← Product Code [IYN](/productcode/IYN) · K262548 # EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (K262548) _Philips Ultrasound, LLC · IYN · Sep 25, 2026 · Radiology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K262548 ## Device Facts - **Applicant:** Philips Ultrasound, LLC - **Product Code:** [IYN](/productcode/IYN.md) - **Decision Date:** Sep 25, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1550 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** AI/ML, Real-World Evidence, Pediatric ## Real-World Evidence | Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags | | --- | --- | --- | --- | --- | --- | | K262548 · Sep 25, 2026 | EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | Retrospective transthoracic echocardiography (TTE) examinations | A retrospective study of 217 clinical TTE examinations was used to validate the performance of the 2D Auto LA software feature by comparing automated measurements against a reference standard established by qualified sonographers. | Retrospective study; Echocardiography; Software validation; Left atrial quantification | ### Clinical Evidence | Study Design | Population | Comparator | Key Endpoints | | --- | --- | --- | --- | | Retrospective clinical performance study of 2D Auto LA; Retrospective clinical performance study | 217 adult subjects undergoing transthoracic echocardiography (TTE); Sample Size: 217 examinations (170 for LA ESV analysis, 190 for LA strain analysis); Number of Sites: 2 | Reference standard established by qualified sonographer assessments averaged across three independent blinded reviewers | Agreement of biplane left atrial end-systolic volume (LA ESV) and biplane left atrial strain reservoir at end diastole (LASr ED) | ## Indications for Use The intended use of EPIQ Inspira Series 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 (3D/4D), M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode, Power Doppler, 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. 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 (3D/4D), M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, 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 Inspira and Affiniti Series are software-controlled diagnostic ultrasound systems; provide imaging and fluid flow analysis. New feature '2D Auto LA' automates left atrial (LA) quantification for adult transthoracic echocardiography (TTE). Inputs: 2D echocardiographic image loops (apical 4-chamber/2-chamber views). Processing: AI-based endocardial border detection; speckle tracking-based strain analysis; Simpson’s method for biplane volume calculation. Outputs: LA strain parameters (reservoir, conduit, contraction) and end-systolic volume (ESV). Used in clinics, hospitals, and point-of-care by trained healthcare professionals. Clinician reviews, edits, or accepts automated outputs; retains final responsibility for clinical decisions. Benefits: improved workflow efficiency for cardiac assessment while maintaining clinician-in-the-loop oversight. ## Clinical Evidence Retrospective study of 217 adult TTE examinations. Evaluated 2D Auto LA for biplane LA ESV (n=170) and biplane LASr ED (n=190). Ground truth established by three blinded reviewers. Primary endpoints: Bland-Altman agreement vs. reference standard. Results: Biplane LA ESV limits of agreement –11.10% to 21.97%; biplane LASr ED limits of agreement –5.99% to 11.05%. Both endpoints met predefined acceptance criteria (±46% for ESV, ±28% for strain). ## Technological Characteristics General-purpose ultrasound system; B-mode, M-mode, Doppler, Harmonic imaging. Software-controlled; AI-assisted, non-adaptive (locked) algorithms for quantification. Compatible with adult cardiac transducers. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, and ISO 14971. No patient-contacting material changes. Standalone system architecture. ## Regulatory 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 - EPIQ and Affiniti Series Diagnostic Ultrasound System ([K253595](/device/K253595.md)) - QLAB Advanced Quantification Software 13.0 (AutoStrain LA) ([K190913](/device/K190913.md)) ## Reference Devices - Verisight ICE catheter ([K200812](/device/K200812.