K Number

Device Name

TOMTEC-ARENA

Manufacturer

TOMTEC Imaging Systems GmbH

Date Cleared

2022-01-06

(59 days)

Product Code

QIH LLZ

Regulation Number

892.2050

Intended 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 physician in the diagnosis.

Device Description

TOMTEC-ARENA is a clinical software package for reviewing, quantifying and reporting digital medical data. The software can be integrated into 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: - IMAGE-COM - I REPORTING - AutoStrain LV / SAX / RV / LA I - 2D CPA - FETAL 2D CPA ■ - 4D LV-ANALYSIS - . 4D RV-FUNCTION - I 4D CARDIO-VIEW - I 4D MV-ASSESSMENT - I 4D SONO-SCAN - TOMTEC DATACENTER (incl. STUDY LIST, DATA MAINTENANCE, WEB ■ REVIEW) The purpose of this traditional 510(k) pre-market notification is to introduce semi-automated cardiac measurements based on an artificial intelligence and machine learning (AI/ML) algorithm. The Al/ML algorithm is a Convolutional Network (CNN) developed using a Supervised Learning approach. This Al/ML algorithm enables TOMTEC-ARENA to produce semi-automated and editable echocardiographic measurements on BMODE and DOPPLER datasets. The algorithm was developed using a controlled internal process that defines activities from the inspection of input data to the training and deployment of the algorithm: The training process begins with the model observing, and optimizing its parameters based on the training pool data. The model's prediction and performance are then evaluated against the test pool. The test pool data is set aside at the beginning of the project. During the training process, the Al/ML algorithm learned to predict measurements by being presented with a large number of echocardiographic data manually generated by qualified healthcare professionals. The echocardiographic studies were randomly assigned to be either used for training (approx. 2,800 studies) or testing (approx. 500 studies). A semi-automated measurement consists of a cascade of detection steps. It starts with a rough geometric estimate, which is subsequently refined more and more: The user selects a frame on which the semi-automated measurements shall be performed in TOMTEC-ARENA. Image- & metadata, e.g. pixel spacing, are transferred to the semi-automated measurement detector. The semi-automated measurement detector predicts the position of start and end caliper in the pixel coordinate system. These co-coordinates are transferred back to the CalcEngine, which converts the received data back into real world coordinates (e.g. mm) and creates the graphical overlay. This superimposed line can be edited by the user. The end user can edit, accept, or reject the measurement(s). This feature does not introduce any new measurements, but allows the end user to perform semi-automated measurements. The end user can also still perform manual measurements and it is not mandatory to use the semi-automated measurements. The semi-automated measurements are licensed separately.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K201632

Reference Devices

K211597

AI/ML (Artificial Intelligence / Machine Learning)

Yes
The device description explicitly states that the purpose of the 510(k) is to introduce semi-automated cardiac measurements based on an artificial intelligence and machine learning (AI/ML) algorithm, specifically a Convolutional Network (CNN) developed using a Supervised Learning approach.

Therapeutic

No
This device is a software package for reviewing, quantifying, and reporting digital medical data to support diagnosis, not for providing therapy directly.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the software supports "the physician in the diagnosis."

SaMD (Software as a Medical Device)

Yes

The device is described as a "clinical software package" and its function is to review, quantify, and report digital medical data. While it integrates with third-party platforms for services like database and import/export, the core medical device functionality is performed by the software itself, including the new AI/ML algorithm for semi-automated measurements. There is no mention of hardware components being part of the device being submitted for clearance.

IVD (In Vitro Diagnostic)

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.
Device Function: The TOMTEC-ARENA software processes and quantifies medical imaging data (echocardiographic data in this case) acquired from patients. It does not analyze samples taken from the body.
Intended Use: The intended use is to support physicians in the diagnosis by quantifying and reporting on structures and function based on imaging data. This is distinct from analyzing biological samples.

While the software is a medical device used in diagnosis, its function falls under the category of medical image processing and analysis software, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

The provided input does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.

