VesselNavigator provides image guidance by superimposing live fluoroscopic images on a 3D volume of the vessel anatomy to assist in catheter maneuvering and device placement.

VesselNavigator is intended to assist in the treatment of endovascular diseases during procedures such as (but not limited to) AAA, TAA, carotid stenting, iliac interventions.

Device Description

VesselNavigator is a software product (Interventional Tool) intended to assist in the treatment of endovascular diseases during an endovascular intervention procedure. VesselNavigator is intended to be used in combination with a Philips Interventional X-ray system. VesselNavigator can be used during any endovascular intervention and covers all vascular anatomy except coronaries and intracranial vessels.

It provides live 3D image guidance for navigating endovascular devices through intended vascular structures in the body, reusing previously acquired diagnostic 3D images. After registration, the 3D volume can be used as a 3D roadmap for navigation; live 2D fluoroscopic images will be overlaid on the 3D volume. In addition, VesselNavigator provides tools to segment the relevant vasculature in the 3D volume (where the end-user is able to edit the segmentation results), place landmarks for easy recognition of key anatomical points of interests, and store and recall of preferred view angles.

AI/ML Overview

The provided text does not contain specific acceptance criteria for the device (VesselNavigator) or a detailed study proving it meets such criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity).

The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies with quantitative acceptance criteria typically found in, for example, AI/ML device submissions.

However, based on the information provided, here's a breakdown of what can be extracted or inferred regarding performance and validation:

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

No explicit quantitative acceptance criteria or detailed performance metrics (accuracy, precision, etc.) are provided in this document. The "performance" described is largely functional and safety-related, aimed at demonstrating substantial equivalence.

Acceptance Criteria (Inferred from "Nonclinical Performance Data")	Reported Device Performance
Compliance with IEC 62304 (Medical device software)	Complies
Compliance with IEC 62366 (Usability engineering)	Complies
Compliance with ISO 14971 (Risk management)	Complies
Compliance with NEMA PS 3.1-3.20 (DICOM)	Complies
Compliance with FDA Guidance for "Software Contained in Medical Devices"	Complies
Software verification for system level requirements	Tests performed successfully
Software verification for identified hazard mitigations	Tests performed successfully
Vessel segmentation tool validation	Tested and validated
Intended use and commercial claims validation	Tested and validated
Usability testing with representative intended users	Tested and validated
Does not raise new questions on safety or effectiveness	No new questions raised
As safe and effective as its predicate device	Demonstrated

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

The document primarily describes software verification and validation, and usability testing. It does not mention a "test set" in the context of a dataset of patient cases used to evaluate algorithmic performance (e.g., a test set for an AI model). Therefore, information on sample size and data provenance for such a test set is not available in this document.

The validation included "usability testing with representative intended users," but the number of users or specific test cases is not provided.

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

This information is not available. The document focuses on software engineering and usability validation, not on evaluating diagnostic or analytical performance against expert-established ground truth on a clinical dataset.

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

This information is not available. There is no mention of a clinical "test set" requiring expert adjudication.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed and is not mentioned. The device is a "VesselNavigator" and is presented as an "Interventional Tool" providing "image guidance by superimposing live fluoroscopic images on a 3D volume." The submission indicates that "clinical studies to support substantial equivalence" were not required. The focus is on the device's functional equivalence and safety, not on improving human reader performance.

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

A standalone performance evaluation (algorithm only) as typically understood for an AI/ML diagnostic device is not described in this document. The "VesselNavigator" is explicitly an "Interventional Tool" intended to "assist in catheter maneuvering and device placement" by superimposing images, implying a human-in-the-loop workflow. While there is a "vessel segmentation tool" as part of the functionality, its standalone segmentation performance (e.g., accuracy against ground truth) is not detailed. The validation mentioned "Software verification testing... as well as the identified hazard mitigations" and "Software validation testing included testing of the vessel segmentation tool, the intended use and commercial claims, and usability testing," but without specific performance metrics for the segmentation algorithm itself.

