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.

Device Description

The purpose of this Special 510(k) Pre-Market Notification is to introduce the Smart View Select (SVS) software application onto the EPIQ Series Diagnostic Ultrasound Systems and to introduce the Segmental Wall Motion software application onto both the EPIQ and Affiniti Series Diagnostic Ultrasound Systems.

Smart View Select is an automated software feature that assists the user in selection of images for analysis with the existing Philips AutoStrain LV or 2D Auto LV application in Adult Echo Transthoracic (TTE) examination. This feature automatically classifies each acquired image by view and selects an appropriate set of images for left ventricle (LV) analysis. The classification is based on a Deep Learning Al interface engine; the selection is a non-Al algorithm that considers the view classification and image depth to select the optimal set of images.

The Segmental Wall Motion software automatically evaluates the segmental (regional) function of the left ventricle (LV) from adult TTE echo examinations. For input, the SWM algorithm uses 3 apical views (A4C, A2C and A3C) and performs border detection and tracking to identify each of the LV segments based on the three views. The application then provides segmental wall motion scores for each of the 17 segments of the LV by using machine learning algorithms and an overall wall motion score index (WMSI) is calculated as the average of the segmental scores.

No hardware changes to the EPIQ or Affiniti systems are required when using SVS or SWM, and existing, cleared Philips TTE transducers are used with these software applications.

The SVS feature is supported by all EPIQ models running software version 11.0 or higher including EPIQ CVx/CVxi, EPIQ Elite Advanced, EPIQ Elite, EPIQ 7, EPIQ 5. The SWM feature is supported by the same EPIQ models running software version VM11.0 or higher, as well as all Affiniti models including Affiniti CVx, Affiniti 70, Affiniti 50, and Affiniti 30. The SVS and SWM software are associated with the cardiac adult indication.

AI/ML Overview

The provided FDA 510(k) clearance letter and summary describe the acceptance criteria and a study conducted to prove that the Philips EPIQ Series and Affiniti Series Diagnostic Ultrasound Systems, with the new Smart View Select (SVS) and Segmental Wall Motion (SWM) software applications, meet these criteria for substantial equivalence.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

Device Under Evaluation: Philips EPIQ Series and Affiniti Series Diagnostic Ultrasound Systems with Smart View Select (SVS) and Segmental Wall Motion (SWM) software applications.

Feature / Metric	Acceptance Criteria (Pre-defined)	Reported Device Performance
Smart View Select (SVS) Workflow Enhancement Algorithm:
Pearson's Correlation Coefficient for GLS Output	Lower Confidence Bound (95% CI) > 0.8 (compared to manual clip selection ground truth)	0.911 (95% CI: 0.855, 0.946). Lower Confidence Bound: 0.855
Pearson's Correlation Coefficient for EF Output	Lower Confidence Bound (95% CI) > 0.8 (compared to manual clip selection ground truth)	0.941 (95% CI: 0.903, 0.965). Lower Confidence Bound: 0.903
Segmental Wall Motion (SWM) Algorithm:
Pearson's Correlation Coefficient for WMSI (Manual Workflow)	Lower Confidence Bound (95% CI) > 0.8 (compared to LVivo SWM ground truth)	0.957 (95% CI: 0.933, 0.972). Lower Confidence Bound: 0.933
Pearson's Correlation Coefficient for WMSI (SVS Workflow)	Lower Confidence Bound (95% CI) > 0.8 (compared to LVivo SWM ground truth)	0.913 (95% CI: 0.857, 0.948). Lower Confidence Bound: 0.857

2. Sample size used for the test set and the data provenance

The document does not explicitly state the exact numerical sample size (number of subjects/exams) for the test sets in either study. It mentions the studies were retrospective.

Data Provenance: Retrospective (from existing subject exams). The country of origin of the data is not specified in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Three (3) reviewers participated in establishing ground truth for both studies.
Qualifications of Experts: Described as "clinical experts." No further specific qualifications (e.g., years of experience, subspecialty) are provided in the document.