Overview

Intended Use / Indications for Use

Product codes

QIH, LLZ

Device Description

Mentions image processing

Yes

Mentions AI, DNN, or ML

Yes

Input Imaging Modality

BMODE and DOPPLER datasets (Echocardiographic data)

Anatomical Site

cardiovascular, fetal, and abdominal structures

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Physician in the diagnosis. Hospitals, clinics, and physician's offices.

Description of the training set, sample size, data source, and annotation protocol

The echocardiographic studies were randomly assigned to be either used for training (approx. 2,800 studies) or testing (approx. 500 studies). During the training process, the Al/ML algorithm learned to predict measurements by being presented with a large number of echocardiographic data manually generated by qualified healthcare professionals.

Description of the test set, sample size, data source, and annotation protocol

The echocardiographic studies were randomly assigned to be either used for training (approx. 2,800 studies) or testing (approx. 500 studies). The test pool data is set aside at the beginning of the project. The model's prediction and performance are then evaluated against the test pool.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

No clinical testing conducted in support of substantial equivalence when compared to the predicate devices. 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. 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. Venfication activities performed confirmed that the differences in the design did not adversely affect the safety and effectiveness of the subject device.

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

Not Found

Predicate Device(s)

K201632

Reference Device(s)

K211597

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

TOMTEC Imaging Systems GmbH % Mr. Marc Bergenthal Manager Regulatory Affairs Freisinger Strasse 9 Unterschleissheim, Bavaria 85716 GERMANY

January 6, 2022

Re: K213544

Trade/Device Name: TOMTEC-ARENA Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH, LLZ Dated: October 27, 2021 Received: November 8, 2021

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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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 (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

Indications for Use

510(k) Number (if known) K213544

Device Name TOMTEC-ARENA

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for TOMTEC. The logo consists of a stylized "TT" symbol on the left, followed by the word "TOMTEC" in a simple, sans-serif font. The entire logo is in black and white.

510(K) SUMMARY

K213544

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: regulatory@tomtec.de
Tel: (+49) 89 32175 555
Fax: (+49) 89 32175 750 |
|------------------|------------------------------------------------------------------------------------------------------|
| Sponsor: | TOMTEC Imaging Systems GmbH
Freisinger Strasse 9
85716 Unterschleissheim
Germany |

Date prepared: October 27, 2021

2) NAME OF THE DEVICE, INCLUDING THE TRADE OR PROPRIETARY NAME IF APPLICABLE, THE COMMON OR USUAL NAME, AND THE CLASSIFICATION NAME, IF KNOWN

Common Name:	Picture archiving and communications system
Proprietary Name:	TOMTEC-ARENA
Classification Name:	21 CFR 892.2050,
System, Image Processing, Radiological
Class:	2
Classification Product Code:	QIH
Subsequent Product Code:	LLZ

3) INDICATIONS FOR USE

4) DEVICE DESCRIPTION

TOMTEC-ARENA is a clinical software package for reviewing, quantifying and reporting digital medical data. The software can be integrated into 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.

Image /page/4/Picture/1 description: The image shows the logo for TOMTEC. The logo consists of two stylized black "T" letters next to the word "TOMTEC" in a bold, sans-serif font. The two "T" letters are connected at the top, forming a unique design element.

TTA2 consists of the following optional modules:

IMAGE-COM
I REPORTING
AutoStrain LV / SAX / RV / LA I
2D CPA
FETAL 2D CPA ■
4D LV-ANALYSIS
. 4D RV-FUNCTION
I 4D CARDIO-VIEW
I 4D MV-ASSESSMENT
I 4D SONO-SCAN
TOMTEC DATACENTER (incl. STUDY LIST, DATA MAINTENANCE, WEB ■ REVIEW)

The purpose of this traditional 510(k) pre-market notification is to introduce semi-automated cardiac measurements based on an artificial intelligence and machine learning (AI/ML) algorithm. The Al/ML algorithm is a Convolutional Network (CNN) developed using a Supervised Learning approach.

This Al/ML algorithm enables TOMTEC-ARENA to produce semi-automated and editable echocardiographic measurements on BMODE and DOPPLER datasets. The algorithm was developed using a controlled internal process that defines activities from the inspection of input data to the training and deployment of the algorithm:

The training process begins with the model observing, and optimizing its parameters based on the training pool data. The model's prediction and performance are then evaluated against the test pool. The test pool data is set aside at the beginning of the project.

