Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes image processing and co-registration, but there is no mention of AI, ML, or related terms like deep learning or neural networks. The performance studies focus on software verification and validation, usability, and simulated use, not on the performance metrics typically associated with AI/ML models (e.g., sensitivity, specificity, AUC).

Therapeutic

No
The device is described as an "image acquisition and processing system" that provides quantitative information and enhances visualization. Its objective is to "optimize and facilitate trans-catheter cardiovascular interventions by means of automated on-line image processing." It assists in visualizing and quantifying information, rather than directly treating or curing a disease or condition.

Diagnostic

Yes

The device provides quantitative information regarding the calculated dimensions of arterial segments and enhances visualization of the stent deployment region, which are functions commonly associated with diagnostic devices for assessing physiological conditions and guiding medical procedures.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "workstation situated in the coronary catheterization laboratory" and "captures angiographic and intravascular ultrasound (IVUS) image streams, as well as physiological (FFR/iFR) displayed value streams". This indicates the system includes hardware components for image and data acquisition and processing, not just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the SyncVision System is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is typically used for diagnosis, monitoring, or screening.
SyncVision System Function: The SyncVision System processes and displays images and physiological data acquired in-procedure within the catheterization lab. It works with angiographic x-ray images, IVUS images, and intravascular pressure values. These are direct measurements and visualizations of the internal anatomy and physiology, not analyses of in vitro specimens.
Intended Use: The intended use focuses on providing quantitative information about arterial segments, enhancing visualization during procedures, and co-registering different imaging modalities and pressure values. This is all related to in vivo assessment and procedural guidance.

The device is clearly described as an image acquisition and processing system used during and after coronary catheterization procedures, directly interacting with the patient's internal environment through imaging and pressure sensing. This aligns with the definition of a medical device used for diagnosis and treatment guidance in vivo, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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

Product codes

OWB

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Angiography/fluoroscopy/Intravascular Ultrasound (IVUS)/FFR/iFR pressure wires

Anatomical Site

Heart and the blood vessels directly connected to it. Specifically, coronary catheterization.

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)

Study Type: Non-clinical performance testing, specifically software verification and validation, and usability validation.
Sample Size: Not specified.
Key Results: The test results demonstrated passing results in all cases when compared to acceptance criteria defined in the respective test plans and protocols.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

SyncVision System, K172574

Reference Device(s)

K190078

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

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

2

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 Corporation
2870 Kilgore Road
Rancho Cordova, CA 95670
Establishment Registration Number: 2939520
CONTACT/
SUBMITTER:	Rand Daoud
Regulatory Affairs Specialist, 4
Tel: (858) 720-4049
Email: rand.daoud@philips.com
Philips Volcano
3721 Valley Center Dr.
Suite 500
San 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 (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:

3

. 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.

4

Table 1. Modification Comparison Table:

| Technical
Attributes | Predicate Device
SyncVision System
SW4.1 | Proposed Device
SyncVision System
SW4.2 | Comments |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Automation of the
IVUS Co-
Registration
workflow to align
with Physiology Co-
Registration
workflow as
implemented in
software version 4.1
and 4.1.1. | K172574
The user must manually
switch to IVUS Co-
registration to perform an
angiogram, and must
manually indicate the
pathway to be used for the
IVUS pullback. Once IVUS
pullback is completed, the
System generates and
displays the IVUS Co-
registration results. | The SyncVision System
automatically switches
to IVUS Co-registration
Mode Display upon
detection of a live IVUS
image, The system also
automatically selects
the angiogram roadmap
frame and calculates
the pathway to be used
for co-registration. | This
modification
eliminates the
need for the
user to perform
the pathway
selection process
manually. |
| Exit Co-
Registration
Mode: | 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-
registration
region
indicator: | 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 Roadmap
Pathway Editor. | In the current System, the
Roadmap Pathway Editor is
split into two different
screens: 1) editing and
confirming the pathway
(Pathway Confirmation
Phase) | In the proposed System,
all Roadmap Pathway
Editor actions are
displayed on one
screen. | This improved
Roadmap Pathway
Editor allows the
user to observe,
adjust and confirm
the roadmap image
and 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 location
of the selected IVUS
image on the Co-
Registered Roadmap
image. | | in the enlarged
IVUS window. |
| New Snapshot
feature that enables
creating and saving
screenshots. | In the current System, the
user can export result
snapshots from the
procedure to a USB drive
only in offline mode. | In the proposed System,
a new Snapshot Button
has been added to the
SyncVision system to
enable an easy way to
capture screenshots
during the procedure
and during the review
of the procedure in
offline mode. A USB
drive is not required to
save snapshots, but it is
required to export them
from the system in
offline mode. | Provides users with
the ability to save
snapshot images
from the SyncVision
System during the
procedure and also
when the System is
in offline mode. |
| Saving
snapshots in the
Results Tab: | In the current System,
the Reports Tab contains
stored images of QCA
and VE results. The
images are saved
automatically after
performing QCA or VE on
an Angiogram. | In the proposed
System, only saved
snapshots will be
displayed in the
Reports Tab. The
user will have the
ability to browse
between the saved
snapshots and if
desired, add
annotated text to
summarize findings.
QCA and VE results
will not be saved
unless the user
selects to save a
snapshot of the
results. | Provides users a
location to
review all saved
snapshots and
to write a
summary of case
findings. |
| Compatibility with
new IntraSight
System (K190078). | The current SyncVision
System is compatible with
Volcano S5/CORE Systems
with IVUS versions 3.4, 3.5
and FFR/iFR Software
version 2.5.X. | The proposed
SyncVision System SW
4.2 is also compatible
with the current
IVUS/FM Software
Versions (IVUS v3.4,
v3.5 / FFR/iFR v2.5.1),
as well as with
Volcano's IntraSight
System IVUS Software | SyncVision SW
Verification
testing has been
conducted for all
compatible
Systems. |
| Compatibility with
Siemens Artis One
X-Ray System. | The current
SyncVision System is
compatible with the
following
catheterization lab x-
ray systems:
Siemens Axiom &
Siemens Artis
Zee/Q Philips Allura Xper
FD10/20 & Philips
Allura Clarity GE Innova Toshiba Infinix Philips Intuis Philips Azurion Shimadzu Trinias/Voyager | v5.0 / iFR/FFR Software
v5.0), recently cleared
under K190078.
The proposed
SyncVision
System
software
version 4.2, is
also
compatible
with the X-Ray
systems that
run on SW
v4.1, as well as
with:
Siemens Artis
One | SyncVision
qualification
with the list of X-
Ray systems
identified was
conducted. |
| Other Changes:
GUI
Updates. Fixes for
deferred
defects
from
Syncvision
4.1.x. Minor
Additions. | N/A | Updates to the GUI and
minor software
additions were
implemented as part of
the software
modifications made
with the proposed SW
version 4.2.
Fixes for deferred
defects from the prior
SW version 4.1.X were
also made. | All software
modifications do
not affect the
intended use or
scientific
technologies or
the devices, and
the fundamental
operating
principles are
essentially the
same to the
predicate device |

