(532 days)
No
The summary describes image processing techniques for edge detection and measurement but does not mention AI, ML, or any related concepts like neural networks or deep learning. The performance studies focus on traditional statistical measures of precision and accuracy compared to manual measurements.
No.
The device is described as a software program intended to aid healthcare professionals in the quantitative analysis of vascular ultrasound images, providing measurements and analyses (e.g., diameter changes, IMT, plaque analysis) that assess cardiovascular parameters. It does not exert a direct therapeutic effect on the patient.
Yes.
The device is intended to aid in the "quantitative analysis of vascular ultrasound images" for measurements such as "diameter and its changes on the brachial artery," "diameter and its changes on the carotid Intima-Media Thickness," and "carotid plaque analysis." These are all measurements used to assess a patient's medical condition, which is the definition of a diagnostic device.
Yes
The device is described as a "software program" and its function is to analyze ultrasound images. While it processes data from ultrasound systems, the device itself is solely the software for analysis and does not include the ultrasound hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Cardiovascular Suite 4.2.1 is a software program that analyzes ultrasound images of blood vessels. It processes existing images or real-time video output from an ultrasound system.
- Input: The input is imaging data (ultrasound images), not biological samples from the patient.
- Purpose: The software aids in the quantitative analysis of vascular structures (diameter, thickness, plaque) based on the visual information from the ultrasound. It does not perform any tests on biological specimens.
Therefore, while it is a medical device used in the diagnostic process, it falls under the category of image analysis software rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
DQK
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Ultrasound image sequences in B-mode modality; Ultrasound image sequences in Duplex mode (simultaneous acquisition of B-mode and Doppler)
Anatomical Site
Brachial artery, carotid artery
Indicated Patient Age Range
Adults
Intended User / Care Setting
The software is to be used only by trained healthcare professionals, such as laboratory technicians, nurses, doctors and/or ultrasonographers.
Description of the training set, sample size, data source, and annotation protocol
Not Found.
Description of the test set, sample size, data source, and annotation protocol
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:
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 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: Carotid artery, US modality: B-mode, # of images (online / offline): 120 (60/60)
Site of scan: Brachial artery, US modality: Dual (B-mode + PWD), # of images (online / offline): 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Carotid analyzer - accuracy:
Agreement with RF based gold-standard [JUM 2010 BIANCHINI et Al]:
Bland&Altman analysis (bias value ± standard deviation):
IMT 0.006 ± 0.039mm
Diameter 0.060 ± 0.110mm
Distension 0.016 ± 0.039mm
Carotid analyzer - precision:
- Intra-observer intra-session variability: 7%±6% for IMT, 2%±1% for diastolic diameter, 11%±7% for distension, 11%±7% for cross sectional compliance coefficient and 13%±8% for cross sectional distensibility coefficient.
- Inter-observer intra-session variability: 8%±8% for IMT, 3%±2% for diastolic diameter, 11%±10% for distension, 12%±11% for cross sectional compliance coefficient and 13%±12% for cross sectional distensibility coefficient.
- intra-observer inter-session variability: 6%±6% for IMT, 3%±2% for diastolic diameter, 12%±10% for distension, 16%±11% for cross sectional compliance coefficient and 17%±12% for cross sectional distensibility coefficient.
Data from a single center study.
FMD analyzer - accuracy:
Accuracy evaluated on synthetic image sequences: error in assessing % diameter variation equal to 0.013%.
FMD analyzer - precision:
Precision was assessed in terms of reproducibility.
Intra-observer intra-session variability: 9.9±8.4%
Intra-observer inter-session variability: 12.9±11.6%
Data from a multicenter study [REF].
RESULTS (Validation Testing of Measurements):
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.
These results are maintained for each compatible ultrasound device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found.
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found.
§ 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).
0
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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
1
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
2
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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3
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 |
4
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.
5
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.
6
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.
