Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard image processing and visualization tools for vascular analysis and does not mention AI, ML, or related terms.

Therapeutic

No.
The device is described as an application for visualization, assessment, and quantification of vascular datasets from existing CTA and MRA data, and it explicitly states that the "physician retains the ultimate responsibility for making the final diagnosis." This indicates it is a diagnostic tool, not a therapeutic one.

Diagnostic

No
The device is intended for visualization, assessment, and quantification of vascular datasets, providing tools for analysis and measurement. It is explicitly stated that "The physician retains the ultimate responsibility for making the final diagnosis," indicating that the device provides data for diagnosis rather than performing the diagnosis itself.

SaMD (Software as a Medical Device)

Yes

The device is described as an "application" launched from a "Platform" and its description focuses entirely on software functionalities like visualization, assessment, quantification, segmentation, and measurement tools applied to existing imaging data. There is no mention of any hardware components being part of the device itself.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for "visualization, assessment and quantification of vascular datasets" from CTA and MRA data. This involves processing and analyzing medical images, not analyzing samples taken from the human body (like blood, urine, tissue, etc.).
Device Description: The description focuses on image processing, segmentation, measurement, and visualization tools applied to imaging data. It does not mention any components or processes related to analyzing biological samples.
Input: The input is CTA and MRA data, which are medical imaging modalities, not biological samples.
Lack of IVD Characteristics: There is no mention of reagents, calibrators, controls, or any other elements typically associated with in vitro diagnostic devices.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device operates on medical images, which falls under the category of medical imaging software or image processing software, not IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

JAK

Device Description

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).

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT Angiography and MR Angiography

Anatomical Site

Head and neck, body, peripherals

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical performance tests has been performed on Multimodality Advanced Vessels Analysis (MM AVA) application and demonstrates compliance with the following International and FDA-recognized consensus standards:

ISO 14971 Medical devices Application of risk management to medical devices
IEC 62304 Medical device software Software life cycle processes
NEMA PS 3.1-3.21 Digital Imaging and Communications in Medicine (DICOM) Standard
IEC 62366-1 Medical devices Part 1: Application of usability engineering to medical devices

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.

The test results in this 510(k) premarket notification demonstrate that Multimodality Advanced Vessels Analysis (MM AVA) application:

. Complies with the aforementioned international and FDA-recognized consensus standards and FDA guidance documents, and
Meets the acceptance criteria and is adequate for its intended use and specifications. .

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K060937, K112020, K130749

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

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

1

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 4-6
5684 PC Best
The Netherlands
Establishment Registration Number: 3003768277 |

---------------	---------------------------------------------------------------------------------------------------------------------------------------------

| Primary Person: | Contact Vered Nitzan
Regulatory Affairs Lead
Phone: +972 54-9797047
E-mail: vered.nitzan@Philips.com |

-----------------	---------------------------------------------------------------------------------------------------------------

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

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

4

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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Image /page/5/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, providing a strong contrast that makes the word stand out.

