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 IVUSimages.
To obtain a co-registration of an angiographic x-ray image and intravascular blood pressure values.

Device Description

The SyncVision System (the System) is an image acquisition and processing workstation situated in the coronary catheterization laboratory and is intended to be used during coronary catheterization procedures. The SyncVision System captures angiographic and intravascular ultrasound (IVUS) image streams, as well as physiological (FFR/iFR) displayed value streams, and works in conjunction with currently marketed Volcano IVUS Systems.
The SyncVision System intends to capture the fluoroscopic image stream on line and perform the following functions in order to assist interventional cardiologist in visualizing and quantifying the information resulting from images produced by the existing imaging modalities:

. During lesion evaluation: Angiogram selection, quantitative coronary measurements (lesion diameters, length, and percent stenosis) and vessel region enhancement are performed instantly and on line.
. During device positioning, deployment and post-deployment, an on-line enhanced image stream is displayed side-by-side to the existing Fluoroscopic image stream.
Import and display of image data from endoluminal modalities, lead to a joint display of images acquired by X-ray and endoluminal imaging, and correspond to the same selected luminal locations or segments (also known as co-registration of such modalities).
Import and display of values derived from intracoronary pressure measurements lead to a joint display of images acquired by X-ray and pressure values, and correspond to the same selected locations or segments (also known as co-registration of such modalities).
The objective of the SyncVision System is to optimize and facilitate trans-catheter cardiovascular interventions by means of automated on-line image processing. The current focus of the SyncVision System is on trans-catheter diagnostic and therapeutic interventions performed on the heart and the blood vessels directly connected to it.

AI/ML Overview

The provided text is a 510(k) Summary for the Volcano Corporation's SyncVision System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical or standalone performance study.

Therefore, the information required to answer most of the questions, particularly regarding detailed acceptance criteria, specific study designs (like MRMC or standalone performance), sample sizes, expert qualifications for ground truth, and adjudication methods, is not present in this document. The document explicitly states:

"The SyncVision System did not require clinical data since substantial equivalence to the currently marketed predicate device was demonstrated with the following attributes:

Indication for use;

Technological characteristics;

Non-clinical performance testing; and

Safety and effectiveness."

"Completion of these tests and the differences between the new SyncVision System and the predicate device SyncVision System do not raise any new questions regarding safety or effectiveness. Based on the information provided in this 510(k) submission, the SyncVision System is considered substantially equivalent to the currently marketed predicate device."

However, I can extract information about the non-clinical performance testing which serves as the "study that proves the device meets the acceptance criteria" in the context of this 510(k) submission for demonstrating substantial equivalence.

Here's what can be extracted and what cannot:

Acceptance Criteria and Study for SyncVision System (K190626)

Based on the provided 510(k) Summary, the "acceptance criteria" and "study" are primarily focused on demonstrating substantial equivalence through non-clinical performance testing, rather than a de novo clinical trial with specific performance metrics against a medical condition.

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

The document describes the types of tests performed but does not provide specific quantitative acceptance criteria or detailed reported performance metrics in a table format. It generally states:

Test Type	Acceptance Criteria (Implied)	Reported Device Performance
Software Verification and Validation (Unit, Integration, System Level/General)	Meets defined software specifications and functional requirements.	"The test results demonstrated passing results in all cases when compared to acceptance criteria defined in the respective test plans and protocols."
QCA Verification	Accurate Quantitative Coronary Analysis (QCA) measurements.	"The test results demonstrated passing results in all cases when compared to acceptance criteria defined in the respective test plans and protocols."
IVUS Co-Registration Verification	Accurate co-registration between IVUS images and angiograms.	"The test results demonstrated passing results in all cases when compared to acceptance criteria defined in the respective test plans and protocols."
FM Co-Registration Verification	Accurate co-registration with physiological measurements.	"The test results demonstrated passing results in all cases when compared to acceptance criteria defined in the respective test plans and protocols."
Usability Validation	Meets usability and human factors requirements.	"The test results demonstrated passing results in all cases when compared to acceptance criteria defined in the respective test plans and protocols."
Simulated Use, Design & Usability/Human Factors Engineering Validation Test	Acceptable performance in simulated clinical scenarios.	"The test results demonstrated passing results in all cases when compared to acceptance criteria defined in the respective test plans and protocols."