4. Adjudication method for the test set

Adjudication Method: For both the SVS and SWM studies, the ground truth was established as the "average across reviewers" for each output (GLS and EF for SVS; WMSI for SWM). This implies a consensus or averaging approach rather than a specific hierarchical adjudication process (like 2+1 or 3+1).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: The studies described are not MRMC comparative effectiveness studies designed to evaluate the improvement of human readers with AI assistance. Instead, they are analytical validity studies evaluating the agreement of the AI-powered workflows (SVS and SWM) with an established ground truth or reference (manual clip selection and LVivo SWM, respectively).
Effect Size of Human Improvement: Therefore, no effect size related to how much human readers improve with AI vs. without AI assistance is reported. The focus is on the performance of the AI-assisted workflow compared to a manual or reference workflow.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Standalone Performance: For the SVS study, the "automatically obtained GLS and EF results with SVS selected clips" were compared against the ground truth. This suggests a form of standalone evaluation of the SVS algorithm's selection capability and its impact on the subsequent automated analysis. The SWM algorithm, while described as "semi-automated" where users are expected to review and concur, was also tested in an "un-edited" fashion for comparison in the SVS workflow path, which leans towards evaluating its automated output. However, the overall claims and clinical use imply human review (semi-automated).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Smart View Select (SVS) Study Ground Truth: "Manual selection of clips from subject exam and subsequent semi-automated processing of the clips with AutoStrain LV software to evaluate GLS and EF, which served as ground truth (average across reviewers for each output)." This is based on expert consensus (average across reviewers) following a manual workflow using a previously cleared software (AutoStrain LV).
Segmental Wall Motion (SWM) Study Ground Truth: "Processing of the clips with LVivo application for WMSI output, which served as ground truth in the study (average across reviewers)." This is also based on expert consensus using a previously cleared or referenced software (LVivo SWM, which is the reference device K161382).

8. The sample size for the training set

The document does not provide any information about the sample size used for training the Deep Learning AI interface engine for SVS or the machine learning algorithms for SWM. It only mentions the retrospective data analysis studies for performance evaluation (test set).

9. How the ground truth for the training set was established

As the document does not provide information on the training set, details about how its ground truth was established are also not available in the provided text.

Summary

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April 24, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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 Michael Chambers Sr. Regulatory Affairs Specialist 22100 Bothell Everett Highway BOTHELL WA 98021

Re: K240850

Trade/Device Name: EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX, QIH, OBJ Dated: March 25, 2024 Received: March 27, 2024

Dear Michael Chambers:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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).

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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

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Indications for Use

Submission Number (if known)

K240850

Device Name

EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems

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:

The clinical environments where EPIQ Series Diagnostic Ultrasound Systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.

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:

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

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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)

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2HIL

Special 510(k) Summary

This summary of safety and effectiveness information is submitted in accordance with 21 CFR § 807.92.

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Date Prepared: March 27, 2024

l. Submitter

Manufacturer Name andAddress	Philips Ultrasound LLC22100 Bothell Everett Hwy Bothell,WA 98021-8431 USA
Contact Information	Mike ChambersSenior Regulatory Affairs Specialist22100 Bothell Everett HwyBothell, WA 98021-8431 USA+1 (315) 262-7702
Secondary Contact	Erdit GremiDirector, Requlatory AffairsPhilips Ultrasound LLC22100 Bothell Everett HwyBothell, WA 98021-8431 USA+1 (617) 798-8092

II. Device

Proprietary Name	EPIQ Series Diagnostic Ultrasound SystemAffiniti 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 ImageProcessing Software	892.2050	QIH
	Diagnostic Intravascular Catheter	870.1200	OBJ**EPIQ only
Device Class	Class II
Review Panel	Radiology
Predicate Device	K233788; Philips EPIQ Series Diagnostic Ultrasound SystemK233788; Philips Affiniti Series Diagnostic Ultrasound System
Reference Devices	K212466; LVivo SeamlessK161382; LVivo Software Application with LVivo SG

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III. Device Description

No hardware changes to the EPIQ or Affiniti systems are required when using SVS or SWM, and existing, cleared Philips TTE transducers are used with these software applications.

