(38 days)
Not Found
No
The summary describes automated image processing and co-registration but does not mention AI, ML, or related terms like neural networks or deep learning. The performance studies focus on software verification and validation against standards, not on evaluating AI/ML model performance.
No
The device is an image acquisition and processing system designed to provide quantitative information and enhance visualization for diagnostic purposes during cardiovascular interventions. It does not exert any direct therapeutic action on the patient.
Yes
The device provides "quantitative information regarding the calculated dimensions of arterial segments" and performs "quantitative coronary measurements (lesion diameters, length, and stenosis percentage)," which are diagnostic functions.
No
The device description explicitly states that the System includes hardware components such as a workstation, joystick, monitor, keyboard, mouse, isolation transformer, and cables.
Based on the provided information, the Sync Vision System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Sync Vision System's Function: The Sync Vision System processes and displays medical images (angiography, IVUS) and physiological data (FFR/iFR) acquired in vivo (within the living body). It does not analyze biological specimens.
- Intended Use: The intended use focuses on image acquisition, processing, visualization enhancement, and co-registration of in vivo imaging and physiological data to assist in trans-catheter cardiovascular interventions. This is distinct from the analysis of in vitro samples.
- Device Description: The description details a system that integrates and processes data from existing imaging modalities and pressure wires used during a procedure, not a system for analyzing biological samples.
Therefore, the Sync Vision System falls under the category of medical imaging and data processing systems used during and after medical procedures, not IVD devices.
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 pressure values.
Product codes
OWB
Device Description
The SyncVision System (System) is displayed on a monitor that is situated next to the native xray, IVUS and FFR/iFR imaging and displayed value streams either in the cath lab or in the control room. The System provides a means to view the angiographic, IVUS, and FFR/IFR values on a single display and automates the manual registration processes performed by the physician.
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.
The SyncVision System's core component is an image acquisition and processing workstation situated in the coronary catheterization control room. The System also includes additional components such as a procedure room joystick, control room monitor, keyboard and mouse, medical grade isolation transformer along with site-specific cables and video equipment. 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 intends to capture the fluoroscopic image stream on line and perform the following functions for the purpose of assisting the interventional cardiologist in visualizing and quantitating the information resulting from images produced by the existing imaging modalities:
- During lesion evaluation: Angiogram selection, quantitative coronary measurements (lesion diameters, length, and stenosis percentage), vessel region enhancement and vessel region stabilization are performed instantly and on line.
- During device positioning, deployment and post-deployment: An on-line image stream, that is enhanced and stabilized, is displayed side-by-side with the existing fluoroscopic image stream.
- . Import and display of IVUS images, leading to a joint display of images acquired by X-Ray and IVUS images corresponding to same selected luminal locations or segments (also known as IVUS Co-registration).
- Import and display of Physiological values, leading to a joint display of images acquired by X-Ray and Physiological values corresponding to same selected luminal locations or segments (also known as Physiological Co-registration).
The Co-Registration is an automation of a manual workflow process used by interventional cardiologists today. The manual procedure in the cath lab for utilizing x-ray and IVUS image streams calls for referencing the native x-ray and IVUS image streams of the patient's vasculature separately on different displays. This configuration requires the cardiologist to estimate an identical location on the patient's vasculature on the two native image streams (xray and IVUS) 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 streams automatically on adjacent windows on the same display.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Image Source: Angiography/fluoroscopy/Intravascular Ultrasound (IVUS)/FFR/iFR pressure wires
Source Image Type: Native angiography/fluoroscopy/ultrasound images
Anatomical Site
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.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended for use by clinicians, technicians and research personnel.
To be used in the catheterization lab; online during the procedure, and offline for immediate post-procedural analysis.
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)
Non-clinical performance testing has been performed on the SyncVision System software and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance documents:
- IEC 62304 Medical device software – Software life cycle processes (Edition 1.0, 2006). FDA/CDRH recognition number 13-32.
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
- Unit, Integration, and System Level/General Verification Software Testing
- QCA Verification
- IVUS co-Registration Verification .
- FM Co-Registration Verification
- Software Validation
- FM Co-Registration Visual Validation
- 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.