| Item
No. | Device
Characteristic. | Proposed Device
Cardiovascular Suite | Primary Predicate
Device Vascular
Tools 5 | Reference Device:
M'Ath Std. | Reference Device:
K090461, the IMAGE-
ARENA 4.0 AND IA
APPLICATIONS 2D
CARDIAC
PERFORMANCE
ANALYSIS 1.0 by
TOMTEC IMAGING
SYSTEMS, GMBH | Comparison
Analysis: Identical
/ Substantially
Equivalent /
Modified / Cannot
Be Determined /
Not Applicable | Rationale as to why
Modification or
Difference from Predicate
to Subject Device Does
Not Impact Safety and
Effectiveness. |
|-------------|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | 510 (k)
Number | K202094 | K033266 | K040686 | K090461 | N/A | Difference in 510k numbers do not
impact safety or efficacy of the
product. |
| 2 | Device Name,
Model | Cardiovascular Suite | Vascular Tools 5 | M'Ath® Std | IMAGE-ARENA 4.0
AND IA APPLICATIONS
2D CARDIAC
PERFORMANCE
ANALYSIS 1.0 | N/A | Difference in Names do not impact
safety or efficacy of the product. |
| Item
No. | Device
Characteristic. | Proposed Device
Cardiovascular Suite | Primary Predicate
Device Vascular
Tools 5 | Reference Device:
M'Ath Std. | Reference Device:
K090461, the IMAGE-
ARENA 4.0 AND IA
APPLICATIONS 2D
CARDIAC
PERFORMANCE
ANALYSIS 1.0 by
TOMTEC IMAGING
SYSTEMS, GMBH | Comparison
Analysis: Identical
/ Substantially
Equivalent /
Modified / Cannot
Be Determined /
Not Applicable | Rationale as to why
Modification or
Difference from Predicate
to Subject Device Does
Not Impact Safety and
Effectiveness. |
| 3 | Manufacturer | QUIPU SRL | MEDICAL
IMAGING
APPLICATIONS
LLC | Intelligence in
Medical
Technologies | TOMTEC IMAGING
SYSTEMS, GMBH | N/A | Differences do not impact safety or
efficacy. |
| 4 | CFR Reference | 870.1425 | 870.1425 | CFR 892.2050 | 892.2050 | N/A | Differences do not impact safety or
efficacy. |
| 5 | FDA Review
Panel | Cardiovascular | Cardiovascular | Radiology | Radiology | N/A | Differences do not impact safety or
efficacy. |
| 6 | FDA Device
Name | Computer, Diagnostic,
Programmable | Programmable
diagnostic computer | System, Image
processing,
Radiological | Ultrasonic pulsed doppler
imaging system | N/A | Differences do not impact safety or
efficacy. |
| 7 | FDA Product
Code | DQK | DQK | LLZ | LLZ, DQK | N/A | Differences do not impact safety or
efficacy. |
| 8 | Class | II | II | II | II | Identical | N/A |
| Item
No. | Device
Characteristic. | Proposed Device
Cardiovascular Suite | Primary Predicate
Device Vascular
Tools 5 | Reference Device:
M' Ath Std. | Reference Device:
K090461, the IMAGE-
ARENA 4.0 AND IA
APPLICATIONS 2D
CARDIAC
PERFORMANCE
ANALYSIS 1.0 by
TOMTEC IMAGING
SYSTEMS, GMBH | Comparison
Analysis: Identical
/ Substantially
Equivalent /
Modified / Cannot
Be Determined /
Not Applicable | Rationale as to why
Modification or
Difference from Predicate
to Subject Device Does
Not Impact Safety and
Effectiveness. |
| 9 | Indications for
use | The Cardiovascular Suite is a
software program for the
quantitative analysis of
vascular ultrasound images,
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 | Vascular Tools 5"
software program
has been developed
to aid in quantitative
analysis of
longitudinal
vascular ultrasound
images, particularly
to determine
vascular diameter
and intima-media
thickness, as well as
their changes as
depicted in brachial
and carotid arterial
ultrasound images. | M'Ath Std
software is a
Windows-based
application
program running
on a personal
computer that is
intended to aid the
physician in the
organization of
patient data
relating to the
ultrasound images
or video acquired
during echo-
cardiology exams
of the
cardiovascular
system, including
the patient's | The Image-Arena Platform
Software is intended to
serve as a data
management platform for
clinical application
packages. It provides
information that is used for
clinical diagnosis
purposes. The software is
suited for stand-alone
workstations as well as for
networked multisystem
installations and therefore
is an image management
system for research and
routine use in both
physician practices and
hospitals. It is intended as
a general purpose digital
medical image processing | Substantially Equivalent | Differences do not impact safety or
efficacy. |
| Item
No. | Device
Characteristic. | Proposed Device
Cardiovascular Suite | Primary Predicate
Device Vascular
Tools 5 | Reference Device:
M'Ath Std. | Reference Device:
K090461, the IMAGE-
ARENA 4.0 AND IA
APPLICATIONS 2D
CARDIAC
PERFORMANCE
ANALYSIS 1.0 by
TOMTEC IMAGING
SYSTEMS, GMBH | Comparison
Analysis: Identical
/ Substantially
Equivalent /
Modified / Cannot
Be Determined /
Not Applicable | Rationale as to why
Modification or
Difference from Predicate
to Subject Device Does
Not Impact Safety and
Effectiveness. |
| | | | | characteristics.
Additionally, the
software allows the
physician to make
measurements to
determine the
intima-media
thickness of the
carotid artery from
the acquired
images and stores
them with the
patient file. | tool for cardiology. As the
Image-Arena Applications
software tool package is
modular structured,
clinical applications
packages with different
indications for use can be
connected. Echo-Com
software is intended to
serve as a versatile
solution for Stress Echo
examinations in patients
who may not be receiving
enough blood or oxygen
because of blocked
arteries. Image-Corn
software is intended for
reviewing, measuring and
reporting of DICOM dBta
of thi batdiah rodadlities. | | |
| Item
No. | Device
Characteristic. | Proposed Device
Cardiovascular Suite | Primary Predicate
Device Vascular
Tools 5 | Reference Device:
M'Ath Std. | Reference Device:
K090461, the IMAGE-
ARENA 4.0 AND IA
APPLICATIONS 2D
CARDIAC
PERFORMANCE
ANALYSIS 1.0 by
TOMTEC IMAGING
SYSTEMS, GMBH | Comparison
Analysis: Identical
/ Substantially
Equivalent /
Modified / Cannot
Be Determined /
Not Applicable | Rationale as to why
Modification or
Difference from Predicate
to Subject Device Does
Not Impact Safety and
Effectiveness. |
| | | | | | US and XA. -It can be'
driven by Image;Arena or
other third party platforms
and is intended to launch
other clinical applications.
