(59 days)
Not Found
Yes
The document explicitly mentions the use of "machine learning algorithms" for creating 3D surface models and in the "3D Auto MV Q-App".
No.
The device is described as software for quantification and reporting to support diagnosis, not for treatment or therapy.
Yes
The Indications for Use explicitly state that the software supports "physicians in the diagnosis" of patients with suspected disease.
Yes
The device is described as a "clinical software package" and its components are listed as "optional modules" which are software-based. While it interacts with platforms and receives data from imaging modalities, the core device itself is the software for reviewing, quantifying, and reporting. There is no mention of hardware components being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physicians in the diagnosis." This describes a device that processes and analyzes medical images obtained directly from the patient, not a device that analyzes samples (like blood, urine, or tissue) in vitro (outside the body).
- Device Description: The description clearly states it's a "clinical software package for reviewing, quantifying and reporting digital medical data." It works with "digital medical data acquired with different modalities" and "image data acquired on Philips ultrasound systems." This reinforces its role in image analysis, not in vitro testing.
- Input Imaging Modality: The listed modalities are all imaging techniques (ultrasound, Cath Lab examinations), not methods for analyzing biological samples.
- Anatomical Site: The focus is on anatomical structures and function within the body.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. This device operates on images of the body itself, not on biological samples.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physicians in the diagnosis.
Product codes
LLZ, QIH
Device Description
TOMTEC-ARENA (TTA2) is a clinical software package for reviewing, quantifying and reporting digital medical data. The software is compatible with different IMAGE-ARENA platforms and third party platforms. Platforms enhance the workflow by providing the database, import, export and other services. All analyzed data and images will be transferred to the platform for archiving, reporting and statistical quantification purposes. TTA2 consists of the following optional modules: TOMTEC-ARENA SERVER & CLIENT, IMAGE-COM/ECHO-COM, REPORTING, AutoStrain (LV, LA, RV), 2D CARDIAC-PERFORMANCE ANALYSIS (Adult and Fetal), 4D LV-ANALYSIS, 4D RV-FUNCTION, 4D CARDIO-VIEW, 4D MV-ASSESSMENT, 4D SONO-SCAN.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
3D surface model is created automatically using machine learning algorithms without user interaction.
The 3D Auto MV Q-App is a semi-automatic tool that essentially is an integration of the machine-learning derived segmentation engine of the QLAB HeartModel and the TOMTEC-Arena TTA2 4D MV-Assessment application thereby providing a dynamic Mitral Valve clinical quantification tool.
3D surface model is created semi-automatically using machine learning algorithm without user interaction.
Input Imaging Modality
multi-dimensional digital medical data acquired with different modalities.
ultrasound machines
3D/4D echocardiography data
2D speckle tracking
echo B-Mode datasets
Anatomical Site
cardiovascular, fetal, and abdominal structures and function.
Right Ventricle
mitral valve
left ventricle
left atrium
Indicated Patient Age Range
Adult and Fetal
Intended User / Care Setting
Hospitals, clinics, and physician's offices.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
No clinical testing conducted in support of substantial equivalence when compared to the predicate devices.
The proposed modifications were tested in accordance with TOMTEC's internal processes. Design Control activities to assure the safe and effective performance of the modified TOMTEC-ARENA include but are not limited to the following: Product Specifications, Design Review, Risk Analysis, Software Verification.
TOMTEC-ARENA is considered a Moderate Level of Concern. Software verification was performed according to the standard IEC 62304 "Medical device software - Software lifecycle processes".
A Summative Usability Evaluation was performed considering FDA's Guidance for Industry and FDA Staff "Applying Human Factors and Usability Engineering to Medical Devices" and according to the standard IEC 62366-1 "Medical devices - Part 1: Application of usability engineering to medical devices". TOMTEC-ARENA has been found to be safe and effective for the intended users, uses, and use environments.