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

Sample Size for Test Set: Not specified. The non-clinical performance testing likely used a set of pre-recorded or simulated data, but the number of cases or data points is not mentioned.
Data Provenance: Not specified. It's likely internal company data for verification and validation, but no country of origin is mentioned. The testing was "non-clinical," implying it was not derived from patient data in a publically reported clinical study, but rather from internal development and engineering tests. The document states it did not require clinical data.
Retrospective or Prospective: Not applicable, as this was non-clinical testing.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. For non-clinical software verification, "ground truth" might be established by engineering specifications, known algorithmic outputs, or comparison to results from the predicate device.

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

Adjudication Method: Not specified. For non-clinical software testing, formal adjudication methods as seen in clinical trials are typically not employed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

MRMC Study: No. The document explicitly states that the device "did not require clinical data" and implies that no such comparative effectiveness study was performed as part of this 510(k) submission.

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

Standalone Performance: The verification and validation testing, particularly for QCA, IVUS co-registration, and FM co-registration, would involve "algorithm only" performance evaluation against predefined criteria or the predicate device's behavior. However, specific standalone performance metrics (e.g., accuracy, sensitivity, specificity for a diagnostic task) are not provided beyond the general statement of "passing results." The document focuses on feature and workflow enhancements.

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

Type of Ground Truth: Not explicitly stated. For "QCA Verification," "IVUS co-Registration Verification," and "FM Co-Registration Verification," the ground truth was likely established by the known true values or expected outputs of the algorithms, possibly derived from highly accurate manual measurements or comparison to the predicate device's proven performance. It was not clinical ground truth (e.g., pathology, outcomes).

8. The sample size for the training set:

Training Set Sample Size: Not applicable/not specified. The document does not describe the use of machine learning or AI models that would require a distinct training set. The descriptions of "digital edge detection by calculation of the derivatives (or gradients) of the density curve" suggest a more traditional image processing approach rather than a data-driven AI model that needs a training phase, though such models could be integrated. Given the focus on "software modifications" rather than a new core algorithm, a specific training set akin to deep learning is unlikely to be discussed in a 510(k) for substantial equivalence if the underlying principles are unchanged.

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

Ground Truth for Training Set: Not applicable, as no training set for an AI/ML model is mentioned.

Summary

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April 12, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Volcano Corporation % Rand Daoud Regulatory Affairs Specialist, 4 3721 Valley Centre Dr., Suite 500 SAN DIEGO CA 92130

Re: K190626

Trade/Device Name: SyncVision System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB Dated: March 11, 2019 Received: March 12, 2019

Dear Rand Daoud:

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/cfpmp/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 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

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

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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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:	March 8th, 2019
SPONSER:	Volcano Corporation2870 Kilgore RoadRancho Cordova, CA 95670Establishment Registration Number: 2939520
CONTACT/SUBMITTER:	Rand DaoudRegulatory Affairs Specialist, 4Tel: (858) 720-4049Email: rand.daoud@philips.comPhilips Volcano3721 Valley Center Dr.Suite 500San Diego, CA 92130
DEVICE:
Trade Name:	SyncVision System
Common Name:	SyncVision System
Classification Name:	Image-Intensified Fuoroscopic X-Ray System
Classification:	21 CFR 892.1650
Device Class:	Class II
Product Code:	OWB
Panel:	Radiology
PREDICATE DEVICE:	SyncVision System, K172574

DEVICE DESCRIPTION:

The SyncVision System intends to capture the fluoroscopic image stream on line and perform the following functions in order to assist interventional cardiologist in visualizing and quantifying the information resulting from images produced by the existing imaging modalities:

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. During lesion evaluation: Angiogram selection, quantitative coronary measurements (lesion diameters, length, and percent stenosis) and vessel region enhancement are performed instantly and on line.
. During device positioning, deployment and post-deployment, an on-line enhanced image stream is displayed side-by-side to the existing Fluoroscopic image stream.
Import and display of image data from endoluminal modalities, lead to a joint display of images acquired by X-ray and endoluminal imaging, and correspond to the same selected luminal locations or segments (also known as co-registration of such modalities).
Import and display of values derived from intracoronary pressure measurements lead to a joint display of images acquired by X-ray and pressure values, and correspond to the same selected locations or segments (also known as co-registration of such modalities).

The objective of the SyncVision System is to optimize and facilitate trans-catheter cardiovascular interventions by means of automated on-line image processing. The current focus of the SyncVision System is on trans-catheter diagnostic and therapeutic interventions performed on the heart and the blood vessels directly connected to it.

INDICATIONS FOR 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 IVUSimages.
To obtain a co-registration of an angiographic x-ray image and intravascular blood pressure values.

COMPARISON OF CHARACTERISTICS:

The primary software modifications to the SyncVision Software V4.2 are to enhance the NUS Co-Registration capability, which correlates between IVUS images and their respective locations on a selected angiographic image, also known as Angiographic Roadmap. Feature, compatibility, and other minor changes were also made.

The proposed modifications to the SyncVision System does not affect the intended use or scientific technologies or the devices, and the fundamental operating principles are essentially the same. The indications for use are identical to those of the currently marketed predicate device, SyncVision System, K161756.

A summary of the modifications are provided in Table 1 below.

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Table 1. Modification Comparison Table:

TechnicalAttributes	Predicate DeviceSyncVision SystemSW4.1	Proposed DeviceSyncVision SystemSW4.2	Comments
Automation of theIVUS Co-Registrationworkflow to alignwith Physiology Co-Registrationworkflow asimplemented insoftware version 4.1and 4.1.1.	K172574The user must manuallyswitch to IVUS Co-registration to perform anangiogram, and mustmanually indicate thepathway to be used for theIVUS pullback. Once IVUSpullback is completed, theSystem generates anddisplays the IVUS Co-registration results.	The SyncVision Systemautomatically switchesto IVUS Co-registrationMode Display upondetection of a live IVUSimage, The system alsoautomatically selectsthe angiogram roadmapframe and calculatesthe pathway to be usedfor co-registration.	Thismodificationeliminates theneed for theuser to performthe pathwayselection processmanually.
Exit Co-RegistrationMode:	The current System does not allow the user to exit the FM Co-Registration Mode upon detection of a trigger (such as: Zeroing Request / Valid Pd Value), on the Core System.	The proposed System has a new Exit Button allowing the user to exit the FM Co-Registration Mode should a trigger on the Core System be detected.	Providing the ability to exit the Co-Registration mode improves the workflow and allows the user to exit the Co-Registration mode display and return to the Active Session in SyncVision, so that all SyncVision applications become available for use.
IVUS Co-registrationregionindicator:	The current System does not provide the use with features to aid in visualization of a Co-registered segment on the Roadmap.	In the proposed System, the most distal and proximal points on the Co-registered vessel are marked with white triangles.	Provides users with visual aids on a Co-Registered vessel.
Simplified RoadmapPathway Editor.	In the current System, theRoadmap Pathway Editor issplit into two differentscreens: 1) editing andconfirming the pathway(Pathway ConfirmationPhase)	In the proposed System,all Roadmap PathwayEditor actions aredisplayed on onescreen.	This improvedRoadmap PathwayEditor allows theuser to observe,adjust and confirmthe roadmap imageand pathway, all in
	2) changing the roadmap image and re-drawing the pathway (Pathway Indication Phase).		one screen.
Show Pathway on the IVUS Co-registration Result Tab:	The user has the ability to perform a length measurement to visualize the Co-Registered segment on the Roadmap, but there are no System features that aid with this visualization.	In the fully automated workflow, once the results are displayed, a yellow line is projected on the Pathway is also displayed on the roadmap image. The user can turn on/off the pathway display by clicking the Show Pathway checkbox.	This modification aids the user in visualizing the pathway that was automatically selected by the SW or manually drawn by the user.
Improved user interface functionality of IVUS 2D measurements: Perform IVUS Measurements on the Result Tab.	In the current System, the user can perform IVUS 2D measurements on a dedicated window with an enlarged IVUS image. The user can perform diameter and area measurements and browse between different IVUS frames. In this window however, the user cannot view the corresponding location of the selected IVUS image on the co-registered roadmap image or the co-registered IVUS longitudinal view.	In the proposed System software version 4.2, the user can perform diameter and area measurements on the IVUS co-registered image on the result tab (meaning they are no longer required to open the dedicated measurement window). This gives the user the ability to perform the required measurements on the IVUS frames while observing the corresponding location on the co-registered roadmap image or the co-registered IVUS longitudinal view	The IVUS measurements tools and functionality are identical to the current version. If needed, the user will still have the ability to enlarge the IVUS image and perform the IVUS measurements on the same enlarged window as in the current version.This new modification however provides users the ability to perform IVUS measurements on the IVUS image displayed in the IVUS Co-registration result screen.
Roadmap image display on the IVUS measurements enlarged	In the current System, the user can perform IVUS measurements on a dedicated window with an enlarged IVUS image.	In the proposed System, a smaller scale Roadmap image is added to the enlarged IVUS	Provides users with the ability to review the corresponding location on the
	corresponding locationof the selected IVUSimage on the Co-Registered Roadmapimage.		in the enlargedIVUS window.
New Snapshotfeature that enablescreating and savingscreenshots.	In the current System, theuser can export resultsnapshots from theprocedure to a USB driveonly in offline mode.	In the proposed System,a new Snapshot Buttonhas been added to theSyncVision system toenable an easy way tocapture screenshotsduring the procedureand during the reviewof the procedure inoffline mode. A USBdrive is not required tosave snapshots, but it isrequired to export themfrom the system inoffline mode.	Provides users withthe ability to savesnapshot imagesfrom the SyncVisionSystem during theprocedure and alsowhen the System isin offline mode.
Savingsnapshots in theResults Tab:	In the current System,the Reports Tab containsstored images of QCAand VE results. Theimages are savedautomatically afterperforming QCA or VE onan Angiogram.	In the proposedSystem, only savedsnapshots will bedisplayed in theReports Tab. Theuser will have theability to browsebetween the savedsnapshots and ifdesired, addannotated text tosummarize findings.QCA and VE resultswill not be savedunless the userselects to save asnapshot of theresults.	Provides users alocation toreview all savedsnapshots andto write asummary of casefindings.
Compatibility withnew IntraSightSystem (K190078).	The current SyncVisionSystem is compatible withVolcano S5/CORE Systemswith IVUS versions 3.4, 3.5and FFR/iFR Softwareversion 2.5.X.	The proposedSyncVision System SW4.2 is also compatiblewith the currentIVUS/FM SoftwareVersions (IVUS v3.4,v3.5 / FFR/iFR v2.5.1),as well as withVolcano's IntraSightSystem IVUS Software	SyncVision SWVerificationtesting has beenconducted for allcompatibleSystems.
Compatibility withSiemens Artis OneX-Ray System.	The currentSyncVision System iscompatible with thefollowingcatheterization lab x-ray systems:Siemens Axiom &Siemens ArtisZee/Q Philips Allura XperFD10/20 & PhilipsAllura Clarity GE Innova Toshiba Infinix Philips Intuis Philips Azurion Shimadzu Trinias/Voyager	v5.0 / iFR/FFR Softwarev5.0), recently clearedunder K190078.The proposedSyncVisionSystemsoftwareversion 4.2, isalsocompatiblewith the X-Raysystems thatrun on SWv4.1, as well aswith:Siemens ArtisOne	SyncVisionqualificationwith the list of X-Ray systemsidentified wasconducted.
Other Changes:GUIUpdates. Fixes fordeferreddefectsfromSyncvision4.1.x. MinorAdditions.	N/A	Updates to the GUI andminor softwareadditions wereimplemented as part ofthe softwaremodifications madewith the proposed SWversion 4.2.Fixes for deferreddefects from the priorSW version 4.1.X werealso made.	All softwaremodifications donot affect theintended use orscientifictechnologies orthe devices, andthe fundamentaloperatingprinciples areessentially thesame to thepredicate device

