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 (K233788).

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 (K233788) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Q: What are the predicate devices for EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System?

Philips EPIQ Series Diagnostic Ultrasound System (K211597); Philips Affiniti Series Diagnostic Ultrasound System (K211597).

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.

K233788 · Philips Ultrasound, LLC · IYN · Feb 13, 2024 · Radiology

Device Facts

Record ID	K233788
Device Name	EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
Applicant	Philips Ultrasound, LLC
Product Code	IYN · Radiology
Decision Date	Feb 13, 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. The intended use of Affiniti Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body.

Device Story

EPIQ and Affiniti Series Diagnostic Ultrasound Systems are diagnostic imaging devices. The new 'Smart Doppler View ID' feature uses an AI-based algorithm to automate the navigation of touch screen calculation groups during adult cardiac transthoracic echocardiography (TTE). Input consists of Doppler spectrum data acquired by the user. The algorithm identifies the appropriate Doppler calculation package (Aortic, Mitral, Tricuspid, Pulmonic, Venous, or TDI) and highlights it on the system display. This automates manual menu navigation, streamlining clinician workflow. The user retains the ability to manually override the selection. The device is operated by trained healthcare professionals (cardiologists, sonographers) in clinical environments. The output assists in efficient measurement selection, potentially reducing exam time and improving workflow consistency without altering the underlying diagnostic imaging or measurement capabilities.

Clinical Evidence

No clinical investigation was required. Performance was validated using a retrospective study of 1,100 TTE cardiac clips from 400 subjects. The algorithm's output (touchscreen selection) was compared to ground truth (standard of care measurements per ASE guidelines). The primary endpoint, accuracy, was 97.5% (95% CI: 96.3%, 98.3%), p < 0.0001. The study population was diverse in age, sex, and body habitus, representative of the intended clinical population.

Technological Characteristics

Diagnostic ultrasound system using pulsed Doppler and pulsed echo imaging. Software-based AI feature (Smart Doppler View ID) for automated UI navigation. Compatible with existing commercialized Philips transducers (e.g., X5-1, S5-1, S4-2). Complies with IEC 62304 (software life cycle) and ISO 14971 (risk management). No hardware changes; no new acoustic output or biocompatibility testing required.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis of the human body, including abdominal, cardiac (adult, fetal, pediatric), cerebral vascular, cephalic (adult, neonatal), fetal/obstetric, gynecological, intraoperative (vascular, cardiac), intra-luminal, intra-cardiac echo, musculoskeletal (conventional, superficial), ophthalmic, urology, pediatric, peripheral vessel, small organ (breast, thyroid, testicle), transesophageal (cardiac), 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 (K211597)
Philips Affiniti Series Diagnostic Ultrasound System (K211597)

Reference Devices

Philips EPIQ Series Diagnostic Ultrasound System (K231190)

