The Multimodality Advanced Vessel Analysis by Philips Medical Systems Nederland B.V.

Philips Medical Systems' Multimodality Advanced Vessels Analysis (MM AVA) application is intended for visualization, assessment, and quantification of vessels in CTA and MRA data with a unified workflow for both modalities. For CTA data, it provides both automatic and manual bone removal and vessels segmentation including extraction of vessel centerlines, lumen contours and vessel contours. For both modalities, it provides tools for extracting and editing centerlines. MM AVA offers inspection views for selected vessels centerlines and local analysis. It allows creating, capturing, and reviewing of basic user selected endovascular measurements (and calculations when applicable), as well as predefined measurements sets and measurements correlations. The physician retains the ultimate responsibility for making the final diagnosis. Philips Medical Systems' MM AVA is launched from Philips Medical Systems' IntelliSpace Portal (ISP) Platform (K162025).

AI/ML Overview

The provided document outlines the substantial equivalence of Philips Medical Systems' Multimodality Advanced Vessel Analysis (MM AVA) application to existing predicate devices. However, this submission does not contain details about specific acceptance criteria, study methodologies (like sample size for test and training sets, data provenance, expert qualifications, or adjudication methods), or performance metrics demonstrating the device meets quantitative acceptance criteria.

The document states:

"The test results in this 510(k) premarket notification demonstrate that Multimodality Advanced Vessels Analysis (MM AVA) application: ... Meets the acceptance criteria and is adequate for its intended use and specifications." (Page 17)
It also mentions that "Philips Medical Systems' Multimodality Advanced Vessels Analysis (MM AVA) application was tested in accordance with Philips verification and validation processes. Verification and Validation tests have been performed to address intended use, the technological characteristics, requirement specifications and the risk management results." (Page 17)

However, the specifics of these "acceptance criteria" and the "test results" demonstrating they were met are not provided in the publicly available sections of this 510(k) summary. This summary focuses on establishing substantial equivalence based on features, intended use, and existing standards rather than detailed performance study results against predefined objective metrics.

Therefore, I cannot populate the requested table or answer the specific questions about the study design that proves the device meets the acceptance criteria, as that information is not present in the provided text.

Based on the available text, here's what can be stated:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria (e.g., Specificity, Sensitivity, Accuracy, etc.)	Reported Device Performance
Not specified in the provided document.	Not specified in the provided document.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not specified in the provided document.
Data Provenance: Not specified in the provided document (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not specified in the provided document.
Qualifications of Experts: Not specified in the provided document.

4. Adjudication method for the test set:

Adjudication Method: Not specified in the provided 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:

MRMC Study Done: Not specified whether an MRMC study was performed in the context of human-in-the-loop performance. The document focuses on the software's features and its substantial equivalence to predicate devices, not on human reader improvement with AI assistance.

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

Standalone Performance Study: The document states "Non-clinical performance tests has been performed on Multimodality Advanced Vessels Analysis (MM AVA) application" and "Philips Medical Systems Multimodality Advanced Vessels Analysis (MM AVA) application was tested in accordance with Philips verification and validation processes." This implies standalone testing, but specific performance metrics (e.g., accuracy of automatic measurements) are not detailed.

7. The type of ground truth used:

Type of Ground Truth: Not specified in the provided document.

8. The sample size for the training set:

Sample Size for Training Set: Not specified in the provided document.

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

Ground Truth Establishment for Training Set: Not specified in the provided document.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence through feature comparison and compliance with general standards and internal validation processes, rather than presenting detailed performance study results that would typically include the requested information.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION".

November 25, 2020

Philips Medical Systems Nederland B.V. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114

Re: K203216

Trade/Device Name: The Multimodality Advanced Vessel Analysis (MM AVA) application Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: October 28, 2020 Received: November 2, 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

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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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 mediation-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,

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) K203216

Device Name

The Multimodality Advanced Vessel Analysis (MM AVA) application

Indications for Use (Describe)

The Multimodality Advanced Vessels Analysis (MM AVA) application is intended for visualization, assessment and quantification of vascular datasets.

