The Multimodality Advanced Vessel Analysis
Device Facts
| Record ID | K203216 |
|---|---|
| Device Name | The Multimodality Advanced Vessel Analysis |
| Applicant | Philips Medical Systems Nederland B.V. |
| Product Code | JAK · Radiology |
| Decision Date | Nov 25, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1750 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device, 3rd-Party Reviewed |
Indications for Use
The Multimodality Advanced Vessels Analysis (MM AVA) application is intended for visualization, assessment, and quantification of vascular datasets.
Device Story
MM AVA is a software application for visualization, assessment, and quantification of vascular datasets from CTA and MRA. It operates on the Philips IntelliSpace Portal (ISP) platform. Input data consists of CTA and MRA images. The device performs automatic and manual bone removal (CTA), vessel segmentation, centerline extraction, and labeling. It provides tools for curved/straightened multiplanar reconstruction (MPR), cross-sectional/longitudinal views, and 3D volume rendering. Physicians use these tools to perform measurements (diameter, length, angle, tortuosity, stenosis, aneurysm) and review vascular anatomy. The application supports clinical decision-making by providing quantitative data and visualization for vascular assessment. It is intended for use by clinicians in a clinical setting. The physician retains ultimate responsibility for diagnosis.
Clinical Evidence
Bench testing only. Verification and validation testing were performed in accordance with Philips processes to address intended use, technological characteristics, requirements, and risk management. Compliance with ISO 14971, IEC 62304, NEMA PS 3.1-3.21 (DICOM), and IEC 62366-1 was demonstrated.
Technological Characteristics
Software-based image processing application. Features include automatic/manual bone removal, vessel centerline extraction, labeling, and 3D volume rendering. Connectivity via DICOM standard. Operates on Philips IntelliSpace Portal (ISP) platform. Software lifecycle follows IEC 62304.
Indications for Use
Indicated for visualization, assessment, and quantification of vascular datasets in CTA and MRA images for patients requiring vascular analysis.
Regulatory Classification
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.
Predicate Devices
Submission Summary (Full Text)
{0}------------------------------------------------
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
{2}------------------------------------------------
### 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)
### 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."
{3}------------------------------------------------
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.<br>Veenpluis 4-6<br>5684 PC Best<br>The Netherlands<br>Establishment Registration Number: 3003768277 |
|---------------|---------------------------------------------------------------------------------------------------------------------------------------------|
|---------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Person: | Contact Vered Nitzan<br>Regulatory Affairs Lead<br>Phone: +972 54-9797047<br>E-mail: vered.nitzan@Philips.com |
|-----------------|---------------------------------------------------------------------------------------------------------------|
|-----------------|---------------------------------------------------------------------------------------------------------------|
#### II. Device information
| Device: | |
|----------------------------|--------------------------------------------------------------------|
| Trade Name: | The Multimodality Advanced Vessel Analysis<br>(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
- 2. Provides automatic vessel centerline extraction and labeling for the main vessels (CTA data)
- 3. Provides a set of centerline creation and editing tools (manual and semi-automatic)
- 4. Provides dedicated views for vessels review: Curved MPRS, Straighten MPR, Crosssectional and Longitudinal MPR
- 5. Provides 3D Volume rendering capabilities for CTA and MRA, including different volumetric presentation options such as Volume rendering, MIP (Maximum Intensity Projection) etc.
- 6. Allows measurements along a vessel centerline, based on a user selected location/s such as Max Diameter, Min Diameter and Area
- 7. Allows the calculation of measurements such as: Length, Angle, Tortuosity, Stenosis, Aneurysm etc. based on user selected locations and their intra-correlations.
- 8. Allows navigation and local inspection of images, including capturing measurements such as diameters (Quick Inspection)
- 9. Allows Batch (series of images processed by user) generation for any of the selected user views.
#### IV. Intended Use and Indications for Use:
{5}------------------------------------------------
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.
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and appear to be a sans-serif font. The background is plain white, which makes the blue text stand out.