Related Devices

K243794 — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System · Philips Ultrasound, LLC · Feb 6, 2025
K211597 — EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System · Philips Medical Systems · Sep 8, 2021
K251455 — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System · Philips Ultrasound, LLC · Jul 24, 2025
K250886 — EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems · Philips Ultrasound, LLC · Jun 18, 2025
K251110 — EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems · Philips Ultrasound, LLC · May 9, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ February 13, 2024 Image /page/0/Picture/1 description: The image shows the logo for 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 Sr. Regulatory Affairs Specialist 22100 Bothell Everett Hwy BOTHELL WA 98021 Re: K233788 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, QIH Dated: November 17, 2023 Received: November 28, 2023 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. 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). {1}------------------------------------------------ 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. 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-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 {2}------------------------------------------------ ## Indications for Use Submission Number (if known) K233788 Device Name EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System Indications for Use (Describe) EPIQ: 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 quidance 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. 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. 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 {3}------------------------------------------------ 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) 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}------------------------------------------------ # PHIL ### l. 510(k) Summary This summary of safety and effectiveness information is submitted in accordance with 21 CFR § 807.92. 510(k) Number: K233788 Date Prepared: February 13, 2024 ### II. 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 | Tamara Daniels Senior Regulatory Affairs Manager 22100 Bothell Everett Hwy Bothell, WA 98021-8431 USA +1 (203) 213-6862 | ### lll. 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 | | | Automated Radiological Image Processing Software | 892.2050 | QIH | | | Diagnostic Intravascular Catheter | 870.1200 | OBJ* | | | *Applicable only to Philips EPIQ Series Diagnostic Ultrasound System, per clearance under K202216; Not applicable for Philips Affiniti Series Diagnostic Ultrasound System | | | | Device Class | Class II | | | | Review Panel | Radiology | | | | Predicate Device | K211597; Philips EPIQ Series Diagnostic Ultrasound System K211597; Philips Affiniti Series Diagnostic Ultrasound System | | | | Reference Device | K231190; Philips EPIQ Series Diagnostic Ultrasound System | | | {5}------------------------------------------------ #### IV. Device Description The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the Smart Doppler View ID software feature onto the EPIQ and Affiniti Series Diagnostic Ultrasound Systems. The purpose of the Smart Doppler View ID feature is to enhance the user's workflow through providing automation of the navigation of the touch screen groups on the Ultrasound System associated with Dopler Measurements. Without the Smart Doppler View ID feature, users must manually navigate to the desired Doppler Calculation Package Group on the Ultrasound System's various screens to perform a measurement. The Smart Doppler View ID feature automates this navigation and selects the associated calculation package group for the user based on the provided Doppler Spectrum acquired by the user using an artificial intelligence-based algorithm. Smart Doppler View ID maps to six Doppler Calculations Package groups on the Ultrasound System screen: - Aortic Valve - Mitral Valve - Tricuspid Valve - . Pulmonic Valve - Venous Flow - · TDI Vel (Tissue Doppler Imaging Velocity) & Ratio No hardware changes to the EPIQ or Affiniti systems are required when using the Smart Doppler View ID feature, and existing, commercialized Philips transducers are used for the Smart Doppler View ID feature. The feature is supported by all EPIQ and Affiniti models running software version 11.0 or higher including EPIQ CVx/CVxi, EPIQ Elite Advanced, EPIQ 7, EPIQ 5, Affiniti CVx, Affiniti 70, Affiniti 50, and Affiniti 30. The Smart Doppler View ID feature is associated with the cardiac adult indication. #### V. 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. 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. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "PHILIPS" in blue, block letters against a white background. The font is bold and sans-serif, giving the logo a clean and modern appearance. The letters are evenly spaced and aligned, creating a visually balanced and recognizable brand mark. 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 Smart Doppler View ID feature. The Smart Doppler View ID is associated with the Cardiac Adult indication. ### Affiniti Intended Use: The intended use of Affiniti Series Diagnostic Ultrasound Systems is 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, Transvaginal, Lung. 