Who is the manufacturer of SyncVision System?

Volcano Corporation filed the 510(k) submission for SyncVision System (K161756).

What is the FDA product code for SyncVision System?

OWB. It is classified under 21 CFR 892.1650 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for SyncVision System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like SyncVision System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SyncVision System

Q: What are the predicate devices for SyncVision System?

Volcano SyncVision System (K151904).

K161756 · Volcano Corporation · OWB · Sep 5, 2016 · Radiology

Device Facts

Record ID	K161756
Device Name	SyncVision System
Applicant	Volcano Corporation
Product Code	OWB · Radiology
Decision Date	Sep 5, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1650
Device Class	Class 2

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.

Device Story

SyncVision System is an image acquisition/processing workstation for interventional cardiology. Inputs include angiographic x-ray streams, IVUS image streams, FFR/iFR pressure values, and ECG signals. System transforms these inputs by automating co-registration of angiographic images with IVUS or pressure data, stabilizing/enhancing vessel images, and calculating arterial dimensions (diameter, length, % stenosis). Used in catheterization labs or control rooms by interventional cardiologists. Hardware includes workstation (PC with frame grabber, graphics/data acquisition cards), LCD monitor, keyboard, mouse, and procedure-room joystick. Output is displayed on a monitor side-by-side with native imaging, assisting clinicians in lesion evaluation, device positioning, and post-deployment assessment. Benefits include improved visualization of anatomical locations across modalities and automated workflow, reducing manual estimation requirements.

Clinical Evidence

No clinical data. Evidence consists of software verification and validation and simulated use validation testing.

Technological Characteristics

Workstation-based image processing system. Components: PC, high-resolution dual-channel frame grabber, graphics processing card, data acquisition card for ECG, LCD monitor, joystick. Connectivity: Wired integration with x-ray systems, IVUS systems, and FFR/iFR pressure measurement systems. Software-based processing for image enhancement, stabilization, and co-registration. No sterile or patient-contacting components.

Indications for Use

Indicated for use in the catheterization lab during coronary catheterizations to provide quantitative arterial measurements, enhance stent deployment visualization, and co-register angiographic x-ray images with IVUS images or intravascular blood pressure values.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Volcano SyncVision System (K151904)

Reference Devices

SyncVision System (K132558)

Related Devices

K172574 — SyncVision System · Volcano Corporation · Oct 5, 2017
K151904 — SyncVision System · Volcano Corporation · Jul 31, 2015
K132558 — SYNC-RX SYSTEM · Volcano Corporation · Dec 12, 2013
K253714 — IntraSight Plus · Philips Image Guided Therapy Corporation · Feb 24, 2026
K230884 — AVVIGO'+ Multi-Modality Guidance System · Boston Scientific Corporation · Sep 26, 2023

Submission Summary (Full Text)

{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 Volcano 3721 Valley Centre Dr., Suite 500 San Diego, CA 92130 | |------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | CONTACT/ SUBMITTER: | Elaine Alan Sr. Regulatory Affairs Specialist Philips Volcano 3721 Valley Center Dr. San Diego, CA 92130 Tel: 858-764-1281 Email: ealan@volcanocorp.com | | DATE OF SUBMISSION: | June 24, 2016 | | DEVICE: | Image-intensified fluoroscopic x-ray system | | TRADE NAME: | SyncVision System | | COMMON NAME: | SyncVision System | | PRODUCT CODE: | OWB | | CLASSIFICATION: | 21 CFR 892.1650 Class 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. 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). 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. | Technical Attributes | Proposed SyncVision System SW 4.0/HW 2.1 | Predicate Device SyncVision System SW3.2/HW2.1 K132558 | Comment | |-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------| | 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 IVUS images. • To obtain a co-registration of an angiographic x-ray image and | 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. | Expansion of the Indications for Use to include the FFR/iFR Co- Registration functionality | # Table 1: Comparison Matrix of Changes {6}------------------------------------------------ | Technical Attributes | Proposed SyncVision System SW 4.0/HW 2.1 | Predicate Device SyncVision System SW3.2/HW2.1 K132558 | Comment | |--------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------| | | intravascular blood pressure values | | | | Compatibility with the catheter- laboratory fluoroscopy Systems | - Siemens Axiom Artis & Siemens Artis Zee - Philips Allura Xper FD10/20 & Philips Allura Clarity - GE Innova - Toshiba Infinix - Shimadzu Trinias/Voyager | - Siemens Axiom Artis & Siemens Artis Zee - Philips Allura Xper FD10/20 & Philips Allura Clarity - GE Innova - Toshiba Infinix | Increased through x-ray qualification process | | Compatible with the following IVUS system & catheters | - Volcano s5/CORE System with SW version 3.2.2 and above, and FM software version 2.4.1 - Eagle Eye Platinum IVUS catheter - Verrata pressure guide wire | - Volcano s5 / Core (mobile or integrated configurations) with SW version 3.2.2 and above - Eagle Eye Platinum IVUS catheter | Added compatibility due to the new FFR/iFR features | | Image Source | Angiography/fluoroscopy/ Intravascular Ultrasound (IVUS)/ FFR/iFR pressure wires | Angiography/fluoroscopy/ Intravascular Ultrasound (IVUS) | Added new FFR/iFR pressure wire as a source | | Image Frame Selection for Measurement S | Angiogram - The system automatically presents an image frame, and in most cases this will be a frame in which the vessel is filled with contrast media IVUS – User selectable FFR/iFR - user selectable | Angiogram - The system automatically presents an image frame, and in most cases this will be a frame in which the vessel is filled with contrast media IVUS – User selectable | Added FFR/iFR Co- Registration functionality | # 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.