product Code	LLZ	LLZ	JAK
Class	II	II	II
Target	Prostate	Prostate	Multiple (includingProstate)
AnatomyAccess	Transrectal & Transperineal	Transrectal &Transperineal	Multiple (includingTransrectal)
Software
Windows O.S.	Yes	Yes	Yes
MedicalImagingSoftware	Yes	Yes	Yes
Image Display
Multi-ModalitySupport	Yes	Yes	Yes
General Image2D/3D Review	Yes	Yes	Yes
3D RenderingView	Yes	Yes	Yes
Live 2DUltrasound	Yes	Yes	Yes
ImageProcessing
GlandSegmentation	Yes	Yes	Yes
ImageRegistration	Yes	Yes	Yes
RigidRegistration	Yes	Yes	Yes
ElasticRegistration	Yes	Yes	Yes
Multi-PlanarReformatting(MPR)	Yes	Yes	Yes
Connectivity
DICOMImport/Export	Yes	Yes	Yes
UltrasoundVideo	Yes	Yes	Yes
Review Tools
StandardImage ViewingTools	Yes	Yes	Yes
MeasurementTools	Yes	Yes	Yes
Product	Submitted Device:InvivoUroNav 3	Predicate Device:InvivoUroNav (Version 2.0)K153073	Predicate Device:Philips HealthcarePercuNavK121498
AnnotationTools	Yes	Yes	Yes
SegmentationTools	Yes	Yes	Yes
ReportingTools	Yes	Yes	Yes
Video Capture	Yes	Yes	Yes
ImageOverlays	Yes	Yes	Yes
Planning &Navigation
Import PriorPlans	Yes	Yes	Yes
Import/AddTargets	Yes	Yes	Yes
Plan/MarkLocations	Yes	Yes	Yes
NavigationType	Electromagnetic	Electromagnetic	Electromagnetic

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The new device and predicate devices are substantially equivalent in the areas of technological characteristics such as basic design, features, features, energy source, and method of operation, general function, application, and intended use. The new device does not raise any new potential safety risks and is equivalent in performance to the existing legally marketed devices.

Conclusion

The 510(k) Pre-Market Notification for UroNav 3 contains adequate information, data, and nonclinical test results to enable FDA-CDRH to determine substantial equivalence to the predicate device. Invivo has determined that its device, UroNav 3, is substantially equivalent to the identified predicate device listed above. A comparison with the legally marketed predicate device indicates that it is substantially equivalent to this device, and that it does not raise any new safety or efficacy concerns. Nonclinical tests demonstrate that the device is safe, effective, and is substantially equivalent to the predicate device.

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Regulation Number and Section

§ 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).