- Simulated Use, Design & Usability/Human Factors Engineering Validation Test
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
QCA Measurement Precision:
- MLD Precision: 0.15 mm
- % Narrowing Precision: 5%
- Segment Precision: 0.5 mm
IVUS C-Registration Measurements: (Diameter and Length)
- Diameter: Precision ≤ 0.1mm
- Length: Precision ≤ 0.5mm
Manual Diameter Measurements on axial IVUS images:
- Precision ≤ 0.1mm
Area Measurement Precision:
- Precision ≤ ±0.1mm²
FFR/iFR Co-Registration Length Measurements:
- Precision ≤ 2.0 mm
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 5, 2017
Volcano Corporation % Ms. Elaine Alan Regulatory Affairs Specialist 3721 Valley Centre Drive. Suite 500 SAN DIEGO CA 92130
Re: K172574
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: August 25, 2017 Received: August 28, 2017
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 (DICE) 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. 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 (DICE) 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,
Michael D. O'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) K172574
Device Name SyncVision System
Indications for Use (Describe)
- The Sync Vision 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.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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/1 description: The image contains the word "VOLCANO" in large, bold, blue letters. To the left of the word is a gray square with rounded corners. Inside the square is a white triangle with a blue triangle inside of it. The blue triangle is pointing downwards.
510(k) Summary
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
| Date Prepared: | September 29, 2017 |
|---|---|
| ---------------- | -------------------- |
CONTACT/
| SUBMITTER: | Elaine Alan
Regulatory Affairs Specialist
Volcano Corporation
3721 Valley Center Dr.
San Diego, CA 92130 | | Tel: 858-764-1281
Email: ealan@volcanocorp.com |
|---------------|----------------------------------------------------------------------------------------------------------------------|-----------|---------------------------------------------------|
| Manufacturer: | Volcano Corporation
2870 Kilgore Road
Rancho Cordova, CA 95670
Establishment Registration Number: 2939520 | | |
| DEVICE: | Trade Name: | | SyncVision System |
| | Common Name: | | SyncVision System |
| | Classification Name: | | Interventional fluoroscopic x-ray system |
| | Classification: | | 21 CFR 892.1650 |
| | Device Class : | Class II | |
| | Product Code: | OWB | |
| | Panel: | Radiology | |
PREDICATE DEVICE: SyncVision System, K161756
Volcano Corporation
Philips Volcano, 3721 Valley Centre Drive, Suite 500, San Diego, CA 92130 USA
www.volcanocorp.com, Tel 800 228 4728, Fax 916 638 8112
4
DEVICE DESCRIPTION:
The current standard procedure in the catheterization laboratory (cath lab) for utilizing x-ray and IVUS image streams calls for referencing the native x-ray, IVUS and FFR/iFR imaging and displayed value streams 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, IVUS image streams, and FFR/iFR displayed value streams visually on adjacent windows on the same display.
The SyncVision System (System) is displayed on a monitor that is situated next to the native xray, IVUS and FFR/iFR imaging and displayed value streams either in the cath lab or in the control room. The System provides a means to view the angiographic, IVUS, and FFR/IFR values on a single display and automates the manual registration processes performed by the physician.
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.
The SyncVision System's core component is an image acquisition and processing workstation situated in the coronary catheterization control room. The System also includes additional components such as a procedure room joystick, control room monitor, keyboard and mouse, medical grade isolation transformer along with site-specific cables and video equipment. 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 intends to capture the fluoroscopic image stream on line and perform the following functions for the purpose of assisting the interventional cardiologist in visualizing and quantitating the information resulting from images produced by the existing imaging modalities:
- During lesion evaluation: Angiogram selection, quantitative coronary measurements (lesion diameters, length, and stenosis percentage), vessel region enhancement and vessel region stabilization are performed instantly and on line.
- During device positioning, deployment and post-deployment: An on-line image stream, that is enhanced and stabilized, is displayed side-by-side with the existing fluoroscopic image stream.
- . Import and display of IVUS images, leading to a joint display of images acquired by X-Ray and IVUS images corresponding to same selected luminal locations or segments (also known as IVUS Co-registration).