The clinical application
package 2D Cardiac
Performance Analysis is
indicated for cardiac
quantification based on
echocardiographic data. It
provides measurements of
myocardial function
(displacement, velocity
and strain) that is used for
clinical diagnosis purposes
of patients with suspected
heart disease. | | |
| Item
No. | Device
Characteristic. | Proposed Device
Cardiovascular Suite | Primary Predicate
Device Vascular
Tools 5 | Reference Device:
M'Ath Std. | Reference Device:
K090461, the IMAGE-
ARENA 4.0 AND IA
APPLICATIONS 2D
CARDIAC
PERFORMANCE
ANALYSIS 1.0 by
TOMTEC IMAGING
SYSTEMS, GMBH | Comparison
Analysis: Identical
/ Substantially
Equivalent /
Modified / Cannot
Be Determined /
Not Applicable | Rationale as to why
Modification or
Difference from Predicate
to Subject Device Does
Not Impact Safety and
Effectiveness. |
| 10 | Anatomical
structure of use | Carotid and brachial artery | Same | Cardio vascular
bed | Cardiovascular Bed | Identical to Predicate | N/A - Cardiovascular Suite analyzes
carotid and brachial artery. These
sites are included in the predicate's
anatomical structure of use. |
| 11 | Cardiovascular
Plaque
Measurement
function
included | Yes | No | Yes | No | Identical to Reference
Device | N/A-Cardiovascular Suite' tool for
carotid plaque includes geometrical
and density measurements
substantially equivalent to those of
the reference device |
| 12 | Flow-Mediated
Dilatation
(FMD)
function
included | Yes | Yes | No | No | Identical to Predicate | N/A |
| 13 | IMT - Intima
Media
Thickness | Yes | Yes | Yes | Yes | Identical to Predicate and
Reference Devices | N/A |
| Item
No. | Device
Characteristic. | Proposed Device
Cardiovascular Suite | Primary Predicate
Device Vascular
Tools 5 | Reference Device:
M'Ath Std. | Reference Device:
K090461, the IMAGE-
ARENA 4.0 AND IA
APPLICATIONS 2D
CARDIAC
PERFORMANCE
ANALYSIS 1.0 by
TOMTEC IMAGING
SYSTEMS, GMBH | Comparison
Analysis: Identical
/ Substantially
Equivalent /
Modified / Cannot
Be Determined /
Not Applicable | Rationale as to why
Modification or
Difference from Predicate
to Subject Device Does
Not Impact Safety and
Effectiveness. |
| | function
included | | | | | | |
| 14 | Hardware
requirements | Laptop or PC running
Mac OS X, Microsoft
Windows
Operating System (OS) | Laptop or PC
running Microsoft
Windows
Operating System
(OS) | Microsoft
Windows
operating system | Microsoft Windows
operating system on a
laptop or PC | Modified | Differences do not impact safety or
efficacy. Cardiovascular Suite can be
used on Laptop or PC running
Microsoft Windows Operating
System (OS) as the predicate.
