Who is the manufacturer of FETOLY-HEART?

Diagnoly filed the 510(k) submission for FETOLY-HEART (K241380).

What is the FDA product code for FETOLY-HEART?

IYN. It is classified under 21 CFR 892.1550 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for FETOLY-HEART?

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

Does FETOLY-HEART use AI or machine learning?

Yes. FETOLY-HEART (K241380) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list and has a Predetermined Change Control Plan (PCCP).

Who can help prepare an FDA 510(k) submission like FETOLY-HEART?

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 FETOLY-HEART 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.

FETOLY-HEART

K241380 · Diagnoly · IYN · Sep 11, 2024 · Radiology

Device Facts

Record ID	K241380
Device Name	FETOLY-HEART
Applicant	Diagnoly
Product Code	IYN · Radiology
Decision Date	Sep 11, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device, PCCP

Intended Use

Fetoly-Heart is intended to analyze fetal ultrasound image sequences using machine learning techniques to automatically detect heart views and quality criteria within the views. The device is intended for use as a concurrent reading aid during the acquisition and interpretation of fetal ultrasound images. Fetoly-Heart is indicated for use during routine fetal heart examination of 2nd and 3rd trimester pregnancy (gestational age: from 17 to 40 weeks).

Device Story

FETOLY-HEART is a software-based concurrent reading aid for fetal ultrasound examinations. It connects to an ultrasound machine via HDMI to receive real-time image streams. A frozen deep learning algorithm, trained via supervised learning, analyzes these streams to detect five standard fetal heart views (Abdomen, 4CH, LVOT, RVOT, 3VX) and 52 associated anatomical quality criteria. The software provides two primary outputs: a real-time completeness overview indicating verified views/criteria, and a gallery of selected images illustrating these verified findings. It is operated by healthcare professionals (sonographers, obstetricians, radiologists, maternal-fetal medicine specialists, pediatric cardiologists) in clinical settings. The output assists clinicians in assessing examination completeness per national/international guidelines. By providing real-time feedback on view acquisition and quality, the device helps ensure comprehensive cardiac screening, potentially improving diagnostic accuracy and workflow efficiency.

Clinical Evidence

Bench testing only. Standalone performance study on 2,288 images from 480 patient cases across 7 clinical sites. Results: Fetal heart view detection sensitivity ≥ 97.6% and specificity ≥ 98.3% across all views. Quality criteria detection sensitivity ≥ 90.3% and specificity ≥ 99.0%. Mean Intersection over Union (mIoU) for bounding box localization ≥ 51.2%. All performance goals (sensitivity ≥ 85%/90%, specificity ≥ 85%/90%, mIoU ≥ 50%) were met with 95% confidence intervals.

Technological Characteristics

Software-based, edge-deployed (local hardware connected via HDMI). Utilizes deep learning computer vision algorithms for image analysis. Compatible with GE, Samsung, and Canon ultrasound systems. No specific material standards applicable as it is a software-only device. Cybersecurity controls and software verification per IEC 62304 included.

Indications for Use

Indicated for routine fetal heart examination in pregnant women during 2nd and 3rd trimesters (gestational age 17-40 weeks).

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

Sonio Detect (K240406)

Reference Devices

SonoLystLive view suggestion feature within the Voluson Expert Series 22/20/18 (K220358)