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SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:

A comparison of the technological characteristics between the new device and those of the predicate device is provided in Table 2 below.

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Predicate Device SyncVision Technical Proposed Device SyncVision System SW4.1 Comment Attributes System SW4.2 K172574 The SyncVision System is an The SyncVision System is an image acquisition and processing image acquisition and processing system. It is indicated for use as system. It is indicated for use as follows: follows: • To provide quantitative • To provide quantitative information regarding the information regarding the calculated dimensions of arterial calculated dimensions of arterial segments. segments. • To enhance visualization of the • To enhance visualization of the stent deployment region. stent deployment region. Indications for Use • To be used in-procedure in the • To be used in-procedure in the Same catheterization lab and off-line for catheterization lab and off-line for post-procedural analysis. post-procedural analysis. • To obtain a co-registration of an • To obtain a co-registration of an angiographic x-ray image and angiographic x-ray image and IVUS images. IVUS images. • To obtain a co-registration of an • To obtain a co-registration of an angiographic x-ray image and angiographic x-ray image and intravascular blood pressure intravascular blood pressure values. values. Intended for use by clinicians, Intended for use by clinicians, User Group technicians and research technicians and research Same personnel personnel Accessory to existing vessel image Accessory to existing vessel image systems for image manipulation systems for image manipulation Application Same and co-registration and to provide and co-registration and to provide vessel measurements vessel measurements To be used in the catheterization To be used in the catheterization lab; online during the procedure, lab; online during the procedure, Use Environment Same and offline for immediate postand offline for immediate postprocedural analysis procedural analysis . Siemens Axiom Artis & ● Siemens Axiom Artis & Siemens Artis Zee Siemens Artis Zee Philips Allura Xper FD10/20 & . Philips Allura Xper FD10/20 & ● Philips Allura Clarity Compatibility with Philips Allura Clarity Substantially the cath- laboratory ● GE Innova ● GE Innova Equivalent fluoroscopy . Toshiba Infinix . Toshiba Infinix Systems Shimadzu Trinias/Voyager Shimadzu Trinias/Voyager ● Philips Intuis ● Philips Intuis Philips Azurion (Allura R9) Philips Azurion (Allura R9) Siemens Artis One

Table 2. Technological Comparison Table:

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SUMMARY OF NON-CLINICAL PERFORMANCE DATA:

Applicable non-clinical performance testing has been performed on the SyncVision System to evaluate the modifications to the SyncVision System software. The following tests were conducted:

. Software Verification and Validaiton
- Unit, Integration, and System Level/General Verification Software Testing .
- . QCA Verification
- . IVUS co-RegistrationVerification
- . FM Co-RegistrationVerification

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Usability Validation
Simulated Use, Design & Usability/Human Factors Engineering Validation Test ■

The test results demonstrated passing results in all cases when compared to acceptance criteria defined in 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.

Electromagnetic compatibility and electrical safety testing was not required for the software changes that are the subject of this Premarket Notification. There were no design changes to the hardware, cables or power supply as a result of the proposed software changes. Therefore it was determined that packaging validation, electrical safety, electromagnetic compatibility, and acoustic noise level testing were not required.

