Who is the manufacturer of EPIQ Series Diagnostic Ultrasound System?

Philips Ultrasound, LLC filed the 510(k) submission for EPIQ Series Diagnostic Ultrasound System (K240980).

What is the FDA product code for EPIQ Series Diagnostic Ultrasound System?

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

What is the regulatory pathway for EPIQ Series Diagnostic Ultrasound System?

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

Does EPIQ Series Diagnostic Ultrasound System use AI or machine learning?

Yes. EPIQ Series Diagnostic Ultrasound System (K240980) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for EPIQ Series Diagnostic Ultrasound System?

Philips EPIQ Series Diagnostic Ultrasound System (K233788).

Who can help prepare an FDA 510(k) submission like EPIQ Series Diagnostic Ultrasound System?

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 EPIQ Series Diagnostic Ultrasound System 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.

EPIQ Series Diagnostic Ultrasound System

K240980 · Philips Ultrasound, LLC · IYN · Oct 7, 2024 · Radiology

Device Facts

Record ID	K240980
Device Name	EPIQ Series Diagnostic Ultrasound System
Applicant	Philips Ultrasound, LLC
Product Code	IYN · Radiology
Decision Date	Oct 7, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	AI/ML, Pediatric

Intended Use

The intended use of EPIQ Ultrasound Diagnostic System 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, Intraoperative (Vascular), Intraoperative (Cardiac), intra-luminal, intra-cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transvaginal, Lung. The clinical environments where EPIQ Series 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.

Device Story

EPIQ Series Diagnostic Ultrasound System updated with 3D Auto TV and 3D Auto CFQ software applications. 3D Auto TV performs semi-automated quantification of tricuspid valve annulus via model-based segmentation of ultrasound images. 3D Auto CFQ provides semi-automated quantification of mitral regurgitation volume and peak flow rate using 3D color flow images and a fluid dynamic model of blood flow through an irregular orifice. System used in clinics/hospitals by trained healthcare professionals. Software processes acquired 3D ultrasound data to generate anatomical models and flow measurements. Outputs assist clinicians in assessing valvular morphology and function. No hardware changes; compatible with existing cleared Philips transducers. Benefits include standardized, semi-automated quantification of complex cardiac structures and regurgitant flow, supporting clinical decision-making in cardiovascular disease management.

Clinical Evidence

No clinical investigation performed. Non-clinical performance validation conducted. 3D Auto TV evaluated against manual measurements (4D Cardio-View) using TTE/TEE clips; demonstrated high agreement (annulus size/shape limits of agreement within acceptance criteria). 3D Auto CFQ validated against cardiac MRI (CMR) for regurgitant volume (bias and LoA within acceptance criteria) and against 2D PISA for peak flow rate (Pearson's correlation > 0.8). In silico phantom testing confirmed measurement primitive accuracy within +/- 1%.

Technological Characteristics

Software-based diagnostic ultrasound system. Features semi-automated quantification algorithms (3D Auto TV, 3D Auto CFQ) for cardiac analysis. Operates on existing EPIQ hardware platforms (v11.0+). Connectivity via standard ultrasound system interfaces. No hardware, transducer, or patient-contact material changes. Software life cycle compliant with IEC 62304; risk management per ISO 14971.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis of the human body, including abdominal, cardiac (adult, fetal, pediatric), vascular, cephalic, obstetric, gynecological, intraoperative, musculoskeletal, ophthalmic, urological, pediatric, peripheral vessel, small organ, transesophageal, transrectal, transvaginal, and lung applications. Used in clinics, hospitals, and point-of-care settings by trained healthcare professionals.

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

Philips EPIQ Series Diagnostic Ultrasound System (K233788)

Reference Devices

TOMTEC-ARENA, TOMTEC Imaging Systems GmbH (K213544)
QLAB Advanced Quantification Software (K200974)