Completion of all verification activities demonstrated that the subject device meets all design and performance requirements. Verification activities performed that the differences in the design did not adversely affect the safety and effectiveness of the subject device.
Testing performed demonstrated that the proposed TOMTEC-ARENA (TTA2.40) meets defined requirements and performance claims.
Key Metrics
EDV, ESV, RVEF, SV, RVLS, TAPSE, FAC (4D RV-FUNCTION)
Prolapse Height, Open Coaptation Gap, Open Coaptation Width, Open Coaptation Area 3D, C-shaped Annulus, Distal Anterior Leaflet Angle (4D MV-ASSESSMENT)
LA EDV (LA EDVI), LA ESV (LA ESVI), LA PreAV (LA PreAVI), LA trueEF, LA EF, LA GLS (4D LV-ANALYSIS)
GLS (Global Peak Longitudinal Strain), LASr ED, LAScd ED, LASct ED, LASr AC, LAScd AC, LASct AC (AutoStrain)
Annulus dmin, Annulus dmax, Annulus dmean, Annulus Area, Annulus Perimeter, Annulus d(area), Ann-Ost left diam, Ann-Ost right diam, MV E Valsalva, MV A Valsalva, MV E/A Valsalva (IMAGE-COM)
LVLd (A4C), LVLs (A4C), LVLd (A2C), LVLs (A2C), AVC (AutoStrain Measurements)
MAPSE (lateral and septal), Basal ventricle diameter at ES and ED of RV and LV, Ventricle length at ES and ED of RV and LV, Myocardial area at ED of LV and RV (2D CARDIAC-PERFORMANCE ANALYSIS)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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August 14, 2020
TOMTEC Imaging Systems GmbH % Mr. Marc Bergenthal Manager Regulatory Affairs Edisonstrasse 6 Unterschleissheim, Bavaria 85716 GERMANY
Re: K201632
Trade/Device Name: TOMTEC-ARENA Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: June 12, 2020 Received: June 16, 2020
Dear Mr. Bergenthal:
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 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
1
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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health 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) K201632
Device Name TOMTEC-ARENA
Indications for Use (Describe)
Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physicians in the diagnosis.
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) |
|---|---|
iption 06c (Part 21 CFR 801 Subpart D)
|_ | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
This 510(k) summary is provided as part of the Premarket Notification in compliance with 21CFR, Part 807, Subpart E, Section 807.92.
1) SUBMITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON
| Primary Contact: | Marc Bergenthal
Email: marc.bergenthal@tomtec.de
Tel: (+49) 89 32175 555
Fax: (+49) 89 32175 750 |
|------------------|-----------------------------------------------------------------------------------------------------------|
| Sponsor: | TOMTEC Imaging Systems GmbH
Edisonstrasse 6
85716 Unterschleissheim
Germany |
- NAME OF THE DEVICE, INCLUDING THE TRADE OR PROPRIETARY NAME IF APPLICABLE, THE COMMON OR USUAL NAME, AND THE CLASSIFICATION
June 12, 2020
NAME, IF KNOWN
Date prepared:
| Common Name: | Picture archiving and communications system |
|---|---|
| Proprietary Name: | TOMTEC-ARENA |
| Classification Name: | 21 CFR 892.2050, |
| System, Image Processing, Radiological | |
| Product code: | QIH, Class II |
3) INDICATIONS FOR USE
Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physicians in the diagnosis.
4) DEVICE DESCRIPTION
TOMTEC-ARENA (TTA2) is a clinical software package for reviewing, quantifying and reporting digital medical data. The software is compatible with different IMAGE-ARENA platforms and third party platforms.
Platforms enhance the workflow by providing the database, import, export and other services. All analyzed data and images will be transferred to the platform for archiving, reporting and statistical quantification purposes.
TTA2 consists of the following optional modules:
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- TOMTEC-ARENA SERVER & CLIENT .