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 Affiniti Ultrasound System Indications for Use due to the introduction of the Smart Doppler View ID feature. The Smart Doppler View ID is associated with the Cardiac Adult indication. #### VI. Comparison of Technological Characteristics with the Predicate The purpose of the submission is to introduce the Smart Doppler View ID feature to the EPIQ Series Diagnostic Ultrasound System and Affiniti Series Diagnostic Ultrasound System. The subject devices are substantially equivalent to the predicate devices (K211597) and reference device (K231190). | Feature | EPIQ Series Diagnostic Ultrasound System Affiniti Series Diagnostic Ultrasound System Proposed Devices | Philips EPIQ Series Diagnostic Ultrasound System Affiniti Diagnostic Ultrasound System (K211597) Predicate Devices | Philips EPIQ Series Diagnostic Ultrasound System (K231190) Reference Device | Comparison | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | USA FDA Classification | Class II | Class II | Class II | Identical | | Primary Product Code | IYN | IYN | IYN | Identical | | Primary Regulation Number | 21 CFR 892.1550 | 21 CFR 892.1550 | 21 CFR 892.1550 | Identical | | Marketing Name of Application | Smart Doppler View ID | Not applicable since the application is new | Not applicable since the application is new | Subject of this submission | | | EPIQ Series Diagnostic Ultrasound System | Philips EPIQ Series Diagnostic Ultrasound System | Philips EPIQ Series Diagnostic Ultrasound System | | | Feature | Affiniti Series Diagnostic Ultrasound System | Affiniti Diagnostic Ultrasound System | | Comparison | | | Proposed Devices | (K211597) Predicate Devices | (K231190) Reference Device | | | Application Description | The proposed Smart Doppler View ID feature is intended to be used Adult Cardiology Transthoracic examinations to automate the navigation of the Calculations Package group associated with Doppler Measurements. Without the Smart Doppler View ID feature, users must manually navigate to the desired Doppler Calculations Package Group on the Ultrasound System to perform a measurement. The Smart Doppler View ID feature automates this navigation and selects the associated Calculations Package group for the user based on the provided Doppler Spectrum acquired by the user. Automated selection of Calculation Package Groups by Smart Doppler | Manual selection by the user of Calculations Package group on the ultrasound system associated with measurement groups on the ultrasound system. Manual selection of Calculation Package Groups by the user: | Manual selection by the user of Calculations Package group on the ultrasound system associated with measurement groups on the ultrasound system. Manual selection of Calculation Package Groups by the user: | Subject of this submission. The Smart Doppler View ID automates the selection of Calculations Package group on the ultrasound system during Adult Cardiology Transthoracic examinations, where the predicate and reference devices require users to manually navigate to their desired Calculations Package group to perform subsequent measurements. The Smart Doppler View ID feature does not perform any measurements itself and is only intended to automate the selection of the Calculations Package group associated with an acquired doppler spectrum. There is no change to the Calculation Package Groups available to the user. | | | View ID: • Aortic Valve • Mitral Valve • Tricuspid Valve • Pulmonic Valve • Venous Flow • TDI Vel & Ratio | • Aortic Valve • Mitral Valve • Tricuspid Valve • Pulmonic Valve • Venous Flow • TDI Vel & Ratio | • Aortic Valve • Mitral Valve • Tricuspid Valve • Pulmonic Valve • Venous Flow • TDI Vel & Ratio | | | User Interface Presentation | After a user acquires a doppler spectrum, a Calculations Package group is automatically highlighted on the ultrasound system display for the user by Smart Doppler View ID. From the highlighted Calculations Package group, the user may select a desired measurement to perform on the image. If the user disagrees with the highlighted Calculations Package group, they can manually navigate to their desired Calculations Package group. | After a user acquires a doppler spectrum, the user must manually navigate to the desired Calculations Package group. From the manually selected Calculations Package group, the user may select a desired measurement to perform on the image. | After a user acquires a doppler spectrum, the user must manually navigate to the desired Calculations Package group. From the manually selected Calculations Package group, the user may select a desired measurement to perform on the image. | The only difference with Smart Doppler View ID is that the Measurement Calculations Package group is automatically highlighted for the user after a doppler spectrum is acquired. Without Smart Doppler View ID, users must manually navigate to their desired Calculations Package group. There is no change to the user's functionality once the Calculations Package group is selected for them compared to their workflow