(532 days)
The Cardiovascular Suite 4.2.1 is a software program that is intended to aid trained healthcare in the quantitative analysis of vascular ultrasound images in adults, particularly for the measurement of the diameter and its changes on the brachial artery, the diameter and its changes on the carotid Intima-Media Thickness, and for carotid plaque analysis.
The Cardiovascular Suite 4.2.1 is a software indicated for estimating early cardiovascular parameters by identifying and tracking the edges of the arteries by analyzing sequences of ultrasound images or single images of the longitudinal section of the vessel. The software consists of two main functional measurement modules: 1) the FMD-Studio for measuring Flow-Mediated-Dilation (FMD) of the brachial artery, by processing sequences of ultrasound image 2) The Carotid-Studio for measuring, by processing sequences of ultrasound images, the thickness of the carotid intima-media and the instantaneous carotid diameter that, associated with a pressure estimate, can provide arterial elasticity parameters. On single images, the software also provides a tool for Plaque Measurement and Quantification. The system is able to process previously recorded video files or directly process the video output of an ultrasound system in real time.
Here's a summary of the acceptance criteria and the study details for the Cardiovascular Suite 4.2.1, based on the provided document:
Acceptance Criteria and Device Performance
The acceptance criteria are implied by the precision and accuracy metrics evaluated during the validation testing. The device is considered to meet these criteria if its performance falls within acceptable ranges for repeatability and agreement with an expert's measurements. The table below summarizes the reported device performance, which serves as the fulfillment of these implied criteria.
Table of Acceptance Criteria and Reported Device Performance
| Measurement/Metric | Acceptance Criterion (Implied by reported performance) | Reported Device Performance (Cardiovascular Suite 4.2.1) |
|---|---|---|
| FMD Studio Precision | Coefficient of Variation (CV) | |
| Intra-observer intra-session FMD% variability | ≤ 10% | 9.9% ± 8.4% (reported as 10%) |
| Intra-observer inter-session FMD% variability | ≤ 13% | 12.9% ± 11.6% (reported as 13%) |
| Shear Rate measurement precision | ≤ 2.3% (specifically stated) | 2.3% |
| Carotid Studio Precision | Coefficient of Variation (CV) | |
| Intra-session Diameter variation | ≤ 2% | 2% |
| Intra-session IMT | ≤ 6% | 6% |
| Inter-session Diameter variation | ≤ 3% | 3% |
| Inter-session Diameter variation (cardiac cycle) | ≤ 12% | 12% |
| Inter-session IMT | ≤ 6% | 6% |
| Plaque geometric and statistics (single image) | ≤ 10% | < 10% for each measurement |
| Carotid Analyzer Accuracy (IMT) | Bias ± SD for IMT accuracy (specifically stated) | 0.006 ± 0.039mm |
| Carotid Analyzer Accuracy (Diameter) | Bias ± SD for Diameter accuracy (specifically stated) | 0.060 ± 0.110mm |
| Carotid Analyzer Accuracy (Distension) | Bias ± SD for Distension accuracy (specifically stated) | 0.016 ± 0.039mm |
| FMD Analyzer Accuracy (% diameter variation) | Error ≤ 0.013% (specifically stated) | 0.013% |
Study Information
-
Sample sizes used for the test set and the data provenance:
- FMD Studio Precision: 135 healthy volunteers. The data provenance is from seven Italian centers (prospective study, country of origin: Italy).
- Carotid Studio Precision: 10 healthy volunteers. The provenance is not explicitly stated but implies a controlled, prospective study.
- Compatible Ultrasound Devices Accuracy: Not explicitly stated as a numerical sample size but refers to "full set of images" and "each sub-set of images coming from each of the 15 devices." This suggests a test set composed of images from 15 different ultrasound devices, with a total of 120 carotid artery images (60 online/60 offline) and 120 brachial artery images (60 online/60 offline). The provenance is not explicitly stated.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Carotid Studio Precision: Two Clinical Operators (Opr 1 and Opr 2) performed measurements. Their specific qualifications (e.g., "radiologist with 10 years of experience") are not provided.
- Compatible Ultrasound Devices Accuracy: An unspecified "expert" provided the gold-standard manual measurements. The specific qualifications of this expert are not provided.
-
Adjudication method for the test set:
- Carotid Studio Precision: For the "precision" part of the Carotid Studio module, Opr 1 and Opr 2 each measured vessels three times. Opr 1 repeated the analysis during a second session. This suggests direct comparison of individual measurements for variability, rather than a formal adjudication of a ground truth.
- Compatible Ultrasound Devices Accuracy: The device's measurements were "compared with gold-standard measurements manually obtained by an expert." This implies a direct comparison rather than a consensus or adjudication among multiple readers/experts.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study is described where human readers' performance with and without AI assistance is evaluated. The studies focus on the precision and accuracy of the device itself or comparison between the device and expert/gold-standard measurements.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the performance testing described for both FMD Studio and Carotid Studio precision, and the accuracy comparisons for both modules, appear to be evaluating the standalone performance of the Cardiovascular Suite 4.2.1 software. For instance, the "accuracy of the following measurement of the CVS software was evaluated" and "The measurements were carried out by our software and compared with gold-standard measurements manually obtained by an expert." This indicates standalone algorithm performance evaluation.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- FMD Studio Accuracy: Evaluated on "synthetic image sequences."
- Carotid Studio Accuracy: Agreement with "RF based gold-standard" (likely referring to RadioFrequency-based quantitative ultrasound measurements) and "manual measurements manually obtained by an expert".
- Precision Studies: The ground truth for precision studies is the measurement itself, with the focus on consistency across repeated measurements by the same or different operators.
-
The sample size for the training set:
- The document does not explicitly state the sample size used for training the algorithm. It focuses on validation testing.
-
How the ground truth for the training set was established:
- Since the training set size is not provided, the method for establishing its ground truth is also not elaborated upon in this document.
