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

EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

Q: Who is the manufacturer of EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System?

Philips Ultrasound, LLC filed the 510(k) submission for EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (K243794).

Q: What is the FDA product code for EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System?

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

Q: What is the regulatory pathway for EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System?

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

Q: Does EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System use AI or machine learning?

Yes. EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (K243794) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Q: Can an AI/ML device like EPIQ Series Diagnostic Ultrasound System; Affiniti 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.

K243794 · Philips Ultrasound, LLC · IYN · Feb 6, 2025 · Radiology

Device Facts

Record ID	K243794
Device Name	EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
Applicant	Philips Ultrasound, LLC
Product Code	IYN · Radiology
Decision Date	Feb 6, 2025
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), Transrectal, Transvaginal, Lung. Modes of operation include: B Mode, M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode . Power Doppler and Harmonic Imaging. 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 quidance. 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. The intended use of Affiniti 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, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung. Modes of operation include: B Mode, M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode , Power Doppler and Harmonic Imaging. The clinical environments where the Affiniti diagnostic ultrasound systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients. 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 and Affiniti Series Diagnostic Ultrasound Systems utilize AutoMeasure V3 software to provide semi-automated 2D, Doppler, and M-mode measurements during adult echocardiography. Input data consists of transthoracic echocardiography (TTE) clips acquired with an adult cardiology transthoracic transducer and ECG signal. The device uses an AI-based machine learning algorithm to detect anatomical structures and initialize measurement calipers. Output is presented to the clinician as semi-automated, editable measurements. Used in clinics, hospitals, and point-of-care settings by sonographers, physicians, and biomedical engineers. The clinician reviews, edits, accepts, or rejects the automated measurements, facilitating clinical decision-making for cardiovascular disease diagnosis and treatment guidance.

Clinical Evidence

Performance validation study using 7,127 TTE cardiac clips from 3,964 subjects (mean age 59.0, 51.4% female). Study compared AutoMeasure V3 parameters against Standard of Care (SOC) ground truth measurements. Results demonstrated high agreement across demographic variables (age, BMI, gender, race) and clinical status, meeting pre-defined acceptance criteria based on inter-observer variability. No new clinical investigation was required for this submission.

Technological Characteristics

Diagnostic ultrasound system with pulsed Doppler, pulsed echo, and image management capabilities. Software-based AutoMeasure V3 feature uses AI/ML algorithms for semi-automated measurement initialization. Complies with IEC 62304 (software life cycle) and ISO 14971 (risk management). Operates on EPIQ/Affiniti systems running software version 13.0 or higher.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis of the human body, including abdominal, cardiac (adult/pediatric/fetal), vascular, cephalic, fetal/obstetric, gynecological, intraoperative, musculoskeletal, ophthalmic, urological, small organ, 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 and Philips Affiniti Series Diagnostic Ultrasound System (K240850)

