(38 days)
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.
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 provided document, a 510(k) premarket notification for the Volcano Corporation's SyncVision System (K172574), is for software modifications to an already cleared device (K161756). Therefore, the study described focuses on software verification and validation, rather than a de novo clinical study with human readers or standalone performance.
Here's a breakdown of the acceptance criteria and the study conducted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes software verification and validation, with "passing results in all cases when compared to acceptance criteria defined in the respective test plans and protocols." Specific quantitative acceptance criteria or detailed results are not provided in this summary. Instead, the document summarizes the types of tests performed and the ultimate finding of compliance.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Software Verification | All criteria passed |
| Unit, Integration, and System Level/General Verification Software Testing | All criteria passed |
| QCA Verification | All criteria passed |
| IVUS Co-Registration Verification | All criteria passed |
| FM Co-Registration Verification | All criteria passed |
| Software Validation (FM Co-Registration Visual Validation) | All criteria passed |
| Usability Validation (Simulated Use, Design & Usability/Human Factors Engineering Validation Test) | All criteria passed |
2. Sample Size for the Test Set and Data Provenance
The document does not specify general "test set" sample sizes or data provenance (e.g., country of origin, retrospective/prospective) because this submission is for software modifications to an existing device. Instead, it refers to internal software verification and validation activities. These tests would typically use simulated data, previously acquired clinical data (from the predicate device or other sources), or a combination thereof to evaluate the new software's functionality. The details of these internal test data sets are not disclosed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the summary. For software verification and validation, ground truth would be established by comparing the software's output against expected results in simulated scenarios or against data with known ground truth (e.g., manually calculated measurements or outputs from the predicate device). The expertise required would depend on the nature of the specific test.
4. Adjudication Method for the Test Set
The adjudication method is not explicitly stated. Given that this is a software verification and validation submission for modifications, it's likely that internal quality control processes, including expert review and comparison to established benchmarks or predicate device performance, would have been used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted and described in this document. The submission focuses on demonstrating substantial equivalence of the modified software to the predicate device through non-clinical performance testing.
6. Standalone Performance (Algorithm Only)
Yes, a standalone (algorithm only) performance assessment was inherent in the "Software Verification" and "Software Validation" mentioned. These tests evaluate the software's functionality and accuracy independent of human interaction, though "Simulated Use" would involve human interaction to assess usability. The document confirms that various components of the software, such as QCA, IVUS co-registration, and FM co-registration, underwent verification and validation.
7. Type of Ground Truth Used
The specific types of ground truth for the internal software verification and validation are not detailed in this summary. However, for a device like SyncVision, which performs quantitative measurements and co-registration, the ground truth for these tests would likely involve:
- Known input parameters and expected output calculations for quantitative analysis (QCA, measurements).
- Reference standard alignments or known spatial relationships for co-registration components (IVUS co-registration, FM co-registration).
- Comparison to the performance of the predicate device for functional equivalence.
8. Sample Size for the Training Set
The document does not mention a training set, as it is a 510(k) submission for software modifications to a previously cleared device, not a de novo algorithm development. If the modifications involved machine learning components, a training set would be relevant, but such details are not provided here.
9. How the Ground Truth for the Training Set Was Established
As no training set is described, this information is not applicable and not provided in the document.
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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
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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
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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)
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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 AlanRegulatory Affairs SpecialistVolcano Corporation3721 Valley Center Dr.San Diego, CA 92130 | Tel: 858-764-1281Email: ealan@volcanocorp.com | |