Related Devices

K132165 — QLAB QUANTIFICATION SOFTWARE · Philips Ultrasound, Inc. · Aug 9, 2013
K241659 — Ultrasound Workspace (UWS 6.0) · Philips Ultrasound, LLC · Feb 10, 2025
K200974 — QLAB Advanced Quantification Software · Philips Health Care · Jun 3, 2020
K211597 — EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System · Philips Medical Systems · Sep 8, 2021
K130159 — QLAB QUANTIFICATION SOFTWARE HEART MODEL · Philips Health Care · May 13, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ October 7, 2024 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Philips Ultrasound LLC Michael Chambers Senior Regulatory Affairs Specialist 22100 Bothell Everett Hwy Bothell, WA 98021 Re: K240980 Trade/Device Name: EPIQ Series Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX, QIH, OBJ Dated: April 10, 2024 Received: August 19, 2024 Dear Michael Chambers: 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. {1}------------------------------------------------ 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 (QS) 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 Rule"). 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. 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. {2}------------------------------------------------ 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, # 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) K240980 Device Name EPIQ Series Diagnostic Ultrasound System Indications for Use (Describe) The intended use of EPIQ Ultrasound Diagnostic System 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, Intraoperative (Vascular), Intraoperative (Cardiac), intra-luminal, intra-cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transvaginal, Lung. The clinical environments where EPIQ Series 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. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) # 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}------------------------------------------------ # 510(k) Summary This summary of safety and effectiveness information is submitted in accordance with 21 CFR § 807.92. 510(k) Number: K240980 Date Prepared: August 16, 2024 ## l. Submitter | Manufacturer Name and Address | Philips Ultrasound LLC 22100 Bothell Everett Hwy Bothell, WA 98021-8431 USA | |----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Information | Mike Chambers Senior Regulatory Affairs Specialist 22100 Bothell Everett Hwy Bothell, WA 98021-8431 USA +1 (315) 262-7702 | | Secondary Contact | Erdit Gremi Director, Regulatory Affairs Philips Ultrasound LLC 22100 Bothell Everett Hwy Bothell, WA 98021-8431 USA +1 (617) 798-8092 | ## II. Device EPIQ Series Diagnostic Ultrasound System Common Name Proprietary Name Regulation Description Diagnostic Ultrasound System and Transducers | Classification Description | 21 CFR § | Product Code | |-----------------------------------------------------|----------|--------------| | Primary | | | | System, imaging, pulsed doppler, ultrasonic | 892.1550 | IYN | | Secondary | | | | System, imaging, pulsed echo, ultrasonic | 892.1560 | IYO | | Transducer, ultrasonic, diagnostic | 892.1570 | ITX | | Automated Radiological Image Processing Software | 892.2050 | QIH | | Diagnostic Intravascular Catheter | 870.1200 | OBJ | | Device Class | Class II | |-------------------|------------------------------------------------------------------------------------------------------| | Review Panel | Radiology | | Predicate Device | K233788; Philips EPIQ Series Diagnostic Ultrasound System | | Reference Devices | K213544; TOMTEC-ARENA, TOMTEC Imaging Systems GmbH K200974; QLAB Advanced Quantification Software | {5}------------------------------------------------ #### 111. Device Description The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the 3D Auto TV (Tricuspid Valve) software application onto the EPIQ Series Diagnostic Ultrasound Systems. The 3D Auto TV software enables semi-automated quantification of the tricuspid valve. At a high level, this is accomplished through automatically derived measurements from a segmented model of the tricuspid valve annulus formed by the software through model-based segmentation of the acquired ultrasound images. The 3D Auto CFQ software provides semi-automated quantification of Mitral Requrgitation (MR) volume and peak flow rate based on 3D color flow images. This application uses a known fluid dynamic model of flow that is adapted to the acquired color information. This allows quantitative assessment of mitral valve leakage during systole. The derived result supports the assessment of mitral regurgitation volume and peak flow rate. No hardware changes to the EPIQ systems are required when using the 3D Auto TV and 3D Auto CFQ, and existing, cleared Philips transducer(s) are used for the software applications. The software applications are supported by all EPIQ models running software version 11.0 or higher including EPIQ CVx/CVxi. EPIQ Elite Advanced. EPIQ 7. EPIQ 5. The software applications are both associated with the cardiac adult indication. ### IV. Intended Use and Indications for Use # EPIQ Intended Use The intended use of EPIQ Ultrasound Diagnostic System is diagnostic ultrasound imaging and fluid flow analysis of the human body. # EPIQ Indications for Use: The intended use of EPIQ Ultrasound 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, Intraoperative (Vascular), Intraoperative (Cardiac), intra-luminal, intra-cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung. The clinical environments where EPIQ Series 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. Note: There are no changes to the EPIQ Ultrasound System Indications for Use due to the introduction of the 3D Auto TV or 3D Auto CFQ software applications. Both are associated with the Cardiac Adult indication. {6}------------------------------------------------ ### V. Comparison of Technological Characteristics with the Predicate The purpose of the submission is to introduce the 3D Auto TV and 3D Auto CFQ software applications to the EPIQ Series Diagnostic Ultrasound System. The subject device is substantially equivalent to the predicate device (K233788). The following tables provide an overview of the comparison of similarities and differences between the proposed device and the predicates. Details are provided in Attachment 005 of the submission. | Feature | EPIQ Series Diagnostic Ultrasound System Feature: 3D Auto TV Proposed Device | EPIQ Series Diagnostic Ultrasound System K233788 Predicate Device | TOMTEC-ARENA Feature: 4D CARDIO- VIEW K213544 Reference Device | QLAB Advanced Quantification Software Feature: 3D Auto MV K200974 Reference Device | Comparison | |-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | Abdominal, Cardiac Adult, Cardiac other (Fetal). Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), intra-luminal, intra- cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial). Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle). Transesophageal (Cardiac), Transrectal, Transvaginal, Lung. | Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), intra-luminal, intra- cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial). Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle). Transesophageal (Cardiac), Transrectal, Transvaginal, Lung. | Quantification and reporting of cardiovascular, fetal, and abdominal structures and functions of patients with suspected disease to support the physician in the diagnosis. | QLAB Quantification software is a software application package. It is designed to view and quantify image data acquired on Philips ultrasound systems | Identical to predicate | | Intended Users | Trained healthcare professionals Intended for sonographers, physicians, and biomedical engineers who operate and maintain your product. Before use of the system and user information, the user must be familiar with ultrasound techniques. Sonography training and clinical procedures are not included in the User Manual or with the EPIQ Series Diagnostic Ultrasound System. | Trained healthcare professionals Intended for sonographers, physicians, and biomedical engineers who operate and maintain your product. Before use of the system and user information, the user must be familiar with ultrasound techniques. Sonography training and clinical procedures are not included in the User Manual or with the EPIQ Series Diagnostic Ultrasound System. | Licensed medical practitioners or assistant medical technicians | Trained healthcare professionals | Identical to predicate | | Feature | EPIQ Series Diagnostic Ultrasound System Feature: 3D Auto TV Proposed Device | EPIQ Series Diagnostic Ultrasound System K233788 Predicate Device | TOMTEC-ARENA Feature: 4D CARDIO- VIEW K213544 Reference Device | QLAB Advanced Quantification Software Feature: 3D Auto MV K200974 Reference Device | Comparison | | Intended User Environment | Clinics, hospitals, and clinical point-of-care for diagnosis of patients. | Clinics, hospitals, and clinical point-of-care for diagnosis of patients. | Inside and outside of Hospitals, Clinics, and Physician's offices | Clinics, hospitals, and clinical point-of-care for diagnosis of patients. | Identical to predicate | | USA FDA Classification | Class II | Class II | Class II | Class II | Identical to predicate | | Primary Product Code | IYN | IYN | QIH | QIH | Identical to predicate | | Application Description | The 3D Auto TV software solution is intended for use with the Philips EPIQ Diagnostic Ultrasound Systems. The software enables semi-automated quantification of the tricuspid valve. At a high level, this is accomplished through automatically derived measurements from a segmented model of the tricuspid valve annulus formed by the software through model-based segmentation of the acquired ultrasound images. | The predicate EPIQ Series Diagnostic Ultrasound System does not currently have a dedicated software application for quantification of the tricuspid valve annulus. The subject of this submission is to introduce the 3D Auto TV software onto the predicate device. | 4D CARDIO-VIEW is an advanced analysis tool for 3D/4D echocardiography data. Anatomical structure visualization, volume measurements (LV and/or generic), and specified or manual measurements are possible for cardiac structures including, but not limited to, the tricuspid valve. Various tools are available for rendering that display 2- and 3-dimensional morphology and function for defined structures. | 3D Auto MV is a semi- automated software application intended for the analysis of Mitral Valve (MV) anatomy and function. This application generates models of anatomical structures of interest such as the MV annulus, leaflets, and the closure line, which allows for quantification of pre- and post- operative valvular function and a comparison of morphology. | Similar to the reference device features. The functionality and workflow of the 3D Auto TV software is very similar to the 3D Auto MV tool, where measurement parameters are derived from models of the mitral valve (in the case of 3D Auto MV) and tricuspid valve (in the case of 3D Auto TV). Manual measurements are also able to be performed on both software applications. Comparing 3D Auto TV to 4D CARDIO-VIEW, both software have functionality for quantifying the tricuspid valve. The proposed 3D Auto TV allows for semi- automated quantification, where the reference device is fully manual. As we demonstrate high agreement in the measurement outputs on the same patients when quantified using the proposed 3D Auto TV software and the reference 4D CARDIO- VIEW application, there are no new questions raised of safety or effectiveness. | | Contour Generation | 3D surface model is created semi- automatically using machine learning algorithm without user interaction. User is able to edit, accept, or reject the initial landmark | No standard tricuspid valve (TV) quantification parameters included as part of the system. | 3D surface model is created based on user defined anatomical landmarks. User is able to edit the contour of the surface model before proceeding with the workflow. | 3D surface model is created semi-automatically using machine learning algorithm without user interaction. User is able to edit, accept, or reject the initial landmark proposals of the mitral valve anatomical locations. | Subject device uses identical method for contour generation as the reference device K200974. The only difference is the algorithm is trained on tricuspid valve images, where the reference | | Feature | EPIQ Series Diagnostic Ultrasound System Feature: 3D Auto TV Proposed Device | EPIQ Series Diagnostic Ultrasound System K233788 Predicate Device | TOMTEC-ARENA Feature: 4D CARDIO-VIEW K213544 Reference Device | QLAB Advanced Quantification Software Feature: 3D Auto MV K200974 Reference Device | Comparison | | | valve anatomical locations. | | |…

EPIQ Series Diagnostic Ultrasound System

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