#### VI. Substantial Equivalence to Predicate Devices:
| Feature | The proposed device:<br>MM AVA Application | Primary Predicate:<br>Brilliance Volume<br>(K060937) | Secondary Predicate:<br>Siemens syngo.CT<br>Vascular Analysis<br>(K112020) | Secondary Predicate:<br>Siemens syngo.MR<br>Vascular<br>(K130749) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification<br>Name | System, X-Ray,<br>Tomography, Computed | System, X-Ray,<br>Tomography, Computed | System, X-Ray,<br>Tomography, Computed | System, Image Processing,<br>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-<br>ray system | Computed tomography x-<br>ray system | Computed tomography x-<br>ray system | Picture Archiving and<br>Communication System<br>(PACS) |
| Regulation Number | 21 CFR 892.1750 | 21 CFR 892.1750 | 21 CFR 892.1750 | 21 CFR 892.2050 |
| Indication for Use | The Multimodality<br>Advanced Vessels Analysis<br>(MM AVA) application is | The "Brilliance Volume" is<br>a Computed Tomography<br>X-Ray System intended to | syngo CT Vascular<br>Analysis is an image<br>analysis software package | The software comprising<br>the syngo.MR post-<br>processing applications are |
| | The proposed device: | Primary Predicate: | Secondary Predicate: | Secondary Predicate: |
| Feature | MM AVA Application | Brilliance Volume<br>(K060937) | Siemens syngo.CT<br>Vascular Analysis<br>(K112020) | Siemens syngo.MR<br>Vascular<br>(K130749) |
| | intended for visualization,<br>assessment and<br>quantification of<br>vascular datasets. | produce<br>cross-sectional images of<br>the body by computer<br>reconstruction of x-ray<br>transmission data<br>taken at different angles<br>and planes. This device<br>may include signal analysis<br>and display<br>equipment, patient, and<br>equipment supports,<br>components and<br>accessories. | for evaluating enhanced CT<br>images. Combining digital<br>image processing and<br>visualization tools<br>(multiplanar reconstruction<br>(MPR) thin/thick,<br>maximum intensity<br>projection (MIP) thin/thick,<br>inverted MIP thin/thick,<br>volume rendering<br>technique (VRT), curved<br>planar reformation (CPR),<br>processing tools (bone<br>removal (based both on<br>single energy and Dual<br>Energy), table removal)<br>and evaluation tools (vessel<br>centerline calculation,<br>lumen calculation, stenosis<br>calculation) and reporting<br>tools (lesion location,<br>lesion characteristics and | post-processing software /<br>applications to be used for<br>viewing and evaluating the<br>designated images<br>provided by a magnetic<br>resonance diagnostic<br>device.<br>syngo.MR Vascular is a<br>syngo based post-<br>processing software for<br>viewing, manipulating, and<br>evaluating MR vascular<br>images. |
| Feature | The proposed device:<br>MM AVA Application | Primary Predicate:<br>Brilliance Volume<br>(K060937) | Secondary Predicate:<br>Siemens syngo.CT<br>Vascular Analysis<br>(K112020) | Secondary Predicate:<br>Siemens syngo.MR<br>Vascular<br>(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<br>(K060937) | Siemens syngo.CT<br>Vascular Analysis<br>(K112020) | Siemens syngo.MR<br>Vascular<br>(K130749) |
| Intended body part | Head and neck, body,<br>peripherals | Head and neck, body,<br>peripherals | Head and neck, body,<br>peripherals | Head and neck, body,<br>peripherals |
| Type of scans | CT Angiography and MR<br>Angiography | CT Angiography | CT Angiography | MR Angiography |
| Automatic bone removal<br>for CTA data | Yes | Yes | Yes<br>(Including Dual Energy) | NA |