without Doppler View ID. | | | EPIQ Series Diagnostic Ultrasound System Affiniti Series Diagnostic Ultrasound System Proposed Devices | Philips EPIQ Series Diagnostic Ultrasound System Affiniti Diagnostic Ultrasound System (K211597) Predicate Devices | Philips EPIQ Series Diagnostic Ultrasound System (K231190) Reference Device | Comparison | | Feature | | | | | | Compatible transducers | EPIQ: X5-1, X5-1c, and S5-1 are already commercially available and compatible with the EPIQ Ultrasound System. Affiniti: S5-1, X5-1, and S4-2 are already commercially available and compatible with the Affiniti Ultrasound System. No new transducers. Transducer modes for Smart Doppler View ID: 2D, PWD, CWD, TDI. No new transducer modes. | No new transducers and no new modes | The K231190 submission introduced the mL26-8 transducer. This transducer is not compatible with the proposed Smart Doppler View ID feature. | No new transducers or modes are being introduced in this submission. All transducers are already available with the EPIQ and Affiniti Ultrasound Systems. | | Measurements Performed | No measurements are performed by the Smart Doppler View ID feature. Any cardiac adult TTE measurements resulting from the view selection are performed either manually by the user or by the commercially available AutoMeasure function (K211597). | Any cardiac adult TTE measurements resulting from the view selection are performed either manually by the user or by the commercially available AutoMeasure function (K211597). | Any cardiac adult TTE measurements resulting from the view selection are performed either manually by the user or by the commercially available AutoMeasure function (K211597) | No new measurements are being introduced in this submission. The subject of this submission is to provide workflow enhancements using an artificial intelligence - application. | | Application performance | Algorithm accuracy of 97.5% (95%CI 96.3%, 98.3%), p-value <0.0001 compared to the ground truth | N/A - the equivalent functionality is performed manually by users to select the appropriate calculation package group (touch screen group) | N/A - the equivalent functionality is performed manually by users to select the appropriate calculation package group (touch screen group) | Subject of this submission | {7}------------------------------------------------ # PHILIPS {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and appear to be a sans-serif font. The background is a light gray or white color, providing contrast to the blue letters. #### VII. Safety Considerations The proposed EPIQ Series Diagnostic Ultrasound System and Affiniti Series Diagnostic Ultrasound System, including Smart Doppler View ID feature, and compatible transducers are all Track 3 Devices and comply with the referenced standards as well as the FDA ultrasound guidance document, Guidance for Industry and FDA Staff - Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, issued in February 2023. #### Nonclinical Performance Data VIII. The proposed modification of the EPIQ Series and Affiniti Series Diagnostic Ultrasound Systems was tested in accordance with Philips internal procedures. Philips Ultrasound tested the subject devices per the following standards to ensure the continued safe and effective performance: - . IEC 62304 Medical device software - Software life cycle processes, 2006 + A 2015 - . ISO 14971 Medical devices- Application of risk management to medical devices, 2019 Non-clinical verification testing was conducted to address the change and performance test data were provided to support the introduction of the subject software algorithm for the Smart Doppler View ID {9}------------------------------------------------ software feature. The activities to assure the safe and effective performance of the software revision included, but are not limited to, the following: - . Requirements Review - . Risk Analysis and Management Review - . Product Specification Review - . Design Reviews Non-Clinical Verification Testing of requirements, consisted of feature-specific functional testing, transducer compatibility, user interface and workflow testing related to Smart Doppler View ID Software Feature introduced in this submission as part of the software verification activities for the system and for X5-1, S5-1, X5-1c, and S4-2 transducers supporting the Smart Doppler View ID Software feature. Since this is a software-only change and no new hardware was added, no acoustic output, cleaning and disinfectant, thermal, electromagnetic, and mechanical safety testing were required. Biocompatibility testing is not needed for the subject EPIQ and Affiniti Series Diagnostic Ultrasound Systems with Smart Doppler View ID. The transducer patient contact materials and manufacturing processes are not impacted by the release of the subject EPIQ and Affiniti Series Diagnostic Ultrasound Systems with Smart Doppler View ID. ### IX. Clinical Data ### Summary of Clinical Tests There was no clinical investigation needed for this premarket submission of the EPIQ and Affiniti Series Diagnostic Ultrasound Systems with Smart Doppler View ID feature, which is an artificial intelligencebased feature. ### Artificial Intelligence