- Import and display of Physiological values, leading to a joint display of images acquired by X-Ray and Physiological values corresponding to same selected luminal locations or segments (also known as Physiological Co-registration).
The Co-Registration is an automation of a manual workflow process used by interventional cardiologists today. The manual procedure in the cath lab for utilizing x-ray and IVUS image
5
streams calls for referencing the native x-ray and IVUS image streams of the patient's vasculature separately on different displays. This configuration requires the cardiologist to estimate an identical location on the patient's vasculature on the two native image streams (xray and IVUS) 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 streams automatically on adjacent windows on the same display.
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 pressure values.
The primary modifications are to software of the SyncVision Software to enhance the Physiology Co-Registration capability, which correlates between physiological values obtained from Volcano's pressure wire pullback (both iFR and FFR calculations) and their respective locations on a selected angiographic image. There are also administrative, infrastructure, and service modifications. The primary modifications of the new device compared to the predicate device are provided in the Modification Comparison table below.
| Proposed Modification | Predicate Device
SyncVision System
SW 4.0/HW 2.1
K161756 | Proposed Device
SyncVision System
SW4.1/HW2.1 | Comments |
|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Automated Roadmap:
Automation of the
Pathway indication phase
in the Physiology Co-
Registration workflow | During co-registration
set-up, after performing
an angiogram and the
pressure wire pullback,
the system selects the
angiogram frame to be
used then the user
manually indicates the
pathway to be used for
the physiology pullback. | During co-registration
set-up, after
performing an
angiogram and the
pressure wire pullback,
the system selects the
angiogram frame and
automatically
calculates the pathway
to be used for co-
registration. | Eliminates the need to
perform the manual
processes.
The user may still elect to
edit or manually draw the
pathway. A new Edit
Pathway button has been
added to the GUI for this
function. |
| Co-registration region
indication represented by
white triangle at the
proximal & distal ends of
the co-registration region. | During co-registration
set-up, after performing
an angiogram and the
pressure wire pullback,
the area in which the
pullback was performed
is not indicated. | During co-registration
set-up, after
performing an
angiogram and the
pressure wire pullback,
the area in which the
pullback was
performed is marked | Aids the user in visualizing
the area of interest of the
vessel that was used for Co-
Registration. |
| Proposed Modification | Predicate Device
SyncVision System
SW 4.0/HW 2.1
K161756 | Proposed Device
SyncVision System
SW4.1/HW2.1 | Comments |
| Display of Measurement
Points - Display white dots
on the roadmap,
representing the iFR
measurement location. | Display of 'white dots'
not available. In the
current system to view a
single measured point
the user clicks along the
Roadmap and the cursor
indicates the measured
location on the Roadmap. | The measured points
will appear as 'white
dots' along the
Roadmap. The user is
able to view and click
all measured points
along the Roadmap. | Provides the user with a
visual aid of where the
values were measured
during pullback. |
| Allow multiple length
measurements in the
Physiology Co-Registration
results tab | The user can perform
only one length
measurement at a time
along the vessel or the
trend line. | The user can perform
multiple length
measurements at a
time along the vessel
or the trend line. | New feature enhancement. |
| Enhancement related to
Tri-registration workflow | After performing Tri-
registration between
Angiography, Physiology,
and IVUS the user must
switch between screens
to see the desired view. | After performing Tri-
registration a joint
display comprising of
Angiography,
Physiology, and IVUS
Co-Registration data is
provided on one
screen. | Improvement to workflow |
| Enhancement related to
Tri-registration workflow | The user needs to
perform an IVUS Co-
Registration first and
then perform Physiology
Co-Registration using the
same Roadmap image in
order to obtain Tri-
Registration. | The workflow is
flexible as the user can
perform Co-
Registrations in any
order. | Improvement to workflow |
| Addition of "iFR
Estimated" calculation on
the GUI | When performing a single
length measurement the
system calculates and
displays the number of
yellow pressure drops
within a length