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January 11, 2022
Quipu S.R.L % Dallas Thomas Principal Medical Device Regulatory Consultant Thomas Regulatory Resolutions, Inc. 5613 Tiger Way Winter Garden, Florida 34787
Re: K202094
Trade/Device Name: Cardiovascular Suite 4.2.1 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: December 27, 2021 Received: December 29, 2021
Dear Dallas Thomas:
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/cfpmn/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
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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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202094
Device Name Cardiovascular Suite 4.2.1
Indications for Use (Describe)
The Cardiovascular Suite 4.2.1 is a software program that is intended to aid trained healthcare in the quantitative analysis of vascular ultrasound images in adults, particularly for the measurement of the diameter and its changes on the brachial artery, the diameter and its changes on the carotid Intima-Media Thickness, and for carotid plaque analysis.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
5.1 General Information
11 January 2022 Preparation Date:
Primary Submission Contact
Dallas L. Thomas, RAC, MHA, MPA, SSYB
Medical Device Regulatory Consultant Thomas Regulatory Resolutions Inc. 5613 Tiger Way Winter Garden, Florida USA 34787 +1 561 898 0260
Manufacturer / Submitter
Vincenzo Gemignani
President
Quipu S.R.L Moruzzi 1 56124 Pisa Italy VAT IT-01995110507 Tel: 39 328 3074229 Email: gemignani@quipu.eu
5.2 Regulatory Information
| Subject Device Name | Cardiovascular Suite 4.2.1 |
|---|---|
| Classification Names | Computer, Diagnostic, Programmable |
| Device Classification | II |
| Common Name | Cardiovascular Suite 4.2.1 |
| FDA Product Code | DQK |
| CFR References | 870.1425 |
| Review Panel | Cardiovascular |
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5.3 Identification of Predicate Device
Quipu regards the Cardiovascular Suite to be substantially equivalent to the predicate K033266, which is the "Vascular Tools 5" consisting of modules: "Brachial Analyzers5", "Carotid Analyzer 5", as commercialized by Medical Imaging Applications LLC. Additionally we are including the reference devices as follows for further consideration for substantial equivalence: Reference Device: M'Ath Std K040686 by Intelligence in Medical Technologies and Reference Device: K090461, the IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0 by TOMTEC IMAGING SYSTEMS, GMBH
5.4 Subject Device Description
The Cardiovascular Suite 4.2.1 is a software indicated for estimating early cardiovascular parameters by identifying and tracking the edges of the arteries by analyzing sequences of ultrasound images or single images of the longitudinal section of the vessel.
The software consists of two main functional measurement modules:
-
the FMD-Studio for measuring Flow-Mediated-Dilation (FMD) of the brachial artery, by processing sequences of ultrasound image
-
The Carotid-Studio for measuring, by processing sequences of ultrasound images, the thickness of the carotid intima-media and the instantaneous carotid diameter that, associated with a pressure estimate, can provide arterial elasticity parameters. On single images, the software also provides a tool for Plaque Measurement and Quantification.
The system is able to process previously recorded video files or directly process the video output of an ultrasound system in real time.
The software is to be used only by trained healthcare professionals, such as laboratory technicians, nurses, doctors and/or ultrasonographers.
The use of the system for analyzing people with a distorted anatomy of the examined arterial tract is not recommended.
ર્સ્ટ Indications for Use
Per the current proposed product labeling, the indications for the Cardiovascular Suite 4.2.1 are quoted as follows:
Indications for Use
The Cardiovascular Suite 4.2.1 is a software program that is intended to aid trained healthcare practitioners in the quantitative analysis of vascular ultrasound images in adults, particularly for the measurement of the diameter and its changes on the brachial artery, the diameter and its changes on the carotid artery, the Carotid Intima-Media Thickness, and for carotid plaque analysis.
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Contraindications
The Cardiovascular Suite 4.2.1 device is not intended for use as a test that provides a direct diagnosis of any cardiovascular disease. It is intended to supplement, not substitute, the physician's decision-making process for diagnosis and treatment. It should be used in conjunction with knowledge of the patient's history and other clinical findings. It is not intended for use in pediatric population.
Please note that the above indication is slightly reworded compared to the already cleared indications for the predicate Vascular Tools 5 and updated accordingly per current FDA Guidance. The indications for use statement also provides further clarification that is complementary to the cleared predicate indications for use.
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Substantial Equivalence Discussion 5.6
Any modifications between the predicate device are provided in while the table below. The review of the indications for use and comparison characteristics provided in Error! Reference source not found. demonstrate that 4.2.1 is substantially equivalent o the predicate device, Vascular Tools 5. A reference device was also included.
Table 1. Substantial Equivalence Discussion
Please note a number of published article references are provided in this table.
| ItemNo. | DeviceCharacteristic. | Proposed DeviceCardiovascular Suite | Primary PredicateDevice VascularTools 5 | Reference Device:M'Ath Std. | Reference Device:K090461, the IMAGE-ARENA 4.0 AND IAAPPLICATIONS 2DCARDIACPERFORMANCEANALYSIS 1.0 byTOMTEC IMAGINGSYSTEMS, GMBH | ComparisonAnalysis: Identical/ SubstantiallyEquivalent /Modified / CannotBe Determined /Not Applicable | Rationale as to whyModification orDifference from Predicateto Subject Device DoesNot Impact Safety andEffectiveness. |
|---|---|---|---|---|---|---|---|
| 1 | 510 (k)Number | K202094 | K033266 | K040686 | K090461 | N/A | Difference in 510k numbers do notimpact safety or efficacy of theproduct. |
| 2 | Device Name,Model | Cardiovascular Suite | Vascular Tools 5 | M'Ath® Std | IMAGE-ARENA 4.0AND IA APPLICATIONS2D CARDIACPERFORMANCEANALYSIS 1.0 | N/A | Difference in Names do not impactsafety or efficacy of the product. |
| ItemNo. | DeviceCharacteristic. | Proposed DeviceCardiovascular Suite | Primary PredicateDevice VascularTools 5 | Reference Device:M'Ath Std. | Reference Device:K090461, the IMAGE-ARENA 4.0 AND IAAPPLICATIONS 2DCARDIACPERFORMANCEANALYSIS 1.0 byTOMTEC IMAGINGSYSTEMS, GMBH | ComparisonAnalysis: Identical/ SubstantiallyEquivalent /Modified / CannotBe Determined /Not Applicable | Rationale as to whyModification orDifference from Predicateto Subject Device DoesNot Impact Safety andEffectiveness. |