|---|---|---|---|
| Manufacturer: | Volcano Corporation2870 Kilgore RoadRancho Cordova, CA 95670Establishment 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
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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
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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 DeviceSyncVision SystemSW 4.0/HW 2.1K161756 | Proposed DeviceSyncVision SystemSW4.1/HW2.1 | Comments |
|---|---|---|---|
| Automated Roadmap:Automation of thePathway indication phasein the Physiology Co-Registration workflow | During co-registrationset-up, after performingan angiogram and thepressure wire pullback,the system selects theangiogram frame to beused then the usermanually indicates thepathway to be used forthe physiology pullback. | During co-registrationset-up, afterperforming anangiogram and thepressure wire pullback,the system selects theangiogram frame andautomaticallycalculates the pathwayto be used for co-registration. | Eliminates the need toperform the manualprocesses.The user may still elect toedit or manually draw thepathway. A new EditPathway button has beenadded to the GUI for thisfunction. |
| Co-registration regionindication represented bywhite triangle at theproximal & distal ends ofthe co-registration region. | During co-registrationset-up, after performingan angiogram and thepressure wire pullback,the area in which thepullback was performedis not indicated. | During co-registrationset-up, afterperforming anangiogram and thepressure wire pullback,the area in which thepullback wasperformed is marked | Aids the user in visualizingthe area of interest of thevessel that was used for Co-Registration. |
| Proposed Modification | Predicate DeviceSyncVision SystemSW 4.0/HW 2.1K161756 | Proposed DeviceSyncVision SystemSW4.1/HW2.1 | Comments |
| Display of MeasurementPoints - Display white dotson the roadmap,representing the iFRmeasurement location. | Display of 'white dots'not available. In thecurrent system to view asingle measured pointthe user clicks along theRoadmap and the cursorindicates the measuredlocation on the Roadmap. | The measured pointswill appear as 'whitedots' along theRoadmap. The user isable to view and clickall measured pointsalong the Roadmap. | Provides the user with avisual aid of where thevalues were measuredduring pullback. |
| Allow multiple lengthmeasurements in thePhysiology Co-Registrationresults tab | The user can performonly one lengthmeasurement at a timealong the vessel or thetrend line. | The user can performmultiple lengthmeasurements at atime along the vesselor the trend line. | New feature enhancement. |
| Enhancement related toTri-registration workflow | After performing Tri-registration betweenAngiography, Physiology,and IVUS the user mustswitch between screensto see the desired view. | After performing Tri-registration a jointdisplay comprising ofAngiography,Physiology, and IVUSCo-Registration data isprovided on onescreen. | Improvement to workflow |
| Enhancement related toTri-registration workflow | The user needs toperform an IVUS Co-Registration first andthen perform PhysiologyCo-Registration using thesame Roadmap image inorder to obtain Tri-Registration. | The workflow isflexible as the user canperform Co-Registrations in anyorder. | Improvement to workflow |
| Addition of "iFREstimated" calculation onthe GUI | When performing a singlelength measurement thesystem calculates anddisplays the number ofyellow pressure dropswithin a lengthmeasurement, this iscalled "iFR drop inselection" (which is not anew feature). Thephysician then manuallyadds this number to theiFR distal value shown onthe screen as asupplement reference. | When performingsingle or multiplelength measurementsthe system calculatesthe number of theyellow pressure dropswithin the lengthmeasurement, this iscalled "iFR drop inselection". The Systemadds this number tothe iFR distal value anddisplays the result onthe screen as "iFREstimated". | The result of the calculationis shown on the screen asan iFR Estimated value. Thisvalue will now be displayedfor ease of use to theclinician. |
| Proposed Modification | Predicate DeviceSyncVision SystemSW 4.0/HW 2.1K161756 | Proposed DeviceSyncVision SystemSW4.1/HW2.1 | Comments |
| Compatibility with newVolcano FFR Software(SW) version 2.5 | Compatible with FFRSoftware version 2.4.1 | Compatible with FFRSoftware version 2.5 | Compatible with the latestsoftware version |
| Compatibility with the newpressure wire Verrata®Plus | Compatible with Verratapressure wire | Compatible withVerrata Plus pressurewire | Additional pressure wirecompatibility added |
| Removal of the use of theECG signal | The system can processCo-registration with orwithout an ECG signal:-if ECG is used the Systemuses the ECG signal forautomatic angiogramframe selection-if ECG is not used Systemselects the middle frameof the angiogram. | Removed the ECGsignal option. TheSystem automaticallyselects the angiogramframe. | Removed ECG option fromworkflow.The option to modify theframe selection or manuallyselect an angiogram frameis still available to the user. |
Modification Comparison