measurement, this is
called "iFR drop in
selection" (which is not a
new feature). The
physician then manually
adds this number to the
iFR distal value shown on
the screen as a
supplement reference. | When performing
single or multiple
length measurements
the system calculates
the number of the
yellow pressure drops
within the length
measurement, this is
called "iFR drop in
selection". The System
adds this number to
the iFR distal value and
displays the result on
the screen as "iFR
Estimated". | The result of the calculation
is shown on the screen as
an iFR Estimated value. This
value will now be displayed
for ease of use to the
clinician. |
| Proposed Modification | Predicate Device
SyncVision System
SW 4.0/HW 2.1
K161756 | Proposed Device
SyncVision System
SW4.1/HW2.1 | Comments |
| Compatibility with new
Volcano FFR Software
(SW) version 2.5 | Compatible with FFR
Software version 2.4.1 | Compatible with FFR
Software version 2.5 | Compatible with the latest
software version |
| Compatibility with the new
pressure wire Verrata®
Plus | Compatible with Verrata
pressure wire | Compatible with
Verrata Plus pressure
wire | Additional pressure wire
compatibility added |
| Removal of the use of the
ECG signal | The system can process
Co-registration with or
without an ECG signal:
-if ECG is used the System
uses the ECG signal for
automatic angiogram
frame selection
-if ECG is not used System
selects the middle frame
of the angiogram. | Removed the ECG
signal option. The
System automatically
selects the angiogram
frame. | Removed ECG option from
workflow.
The option to modify the
frame selection or manually
select an angiogram frame
is still available to the user. |
Modification Comparison
6
7
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:
The subject device provides additional angiographic features to the predicate device SyncVision System, cleared under K161756. There are no hardware or component changes. The software changes are enhancements to the current features, administrative, infrastructure, and service changes.
This submission is for software and subsequent labeling changes. The devices are identical in terms of:
- Indications for use,
- Design,
- Materials,
- . Specifications,
- Principles of Operation, and ●
- Fundamental Scientific Technology. ●
A comparison of the technological characteristics between the new device and those of the predicate device is provided in the Technological Comparison table below:
| Technical
Attributes | Predicate Device
SyncVision System
SW 4.0/HW 2.1
K161756 | Proposed Device
SyncVision System
SW4.1/HW2.1 | 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 | The SyncVision System is an image
acquisition and processing system.
It is indicated for use as follows:
• To provide quantitative
information regarding the | Same |
| Technical
Attributes | Predicate Device
SyncVision System
SW 4.0/HW 2.1
K161756 | Proposed Device
SyncVision System
SW4.1/HW2.1 | Comment |
| | 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. | 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. | |
| User Group | Intended for use by clinicians,
technicians and research personnel | Intended for use by clinicians,
technicians and research
personnel | Same |
| Application | Accessory to existing vessel image
systems for image manipulation
and co-registration and to provide
vessel measurements | Accessory to existing vessel image
systems for image manipulation
and co-registration and to provide
vessel measurements | Same |
| Use
Environment | To be used in the catheterization
lab; online during the procedure,
and offline for immediate post-
procedural analysis. | To be used in the catheterization
lab; online during the procedure,
and offline for immediate post-
procedural analysis | Same |
| 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
- Shimadzu Trinias/Voyager
- Philips Intuis
- Philips Azurion (Allura R9) | Additional
systems |
| Compatible
with the
following IVUS
system &
catheters | - Volcano s5/CORE Systems 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 Systems with
SW version 3.4 and 3.5, and FM
software version 2.5 - Eagle Eye Platinum IVUS catheter
- Verrata pressure guide wire
- Verrata Plus pressure guide wire | Updated to
current
s5/CORE
Systems
software, and
the FM
software
version 2.5.
Additional
pressure guide
wire |
| | Predicate Device
SyncVision System
SW 4.0/HW 2.1
K161756 | Proposed Device
SyncVision System
SW4.1/HW2.1 | Comment |
| Technical
Attributes | | | |
| Compatible
ECG Monitors | Compatible with most modern ECG
monitors which are equipped with
an Auxiliary output signal and are
commonly used in the cath-lab and
have analog outputs (input range
$\pm$ 10V). ADC resolution: 16 bit.
Minimum amplitude required is
200mV.