- . IMAGE-COM/ECHO-COM
- REPORTING ●
- AutoStrain (LV, LA, RV) ●
- . 2D CARDIAC-PERFORMANCE ANALYSIS (Adult and Fetal)
- . 4D LV-ANALYSIS
- 4D RV-FUNCTION
- . 4D CARDIO-VIEW
- 4D MV-ASSESSMENT
- 4D SONO-SCAN .
5) SUBSTANTIALLY EQUIVALENT DEVICES
Primary Predicate Device: TomTec-Arena TTA2 K150122 (February 13, 2015) Secondary Predicate Device: QLAB Advanced Quantification Software K200974 (June 03, 2020)
TOMTEC Imaging Systems GmbH believes that the TOMTEC-ARENA modifications that are the subject of this 510(k) are substantially equivalent to TomTec-Arena TTA2 (K150122).
6) TECHNOLOGICAL COMPARISON TO PREDICATE DEVICES
The TOMTEC-ARENA software with the modified modules has the same intended use and technological characteristics as the legally marketed predicate devices. A comparison of the proposed TOMTEC-ARENA application to the currently marketed primary predicate device (TomTec-Arena TTA2) and secondary predicate device (QLAB Advanced Quantification Software) are provided in the tables below:
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| Feature | Primary Predicate Device
TomTec-Arena
(K150122) | Secondary Predicate Device
QLAB
(K200974) | Subject Device
TOMTEC-ARENEA | Discussion / Comment |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| GENERAL COMPARISON
Intended Use | TomTec-Arena software is a clinical
software package designed for
review, quantification and reporting of
structures and function based on
multi-dimensional digital medical data
acquired with different modalities.
TomTec-Arena is not intended to be
used for reading of mammography
images. | QLAB Quantification software is a
software application package. It is
designed to view and quantify image
data acquired on Philips ultrasound
systems. | TOMTEC-ARENA software is a
clinical software package designed
for review, quantification and
reporting of structures and function
based on multi-dimensional digital
medical data acquired with different
modalities.TOMTEC-ARENA is not
intended to be used for reading of
mammography images. | Intended Use of primary and subject
device are identical
(unchanged)Intended Use/Indications
for use of secondary predicate and
subject device are comparable and
considered equivalent. |
| Indications for
Use | Indications for use of TomTec-Arena
TTA2 software are quantification and
reporting of cardiovascular, fetal,
abdominal structures and function of
patients with suspected disease to
support the physicians in the
diagnosis | QLAB Quantification software is a
software application package. It is
designed to view and quantify image
data acquired on Philips ultrasound
systems. | Indications for use of TOMTEC-
ARENA TTA2 software are
quantification and reporting of
cardiovascular, fetal, abdominal
structures and function of patients
with suspected disease to support the
physicians in the diagnosis | Indications for use of primary and
subject device are identical
(unchanged).
Intended Use/Indications for use of
secondary predicate and subject
device are comparable and
considered equivalent. |
| Anatomical Site | Quantification and reporting of
cardiovascular, fetal, and abdominal
structures and function. | Quantification of imaging data
acquired from ultrasound machines of
various anatomical structures and
function. | Quantification and reporting of
cardiovascular, fetal, and abdominal
structures and function. | Identical to primary and secondary
predicate. |
| where used
(hospital, home,
ambulance, etc.) | Hospitals, clinics, and physician's
offices. | Hospitals, clinics, and physician's
offices. | Hospitals, clinics, and physician's
offices. | Identical to primary and secondary
predicate. |
| Design | Software as a medical device | Software as a medical device | Software as a medical device | Identical to primary and secondary
predicate. |
| 4D RV-FUNCTION | | | | |
| Application
Description | 4D RV-Function provides a
comprehensive evaluation of the right
ventricle including volumes and strain
analysis. It provides EDV, ESV,
RVEF, SV, RVLS, TAPSE and FAC.