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} **FDA U.S. FOOD & DRUG** ADMINISTRATION September 25, 2026 Philips Ultrasound, LLC Swetha Paritala Principal Regulatory Affairs Specialist 22100 Bothell Everett Hwy. Bothell, Washington 98021 Re: K262548 Trade/Device Name: EPIQ Inspira 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, QIH, OBJ, LLZ Dated: July 23, 2026 Received: July 23, 2026 Dear Swetha Paritala: 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K262548 - Swetha Paritala Page 2 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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory- {2} K262548 - Swetha Paritala Page 3 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 | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K262548 | ? | | Please provide the device trade name(s). | | ? | | EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | | | | Please provide your Indications for Use below. | | ? | | EPIQ Inspira 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 Mode (3D/4D), M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode, Power Doppler, 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.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 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. Modes of operation include: B Mode (3D/4D), M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging.The clinical environments where the Affiniti diagnostic ultrasound systems can be used include clinics, | | | {4} 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. | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | | --- | --- | --- | | Please select the age group(s) for which the device(s) is to be used | ☑ Neonates/Newborns (Birth to < 29 days old) ☑ Infants (29 days old to < 2 years old) ☑ Children (2 years old to < 12 years old) ☑ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? | {5} PHILIPS Traditional 510(k) EPIQ Inspira Series Diagnostic Ultrasound system Affiniti Series Diagnostic Ultrasound system 510(k) Summary K262548 510(k) Summary This summary of safety and effectiveness information is submitted in accordance with 21 CFR § 807.92. 510(k) Number: Date Prepared: 25 September 2026 # I. Submitter Manufacturer Name and Address Philips Ultrasound LLC 22100 Bothell Everett Hwy Bothell, WA 98021-8431 USA Contact Information Swetha Paritala Principal Regulatory Affairs Specialist Philips Ultrasound LLC 22100 Bothell Everett Highway Bothell, WA 98021-8431 USA Swetharao.paritala@philips.com Phone: +1.412.969.1010 Secondary Contact Aditi Chaubal Sr. Regulatory Manager Philips Ultrasound LLC 22100 Bothell Everett Hwy Bothell, WA 98021-8431 USA aditi.chaubal@philips.com Phone: +1 425.482.8243 # II. Device Proprietary Name EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System Common Name Diagnostic Ultrasound System and Transducers; System, Imaging Processing, Radiological Device Class Class II Review Panel Radiology Classification Regulation | 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 | | System, image processing, radiological | 892.2050 | LLZ | | Diagnostic Intravascular Catheter | 870.1200 | OBJ* | *EPIQ only, compatibility with Verisight ICE catheter (cleared under K200812) 5 {6} PHILIPS Traditional 510(k) EPIQ Inspira Series Diagnostic Ultrasound system Affiniti Series Diagnostic Ultrasound system 510(k) Summary # **Predicate Devices** Primary: EPIQ and Affiniti Series Diagnostic Ultrasound System; K253595 Secondary: QLAB Advanced Quantification Software 13.0 (AutoStrain LA); K190913 ### III. Device Description The purpose of this Traditional 510(k) Pre-Market Notification is to introduce 2D Auto LA, an automated left atrial quantification software feature, for use on the EPIQ Inspira Series and Affiniti Series Diagnostic Ultrasound Systems, as well as the introduction of the EPIQ Inspira Series as a new variant within the EPIQ Series Diagnostic Ultrasound System family. The Philips EPIQ Inspira Series and Affiniti Series Diagnostic Ultrasound Systems are general-purpose, software-controlled diagnostic ultrasound systems intended for diagnostic ultrasound imaging and fluid flow analysis of the human body and support multiple clinical applications, including adult cardiac imaging. 2D Auto LA is an assistive, user-initiated software feature that supports routine adult transthoracic echocardiography (TTE) workflow by providing automated quantification of left atrial (LA) size and function from retrospectively acquired two-dimensional echocardiographic image loops, including apical four-chamber (A4C) and apical two-chamber (A2C) views. The feature provides biplane left atrial strain (LASr, LAScd, LASct) and left atrial end-systolic volume (ESV) measurements using established methods. The feature supports workflow efficiency through automation of measurements while maintaining a clinician-in-the-loop workflow. 