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:

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.

Note: There are no changes to the EPIQ Ultrasound System Indications for Use due to the introduction

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of the SVS or SWM software applications. These software applications are 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), 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.

Note: There are no changes to the Affiniti Ultrasound System Indications for Use due to the introduction of the SWM software application. This software applications is associated with the Cardiac Adult indication.

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PHILIPS

V. Comparison of Technological Characteristics with the Predicate

The purpose of the submission is to introduce the SVS software application feature to the EPIQ Series Diagnostic Ultrasound System and the SWM software application to both EPIQ and Affiniti. The subject device is substantially equivalent to the predicate device (K233788).

Feature	EPIQ Series DiagnosticUltrasound SystemFeatures: SVS and SWMProposed Device	EPIQ Series DiagnosticUltrasound SystemK233788Predicate Device	LVivo SeamlessK212466Reference Device	LVivo SoftwareApplicationFeature: LVivo SG K161382Reference Device	Comparison
Indications forUse	Abdominal, CardiacAdult, Cardiac other(Fetal), CardiacPediatric, CerebralVascular, 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, CardiacAdult, Cardiac other(Fetal), CardiacPediatric, CerebralVascular, 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.	LVivo platform isintended for non-invasive processing ofultrasound images todetect, measure, andcalculate relevantmedical parameters ofstructures and functionof patients withsuspected disease.	LVivo platform isintended for non-invasive processing ofultrasound images todetect, measure, andcalculate relevantmedical parameters ofstructures and functionof patients withsuspected disease.	Identical to predicate
	Trained healthcareprofessionals	Trained healthcareprofessionals	Trained healthcareprofessionals	Trained healthcareprofessionals	Identical to predicate
Intended Users	Intended forsonographers,physicians, andbiomedical engineerswho operate andmaintain your product.	Intended forsonographers,physicians, andbiomedical engineerswho operate andmaintain your product.
	Before use of thesystem and userinformation, the usermust be familiar withultrasound techniques.Sonography trainingand clinical proceduresare not included in theUser Manual or with theEPIQ Series DiagnosticUltrasound System.	Before use of thesystem and userinformation, the usermust be familiar withultrasound techniques.Sonography trainingand clinical proceduresare not included in theUser Manual or with theEPIQ Series DiagnosticUltrasound System.
Intended UserEnvironment	Clinics, hospitals, andclinical point-of-care fordiagnosis of patients.	Clinics, hospitals, andclinical point-of-care fordiagnosis of patients.	Professional healthcareenvironments	Professional healthcareenvironments	Identical to predicate
Feature	EPIQ Series DiagnosticUltrasound SystemFeatures: SVS and SWMProposed Device	EPIQ Series DiagnosticUltrasound SystemK233788Predicate Device	LVivo SeamlessK212466Reference Device	LVivo SoftwareApplicationFeature: LVivo SGK161382Reference Device	Comparison
USA FDAClassification	Class II	Class II	Class II	Class II	Identical to predicate
PrimaryProduct Code	IYN	IYN	QIH	LLZ	Identical to predicate
PrimaryRegulationName	System, Imaging,Pulsed Doppler,Ultrasonic	System, Imaging,Pulsed Doppler,Ultrasonic	Automated RadiologicalImageProcessing Software	Medical imagemanagement andprocessing system.	Identical to predicate
PrimaryRegulationNumber	21 CFR 892.1550	21 CFR 892.1550	21 CFR 892.2050	21 CFR 892.2050	Identical to predicate
SecondaryProduct Codes	ITXIYOOBJQIH	ITXIYOOBJQIH	N/A	N/A	Identical to predicate
SecondaryRegulationName	Diagnostic ultrasonictransducerUltrasonic pulsed echoimagingsystemDiagnosticintravascular catheterAutomated RadiologicalImageProcessing Software	Diagnostic ultrasonictransducerUltrasonic pulsed echoimagingsystemDiagnosticintravascular catheterAutomated RadiologicalImageProcessing Software	N/A	N/A	Identical to predicate
SecondaryRegulationNumber	21 CFR 892.157021 CFR 892.156021 CFR 870.120021 CFR 892.2050	21 CFR 892.157021 CFR 892.156021 CFR 870.120021 CFR 892.2050	N/A	N/A	Identical to predicate
Reusable-Systems andTransducers	Yes	Yes	No, software-only	No, software-only	Identical to predicate
Duration of use	Limited (≤ 24 hours)	Limited (≤ 24 hours)	N/A, software-only	N/A, software-only	Identical to predicate