Related Devices

K251368 — FETOLY · Diagnoly · Sep 12, 2025
K251456 — BrightHeart View Classifier · Brightheart · Jun 5, 2025
K252294 — Fetal EchoScan (v1.2) · Brightheart · Dec 8, 2025
K230365 — Sonio Detect · Sonio · Jul 25, 2023
K243684 — BrightHeart View Classifier · Brightheart · May 7, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ September 11, 2024 Image /page/0/Picture/1 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 text logo on the right. The FDA text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION". Diagnoly % Nima Akhlaghi Associate Director, Digital Health Regulatory Affairs MCRA, LLC 505 Park Avenue, 14th Floor New York, NY 10022 Re: K241380 Trade/Device Name: FETOLY-HEART Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, QIH Dated: August 9, 2024 Received: August 9, 2024 Dear Nima Akhlaghi: 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 (the 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 available 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. FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an {1}------------------------------------------------ established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rele"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. {2}------------------------------------------------ Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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, # Yanna S. Kang -S Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use Submission Number (if known) K241380 Device Name FETOLY-HEART Indications for Use (Describe) Fetoly-Heart is intended to analyze fetal ultrasound image sequences using machine learning techniques to automatically detect heart views and quality criteria within the views. The device is intended for use as a concurrent reading aid during the acquisition and interpretation of fetal ultrasound images. Fetoly-Heart is indicated for use during routine fetal heart examination of 2nd and 3rd trimester pregnancy (gestational age: from 17 to 40 weeks). Type of Use (Select one or both, as applicable) 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." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a logo for a company called DIAGNOLY. The logo features a blue magnifying glass with a stack of three horizontal lines inside the lens. The word "DIAGNOLY" is written in blue, sans-serif font below the magnifying glass. The background of the image is white. In accordance with 21 CFR 807.92 the 510(k) summary for FETOLY-HEART is provided below. #### 510(k) owner 1 | Owner | Diagnoly 60 Avenue Rockefeller 69008 Lyon, France +33(0)4.78.76.85.75 | |--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------| | Primary contact person | Ivan Voznyuk Chief Executive Officer Diagnoly Phone: +33(0)6.95.87.04.55 Email: ivan@diagnoly.com | | Secondary contact person | Nima Akhlaghi Associate Director, Digital Health Regulatory Affairs MCRA, LLC Phone: 202.742.3889 Email: nakhlaghi@mcra.com | | Date prepared | 2024-08-30 | #### 2 Device | Trade Name | FETOLY-HEART | |---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Classification name | Accessory to Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550 Accessory to Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560 Medical image management and processing system, 21 CFR 892.2050 | | Class | II | | Product code | IYN (Primary) IYO, QIH (secondary) | #### Predicate device identification ന The predicate device used for FETOLY-HEART is the cardiac-related component of Sonio Detect (K240406). Additionally, a reference device was chosen for FETOLY-HEART based on its substantially equivalent technical characteristics of automatic extraction of views from a sequence of images. This reference {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows a logo for a company called DIAGNOLY. The logo features a blue magnifying glass with a stylized image of a stack of objects inside the lens. The text "DIAGNOLY" is written in blue below the magnifying glass. device corresponds to the SonoLystLive view suggestion feature within the Voluson Expert Series 22/20/18 (K220358). ### Device description 4 FETOLY-HEART is a software that aims at helping sonographers, obstetricians, radiologists, maternal-fetal medicine specialists, and pediatric cardiologists (designated as healthcare professionals i.e. HCPs) to perform fetal ultrasound examinations of the fetal heart in real-time. FETOLY-HEART can be used by HCPs during fetal ultrasound examinations in the second and third trimesters (gestational age window: from 17 to 40 weeks). The software is intended to assist HCPs in the completeness assessment of the fetal heart ultrasound examination in accordance with national and international guidelines. To utilize FETOLY-HEART, the software needs to be installed on a hardware device which is connected to an Ultrasound Machine through an HDMI connection. The software receives ultrasound images captured by the connected Ultrasound Machine in real-time. The software's frozen deep learning algorithm, which was trained by supervised learning, analyzes images of this ultrasound image stream to detect heart views and quality criteria within those views. The software provides the following user-accessible information: - . Examination completeness: the software displays in real-time which heart views and quality criteria are verified by the software during the examination. It