SUMMARY OF CLINICAL PERFORMANCE DATA:

The SyncVision System did not require clinical data since substantial equivalence to the currently marketed predicate device was demonstrated with the following attributes:

Indication for use;
Technological characteristics;
Non-clinical performance testing; and
Safety and effectiveness.

These attributes demonstrated that the clinical performance of the modified device is substantially equivalent to the predicate device.

CONCLUSION:

Completion of these tests and the differences between the new SyncVision System and the predicate device SyncVision System do not raise any new questions regarding safety or effectiveness. Based on the information provided in this 510(k) submission, the SyncVision System is considered substantially equivalent to the currently marketed predicate device.

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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.

TechnicalAttributes	Predicate Device SyncVisionSystem SW4.1K172574	Proposed Device SyncVisionSystem SW4.2	Comment
Compatible withthe following IVUSsystem & catheters	Volcano s5/CORESystems with SW version3.4 and 3.5, and FM(FFR/iFR) softwareversion 2.5.xEagle Eye Platinum IVUScatheterVerrata pressure guidewireVerrata Plus pressureguide wire	Volcanos5/CORE/IntraSightSystems with IVUS SWversions 3.4, 3.5, and 5.0and FFR/iFR softwareversions 2.5.1 and 5.0Eagle Eye Platinum IVUScatheterVerrata and Verrata Pluspressure guide wire	SubstantiallyEquivalent
Image Source	Angiography/fluoroscopy/Intravascular Ultrasound (IVUS)/FFR/iFR pressure wires	Angiography/fluoroscopy/Intravascular Ultrasound (IVUS)/FFR/iFR pressure wires	Same
Source Image Type	Native angiography/fluoroscopy/ultrasound images	Native angiography/fluoroscopy/ultrasound images	Same
Image Size	Any image size, according tonative source image	Any image size, according tonative source image	Same
Image Depthsupport	X-Ray: 8 bit grayscaleIVUS: 24 bit RGB or converted toan 8 bit grayscale to display IVUSin black & white	X-Ray: 8 bit grayscaleIVUS: 24 bit RGB or converted toan 8 bit grayscale to display IVUSin black & white	Same
Image FrameSelection forMeasurements	Angiogram - The systemautomatically presents an imageframe, and in most cases this willbe a frame in which the vessel isfilled with contrast mediaIVUS - User selectable FFR/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 FFR/iFR -user selectable	Same
Manual Override	Manual override of selectedangiogram or IVUS image	Manual override of selectedangiogram or IVUS image	Same
QuantitativeInformation	Quantitative Coronary Analysis(QCA) applied to angiogram	Quantitative Coronary Analysis(QCA) applied to angiogram	Same
QCA Interface	The user marks the designatedlesion, location, or diameter usinga point-and-click input device	The user marks the designatedlesion, location, or diameter usinga point-and-click input device	Same
QCA Calibration	Optional, using the GuidingCatheter. If a calibration was notperformed, only the % stenosiswill be calculated and displayed	Optional, using the GuidingCatheter. If a calibration was notperformed, only the % stenosiswill be calculated and displayed	Same
TechnicalAttributes	Predicate Device SyncVisionSystem SW4.1K172574	Proposed Device SyncVisionSystem SW4.2	Comment
Edge Detection	Digital edge detection bycalculation of the derivatives (orgradients) of the density curveacross the lumen and finding theirpeak values, followed by least-cost optimization	Digital edge detection bycalculation of the derivatives (orgradients) of the density curveacross the lumen and finding theirpeak values, followed by least-cost optimization	Same