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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Image /page/3/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. Above the word "PHILIPS" is the alphanumeric code "K203216" in a smaller, black font. The background of the image is white. The text is centered.

510(k) Summary

The Multimodality Advanced Vessel Analysis (MM AVA) Application

Date Prepared: October 6, 2020

I. Submitter's name and address

Manufacturer:	Philips Medical Systems Nederland B.V.Veenpluis 4-65684 PC BestThe NetherlandsEstablishment Registration Number: 3003768277
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Primary Person:	Contact Vered NitzanRegulatory Affairs LeadPhone: +972 54-9797047E-mail: vered.nitzan@Philips.com
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II. Device information

Device:
Trade Name:	The Multimodality Advanced Vessel Analysis(MM AVA) application
Classification Name:	Computed tomography x-ray system
Classification Regulation:	21 CFR 892.1750
Classification Panel:	Radiology
Device Class:	II
Primary Product Code:	JAK

III. Device Description

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removal and vessels segmentation including extraction of vessel centerlines, lumen contours and vessel contours. For both modalities, it provides tools for extracting and editing centerlines.

MM AVA offers inspection views for selected vessels centerlines and local analysis. It allows creating, capturing, and reviewing of basic user selected endovascular measurements (and calculations when applicable), as well as predefined measurements sets and measurements correlations.

The physician retains the ultimate responsibility for making the final diagnosis.

Philips Medical Systems' MM AVA is launched from Philips Medical Systems' IntelliSpace Portal (ISP) Platform (K162025).

Kev Features:

1. Provides automatic bone removal for CTA data
1. Provides automatic vessel centerline extraction and labeling for the main vessels (CTA data)
1. Provides a set of centerline creation and editing tools (manual and semi-automatic)
1. Provides dedicated views for vessels review: Curved MPRS, Straighten MPR, Crosssectional and Longitudinal MPR
1. Provides 3D Volume rendering capabilities for CTA and MRA, including different volumetric presentation options such as Volume rendering, MIP (Maximum Intensity Projection) etc.
1. Allows measurements along a vessel centerline, based on a user selected location/s such as Max Diameter, Min Diameter and Area
1. Allows the calculation of measurements such as: Length, Angle, Tortuosity, Stenosis, Aneurysm etc. based on user selected locations and their intra-correlations.
1. Allows navigation and local inspection of images, including capturing measurements such as diameters (Quick Inspection)
1. Allows Batch (series of images processed by user) generation for any of the selected user views.

IV. Intended Use and Indications for Use:

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The Multimodality Advanced Vessels Analysis (MM AVA) application is intended for visualization, assessment, and quantification of vascular datasets.

V. Predicate Devices:

The following table shows the predicate devices of the proposed Philips Medical Systems Multimodality Advanced Vessels Analysis (MM AVA) application:

	Device Name	Manufacturer	510k No
Primary Predicate	Brilliance Volume	Philips Medical Systems (Cleveland), Inc.	K060937
Secondary Predicate	syngo.CT Vascular Analysis	Siemens Medical Solutions, Inc.	K112020
Secondary Predicate	syngo.MR Vascular	Siemens Medical Solutions, Inc.	K130749

The proposed Philips Medical Systems Multimodality Advanced Vessels Analysis (MM AVA) application and its predicate devices, Brilliance Volume (K060937), syngo.CT Vascular Analysis (K112020) and syngo.MR Vascular (K130749) are equivalent regarding their intended uses, clinical indications, principle of operation and fundamental technology.