During the training process, the Al/ML algorithm learned to predict measurements by being presented with a large number of echocardiographic data manually generated by qualified healthcare professionals.

The echocardiographic studies were randomly assigned to be either used for training (approx. 2,800 studies) or testing (approx. 500 studies).

A semi-automated measurement consists of a cascade of detection steps. It starts with a rough geometric estimate, which is subsequently refined more and more:

The user selects a frame on which the semi-automated measurements shall be performed in TOMTEC-ARENA. Image- & metadata, e.g. pixel spacing, are transferred to the semi-automated measurement detector. The semi-automated measurement detector predicts the position of start and end caliper in the pixel coordinate system. These co-coordinates are transferred back to the CalcEngine, which converts the received data back into real world coordinates (e.g. mm) and creates the graphical overlay. This superimposed line can be edited by the user.

The end user can edit, accept, or reject the measurement(s).

This feature does not introduce any new measurements, but allows the end user to perform semi-automated measurements. The end user can also still perform manual measurements and it is not mandatory to use the semi-automated measurements. The semi-automated measurements are licensed separately.

5) SUBSTANTIALLY EQUIVALENT DEVICES

TOMTEC-ARENA Predicate Device: K201632 (August 14, 2020) Reference Device: EPIQ and Affiniti Series Diagnostic Ultrasound System K211597 (September 08, 2021)

TOMTEC Imaging Systems GmbH believes that the TOMTEC-ARENA (TTA2.50) modifications that are the subject of this 510(k) are substantially equivalent to TOMTEC-ARENA (TTA2.40) (K201632).

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 predicate device (TOMTEC-ARENA) and reference device (Philips EPIQ and Affiniti Ultrasound Systems with Auto Measure) are provided in the tables below:

Image /page/6/Picture/1 description: The image shows the logo for TOMTEC. The logo consists of a stylized "T" and "F" joined together, followed by the word "TOMTEC" in all capital letters. The logo and text are in black and are set against a white background.

GENERAL COMPARISON
Feature	Predicate Device
TOMTEC-ARENA	Reference Device
Philips EPIQ and Affiniti Ultrasound
Systems with Auto Measure	Subject Device
TOMTEC-ARENA	Discussion /
Comment
K-number	K201632	K211597	Not available	Subject of this
submission is
TOMTEC-ARENA.
Regulation Number
and Regulation Name	21 CFR 892.2050;
System, Image processing,
Radiological -
Picture Archiving and
Communications System
(PACS)	21 CRF 892.1550
Ultrasonic pulsed doppler imaging system.	21 CFR 892.2050;
System, Image processing,
Radiological -
Picture Archiving and
Communications System
(PACS)	Identical to predicate
device.
Classification Product
Code	LLZ	IYN	QIH	Identical to predicate
device (primary and
secondary product
code switched).
Subsequent Product
Codes	QIH	ITX, IYO, OBJ, QIH	LLZ	Identical to predicate
device (primary and
secondary product
code switched).
Class	2	2	2	Identical to predicate
and reference device.
Classification Panel	Radiology	Radiology	Radiology	Identical to predicate
and reference device.
Device Name	TOMTEC-ARENA	EPIQ Series Diagnostic Ultrasound System,
Affiniti Series Diagnostic Ultrasound System	TOMTEC-ARENA	Identical to predicate
device.
Version	TTA2.40	VM 9.0
(Ultrasound System Software
version/platform)	TTA2.50	Version of subject
device changed due to
new features.
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.	The intended use of Philips EPIQ series
diagnostic ultrasound systems is diagnostic
ultrasound imaging and fluid flow analysis of the
human body, with the following indications for
use:Abdominal, Cardiac Adult, Cardiac other
(Fetal), Cardiac Pediatric, Cerebral Vascular,
Cephalic (Adult), Cephalic (Neonatal),
Fetal/Obstetric, Gynecological, Intra-cardiac
Echo, Intra-luminal, Intraoperative (Vascular),
Intraoperative (Cardiac),
Musculoskeletal(Conventional), Musculoskeletal
(Superficial), Other: Urology, Pediatric, Peripheral
Vessel, Small Organ (Breast, Thyroid, Testicle),
Transesophageal (Cardiac), Transrectal,
Transvaginal, Lung.	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/
Indications for use of
predicate and subject
device are identical
(unchanged).Intended
Use/ Indications for
use of reference
device and subject
device are similar and
considered equivalent
(specifically if
compared for the
clinical use case/
workflow of the subject
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 physician in the diagnosis	The clinical environments where Philips EPIQ
diagnostic ultrasound systems can be used
include clinics, hospitals, and clinical point-of care
for diagnosis of patients.
When integrated with Philips EchoNavigator, the
systems can assist the interventionalist and
surgeon with image guidance during treatment of
cardiovascular disease in which the procedure
uses both live X-ray and live echo guidance.The
systems are intended to be installed, used, and
operated only in accordance with the safety
procedures and operating instructions given in
the product user information. Systems are to be
operated only by appropriately trained healthcare
professionals for the purposes for which they
were designed.
However, nothing stated in the user information
reduces your responsibility for sound clinical
judgement and best clinical procedure.	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 physician in the diagnosis	feature).
where used
(hospital, home,
ambulance, etc.)	Hospitals, clinics, and
physician's offices.	Clinics, hospitals, and clinical point-of care
for diagnosis of patients.	Inside and outside of
Hospitals, Clinics, and
Physician's offices.	Subject of submission;
The intended use
environment was
revised and extended.
Environmental
conditions have been
considered.
Design	Software as a medical device	Hardware and Software	Software as a medical device	Identical to predicate
and reference device.