| 3 | Manufacturer | QUIPU SRL | MEDICALIMAGINGAPPLICATIONSLLC | Intelligence inMedicalTechnologies | TOMTEC IMAGINGSYSTEMS, GMBH | N/A | Differences do not impact safety orefficacy. |
| 4 | CFR Reference | 870.1425 | 870.1425 | CFR 892.2050 | 892.2050 | N/A | Differences do not impact safety orefficacy. |
| 5 | FDA ReviewPanel | Cardiovascular | Cardiovascular | Radiology | Radiology | N/A | Differences do not impact safety orefficacy. |
| 6 | FDA DeviceName | Computer, Diagnostic,Programmable | Programmablediagnostic computer | System, Imageprocessing,Radiological | Ultrasonic pulsed dopplerimaging system | N/A | Differences do not impact safety orefficacy. |
| 7 | FDA ProductCode | DQK | DQK | LLZ | LLZ, DQK | N/A | Differences do not impact safety orefficacy. |
| 8 | Class | II | II | II | II | Identical | N/A |
| ItemNo. | DeviceCharacteristic. | Proposed DeviceCardiovascular Suite | Primary PredicateDevice VascularTools 5 | Reference Device:M' Ath Std. | Reference Device:K090461, the IMAGE-ARENA 4.0 AND IAAPPLICATIONS 2DCARDIACPERFORMANCEANALYSIS 1.0 byTOMTEC IMAGINGSYSTEMS, GMBH | ComparisonAnalysis: Identical/ SubstantiallyEquivalent /Modified / CannotBe Determined /Not Applicable | Rationale as to whyModification orDifference from Predicateto Subject Device DoesNot Impact Safety andEffectiveness. |
| 9 | Indications foruse | The Cardiovascular Suite is asoftware program for thequantitative analysis ofvascular ultrasound images,particularly for themeasurement of the diameterand its changes on thebrachial artery, the diameterand its changes on the carotidartery, the Carotid Intima-Media Thickness, and forcarotid plaque analysis | Vascular Tools 5"software programhas been developedto aid in quantitativeanalysis oflongitudinalvascular ultrasoundimages, particularlyto determinevascular diameterand intima-mediathickness, as well astheir changes asdepicted in brachialand carotid arterialultrasound images. | M'Ath Stdsoftware is aWindows-basedapplicationprogram runningon a personalcomputer that isintended to aid thephysician in theorganization ofpatient datarelating to theultrasound imagesor video acquiredduring echo-cardiology examsof thecardiovascularsystem, includingthe patient's | The Image-Arena PlatformSoftware is intended toserve as a datamanagement platform forclinical applicationpackages. It providesinformation that is used forclinical diagnosispurposes. The software issuited for stand-aloneworkstations as well as fornetworked multisysteminstallations and thereforeis an image managementsystem for research androutine use in bothphysician practices andhospitals. It is intended asa general purpose digitalmedical image processing | Substantially Equivalent | Differences do not impact safety orefficacy. |
| ItemNo. | DeviceCharacteristic. | Proposed DeviceCardiovascular Suite | Primary PredicateDevice VascularTools 5 | Reference Device:M'Ath Std. | Reference Device:K090461, the IMAGE-ARENA 4.0 AND IAAPPLICATIONS 2DCARDIACPERFORMANCEANALYSIS 1.0 byTOMTEC IMAGINGSYSTEMS, GMBH | ComparisonAnalysis: Identical/ SubstantiallyEquivalent /Modified / CannotBe Determined /Not Applicable | Rationale as to whyModification orDifference from Predicateto Subject Device DoesNot Impact Safety andEffectiveness. |
| characteristics.Additionally, thesoftware allows thephysician to makemeasurements todetermine theintima-mediathickness of thecarotid artery fromthe acquiredimages and storesthem with thepatient file. | tool for cardiology. As theImage-Arena Applicationssoftware tool package ismodular structured,clinical applicationspackages with differentindications for use can beconnected. Echo-Comsoftware is intended toserve as a versatilesolution for Stress Echoexaminations in patientswho may not be receivingenough blood or oxygenbecause of blockedarteries. Image-Cornsoftware is intended forreviewing, measuring andreporting of DICOM dBtaof thi batdiah rodadlities. | ||||||
| ItemNo. | DeviceCharacteristic. | Proposed DeviceCardiovascular Suite | Primary PredicateDevice VascularTools 5 | Reference Device:M'Ath Std. | Reference Device:K090461, the IMAGE-ARENA 4.0 AND IAAPPLICATIONS 2DCARDIACPERFORMANCEANALYSIS 1.0 byTOMTEC IMAGINGSYSTEMS, GMBH | ComparisonAnalysis: Identical/ SubstantiallyEquivalent /Modified / CannotBe Determined /Not Applicable | Rationale as to whyModification orDifference from Predicateto Subject Device DoesNot Impact Safety andEffectiveness. |
| US and XA. -It can be'driven by Image;Arena orother third party platformsand is intended to launchother clinical applications.The clinical applicationpackage 2D CardiacPerformance Analysis isindicated for cardiacquantification based onechocardiographic data. Itprovides measurements ofmyocardial function(displacement, velocityand strain) that is used forclinical diagnosis purposesof patients with suspectedheart disease. | |||||||
| ItemNo. | DeviceCharacteristic. | Proposed DeviceCardiovascular Suite | Primary PredicateDevice VascularTools 5 | Reference Device:M'Ath Std. | Reference Device:K090461, the IMAGE-ARENA 4.0 AND IAAPPLICATIONS 2DCARDIACPERFORMANCEANALYSIS 1.0 byTOMTEC IMAGINGSYSTEMS, GMBH | ComparisonAnalysis: Identical/ SubstantiallyEquivalent /Modified / CannotBe Determined /Not Applicable | Rationale as to whyModification orDifference from Predicateto Subject Device DoesNot Impact Safety andEffectiveness. |
| 10 | Anatomicalstructure of use | Carotid and brachial artery | Same | Cardio vascularbed | Cardiovascular Bed | Identical to Predicate | N/A - Cardiovascular Suite analyzescarotid and brachial artery. Thesesites are included in the predicate'sanatomical structure of use. |
| 11 | CardiovascularPlaqueMeasurementfunctionincluded | Yes | No | Yes | No | Identical to ReferenceDevice | N/A-Cardiovascular Suite' tool forcarotid plaque includes geometricaland density measurementssubstantially equivalent to those ofthe reference device |
| 12 | Flow-MediatedDilatation(FMD)functionincluded | Yes | Yes | No | No | Identical to Predicate | N/A |
| 13 | IMT - IntimaMediaThickness | Yes | Yes | Yes | Yes | Identical to Predicate andReference Devices | N/A |
| ItemNo. | DeviceCharacteristic. | Proposed DeviceCardiovascular Suite | Primary PredicateDevice VascularTools 5 | Reference Device:M'Ath Std. | Reference Device:K090461, the IMAGE-ARENA 4.0 AND IAAPPLICATIONS 2DCARDIACPERFORMANCEANALYSIS 1.0 byTOMTEC IMAGINGSYSTEMS, GMBH | ComparisonAnalysis: Identical/ SubstantiallyEquivalent /Modified / CannotBe Determined /Not Applicable | Rationale as to whyModification orDifference from Predicateto Subject Device DoesNot Impact Safety andEffectiveness. |
| functionincluded | |||||||