2D Auto LA includes the following principal functional components: - Automated detection of left atrial endocardial borders using previously cleared AI-based contour detection - Speckle tracking–based strain analysis for computation of left atrial strain parameters (reservoir, conduit, and contraction phases) - Biplane LA volume calculation using Simpson's method based on A4C and A2C views - Visualization of results including strain curves, contour overlays, and numerical outputs - User interaction capabilities for editing contours, adjusting cardiac cycle selection, and refining analysis parameters prior to finalization The user remains responsible for selection of appropriate image data, verification of image quality, and review of automated outputs. The user may accept, edit, or reject measurements prior to clinical use. If automated analysis is not satisfactory, the user can perform manual adjustments or revert to standard manual measurement workflows. 2D Auto LA is compatible with the EPIQ Inspira Series and Affiniti Series Diagnostic Ultrasound Systems and operates with supported adult cardiac transducers. The relevant imaging mode for the feature is two-dimensional (2D/B-mode) echocardiographic imaging. ### IV. Intended Use & Indications for Use The intended use of EPIQ Inspira and Affiniti series Ultrasound Diagnostic System is diagnostic ultrasound imaging and fluid flow analysis of the human body. System Level (i.e., EPIQ Inspira series Diagnostic Ultrasound System) Indications for Use: The intended use of EPIQ Inspira Series 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 (3D/4D), M Mode, PW Doppler, CW Doppler, Color Doppler, Color 5 {7} PHILIPS Traditional 510(k) EPIQ Inspira Series Diagnostic Ultrasound system Affiniti Series Diagnostic Ultrasound system 510(k) Summary M Mode, Power Doppler, 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. 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 responsibility for sound clinical judgement and best clinical procedure. Note: There are no changes to the EPIQ Inspira Ultrasound System Indications for Use due to the modification of the 2D Auto LA software applications. System Level (i.e., Affiniti Diagnostic Ultrasound System) Indications for Use: The intended use of Affiniti Series Ultrasound Diagnostic 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 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 modification of the 2D Auto LA software application. ### V. Comparison of Technological Characteristics with the Predicate The subject devices maintain the same intended use as the predicate devices, with no changes to the diagnostic purpose or supported clinical applications. Both the subject and predicate devices are indicated for diagnostic ultrasound imaging and fluid flow analysis and are intended for use by appropriately trained healthcare professionals in the same clinical environments. The EPIQ Inspira Series Diagnostic Ultrasound System is identical to the predicate EPIQ and Affiniti Series Diagnostic Ultrasound System (K253595) in terms of hardware platform, software architecture, imaging modes, and fundamental operating principles. The subject and predicate devices share the same FDA device classification and product codes. Acoustic output characteristics are equivalent, and there are no changes to transducer compatibility, patient-contacting materials, packaging, or manufacturing processes. Accordingly, no new risks are introduced at the system level. At the feature level, 2D Auto LA is an AI-assisted cardiac ultrasound quantification tool introduced as a software-only feature on the Philips EPIQ Inspira Series and Affiniti Series Diagnostic Ultrasound Systems. The 2D Auto LA builds upon and integrates functionalities from its predicate devices, AutoMeasure (K253595) and QLAB Advanced Quantification Software (AutoStrain LA, K190913). All features are designed to support quantitative assessment of left atrial (LA) size and function during routine 5 {8} PHILIPS Traditional 510(k) EPIQ Inspira Series Diagnostic Ultrasound system Affiniti Series Diagnostic Ultrasound system 510(k) Summary adult transthoracic echocardiography (TTE) exams while maintaining user control and clinical oversight. The predicate AutoStrain LA provides speckle tracking-based strain analysis of the left atrium, while AutoMeasure enables automated measurement of cardiac structures including left atrial volumes. The 2D Auto LA feature integrates these capabilities into a unified workflow, providing automated and semi-automated biplane LA strain and volume measurements derived from apical four-chamber (A4C) and apical two-chamber (A2C) views. Similar to the predicate devices, the subject device operates using AI-assisted, non-adaptive (locked) algorithms and requires user review, editing, and acceptance of all outputs prior to clinical use. The primary technological difference between 2D Auto LA and its predicate devices lies in the integration of previously cleared functionalities into a single application and the extension to biplane LA strain and volume analysis. This integration improves workflow efficiency but does not modify image acquisition, underlying image data, or fundamental