Cardiovascular Suite can be used
also on Mac OS X, which presents
performances comparable to the
Microsoft Windows Operating
System and is considered one of the
most robust and user friendly
operating system available on the
market. Therefore, this addition with
respect to the predicate device, does
not result in differences in the
performance and safety of the device. |
| Item
No. | Device
Characteristic. | Proposed Device
Cardiovascular Suite | Primary Predicate
Device Vascular
Tools 5 | Reference Device:
M'Ath Std. | Reference Device:
K090461, the IMAGE-
ARENA 4.0 AND IA
APPLICATIONS 2D
CARDIAC
PERFORMANCE
ANALYSIS 1.0 by
TOMTEC IMAGING
SYSTEMS, GMBH | Comparison
Analysis: Identical
/ Substantially
Equivalent /
Modified / Cannot
Be Determined /
Not Applicable | Rationale as to why
Modification or
Difference from Predicate
to Subject Device Does
Not Impact Safety and
Effectiveness. |
| 15 | On-line / off-
line operation | On-line and off-line. | Same | Not Publicly
Available | Offline Only | Identical to Predicate | N/A |
| 16 | Supported data
formats | Cardiovascular Suite works
on A) Video formats:
DICOM, AVI, MP4, MOV
B)Image formats: DICOM,
PNG, JPG, BMP, TIF . These
data formats are similar to
those of predicate and
reference 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 formats
do not impact safety or efficacy. |
| 17 | Calibration | Mandatory, manually
performed | Same | manually
performed and
automatically
DICOM | Not Publicly Available | Identical to Predicate | N/A- Calibration is mandatory for all
the systems |
| 18 | Information for
operator in case
of | Warning popups and included
in instructions for use. | Same | Not Publicly
Available | Not Publicly Available | Identical to Predicate | Differences do not impact safety or
efficacy. |
| Item
No. | Device
Characteristic. | Proposed Device
Cardiovascular Suite | Primary Predicate
Device Vascular
Tools 5 | Reference Device:
M'Ath Std. | Reference Device:
K090461, the IMAGE-
ARENA 4.0 AND IA
APPLICATIONS 2D
CARDIAC
PERFORMANCE
ANALYSIS 1.0 by
TOMTEC IMAGING
SYSTEMS, GMBH | Comparison
Analysis: Identical
/ Substantially
Equivalent /
Modified / Cannot
Be Determined /
Not Applicable | Rationale as to why
Modification or
Difference from Predicate
to Subject Device Does
Not Impact Safety and
Effectiveness. |
| | inappropriate
use | | | | | | |
| 19 | Patient/ data
storage | Yes: Data archive available | Same | Same | same | Identical to Predicate and
Reference Device | N/A-Patients data and images are
stored into the archive of the
software |
| 20 | Data export | Reporting in Microsoft Excel
,RTF, RTFd, PDF, TAB
Separated Values, Comma
Separated Values, HTML
format. | Reporting in
Microsoft Excel or
SAS format. | DICOM and pdf
format | Data can be exported in
PDF format. | Modified | Differences do not impact safety or
efficacy. Cardiovascular Suite
reporting in Microsoft Excel , PDF,
TAB Separated Values, Comma
Separated Values. The additional
format with respect to the
predicate/references can be read by
the same software program
(Microsoft Excel and SAS).
Moreover, the software architecture
and more specifically the data export
module, has been tested and
validated according to IEC 62304 |
| Item
No. | Device
Characteristic. | Proposed Device
Cardiovascular Suite | Primary Predicate
Device Vascular
Tools 5 | Reference Device:
M'Ath Std. | Reference Device:
K090461, the IMAGE-
ARENA 4.0 AND IA
APPLICATIONS 2D
CARDIAC
PERFORMANCE
ANALYSIS 1.0 by
TOMTEC IMAGING
SYSTEMS, GMBH | Comparison
Analysis: Identical
/ Substantially
Equivalent /
Modified / Cannot
Be Determined /
Not Applicable | Rationale as to why
Modification or
Difference from Predicate
to Subject Device Does
Not Impact Safety and
Effectiveness. |
| | | | | | | | and taking into consideration risk
analysis and reduction. Therefore,
this addition with respect to the
predicate device, does not result in
differences in the performance and
safety of the device. |
| 21 | Modules | Two: one for FMD analysis
and the other for Carotid
analysis | Same | Not Publicly
Available | Multiple Modules based
on Publicly Available data
from 510k Summary. | Identical to Predicate and
Reference Device | N/A-Two modules both for
Cardiovascular Suite and the
predicate device. |
| 22 | Multi-user
Functionality | Yes: protected user access by
password to the software | No | Not Publicly
Available | Yes, multi user
functionality included. | Substantially Equivalent to
Reference device. | N/A- Comment: Cardiovascular
Suite provides a protected user
access by password to the software.
This feature has been introduced to
guarantee safety in data access.
Moreover, the multi-user access of
the software has been tested and
validated according to IEC 62304
and taking into consideration risk |
| Item
No. | Device
Characteristic. | Proposed Device
Cardiovascular Suite | Primary Predicate
Device Vascular
Tools 5 | Reference Device:
M' Ath Std. | Reference Device:
K090461, the IMAGE-
ARENA 4.0 AND IA
APPLICATIONS 2D
CARDIAC
PERFORMANCE
ANALYSIS 1.0 by
TOMTEC IMAGING
SYSTEMS, GMBH | Comparison
Analysis: Identical
/ Substantially
Equivalent /
Modified / Cannot
Be Determined /
Not Applicable | Rationale as to why
Modification or
Difference from Predicate
to Subject Device Does
Not Impact Safety and
Effectiveness. |
| | | | | | | | analysis and reduction. Therefore,
this addition with respect to the
predicate device, does not result in
differences in the performance and
safety of the device. |
| 23 | Licensing
Issuance | Dongle Licensekey and web
based | Web based | LICENSE KEY | Not Publicly Available | Substantially Equivalent to
attributes of both
Predicate & Reference
Devices | The systems provide a licensing
approach web-based. In addition,
Cardiovascular Suite can provide
license to the customer by dongle-
key use. Dongle form is tightly
controlled licensing. Moreover, the
licensing process of the software has
been tested and validated and it is
further verified during the production
procedure. Therefore, this addition
with respect to the predicate device,
does not result in differences in the
performance and safety of the device. |
| Item
No. | Device
Characteristic. | Proposed Device
Cardiovascular Suite | Primary Predicate
Device Vascular
Tools 5 | Reference Device:
M'Ath Std. | Reference Device:
K090461, the IMAGE-
ARENA 4.0 AND IA
APPLICATIONS 2D
CARDIAC
PERFORMANCE
ANALYSIS 1.0 by
TOMTEC IMAGING
SYSTEMS, GMBH | Comparison
Analysis: Identical
/ Substantially
Equivalent /
Modified / Cannot
Be Determined /
Not Applicable | Rationale as to why
Modification or
Difference from Predicate
to Subject Device Does
Not Impact Safety and
Effectiveness. |
| 24 | FMD Input
image modality | Ultrasound image sequences
in B-mode modality;
Ultrasound image sequences
in Duplex mode
(simultaneous acquisition of
B-mode and Doppler) | Ultrasound image
sequences in B-
mode modality;
Doppler Flow
Analysis not
supported | B-mode and color
flow | Not Included | Substantially Equivalent to
Predicate | Differences do not impact safety or
efficacy. Cardiovascular Suite
supports B-mode as the predicate and
reference device. In addition Doppler
flow analysis is also supported part
of the predicate device. |
| 25 | Measured
/computed
parameters | Flow Mediated Dilation
(FMD).