| 14 | Hardwarerequirements | Laptop or PC runningMac OS X, MicrosoftWindowsOperating System (OS) | Laptop or PCrunning MicrosoftWindowsOperating System(OS) | MicrosoftWindowsoperating system | Microsoft Windowsoperating system on alaptop or PC | Modified | Differences do not impact safety orefficacy. Cardiovascular Suite can beused on Laptop or PC runningMicrosoft Windows OperatingSystem (OS) as the predicate.Cardiovascular Suite can be usedalso on Mac OS X, which presentsperformances comparable to theMicrosoft Windows OperatingSystem and is considered one of themost robust and user friendlyoperating system available on themarket. Therefore, this addition withrespect to the predicate device, doesnot result in differences in theperformance and safety of the device. |
| ItemNo. | DeviceCharacteristic. | Proposed DeviceCardiovascular Suite | Primary PredicateDevice VascularTools 5 | Reference Device:M'Ath Std. | Reference Device:K090461, the IMAGE-ARENA 4.0 AND IAAPPLICATIONS 2DCARDIACPERFORMANCEANALYSIS 1.0 byTOMTEC IMAGINGSYSTEMS, GMBH | ComparisonAnalysis: Identical/ SubstantiallyEquivalent /Modified / CannotBe Determined /Not Applicable | Rationale as to whyModification orDifference from Predicateto Subject Device DoesNot Impact Safety andEffectiveness. |
| 15 | On-line / off-line operation | On-line and off-line. | Same | Not PubliclyAvailable | Offline Only | Identical to Predicate | N/A |
| 16 | Supported dataformats | Cardiovascular Suite workson A) Video formats:DICOM, AVI, MP4, MOVB)Image formats: DICOM,PNG, JPG, BMP, TIF . Thesedata formats are similar tothose of predicate andreference devices. | DICOM, AVI, TIF,CRI, JPEG, BMP,RAW. | AVI, JPEG, GIF,TIFF, BMP, PCX,PCD, TGA, EPS,IMG, DICOM | DICOM | Modified | Differences in supported data formatsdo not impact safety or efficacy. |
| 17 | Calibration | Mandatory, manuallyperformed | Same | manuallyperformed andautomaticallyDICOM | Not Publicly Available | Identical to Predicate | N/A- Calibration is mandatory for allthe systems |
| 18 | Information foroperator in caseof | Warning popups and includedin instructions for use. | Same | Not PubliclyAvailable | Not Publicly Available | Identical to Predicate | Differences do not impact safety orefficacy. |
| ItemNo. | DeviceCharacteristic. | Proposed DeviceCardiovascular Suite | Primary PredicateDevice VascularTools 5 | Reference Device:M'Ath Std. | Reference Device:K090461, the IMAGE-ARENA 4.0 AND IAAPPLICATIONS 2DCARDIACPERFORMANCEANALYSIS 1.0 byTOMTEC IMAGINGSYSTEMS, GMBH | ComparisonAnalysis: Identical/ SubstantiallyEquivalent /Modified / CannotBe Determined /Not Applicable | Rationale as to whyModification orDifference from Predicateto Subject Device DoesNot Impact Safety andEffectiveness. |
| inappropriateuse | |||||||
| 19 | Patient/ datastorage | Yes: Data archive available | Same | Same | same | Identical to Predicate andReference Device | N/A-Patients data and images arestored into the archive of thesoftware |
| 20 | Data export | Reporting in Microsoft Excel,RTF, RTFd, PDF, TABSeparated Values, CommaSeparated Values, HTMLformat. | Reporting inMicrosoft Excel orSAS format. | DICOM and pdfformat | Data can be exported inPDF format. | Modified | Differences do not impact safety orefficacy. Cardiovascular Suitereporting in Microsoft Excel , PDF,TAB Separated Values, CommaSeparated Values. The additionalformat with respect to thepredicate/references can be read bythe same software program(Microsoft Excel and SAS).Moreover, the software architectureand more specifically the data exportmodule, has been tested andvalidated according to IEC 62304 |
| ItemNo. | DeviceCharacteristic. | Proposed DeviceCardiovascular Suite | Primary PredicateDevice VascularTools 5 | Reference Device:M'Ath Std. | Reference Device:K090461, the IMAGE-ARENA 4.0 AND IAAPPLICATIONS 2DCARDIACPERFORMANCEANALYSIS 1.0 byTOMTEC IMAGINGSYSTEMS, GMBH | ComparisonAnalysis: Identical/ SubstantiallyEquivalent /Modified / CannotBe Determined /Not Applicable | Rationale as to whyModification orDifference from Predicateto Subject Device DoesNot Impact Safety andEffectiveness. |
| and taking into consideration riskanalysis and reduction. Therefore,this addition with respect to thepredicate device, does not result indifferences in the performance andsafety of the device. | |||||||
| 21 | Modules | Two: one for FMD analysisand the other for Carotidanalysis | Same | Not PubliclyAvailable | Multiple Modules basedon Publicly Available datafrom 510k Summary. | Identical to Predicate andReference Device | N/A-Two modules both forCardiovascular Suite and thepredicate device. |
| 22 | Multi-userFunctionality | Yes: protected user access bypassword to the software | No | Not PubliclyAvailable | Yes, multi userfunctionality included. | Substantially Equivalent toReference device. | N/A- Comment: CardiovascularSuite provides a protected useraccess by password to the software.This feature has been introduced toguarantee safety in data access.Moreover, the multi-user access ofthe software has been tested andvalidated according to IEC 62304and taking into consideration risk |
| ItemNo. | DeviceCharacteristic. | Proposed DeviceCardiovascular Suite | Primary PredicateDevice VascularTools 5 | Reference Device:M' Ath Std. | Reference Device:K090461, the IMAGE-ARENA 4.0 AND IAAPPLICATIONS 2DCARDIACPERFORMANCEANALYSIS 1.0 byTOMTEC IMAGINGSYSTEMS, GMBH | ComparisonAnalysis: Identical/ SubstantiallyEquivalent /Modified / CannotBe Determined /Not Applicable | Rationale as to whyModification orDifference from Predicateto Subject Device DoesNot Impact Safety andEffectiveness. |
| analysis and reduction. Therefore,this addition with respect to thepredicate device, does not result indifferences in the performance andsafety of the device. | |||||||
| 23 | LicensingIssuance | Dongle Licensekey and webbased | Web based | LICENSE KEY | Not Publicly Available | Substantially Equivalent toattributes of bothPredicate & ReferenceDevices | The systems provide a licensingapproach web-based. In addition,Cardiovascular Suite can providelicense to the customer by dongle-key use. Dongle form is tightlycontrolled licensing. Moreover, thelicensing process of the software hasbeen tested and validated and it isfurther verified during the productionprocedure. Therefore, this additionwith respect to the predicate device,does not result in differences in theperformance and safety of the device. |
| ItemNo. | DeviceCharacteristic. | Proposed DeviceCardiovascular Suite | Primary PredicateDevice VascularTools 5 | Reference Device:M'Ath Std. | Reference Device:K090461, the IMAGE-ARENA 4.0 AND IAAPPLICATIONS 2DCARDIACPERFORMANCEANALYSIS 1.0 byTOMTEC IMAGINGSYSTEMS, GMBH | ComparisonAnalysis: Identical/ SubstantiallyEquivalent /Modified / CannotBe Determined /Not Applicable | Rationale as to whyModification orDifference from Predicateto Subject Device DoesNot Impact Safety andEffectiveness. |
| 24 | FMD Inputimage modality | Ultrasound image sequencesin B-mode modality;Ultrasound image sequencesin Duplex mode(simultaneous acquisition ofB-mode and Doppler) | Ultrasound imagesequences in B-mode modality;Doppler FlowAnalysis notsupported | B-mode and colorflow | Not Included | Substantially Equivalent toPredicate | Differences do not impact safety orefficacy. Cardiovascular Suitesupports B-mode as the predicate andreference device. In addition Dopplerflow analysis is also supported partof the predicate device. |