The configuration of the SyncVision
System is compatible with common
layouts and configurations of
catheter laboratories. | N/A | ECG
acquisition is
no longer
required for
angiogram
frame
selection |
| 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 to native
source image | Any image size, according to native
source image | Same |
| Image Depth
support | X-Ray: 8 bit grayscale
IVUS: 24 bit RGB or converted to an
8 bit grayscale to display IVUS in
black & white | X-Ray: 8 bit grayscale
IVUS: 24 bit RGB or converted to
an 8 bit grayscale to display IVUS in
black & white | Same |
| Image Frame
Selection for
Measurements | 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
FFR/iFR - user selectable | Same |
| Manual
Override | Manual override of selected
angiogram or IVUS image | Manual override of selected
angiogram or IVUS image | Same |
| Quantitative
Information | Quantitative Coronary Analysis
(QCA) applied to angiogram and
IVUS images | Quantitative Coronary Analysis
(QCA) applied to angiogram and
IVUS images | Same |
| QCA Interface | The user marks the designated
lesion, location, or diameter using a
point-and-click input device | The user marks the designated
lesion, location, or diameter using
a point-and-click input device | Same |
| QCA Calibration | Optional, using the Guiding
Catheter. If a calibration was not
performed, only the % stenosis will
be calculated and displayed | Optional, using the Guiding
Catheter. If a calibration was not
performed, only the % stenosis will
be calculated and displayed | Same |
| Edge Detection | Digital edge detection by
calculation of the derivatives (or
gradients) of the density curve
across the lumen and finding their | Digital edge detection by
calculation of the derivatives (or
gradients) of the density curve
across the lumen and finding their | Same |
| | Predicate Device
SyncVision System | Proposed Device | |
| Technical
Attributes | SW 4.0/HW 2.1 | SyncVision System
SW4.1/HW2.1 | Comment |
| | K161756 | | |
| | peak values, followed by least-cost | peak values, followed by least-cost | |
| QCA Display | optimization
Angiogram: Vessel walls
superimposed on the vessel image
in addition to Minimum Lumen
Diameter (MLD) marker line and
two reference-point marker lines.
IVUS: Diameter is displayed on the
IVUS axial image and length is
displayed on the IVUS longitudinal
view | optimization
Angiogram: Vessel walls
superimposed on the vessel image
in addition to Minimum Lumen
Diameter (MLD) marker line and
two reference-point marker lines.
IVUS: Diameter is displayed on the
IVUS axial image and length is
displayed on the IVUS longitudinal
view | Same |
| Vessel | 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 |
| QCA
Measurement
Precision | -MLD Precision: 0.15 mm - % Narrowing Precision: 5%
- Segment Precision: 0.5 mm | -MLD Precision: 0.15 mm
- % Narrowing Precision: 5%
- Segment Precision: 0.5 mm | Same |
| IVUS C-
Registration
Measurements:
(Diameter and
Length | Diameter: Precision ≤ 0.1mm
Length: Precision ≤ 0.5mm | Diameter: Precision ≤ 0.1mm
Precision ≤ 0.5mm | Same |
| Manual
Diameter
Measurements
on axial IVUS
images | Precision ≤ 0.1mm | Precision ≤ 0.1mm | Same |
| Area
Measurement
Precision | Precision ≤ ±0.1mm² | Precision ≤ ±0.1mm² | Same |
| FFR/iFR Co-
Registration
Length
Measurements | Precision ≤ 2.0 mm | Precision ≤ 2.0 mm | Same |
| Balloon/Stent
Enhancement | Enhanced visualization of the stent
deployment region by tracking and
alignment of balloon markers, and
averaging of multiple consecutive
frames. Enhancement is performed
by means of temporal and spatial
filtering of the aligned frames. | Enhanced visualization of the stent
deployment region by tracking and
alignment of balloon markers, and
averaging of multiple consecutive
frames. Enhancement is
