To provide quantitative information regarding the calculated dimensions of arterial segments.
To enhance visualization of the stent deployment region.
To be used in-procedure in the catheterization lab and off-line for post-procedural analysis.
To obtain a co-registration of an angiographic x-ray image and IVUS images.
To obtain a co-registration of an angiographic x-ray image and intravascular blood pressure values.

Device Description

The SyncVision System is an image acquisition and processing workstation situated in the coronary catheterization lab and intended to be used during coronary catheterizations. The SyncVision System captures angiographic and intravascular ultrasound (IVUS) image streams and FFR/iFR displayed value streams and performs the following display functions for assisting the interventional cardiologist:

During Lesion Evaluation; angiogram and IVUS image selection, quantitative coronary measurements (lesion diameters, length, % stenosis), vessel region enhancement and vessel region stabilization are performed instantly and online.
. During Device Positioning, Deployment and Post-deployment; an on-line image stream derived from the native angiographic image stream that is enhanced and stabilized, is displayed side-by-side to the native angiographic and IVUS image streams.
. Import and display of image data from endoluminal modalities, leading to a joint display of images acquired by x-Ray and endoluminal imaging and corresponding to same selected luminal locations or segments (also known as co-registration of such modalities).

AI/ML Overview

The provided text describes a 510(k) premarket notification for the SyncVision System, focusing on software and labeling changes, and an expansion of the Indications For Use. The submission aims to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative manner (e.g., minimum accuracy, sensitivity, or specificity thresholds). Instead, it mentions "Applicable testing was performed as required by the Quality System to evaluate the modifications to the SyncVision System software." The reported performance is a qualitative statement: "The test results were found to be acceptable by the respective test plans and protocols."

Therefore, based on the provided text, a table of quantitative acceptance criteria and specific device performance metrics cannot be constructed.

2. Sample Size Used for the Test Set and the Data Provenance

The document states "Applicable testing was performed...Software Verification and Validation" and "Simulated Use Validation." However, it does not provide any details regarding the:

Sample size used for these tests.
Data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The document does not provide any information about experts, ground truth establishment, or their qualifications for the test set.

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

The document does not provide any information about an adjudication method for the test set.

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

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. The device's function is described as automating a manual workflow process (co-registration of angiographic x-ray and IVUS/FFR/iFR images/values). It facilitates clinical decision making by presenting aligned information, rather than directly acting as an AI diagnostic aid that human readers would "improve with."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

The document describes the SyncVision System as an "image acquisition and processing system" that automates a co-registration process. While the system performs functions like "automatic presents an image frame" and "automates the manual registration processes," it is designed to be used "in-procedure in the catheterization lab" by an "interventional cardiologist." This implies a human-in-the-loop scenario. The text does not explicitly state if a standalone algorithm-only performance study was conducted.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document does not specify the type of ground truth used for any testing.

8. The Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. This is a 510(k) submission primarily focusing on software and labeling changes for an existing device, and it does not detail the development or training of new AI models.

9. How the Ground Truth for the Training Set was Established

As no training set is mentioned (see point 8), the document naturally does not provide any information on how its ground truth was established.

Summary of available information regarding acceptance criteria and study:

The provided text focuses on demonstrating substantial equivalence to a predicate device based on software verification and validation and simulated use validation tests. It confirms that "test results were found to be acceptable by the respective test plans and protocols," but does not offer specific quantitative acceptance criteria or detailed performance metrics. Furthermore, it lacks information on sample sizes, data provenance, expert involvement, adjudication methods, or the specifics of any comparative effectiveness or standalone studies. The nature of the device, which automates an image co-registration workflow for interventional cardiologists, suggests a human-in-the-loop design rather than a fully autonomous AI diagnostic tool requiring extensive standalone performance evaluation in the context of this submission.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping and connected by flowing lines.

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

September 5, 2016

Volcano Corporation % Ms. Elaine Alan Regulatory Affairs Specialist 3721 Valley Centre Drive, Suite 500 SAN DIEGO CA 92130

Re: K161756

Trade/Device Name: SyncVision System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB Dated: June 27, 2016 Received: June 28, 2016

Dear Ms. Alan:

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.

{1}------------------------------------------------

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. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K161756

Device Name SyncVision System

Indications for Use (Describe)

The SyncVision System is an image acquisition and processing system. It is indicated for use as follows:
· To provide quantitative information regarding the calculated dimensions of arterial segments.
· To enhance visualization of the stent deployment region.
· To be used in-procedure in the catheterization lab and off-line for post-procedural analysis.
· To obtain a co-registration of an angiographic x-ray image and IVUS images.
· To obtain a co-registration of an angiographic x-ray image and intravascular blood pressures.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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. The font is sans-serif and the letters are evenly spaced. The word is the only element in the image and it is centered.