Distance measurements can also be
analyzed. This software
delivers a quick and reproducible
analysis of the right ventricle, thus | The 3D Auto RV Q-App is an
integration of the segmentation
engine of the QLAB HeartModel and
the TOMTEC-ARENA 4D RV-
Function thereby providing a dynamic
Right Ventricle clinical functionality. | The 4D RV-Function is a right
ventricular quantification tool for
routine clinical work, pulmonary
hypertension, and right-sided heart
failure. The application helps to
overcome complexity of right-
ventricle analysis by calculating
standard values based on a semi- | Revised for clarity. Considered
equivalent to primary predicate. No
impact to the safety or effectiveness
of the device.
Comparable and considered
equivalent to secondary predicate.
This modification to QLAB was
cleared by K191647. |
| | increasing your diagnostic confidence
by visualizing the complexity of the
RV shape in 3D. | | automatically generated 3D surface
model. | |
| SW Version | 2.0 | 15.0 | 3.0 | Updated due to changes to SW code.
Integrates HeartModel auto-
segmentation technology with 4D RV-
Function algorithm for RV border
placement. |
| Measurements | Volume and function of Right
Ventricle | EDVI
ESVI | Added:
EDVI
ESVI | Added measurements are identical to
secondary predicate device. |
| Export Formats: | As cleared | Beutel value export into .stl and .obj
format | Added:
Beutel value export into .stl and .obj
format | Identical to secondary predicate.
Workflow improvements for user
convenience.
No impact to the safety or
effectiveness of the device. |
| Contour
Generation | 3D surface model is created based
on user defined anatomical
landmarks. User is able to edit the
contour of the surface model. | 3D surface model is created
automatically using machine learning
algorithms without user interaction.
User is able to edit, accept or reject
the contours or the anatomical
landmarks. | 3D surface model is created
automatically using machine learning
algorithms without user interaction.
User is able to edit, accept or reject
the contours or the anatomical
landmarks. | Identical to secondary predicate.
Workflow improvements for user
convenience.
No impact to the safety or
effectiveness of the device. |
| 4D MV-ASSESSMENT | | | | |
| Application
Description | 4D MV-Assessment is used for
comprehensive morphological and
functional assessment of the mitral
valve. Based on an easy and intuitive
workflow the application package
generates models of anatomical
structures such as MV annulus,
leaflet and the closure line.
Automatically derived parameters
allow quantification of pre- and post-
operative valvular function and
comparison of morphology. 4D MV-
Assessment improves the
presentation of anatomy and findings
and visualizes the complex
morphology and dynamics of the
mitral valve. | The 3D Auto MV Q-App is a semi-
automatic tool that essentially is an
integration of the machine-learning
derived segmentation engine of the
QLAB HeartModel and the TOMTEC-
Arena TTA2 4D MV-Assessment
application thereby providing a
dynamic Mitral Valve clinical
quantification tool. | 4D MV-ASSESSMENT provides a
morphological and functional analysis
of the mitral valve (MV) using 3D/4D
echocardiography data. Models of
anatomical structures such as MV
annulus, leaflets and the closure line
are generated. The derived
parameters allow quantification of
pre- and post-operative valvular
function and a comparison of
morphology. | Revised for clarity. Considered
equivalent to primary predicate. No
impact to the safety or effectiveness
of the device.
Comparable and considered
equivalent to secondary predicate.
This modification to QLAB was
cleared by K200974- |
| SW Version | 2.3 | 15.0 | 2.5 | Updated due to changes to SW code. |
| Measurements | As cleared | Prolapse Height
Open Coaptation Gap
Open Coaptation Width
Open Coaptation Area 3D
C-shaped Annulus
Distal Anterior Leaflet Angle | Added:
Prolapse Height
Open Coaptation Gap
Open Coaptation Width
Open Coaptation Area 3D
C-shaped Annulus
Distal Anterior Leaflet Angle | Identical to secondary predicate. |
| Contour
Generation | 3D surface model is created based
on user defined anatomical
landmarks.