Device Track	Track 3	Track 3	N/A, software-only	N/A, software-only	Identical to predicate
ApplicationDescription	Smart View Select is anautomated softwarefeature that assists theuser in selection ofimages for analysiswith the existing PhilipsAutoStrain LV or 2DAuto LV application inAdult EchoTransthoracic (TTE)examination.The SWM softwareautomatically evaluatesthe segmental(regional) function ofthe left ventricle (LV)from adult TTE echoexaminations.Note: Per FDA	The predicate EPIQSeries DiagnosticUltrasound Systemdoes not currently havea dedicated softwareapplication containingthe functionalityintroduced in thesubject submission for(1) automatic selectionof 4CH,2CH, and 3CHviews for left ventricle(LV) analysis or (2)(semi-) automatedsegmental wall motionevaluation of the leftventricle (LV).	The LVivoSeamlesssoftware is astandalone applicationthat extends the LVivoPlatform and runsoffline on a server. Thesystem accepts echoexamination that aresent from the USdevice using DICOMcommunication. Theexaminations containclips in DICOM format.The LVivoSeamlessscans the entireexamination andselects automatically4CH,2CH and 3CHviews for EF and GLSevaluation and runs theLVivoEF and the	The LVivoSG is adecision supportsystem (software) forautomated segmentalwall motion evaluationof the left ventricle (LV).The LVivoSG is basedon a proprietaryalgorithm for LVregional motionparameters calculationand wall motionclassification.The LVivoSG uses theLVivo platform to detectthe LV inner borders(endocard) from whichthe wall motionparameters arecalculated. As part ofthe LVivoSG	The subject EPIQ SeriesDiagnostic UltrasoundSystem integrates the LVivoSeamless algorithm of theK212466 reference deviceas "Smart View Select" andthe LVivo SWM module ofthe LVivo SG K161382reference device as"Segmental Wall Motion".Minor changes have beenmade to the referenceLVivo Seamless and LVivoSG software applications inthe subject SVS and SWMapplications, as describedbelow.
	EPIQ Series DiagnosticUltrasound SystemFeatures: SVS andSWMProposed Device	EPIQ Series DiagnosticUltrasound SystemK233788Predicate Device	LVivo SeamlessK212466Reference Device	LVivo SoftwareApplicationFeature: LVivo SGK161382Reference Device	Comparison
Feature	PerformanceAssessment ofQuantitative Imaging inRadiological DevicePremarketSubmissions, the SWMsoftware is a semi-automated quantitativeimaging algorithm, asusers are generallyexpected to review andconcur with theinitialization andgenerated results. Theusers can also editalgorithm generatedsegmental wall motionscores for individualsegments based ontheir clinical expertise.		results are sent backusing DICOMcommunication to thePACS server andbecome part of thestudy. The clinician thatreviews theexaminations at thePACS workstation willbe able view the outputof the LVivoEF andLVivoStrain as part ofthe study review.	platform supports alsoedge detection andtracking in additionalplane, the apical long(3CH). The LVivoSGprovides fullyautomatedmeasurements of theregional left ventricularsystolic function fromthree apical views thefour chamber (4CH),two chamber (2CH)and long (3CH).
Deep NeuralNetwork utilizedfor optimaltriplet selection	LVivo Seamless AIneural network	Not applicable - doesnot contain functionalityfor optimal tripletselection	LVivo Seamless Alneural network	Not applicable - doesnot contain functionalityfor optimal tripletselection	The subject SVS softwareapplication utilizes theidentical, unchanged deepneural network for viewidentification and optimaltriplet (A4C, A2C, and A3C)selection for subsequent LVanalysis
Scan depthconsidered foroptimal tripletselection?	Yes - the subject SVSsoftware applicationuses an additionalheuristic logic step, afterthe deep neural networkidentifies the views anddetermines a list of 3 clipcombinations (triplets),to preferentially selecttriplets of shallower scandepths, provided thedepth exceeds 10cmand the variation ofdepths of each clips is1 cm or less	Not applicable - doesnot contain functionalityfor optimal tripletselection	Not applicable - scandepth is not consideredin the selection of theoptimal triplets for theuser	Not applicable - doesnot contain functionalityfor optimal tripletselection	The subject SVS softwareapplication adds anadditional heuristic logicstep for preferentiallyselecting certain scandepths from the referenceLVivo Seamless. TheNeural Network of thereference device isunchanged, as describedabove. Performance testinghas demonstrated verystrong correlation betweenthe LV analysis outputs(EF, GLS) from clipsselected by the subject SVSsoftware application andclips manually selected byclinical users. Therefore,the additional heuristic logicstep of the subject SVSsoftware does not raise newor different questions ofsafety or effectiveness incomparison to the referencedevice K212466.