510(k) Summary Revised

SPONSOR:	Philips Volcano3721 Valley Centre Dr., Suite 500San Diego, CA 92130
CONTACT/SUBMITTER:	Elaine AlanSr. Regulatory Affairs SpecialistPhilips Volcano3721 Valley Center Dr.San Diego, CA 92130Tel: 858-764-1281Email: ealan@volcanocorp.com
DATE OFSUBMISSION:	June 24, 2016
DEVICE:	Image-intensified fluoroscopic x-ray system
TRADE NAME:	SyncVision System
COMMONNAME:	SyncVision System
PRODUCT CODE:	OWB
CLASSIFICATION:	21 CFR 892.1650Class II Device
PANEL:	Radiology
PREDICATE DEVICE:	Volcano SyncVision System, K151904

Image /page/3/Picture/3 description: The image shows the Philips logo. The logo is a blue shield shape with the word "PHILIPS" at the top. Inside the shield are four stars and three wavy lines.

® VOLCANO

Philips Volcano, 3721 Valley Centre Drive, Suite 500, San Diego, CA 92130 USA
www.volcanocorp.com, Tel 800 228 4728, Fax 916 638 8112

Philips Volcano

{4}------------------------------------------------

DEVICE DECRISPTION:

The current standard procedure in the catheterization laboratory for utilizing x-ray, IVUS image streams, and FFR/iFR pressure measurements calls for referencing the native x-ray, IVUS imaging streams, and FFR/iFR intravascular blood pressure values of the patient's vasculature separately on different displays or monitor. This configuration requires the physician, usually an interventional cardiologist, to estimate an identical location on the patient's vasculature location on both the x-ray and IVUS image streams/FFR/iFR intravascular blood pressure values visually on adjacent windows on the same display. The SyncVision System is displayed on a monitor that is situated next to the native x-ray and IVUS image streams/FFR/iFR intravascular blood pressure values in either the catheterization lab or in the control room. The System provides a means to view the angiographic and IVUS image streams or FFR/IFR intravascular blood pressure values on a single display and automates the manual registration processes performed by the physician.

The System is comprised of a workstation, LCD monitor, keyboard, mouse and an isolation transformer installed in the control room of the catheterization lab, as well as a user input device (joystick) installed in the procedure room. The workstation is comprised of a PC equipped with an internal high-resolution dual channel frame grabber, a high-performance graphic processing card and a data acquisition card for ECG signal acquisition. The joystick allows the user to control all of the functions of the System from the procedure room. Cables connect the workstation to data sources which are an input device; the joystick previously mentioned, the x-ray imaging system, the IVUS imaging/FFR/iFR intravascular pressure measurement system, and the ECG monitor. Cables also connect the workstation to an existing output monitor (not supplied with the System) situated in the procedure room and provide the user in the procedure room with the visual output of the System side-by-side to the existing displays.

During Lesion Evaluation; angiogram and IVUS image selection, quantitative coronary measurements (lesion diameters, length, % stenosis), vessel region enhancement and vessel region stabilization are performed instantly and online.
. During Device Positioning, Deployment and Post-deployment; an on-line image stream derived from the native angiographic image stream that is enhanced and stabilized, is displayed side-by-side to the native angiographic and IVUS image streams.
. Import and display of image data from endoluminal modalities, leading to a joint display of images acquired by x-Ray and endoluminal imaging and corresponding to same selected luminal locations or segments (also known as co-registration of such modalities).

The Co-Registration is an automation of a manual workflow process used by interventional cardiologists today. The manual procedure in the catheterization lab for utilizing x-Ray, IVUS

{5}------------------------------------------------

image streams and FFR/iFR displayed value streams calls for referencing the native x-ray and IVUS image streams/FFR/iFR displayed value streams of the patient's vasculature separately on different displays. This common configuration requires the cardiologist to estimate an identical location on the patient's vasculature on the two native image streams (x-ray and IVUS/FFR/iFR) on two separate displays. The SyncVision System automates this process by providing an option to display an identical anatomical location on both the x-Ray and IVUS image or FFR/iFR displayed value streams automatically on adjacent windows on the same display.