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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:
| TechnicalAttributes | Predicate DeviceSyncVision SystemSW 4.0/HW 2.1K161756 | Proposed DeviceSyncVision SystemSW4.1/HW2.1 | Comment |
|---|---|---|---|
| Indications forUse | The SyncVision System is an imageacquisition and processing system.It is indicated for use as follows:• To provide quantitativeinformation regarding the | The SyncVision System is an imageacquisition and processing system.It is indicated for use as follows:• To provide quantitativeinformation regarding the | Same |
| TechnicalAttributes | Predicate DeviceSyncVision SystemSW 4.0/HW 2.1K161756 | Proposed DeviceSyncVision SystemSW4.1/HW2.1 | Comment |
| calculated dimensions of arterialsegments.- To enhance visualization of thestent deployment region.- To be used in-procedure in thecatheterization lab and off-line forpost-procedural analysis.- To obtain a co-registration of anangiographic x-ray image and IVUSimages.- To obtain a co-registration of anangiographic x-ray image andintravascular blood pressurevalues. | calculated dimensions of arterialsegments.- To enhance visualization of thestent deployment region.- To be used in-procedure in thecatheterization lab and off-line forpost-procedural analysis.- To obtain a co-registration of anangiographic x-ray image and IVUSimages.- To obtain a co-registration of anangiographic x-ray image andintravascular blood pressurevalues. | ||
| User Group | Intended for use by clinicians,technicians and research personnel | Intended for use by clinicians,technicians and researchpersonnel | Same |
| Application | Accessory to existing vessel imagesystems for image manipulationand co-registration and to providevessel measurements | Accessory to existing vessel imagesystems for image manipulationand co-registration and to providevessel measurements | Same |
| UseEnvironment | To be used in the catheterizationlab; online during the procedure,and offline for immediate post-procedural analysis. | To be used in the catheterizationlab; online during the procedure,and offline for immediate post-procedural analysis | Same |
| Compatibilitywith thecatheter-laboratoryfluoroscopySystems | - Siemens Axiom Artis & SiemensArtis Zee- Philips Allura Xper FD10/20 &Philips Allura Clarity- GE Innova- Toshiba Infinix- Shimadzu Trinias/Voyager | - Siemens Axiom Artis & SiemensArtis Zee- Philips Allura Xper FD10/20 &Philips Allura Clarity- GE Innova- Toshiba Infinix- Shimadzu Trinias/Voyager- Philips Intuis- Philips Azurion (Allura R9) | Additionalsystems |
| Compatiblewith thefollowing IVUSsystem &catheters | - Volcano s5/CORE Systems withSW version 3.2.2 and above, andFM software version 2.4.1- Eagle Eye Platinum IVUS catheter- Verrata pressure guide wire | - Volcano s5/CORE Systems withSW version 3.4 and 3.5, and FMsoftware version 2.5- Eagle Eye Platinum IVUS catheter- Verrata pressure guide wire- Verrata Plus pressure guide wire | Updated tocurrents5/CORESystemssoftware, andthe FMsoftwareversion 2.5.Additionalpressure guidewire |
| Predicate DeviceSyncVision SystemSW 4.0/HW 2.1K161756 | Proposed DeviceSyncVision SystemSW4.1/HW2.1 | Comment | |
| TechnicalAttributes | |||
| CompatibleECG Monitors | Compatible with most modern ECGmonitors which are equipped withan Auxiliary output signal and arecommonly used in the cath-lab andhave analog outputs (input range$\pm$ 10V). ADC resolution: 16 bit.Minimum amplitude required is200mV.The configuration of the SyncVisionSystem is compatible with commonlayouts and configurations ofcatheter laboratories. | N/A | ECGacquisition isno longerrequired forangiogramframeselection |
| Image Source | Angiography/fluoroscopy/Intravascular Ultrasound (IVUS)/FFR/iFR pressure wires | Angiography/fluoroscopy/Intravascular Ultrasound (IVUS)/FFR/iFR pressure wires | Same |
| Source ImageType | Nativeangiography/fluoroscopy/ultrasound images | Nativeangiography/fluoroscopy/ultrasound images | Same |
| Image Size | Any image size, according to nativesource image | Any image size, according to nativesource image | Same |
| Image Depthsupport | X-Ray: 8 bit grayscaleIVUS: 24 bit RGB or converted to an8 bit grayscale to display IVUS inblack & white | X-Ray: 8 bit grayscaleIVUS: 24 bit RGB or converted toan 8 bit grayscale to display IVUS inblack & white | Same |
| Image FrameSelection forMeasurements | Angiogram - The systemautomatically presents an imageframe, and in most cases this willbe a frame in which the vessel isfilled with contrast mediaIVUS - User selectableFFR/iFR - user selectable | Angiogram - The systemautomatically presents an imageframe, and in most cases this willbe a frame in which the vessel isfilled with contrast mediaIVUS - User selectableFFR/iFR - user selectable | Same |
| ManualOverride | Manual override of selectedangiogram or IVUS image | Manual override of selectedangiogram or IVUS image | Same |
| QuantitativeInformation | Quantitative Coronary Analysis(QCA) applied to angiogram andIVUS images | Quantitative Coronary Analysis(QCA) applied to angiogram andIVUS images | Same |
| QCA Interface | The user marks the designatedlesion, location, or diameter using apoint-and-click input device | The user marks the designatedlesion, location, or diameter usinga point-and-click input device | Same |