Borderinitializationalgorithm(s)utilized forsegmental wallmotion	Primary - from K161382Secondary - fromcleared AutoStrain LV(K190913)	Not applicable - doesnot contain functionalityfor segmental wallmotion	Not applicable - thisapplication does notcontain functionality forsegmental wall motion	From K161382	Subject devicepreferentially utilizesidentical border initializationalgorithm as referencedevice K161382.If the reference device'salgorithm is unsuccessful inthe subject SWM, it will use
Feature	EPIQ Series Diagnostic Ultrasound System Features: SVS and SWMProposed Device	EPIQ Series Diagnostic Ultrasound System K233788Predicate Device	LVivo Seamless K212466Reference Device	LVivo Software Application Feature: LVivo SG K161382Reference Device	Comparison
SWM scoring adjustment	Users manually edit scores using a drop-down selection	Not applicable – does not contain functionality for segmental wall motion	Not applicable – this application does not contain functionality for segmental wall motion	Users must manually edit the borders to attempt to edit scores	the border initialization of the cleared AutoStrain LV (K190913) as a back-up.Performance testing has demonstrated very strong correlation between the SWM scoring of the subject software application compared to the scoring of the reference device on the same clips. Therefore, there are no new or increased risks for the use of the AutoStrain LV border initialization in the subject SWM software application as a back-up.In the cleared LVivo SG, users must manually adjust the chamber borders to influence the SWM scores. In the subject SWM on VM11, users may manually select different SWM scores for each segment using a drop-down menu. Any scores which are manually changed from those calculated by the software application will be indicated by an asterisk (*). This change in editing does not introduce new risks because it is providing a simpler way for the user to edit their segmental wall motion score(s) – instead of having to edit the border contours to influence the SWM score as on the cleared LVivo SG, user can directly edit each segment's
Feature	Affiniti Series DiagnosticUltrasound SystemFeature: SWMProposed Device	Affiniti Series DiagnosticUltrasound SystemK233788Predicate Device	LVivo Software ApplicationFeature: LVivo SGK161382Reference Device	Comparison
Indications forUse	Abdominal, Cardiac Adult,Cardiac Other (Fetal), CardiacPediatric, 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.	Abdominal, Cardiac Adult,Cardiac Other (Fetal), CardiacPediatric, 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.	LVivo platform is intended fornon-invasive processing ofultrasound images to detect,measure, and calculate relevantmedical parameters ofstructures and function ofpatients with suspecteddisease.	Identical to predicate
Intended Users	Trained healthcareprofessionalsIntended for sonographers,physicians, and biomedicalengineers who operate andmaintain your product.Before use of the system anduser information, the user mustbe familiar with ultrasoundtechniques. Sonography trainingand clinical procedures are notincluded in the User Manual orwith the Affiniti SeriesDiagnostic Ultrasound System.	Trained healthcareprofessionalsIntended for sonographers,physicians, and biomedicalengineers who operate andmaintain your product.Before use of the system anduser information, the user mustbe familiar with ultrasoundtechniques. Sonography trainingand clinical procedures are notincluded in the User Manual orwith the Affiniti SeriesDiagnostic Ultrasound System.	Trained healthcareprofessionals	Identical to predicate
Intended UserEnvironment	Clinics, hospitals, and clinicalpoint-of-care for diagnosis ofpatients.	Clinics, hospitals, and clinicalpoint-of-care for diagnosis ofpatients.	Professional healthcareenvironments	Identical to predicate
USA FDAClassification	Class II	Class II	Class II	Identical to predicate
PrimaryProduct Code	IYN	IYN	LLZ	Identical to predicate
PrimaryRegulationName	System, Imaging, PulsedDoppler, Ultrasonic	System, Imaging, PulsedDoppler, Ultrasonic	Medical image managementand processing system.	Identical to predicate
PrimaryRegulationNumber	21 CFR 892.1550	21 CFR 892.1550	21 CFR 892.2050	Identical to predicate
SecondaryProduct Codes	ITXIYOOBЈQIH	ITXIYOOBJQiH	N/A	Identical to predicate
SecondaryRegulationName	Diagnostic ultrasonic transducerUltrasonic pulsed echo imagingsystemDiagnostic intravascular	Diagnostic ultrasonic transducerUltrasonic pulsed echo imagingsystemDiagnostic intravascular	N/A	Identical to predicate