User is able to edit the contour of the
surface model before proceeding with
the workflow. | 3D surface model is created semi-
automatically using machine learning
algorithm without user interaction.
User is able to edit, accept, or reject
the initial landmark proposals of the
mitral valve anatomical locations. | 3D surface model is created semi-
automatically using machine learning
algorithm without user interaction.
User is able to edit, accept, or reject
the initial landmark proposals of the
mitral valve anatomical locations. | Identical to secondary predicate.
Workflow improvements for user
convenience in initial model display
and landmark proposal.
User is still able to edit, accept or
reject the contours.
No impact to the safety or
effectiveness of the device. |
| 4D LV-ANALYSIS | | | | |
| Application
Description | Volume quantification and function
analysis of the left ventricle based on
3D data has proven to be more
accurate and reproducible than using
2D clips. 4D LV-Analysis is a vendor
independent offline solution for 3D
speckle tracking. It provides an
automated workflow for quantitative
and reproducible analysis of left
ventricular deformation and global
strain values. 4D LV Function is a
basic application for the assessment
of left ventricular volumes, EF and
GLS while 4D LV Analysis allows for
advanced investigations including
twist, regional strain and deformation
analysis. Results are mapped onto
the LV Beutel surface for clear
visualization. All results can be stored
and exported. | The Dynamic HeartModel (DHM)
provides automatic 3D anatomical
borders and left ventricle (LV) and left
atrium (LA) border tracking across all
frames of the cardiac cycle or cycles. | 4D LV-ANALYSIS provides
morphological and functional
analyses of the left ventricle. Based
on 3D echo datasets a 4D model
(Beutel) is generated that represents
the cavity of the LV and optionally
also the LA. Volumes, Strain and
Displacement are quantified on a
global and segmental level. | Revised for clarity. Considered
equivalent to primary predicate. No
impact to the safety or effectiveness
of the device.
Comparable and considered
equivalent to secondary predicate. |
| SW Version | 3.1 | 15.0 | 3.2 | Updated due to changes to SW code. |
| Measurements | As cleared | | | Same technology extended to Atrium
(LA Option in 4D LV-Analysis). |
| | | LAVmin
LAVmax | Added:
LA EDV (LA EDVI)
LA ESV (LA ESVI)
LA PreAV (LA PreAVI) | LA EDV corresponds to LAVmin, and
LA ESV corresponds to LAVmax.
LA PreAV is based on the same
dynamic quantification as LA volume
curve (prior to contraction). |
| | | LA EF | LA trueEF
LA EF
LA GLS | LA trueEF uses the same formula as
LA EF but different volume values
(LA PreAV instead of LAVmax).
LA GLS is a well-known parameter
and described in clinical literature.
Identical to secondary predicate (see
"4D RV-Function"). |
| Export formats: | As cleared | Beutel value export into .stl and .obj format | Added:
Beutel value export into .stl and .obj format | |
| Enhancements: | As cleared | n/a | Adapted Bullseye based an ASE2015
guideline.
Workflow improvements by removed
Beutel revision step & contour
proposal and retracking within
tracking revision step. | Workflow improvements for user
convenience. No impact to the safety
or effectiveness of the device. |
| AUTOSTRAIN | | | | |
| Application
Description | n/a - features and functionality were
part of IMAGE-COM (AutoSTRAIN
Addins) and 2D CPA | AutoStrain LV, LA, RV included | AutoStrain is a quantification tool of
global and regional function based on
contour detection and tracking. It
supports a bull's eye display of Time
to Peak Longitudinal Strain and End-
Systolic Longitudinal Strain. Further,
this CAP provides the calculation of
GLS (Global Peak Longitudinal
Strain). | Based on cleared Addins of IMAGE-
COM and 2D CPA, a dedicated
module (CAP) was released.