is the main and principal output of the FETOLY-HEART device. The verified heart views and quality criteria are accessible by clinicians at any moment of the ultrasound examination, in real-time. - . Completeness illustration: the software selects an image subset that illustrates the verified views and quality criteria. These images can be reviewed by clinicians to verify the views and criteria's presence. This is a secondary output of the FETOLY-HEART device. Optionally, clinicians can display detected quality criteria localization on selected images. | Heart views | Quality criteria within the views | | |---------------------------------------------------------|-----------------------------------|---------------------------------------------------------------| | Image: Heart view (A) ABD Abdomen view (n = 8) | (A1) Sp Spine | | | | (A2) IRb Left rib | | | | (A3) rRb Right rib | | | | (A4) Ao Descending aorta | | | | (A5) VC Inferior vena cava | | | | (A6) St Stomach | | | | (A7) Uv Umbilical vein | | | | (A8) Ap Thorax apex | | | | (B1) Sp Spine | | | | | | | | (B2) IRb | Left rib | | | (B3) rRb | Right rib | | | (B4) Ao | Descending aorta | | | (B5) IPV | Left pulmonary vein | | | (B6) rPV | Right pulmonary vein | | | (B7) LA | Left atrium | | | (B8) RA | Right atrium | | (B) 4CH | (B9) FOP | Foramen Ovale flap (Vieussens valve) | | Four chamber view (n = 19) | (B10) FO | Open Foramen Ovale | | | (B11) MV | Mitral valve | | | (B12) TV | Tricuspid valve | | | (B13) bCr | Connection between crux and atrial septum (vestibular septum) | | | (B14) Cr | Atrioventricular valve offset in crux | | | (B15) tCr | Connection between interventricular septum and crux | | | (B16) IVS | Interventricular septum | | | (B17) LV | Left ventricle | | | (B18) RV | Right ventricle | | | (B19) Str | Sternum | | | (C1) LA | Left atrium | | | (C2) aAo | Proximal ascending aorta | | (C) LVOT | (C3) SV | Semilunar valves | | | (C4) LV | Left ventricle | | | (C5) IVS | Interventricular septum | | Left Ventricular Outflow Tract view (n = 6) | (C6) RV | Right ventricle | | | (D1) dAo | Descending aorta | | | (D2) Tr | Trachea / bronchi | | | (D3) IPA | Left pulmonary artery | | | (D4) Du | Ductus arteriosus | | | (D5) rPA | Right pulmonary artery | | | (D6) Or | Origin of pulmonary arteries | | (D) RVOT | (D7) S | Septum between pulmonary artery trunk and ascending aorta | | Right Ventricular Outflow Tract view (n = 10) | (D8) aAo | Ascending aorta | | | (D9) SVC | Superior vena cava | | | (D10) PA | Pulmonary trunk | | | (E1) Sp | Spine | | | (E2) Tr | Trachea | | | (E3) ES | Side space on the left of ductus / pulmonary artery | | | (E4) PA | Main pulmonary artery | | | (E5) Du | Ductus (Ductal arch) | | | (E6) aAo | Ascending aorta | | (E) 3VX (E7) aAr | | Aortic arch | | Three vessels view (n = 9) | (E8) SVC | Superior vena cava | | | (E9) Th | Thymus / sternum | #### Definition of a complete examination 4.1 {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows a logo for a company called DIAGNOLY. The logo features a blue magnifying glass with a stylized image of a stack of three cones inside. The company name, DIAGNOLY, is written in blue text below the magnifying glass. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows a logo for a company called "Diagnoly". The logo features a blue magnifying glass with a stack of three cone-shaped objects inside the lens. The word "Diagnoly" is written in blue, sans-serif font below the magnifying glass. Table 1. List of 52 quality criteria defining the 5 views recommended by the International Society of Ultrasound in Obstetrics and Gynecology for the foetal heart screening of 2nd and 3rd trimesters of pregnancy. Abbreviations from this table are corresponding to the abbreviations used within the software. International and national guidelines- recommend 5 foetal cardiac views for routine ultrasound examination of 2nd and 3rd trimesters: (A) Abdomen view, (B) Four chamber view, (C) Left Ventricular Outflow Tract view, (D) Right Ventricular Outflow Tract view, (E) Three vessels view. The quality of these 5 heart views depends on the presence of 52 anatomical quality criteria within the views (Table 1). Thus, an examination can be defined as complete when all 5 heart views and their quality criteria are obtained by the HCP. #### Functionality 1: completeness overview 4.2 The software assesses the completeness of the foetal ultrasound examination. It verifies whether all the information corresponding to the recommended guidelines for the foetal heart examination has been acquired. This information corresponds to the presence of 5 main foetal cardiac views and 52 quality criteria, detailed in the above section, allowing for compliance in cardiac screening. #### Functionality 2: completeness illustration 4.3 This functionality was developed to enhance the security of the completeness evaluation which is done by the first module. It enables clinicians to verify the examination completeness overview, i.e. verified views and quality criteria by the software through the gallery page of the software interface. Operating continuously, it evaluates each image processed by the first module in real-time, retaining an image set as visual evidence of the verified heart views and quality criteria up to that moment. FETOLY-HEART does not aim to select the 'best' or of 'high' diagnostic quality according to a given qualitative scale. Rather, FETOLY-HEART aims to select images illustrating the examination quantitative completeness in terms of verified views and quality criteria. #### Indications for use ഗ FETOLY-HEART is intended to analyse fetal ultrasound images and clips using machine learning techniques to automatically detect heart views and quality criteria within the views. The device is intended for use as a concurrent reading aid during the acquisition and interpretation of fetal ultrasound images. FETOLY-HEART is indicated for use during routine fetal heart examination of 2nd and 3rd trimester pregnancy (gestational age: from 17 to 40 weeks). 