ТГтомтес

Image /page/8/Picture/1 description: The image contains a logo with the text "TOMTEC" in a bold, sans-serif font. To the left of the text is a stylized graphic consisting of two intersecting lines that form a shape resembling the letters "T" and "Г". The logo is simple and modern in appearance, with a focus on clean lines and geometric shapes.

IMAGE-COM
Feature	Predicate Device
TOMTEC-ARENA	Reference Device
Philips EPIQ and Affiniti Ultrasound
Systems
with Auto Measure	Subject Device
TOMTEC-ARENA	Discussion /
Comment
Application
description	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.	Auto Measure is an optional software feature
on the EPIQ/Affinity Series Diagnostic
Ultrasound System that provides the end
user with semi automated adult
echocardiography 2D and Doppler
measurements through an Al-algorithm,
training via machine-learning techniques. It
is intended to be used with an Adult
Cardiology Transthoracic transducer and
acquisitions that include an ECG. These
measurements are routinely collected during
a transthoracic ECG, per The American
Society of Echo cardiography (ASE)
recommendations	unchanged	Identical to predicate
device.
Similar and considered
equivalent to the
reference device
(specifically if
compared for the
clinical use
case/workflow of the
subject feature).
SW Version	5.5.5	9.0	5.5.7	Version of module
IMAGE-COM changed
due to new features.

Image /page/9/Picture/1 description: The image shows the logo for TOMTEC. The logo consists of two parts: a stylized "T" symbol on the left and the word "TOMTEC" on the right. The "T" symbol is made up of thick, black lines, and the word "TOMTEC" is written in a simple, sans-serif font, also in black.

| Semi-automated
measurements
(BMODE) | Ao Asc diam
Ao Ann diam
Ao STJ diam
Ao SV diam
IVSd
LA diam systole
LVIDd
LVIDs
LVOT diam
LVPWd
RVDd base (RVD1)
RVDd mid (RVD2)
RVLd
RVOT diam lax
RVOT diam prox
TV Ann diam ant-post
IVSd-LVIDd-LVPWd (same line) | Asc Ao Diam
Ao STJ Diam
Ao Sinus Diam
IVSd
LVIDd
LVIDs
LVOT Diam
LVPWd
RV Base
RV Mid
RV Length
TV Annulus | unchanged | For these
measurements, a
measurement
suggestion can now be
initialized on a self-
selected image within
a clip. The
measurement
suggestion can be
edited. Manual
measurements as with
TTA2.40.00 are still
possible.Support of
additional semi-
automated
measurements
compared to reference
device. Additional
measurements rely on
same principle/
technology (e.g. line
detection, single-point)
as those included in
reference device. |