measurement principles. The user retains full control to review, accept, reject, or manually adjust all generated outputs using existing system tools. There are no changes to system hardware, imaging modes, or clinical workflow as a result of introducing 2D Auto LA. The feature operates entirely within the existing ultrasound system architecture and includes safeguards that allow users to revert to manual operation if needed. The addition of 2D Auto LA does not introduce new indications for use, new diagnostic claims, or changes to device classification. Verification and validation activities, including software verification and system-level testing performed in accordance with IEC 62304 and ISO 14971, demonstrate that the subject device performs as intended and meets applicable safety and performance requirements. Feature-Level Comparison - Summary Table | Feature | 2D Auto LA (Subject Device) | AutoMeasure (K253595) | AutoStrain LA (K190913) | Comparison | | --- | --- | --- | --- | --- | | Primary Function | LA strain + volume (biplane) | Cardiac measurements (incl. LA volume) | LA strain analysis | Integrated functionality | | Workflow | Automated + user review | Semi-automated | Semi-automated | Similar | | AI Usage | AI-assisted, locked | AI-assisted | AI-assisted | Identical behavior | | Outputs | Strain + ESV (biplane) | Volume measurements | Strain parameters | Combined outputs | | User Control | Review/edit/accept | Review/edit | Review/edit | Identical | | Diagnostic Role | Decision-support only | Decision-support | Decision-support | Identical | Based on the similarities in intended use, system architecture, and technological characteristics, and considering that the differences are limited to software integration and workflow optimization that do not impact clinical interpretation or system operation, the subject device is substantially equivalent to the predicate devices. ## VI. Safety Considerations The proposed EPIQ Inspira Series and Affiniti Series Diagnostic Ultrasound Systems, including the 2D Auto LA software functionality 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 (February 2023). The safety considerations of the predicate devices are applicable since the subject devices, at a system level, are identical systems with the addition of a new trade name and software-only functionality. 5 {9} PHILIPS Traditional 510(k) EPIQ Inspira Series Diagnostic Ultrasound system Affiniti Series Diagnostic Ultrasound system 510(k) Summary ### VII. Nonclinical Performance Data Philips Ultrasound performed the following testing to ensure the safety and effectiveness of the proposed subject device: - IEC 60601-1:2005+AMD1:2012+AMD2:2020 Medical electrical equipment – Part 1: General requirements for basic and essential performance - IEC 60601-1-2: 2014+AMD1:2020 Medical Electrical Equipment – Part 1-2: General requirements for safety; electromagnetic compatibility – requirements and tests - IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – collateral standard: usability - IEC 60601-2-37:2024 Medical electrical equipment – Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment - IEC 62304:2006+AMD1:2015 Medical Device Software – Software life cycle process - IEC 62366-1:2015+AMD1:2020 Medical devices – Application of usability engineering to medical devices - ISO 14971:2019 Medical devices – Application of risk management to medical devices Non-Clinical verification testing has been performed addressing system level requirements according to system and design specifications, and risk control measures. Design Control activities to assure the safety and effectiveness of the subject device include but are not limited to the following: - Requirements Review - Risk Analysis and Risk Management Review - Product Specification Review - Design Review - Software verification specific to 2D Auto LA functionality ### VIII. Clinical Data A retrospective clinical performance study was conducted to evaluate the performance of the 2D Auto LA application for automated and semi-automated quantification of left atrial (LA) end-systolic volume (ESV) and left atrial strain reservoir at end diastole (LASr ED) on Philips EPIQ Inspira and Affiniti Diagnostic Ultrasound Systems. The study included 217 transthoracic echocardiography (TTE) examinations obtained from 217 adult subjects representing a broad range of demographic and clinical characteristics. Of these examinations, 170 were included in the LA ESV analysis subset and 190 were included in the LA strain analysis subset. Ground truth measurements were established using qualified sonographer assessments and averaged across three independent blinded reviewers. The study was conducted at two clinical sites and utilized predefined