Shear rate detection | Flow Mediated
Dilation (FMD) | Not Publicly
Available | Not Publicly Available | Modified | Both devices provide instantaneous
brachial diameter that can be used to
evaluate Flow-Mediated-Dilation. In
addition, FMD Studio, thanks to the
Doppler Flow Analysis can provide
Shear rate estimation, which is not
expected to result in differences in
safety and efficacy. |
| 26 | Exam type | Measurement performed on
B-mode longitudinal section
of the artery, which is imaged | Same | Not Publicly
Available | Not Publicly Available,
however based on the
product website they do
include multiple | Identical to predicate | N/A- Measurement performed on B-
mode longitudinal section of the
artery, which is imaged above the |
| Item
No. | Device
Characteristic. | Proposed Device
Cardiovascular Suite | Primary Predicate
Device Vascular
Tools 5 | Reference Device:
M'Ath Std. | Reference Device:
K090461, the IMAGE-
ARENA 4.0 AND IA
APPLICATIONS 2D
CARDIAC
PERFORMANCE
ANALYSIS 1.0 by
TOMTEC IMAGING
SYSTEMS, GMBH | Comparison
Analysis: Identical
/ Substantially
Equivalent /
Modified / Cannot
Be Determined /
Not Applicable | Rationale as to why
Modification or
Difference from Predicate
to Subject Device Does
Not Impact Safety and
Effectiveness. |
| | | above the antecubital fossa in
the longitudinal plane | | | measurement
functionalities. | | antecubital fossa in the longitudinal
plane |
| 27 | Detection
algorithm /
other
algorithms | Contour tracking algorithm
based on edge detection
operator. | Globally optimal
graph search border
detection approach | Not Publicly
Available | Not Publicly Available | Modified | Differences do not impact safety or
efficacy. Contour tracking approach.
Both devices include an algorithm
for the automatic detection of the
border of the vessel, which is used
for the computation of the vessel
diameter.
The brachial analysis module of
Vascular Tools 5 performs an
automatic detection of the edges of
the vessel using a globally optimal
graph search border detection
approach. [REF] The operator draw
a region of interest (ROI) in which
the best definition of the edges of the
vessel is detectable on the first frame
of the individual frame sequences or |
| Item
No. | Device
Characteristic. | Proposed Device
Cardiovascular Suite | Primary Predicate
Device Vascular
Tools 5 | Reference Device:
M'Ath Std. | Reference Device:
K090461, the IMAGE-
ARENA 4.0 AND IA
APPLICATIONS 2D
CARDIAC
PERFORMANCE
ANALYSIS 1.0 by
TOMTEC IMAGING
SYSTEMS, GMBH | Comparison
Analysis: Identical
/ Substantially
Equivalent /
Modified / Cannot
Be Determined /
Not Applicable | Rationale as to why
Modification or
Difference from Predicate
to Subject Device Does
Not Impact Safety and
Effectiveness. |
| | | | | | | | movie clips. The analysis proceeds
automatically 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 |
| Item
No. | Device
Characteristic. | Proposed Device
Cardiovascular Suite | Primary Predicate
Device Vascular
Tools 5 | Reference Device:
M'Ath Std. | Reference Device:
K090461, the IMAGE-
ARENA 4.0 AND IA
APPLICATIONS 2D
CARDIAC
PERFORMANCE
ANALYSIS 1.0 by
TOMTEC IMAGING
SYSTEMS, GMBH | Comparison
Analysis: Identical
/ Substantially
Equivalent /
Modified / Cannot
Be Determined /
Not Applicable | Rationale as to why
Modification or
Difference from Predicate
to Subject Device Does
Not Impact Safety and
Effectiveness. |
| | | | | | | | recorded measurements. The results
obtained using the two systems have
been evaluated in a comparison study
[Faita et Al, REF] performed on 60
participants, which showed an
excellent level of agreement in vessel
edge location and subsequent
diameter evaluation. Therefore the
difference in the detection algorithm
does not result in differences in the
performance and safety of the device. |
| 28 | ECG gating | Not required | Not required | Not Publicly
Available | Not Included | Identical to predicate | N/A |
| 29 | Output
(displayed /
stored data and
results) | Instantaneous diameter chart
Mean diameter chart