This CAP only includes features and
measurements that were already
available in IMAGE-COM (and
respective Addins), 2D CPA or have
been cleared by QLAB. The
integration "on cart" requires
dedicated CAPs (e.g. for the
application layout). This CAP is used
in the same clinical context and
workflows. No impact to the safety or
effectiveness of the device. |
| SW Version | n/a - features and functionality were
part of IMAGE-COM (AutoSTRAIN
Addins) and 2D CPA | 15.0 | 2.1 | No previous SW version as features
and functionality were included in
IMAGE-COM and/or 2D CPA |
| Measurements | n/a - features and functionality were
part of IMAGE-COM (AutoSTRAIN
Addins) and 2D CPA | | Added: | Measurements available within this
CAP were already available in
IMAGE-COM/2D CPA or are identical
to the secondary predicate (QLAB).
No impact to the safety or
effectiveness of the device. |
| | | LASr ED | LASr ED | |
| | | LAScd ED | LAScd ED | |
| | | LASct ED | LASct ED | |
| | | LASr AC | LASr AC | |
| | | LAScd AC | LAScd AC | |
| | | LASct AC | LASct AC | |
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ТГтомтес
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Image /page/9/Picture/1 description: The image shows the logo for TOMTEC. The logo consists of a stylized "TT" symbol followed by the word "TOMTEC" in a bold, sans-serif font. The logo is black and white.
| Feature | Primary Predicate Device
TomTec-Arena
(K150122) | Subject Device
TOMTEC-ARENEA | Discussion / Comment |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IMAGE-COM | | | |
| Application
description | Image-Com is a dedicated DICOM viewer for
cardiovascular ultrasound and Cath Lab
examinations. Easy and quick
image review is supported by a variety of time
saving features. Prior studies can easily be
compared with current
examinations and the simultaneous display of Cath
Lab, echo or nuclear medicine examinations
provides additional
clinical information. | IMAGE-COM is a basic module for reviewing and
measuring digital medical data. It supports routine
workflows for loading, analyzing and saving
medical studies, e.g. for the purpose of creating
reports. IMAGE-COM is where basic
measurements can be performed and the entry
point for advanced analysis modules. Study related
routine measurements can be imported, displayed,
edited and exported to accompanying reporting
systems. | Revised for clarity. Considered equivalent to
primary predicate. No impact to the safety or
effectiveness of the device. |
| SW Version | 5.4 | 5.5 | Updated due to changes to SW code. |
| Measurements | ECHO | Added:
Annulus dmin
Annulus dmax
Annulus dmean
Annulus Area
Annulus Perimeter
Annulus d(area)
Ann-Ost left diam
Ann-Ost right diam
MV E Valsalva
MV A Valsalva
MV E/A Valsalva | Existing ECHO measurements have been
extended. No impact to the safety or effectiveness
of the device. |
| Measurements
(continued) | Vascular | Renal (AT & AI) | Existing Vascular measurements have been
extended. No impact to the safety or effectiveness
of the device. |
| Exam Types | | | |
| | ECHO and Vascular | Added:
Pediatric
Cath | ECHO and Vascular were extended to Pediatric.
Extension of existing measurement methods to
Cath. |
| Deployment | Application based (FAT) | Browser support added | IMAGE-COM is available as a zero footprint
solution (TOMTEC ZERO). No change in intended
use or use environment. No impact to the safety or
effectiveness of the device. |
| Auto LV | AutoLV enables IMAGE-COM to quantify left
ventricular function based on 4-chamber and 2-
chamber views of the left ventricle (biplane
Simpson) with a single mouse click per view | Unchanged | Identical to primary predicate. |
| Auto Strain | The AutoStrain application yields cardiac function
analysis based on a workflow. After selecting views
to analyze, and starting the application results are
shown directly for user's review. | Unchanged | Identical to primary predicate. |
| AutoSTRAIN
Measurements
(continued) | As cleared | Added:
LVLd (A4C)
LVLs (A4C)
LVLd (A2C)
LVLs (A2C)
AVC | Length measurements/values added because of
user needs:
User is able to double check if LV axis is acquired
without foreshortening. In this case both Diastolic
and Systolic Major Axis should be similar. |
| AutoSTRAIN
Enhancements | Bullseye (16 segments) | Bullseye (18 segments) | Adapted Bullseye based on ASE2015 guideline. |
| Auto LA | AutoLA* is a fast and intuitive automation of
Simpson's biplane method.
