Who is the manufacturer of TOMTEC-ARENA?

Tomtec Imaging Systems GmbH filed the 510(k) submission for TOMTEC-ARENA (K213544).

What is the FDA product code for TOMTEC-ARENA?

QIH. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for TOMTEC-ARENA?

510(k) clearance (submission type: Traditional).

Does TOMTEC-ARENA use AI or machine learning?

Yes. TOMTEC-ARENA (K213544) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like TOMTEC-ARENA?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like TOMTEC-ARENA get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

TOMTEC-ARENA

K213544 · Tomtec Imaging Systems GmbH · QIH · Jan 6, 2022 · Radiology

Device Facts

Record ID	K213544
Device Name	TOMTEC-ARENA
Applicant	Tomtec Imaging Systems GmbH
Product Code	QIH · Radiology
Decision Date	Jan 6, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

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 Story

TOMTEC-ARENA is a clinical software package for reviewing, quantifying, and reporting digital medical data (B-mode and Doppler echocardiographic datasets). It functions as a standalone software application or integrated into third-party platforms. The device features an AI/ML-based module that provides semi-automated measurements of cardiovascular structures. Input data (images and metadata like pixel spacing) are processed by a Convolutional Neural Network (CNN) to predict start and end caliper positions. The system outputs graphical overlays on the images, which the clinician can review, edit, accept, or reject. Used in hospitals, clinics, and physician offices, the device assists clinicians in diagnostic workflows. By automating routine measurements, it aims to improve workflow efficiency while maintaining physician oversight for clinical decision-making.

Clinical Evidence

No clinical testing conducted. Substantial equivalence is supported by bench testing, software verification (IEC 62304), and summative usability evaluation (IEC 62366-1).

Technological Characteristics

Software as a medical device (SaMD). Features a CNN-based AI/ML algorithm for semi-automated measurement of echocardiographic data. Operates on digital medical images (B-mode/Doppler). Software lifecycle follows IEC 62304; usability follows IEC 62366-1. Moderate level of concern.

Indications for Use

Indicated for patients with suspected cardiovascular, fetal, or abdominal disease requiring quantification and reporting of structures and function to support physician diagnosis.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

TOMTEC-ARENA (K201632)

Reference Devices

EPIQ and Affiniti Series Diagnostic Ultrasound System (K211597)

Related Devices

K241430 — EchoMeasure · Icardio.Ai · Oct 10, 2024
K243794 — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System · Philips Ultrasound, LLC · Feb 6, 2025
K211597 — EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System · Philips Medical Systems · Sep 8, 2021
K201632 — TOMTEC-ARENA · Tomtec Imaging Systems GmbH · Aug 14, 2020
K150122 — TOMTEC-ARENA TTA2 · Tomtec Imaging Systems GmbH · Feb 13, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 (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 {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K213544 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 physician in the diagnosis. X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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 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. ### 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. {4}------------------------------------------------ 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). {5}------------------------------------------------ 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: {6}------------------------------------------------ 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. | {7}------------------------------------------------ # ТГтомтес {8}------------------------------------------------ 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. | {9}------------------------------------------------ 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. | |-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-----------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-----------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| {10}------------------------------------------------ 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 | 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. | |---------------------------------------------|-------------------------------|---------------------------------------------|-----------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | MV E Vel | MV Peak E Vel | | | | | MV E/A Slope | MV Inflow | | | | | (MV A Vel, MV E Vel, MV Time) | (MV Dec Time, MV Peak E Vel, MV Peak A Vel) | | | | | MV Dec. Slope | | | | | | (MV Dec Time, MV E Vel) | | | | | | LVOT VTI | LVOT VTI | | | | | | LVOT Vmax | | | | | AV VTI | AV VTI | | | | | | AV Vmax | | | | | PV VTI | PV VTI | | | | | | PV Vmax | | | | | TR Vmax | TR Vmax | | | | | LV E'(I) | Lat E' Vel | | | | | LV A'(I) | Lat A' Vel | | | | | | Lat Vel | | 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. | | | | (Lat E' Vel, Lat A' Vel) | | | | | LV E'(s) | Med E' Vel | | | | | LV A'(s) | Med A' Vel | | | | | | Med Vel | | | | | RV A'(I) | (Med E' Vel, Med A' Vel) | | | | | | | | (MV Dec. Slope is calculated from MV E Vel and MV Dec Time) | | | RV E'(I) | RV S Vel | | | | | RV S'(I) | | | | {11}------------------------------------------------ ## 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. | {12}------------------------------------------------ Image /page/12/Picture/1 description: The image shows the logo for TOMTEC. The logo consists of a stylized "T" symbol on the left, followed by the word "TOMTEC" in a bold, sans-serif font. The entire logo is in black and the background is white. ### 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).