| Feature | The proposed device:<br>MM AVA Application | Primary Predicate:<br>Brilliance Volume<br>(K060937) | Secondary Predicate:<br>Siemens syngo.CT<br>Vascular Analysis<br>(K112020) | Secondary Predicate:<br>Siemens syngo.MR<br>Vascular<br>(K130749) |
| Semi-automatic bone<br>removal for CTA data | Yes | Yes | Yes | No |
| Bone Removal Edit for<br>CTA data<br>Manual interactions for<br>correction of bone<br>removal<br>results. | Yes | Yes | Yes | NA |
| Automatic vessel<br>centerline extraction | Yes (CT only) | Yes | Yes | No |
| Automatic vessel labeling | Yes (CT only) | Yes | Yes | No |
| Manual Vessel Tracking<br>Manual drawing and<br>editing of vascular paths<br>for curved MPR | Yes (manual and semi-<br>automatic) | Yes | Yes | Yes |
| Feature | The proposed device:<br>MM AVA Application | Primary Predicate:<br>Brilliance Volume<br>(K060937) | Secondary Predicate:<br>Siemens syngo.CT<br>Vascular Analysis<br>(K112020) | Secondary Predicate:<br>Siemens syngo.MR<br>Vascular<br>(K130749) |
| visualization | | | | |
| Vessel Tracking<br>Tools for semi-automatic<br>tracking and editing of<br>vascular structures. | Yes | Yes | Yes | Yes |
| Vessel centerline and<br>lumen contours<br>extraction | Yes | Yes | Yes | Yes |
| (Semi) automatic<br>segmentation of vessel<br>anatomy | Yes | Yes | Yes | Yes |
| Curved MPR (CPR) and<br>Cross Section MPR<br>Visualization of vessels in<br>curved MPR with<br>corresponding cross-<br>sectional Images. | Yes | Yes | Yes | Yes |
| Feature | The proposed device:<br>MM AVA Application | Primary Predicate:<br>Brilliance Volume<br>(K060937) | Secondary Predicate:<br>Siemens syngo.CT<br>Vascular Analysis<br>(K112020) | Secondary Predicate:<br>Siemens syngo.MR<br>Vascular<br>(K130749) |
| Curved reformat vessel<br>views | Yes | Yes | Yes | Yes |
| Vessel aligned MPR views<br>(Straighten MPR) | Yes | Yes | Yes | Yes |
| 3D volumetric vessel<br>views | Yes | Yes | Yes | Yes |
| Diameter measurement | Yes | Yes | Yes | Yes |
| Stenosis Measurement<br>Stenosis values based on<br>lumen contouring. | Yes | Yes | Yes | Yes |
| Aneurysm measurement | Yes | Yes | Not specified | Not specified |
| 3D vascular<br>measurements (diameter,<br>stenosis, aneurysm) | Yes | Yes | Yes | Yes |
| Feature | The proposed device:<br>MM AVA Application | Primary Predicate:<br>Brilliance Volume<br>(K060937) | Secondary Predicate:<br>Siemens syngo.CT<br>Vascular Analysis<br>(K112020) | Secondary Predicate:<br>Siemens syngo.MR<br>Vascular<br>(K130749) |
| Measurements<br>editing<br>Functionality for editing<br>values of clinical findings<br>such as location,<br>pathology, etc. | Yes | Yes | Yes | Yes |
| Lumen evaluation<br>Delineation of vessel<br>contours for vascular<br>analysis | Yes | Yes | Yes | Yes |
| Navigate Along Vessel<br>Semi-automatic alignment<br>of MPR views to local<br>vascular anatomy with<br>interactive navigation<br>along<br>vessel course. | Yes | Yes | Yes | Yes |
| Feature | The proposed device:<br>MM AVA Application | Primary Predicate:<br>Brilliance Volume<br>(K060937) | Secondary Predicate:<br>Siemens syngo.CT<br>Vascular Analysis<br>(K112020) | Secondary Predicate:<br>Siemens syngo.MR<br>Vascular<br>(K130749) |
| Review Marker<br>Functionality for setting<br>location of a clinical<br>finding on any view. | Yes | Yes | Yes | Yes |
| Curved and Cross-<br>Sectional Ranges<br>Creation of MPR series<br>around and along vessels<br>path. | Yes | Yes | Yes | Yes |
| Basic Reading<br>Functionality<br>Conventional navigation<br>on 2D and 3D views,<br>change of layouts, adapt<br>window values. | Yes | Yes…