	Affiniti Series DiagnosticUltrasound SystemFeature: SWMProposed Device	Affiniti Series DiagnosticUltrasound SystemK233788Predicate Device	LVivo Software ApplicationFeature: LVivo SGK161382Reference Device	Comparison
Feature	Automated Radiological ImageProcessing Software	Automated Radiological ImageProcessing Software
SecondaryRegulationNumber	21 CFR 892.157021 CFR 892.156021 CFR 870.120021 CFR 892.2050	21 CFR 892.157021 CFR 892.156021 CFR 870.120021 CFR 892.2050	N/A	Identical to predicate
Reusable-Systems andTransducers	Yes	Yes	No, software-only	Identical to predicate
Duration of use	Limited (≤ 24 hours)	Limited (≤ 24 hours)	N/A, software-only	Identical to predicate
Device Track	Track 3	Track 3	N/A, software-only	Identical to predicate
ApplicationDescription	The SWM softwareautomatically evaluates thesegmental (regional) function ofthe left ventricle (LV) from adultTTE echo examinations.Note: Per FDA GuidanceTechnical PerformanceAssessment of QuantitativeImaging in Radiological DevicePremarket Submissions, theSWM software is a semi-automated quantitative imagingalgorithm, as users aregenerally expected to reviewand concur with the initializationand generated results. Theusers can also edit algorithmgenerated segmental wallmotion scores for individualsegments based on their clinicalexpertise.	The predicate Affiniti SeriesDiagnostic Ultrasound Systemdoes not currently have adedicated software applicationcontaining the functionalityintroduced in the subjectsubmission for (semi-)automated segmental wallmotion evaluation of the leftventricle (LV).	The LVivoSG is a decisionsupport system (software) forautomated segmental wallmotion evaluation of the leftventricle (LV). The LVivoSG isbased on a proprietaryalgorithm for LV regional motionparameters calculation and wallmotion classification.The LVivoSG uses the LVivoplatform to detect the LV innerborders (endocard) from whichthe wall motion parameters arecalculated. As part of theLVivoSG development, theLVivo platform supports alsoedge detection and tracking inadditional plane, the apical long(3CH). The LVivoSG providesfully automated measurementsof the regional left ventricularsystolic function from threeapical views the four chamber(4CH), two chamber (2CH) andlong (3CH).	The subject Affiniti SeriesDiagnostic UltrasoundSystem integrates the LVivoSWM module of the LVivoSG K161382 referencedevice as "Segmental WallMotion". The subject SWMsoftware application utilizesthe border initialization ofthe cleared AutoStrain LVsoftware in the event thatthe border initializationalgorithm from LVivo SG isunsuccessful. Otherwise,there is no differencebetween the subject SWMsoftware application and thereference LVivo SG's SWMmodule and no changeshave been made to itsalgorithms.
Borderinitializationalgorithm(s)utilized forsegmental wallmotion	Primary - from K161382Secondary - from clearedAutoStrain LV (K190913)	Not applicable - does notcontain functionality forsegmental wall motion	From K161382	Subject devicepreferentially utilizesidentical border initializationalgorithm as referencedevice K161382.If the reference device'salgorithm is unsuccessful inthe subject SWM, it will usethe border initialization ofthe cleared AutoStrain LV(K190913) as a back-up.Performance testing hasdemonstrated very strongcorrelation between theSWM scoring of the subjectsoftware applicationcompared to the scoring ofthe reference device on thesame clips. Therefore, thereare no new or increasedrisks for the use of theAutoStrain LV borderinitialization in the subject
Feature	Affiniti Series DiagnosticUltrasound SystemFeature: SWMProposed Device	Affiniti Series DiagnosticUltrasound SystemK233788Predicate Device	LVivo Software ApplicationFeature: LVivo SGK161382Reference Device	Comparison
				SWM software applicationas a back-up.
SWM scoringadjustment	Users manually edit scoresusing a drop-down selection	Not applicable - does notcontain functionality forsegmental wall motion	Users must manually edit theborders to attempt to edit scores	In the cleared LVivo SG,users must manually adjustthe chamber borders toinfluence the SWM scores.In the subject SWM onVM11, users may manuallyselect different SWM scoresfor each segment using adrop-down menu. Anyscores which are manuallychanged from thosecalculated by the softwareapplication will be indicatedby an asterisk (*). Thischange in editing does notintroduce new risksbecause it is providing asimpler way for the user toedit their segmental wallmotion score(s) - instead ofhaving to edit the bordercontours to influence theSWM score as on thecleared LVivo SG, user candirectly edit each segment'sscore with the drop-down