| 25 | Measured/computedparameters | Flow Mediated Dilation(FMD).Shear rate detection | Flow MediatedDilation (FMD) | Not PubliclyAvailable | Not Publicly Available | Modified | Both devices provide instantaneousbrachial diameter that can be used toevaluate Flow-Mediated-Dilation. Inaddition, FMD Studio, thanks to theDoppler Flow Analysis can provideShear rate estimation, which is notexpected to result in differences insafety and efficacy. |
| 26 | Exam type | Measurement performed onB-mode longitudinal sectionof the artery, which is imaged | Same | Not PubliclyAvailable | Not Publicly Available,however based on theproduct website they doinclude multiple | Identical to predicate | N/A- Measurement performed on B-mode longitudinal section of theartery, which is imaged above the |
| ItemNo. | DeviceCharacteristic. | Proposed DeviceCardiovascular Suite | Primary PredicateDevice VascularTools 5 | Reference Device:M'Ath Std. | Reference Device:K090461, the IMAGE-ARENA 4.0 AND IAAPPLICATIONS 2DCARDIACPERFORMANCEANALYSIS 1.0 byTOMTEC IMAGINGSYSTEMS, GMBH | ComparisonAnalysis: Identical/ SubstantiallyEquivalent /Modified / CannotBe Determined /Not Applicable | Rationale as to whyModification orDifference from Predicateto Subject Device DoesNot Impact Safety andEffectiveness. |
| above the antecubital fossa inthe longitudinal plane | measurementfunctionalities. | antecubital fossa in the longitudinalplane | |||||
| 27 | Detectionalgorithm /otheralgorithms | Contour tracking algorithmbased on edge detectionoperator. | Globally optimalgraph search borderdetection approach | Not PubliclyAvailable | Not Publicly Available | Modified | Differences do not impact safety orefficacy. Contour tracking approach.Both devices include an algorithmfor the automatic detection of theborder of the vessel, which is usedfor the computation of the vesseldiameter.The brachial analysis module ofVascular Tools 5 performs anautomatic detection of the edges ofthe vessel using a globally optimalgraph search border detectionapproach. [REF] The operator drawa region of interest (ROI) in whichthe best definition of the edges of thevessel is detectable on the first frameof the individual frame sequences or |
| ItemNo. | DeviceCharacteristic. | Proposed DeviceCardiovascular Suite | Primary PredicateDevice VascularTools 5 | Reference Device:M'Ath Std. | Reference Device:K090461, the IMAGE-ARENA 4.0 AND IAAPPLICATIONS 2DCARDIACPERFORMANCEANALYSIS 1.0 byTOMTEC IMAGINGSYSTEMS, GMBH | ComparisonAnalysis: Identical/ SubstantiallyEquivalent /Modified / CannotBe Determined /Not Applicable | Rationale as to whyModification orDifference from Predicateto Subject Device DoesNot Impact Safety andEffectiveness. |
| movie clips. The analysis proceedsautomatically in supervision mode | |||||||
| thus allowing the operator to exclude | |||||||
| from the analysis poor-quality frames | |||||||
| or frames in which the edges of the | |||||||
| vessel are not correctly detected. | |||||||
| Similarly, using FMD Studio, the | |||||||
| approximate position of the edges of | |||||||
| the vessel is manually located before | |||||||
| starting the examination. After this | |||||||
| procedure, an automatic contour | |||||||
| tracking algorithm, based on a | |||||||
| mathematical edge detector operator | |||||||
| (first order absolute central moment | |||||||
| [REF]), locates and tracks the edges, | |||||||
| supplying information about quality | |||||||
| and time course of measurements in | |||||||
| real time. On completion of the | |||||||
| analysis, both methods automatically | |||||||
| generate a report, with all the | |||||||
| ItemNo. | DeviceCharacteristic. | Proposed DeviceCardiovascular Suite | Primary PredicateDevice VascularTools 5 | Reference Device:M'Ath Std. | Reference Device:K090461, the IMAGE-ARENA 4.0 AND IAAPPLICATIONS 2DCARDIACPERFORMANCEANALYSIS 1.0 byTOMTEC IMAGINGSYSTEMS, GMBH | ComparisonAnalysis: Identical/ SubstantiallyEquivalent /Modified / CannotBe Determined /Not Applicable | Rationale as to whyModification orDifference from Predicateto Subject Device DoesNot Impact Safety andEffectiveness. |
| recorded measurements. The resultsobtained using the two systems havebeen evaluated in a comparison study[Faita et Al, REF] performed on 60participants, which showed anexcellent level of agreement in vesseledge location and subsequentdiameter evaluation. Therefore thedifference in the detection algorithmdoes not result in differences in theperformance and safety of the device. | |||||||
| 28 | ECG gating | Not required | Not required | Not PubliclyAvailable | Not Included | Identical to predicate | N/A |
| 29 | Output(displayed /stored data andresults) | Instantaneous diameter chartMean diameter chartTime averaged positive ShearRate Charttime averaged positive shear | 1 - Instantaneousdiameter chart2 – Third orderpolynomial fit chart3 - EKG gated | Not PubliclyAvailable | Not Publicly Available,but they do includemultiple data formatsbased on product details. | Modified | Differences in output displays ofstored data and results, do not impactsafety or efficacy. |
| ItemNo. | DeviceCharacteristic. | Proposed DeviceCardiovascular Suite | Primary PredicateDevice VascularTools 5 | Reference Device:M'Ath Std. | Reference Device:K090461, the IMAGE-ARENA 4.0 AND IAAPPLICATIONS 2DCARDIACPERFORMANCEANALYSIS 1.0 byTOMTEC IMAGINGSYSTEMS, GMBH | ComparisonAnalysis: Identical/ SubstantiallyEquivalent /Modified / CannotBe Determined /Not Applicable | Rationale as to whyModification orDifference from Predicateto Subject Device DoesNot Impact Safety andEffectiveness. |
| ratetime averaged negative shearrate | Doppler flowDoppler Waveformenvelop detection: | ||||||
| Mean diameter | 1 measure per frame | ||||||
| D Baseline [mm]: value of | – Flow Integral | ||||||
| the baseline diameter | AUC on Cycle | ||||||
| D Maximum [mm]: value of | 1 measure per frame | ||||||
| the maximum diameter | – Flow Maximum in | ||||||
| during vasodilation | Cycle | ||||||
| D Recovery [mm]: diameter | 1 measure per frame | ||||||
| value in the recovery phase | - Flow Average in | ||||||
| after vasodilation | Cycle | ||||||
| MD [%]: Flow Mediated | |||||||
| Dilation | |||||||
| FMDr [%]: Flow Mediated | |||||||
| Dilation calculated in relation | |||||||
| to the diameter in the | |||||||
| recovery phase after | |||||||
| vasodilation | |||||||
| SR Maximum [s- | |||||||
| ItemNo. | DeviceCharacteristic. | Proposed DeviceCardiovascular Suite | Primary PredicateDevice VascularTools 5 | Reference Device:M'Ath Std. | Reference Device:K090461, the IMAGE-ARENA 4.0 AND IAAPPLICATIONS 2DCARDIACPERFORMANCEANALYSIS 1.0 byTOMTEC IMAGINGSYSTEMS, GMBH | ComparisonAnalysis: Identical/ SubstantiallyEquivalent /Modified / CannotBe Determined /Not Applicable | Rationale as to whyModification orDifference from Predicateto Subject Device DoesNot Impact Safety andEffectiveness. |
