The PerculVav system is a stereotaxic accessory for computed tomography (CT), cone beam CT (CBCT), magnetic resonance (MR), ultrasound (US), and positron emission tomography (PET). CT, Ultrasound, PET, and MR may be fused in various combinations, such as CT with MR, MR with ultrasound, and so on. It may include instrumentation to display the simulated image of a tracked insertion tool such as a biopsy needle or probe on a computer monitor screen that shows images of the target organs and the current and the projected future path of the interventional instrument. The PerculNav system is intended for treatment planning and to assist guidance for clinical, interventional, or diagnostic procedures in a clinical setting.

The PercuNav system is also intended to supplement live imaging in clinical interventions to determine the proximity of one device relative to another.

The PercuNav system is not intended to be the sole guidance for any procedure. Procedures that can be guided by the PercuNav system adjunctively include, but are not limited to, the following:

· Image fusion for diagnostic clinical examinations and procedures
· Soft tissue biopsies
· Soft tissue ablation
Bone ablation
· Bone biopsies
· Nerve blocks and pain management
· Drainage placements

Device Description

The Philips PercuNav Image Fusion and Interventional Navigation System provides image-guided diagnostic and intervention that enables fusion of diagnostic images and guidance of tracked instruments to physiciandefined targets. The target can be indicated either pre-procedurally or intra-procedurally, either using images or relative to an indicated position on the patient. The system transforms two-dimensional patient images into dynamic representations that can be fused with live ultrasound or other previously acquired images. Those two-dimensional patient images, or scan sets, are derived from Ultrasound, CT, PET, PET/CT, and MRI. The resulting dynamic representation supports diagnostic review and instrument navigation.

The purpose of this Traditional 510(K) Pre-market Notification is to introduce a new semi-automated visualization tool entitled "Tumor Contouring" to the current PercuNav software system. The Tumor Contouring visualization tool is designed to aid the end user in the planning and targeting of lesions, structures, and other regions of interests prior to an interventional procedure, soft tissue ablation, etc. The Tumor Contouring tool allows the end user to generate and modify a 3D contour around a region or soft tissue structure of interest and then this contour, once accepted by the user, can be visualized and dynamically reformatted and fused in various imaging combinations for later procedures.

AI/ML Overview

The provided text includes a 510(k) summary for the Philips PercuNav Image Fusion and Interventional Navigation System with a new "Tumor Contouring" visualization tool. However, it does not contain explicit acceptance criteria thresholds or detailed study results for the device's performance, as would typically be found in a clinical study report.

The document focuses on demonstrating substantial equivalence to predicate devices through technological comparison and non-clinical testing (software verification, risk analysis, product specifications, design reviews). It explicitly states: "The subject Philips PercuNav System did not require clinical data in order to make a determination for substantial equivalence when compared to the predicate device(s)."

Therefore, based on the provided text:

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

Acceptance Criteria	Reported Device Performance
Not explicitly stated as quantitative performance metrics for the Tumor Contouring tool. The acceptance criteria are implicitly met by successful completion of Philips' internal software verification and validation testing, ensuring the tool meets specifications and user needs.	Testing performed demonstrated that the proposed PercuNav System with the Tumor Contouring visualization tool meets the defined requirements and performance claims.

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

No specific sample size for a "test set" (in the context of clinical or performance data) or data provenance is mentioned. The testing described is primarily internal software verification.

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):

Not applicable. The document does not describe a study involving expert-established ground truth for performance evaluation of the Tumor Contouring tool.

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

Not applicable. No such adjudication method is mentioned as part of the described testing.

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:

No MRMC comparative effectiveness study was done or reported in this document.

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

The "Tumor Contouring" tool is described as "semi-automated," generating a preliminary border that the user must modify and review. This indicates it is not a standalone algorithm without human-in-the-loop performance. The document does not describe a standalone performance study.

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

Not applicable. The document focuses on software verification against specifications and user needs rather than clinical ground truth for the Tumor Contouring feature. The closest mention of "ground truth" would be the implicit correctness against internal software design specifications.

8. The sample size for the training set:

Not applicable. There is no mention of a training set as the device's submission did not involve clinical data or machine learning model training in the context of this summary.

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

Not applicable, as no training set is described.