By selecting apical 4- and 2-chamber views,
AutoLA finds end-systole and proposes tracings of
the left atrial blood tissue interface | Unchanged | Identical to primary predicate. |
| Auto LA
Measurements | LA Vol (Simpson) | Extension of existing left atrium LA volume
(Simpson) measurements with contour proposal
step | Improvement for user convenience. No impact to
the safety or effectiveness of the device. |
| Cath-QCA | Cath QCA is a calculation of stenosis diameter and
area, obstruction and reference diameters and
obstruction length | Unchanged | Identical to primary predicate. |
| Cath-QVLA
Measurements | Cath-QVLA is a calculation of EDV and ESV, EF,
SV, CO of the Left ventricle | Unchanged | Identical to primary predicate. |
| 4D CARDIO-VIEW | | | |
| Application
Description | 4D Cardio-View is a vendor independent offline
solution to review and analyze 3D echo data. It
offers an easy and fast navigation to get the perfect
3D view with just two clicks by using the unique | 4D CARDIO-VIEW is an advanced analysis tool for
3D/4D echocardiography data. Anatomical
structure visualization, volume measurements (LV
and/or generic), and specified or manual | Revised for clarity. Considered equivalent to
primary predicate. No impact to the safety or
effectiveness of the device. |
| | | | |
| | D'Art tool. Features like the multi-slice D'Art
(multiple 2D slices), basic measurements and
workflow based volume measurements make 4D
Cardio-View an all-purpose solution for any cardiac
structure. All measurements and views can be
stored as bookmarks for easy retrieval at any time. | measurements are possible. Various tools are
available for rendering that display 2- and 3-
dimensional morphology and function for defined
structures. | |
| SW Version | 3.0 | 3.1 | Updated due to changes to SW code. |
| Measurements | as cleared | Unchanged | Identical to primary predicate. |
| Export formats: | as cleared | Added:
Beutel value export into .stl and .obj format | Identical to secondary predicate (see "4D RV-Function"). |
| | 2D CARDIAC-PERFORMANCE ANALYSIS (Adult and Fetal) | | |
| Application | 2D Cardiac Performance Analysis is a vendor
independent offline solution for the
quantification of left ventricular deformation.
Detailed analysis of myocardial velocity,
displacement, strain and strain rate is
performed based on 2D speckle tracking in
long or short axis views. Basic parameter
assessment and comprehensive result export
options make 2D CPA suitable for research
and routine use. | 2D CARDIAC PERFORMANCE ANALYSIS
(2D CPA) provides parameters for myocardial
function and deformation analysis. Based on
two dimensional echo B-Mode datasets a
speckle tracking algorithm supports the
calculation of 2D-contour models of the
endocardial and epicardial border.
Corresponding velocities, displacements,
strains, strain rates and functional parameters
can be derived. The results are displayed as
figures, in charts or they are available as
numerical values.
FETAL 2D CARDIAC PERFORMANCE
ANALYSIS (FETAL 2D CPA) is a vendor
independent, offline solution for the
quantification of cardiac deformation of the
fetal heart. Detailed analysis of myocardial
velocity, displacement, strain and strain rate is
performed based on 2D speckle tracking in
the long axis views of the left ventricle and
right ventricle. Basic parameter assessment
as well as advanced quantifications, together
with comprehensive result export options,
make FETAL 2D CPA suitable for research
and routine use. | Revised for clarity. Considered equivalent to
primary predicate. No impact to the safety or
effectiveness of the device.