1 Carvalho JS, Axt-Fliedner R, Chaoui R, Copel JA, Cuneo BF, Goff D, Gordin Kopylov L, Hecher K, Lee W, Moon-Grady A, Mousa HA, Munoz H, Paladini D, Prefumo F, Quarello E, Rychik J, Tutschek B, Wiechec M, Yagel S. ISUOG Practice Guidelines (updated): fetal cardiac screening. Ultrasound Obstet Gynecol 2023; 61: 788-803. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the text "510(k) Summary - K241380". The text is written in a bold, sans-serif font. The words "510(k) Summary" are followed by a dash and then the code "K241380". The text is centered and appears to be the title or heading of a document. Image /page/8/Picture/1 description: The image shows a logo for a company called DIAGNOLY. The logo features a blue magnifying glass with a stack of three objects inside. The word "DIAGNOLY" is written in blue letters below the magnifying glass. # 6 Summary of the technological characteristics of FETOLY-HEART compared to the predicate device | Aspect | Predicate device: Sonio Detect (Cardiac Features) K240406 | Reference device: Voluson Expert 18/20/22 (Cardiac- related SonolystLive Feature) K220358 | Proposed device: FETOLY-HEART | Comparison between Proposed and Predicate device | |---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | General | | | | | | Manufacturer name | Sonio | GE Healthcare | Diagnoly | NA | | Device name | Cardiac-related features in Sonio Detect | Cardiac-related SonolystLive in the Voluson Expert 18/20/22 | FETOLY-HEART | NA | | Product code(s) | IYN (Primary) IYO, QIH (secondary) | IYN (Primary) IYO, ITX (Secondary) | IYN (Primary) IYO, QIH (secondary) | Substantially equivalent Primary codes are the same for all devices | | Regulation number | - Accessory to Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550 - Accessory to Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560 | - Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550 - Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560 - Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX | - Accessory to Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550 - Accessory to Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560 - Medical image management and processing system, 21 CFR 892.2050 | Substantially equivalent All devices are class II devices subject to 510(k) regulatory pathway. | | Brief description | The predicate device is a software that aims at helping sonographers, OB/GYNs, MFMs and Fetal surgeons (all three designated as healthcare professionals i.e. HCP) to perform their routine fetal heart ultrasound | The reference device is a software that aims at helping sonographers, OB/GYNs, MFMs and Fetal surgeons (all three designated as healthcare professionals i.e. HCP) to perform their routine fetal heart ultrasound | FETOLY-HEART is a software that aims at helping sonographers, OB/GYNs, MFMs and Fetal surgeons (all three designated as healthcare professionals i.e. HCPs) to perform their routine fetal heart ultrasound | Substantially equivalent The subject device and the predicate devices have the same objective. | | | examinations in real-time. | examinations in real-time. | examinations in real-time. | | | Indications for use | The predicate device is intended to analyze fetal ultrasound images and clips using machine learning techniques to automatically detect heart views, detect anatomical structures within the views and verify quality criteria of the views. The device is intended for use as a concurrent reading aid during the acquisition and interpretation of fetal ultrasound images. | The device is a general purpose ultrasound system intended for use by qualified and trained healthcare professionals. | FETOLY-HEART is intended to analyse fetal ultrasound images and clips using machine learning techniques to automatically detect heart views and quality criteria within the views. The device is intended for use as a concurrent reading aid during the acquisition and interpretation of fetal ultrasound images. FETOLY-HEART is indicated for use during routine fetal heart examination of 2nd and 3rd trimester pregnancy (gestational age: from 17 to 40 weeks). | Substantially equivalent Indications for Use are the same between predicate and subject devices. | | Targeted population | Pregnant women during the 2nd and 3rd trimester of pregnancy | Pregnant women during the 2nd trimester of pregnancy | Pregnant women during the 2nd and 3rd trimester of pregnancy | Substantially equivalent Subject device has the same intended patient population than the predicate devices. | | Clinical outcome | - Images labeled with correct fetal heart view | - Images labeled with correct fetal heart view | - Images labeled with correct fetal heart view for patient cases | Substantially equivalent Performance testing has successfully