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

The document primarily discusses validation against software requirements, hazard mitigations, intended use, and commercial claims. For functional aspects like the "vessel segmentation tool," the "ground truth" for validation would likely involve comparing the software's output to an expected or manually derived segmentation, but the specifics (e.g., expert manual segmentation, established anatomical models) are not detailed. Clinical outcomes data or pathology as ground truth are not mentioned in relation to performance validation.

8. The sample size for the training set

This information is not available. The document does not describe the device as a machine learning or AI algorithm that undergoes "training" on a dataset in the modern sense. It's described as a "software product" with "functionality to segment the relevant vasculature," which could imply rule-based or traditional image processing algorithms rather than a trained neural network. Therefore, a "training set" in the context of machine learning is not applicable based on the information provided.

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

As described in point 8, the concept of a "training set" as used for AI/ML models is not mentioned or applicable based on the information provided in this 510(k) summary.

Summary

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

August 17, 2015

Philips Medical Systems Nederland B.V. % Liselotte Kornmann, Ph.D. Regulatory Affairs Manager Veenpluis 4-6 5684 PC Best THE NETHERLANDS

Re: K151598

Trade/Device Name: VesselNavigator Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, LLZ Dated: May 18, 2015 Received: June 12, 2015

Dear Dr. Kornmann:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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

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

Sincerely yours.

Michael D'Hara For

Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K151598

Device Name

VesselNavigator

Indications for Use (Describe)

VesselNavigator provides image guidance by superimposing live fluoroscopic images on a 3D volume of the vessel anatomy to assist in catheter maneuvering and device placement.

VesselNavigator is intended to assist in the treatment of endovascular diseases during procedures such as (but not limited to) AAA, TAA, carotid stenting, iliac interventions.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) summary

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.

Date Prepared:	June 9, 2015
Manufacturer:	Philips Medical Systems Nederland B.V.Veenpluis 4-65684 PC BestThe NetherlandsEstablishment Registration Number: 3003768277
Contact Person:	Ms. Liselotte Kornmann, PhDRegulatory Affairs ManagerPhone: +31 611621238E-mail: Liselotte.Kornmann@philips.com
Device:	Trade Name:	VesselNavigator
	Device Name:	VesselNavigator
	Classification Name:	Image-intensified fluoroscopic x-ray system
	Classification Regulation:	21CFR §892.1650
	Classification Panel:	Radiology
	Device Class:	Class II
	Primary Product Code:Secondary Product Code:	OWB (Interventional x-ray system)LLZ (system, image processing, radiological),
Primary PredicateDevice:	Trade Name:	MR-CT Roadmap Rel. 1
	Manufacturer:	Philips Medical Systems Nederland B.V.
	510(k) Clearance:	K121772 (March 21, 2013)
	Classification Regulation:	21 CFR, Part 892.1650
	Classification Name:	Image-intensified fluoroscopic x-ray system
	Classification Panel:	Radiology
	Device Class:	Class II
	Product Code:	OWB (primary), JAK, LLZ (secondary)
Reference Device:	Trade Name:	HeartNavigator Release 2
	Manufacturer:	Philips Medical Systems Nederland B.V.
	510(k) Clearance:	K140138 (June 10, 2014)
	Classification Regulation:	21 CFR, Part 892.1650
	Classification Name:	Image-intensified fluoroscopic x-ray system
	Classification Panel:	Radiology
	Device Class:	Class II
	Product Code:	OWB (primary), LLZ (secondary)

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Device description: VesselNavigator is a software product (Interventional Tool) intended to assist in the treatment of endovascular diseases during an endovascular intervention procedure. VesselNavigator is intended to be used in combination with a Philips Interventional X-ray system. VesselNavigator can be used during any endovascular intervention and covers all vascular anatomy except coronaries and intracranial vessels.

Indications for Use: VesselNavigator provides image guidance by superimposing live fluoroscopic images on a 3D volume of the vessel anatomy to assist in catheter maneuvering and device placement.

VesselNavigator is intended to assist in the treatment of endovascular diseases during procedures such as (but not limited to) AAA, TAA, carotid stenting, iliac interventions.