Summary

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May 14, 2020

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Philips Ultrasound, Inc. % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive. Suite 510k SAINT PAUL MN 55114

Re: K201053

Trade/Device Name: PercuNav Image Fusion and Interventional Navigation Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK, IYO, LLZ Dated: April 20, 2020 Received: April 21, 2020

Dear Prithul Bom:

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/cfpmn/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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reporting

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combination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201053

Device Name

PercuNav Image Fusion and Interventional Navigation

Indications for Use (Describe)

The PercuNav system is also intended to supplement live imaging in clinical interventions to determine the proximity of one device relative to another.

The PercuNav system is not intended to be the sole guidance for any procedure. Procedures that can be guided by the PercuNav system adjunctively include, but are not limited to, the following:

· Image fusion for diagnostic clinical examinations and procedures
· Soft tissue biopsies
· Soft tissue ablation
Bone ablation
· Bone biopsies
· Nerve blocks and pain management
· Drainage placements

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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Section 8: 510(k) Summary

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K201053

Philips PercuNav Image Fusion and Interventional Navigation System

This summary of safety and effectiveness information is submitted in accordance with 21 CFR §807.92

Submitter's name, address, telephone number, contact person 1.

Sponsor:	Philips Ultrasound, Inc.
	22100 Bothell Everett Hwy
	Bothell, WA 98021-8431
Contact Person:	Travis Catania
	Senior Regulatory Affairs Specialist
	22100 Bothell Everett Hwy
	Bothell, WA 98021-8431
	Phone: (908) 227-9423
	Fax: 425-402-3481
Secondary Contact:	Hebe Sun
	Senior Manager, Regulatory Affairs
Date Prepared	January 28, 2020
2.	Name of the device, including the trade of proprietary name if applicable, the common or usual name, andthe classification name, if known:

Proprietary Name:	PercuNav Image Fusion and Interventional Navigation System
Common Name:	PercuNav Image Fusion and Interventional Navigation System
	Computed Tomography X-ray System

Regulation Description:

Classification Description	21 CFR Section	Product Code
Computed Tomography X-ray System	892.1750	JAK
Ultrasound Pulsed Echo Imaging System	892.1560	IYO
Picture Archiving and Communications System (PACS)	892.2050	LLZ

As stated in 21 CFR, parts 892.1750, 892.1560, and 892.2050, each of these generic types of devices have been classified as Class II.

Device Class:

Class II

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3. Indications for Use

The PerculNav system is a stereotaxic accessory for computed tomography (CT), cone beam CT (CBCT), magnetic resonance (MR), ultrasound (US), and positron emission tomography (PET), CT, Ultrasound, PET, and MR may be fused in various combinations, such as CT with ultrasound, and so on. It may include instrumentation to display the simulated imsertion tool such as a biopsy needle or probe on a computer monitor screen that shows images of the target organs and the current and the projected future path of the interventional instrument. The PercuNav system is intended for treatment planning and to assist guidance for clinical, interventional, or diagnostic procedures in a clinical setting.

The PercuNav system is also intended to supplement live imaging in clinical interventions to determine the proximity of one device relative to another.

The PerculVav system is not intended to be the sole guidance for any procedure. Procedures that can be guided by the PercuNav system adjunctively include, but are not limited to, the following:

Image fusion for diagnostic clinical examinations and procedures
· Soft tissue biopsies
Soft tissue ablation
Bone ablation
· Bone biopsies
Nerve blocks and pain management
Drainage placements

Device Description 4.

5. Substantially Equivalent Devices

Primary Predicate Device

Philips PercuNav Image Fusion an Interventional Navigation System K170716 April 21, 2017

Reference Predicate Device

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Philips Ultrasound, Inc.	Traditional 510(k)PercuNav Image Fusion and InterventionalNavigation System		Page 4 of 11
	Philips QLAB Advanced Quantification Software (GI 3 DQ)	K191647	December 20, 2019
	Veran Medical Technologies IG 4 Image Guided Software	K093995	January 27, 2010

6. Technological Comparison to Predicate Devices

The PercuNav Image Fusion and Interventional Navigation System with the addition of the Tumor Contouring visualization tool has the same intended use and similar technological characteristics as the legally marketed primary PercuNav predicate device. A comparison of the proposed PercuNav System (including the Tumor Contouring visualization tool) to the currently marketed predicate PercuNav device and the reference predicates Philips QLAB System (GI 3 DQ application) and Veran Medical Technologies IG 4 Image Guided Software are provided in the table below:

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Table 8.1: Comparison of Subject Philips PerculVar and Interventional Navigation to the predicate Philips Percultay Image Fusion and Interventional Navigation, QLAB Advanced Quantification Software (GI 3DQ Application) and Veran Medical Technologies IG 4 Image Guided System.