5

6

7

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.

8

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:

9

| Technical
Attributes | Predicate Device SyncVision
System SW4.1
K172574 | Proposed Device SyncVision
System SW4.2 | Comment |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Compatible with
the following IVUS
system & catheters | Volcano s5/CORE
Systems with SW version
3.4 and 3.5, and FM
(FFR/iFR) software
version 2.5.xEagle Eye Platinum IVUS
catheterVerrata pressure guide
wireVerrata Plus pressure
guide wire | Volcano
s5/CORE/IntraSight
Systems with IVUS SW
versions 3.4, 3.5, and 5.0
and FFR/iFR software
versions 2.5.1 and 5.0Eagle Eye Platinum IVUS
catheterVerrata and Verrata Plus
pressure guide wire | Substantially
Equivalent |
| 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 | Quantitative Coronary Analysis
(QCA) applied to angiogram | 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 |
| Technical
Attributes | Predicate Device SyncVision
System SW4.1
K172574 | Proposed Device SyncVision
System SW4.2 | Comment |
| Edge Detection | Digital edge detection by
calculation of the derivatives (or
gradients) of the density curve
across the lumen and finding their
peak values, followed by least-
cost optimization | Digital edge detection by
calculation of the derivatives (or
gradients) of the density curve
across the lumen and finding their
peak values, followed by least-
cost optimization | Same |
| QCA Display | Angiogram: Segmentation of the
vessel walls superimposed on the
vessel image in addition to
Minimum Lumen Diameter (MLD)
marker line and two reference-
point marker lines. | Angiogram: Segmentation of the
vessel walls superimposed on the
vessel image in addition to
Minimum Lumen Diameter (MLD)
marker line and two reference-
point marker lines. | Same |
| Vessel
Measurements | 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/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 | Marker detection and alignment | Marker detection and alignment | Same |
| Enhancement
Algorithm | Enhancement is performed
by
means of temporal and spatial
filtering of the aligned frames | Enhancement is performed
by
means of temporal and spatial
filtering of the aligned frames | Same |
| 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 1/8"(9.52x28.57mm) | EUR RAIL 10 x 25 mm US RAIL
3/8" x 1 1/8"(9.52x28.57mm) | Same |
| 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 |
| Technical
Attributes | Predicate Device SyncVision
System SW4.1
K172574 | Proposed Device SyncVision
System SW4.2 | Comment |
| Electrical
Specifications | Class I equipment, per IEC/EN
60601-1

HW 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 | Class I equipment, per IEC/EN
60601-1

HW v2.2:
Input 100V/120V/240V voltage
selector, 50/60Hz.
Output 100V/120V/240V voltage
selector, 50/60Hz.
Minimum power 400VA (at 240V).
Minimum outputs 4 (IEC320 C14
socket).
Over load protection fuse 100V,
120V & 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 | Same |
| Environmental
Conditions | 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%

10

11

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

12

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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