Time averaged positive Shear
Rate Chart
time averaged positive shear | 1 - Instantaneous
diameter chart
2 – Third order
polynomial fit chart
3 - EKG gated | Not Publicly
Available | Not Publicly Available,
but they do include
multiple data formats
based on product details. | Modified | Differences in output displays of
stored data and results, do not impact
safety or efficacy. |
| Item
No. | Device
Characteristic. | Proposed Device
Cardiovascular Suite | Primary Predicate
Device Vascular
Tools 5 | Reference Device:
M'Ath Std. | Reference Device:
K090461, the IMAGE-
ARENA 4.0 AND IA
APPLICATIONS 2D
CARDIAC
PERFORMANCE
ANALYSIS 1.0 by
TOMTEC IMAGING
SYSTEMS, GMBH | Comparison
Analysis: Identical
/ Substantially
Equivalent /
Modified / Cannot
Be Determined /
Not Applicable | Rationale as to why
Modification or
Difference from Predicate
to Subject Device Does
Not Impact Safety and
Effectiveness. |
| | | rate
time averaged negative shear
rate | Doppler flow
Doppler Waveform
envelop 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- | | | | | |
| Item
No. | Device
Characteristic. | Proposed Device
Cardiovascular Suite | Primary Predicate
Device Vascular
Tools 5 | Reference Device:
M'Ath Std. | Reference Device:
K090461, the IMAGE-
ARENA 4.0 AND IA
APPLICATIONS 2D
CARDIAC
PERFORMANCE
ANALYSIS 1.0 by
TOMTEC IMAGING
SYSTEMS, GMBH | Comparison
Analysis: Identical
/ Substantially
Equivalent /
Modified / Cannot
Be Determined /
Not Applicable | Rationale as to why
Modification or
Difference from Predicate
to Subject Device Does
Not Impact Safety and
Effectiveness. |
| | | 1]:maximum value of the
shear rate
SR Baseline[s-1]:maximum
value of the shear rate
SR Area [dimensionless]:
area under the curve of the
shear rate,
Time Average Wall Shear
Rate (computed using
Doppler flow velocity
waveform)
GTN [%]: GTN Induced
Dilation | | | | | |
| 30 | Report review | Yes | Yes | Not Publicly
Available | Yes report review in PDF
is available. | Identical to Predicate and a
reference device. | N/A |
| 31 | CAROTID
Input data
modality | Ultrasound B-mode image
sequences | Ultrasound B-mode
image sequences | Not Publicly
Available | Ultrasound B-mode image
sequences | Identical to predicate and a
reference device. | N/A - Cardiovascular Suite supports
B-mode as the predicate does |
| Item
No. | Device
Characteristic. | Proposed Device
Cardiovascular Suite | Primary Predicate
Device Vascular
Tools 5 | Reference Device:
M'Ath Std. | Reference Device:
K090461, the IMAGE-
ARENA 4.0 AND IA
APPLICATIONS 2D
CARDIAC
PERFORMANCE
ANALYSIS 1.0 by
TOMTEC IMAGING
SYSTEMS, GMBH | Comparison
Analysis: Identical
/ Substantially
Equivalent /
Modified / Cannot
Be Determined /
Not Applicable | Rationale as to why
Modification or
Difference from Predicate
to Subject Device Does
Not Impact Safety and
Effectiveness. |
| 32 | Measurement
type / Output | Intima media thickness
(IMT), diameter and elasticity
of carotid arteries:
mean and maximum IMT
reported for each frame
diameter and IMT
measurement in image
sequences
mean distension, cross-
sectional compliance
coefficient, cross-sectional
distensibility coefficient,
Stiffness, Young module
Doppler Flow Velocity | Intima media
thickness (IMT) and
diameter of carotid
arteries:
mean and maximum
IMT reported for
each frame
diameter and IMT
measurement in
image sequences. | IMT, Plaque
(geometric and
statistics))and
elasticity
parameters | IMT and Diameter of
Carotid Arteries.
Additional measurements
are also available based on
the product website. Also
included the doppler Flow
Velocity. | Modified between
predicate and reference
devices. | Differences do not impact safety or
efficacy. WITH RESPECT TO THE
PREDICATE: The predicate and
reference devices evaluate diameter
and IMT, starting from a region of
interest defined by the operator, in B-
mode image sequences. In addition
diameter data from Carotid Studio,
when combined with an estimate of
pressure, obtained through legally
marketed devices, provide
parameters of arterial elasticity.
