UroNav is a stereotaxic accessory for image-guided interventional and diagnostic procedures of the prostate gland. It provides 2D and 3D visualization of Ultrasound (US) images and the ability to fuse and register these images with those from other imaging modalities such as Magnetic Resonance (MR), Computed Tomography, etc. It also provides the ability to display a simulated image of a tracked insertion tool such as a biopsy needle, guidewire, gridplate or probe on a computer monitor screen that shows images of the target organ and the current and the projected future path of the interventional instrument taking into account patient movement. Other software features include patient data management. 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.

Device Description

UroNav is a medical image processing workstation 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 preprocedurally 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 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 guides, 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. 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 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 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 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 display. UroNav provides an indication of the gridplate coordinates that correspond to the identified target location.

AI/ML Overview

The provided text is a 510(k) summary for Invivo Corporation's UroNav (Version 2.0) device. This document focuses on demonstrating substantial equivalence to pre-existing devices rather than detailing a specific clinical study with acceptance criteria and performance metrics for the UroNav device itself.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, and MRMC studies are not available in this document. The document outlines general nonclinical testing and states that predetermined acceptance criteria were met but does not specify what those criteria or the exact performance results were.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The text 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 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 acceptance criteria (e.g., target accuracy, registration error thresholds) and the quantitative reported device performance against those criteria are not described in this 510(k) summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The nonclinical testing mentioned appears to be internal verification and validation, not a clinical study involving a test set of patient data with a specific sample size or provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. As no clinical test set of patient data is detailed, the establishment of ground truth by external experts is not mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of an MRMC comparative effectiveness study in this document. The UroNav system as described is an image-guided accessory and workstation, not an AI or CAD (Computer-Aided Detection) system whose effect on human reader performance would typically be measured in an MRMC study. The device provides "image-guided intervention and diagnostic information" and acts as a "navigation aid" and "medical image processing workstation."

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not provided in the document, nor is it directly applicable. The device is explicitly described as an accessory for "image-guided interventional and diagnostic procedures" and an "image processing workstation." It is inherently designed for human-in-the-loop use. The document states: "Diagnosis is not performed by the UroNav system but by Radiologists, 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."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided in the document. Since the document describes nonclinical testing, any "ground truth" would likely refer to engineering specifications or known simulated targets rather than clinical pathology or outcomes.

8. The sample size for the training set

This information is not provided in the document. The UroNav device, as described, is an image processing and navigation system, not a machine learning or AI model that relies on training data in the conventional sense.

9. How the ground truth for the training set was established

This information is not provided in the document. (See point 8).

Summary of what is provided related to performance/testing:

The document states that Invivo Corporation conducted "Nonclinical and performance testing" as per their quality procedures. These tests involved "Verification & Validation Test Plans" designed to evaluate all input/output functions and actions of UroNav in each operational mode. The manufacturer attests that these tests were passed and met "predetermined acceptance criteria."

The core of this 510(k) submission is to demonstrate substantial equivalence to existing predicate devices (Eigen 3-D Imaging Workstation K081093, Jet Soft SRL BioJet K122329, and Philips Healthcare PercuNav K121498). The comparison table highlights that UroNav shares similar technological characteristics (e.g., Windows OS, multi-modality support, 3D rendering, live 2D ultrasound, image processing, DICOM connectivity, planning/navigation features) with its predicates. The main difference noted is the use of an Electromagnetic Measurement System (EMMS) instead of mechanical encoding for navigation in comparison to some predicates. This difference is asserted not to raise new safety risks or affect device use or effectiveness.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human profiles or faces, depicted in a dark color.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 16, 2015

Invivo Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, NW BUFFALO MN 55313

Re: K153073

Trade/Device Name: Uronav (Version 2.0) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 21 2015 Received: October 22, 2015

Dear Mr. 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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'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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Form Approved: OMB No.	0910-0120
Expiration Date:	January 31, 2017
	See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

510(k) Number (if known)	K153073
Device Name	UroNav (Version 2.0)
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 the ability to fuse and register these images with those
from other imaging modalities such as Magnetic Resonance (MR), Computed Tomography, etc. It also provides the
ability to display a simulated image of a tracked insertion tool such as a biopsy needle, guidewire, gridplate or probe on a
computer monitor screen that shows images of the target organ and the current and the projected future path of the
interventional instrument taking into account patient movement. Other software features include patient data management.
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.

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)

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."