| 1]:maximum value of theshear rateSR Baseline[s-1]:maximumvalue of the shear rateSR Area [dimensionless]:area under the curve of theshear rate,Time Average Wall ShearRate (computed usingDoppler flow velocitywaveform)GTN [%]: GTN InducedDilation | |||||||
| 30 | Report review | Yes | Yes | Not PubliclyAvailable | Yes report review in PDFis available. | Identical to Predicate and areference device. | N/A |
| 31 | CAROTIDInput datamodality | Ultrasound B-mode imagesequences | Ultrasound B-modeimage sequences | Not PubliclyAvailable | Ultrasound B-mode imagesequences | Identical to predicate and areference device. | N/A - Cardiovascular Suite supportsB-mode as the predicate does |
| ItemNo. | DeviceCharacteristic. | Proposed DeviceCardiovascular Suite | Primary PredicateDevice VascularTools 5 | Reference Device:M'Ath Std. | Reference Device:K090461, the IMAGE-ARENA 4.0 AND IAAPPLICATIONS 2DCARDIACPERFORMANCEANALYSIS 1.0 byTOMTEC IMAGINGSYSTEMS, GMBH | ComparisonAnalysis: Identical/ SubstantiallyEquivalent /Modified / CannotBe Determined /Not Applicable | Rationale as to whyModification orDifference from Predicateto Subject Device DoesNot Impact Safety andEffectiveness. |
| 32 | Measurementtype / Output | Intima media thickness(IMT), diameter and elasticityof carotid arteries:mean and maximum IMTreported for each framediameter and IMTmeasurement in imagesequencesmean distension, cross-sectional compliancecoefficient, cross-sectionaldistensibility coefficient,Stiffness, Young moduleDoppler Flow Velocity | Intima mediathickness (IMT) anddiameter of carotidarteries:mean and maximumIMT reported foreach framediameter and IMTmeasurement inimage sequences. | IMT, Plaque(geometric andstatistics))andelasticityparameters | IMT and Diameter ofCarotid Arteries.Additional measurementsare also available based onthe product website. Alsoincluded the doppler FlowVelocity. | Modified betweenpredicate and referencedevices. | Differences do not impact safety orefficacy. WITH RESPECT TO THEPREDICATE: The predicate andreference devices evaluate diameterand IMT, starting from a region ofinterest defined by the operator, in B-mode image sequences. In additiondiameter data from Carotid Studio,when combined with an estimate ofpressure, obtained through legallymarketed devices, provideparameters of arterial elasticity.Carotid intima-media thickness(IMT) and diameter elasticity aremarkers of structural and functionalvessel wall properties. Bothparameters have been found inpopulation-based studies to beassociated with cardiovascular riskfactors and prevalent cardiovascular |
| ItemNo. | DeviceCharacteristic. | Proposed DeviceCardiovascular Suite | Primary PredicateDevice VascularTools 5 | Reference Device:M'Ath Std. | Reference Device:K090461, the IMAGE-ARENA 4.0 AND IAAPPLICATIONS 2DCARDIACPERFORMANCEANALYSIS 1.0 byTOMTEC IMAGINGSYSTEMS, GMBH | ComparisonAnalysis: Identical/ SubstantiallyEquivalent /Modified / CannotBe Determined /Not Applicable | Rationale as to whyModification orDifference from Predicateto Subject Device DoesNot Impact Safety andEffectiveness. |
| disease. The estimation of carotidelasticity by Carotid Studio has beenimplemented by adopting equationsand modalities suggested by opinionleaders guidelines . CardiovascularSuite measurement methods havebeen validated in terms of accuracyand reproducibility . CardiovascularSuite usability requirements aredefined to avoid confusion in resultsvisualization, highlighting IMT andclearly identifying all the parameters.Finally, it should be mentioned thatthe Cardiovascular Suite device isintended to supplement, notsubstitute, the physician's decision-making process; it should be used inconjunction with knowledge of thepatient's history and other clinicalfindings. | |||||||
| ItemNo. | DeviceCharacteristic. | Proposed DeviceCardiovascular Suite | Primary PredicateDevice VascularTools 5 | Reference Device:M' Ath Std. | Reference Device:K090461, the IMAGE-ARENA 4.0 AND IAAPPLICATIONS 2DCARDIACPERFORMANCEANALYSIS 1.0 byTOMTEC IMAGINGSYSTEMS, GMBH | ComparisonAnalysis: Identical/ SubstantiallyEquivalent /Modified / CannotBe Determined /Not Applicable | Rationale as to whyModification orDifference from Predicateto Subject Device DoesNot Impact Safety andEffectiveness. |
| As a conclusion, this technologicalcharacteristic does change the safetyor effectiveness of the device. WITHRESPECT TO THE REFERENCEDevice M'Ath: both systems evaluatearterial elasticity (distensibility) bycontour tracking algorithm andprovide a tool for plaque analysisbased on similar approaches. | |||||||
| 33 | Exam type | Measurement performed onB-mode longitudinal sectionof the artery. | Same | longitudinal andcross sectional | longitudinal and crosssectional | Identical to predicate | N/A |
| 34 | Detectionalgorithm /otheralgorithms | Contour tracking algorithmbased on edge / borderdetection operator, incombination with patternrecognition approach | Globally optimalgraph search borderdetection approach[SON98, SON02] | Not PubliclyAvailable | Not Publicly Available | Substantially Equivalent toPredicate | N/A |
| ItemNo. | DeviceCharacteristic. | Proposed DeviceCardiovascular Suite | Primary PredicateDevice VascularTools 5 | Reference Device:M'Ath Std. | Reference Device:K090461, the IMAGE-ARENA 4.0 AND IAAPPLICATIONS 2DCARDIACPERFORMANCEANALYSIS 1.0 byTOMTEC IMAGINGSYSTEMS, GMBH | ComparisonAnalysis: Identical/ SubstantiallyEquivalent /Modified / CannotBe Determined /Not Applicable | Rationale as to whyModification orDifference from Predicateto Subject Device DoesNot Impact Safety andEffectiveness. |
| 35 | Identificationof cardiac cycle | Yes | Yes | Yes | Yes | Identical to predicate andreference device | N/A |
| 36 | Identificationof carotidsection | Yes | Yes | Yes | Yes | Identical to predicate andreference device | N/A |
| 37 | Report Review | Yes | Yes | Yes | Yes | Identical to predicate andreference device | N/A |
| 38 | Exam durationtime | 9 minutes brachial analysis/ 5minute carotid analysis | Same | same for carotidanalysis | same for carotid analysis | Identical to predicate | N/A |
| 39 | Target area | Carotid and brachial artery | Same | Carotid | Carotid and other targetssuch as the heart. | Identical to predicate | N/A |
| 40 | Results of theuse of thediagnosticdevice | Results are related to themeasurement of well-knownand accepted cardiovascularbiomarkers. | Same | Not PubliclyAvailable | Not Publicly Available | Identical to predicate | N/A |
| ItemNo. | DeviceCharacteristic. | Proposed DeviceCardiovascular Suite | Primary PredicateDevice VascularTools 5 | Reference Device:M' Ath Std. | Reference Device:K090461, the IMAGE-ARENA 4.0 AND IAAPPLICATIONS 2DCARDIACPERFORMANCEANALYSIS 1.0 byTOMTEC IMAGINGSYSTEMS, GMBH | ComparisonAnalysis: Identical/ SubstantiallyEquivalent /Modified / CannotBe Determined /Not Applicable | Rationale as to whyModification orDifference from Predicateto Subject Device DoesNot Impact Safety andEffectiveness. |
