(70 days)
No
The summary describes image processing and co-registration, but there is no mention of AI, ML, deep learning, or any related concepts in the device description, intended use, or performance studies.
No
The device is an image acquisition and processing system that provides quantitative information and enhances visualization, which are diagnostic and procedural assistance functions, not therapeutic.
Yes
The device provides quantitative information regarding arterial dimensions, enhances visualization for stent deployment, and performs quantitative coronary measurements (lesion diameters, length, % stenosis), which are all aspects of diagnosing or assessing a condition.
No
The device description explicitly states it is a "workstation situated in the coronary catheterization lab" and "captures angiographic and intravascular ultrasound (IVUS) image streams and FFR/iFR displayed value streams," indicating it includes hardware components for acquisition and processing, not just software.
Based on the provided information, the SyncVision System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The SyncVision System directly interacts with the patient's vasculature during a procedure (in-vivo) using imaging modalities like angiography and IVUS. It processes images and data obtained from within the patient, not from a sample taken from the patient.
- The intended use and device description focus on image acquisition, processing, and display for assisting in medical procedures. This is characteristic of medical imaging and analysis systems used during interventions, not diagnostic tests performed on samples in a lab.
- There is no mention of analyzing biological samples (blood, tissue, etc.) which is the core function of an IVD.
The SyncVision System is a medical device used for image-guided procedures and analysis within the patient's body.
N/A
Intended Use / 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 intravascular blood pressures.
Product codes (comma separated list FDA assigned to the subject device)
OWB
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).
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 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Image-intensified fluoroscopic x-ray system, Angiography/fluoroscopy/, Intravascular Ultrasound (IVUS)/, FFR/iFR pressure wires
Anatomical Site
Arterial segments, patient's vasculature (implied coronary)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician, interventional cardiologist, catheterization lab, control room.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Volcano SyncVision System, K151904
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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"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.