-------------------------------------------	----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	---------------------------------------------------------------------------------------------------------------------------------------------	-----------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Image /page/10/Picture/1 description: The image shows the logo for TOMTEC. The logo consists of a stylized "T" followed by the word "TOMTEC" in a sans-serif font. The logo is in black and white.

| Semi-automated
measurements
(DOPPLER) | MV A Vel | MV Peak A Vel measurements, a
measurement
suggestion can now be
initialized on a self-
selected image within
a clip. The
measurement
suggestion can be
edited. Manual
measurements as with
TTA2.40.00 are still
possible. |
|---------------------------------------------|--------- | | MV E Vel | | MV E/A Slope | | | | MV Dec. Slope | | | | LVOT VTI | | | | AV VTI | | | | PV VTI | | | | TR Vmax | | LV E'(I) | | LV A'(I) | | semi-automated
measurements
compared to reference
device. Additional
measurements rely on
same principle/
technology (e.g. line
detection, single-point)
as those included in
reference device. |
| | | | LV E'(s) | | LV A'(s) | | | | RV A'(I) | | calculated from MV E
Vel and MV Dec
Time) | | RV E'(I) | | RV S'(I) | unchanged | For these
----------------------|---------------------------------------------|-----------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MV Peak E Vel | | |
| MV Inflow | | |
(MV A Vel, MV E Vel, MV Time) | (MV Dec Time, MV Peak E Vel, MV Peak A Vel) | | |
| | | |
(MV Dec Time, MV E Vel) | | | |
| LVOT VTI | | |
| LVOT Vmax | | |
| AV VTI | | |
| AV Vmax | | |
| PV VTI | | |
| PV Vmax | | |
| TR Vmax | | |
| Lat E' Vel | | |
| Lat A' Vel | | |
| Lat Vel | | Support of additional
| (Lat E' Vel, Lat A' Vel) | | |
| Med E' Vel | | |
| Med A' Vel | | |
| Med Vel | | |
| (Med E' Vel, Med A' Vel) | | |
| | | (MV Dec. Slope is
|
| RV S Vel | | |
| | | |

ТГтомтес

| Semi-Automation
Technology | As cleared | Semi-automated adult echocardiography 2D
and Doppler measurements are generated
using an artificial intelligence (AI) detection
algorithm without user interaction. After
measurement is generated, the user can edit
(manually adjust the caliper positions),
accept, or reject the measurements. The
automation of measurements is constrained
to the specific imaging mode (2D, Doppler)
as recommended by ASE guidelines. | Semi-automated adult
echocardiography 2D and
Doppler measurements are
generated using an artificial
intelligence (AI) detection
algorithm without user
interaction. After
measurement is generated,
the user can edit (manually
adjust the caliper positions),
accept, or reject the
measurements. The
automation of measurements
is constrained to the specific
imaging mode (2D, Doppler)
as recommended by ASE
guidelines. | Subject of submission;
Proposed feature
includes optional semi-
automation of existing
measurements
available to the end
user during routine
ultrasound exam
similar to reference
device. Semi-
automated
measurements
quantify image data
through an Al-based
algorithm that was
trained with a
machine-learning
model.Workflow
improvements for user
convenience.No
impact to the safety or
effectiveness of the
device. |
|--------------------------------|------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| User Interface
Presentation | As cleared | User selects an adult echocardiography 2D
or Doppler measurement to perform then the
caliper positions are initialized based on the
output of the AI detection algorithm.
The user can edit, accept, or reject the
measurements. | User selects an adult
echocardiography 2D or
Doppler measurement to
perform then the caliper
positions are initialized based
on the output of the Al
detection algorithm.
The user can edit, accept, or
reject the measurements. | Similar to predicate
and reference device.
The set of available
measurements are
unchanged to the
predicate device.
Workflow
improvements for user
convenience.
No impact to the safety
or effectiveness of the
device. |

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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 트

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. Venfication activities performed confirmed 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 (TTA2.50) 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 (TTA2.50) is substantially equivalent to the legally marketed predicate device(s).