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VI. Substantial Equivalence to Predicate Devices:

Feature	The proposed device:MM AVA Application	Primary Predicate:Brilliance Volume(K060937)	Secondary Predicate:Siemens syngo.CTVascular Analysis(K112020)	Secondary Predicate:Siemens syngo.MRVascular(K130749)
Device ClassificationName	System, X-Ray,Tomography, Computed	System, X-Ray,Tomography, Computed	System, X-Ray,Tomography, Computed	System, Image Processing,Radiological
Device Class	Class II	Class II	Class II	Class II
Classification Panel	Radiology	Radiology	Radiology	Radiology
Product Code	JAK	JAK	JAK	LLZ, LNH
Regulation Description	Computed tomography x-ray system	Computed tomography x-ray system	Computed tomography x-ray system	Picture Archiving andCommunication System(PACS)
Regulation Number	21 CFR 892.1750	21 CFR 892.1750	21 CFR 892.1750	21 CFR 892.2050
Indication for Use	The MultimodalityAdvanced Vessels Analysis(MM AVA) application is	The "Brilliance Volume" isa Computed TomographyX-Ray System intended to	syngo CT VascularAnalysis is an imageanalysis software package	The software comprisingthe syngo.MR post-processing applications are
	The proposed device:	Primary Predicate:	Secondary Predicate:	Secondary Predicate:
Feature	MM AVA Application	Brilliance Volume(K060937)	Siemens syngo.CTVascular Analysis(K112020)	Siemens syngo.MRVascular(K130749)
	intended for visualization,assessment andquantification ofvascular datasets.	producecross-sectional images ofthe body by computerreconstruction of x-raytransmission datataken at different anglesand planes. This devicemay include signal analysisand displayequipment, patient, andequipment supports,components andaccessories.	for evaluating enhanced CTimages. Combining digitalimage processing andvisualization tools(multiplanar reconstruction(MPR) thin/thick,maximum intensityprojection (MIP) thin/thick,inverted MIP thin/thick,volume renderingtechnique (VRT), curvedplanar reformation (CPR),processing tools (boneremoval (based both onsingle energy and DualEnergy), table removal)and evaluation tools (vesselcenterline calculation,lumen calculation, stenosiscalculation) and reportingtools (lesion location,lesion characteristics and	post-processing software /applications to be used forviewing and evaluating thedesignated imagesprovided by a magneticresonance diagnosticdevice.syngo.MR Vascular is asyngo based post-processing software forviewing, manipulating, andevaluating MR vascularimages.
Feature	The proposed device:MM AVA Application	Primary Predicate:Brilliance Volume(K060937)	Secondary Predicate:Siemens syngo.CTVascular Analysis(K112020)	Secondary Predicate:Siemens syngo.MRVascular(K130749)
			key images), the software package is designed to support the physician in confirming the presence or absence of physician-identified lesions in blood vessels and evaluation, documentation and follow-up of any such lesion. These visualization/processing/evaluation tools allow for characterization of vascular lesions and lesion size over time, helping the physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue.
	The proposed device:	Primary Predicate:	Secondary Predicate:	Secondary Predicate:
Feature	MM AVA Application	Brilliance Volume(K060937)	Siemens syngo.CTVascular Analysis(K112020)	Siemens syngo.MRVascular(K130749)
Intended body part	Head and neck, body,peripherals	Head and neck, body,peripherals	Head and neck, body,peripherals	Head and neck, body,peripherals
Type of scans	CT Angiography and MRAngiography	CT Angiography	CT Angiography	MR Angiography
Automatic bone removalfor CTA data	Yes	Yes	Yes(Including Dual Energy)	NA