| A clinical evaluation has beenconducted to review thesafety and effectiveness of theuse of these biomarkers forcardiovascular diseases riskstratification.Results can supplement thephysician's decision-makingprocess. They should be usedin conjunction withknowledge of the patient'shistory and other clinicalfindings. | |||||||
| 41 | Carotidanalyzer -accuracy | Agreement with RF basedgold-standard [JUM 2010BIANCHINI et Al]:Bland&Altman analysis (biasvalue ± standard deviation):IMT 0.006 ± 0.039mm | Signed error meanIMT -0.007 ± 0.07mmSigned error maxIMT -0.07± 0.09mm | Not PubliclyAvailable | Not Publicly Available | Modified | Differences are not expected to haveimpact on safety or efficacy. |
| ItemNo. | DeviceCharacteristic. | Proposed DeviceCardiovascular Suite | Primary PredicateDevice VascularTools 5 | Reference Device:M'Ath Std. | Reference Device:K090461, the IMAGE-ARENA 4.0 AND IAAPPLICATIONS 2DCARDIACPERFORMANCEANALYSIS 1.0 byTOMTEC IMAGINGSYSTEMS, GMBH | ComparisonAnalysis: Identical/ SubstantiallyEquivalent /Modified / CannotBe Determined /Not Applicable | Rationale as to whyModification orDifference from Predicateto Subject Device DoesNot Impact Safety andEffectiveness. |
| Diameter 0.060 ± 0.110mm | |||||||
| Distension 0.016 ± 0.039mm | D and Stiffnessaccuracy and | ||||||
| precision not found | |||||||
| 42 | Carotidanalyzer -precision | 1) Intra-observer intra-sessionvariability: 7%±6% for IMT,2%±1% for diastolicdiameter, 11%±7% fordistension, 11%±7% for crosssectional compliancecoefficient and 13%±8% forcross sectional distensibilitycoefficient.2) Inter-observer intra-sessionvariability: 8%±8% for IMT,3%±2% for diastolicdiameter, 11%±10% fordistension, 12%±11% forcross sectional compliance | Intra-subjectreproducibility forthe mean carotidIMThad a coefficient ofvariation of 3% witha mean absolutedifference of 0.02mm (SD 0.01).[PAT10] | Not PubliclyAvailable | Not Publicly Available | Modified | Carotid Studio precision expressed ascoefficient of variation is 2% for thediameter, 11% for the diametervariation during the cardiac cycle,6% for IMT for intra-observer intra-session measurements and 3% for thediameter, 12% for the diametervariation during the cardiac cycle,6% for IMT for intra-observer inter-session measurements. As regardsplaque geometric and statistics datathe precision of the results expressedas coefficient of variation resultedlower than 10% for each |
| ItemNo. | DeviceCharacteristic. | Proposed DeviceCardiovascular Suite | Primary PredicateDevice VascularTools 5 | Reference Device:M'Ath Std. | Reference Device:K090461, the IMAGE-ARENA 4.0 AND IAAPPLICATIONS 2DCARDIACPERFORMANCEANALYSIS 1.0 byTOMTEC IMAGINGSYSTEMS, GMBH | ComparisonAnalysis: Identical/ SubstantiallyEquivalent /Modified / CannotBe Determined /Not Applicable | Rationale as to whyModification orDifference from Predicateto Subject Device DoesNot Impact Safety andEffectiveness. |
| coefficient and $13%\pm12%$ forcross sectional distensibilitycoefficient. 3) intra-observerinter-session variability:$6%\pm6%$ for IMT, $3%\pm2%$ fordiastolic diameter, $12%\pm10%$for distension, $16%\pm11%$ forcross sectional compliancecoefficient and $17%\pm12%$ forcross sectional distensibilitycoefficient.Data from a single centerstudyPlaque alsoNB for compliance anddistensibility rep also dependson pressure estimation | measurement obtained on a singleimage by the same operator. | ||||||
| ItemNo. | DeviceCharacteristic. | Proposed DeviceCardiovascular Suite | Primary PredicateDevice VascularTools 5 | Reference Device:M' Ath Std. | Reference Device:K090461, the IMAGE-ARENA 4.0 AND IAAPPLICATIONS 2DCARDIACPERFORMANCEANALYSIS 1.0 byTOMTEC IMAGINGSYSTEMS, GMBH | ComparisonAnalysis: Identical/ SubstantiallyEquivalent /Modified / CannotBe Determined /Not Applicable | Rationale as to whyModification orDifference from Predicateto Subject Device DoesNot Impact Safety andEffectiveness. |
| 43 | FMD analyzer- accuracy | Accuracy evaluated onsynthetic image sequences:error in assessing % diametervariation equal to 0.013%. | Comparison with anon-automatedmethod (ProsoundSystem, JetPropulsionLaboratory, USA).Brachial ultrasoundtapes from 12patients undergoingendothelial functionassessmentThe correlationbetween the twoapproaches wasexcellent for boththe measurement ofabsolute diameters(r=0.995, P<0.001)and percentagediameter changes | Not PubliclyAvailable | Not Publicly Available | Modified | Accuracy evaluated on syntheticimage sequences: error in assessing% diameter variation equal to0.013%.Please note as mentionedabove that: The results obtainedusing the two systems have beenevaluated in a comparison study[Faita et Al] performed on 60participants, which showed anexcellent level of agreement in vesseledge location and subsequentdiameter evaluation . Thereforedifferences do not change safety orefficacy profile doe to this low rateof difference. |
| ItemNo. | DeviceCharacteristic. | Proposed DeviceCardiovascular Suite | Primary PredicateDevice VascularTools 5 | Reference Device:M'Ath Std. | Reference Device:K090461, the IMAGE-ARENA 4.0 AND IAAPPLICATIONS 2DCARDIACPERFORMANCEANALYSIS 1.0 byTOMTEC IMAGINGSYSTEMS, GMBH | ComparisonAnalysis: Identical/ SubstantiallyEquivalent /Modified / CannotBe Determined /Not Applicable | Rationale as to whyModification orDifference from Predicateto Subject Device DoesNot Impact Safety andEffectiveness. |
| (r=0.973, P<0.001).The BrachialAnalyzerdemonstrated nobias compared withthe other method[MAN02] | |||||||
| 44 | FMD analyzer- precision | Precision was assessed interms of reproducibility.Intra-observer intra-sessionvariability: 9.9±8.4%Intra-observer inter-sessionvariability: 12.9±11.6%Data from a multicenter study[REF]. | In the abovementionedexperimentationBrachial Analyzerdemonstratedexcellent precision(0.07 mm and 1.62percentage diameterchange). [MAN02] | Not PubliclyAvailable | Not Publicly Available | Modified | FMD-Studio precision, expressed ascoefficient of variation, is 10% forintra-observer intra-sessionmeasurements and 13% for intra-observer inter-session measurementsof FMD%. |
| 45 | IEC 62366 | Standard Applied to Product | Same | Not PubliclyAvailable | Not Publicly Available | Identical to Predicate | N/A |
| ItemNo. | DeviceCharacteristic. | Proposed DeviceCardiovascular Suite | Primary PredicateDevice VascularTools 5 | Reference Device:M'Ath Std. | Reference Device:K090461, the IMAGE-ARENA 4.0 AND IAAPPLICATIONS 2DCARDIACPERFORMANCEANALYSIS 1.0 byTOMTEC IMAGINGSYSTEMS, GMBH | ComparisonAnalysis: Identical/ SubstantiallyEquivalent /Modified / CannotBe Determined /Not Applicable | Rationale as to whyModification orDifference from Predicateto Subject Device DoesNot Impact Safety andEffectiveness. |
| 46 | IEC 62304 | Standard Applied to Product | Same | Not PubliclyAvailable | Not Publicly Available | Identical to Predicate | N/A |
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The modifications between the Cardiovascular Suite 4.2.1 and the Vascular Tools 5 predicate are examined in determined that each difference between the devices resulted in no impact to the performance, safety, or efficacy of Cardiovascular Suite 4.2.1 when compared to Vascular Tools 5.