INTENDED USE:

The SyncVision System is an image acquisition and processing system. It is indicated for use as follows:

To provide quantitative information regarding the calculated dimensions of arterial segments.
To enhance visualization of the stent deployment region.
To be used in-procedure in the catheterization lab and off-line for post-procedural analysis.
To obtain a co-registration of an angiographic x-ray image and IVUS images.
To obtain a co-registration of an angiographic x-ray image and intravascular blood pressure values.

COMPARISON OF CHARACTERISTICS:

This submission is for software and labeling changes, and expansion of the Indications for Use. The devices are identical in terms of design, materials, specifications, principles of operation, and fundamental scientific technology. There are no hardware or component changes. The software changes add new features, administrative, and infrastructure changes. A summary of the major changes and compatibility is provided in Table 1, Comparison Matrix of Changes, below with the changes in bold text.

TechnicalAttributes	Proposed SyncVision SystemSW 4.0/HW 2.1	Predicate DeviceSyncVision SystemSW3.2/HW2.1K132558	Comment
Indications forUse	The SyncVision System is an imageacquisition and processing system. Itis indicated for use as follows:• To provide quantitativeinformation regarding the calculateddimensions of arterial segments.• To enhance visualization of thestent deployment region.• To be used in-procedure in thecatheterization lab and off-line forpost-procedural analysis.• To obtain a co-registration of anangiographic x-ray image and IVUSimages.• To obtain a co-registration of anangiographic x-ray image and	The SyncVision System is animage acquisition and processingsystem. It is indicated for use asfollows:• To provide quantitativeinformation regarding thecalculated dimensions of arterialsegments.• To enhance visualization of thestent deployment region.• To be used in-procedure in thecatheterization lab and off-linefor post-procedural analysis.• To obtain a co-registration ofan angiographic x-ray image andIVUS images.	Expansion ofthe Indicationsfor Use toinclude theFFR/iFR Co-Registrationfunctionality

Table 1: Comparison Matrix of Changes

{6}------------------------------------------------

TechnicalAttributes	Proposed SyncVision SystemSW 4.0/HW 2.1	Predicate DeviceSyncVision SystemSW3.2/HW2.1K132558	Comment
	intravascular blood pressurevalues
Compatibilitywith thecatheter-laboratoryfluoroscopySystems	- Siemens Axiom Artis & SiemensArtis Zee- Philips Allura Xper FD10/20 &Philips Allura Clarity- GE Innova- Toshiba Infinix- Shimadzu Trinias/Voyager	- Siemens Axiom Artis & SiemensArtis Zee- Philips Allura Xper FD10/20 &Philips Allura Clarity- GE Innova- Toshiba Infinix	Increasedthrough x-rayqualificationprocess
Compatiblewith thefollowing IVUSsystem &catheters	- Volcano s5/CORE System with SWversion 3.2.2 and above, and FMsoftware version 2.4.1- Eagle Eye Platinum IVUS catheter- Verrata pressure guide wire	- Volcano s5 / Core (mobile orintegrated configurations) withSW version 3.2.2 and above- Eagle Eye Platinum IVUScatheter	Addedcompatibilitydue to thenew FFR/iFRfeatures
Image Source	Angiography/fluoroscopy/Intravascular Ultrasound (IVUS)/FFR/iFR pressure wires	Angiography/fluoroscopy/Intravascular Ultrasound (IVUS)	Added newFFR/iFRpressure wireas a source
Image FrameSelection forMeasurementS	Angiogram - The systemautomatically presents an imageframe, and in most cases this will bea frame in which the vessel is filledwith contrast mediaIVUS – User selectableFFR/iFR - user selectable	Angiogram - The systemautomatically presents an imageframe, and in most cases this willbe a frame in which the vessel isfilled with contrast mediaIVUS – User selectable	Added FFR/iFRCo-Registrationfunctionality

PERFORMANCE DATA:

Applicable testing was performed as required by the Quality System to evaluate the modifications to the SyncVision System software. The following tests were conducted:

Software Verification and Validation
Simulated Use Validation

The test results were found to be acceptable by the respective test plans and protocols.

Sterilization testing was not required as there are no sterile components or accessories for the modified SyncVision System which consists of hardware and software.

Biocompatibility is not applicable to this submission as there are no materials in the modified SyncVision System that come into direct or indirect contact with the patient. Contact with the user involves computer hardware accessories only, i.e., keyboard, mouse.

CONCLUSION:

Completion of these tests concluded that the proposed SyncVision System is substantially equivalent to the predicate device.

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.