Analysis of the fetal heart can be performed
based on the cleared implementation of
speckle tracking that is available in 2D CPA.
Quantification of fetal structures is part of the
cleared Indications for Use. Technology
already available is applied within the
Intended Use/Indications for Use of the
device. Substantial evidence for this
modification is available.
Optimized workflow (exclusively for 4CH clips)
to analyze both ventricles in the same 4CH
clip and within the same application session.
Same algorithm for contour detection is used. |
| SW Version | 1.2 | 1.4 | Updated due to changes to SW code. |
| Measurements | Left ventricle strain calculation | Extended to right ventricle strain and atrium
strain (e.g. GLS and segmental strain/strain
rate values).
- MAPSE (lateral and septal)
- Basal ventricle diameter at ES and ED of RV
and LV - Ventricle length at ES and ED of RV and LV
- Myocardial area at ED of LV and RV | Existing measurements were extended to
right ventricle strain and atrium strain (similar
to LA Option). |
| REPORTING | | | |
| Application
Description | Dedicated module for Ultrasound Reporting. | REPORTING provides various workspaces which
are dedicated to different clinical applications and
supports the workflow within clinical institutions.
Measurements can be imported, modified and
exported in order to support connected reporting
systems. | Revised for clarity. Considered equivalent to
primary predicate. No impact to the safety or
effectiveness of the device. |
| SW Version | 2.01 | 2.40 | SW version is identical and correspond to the
TOMTEC-ARENA version, due to release
dependencies. |
| Workspaces /
Areas | Echo | Added:
Vascular
Stress Echo
Pediatric
Fetal
TEE Pre/Post OP | Based on existing and extended measurements,
new workspaces were added in order to display
and structure those measurements in a dedicated
workspace (view) for easy clinical reporting. No
impact to the safety or effectiveness of the device. |
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Image /page/10/Picture/1 description: The image contains the logo for TOMTEC. The logo consists of a stylized "T" and "F" joined together, followed by the word "TOMTEC" in a sans-serif font. The logo and text are in black and are set against a white background.
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Image /page/12/Picture/1 description: The image shows the logo for TOMTEC. The logo consists of a stylized "T" and "Г" next to the word "TOMTEC". The logo is in black and white and is simple and modern.
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7) NON-CLINICAL PERFORMANCE DATA
The proposed modifications were tested in accordance with TOMTEC's internal processes. Design Control activities to assure the safe and effective performance of the modified TOMTEC-ARENA include but are not limited to the following:
- I Product Specifications
- . Design Review
- . Risk Analysis
- Software Verification
TOMTEC-ARENA is considered a Moderate Level of Concern. Software verification was performed according to the standard IEC 62304 "Medical device software - Software lifecycle processes".
A Summative Usability Evaluation was performed considering FDA's Guidance for Industry and FDA Staff "Applying Human Factors and Usability Engineering to Medical Devices" and according to the standard IEC 62366-1 "Medical devices - Part 1: Application of usability engineering to medical devices". TOMTEC-ARENA has been found to be safe and effective for the intended users, uses, and use environments.
Completion of all verification activities demonstrated that the subject device meets all design and performance requirements. Verification activities performed that the differences in the design did not adversely affect the safety and effectiveness of the subject device.
8) SUMMARY OF CLINICAL TESTS:
No clinical testing conducted in support of substantial equivalence when compared to the predicate devices.
9) CONCLUSION
Verification and validation activities required to establish the performance, functionality, and reliability characteristics of the modified TOMTEC-ARENA software with respect to the predicate device(s) were performed successfully. Testing performed demonstrated that the proposed TOMTEC-ARENA (TTA2.40) meets defined requirements and performance claims.
Based on the conformance to standards, development under TOMTEC's Quality Management System, and the successful verification and validation testing, TOMTEC believes that the proposed TOMTEC-ARENA (TTA2.40) is substantially equivalent to the legally marketed predicate device(s).