	Subject Device	Predicate Device	Reference Predicate Device	Reference Predicate Device	Explanation of Differences
Manufacturer	Philips Ultrasound, Inc.	Philips Ultrasound, Inc.	Philips Ultrasound, Inc.	Veran Medical Technologies	None
Trade Name	PercuNav System	PercuNav System	QLAB System	IG 4 Image Guided System	None
Feature	Tumor Contouring VisualizationTool	PercuNav Software	QAPP - GI 3DQ	IG 4 Software	None
510(k) Number	Pending	K170716	K191647	K093995	None
Regulation Number	21 CFR 892.1750	21 CFR 892.1750	21 CFR 892.2050	21 CFR 892.1750
Regulation Name	Computed tomography x-raysystem	Computed tomography x-ray system	System, Image processing,Radiological - PictureArchiving andCommunications System(PACS)	Computed tomography x-raysystem	Regulation Number,Regulation Name,Classification, and ProductCode are identical betweensubject device and primarypredicate device.
Classification	Class II	Class II	Class II	Class II
Product Code(s)	JAK, IYO, LLZ	JAK, IYO, LLZ	LLZ	JAK
Indications for Use	The PercuNav system is astereotaxic accessory forcomputed tomography (CT),cone beam CT (CBCT), magneticresonance (MR), ultrasound(US), and positron emissiontomography (PET). CT,Ultrasound, PET, and MR may befused in various combinations,such as CT with MR, MR withultrasound, and so on. It mayinclude instrumentation todisplay the simulated image of atracked insertion tool such as abiopsy needle or probe on acomputer monitor screen thatshows images of the targetorgans and the current and theprojected future path of theinterventional instrument. ThePercuNav system is intended for	The PercuNav system is a stereotaxicaccessory for computed tomography(CT), magnetic resonance (MR),ultrasound (US), and positronemission tomography (PET). CT,Ultrasound, PET, and MR may befused in various combinations, suchas CT with MR, MR with ultrasound,and so on. It may includeinstrumentation to display thesimulated image of a trackedinsertion tool such as a biopsy needleor probe on a computer monitorscreen that shows images of thetarget organs and the current and theprojected future path of theinterventional instrument. ThePercuNav system is intended fortreatment planning and guidance forclinical, interventional, or diagnosticprocedures. The PercuNav systemalso supports an image-free mode in	QLAB Quantificationsoftware is a softwareapplication package. It isdesigned to view andquantify image dataacquired on Philipsultrasound systems.	The ig4™ Image GuidedSystem is a stereotacticaccessory for ComputedTomography (CT) or 3Dfluoroscopic x-ray systems.The ig4 System is indicatedfor displaying aninterventional instrumentsuch as a biopsy needle, anaspiration needle, or ablationneedle on a computermonitor that also displaysCT-based or 3D fluoroscopicx-ray based model of thetarget organ(s). The ig4™System is additionallyindicated for overlayingUltrasound images onto themodel of the target organ(s).The ig4™ Systemcompensates for the patient'srespiratory phases.	The Indications for Use of thesubject PercuNav System andthe primary predicatePercuNav System are thesame and have notfundamentally changed fromthe previous clearance of thissystem. The PercuNav andQLAB System are similar inregards to image display andquantification purposes tothe end user. Additionally,the subject PercuNav Systemand the Veran ig4 Systemalso share similar indicationsfor use in regards tovisualization technologiesbeing used for proceduralplanning and instrumentfocused interventions.Moreover, the Veran ig4System is indicated for use
	Subject Device	Predicate Device	Reference Predicate Device	Reference Predicate Device	Explanation of Differences
Manufacturer	Philips Ultrasound, Inc.	Philips Ultrasound, Inc.	Philips Ultrasound, Inc.	Veran Medical Technologies	None
Trade Name	PercuNav System	PercuNav System	QLAB System	IG 4 Image Guided System	None
Feature	Tumor Contouring Visualization Toolguidance for clinical, interventional, or diagnostic procedures in a clinical setting.The PercuNav system is also intended to supplement live imaging in clinical interventions to determine the proximity of one device relative to another.The PercuNav system is not intended to be the sole guidance for any procedure. Procedures that can be guided by the PercuNav system adjunctively include, but are not limited to, the following:• Image fusion for diagnostic clinical examinations and procedures• Soft tissue biopsies• Soft tissue ablation• Bone ablation• Bone biopsies• Nerve blocks and pain management• Drainage placements	PercuNav Softwarewhich the proximity of the interventional device is displayed relative to another device.The PercuNav system is intended to be used in interventional and diagnostic procedures in a clinical setting. The PercuNav system is also intended for use in clinical interventions to determine the proximity of one device relative to another.Example procedures include, but are not limited to, the following:• Image fusion for diagnostic clinical examinations and procedures• Soft tissue biopsies (liver, lung, kidney, breast, pancreas, bladder, adrenal glands, lymph node, mesentery, and so on.)• Soft tissue ablation (liver, kidney, breast, pancreas, lung, and so on)• Bone ablations• Bone biopsies• Nerve blocks and pain management• Drainage placements• Tumor resections	QAPP - GI 3DQ	IG 4 SoftwareThe ig4™ System is intended for use in clinical interventions and for anatomical structures where computed tomography, 3D fluoroscopic x-ray, or ultrasound are currently used for visualizing such procedures.	Nonewith 3D fluoroscopic x-ray systems, which is a term that is synonymous with Cone Beam CT imaging acquisition
System Components	• Field Generator (FG)	• Field Generator (FG)	The sole component of the	• EM tracking	The System Components of
	Subject Device	Predicate Device	Reference Predicate Device	Reference Predicate Device	Explanation of Differences
Manufacturer	Philips Ultrasound, Inc.	Philips Ultrasound, Inc.	Philips Ultrasound, Inc.	Veran Medical Technologies	None
Trade Name	PercuNav System	PercuNav System	QLAB System	IG 4 Image Guided System	None