Carotid intima-media thickness
(IMT) and diameter elasticity are
markers of structural and functional
vessel wall properties. Both
parameters have been found in
population-based studies to be
associated with cardiovascular risk
factors and prevalent cardiovascular |
| Item
No. | Device
Characteristic. | Proposed Device
Cardiovascular Suite | Primary Predicate
Device Vascular
Tools 5 | Reference Device:
M'Ath Std. | Reference Device:
K090461, the IMAGE-
ARENA 4.0 AND IA
APPLICATIONS 2D
CARDIAC
PERFORMANCE
ANALYSIS 1.0 by
TOMTEC IMAGING
SYSTEMS, GMBH | Comparison
Analysis: Identical
/ Substantially
Equivalent /
Modified / Cannot
Be Determined /
Not Applicable | Rationale as to why
Modification or
Difference from Predicate
to Subject Device Does
Not Impact Safety and
Effectiveness. |
| | | | | | | | disease. The estimation of carotid
elasticity by Carotid Studio has been
implemented by adopting equations
and modalities suggested by opinion
leaders guidelines . Cardiovascular
Suite measurement methods have
been validated in terms of accuracy
and reproducibility . Cardiovascular
Suite usability requirements are
defined to avoid confusion in results
visualization, highlighting IMT and
clearly identifying all the parameters.
Finally, it should be mentioned that
the Cardiovascular Suite device is
intended to supplement, not
substitute, the physician's decision-
making process; it should be used in
conjunction with knowledge of the
patient's history and other clinical
findings. |
| Item
No. | Device
Characteristic. | Proposed Device
Cardiovascular Suite | Primary Predicate
Device Vascular
Tools 5 | Reference Device:
M' Ath Std. | Reference Device:
K090461, the IMAGE-
ARENA 4.0 AND IA
APPLICATIONS 2D
CARDIAC
PERFORMANCE
ANALYSIS 1.0 by
TOMTEC IMAGING
SYSTEMS, GMBH | Comparison
Analysis: Identical
/ Substantially
Equivalent /
Modified / Cannot
Be Determined /
Not Applicable | Rationale as to why
Modification or
Difference from Predicate
to Subject Device Does
Not Impact Safety and
Effectiveness. |
| | | | | | | | As a conclusion, this technological
characteristic does change the safety
or effectiveness of the device. WITH
RESPECT TO THE REFERENCE
Device M'Ath: both systems evaluate
arterial elasticity (distensibility) by
contour tracking algorithm and
provide a tool for plaque analysis
based on similar approaches. |
| 33 | Exam type | Measurement performed on
B-mode longitudinal section
of the artery. | Same | longitudinal and
cross sectional | longitudinal and cross
sectional | Identical to predicate | N/A |
| 34 | Detection
algorithm /
other
algorithms | Contour tracking algorithm
based on edge / border
detection operator, in
combination with pattern
recognition approach | Globally optimal
graph search border
detection approach
[SON98, SON02] | Not Publicly
Available | Not Publicly Available | Substantially Equivalent to
Predicate | N/A |
| Item
No. | Device
Characteristic. | Proposed Device
Cardiovascular Suite | Primary Predicate
Device Vascular
Tools 5 | Reference Device:
M'Ath Std. | Reference Device:
K090461, the IMAGE-
ARENA 4.0 AND IA
APPLICATIONS 2D
CARDIAC
PERFORMANCE
ANALYSIS 1.0 by
TOMTEC IMAGING
SYSTEMS, GMBH | Comparison
Analysis: Identical
/ Substantially
Equivalent /
Modified / Cannot
Be Determined /
Not Applicable | Rationale as to why
Modification or
Difference from Predicate
to Subject Device Does
Not Impact Safety and
Effectiveness. |
| 35 | Identification
of cardiac cycle | Yes | Yes | Yes | Yes | Identical to predicate and
reference device | N/A |
| 36 | Identification
of carotid
section | Yes | Yes | Yes | Yes | Identical to predicate and
reference device | N/A |
| 37 | Report Review | Yes | Yes | Yes | Yes | Identical to predicate and
reference device | N/A |
| 38 | Exam duration
time | 9 minutes brachial analysis/ 5
minute carotid analysis | Same | same for carotid
analysis | same for carotid analysis | Identical to predicate | N/A |
| 39 | Target area | Carotid and brachial artery | Same | Carotid | Carotid and other targets
such as the heart. | Identical to predicate | N/A |
| 40 | Results of the
use of the
diagnostic
device | Results are related to the
measurement of well-known
and accepted cardiovascular
biomarkers. | Same | Not Publicly
Available | Not Publicly Available | Identical to predicate | N/A |
| Item
No. | Device
Characteristic. | Proposed Device
Cardiovascular Suite | Primary Predicate
Device Vascular
Tools 5 | Reference Device:
M' Ath Std. | Reference Device:
K090461, the IMAGE-
ARENA 4.0 AND IA
APPLICATIONS 2D
CARDIAC
PERFORMANCE
ANALYSIS 1.0 by
TOMTEC IMAGING
SYSTEMS, GMBH | Comparison
Analysis: Identical
/ Substantially
Equivalent /
Modified / Cannot
Be Determined /
Not Applicable | Rationale as to why
Modification or
Difference from Predicate
to Subject Device Does
Not Impact Safety and
Effectiveness. |
| | | A clinical evaluation has been
conducted to review the
safety and effectiveness of the
use of these biomarkers for
cardiovascular diseases risk
stratification.