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.CT
Vascular Analysis
(K112020) | Secondary Predicate:
Siemens syngo.MR
Vascular
(K130749) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification
Name | 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 and
Communication System
(PACS) |
| Regulation Number | 21 CFR 892.1750 | 21 CFR 892.1750 | 21 CFR 892.1750 | 21 CFR 892.2050 |
| Indication for Use | The Multimodality
Advanced Vessels Analysis
(MM AVA) application is | The "Brilliance Volume" is
a Computed Tomography
X-Ray System intended to | syngo CT Vascular
Analysis is an image
analysis software package | The software comprising
the syngo.MR post-
processing applications are |
| | The proposed device: | Primary Predicate: | Secondary Predicate: | Secondary Predicate: |
| Feature | MM AVA Application | Brilliance Volume
(K060937) | Siemens syngo.CT
Vascular Analysis
(K112020) | Siemens syngo.MR
Vascular
(K130749) |
| | intended for visualization,
assessment and
quantification of
vascular datasets. | produce
cross-sectional images of
the body by computer
reconstruction of x-ray
transmission data
taken at different angles
and planes. This device
may include signal analysis
and display
equipment, patient, and
equipment supports,
components and
accessories. | for evaluating enhanced CT
images. Combining digital
image processing and
visualization tools
(multiplanar reconstruction
(MPR) thin/thick,
maximum intensity
projection (MIP) thin/thick,
inverted MIP thin/thick,
volume rendering
technique (VRT), curved
planar reformation (CPR),
processing tools (bone
removal (based both on
single energy and Dual
Energy), table removal)
and evaluation tools (vessel
centerline calculation,
lumen calculation, stenosis
calculation) and reporting
tools (lesion location,
lesion characteristics and | post-processing software /
applications to be used for
viewing and evaluating the
designated images
provided by a magnetic
resonance diagnostic
device.
syngo.MR Vascular is a
syngo based post-
processing software for
viewing, manipulating, and
evaluating MR vascular
images. |
| Feature | The proposed device:
MM AVA Application | Primary Predicate:
Brilliance Volume
(K060937) | Secondary Predicate:
Siemens syngo.CT
Vascular Analysis
(K112020) | Secondary Predicate:
Siemens syngo.MR
Vascular
(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.CT
Vascular Analysis
(K112020) | Siemens syngo.MR
Vascular
(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 MR
Angiography | CT Angiography | CT Angiography | MR Angiography |
| Automatic bone removal
for 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.CT
Vascular Analysis
(K112020) | Secondary Predicate:
Siemens syngo.MR
Vascular
(K130749) |
| Semi-automatic bone
removal for CTA data | Yes | Yes | Yes | No |
| Bone Removal Edit for
CTA data
Manual interactions for
correction of bone
removal
results. | Yes | Yes | Yes | NA |
| Automatic vessel
centerline extraction | Yes (CT only) | Yes | Yes | No |
| Automatic vessel labeling | Yes (CT only) | Yes | Yes | No |
| Manual Vessel Tracking
Manual drawing and
editing of vascular paths
for 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.CT
Vascular Analysis
(K112020) | Secondary Predicate:
Siemens syngo.MR
Vascular
(K130749) |
| visualization | | | | |
| Vessel Tracking
Tools for semi-automatic
tracking and editing of
vascular structures. | Yes | Yes | Yes | Yes |
| Vessel centerline and
lumen contours
extraction | Yes | Yes | Yes | Yes |
| (Semi) automatic
segmentation of vessel
anatomy | Yes | Yes | Yes | Yes |
| Curved MPR (CPR) and
Cross Section MPR
Visualization of vessels in
curved MPR with
corresponding cross-
sectional Images. | Yes | Yes | Yes | Yes |
| Feature | The proposed device:
MM AVA Application | Primary Predicate:
Brilliance Volume
(K060937) | Secondary Predicate:
Siemens syngo.CT
Vascular Analysis
(K112020) | Secondary Predicate:
Siemens syngo.MR
Vascular
(K130749) |
| Curved reformat vessel
views | Yes | Yes | Yes | Yes |
| Vessel aligned MPR views
(Straighten MPR) | Yes | Yes | Yes | Yes |
| 3D volumetric vessel
views | Yes | Yes | Yes | Yes |
| Diameter measurement | Yes | Yes | Yes | Yes |
| Stenosis Measurement
Stenosis values based on
lumen contouring. | Yes | Yes | Yes | Yes |
| Aneurysm measurement | Yes | Yes | Not specified | Not specified |
| 3D vascular
measurements (diameter,
stenosis, aneurysm) | Yes | Yes | Yes | Yes |
| Feature | The proposed device:
MM AVA Application | Primary Predicate:
Brilliance Volume
(K060937) | Secondary Predicate:
Siemens syngo.CT
Vascular Analysis
(K112020) | Secondary Predicate:
Siemens syngo.MR
Vascular
(K130749) |
| Measurements
editing
Functionality for editing
values of clinical findings
such as location,
pathology, etc. | Yes | Yes | Yes | Yes |
| Lumen evaluation
Delineation of vessel
contours for vascular
analysis | Yes | Yes | Yes | Yes |
| Navigate Along Vessel
Semi-automatic alignment
of MPR views to local
vascular anatomy with
interactive navigation
along
vessel course. | Yes | Yes | Yes | Yes |
| Feature | The proposed device:
MM AVA Application | Primary Predicate:
Brilliance Volume
(K060937) | Secondary Predicate:
Siemens syngo.CT
Vascular Analysis
(K112020) | Secondary Predicate:
Siemens syngo.MR
Vascular
(K130749) |
| Review Marker
Functionality for setting
location of a clinical
finding on any view. | Yes | Yes | Yes | Yes |
| Curved and Cross-
Sectional Ranges
Creation of MPR series
around and along vessels
path. | Yes | Yes | Yes | Yes |
| Basic Reading
Functionality
Conventional navigation
on 2D and 3D views,
change of layouts, adapt
window values. | Yes | Yes | Yes | Yes |
| Bone Opacity for CTA
data | Yes | Yes | Yes | NA |
| Feature | The proposed device:
MM AVA Application | Primary Predicate:
Brilliance Volume
(K060937) | Secondary Predicate:
Siemens syngo.CT
Vascular Analysis
(K112020) | Secondary Predicate:
Siemens syngo.MR
Vascular
(K130749) |
| Table (couch) Removal
Segmentation of patient
table for clear VRT
visualization of anatomy. | Yes | Yes | Yes | NA |
| Angio View
Inverted MIP visualization
of vessels filled with
contrast agent. | Yes | Yes | Yes | Yes |
| Calcification Removal for
CTA data
Masking of high intensity
structures along vessels
for true lumen
visualization. | 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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