Related Devices

K211597 — EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System · Philips Medical Systems · Sep 8, 2021
K242800 — The 5000 Compact Series Ultrasound Systems · Philips Ultrasound, LLC · Nov 15, 2024
K233788 — EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System · Philips Ultrasound, LLC · Feb 13, 2024
K230209 — Sonix Health · Ontact Health Co., Ltd. · Oct 20, 2023
K213544 — TOMTEC-ARENA · Tomtec Imaging Systems GmbH · Jan 6, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ February 6, 2025 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 the FDA logo, which 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 Deval Patel Principal Regulatory Affairs Specialist 22100 Bothell Everett Hwy Bothell, Washington 98021 Re: K243794 Trade/Device Name: EPIQ Series Diagnostic Ultrasound System; Affiniti 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, OBJ, OIH Dated: December 10, 2024 Received: December 10, 2024 Dear Deval Patel: 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. 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-regulatory {2}------------------------------------------------ assistance/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) k243794 Device Name EPIQ Series Diagnostic Ultrasound System Affiniti Series Diagnostic Ultrasound System Indications for Use (Describe) Eblo: 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), Transrectal, Transvaginal, Lung. Modes of operation include: B Mode, M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode . Power Doppler and Harmonic Imaging. 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 quidance. 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. Affiniti: The intended use of Affiniti 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, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung. Modes of operation include: B Mode, M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode , Power Doppler and Harmonic Imaging. {4}------------------------------------------------ The clinical environments where the Affiniti diagnostic ultrasound systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients. 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." {5}------------------------------------------------ ## 510(k) Summary This summary of safety and effectiveness information is submitted in accordance with 21 CFR § 807.92. 510(k) Number: K243794 Date Prepared: October 10, 2024 Date of Revision: February 5, 2025 | I. | Submitter | | |----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Manufacturer Name and Address | Philips Ultrasound LLC 22100 Bothell Everett Hwy Bothell, WA 98021-8431 USA | | | Contact Information | Deval Patel Principal Regulatory Affairs Specialist 22100 Bothell Everett Hwy Bothell, WA 98021-8431 USA +1 (949) 502-1823 | | | 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 | Proprietary Name | EPIQ Series Diagnostic Ultrasound System Affiniti Series Diagnostic Ultrasound System | |------------------|------------------------------------------------------------------------------------------| | Common Name | Diagnostic Ultrasound System and Transducers | | Regulation Description | 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 | | | Medical image management and processing system | 892.2050 | QIH | | | Diagnostic Intravascular Catheter | 870.1200 | OBJ | | Device Class | Class II | | | | Review Panel | Radiology | |--------------|-----------| |--------------|-----------| Predicate Device K240850; Philips EPIQ Series Diagnostic Ultrasound System and Philips Affiniti Series Diagnostic Ultrasound System {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "PHILIPS" in blue, block letters. The letters are bold and sans-serif. The background is a light gray or white color. The word is centered in the image. | Predicate Regulation Description | Classification Description | 21 CFR § | Product Code | |-------------------------------------|---------------------------------------------------|------------------------------------------------|--------------| | | Primary | System, imaging, pulsed doppler, ultrasonic | 892.1550 | | Secondary | System, imaging, pulsed echo, ultrasonic | 892.1560 | IYO | | | Transducer, ultrasonic, diagnostic | 892.1570 | ITX | | | Medical image management and processing system | 892.2050 | QIH | | | Diagnostic Intravascular Catheter | 870.1200 | OBJ | #### III. Device Description The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the change in AutoMeasure V3 software application onto the EPIQ Series Diagnostic Ultrasound Systems and Affiniti Series Diagnostic Ultrasound Systems. Philips AutoMeasure feature provides the end user semi-automated 2D, Doppler and M-mode measurements with an adult cardiology transthoracic transducer and acquisitions that includes an electrocardiogram (ECG). The Auto Measure feature is designed to provide semi-automated and editable measures during an echocardiography. When Auto Measure is enabled, the healthcare professional performs an echocardiography with a workflow that provides the user with a semiautomated measurement that can be edited, accepted, or rejected. AutoMeasure is available in the Adult Echo analysis applications with ECG. Availability is also controlled by transducer and preset via the EPM. The software applications are supported by all EPIQ and Affiniti models running software version 13.0 or higher. #### 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 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), Transrectal, Transvaginal, Lung. Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler and Harmonic Imaging. 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. {7}------------------------------------------------ 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. ## Affiniti Intended Use The intended use of Affiniti Ultrasound Diagnostic ultrasound imaging and fluid flow analysis of the human body. ## Affiniti Indications for Use: The intended use of Affiniti 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, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaqinal, Lunq. Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler and Harmonic Imaging. The clinical environments where the Affiniti diagnostic ultrasound systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients. 