procedures to minimize bias, including independent review, blinded assessments, and washout periods between evaluation steps. Two co-primary endpoints were evaluated using Bland-Altman agreement analyses comparing 2D Auto LA measurements with the reference standard for biplane LA ESV and biplane LASr ED. Predefined acceptance criteria were ±46% for LA ESV and ±28% for LASr ED. The results demonstrated that both co-primary endpoints met their predefined acceptance criteria. For biplane LA ESV, the lower and upper limits of agreement were –11.10% and 21.97%, respectively. For biplane LASr ED, the lower and upper limits of agreement were –5.99% and 11.05%, respectively. These results were well within the prespecified acceptance limits. Exploratory subgroup analyses across age, gender, BMI, ethnicity, and transducer type demonstrated performance generally consistent with the primary analyses. The study demonstrated clinically relevant and meaningful performance of the 2D Auto LA application for quantification of left atrial size and function. Successful achievement of both co-primary endpoints supports the safety and effectiveness of the software and demonstrates performance comparable to qualified human observers. The results support the clinical acceptability of 2D Auto LA for use as a decision-support tool in adult transthoracic echocardiographic assessment of the left atrium ### IX. Sterilization Not applicable. The ultrasound transducers are not supplied sterile. 5 {10} PHILIPS Traditional 510(k) EPIQ Inspira Series Diagnostic Ultrasound system Affiniti Series Diagnostic Ultrasound system 510(k) Summary # X. Conclusion The proposed devices, consisting of the 2D Auto LA feature implemented on the Philips EPIQ Inspira Series and Affiniti Series Diagnostic Ultrasound Systems, have been evaluated for substantial equivalence in accordance with the FDA guidance “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]” (issued July 28, 2014), as well as applicable FDA considerations for artificial intelligence-enabled device software functions as described in the FDA draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” (issued January 05, 2025), which outlines recommended documentation and evaluation approaches to support the assessment of safety and effectiveness of AI-enabled devices. The predicate devices are legally marketed. The intended use and indications for use remain unchanged. The EPIQ Inspira Series is a branding update to an existing FDA-cleared ultrasound platform with identical hardware and software architecture, and the 2D Auto LA does not alter the diagnostic purpose or clinical applications of the system. The EPIQ Inspira and Affiniti Series maintain the same hardware platform, software architecture, imaging modes, acoustic output characteristics, and transducer compatibility as the predicate devices. The primary technological difference is the addition of 2D Auto LA, an AI-assisted software feature that automates portions of the left atrial quantification workflow using previously cleared technologies, including AI-based border detection, speckle tracking strain analysis, and Simpson-based volume calculations. 2D Auto LA uses a fixed, non-adaptive algorithm to provide automated and semi-automated left atrial strain and volume measurements from two-dimensional echocardiographic images. Users retain responsibility for reviewing and confirming all results and may edit contours and measurements based on clinical judgment. Risk management activities conducted in accordance with ISO 14971 demonstrated that identified risks were adequately mitigated. Verification, validation, and performance testing demonstrated that 2D Auto LA met all predefined acceptance criteria. In a retrospective validation study of 217 transthoracic echocardiography examinations, both co-primary endpoints for biplane left atrial volume (ESV) and biplane left atrial strain (LASr ED) met predefined acceptance criteria, supporting the safety and effectiveness of the feature. The EPIQ Inspira Series Diagnostic Ultrasound System is system-level equivalent to the EPIQ Series Diagnostic Ultrasound System (K253595), with no hardware modifications or changes to system electronics, user interface, transducer compatibility, or technical specifications. Therefore, the EPIQ Inspira and Affiniti Series Diagnostic Ultrasound Systems with 2D Auto LA are substantially equivalent to the identified predicate devices with respect to intended use, technological characteristics, safety, and effectiveness. 5 --- **Source:** [https://fda-staging.innolitics.com/device/K262548](https://fda-staging.innolitics.com/device/K262548) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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