performed by means of temporal
and spatial filtering of the aligned
frames. | Same |
| Method
Enhancement
Algorithm | Marker detection and alignment
Enhancement is performed by
means of temporal and spatial
filtering of the aligned frames | Marker detection and alignment
Enhancement is performed by
means of temporal and spatial
filtering of the aligned frames | Same |
| Technical | Predicate Device
SyncVision System | Proposed Device
SyncVision System | Comment |
| Attributes | SW 4.0/HW 2.1
K161756 | SW4.1/HW2.1 | |
| Power Supply | Medical grade isolation
transformer 600VA - Toroid ISB-
060W or compatible | Medical grade isolation
transformer 600VA - Toroid ISB-
060W or compatible | Same |
| Joystick | Standard USB, 2-button | Standard USB, 2-button | Same |
| Joystick
Catheterization | EUR RAIL 10 x 25 mm
US RAIL 3/8" x 1 | EUR RAIL 10 x 25 mm
US RAIL 3/8" x 1 | Same |
| Table Rail
Compatibility | 1/8"(9.52x28.57mm) | 1/8"(9.52x28.57mm) | |
| Monitor | Flat panel 19" or above monitor
with VGA and DVI inputs
Resolution 1280x1024 or above | Flat panel 19" or above monitor
with VGA and DVI inputs
Resolution 1280x1024 or above | Same |
| Mouse and
Keyboard | Keyboard: standard USB keyboard
Mouse: Standard USB mouse | Keyboard: standard USB keyboard
Mouse: Standard USB mouse | Same |
| Operating
System | Windows 7 64bit Professional Ed. | Windows 7 64bit Professional Ed | Same |
| Electrical
Specifications | Class I equipment, per IEC/EN
60601-1
H/W v2.0:
Input 120V to 240V auto voltage
selector 50/60Hz
Output 120V-240V voltage selector
50/60Hz | Class I equipment, per IEC/EN
60601-1
H/W v2.1:
Input 100V to 240V auto voltage
selector 50/60Hz
Output 100V-240V voltage selector
50/60Hz
Minimum power 400VA (at 240V)
Minimum outputs 4 (IEC320 C14
socket)
Over load protection fuse 100V &
240V
On/Off switch
Power cord: medical grade
minimum wire diameter AWG18
(0.75mm²) 3.5m max length
Fuses: 100VA 8.0A, 120VAC: 6.3A,
240VAC: 3.15A | H/W v2.0 not
compatible
with
SyncVision SW
version 4.1 |
| Environmental
Conditions | Ambient temperature range: +15°C
to +35°C (+59°F to +95°F)
Relative humidity range: 30% - 85%
Atmospheric pressure range
700hpa to 1060hpa | Ambient temperature range: +15°C
to +35°C (+59°F to +95°F)
Relative humidity range: 30% -
85% Atmospheric pressure range
700hpa to 1060hpa | same |
| Power
Consumption | ~400W,minimum power 400 VA (@
240V) | ~400W,minimum power 400 VA
(@ 240V) | Same |
| Workstation
Dimensions | Case Type: Super Midi-Tower | Case Type: Super Midi-Tower | No change in
hardware:
Correction of |
| Technical
Attributes | Predicate Device
SyncVision System
SW 4.0/HW 2.1
K161756 | Proposed Device
SyncVision System
SW4.1/HW2.1 | Comment |
| | H/W v2.0 Measurements: (without | Measurements: (without front | the |
| | front panel) 210mm (W) x 460mm | panel) 176 mm (W) x 430 mm (H) x | dimensions |
| | (H) x 460mm (D) | 550 mm (D) | only |
| | H/W v2.1 Measurements: 162 mm | | |
| | (W) x 396 mm (H) x 510 mm (D) | | |
Technological Comparison
8
9
10
11
12
SUMMARY OF NON-CLINICAL PERFORMANCE DATA:
Non-clinical performance testing has been performed on the SyncVision System software and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance documents:
-
. IEC 62304 Medical device software – Software life cycle processes (Edition 1.0, 2006). FDA/CDRH recognition number 13-32.
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
- . Unit, Integration, and System Level/General Verification Software Testing
- . QCA Verification
- IVUS co-Registration Verification .
- . FM Co-Registration Verification
-
. Software Validation
- . FM Co-Registration Visual Validation
-
. 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:
13
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 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.