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 and Affiniti Ultrasound System Indications for Use due to the introduction of the AutoMeasure software applications #### V. Comparison of Technological Characteristics with the Predicate The purpose of the submission is to introduce the change to AutoMeasure V3 software applications to the EPIQ Series Diagnostic Ultrasound System and Affiniti Series Diagnostic Ultrasound System. The subject device is substantially equivalent to the predicate device (K240850). The following tables provide an overview of the comparison of similarities and differences between the proposed device and the predicates. {8}------------------------------------------------ ## DHILIPS ## Table 1: Comparison to Predicate for modification of AutoMeasure V3 onto EPIQ | Feature | EPIQ Series Diagnostic Ultrasound System Feature: AutoMeasure V3 Proposed Device | EPIQ Series Diagnostic Ultrasound System K240850 Predicate 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. | 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. | Identical to predicate | | 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. | Identical to predicate | | USA FDA Classification | Class II | Class II | Identical to predicate | | Primary Product Code | IYN | IYN | Identical to predicate | | Primary Regulation Name | System, Imaging, Pulsed Doppler, Ultrasonic | System, Imaging, Pulsed Doppler, Ultrasonic | Identical to predicate | | Feature | EPIQ Series Diagnostic Ultrasound System Feature: AutoMeasure V3 Proposed Device | EPIQ Series Diagnostic Ultrasound System K240850 Predicate Device | Comparison | | Primary Regulation Number | 21 CFR 892.1550 | 21 CFR 892.1550 | Identical to predicate | | Secondary Product Codes | ITX IYO OBJ QIH | ITX IYO OBJ QIH | Identical to predicate | | Secondary Regulation Name | Diagnostic ultrasonic transducer Ultrasonic pulsed echo imaging system Diagnostic intravascular catheter Automated Radiological Image Processing Software | Diagnostic ultrasonic transducer Ultrasonic pulsed echo imaging system Diagnostic intravascular catheter Automated Radiological Image Processing Software | Identical to predicate | | Secondary Regulation Number | 21 CFR 892.1570 21 CFR 892.1560 21 CFR 870.1200 21 CFR 892.2050 | 21 CFR 892.1570 21 CFR 892.1560 21 CFR 870.1200 21 CFR 892.2050 | Identical to predicate | | Reusable- Systems and Transducers | Yes | Yes | Identical to predicate | | Duration of use | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Identical to predicate | | Application Description | Auto Measure is an optional software feature on the EPIQ Series Diagnostic Ultrasound System that provides the end user with semiautomated adult echocardiography 2D, Doppler or M-mode 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. 2D modes include the following: IVSd LVIDd LVPWd LVIDs Asc Ao Diam LA Vol, A2Cs LA Vol, A4Cs LA Diameter a.p. (PLAX) RA Volume | Auto Measure is an optional software feature on the EPIQ Series Diagnostic Ultrasound System that provides the end user with semiautomated 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. 2D modes include the following: IVSd LVIDd LVPWd LVIDS Asc Ao Diam Doppler modes include the following: MV Peak E Vel, MV Peak A Vel MV Inflow (MV Dec Time, MV Peak E Vel, MV Peak A Vel) LVOT VTI, LVOT Vmax AV VTI, AV Vmax PV VTI, PV Vmax TR Vmax Lat E' Vel, Lat A' | Similar to the reference device features. The functionality and workflow of the AutoMeasure V3 software is Identical to predicate where Auto Measure quantifies image data acquired on the Philips EPIQ Ultrasound System through an Al based algorithm that used a trained machine- learning model. Compared to predicate only new measurements and detectors are added to the existing measurements. Clinical performance studies were completed, and the results showed safety and effectiveness | | Feature | EPIQ Series Diagnostic Ultrasound System Feature: AutoMeasure V3 Proposed Device | EPIQ Series Diagnostic Ultrasound System K240850 Predicate Device | Comparison | | | AoR Diam(2D) = Ao Annlus diam Doppler modes include the following: MV Peak E Vel, MV Peak A Vel MV Inflow (MV Dec Time, MV Peak E Vel, MV Peak A Vel) LVOT VTI, LVOT Vmax AV VTI, AV Vmax PV VTI, PV Vmax TR Vmax Lat E' Vel, Lat A' Vel Lat Vel (Lat E' Vel, Lat A' Vel) Med E' Vel, Med A' Vel Med Vel (Med E' Vel, Med A' Vel) RV S Vel, MR VTI TR VTI M-Modes include the following: TAPSE | Vel Lat Vel (Lat E' Vel, Lat A' Vel) Med E' Vel, Med A' Vel Med Vel (Med E' Vel, Med A' Vel) RV S Vel | | | Semi-Automation Technology | AutoMeasure V3 is created semi- automatically using machine learning algorithm without user interaction. Semi- automated adult echocardiography 2D, Doppler and M-mode 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. | AutoMeasure V3 is created semi-automatically using machine learning algorithm without user interaction. 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. | Subject device uses identical method for contour generation as the reference device K240850. The only difference is the algorithm is new M-mode measurement is added, new detectors are added, and existing detectors are re-trained based on new literature available. | | User Interface | User selects an adult echocardiography 2D, Doppler or M-mode 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. | 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. The proposed AutoMeasure V3 software allows very similar semi-automate measurements as the reference software application AutoMeasure. The proposed Auto Measure V3 software adds additional M-mode measurement and new detectors to the existing measurements (2D and Doppler). | | Feature | Affiniti Series Diagnostic Ultrasound System Feature: AutoMeasure V3 Proposed Device | Affiniti Series Diagnostic Ultrasound System K240850 Predicate 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. | 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 Affiniti 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 Affiniti Series Diagnostic Ultrasound System. | Identical to predicate | | 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. | Identical to predicate | | USA FDA Classification | Class II | Class II | Identical to predicate | | Primary Product Code | IYN | IYN | Identical to predicate | | Primary Requlation Name | System, Imaging, Pulsed Doppler, Ultrasonic | System, Imaging, Pulsed Doppler, Ultrasonic | Identical to predicate | | Feature | Affiniti Series Diagnostic Ultrasound System Feature: AutoMeasure V3 Proposed Device | Affiniti Series Diagnostic Ultrasound System K240850 Predicate Device | Comparison | | Primary Regulation Number | 21 CFR 892.1550 | 21 CFR 892.1550 | Identical to predicate | | Secondary Product Codes | ITX IYO OBJ QIH | ITX IYO OBJ QIH | Identical to predicate…