FORM FDA 3881 (8/14)
Page 1 of 1

PSC Publishing Services (All) 143-641)
EF

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(i) 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 RequlatoryInvivo Corporation3545 SW 47th AvenueGainesville, FL 32608Phone: (352) 384-8590Email: kenrevennaugh@philips.com
Date Prepared:	October 5, 2015
Trade Name:	UroNav (Version 2.0)
Common Name:	Medical Image Processing Workstation
Classification Name:	System, Image Processing, Radiological
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. 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, guidewire, gridplate or probe on a computer monitor screen that shows images of the target organ and the current and the projected future path of the interventional instrument taking into account patient movement. Other software features include patient data management, multi-planar reconstruction, segmentation, image measurements and 2D/3D image registration.

UroNav 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.

Predicate Devices Name	Predicate 510(k) SubmissionReferences
3-D Imaging Workstation	K081093 (Primary)
BioJet	K122329 (Reference)
PercuNav	K121498 (Reference)

Predicate Device Information & Comparison

The design, function, and specifications of UroNav are similar to the identified legally marketed predicate devices. Similar to the devices from Eigen, LLC (K081093), Jet Soft, SRL (K122329) and Philips Healthcare (K121498), UroNav 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 image-processing 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.

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The main difference between UroNav and the Eigen 3-D Imaging Workstation (K081093) and BioJet (K122329) devices is the method used for procedure navigation and tracking. The UroNav system utilizes an Electromagnetic Measurement System (EMMS) for procedure navigation and tracking while the 3-D Imaging Workstation and BioJet devices utilize a mechanical encoding system to determine the location of the ultrasound probe. This difference in navigation and tracking technique does not significantly affect the use of the device, nor does it raise new or additional safety risks. This difference between UroNav and the Eigen 3-D Imaging Workstation and BioJet devices does not impact device safety or effectiveness.

UroNav and PercuNav (K121498) 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, EM navigation, annotation and DICOM functionality.

The differences between UroNav and PercuNav (K121498) include a limited number of indications, options and features of the predicate device, which are not included in the submitted device. While both devices support interventional and diagnostic procedures, 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 and the PercuNav device does not impact device safety or effectiveness.

Other differences between UroNav and the identified predicate devices include minor user interface variations such as GUI design, 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 and the legally marketed predicate devices do not impact device safety or effectiveness.

Safety and Effectiveness

The UroNav 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.

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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 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 has been designed to comply with the applicable standards:

IEC 60601-1:2005
IEC 60601-1-2:2007
EN/ISO 14971:2007
IEC 62366:2007
IEC 60601-1-6:2010

Technological Characteristics

UroNav is a diagnostic and interventional accessory that is comprised of a mobile computer workstation, a commercially-available navigation device and software with functions that are commonly found in various medical imaging 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, 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 utilizes the same technological characteristics as the predicate devices. Both:

are PC based software applications that provide 2D and 3D medical image ー 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

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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 and predicate devices:

Product	Submitted Device:InvivoUroNav (Version2.0)	Primary PredicateDevice:Eigen, LLC3-D ImagingWorkstationK081093	ReferencePredicate Device:Jet Soft SRLBioJetK122329	ReferencePredicate Device:Philips HealthcarePercuNavK121498
Intended Use	UroNav is astereotaxicaccessory forimage-guidedinterventional anddiagnosticprocedures of theprostate gland. Itprovides 2D and3D visualization ofUltrasound (US)images and theability to fuse andregister theseimages with thosefrom other imagingmodalities such asMagneticResonance (MR),ComputedTomography, etc. Italso provides theability to display asimulated image ofa tracked insertiontool such as abiopsy needle,guidewire, gridplateor probe on acomputer monitor	The 3-D ImagingWorkstation isintended to beused by physiciansin the clinic orhospital for 2-D and3-D visualization ofultrasound imagesof the prostategland. Additionalsoftware featuresinclude patient datamanagement,multi-planarreconstruction,segmentation,imagemeasurement and3-D imageregistration.	The BioJetsoftware isintended to beused by physiciansin the clinic orhospital for 2D and3D visualization ofultrasound imagesof the prostategland. Additionalsoftware featuresinclude patient datamanagement,multiplanarreconstruction,segmentation,imagemeasurements,and 3-Dregistration.	PercuNav is astereotaxic accessoryfor ComputedTomography (CT),Magnetic Resonance(MR), Ultrasound(US), PositronEmission Tomography(PET), Single PhotonEmission ComputedTomography(SPECT), RotationalFluoroscopy,Endoscopy, and otherimaging systems. CT,Ultrasound, PET, MR,and RotationalFluoroscopy may befused in variouscombinations, such asCT with MR, MR withultrasound, etc. It mayincludeinstrumentation todisplay the simulatedimage of a trackedinsertion tool such asa biopsy needle,guidewire or probe ona computer monitor
Product	Submitted Device:InvivoUroNav (Version2.0)	Primary PredicateDevice:Eigen, LLC3-D ImagingWorkstationK081093	ReferencePredicate Device:Jet Soft SRLBioJetK122329	ReferencePredicate Device:Philips HealthcarePercuNavK121498
	screen that showsimages of thetarget organ andthe current and theprojected futurepath of theinterventionalinstrument takinginto account patientmovement. Othersoftware featuresinclude patient datamanagement,multiplanarreconstruction,segmentation,imagemeasurements and2D/3D imageregistration.UroNav is intendedfor treatmentplanning andguidance forclinical,interventionaland/or diagnosticprocedures. Thedevice is intendedto be used ininterventional anddiagnosticprocedures in aclinical setting.Exampleprocedures include,but are not limitedto image fusion fordiagnostic clinicalexaminations andprocedures, softtissue biopsies, softtissue ablationsand placement offiducial markers.			screen that showsimages of the targetorgans and thecurrent and theprojected future pathof the interventionalinstrument taking intoaccount patientmovement. This isintended for treatmentplanning andguidance for clinical,interventional and/ordiagnosticprocedures. Thedevice also supportsan image free modein which the proximityof the interventionaldevice is displayedrelative to anotherdevice. The device isintended to be used ininterventional anddiagnostic proceduresin a clinical setting.The device is alsointended for use inclinical interventionsto determine theproximity of onedevice relative toanother. Exampleprocedures include,but are not limited to:• Image fusion fordiagnostic clinicalexaminations andprocedures• Soft tissuebiopsies (liver,lung, kidney,breast, pancreas,bladder, adrenalglands, lymphnode, mesentery,etc.)• Soft tissueablation (liver,kidney, breast,pancreas, lung,etc.)• Bone ablation• Bone biopsies• Nerve Blocks &Pain Management• Drainageplacements