validated the clinical outcomes | | | - Quality criteria identified as "Verified" when detected and "Not verified" when not detected | - Quality criteria identified as "Found" when detected and "Not found" when not detected | - Quality criteria identified as "Verified" when detected and "Not | Substantially equivalent In the subject device, quality criteria bounding box localization can be | | | | | verified" when not detected - Images labeled with the localization of quality criteria | optionally displayed on post-acquisition images to enhance explainability of the Al model. Performance testing has been performed and does not introduce new questions of safety and effectiveness. | | Intended user | Qualified healthcare professional specialized in prenatal ultrasound imaging | Qualified healthcare professional specialized in prenatal ultrasound imaging | Qualified healthcare professional specialized in prenatal ultrasound imaging | Substantially equivalent Subject device has the same intended users as the predicate devices. | | Clinical applications | Fetal/Obstetrics | Fetal/Obstetrics | Fetal/Obstetrics | Substantially equivalent Clinical application is the same for subject and predicate devices. | | Inclusion of a PCCP | N/A | N/A | Included | Different The PCCP in the subject device includes proposed modifications related to modifying model training hyperparameters, additional retraining with new training and validation datasets collected, and addition/removal of heart quality criteria. | | Functionality 1: completeness overview | | | | | | Automatically detect views | Detection of 4ch, 3vx, LVOT, RVOT and Abd views (complete implementation of ISUOG recommendations) | Detection of 4ch, 3vx, LVOT, RVOT and Abd views (complete implementation of ISUOG recommendations) | Detection of 4ch, 3vx, LVOT, RVOT and Abd views (complete implementation of ISUOG recommendations) | Substantially equivalent The subject device includes the detection of the same views than the predicate device | | Automatically detect quality criteria | Detection of 28 heart quality criteria. The quality also incorporates the zoom level of the view. | Detection of NA heart quality criteria. | Detection of 52 heart quality criteria (see Table 1). The quality also incorporates the zoom level of the view. | Substantially equivalent The subject device includes the detection of new quality criteria when compared to the predicate device. This quantitative enhancement has been tested and does not raise any new question of safety and effectiveness. | | Functionality 2: completeness illustration | | | | | | Automatically selects views | NA | Automatic suggestion of views from a sequence of images. | Automatic extraction of views from a sequence of images. | Substantially equivalent This image selection functionality is a feature absent in the predicate device but present in the reference device. Software testing has been performed to validate its use and does not introduce new questions of safety and effectiveness. | | Technical characteristics | | | | | | Data input | Accepts images and image sequences from ultrasound machines | Accepts images and image sequences from ultrasound machines | Accepts images and image sequences from ultrasound machines | Substantially equivalent The input data is the same for the subject device and the predicate and reference devices. | | Algorithm Methodology | Artificial Intelligence: Utilizes computer vision algorithms to analyze ultrasound images and provides visualization of detected landmarks | Artificial Intelligence: Utilizes computer vision algorithms to analyze ultrasound images and provides visualization of detected landmarks | Artificial Intelligence: Utilizes computer vision algorithms to analyze ultrasound images and provides visualization of detected landmarks | Substantially equivalent The subject device and the primary predicate device use both artificial intelligence. | | Platform | Operates in a cloud- based environment functioning independently from the ultrasound equipment. | Operates as a local software embedded in the ultrasound equipment. | Operates as a local software functioning independently from the ultrasound equipment. | Substantially equivalent The edge-based approach reduces exposure to potential cloud-related vulnerabilities and latency issues. Therefore, this difference does not raise any safety or effectiveness concerns. | | Ultrasound Machine compatibility | Compatible with ultrasound system from GE Medical, Samsung, Canon and Philips | NA | Compatible with ultrasound system from GE Medical, Samsung and Canon | Substantially equivalent This compatibility has been tested and validated as part of device generalizability in the performance testing study. | | User interaction | The user can interact with the software to override the software's outputs. The user has the ability to review and edit/override the matching at any time during or at the end of the exam. | NA | The user can interact with the software to override the software's outputs. The user has the ability to review and edit/override the matching at any time during or at the end of the exam. | Substantially equivalent User interactions are the same between primary predicate and subject devices. | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows a logo for a company called DIAGNOLY. The logo features a blue magnifying glass with a stack of three curved lines inside, suggesting a focus on analysis or investigation. The company name, "DIAGNOLY," is written in a stylized blue font below the magnifying glass, emphasizing the company's diagnostic or analytical services. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows a blue magnifying glass with a symbol inside. The symbol consists of several horizontal lines that are stacked on top of each other, resembling a radar or sonar display. Below the magnifying glass, the word "DIAGNOLY" is written in blue, with the letters in a slightly rounded font. {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows a logo for a company called DIAGNOLY. The logo features a blue magnifying glass with a stylized image of a stack of objects inside the lens. The word "DIAGNOLY" is written in blue letters below the magnifying glass. {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows a blue logo for a company called DIAGNOLY. The logo features a magnifying glass with a stylized image of three stacked, truncated cones inside the lens. The word "DIAGNOLY" is written in blue below the magnifying glass. ### Non-clinical performance data 7 # 7.1 FETOLY-HEART testing strategy The following V&V testing were included into the development of the system: - Software verification testing per IEC 62304 standard - Tablet compatibility testing - Cybersecurity verification testing ● - Software Al model validation {13}------------------------------------------------ Image /page/13/Picture/1 description: The image shows a logo for a company called "DIAGNOLY". The logo features a blue magnifying glass with a stylized image of a stack of three horizontal lines inside the lens. The word "DIAGNOLY" is written in blue below the magnifying glass. FETOLY-HEART uses a machine learning (ML) algorithm for detection of heart views and quality criteria within these views in ultrasound images. Modifications to FETOLY-HEART will be made in accordance with the guiding principles on predetermined change control plans (PCCP) for machine learning-enabled medical devices. This PCCP provides a description of the device's planned modifications, and those modifications will be triggered and implemented in a controlled manner that ensures the continued safety and efficacy on the performance testing dataset, mitigating risks associated with changes to the ML model to not adversely impact the device's performance, safety, or effectiveness associated with its indications for use, and an impact assessment of the planned modifications. In accordance with the PCCP, all algorithm modifications will be adequately trained, tuned, and locked prior to release of the software with the modified ML model. The PCCP does not include the implementation of adaptive algorithms that will continuously learn in the field. Implemented modifications to the FETOLY-HEART algorithm will be communicated to users via the software update notifications and through updated labelling. The modifications outlined in the PCCP are summarized in the table below. The PCCP in the subject device with the proposed modifications related to modifying model training hyperparameters, additional retraining and validation datasets collected, and addition/removal of heart quality criteria do not raise different questions of safety and effectiveness from the predicate device (see table below). | Modification | Rationale | Testing Methods | Impact Assessment | |-----------------------------------------------------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Modification of training and/or validation datasets | Increase or recovery (in case of data drift) of FETOLY-HEART's performance. | Re-training of the FETOLY- HEART model with new data to optimize its performance followed by internal testing and a comparison of the initial model to the modified model using performance metrics on the test dataset. | Increased performance metrics of the modified model for view or quality criteria detection. Benefits: Increase or recovery of performance; generalization for diverse cases. Risks: Performance decrease (overfitting, unintended bias). Risk mitigation: The modified model will be tested for superiority on the performance study test dataset which will contain new unseen data. | | Modification of model training hyperparameters | Improvement and optimization of FETOLY- HEART's performance | Re-training of the FETOLY- HEART model with new parameters to optimize its performance followed by internal testing and a comparison of the initial model to the modified model using performance | Increased performance metrics of the modified model for view or quality criteria detection. Benefits: Increased performance; generalization for diverse cases. Risks: Performance decrease (overfitting, unintended bias). | ### Summary of changes to FETOLY-HEART per the PCCP: {14}------------------------------------------------ Image /page/14/Picture/0 description: The image shows a blue logo for a company called "DIAGNOLY". The logo features a blue magnifying glass with a stack of three cone-shaped objects inside. The text "DIAGNOLY" is written in blue below the magnifying glass. | | | metrics on the test dataset. | Risk mitigation: The modified model will be tested for superiority on the performance study test dataset which will contain new unseen data. | |-----------------------------------------------|----------------------------------------------------------…