QCA Display	Angiogram: Segmentation of thevessel walls superimposed on thevessel image in addition toMinimum Lumen Diameter (MLD)marker line and two reference-point marker lines.	Angiogram: Segmentation of thevessel walls superimposed on thevessel image in addition toMinimum Lumen Diameter (MLD)marker line and two reference-point marker lines.	Same
VesselMeasurements	MLD (mm), segment diameter(s)(mm), segment length (mm),reference diameter (mm) and %stenosis	MLD (mm), segment diameter(s)(mm), segment length (mm),reference diameter (mm) and %stenosis	Same
Balloon/StentEnhancement	Enhanced visualization of thestent deployment region bytracking and alignment of balloonmarkers, and averaging ofmultiple consecutive frames.Enhancement is performed bymeans of temporal and spatialfiltering of the aligned frames.	Enhanced visualization of thestent deployment region bytracking and alignment of balloonmarkers, and averaging ofmultiple consecutive frames.Enhancement is performed bymeans of temporal and spatialfiltering of the aligned frames.	Same
Method	Marker detection and alignment	Marker detection and alignment	Same
EnhancementAlgorithm	Enhancement is performedbymeans of temporal and spatialfiltering of the aligned frames	Enhancement is performedbymeans of temporal and spatialfiltering of the aligned frames	Same
Power Supply	Medical grade isolationtransformer 600VA - Toroid ISB-060W or compatible	Medical grade isolationtransformer 600VA - Toroid ISB-060W or compatible	Same
Joystick	Standard USB, 2-button	Standard USB, 2-button	Same
JoystickCatheterization	EUR RAIL 10 x 25 mm US RAIL3/8" x 1 1/8"(9.52x28.57mm)	EUR RAIL 10 x 25 mm US RAIL3/8" x 1 1/8"(9.52x28.57mm)	Same
Monitor	Flat panel 19" or above monitorwith VGA and DVI inputsResolution 1280x1024 or above	Flat panel 19" or above monitorwith VGA and DVI inputsResolution 1280x1024 or above	Same
Mouse andKeyboard	Keyboard: standard USB keyboardMouse: Standard USB mouse	Keyboard: standard USB keyboardMouse: Standard USB mouse	Same
Operating System	Windows 7 64bit Professional Ed	Windows 7 64bit Professional Ed	Same
TechnicalAttributes	Predicate Device SyncVisionSystem SW4.1K172574	Proposed Device SyncVisionSystem SW4.2	Comment
ElectricalSpecifications	Class I equipment, per IEC/EN60601-1HW v2.1:Input 100V to 240V auto voltageselector 50/60HzOutput 100V-240V voltageselector 50/60HzMinimum power 400VA (at 240V)Minimum outputs 4 (IEC320 C14socket)Over load protection fuse 100V &240VOn/Off switchPower cord: medical grademinimum wire diameter AWG18(0.75mm²) 3.5m max lengthFuses: 100VA 8.0A, 120VAC: 6.3A,240VAC: 3.15A	Class I equipment, per IEC/EN60601-1HW v2.2:Input 100V/120V/240V voltageselector, 50/60Hz.Output 100V/120V/240V voltageselector, 50/60Hz.Minimum power 400VA (at 240V).Minimum outputs 4 (IEC320 C14socket).Over load protection fuse 100V,120V & 240VOn/Off Switch.Power cord: medical grademinimum wire diameter AWG18(0.75mm²) 3.5m max lengthFuses: 100VA 8.0A, 120VAC: 6.3A,240VAC: 3.15A	Same
EnvironmentalConditions	Ambient Temperature:+15°C to +35°C (+59°F to +95°F)Relative Humidity:30% - 85%Atmospheric pressure range:700hpa to 1060hpa	Ambient Temperature:+10°C to + 35°C.Relevant Humidity:30-85%Non-condensing pressure range:70-106 kPA	Same
PowerConsumption	~400W,minimum power 400 VA(@ 240V)	~400W, minimum power 400VA(at 240V)	Same
WorkstationDimensions	Case Type: Super Midi-TowerMeasurements: (without frontpanel) 176 mm (W) x 430 mm (H)x 550 mm (D)	Case Type: Super Midi-TowerMeasurements: (without frontpanel) 176 mm (W) x 430 mm (H)x 550 mm (D)	Same