The Indications for Use statement for VesselNavigator is not identical to the predicate device; compared to MR-CT Roadmap, VesselNavigator is intended to assist in the treatment of endovascular diseases during procedures. However, this difference does not alter the intended use of the device nor does it affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate device have the same intended use, by superimposing live fluoroscopic images on a 3D volume of the vessel anatomy and are accessories to the Allura Xper X-ray system (K133292), which is an Interventional X-ray imaging system.

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Technological VesselNavigator employs comparable technology as its predicate device MR-CT characteristics: Roadmap:

Both tools run on a separate interventional tools workstation (Philips ● Interventional Workspot, K121296).
. Both tools provide basic viewing operations to manipulate image data.
. Both tools have comparable snapshot functionality.
Both tools provide an overlay of live 2D fluoroscopy images on a 3D . reconstruction (3D volume) of the vessel tree acquired from a previous MR or CT scan; in this way the 3D volume serves as a roadmap to provide additional information for navigating endovascular devices through vascular structures of the patient.
Both tools support registration of 3D volume with the x-ray system.
. Both tools support manual correction of the registration.
Both tools provide dynamic update to changes of the position of the X-rav equipment; the 3D volume is automatically adjusted to any gantry changes and any lateral or longitudinal table movements.
Both tools have functionality to store roadmaps.
. Both tools can be controlled from the tableside.

The technological differences between VesselNavigator and its predicate device MR-CT Roadmap are noted below

VesselNavigator provides functionality to measure distances. This function ● is identical to the reference device HeartNavigator Release 2.
. VesselNavigator provides functionality to segment the relevant vasculature in the 3D volume (where the end-user is able to edit the segmentation results), place landmarks for easy recognition of key anatomical points of interests, and store and recall of preferred view angles.
. VesselNavigator tools to remove the table and segment and remove specific bone structures from the view

As these differences are considered low risk (only providing further support to the clinicians in performing interventions) and the functionalities were verified and validated with equivalent methods, these differences do not raise new questions on safety or effectiveness.

Therefore, the VesselNavigator is substantially equivalent to the currently marketed predicate device MR-CT Roadmap in terms of technological characteristics.

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Summary of Nonclinical Performance Data:

Non-clinical performance testing has been performed on VesselNavigator and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance document:

IEC 62304 Medical device software Software life cycle processes (Ed. 1.0, ● 2006),
. IEC 62366 Medical devices - Application of usability engineering to medical devices (Ed. 1.0, 2007),
ISO 14971 Medical devices - Application of risk management to medical devices (Ed. 2.0. 2007).
. NEMA PS 3.1-3.20 Digital Imaging and Communications in Medicine (DICOM) Set (2011), and
Guidance for Industry and FDA Staff Guidance for the Content of . Premarket Submissions for Software Contained in Medical Devices" (issued May 11, 2005, document number 337).

Software verification testing has been performed to cover the main system level requirements as well as the identified hazard mitigations. Software validation testing included testing of the vessel segmentation tool, the intended use and commercial claims, and usability testing with representative intended users. All of these tests were used to support substantial equivalence of the subject device.

The test results in this 510(k) premarket notification demonstrate that VesselNavigator:

complies with the aforementioned international and FDA-recognized consensus standards and FDA guidance document, and
. meets the acceptance criteria and is adequate for its intended use.

Therefore, VesselNavigator is substantially equivalent to the currently marketed predicate device MR-CT Roadmap in terms of safety and effectiveness.

Summary of Clinical The subject of this premarket submission, VesselNavigator, did not require Performance Data: clinical studies to support substantial equivalence.

Substantial The VesselNavigator software medical device is substantially equivalent to the Equivalence currently marketed predicate device MR-CT Roadmap in terms of design Conclusion: features, fundamental scientific technology, indications for use, and safety and effectiveness. The (non-)clinical performance tests provided in this 510(k) premarket notification demonstrates that the proposed VesselNavigator is as safe and effective as its predicate device without raising any new safety and/or effectiveness concerns.

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.