Feature	Tumor Contouring VisualizationTool	PercuNav Software	QAPP - GI 3DQ	IG 4 Software	None
	Tool Connection Unit(TCU) PercuNav Software Instrumentation	Tool Connection Unit (TCU) PercuNav Software Instrumentation	QLAB System is a softwareplatform with individuallydesignated QAPPs (i.e. GI 3DQ, etc.).	accessory for needles and ultrasound probes Patient referencing system EM Field Generator and Tracking System Ig4 software	the subject PercuNav Systemand the primary predicatePercuNav System areidentical and have not beenchanged from the previousclearance of this system. Asmentioned, the scope of thissubmission is to introducemodifications to thePercuNav Software inreleasing the TumorContouring visualization tool.The subject PercuNav andthe predicate IG4 Systemsare similar in regards to thesystem componentsincluding technologies tofacilitate instrumentationtracking.
Tracked Instrumentation /Accessories	Patient Tracker Ultrasound Tracker Coaxial Needle Tracker (CNT) Adaptive Needle Tracker (ANT) Button Probes Biopsy and RFA Introducers	Patient Tracker Ultrasound Tracker Coaxial Needle Tracker (CNT) Adaptive Needle Tracker (ANT) Button Probes Biopsy and RFA Introducers	The sole component of theQLAB System is a softwareplatform with individuallydesignated QAPPs (i.e. GI 3DQ, etc.).	EM Tracking accessory for needles and ultrasound probes Patient Referencing System	The Instrumentation /Accessories of the subjectPercuNav System and theprimary predicate PercuNavSystem are identical and havenot been changed from theprevious clearance of thissystem. As mentioned, thescope of this submission is tointroduce modifications to thePercuNav Software inreleasing the TumorContouring visualization tool.The subject PercuNav and the
		Subject Device	Predicate Device	Reference Predicate Device	Reference Predicate Device	Explanation of Differences
Manufacturer		Philips Ultrasound, Inc.	Philips Ultrasound, Inc.	Philips Ultrasound, Inc.	Veran Medical Technologies	None
Trade Name		PercuNav System	PercuNav System	QLAB System	IG 4 Image Guided System	None