| QCA Calibration | Optional, using the GuidingCatheter. If a calibration was notperformed, only the % stenosis willbe calculated and displayed | Optional, using the GuidingCatheter. If a calibration was notperformed, only the % stenosis willbe calculated and displayed | Same |
| Edge Detection | Digital edge detection bycalculation of the derivatives (orgradients) of the density curveacross the lumen and finding their | Digital edge detection bycalculation of the derivatives (orgradients) of the density curveacross the lumen and finding their | Same |
| Predicate DeviceSyncVision System | Proposed Device | ||
| TechnicalAttributes | SW 4.0/HW 2.1 | SyncVision SystemSW4.1/HW2.1 | Comment |
| K161756 | |||
| peak values, followed by least-cost | peak values, followed by least-cost | ||
| QCA Display | optimizationAngiogram: Vessel wallssuperimposed on the vessel imagein addition to Minimum LumenDiameter (MLD) marker line andtwo reference-point marker lines.IVUS: Diameter is displayed on theIVUS axial image and length isdisplayed on the IVUS longitudinalview | optimizationAngiogram: Vessel wallssuperimposed on the vessel imagein addition to Minimum LumenDiameter (MLD) marker line andtwo reference-point marker lines.IVUS: Diameter is displayed on theIVUS axial image and length isdisplayed on the IVUS longitudinalview | 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 |
| QCAMeasurementPrecision | -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-RegistrationMeasurements:(Diameter andLength | Diameter: Precision ≤ 0.1mmLength: Precision ≤ 0.5mm | Diameter: Precision ≤ 0.1mmPrecision ≤ 0.5mm | Same |
| ManualDiameterMeasurementson axial IVUSimages | Precision ≤ 0.1mm | Precision ≤ 0.1mm | Same |
| AreaMeasurementPrecision | Precision ≤ ±0.1mm² | Precision ≤ ±0.1mm² | Same |
| FFR/iFR Co-RegistrationLengthMeasurements | Precision ≤ 2.0 mm | Precision ≤ 2.0 mm | Same |
| Balloon/StentEnhancement | Enhanced visualization of the stentdeployment region by tracking andalignment of balloon markers, andaveraging of multiple consecutiveframes. Enhancement is performedby means of temporal and spatialfiltering of the aligned frames. | Enhanced visualization of the stentdeployment region by tracking andalignment of balloon markers, andaveraging of multiple consecutiveframes. Enhancement isperformed by means of temporaland spatial filtering of the alignedframes. | Same |
| MethodEnhancementAlgorithm | Marker detection and alignmentEnhancement is performed bymeans of temporal and spatialfiltering of the aligned frames | Marker detection and alignmentEnhancement is performed bymeans of temporal and spatialfiltering of the aligned frames | Same |
| Technical | Predicate DeviceSyncVision System | Proposed DeviceSyncVision System | Comment |
| Attributes | SW 4.0/HW 2.1K161756 | SW4.1/HW2.1 | |
| Power Supply | Medical grade isolationtransformer 600VA - Toroid ISB-060W or compatible | Medical grade isolationtransformer 600VA - Toroid ISB-060W or compatible | Same |
| Joystick | Standard USB, 2-button | Standard USB, 2-button | Same |
| JoystickCatheterization | EUR RAIL 10 x 25 mmUS RAIL 3/8" x 1 | EUR RAIL 10 x 25 mmUS RAIL 3/8" x 1 | Same |
| Table RailCompatibility | 1/8"(9.52x28.57mm) | 1/8"(9.52x28.57mm) | |
| Monitor | Flat panel 19" or above monitorwith VGA and DVI inputsResolution 1280x1024 or above | Flat panel 19" or above monitorwith VGA and DVI inputsResolution 1280x1024 or above | Same |
| Mouse andKeyboard | Keyboard: standard USB keyboardMouse: Standard USB mouse | Keyboard: standard USB keyboardMouse: Standard USB mouse | Same |
| OperatingSystem | Windows 7 64bit Professional Ed. | Windows 7 64bit Professional Ed | Same |
| ElectricalSpecifications | Class I equipment, per IEC/EN60601-1H/W v2.0:Input 120V to 240V auto voltageselector 50/60HzOutput 120V-240V voltage selector50/60Hz | Class I equipment, per IEC/EN60601-1H/W v2.1:Input 100V to 240V auto voltageselector 50/60HzOutput 100V-240V voltage selector50/60HzMinimum power 400VA (at 240V)Minimum outputs 4 (IEC320 C14socket)Over load protection fuse 100V &240VOn/Off switchPower cord: medical grademinimum wire diameter AWG18(0.75mm²) 3.5m max lengthFuses: 100VA 8.0A, 120VAC: 6.3A,240VAC: 3.15A | H/W v2.0 notcompatiblewithSyncVision SWversion 4.1 |
| EnvironmentalConditions | Ambient temperature range: +15°Cto +35°C (+59°F to +95°F)Relative humidity range: 30% - 85%Atmospheric pressure range700hpa to 1060hpa | Ambient temperature range: +15°Cto +35°C (+59°F to +95°F)Relative humidity range: 30% -85% Atmospheric pressure range700hpa to 1060hpa | same |
| PowerConsumption | ~400W,minimum power 400 VA (@240V) | ~400W,minimum power 400 VA(@ 240V) | Same |
| WorkstationDimensions | Case Type: Super Midi-Tower | Case Type: Super Midi-Tower | No change inhardware:Correction of |
| TechnicalAttributes | Predicate DeviceSyncVision SystemSW 4.0/HW 2.1K161756 | Proposed DeviceSyncVision SystemSW4.1/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
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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:
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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.
§ 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.