Summary The Smart Doppler View ID algorithm is an Artificial Intelligence (Al) based tool that automates the navigation of the touch screen groups on the Ultrasound System associated with Doppler Measurements. A study was conducted to evaluate the performance of the new algorithm, where 1100 previously collected TTE (transthoracic echo) cardiac clips acquired with doppler mode from 400 subject videos were processed through the Smart Doppler View ID algorithm and its output (touch screens) compared to Standard of Care obtained group of measurements (touch screens). The Standard of Care measurements are those measurements recommended by the American Society of Echocardiography (ASE) guidelines for routine TTE cardiac exams. The dinical performance study were completely distinct from that used during training of the algorithm, and there was no overlap between the two data sets. The primary endpoint was accuracy between Smart Doppler View ID and ground truth. The Ground truth for the study was based on a group of measurements performed by intended users (i.e., Board certified cardiologists and cardiac sonographers) of the Ultrasound Systems as part of Standard of Care TTE exam per ASE guidelines at a large US-based hospital. The Ground truth (touch screen) was determined on a set of measurements performed on acquired Doppler waveforms and mapped to touch screens (i.e., a Power Doppler Waveform acquired to measure the mitral valve inflow is mapped to the Mitral Valve Touch Screen group). All of the Doppler TTE clips included in the ground truthing were acquired by the 16 cardiac sonographers with a high level of expertise, and all these studies have been vetted and interpreted by Board certified cardiologists that have successfully passed the National Board of Echocardiography Examination. Accuracy was evaluated by comparing the ground truth touch screens and Smart Doppler View ID auto-detected touch screen for the same TTE clips as outputted by the algorithm. ### Dataset Subjects from whom the study data were sampled had presented to a USA-based hospital und {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and appear to be a sans-serif font. The background is a light gray or white color, providing contrast to the blue letters. underwent routine TTE adult cardiac exam. Overall. 400 subjects contributed 1100 clips evaluated in this study. The touchscreen distribution in the study closely resembled the anticipated clinical distribution based on typical measurements performed as part of standard of care TTE cardiac assessment exams as recommended by the American Society of Echocardiography (ASE) guidelines. Moreover, subjects whose clips contributed to the study represented a broad range of demographics and body habitus, representative of the intended population. | Demographic | Result (N=400) (% (xx/N) | |-------------------------------------------|---------------------------| | Sex | | | Female | 56.3% (225/400) | | Male | 43.8% (175/400) | | Age (years, mean ± SD (range)) | 61.9 ± 16.6 (18.4, 98.7) | | Height (cm, mean ± SD (range)) | 169.2 ± 10.7 (125,196) | | Weight (kg, mean ± SD (range)) | 84.2 ± 23.7 (40.8, 263.0) | | BSA (m2, mean ± SD (range)) | 1.9 ± 0.3 (1.3, 3.4) | | BMI (kg/m2, mean ± SD (range)) | 29.5 ± 7.8 (15.8,78.5) | | Race | | | White | 31.3% (125/400) | | Asian | 2.8% (11/400) | | Black or African American | 53.8% (215/400) | | American Indian or Alaska Native | 0.3% (1/400) | | Native Hawaiian or Other Pacific Islander | 0.8% (3/400) | | Mixed/More than one race | 9.5% (38/400) | | Other/Unknown/Not Reported | 1.8% (7/400) | The demographic distribution of the study population includes the following: ### Results The results of the primary endpoint analysis demonstrated algorithm accuracy of 97.5% (95%C) 96.3%, 98.3%), p-value <0.0001, thereby meeting the acceptance criteria for the study. ### Conclusion The results of the study demonstrated clinically reasonable, relevant and meaningful performance of the Smart Doppler View ID algorithm in supporting clinicians' workflow by automatically detecting touchscreens during adult cardiac TTE exams with doppler mode. Specifically, success on the primary endpoint of accuracy indicates that the safety and effectiveness of the proposed algorithm is acceptable. Lastly, the algorithm workflow allows users to adjust the touchscreen outputs, if necessary. #### X. Sterilization Not applicable. The ultrasound transducers are not supplied sterile. {11}------------------------------------------------ #### XI. Conclusion For testing, all pre-determined acceptance criteria were met. Results of these tests show that the proposed subject devices meets their intended use. The changes made to the subject devices do not affect the use of the devices, nor do they introduce any new or significantly modified risks. The relevant performance and compatibility tests support a determination that the proposed subject devices do not raise new questions of safety or effectiveness. Therefore, the subject devices are substantially equivalent to the predicate and reference devices in terms of indications for use, design, technological characteristics, modes of operations, safety, and effectiveness.