Results can supplement the
physician's decision-making
process. They should be used
in conjunction with
knowledge of the patient's
history and other clinical
findings. | | | | | |
| 41 | Carotid
analyzer -
accuracy | Agreement with RF based
gold-standard [JUM 2010
BIANCHINI et Al]:
Bland&Altman analysis (bias
value ± standard deviation):
IMT 0.006 ± 0.039mm | Signed error mean
IMT -0.007 ± 0.07
mm
Signed error max
IMT -0.07± 0.09
mm | Not Publicly
Available | Not Publicly Available | Modified | Differences are not expected to have
impact on safety or efficacy. |
| Item
No. | Device
Characteristic. | Proposed Device
Cardiovascular Suite | Primary Predicate
Device Vascular
Tools 5 | Reference Device:
M'Ath Std. | Reference Device:
K090461, the IMAGE-
ARENA 4.0 AND IA
APPLICATIONS 2D
CARDIAC
PERFORMANCE
ANALYSIS 1.0 by
TOMTEC IMAGING
SYSTEMS, GMBH | Comparison
Analysis: Identical
/ Substantially
Equivalent /
Modified / Cannot
Be Determined /
Not Applicable | Rationale as to why
Modification or
Difference from Predicate
to Subject Device Does
Not Impact Safety and
Effectiveness. |
| | | Diameter 0.060 ± 0.110mm | | | | | |
| | | Distension 0.016 ± 0.039mm | D and Stiffness
accuracy and | | | | |
| | | | precision not found | | | | |
| 42 | Carotid
analyzer -
precision | 1) Intra-observer intra-session
variability: 7%±6% for IMT,
2%±1% for diastolic
diameter, 11%±7% for
distension, 11%±7% for cross
sectional compliance
coefficient and 13%±8% for
cross sectional distensibility
coefficient.
2) Inter-observer intra-session
variability: 8%±8% for IMT,
3%±2% for diastolic
diameter, 11%±10% for
distension, 12%±11% for
cross sectional compliance | Intra-subject
reproducibility for
the mean carotid
IMT
had a coefficient of
variation of 3% with
a mean absolute
difference of 0.02
mm (SD 0.01).
[PAT10] | Not Publicly
Available | Not Publicly Available | Modified | Carotid Studio precision expressed as
coefficient of variation is 2% for the
diameter, 11% for the diameter
variation during the cardiac cycle,
6% for IMT for intra-observer 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
plaque geometric and statistics data
the precision of the results expressed
as coefficient of variation resulted
lower than 10% for each |
| Item
No. | Device
Characteristic. | Proposed Device
Cardiovascular Suite | Primary Predicate
Device Vascular
Tools 5 | Reference Device:
M'Ath Std. | Reference Device:
K090461, the IMAGE-
ARENA 4.0 AND IA
APPLICATIONS 2D
CARDIAC
PERFORMANCE
ANALYSIS 1.0 by
TOMTEC IMAGING
SYSTEMS, GMBH | Comparison
Analysis: Identical
/ Substantially
Equivalent /
Modified / Cannot
Be Determined /
Not Applicable | Rationale as to why
Modification or
Difference from Predicate
to Subject Device Does
Not Impact Safety and
Effectiveness. |
| | | coefficient and $13%\pm12%$ for
cross sectional distensibility
coefficient. 3) intra-observer
inter-session variability:
$6%\pm6%$ for IMT, $3%\pm2%$ for
diastolic diameter, $12%\pm10%$
for distension, $16%\pm11%$ for
cross sectional compliance
coefficient and $17%\pm12%$ for
cross sectional distensibility
coefficient.
Data from a single center
study
Plaque also
NB for compliance and
distensibility rep also depends
on pressure estimation | | | | | measurement obtained on a single
image by the same operator. |
| Item
No. | Device
Characteristic. | Proposed Device
Cardiovascular Suite | Primary Predicate
Device Vascular
Tools 5 | Reference Device:
M' Ath Std. | Reference Device:
K090461, the IMAGE-
ARENA 4.0 AND IA
APPLICATIONS 2D
CARDIAC
PERFORMANCE
ANALYSIS 1.0 by
TOMTEC IMAGING
SYSTEMS, GMBH | Comparison
Analysis: Identical
/ Substantially
Equivalent /
Modified / Cannot
Be Determined /
Not Applicable | Rationale as to why
Modification or
Difference from Predicate
to Subject Device Does
Not Impact Safety and
Effectiveness. |
| 43 | FMD analyzer
- accuracy | Accuracy evaluated on
synthetic image sequences:
error in assessing % diameter
variation equal to 0.013%. | Comparison with a
non-automated
method (Prosound
System, Jet
Propulsion
Laboratory, USA).
Brachial ultrasound
tapes from 12
patients undergoing
endothelial function
assessment
The correlation
between the two
approaches was
excellent for both
the measurement of
absolute diameters
(r=0.995, P