Feature	The proposed device:MM AVA Application	Primary Predicate:Brilliance Volume(K060937)	Secondary Predicate:Siemens syngo.CTVascular Analysis(K112020)	Secondary Predicate:Siemens syngo.MRVascular(K130749)
Semi-automatic boneremoval for CTA data	Yes	Yes	Yes	No
Bone Removal Edit forCTA dataManual interactions forcorrection of boneremovalresults.	Yes	Yes	Yes	NA
Automatic vesselcenterline extraction	Yes (CT only)	Yes	Yes	No
Automatic vessel labeling	Yes (CT only)	Yes	Yes	No
Manual Vessel TrackingManual drawing andediting of vascular pathsfor curved MPR	Yes (manual and semi-automatic)	Yes	Yes	Yes
Feature	The proposed device:MM AVA Application	Primary Predicate:Brilliance Volume(K060937)	Secondary Predicate:Siemens syngo.CTVascular Analysis(K112020)	Secondary Predicate:Siemens syngo.MRVascular(K130749)
visualization
Vessel TrackingTools for semi-automatictracking and editing ofvascular structures.	Yes	Yes	Yes	Yes
Vessel centerline andlumen contoursextraction	Yes	Yes	Yes	Yes
(Semi) automaticsegmentation of vesselanatomy	Yes	Yes	Yes	Yes
Curved MPR (CPR) andCross Section MPRVisualization of vessels incurved MPR withcorresponding cross-sectional Images.	Yes	Yes	Yes	Yes
Feature	The proposed device:MM AVA Application	Primary Predicate:Brilliance Volume(K060937)	Secondary Predicate:Siemens syngo.CTVascular Analysis(K112020)	Secondary Predicate:Siemens syngo.MRVascular(K130749)
Curved reformat vesselviews	Yes	Yes	Yes	Yes
Vessel aligned MPR views(Straighten MPR)	Yes	Yes	Yes	Yes
3D volumetric vesselviews	Yes	Yes	Yes	Yes
Diameter measurement	Yes	Yes	Yes	Yes
Stenosis MeasurementStenosis values based onlumen contouring.	Yes	Yes	Yes	Yes
Aneurysm measurement	Yes	Yes	Not specified	Not specified
3D vascularmeasurements (diameter,stenosis, aneurysm)	Yes	Yes	Yes	Yes
Feature	The proposed device:MM AVA Application	Primary Predicate:Brilliance Volume(K060937)	Secondary Predicate:Siemens syngo.CTVascular Analysis(K112020)	Secondary Predicate:Siemens syngo.MRVascular(K130749)
MeasurementseditingFunctionality for editingvalues of clinical findingssuch as location,pathology, etc.	Yes	Yes	Yes	Yes
Lumen evaluationDelineation of vesselcontours for vascularanalysis	Yes	Yes	Yes	Yes
Navigate Along VesselSemi-automatic alignmentof MPR views to localvascular anatomy withinteractive navigationalongvessel course.	Yes	Yes	Yes	Yes
Feature	The proposed device:MM AVA Application	Primary Predicate:Brilliance Volume(K060937)	Secondary Predicate:Siemens syngo.CTVascular Analysis(K112020)	Secondary Predicate:Siemens syngo.MRVascular(K130749)
Review MarkerFunctionality for settinglocation of a clinicalfinding on any view.	Yes	Yes	Yes	Yes
Curved and Cross-Sectional RangesCreation of MPR seriesaround and along vesselspath.	Yes	Yes	Yes	Yes
Basic ReadingFunctionalityConventional navigationon 2D and 3D views,change of layouts, adaptwindow values.	Yes	Yes	Yes	Yes
Bone Opacity for CTAdata	Yes	Yes	Yes	NA
Feature	The proposed device:MM AVA Application	Primary Predicate:Brilliance Volume(K060937)	Secondary Predicate:Siemens syngo.CTVascular Analysis(K112020)	Secondary Predicate:Siemens syngo.MRVascular(K130749)
Table (couch) RemovalSegmentation of patienttable for clear VRTvisualization of anatomy.	Yes	Yes	Yes	NA
Angio ViewInverted MIP visualizationof vessels filled withcontrast agent.	Yes	Yes	Yes	Yes
Calcification Removal forCTA dataMasking of high intensitystructures along vesselsfor true lumenvisualization.	Yes	Yes	Yes(also for dual energy)	NA
DICOM compatible	Yes	Yes	Yes	Yes

Premarket Notification [510(K)] Submission
Philips Medical Systems Nederland B.V.

Section 5-1 Page 5 of 16

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