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5.7 Sterilization and Shelf Life
The Cardiovascular Suite 4.2.1 is a software only and therefore, does not require sterilization and has no patient contacting surface. Therefore no Sterilization or Shelf life testing was conducted.
5.8 Biocompatibility
The Cardiovascular Suite 4.2.1 is a software only and therefore, does not include any patient contactials. Therefore no biocompatibility testing was conducted.
5.9 Product Performance Testing - Software
Performance Software tests of Cardiovascular Suite 4.2.1 have been performed. The passing results from the performance bench testing demonstrate that Cardiovascular Suite 4.2.1 has met the functional requirements and is substantially equivalent to the predicate device.
5.10 Application of Standards
The following standards are applicable to the Cardiovascular Suite 4.2.1.
| OriginalOrder | Standards Applied No. | Standards Title | Equivalent ISO / IECVersion |
|---|---|---|---|
| 1 | EN ISO 13485:2016 | Medical devices - Qualitymanagement systems -Requirements for regulatorypurposes | ISO 13485:2016 |
| 2 | EN ISO 14971:2012 | Application of riskmanagement to medicaldevices | ISO 14971:2007 |
| 3 | EN 1041:2008 +AMD1:2013 | Information supplied by themanufacturer of medicaldevices | N/A |
| 4 | EN 62304:2006 +AMD1:2015 | Medical device software -Software life cycle processes | IEC 62304:2006 +AMD1:2015 |
| 5 | EN 62366:2008 | Medical devices -Application of usabilityengineering to medicaldevices | IEC 62366:2007 |
Table 5: Applied Standards
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| OriginalOrder | Standards Applied No. | Standards Title | Equivalent ISO / IECVersion |
|---|---|---|---|
| 6 | EN ISO 15223-1:2016 | Medical devices - Symbolsto be used with medicaldevice labels, labeling andinformation to be supplied -Part 1: General requirements | ISO 15223-1:2016 |
5.11 Validation Testing of Measurements for the Cardiovascular Suite 4.2.1
Validation testing of the measurements available in the Cardiovascular Suite 4.2.1 were performed and are summarized here.
Precision of the FMD Studio module
The precision of the FMD Studio was assessed in terms of repeatability of the measurement and tested in seven Italian centers, recruiting 135 healthy volunteers aged between 20 and 60. On each subject two different types of repeatability tests were performed:
i) intra-observer intra-session: in this case the same operator has analyzed the same subject twice within the same session, with a time interval of one hour;
ii) intra-observer inter-session: in this case the operator has analyzed twice within two different sessions, with a time interval of three days.
Precision of the Carotid Studio module
For the Carotid Studio module, sequences of the right/left common carotid artery of 10 healthy volunteers were analyzed during two separate sessions after 7 days. In the first session two Clinical Operators (Opr 1 and Opr 2) measured each vessel three times each. During the second session, only Opr 1 repeated the analysis. On each sequence of images, the following elements were calculated automatically through the Carotid Studio: Intima-media thickness (IMT), diastolic diameter (Dd), distension (ΔD), cross-sectional compliance (CC) coefficient and cross-sectional distensibility coefficient (DC).
Compatible ultrasound devices.
A further test was carried out to verify that the claimed accuracy of the CardioVascular Suite (CVS) software is maintained with claimed compatible ultrasound devices.
Scans of both the Carotid artery and the Brachial artery in longitudinal section were used for the and offline analysis setup were tested. For the online setup, the ultrasound images were acquired by the CVS software using
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the Epiphan AV.io HD frame grabber. For the offline setup, images were exported as multimedia file from the ultrasound device and imported in the CVS software by using an external USB flash memory.
| Site of scan | US modality | # of images (online / offline) |
|---|---|---|
| Carotid artery | B-mode | 120 (60/60) |
| Brachial artery | Dual (B-mode + PWD) | 120 (60/60) |
The accuracy of the following measurement of the CVS software was evaluated:
- . Diameter (D)
- Intima Media Thickness (IMT) ●
- Time Average of the Doppler Flow Velocity (TADFV) .
The accuracy of the Shear Rate (SR) was estimated as the root mean square of the TADFV and the D measurements.
The measurements were carried out by our software and compared with gold-standard measurements manually obtained by an expert.
The analysis of accuracy was carried out on the full set of images. The agreement between the CVS software and the Gold Standard was tested by the analysis of the Coefficient of the standard deviation to the mean of the measurements). In addition, each sub-set of images coming from each of the 15 devices was singularly analyzed in order to better identify specific issues that might be related to the single ultrasound device.
Intra-session variability between measurements of the Doppler Flow Velocity was also evaluated.
RESULTS
FMD-Studio precision, expressed as coefficient of variation, is 10% for intra-session measurements and 13% for intra-observer inter-session measurements of FMD%. For the Shear Rate measurement, the estimated precision is 2,3%.
Carotid Studio precision expressed as coefficient of variation is 2% for the diameter variation during the cardiac cycle, 6% for IMT for intra-session measurements and 3% for the diameter, 12% for the diameter variation during the cardiac cycle, 6% for IMT for intra-observer inter-session measurements. As regards geometric and statistics data the precision of the results expressed as coefficient of variation resulted lower than 10% for each measurement obtained on a single image by the same operator.
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These results are maintained for each compatible ultrasound device.
5.12 Conclusion
The subject device Cardiovascular Suite 4.2.1 is substantially equivalent to the predicate device. Cardiovascular Suite 4.2.1 shares a substantially equivalent design, indications for use and technology (i.e. features, materials, and principles of operation) with the predicate device and no new elements pertaining to change in safety or effectiveness have been identified.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).