Feature		Tumor Contouring VisualizationTool	PercuNav Software	QAPP - GI 3DQ	IG 4 Software	None
						predicate IG4 System includesimilar tracked instrumentationand accessories in order totrack needles and/or US probesin the tracking environment.The Tumor Contouring tool
SoftwareDesign	Tool /ApplicationDescription	Visualization tool generatessemi-automated anatomicborder detection based ongreyscale differentiation. Thetool generates a preliminaryborder that the user mustmodify and review. This toolcomputes and presents thevolume of the contour to the enduser.	Transforms two-dimensional patientimages (Ultrasound, CT, PET,PER/CT, and MRI) into dynamicrepresentation that can be fused withlive ultrasound or other previouslyacquired images. The resultingdynamic representation supportsdiagnostic review and instrumentnavigation within tracking volumeproduced by the Field Generator.	Manual anatomic bordertracing then generatesautomated 3D volumemeasurement. Diametermeasurements are manually.This app computes linearmeasurements, areameasurements, stackedcontour volumemeasurements, and ellipsoidvolume measurements.	The ig4TM Image GuidedSystem utilizes electromagnetictracking technology to locateand navigate instrumentsrelative to a CT-based or 3Dfluoroscopic x-ray based modelof the patient anatomy. Thesystem software allowsadditional data overlay of real-time Ultrasound images ontothe model of the patientanatomy.	provides the end user withsimilar functionality as the GI3DQ application as bothallow the user to generate aborder or contour aroundthe region of interest. TheTumor Contouring tool is anextension of the PercuNavSoftware in that it relies onthe PercuNav software togenerate a 3D volume for theuser. Unlike the GI 3DQapplication, the TumorContouring Tool provides apreliminary contour basedon grey scale differentiationto the end user and isconsidered to be semi-automated. However, boththe Tumor Contouring tooland GI 3 DQ, require the userto modify and confirm thecontour before it is accepted.The predicate IG4 Systemprovides similarvisualization functionality tothe subject PercuNav system.
	Subject Device	Predicate Device	Reference Predicate Device	Reference Predicate Device	Explanation of Differences
Manufacturer	Philips Ultrasound, Inc.	Philips Ultrasound, Inc.	Philips Ultrasound, Inc.	Veran Medical Technologies	None
Trade Name	PercuNav System	PercuNav System	QLAB System	IG 4 Image Guided System	None
Feature	Tumor Contouring VisualizationTool	PercuNav Software	QAPP – GI 3DQ	IG 4 Software	None
ContourGeneration	Preliminary borders and 3Dcontour are created semi-automatically based on greyscale differentiation and thenthe user is required to edit,accept, or reject contours. As thecontour is being generated,software displays volumemeasurements for the selectedcontour.	The ability to generate a contourdoes not exist in the predicate deviceand is the subject of the presentsubmission.	Preliminary borders arecreated manually by enduser to create a 3D modeland the user is thenrequired to edit, accept orreject contours.	The ability to generate acontour is not clearlymentioned as part of thistechnology and is unknown ifthis functionality exists	The Tumor Contouring tooland the GI 3DQ applicationboth allow the user to createa contour around a specifiedregion of interest. Thedifference is that the TumorContouring tool isconsidered to be semi-automated in that the toolutilizes grey scaledifferentiation to generate aninitial contour whereas theGI 3DQ requires the user tomanually create the contour.However, both the TumorContouring tool and the GI3DQ application require thatthe end user review andmodify the contour, either atindividual points or theoverall area of the contouritself, prior to accepting thegenerated contour.
QuantificationTechnology	Semi-automated contourgeneration, by which thesoftware produces a preliminarycontour trace and then the usermust edit and accept contour,within the tracking volume.Creates 3D mesh to derivevolume measurement of thecontour generated.	The predicate PercuNav Softwaredoes not produce or derive anyquantifiable measurements relatedto the images.	Manual border tracingover multiple slices;Creates 3D mesh to derivevolume measurement;diameter measurementdone via manual distancemeasurement tool	The quantificationtechnology is not clearlymentioned as part of thistechnology and is unknown ifthis technology exists.	The Tumor Contouringvisualization tool is a semi-automated tool thatproduces a contour around aregion based on grey scaledifferentiation whereas theGI 3DQ application utilizes amanual contour to begenerated by the end user.However, both the Tumor
	Subject Device	Predicate Device	Reference Predicate Device	Reference Predicate Device	Explanation of Differences
Manufacturer	Philips Ultrasound, Inc.	Philips Ultrasound, Inc.	Philips Ultrasound, Inc.	Veran Medical Technologies	None
Trade Name	PercuNav System	PercuNav System	QLAB System	IG 4 Image Guided System	None
Feature	Tumor Contouring VisualizationTool	PercuNav Software	QAPP - GI 3DQ	IG 4 Software	Contouring tool and the GI3DQ application create andutilize the 3D mesh to derivemeasurements for the regionof interest. The TumorContouring tool onlyproduces the volume of thecontour for the end user.

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