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Product	Submitted Device:InvivoUroNav (Version2.0)	Primary PredicateDevice:Eigen, LLC3-D ImagingWorkstationK081093	ReferencePredicate Device:Jet Soft SRLBioJetK122329	ReferencePredicate Device:Philips HealthcarePercuNavK121498
				• Hydrodissections• BladderStimulation• Fiducialplacements• Tumor resections• Sinus procedures• Intranasalprocedures• Transphenoidalprocedures
Decision Date	Pending	05/01/2008	08/16/2012	12/14/2012
Product Code	LLZ	LLZ	LLZ	JAK
Class	II	II	II	II
TargetAnatomy	Prostate	Prostate	Prostate	Multiple
AnatomyAccess	Transrectal &Transperineal	Transrectal &Transperineal	Transrectal &Transperineal	Multiple (includingTransrectal)
Software
Windows O.S.	Yes	Yes	Yes	Yes
MedicalImagingSoftware	Yes	Yes	Yes	Yes
ImageDisplay
Multi-ModalitySupport	Yes	Yes	Yes	Yes
General Image2D/3D Review	Yes	Yes	Yes	Yes
3D RenderingView	Yes	Yes	Yes	Yes
Live 2DUltrasound	Yes	Yes	Yes	Yes
ImageProcessing
GlandSegmentation	Yes	Yes	Yes	Yes
ImageRegistration	Yes	Yes	Yes	Yes
RigidRegistration	Yes	Yes	Yes	Yes
ElasticRegistration	Yes	Yes	No	Yes
Multi-PlanarReformatting(MPR)	Yes	Yes	Yes	Yes
Connectivity
DICOMImport/Export	Yes	Yes	Yes	Yes
UltrasoundVideo	Yes	Yes	Yes	Yes
Review Tools
StandardImage ViewingTools	Yes	Yes	Yes	Yes
Product	Submitted Device:InvivoUroNav (Version2.0)	Primary PredicateDevice:Eigen, LLC3-D ImagingWorkstationK081093	ReferencePredicate Device:Jet Soft SRLBioJetK122329	ReferencePredicate Device:Philips HealthcarePercuNavK121498
MeasurementTools	Yes	Yes	Yes	Yes
AnnotationTools	Yes	Yes	Yes	Yes
SegmentationTools	Yes	Yes	Yes	Yes
ReportingTools	Yes	Yes	Yes	Yes
Video Capture	Yes	Yes	No	Yes
ImageOverlays	Yes	Yes	Yes	Yes
Planning &Navigation
Import PriorPlans	Yes	Yes	Yes	Yes
Import/AddTargets	Yes	Yes	Yes	Yes
Plan/MarkLocations	Yes	Yes	Yes	Yes
NavigationType	Electromagnetic	Mechanical	Mechanical	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, energy source, 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 contains adequate information, data, and nonclinical test results to enable FDA - CDRH to determine substantial equivalence to the predicate devices. Invivo has determined that its device, UroNav, is substantially equivalent to the identified predicate devices listed above. A comparison with the legally marketed predicate devices 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 devices.

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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).