Table 1: Comparison to Predicate - EPIQ

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PHILIPS

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Table 2: Comparison to Predicate - Affiniti

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VI. Safety Considerations

The proposed EPIQ and Affiniti Series Diagnostic Ultrasound Systems, including SVS and SWM software applications, 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.

VII. Nonclinical Performance Data

The proposed modification of the EPIQ 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 ●
IEC 62366-1 Medical devices Part 1: Application of usability engineering to medical devices . Edition 1.1 2020-06 CONSOLIDATED VERSION
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 SVS and SWM software applications. 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

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. Design Reviews

In addition, two retrospective data analysis studies were performed to support the substantial equivalence of the SVS and SWM features integrated onto EPIQ and Affiniti:

The first study was conducted to evaluate the performance of the SVS workflow enhancement algorithm. Three reviewers (clinical experts) participated in the manual selection of clips from subject exam and subsequent semi-automated processing of the clips with AutoStrain LV software to evaluate GLS and EF, which served as ground truth (average across reviewers for each output). The same exams were processed through the SVS software for automatic selection of appropriate clips and subsequent, un-edited evaluation of GLS and EF with AutoStrain LV. GLS and bi-plane EF results for each subject evaluated by the reviewers (averaged across reviewers= ground truth) were compared to the automatically obtained GLS and EF results with SVS selected clips.

The co-primary endpoints for the study were defined as agreements between GLS/EF measured via manual clip selection and compared to SVS clip selection and GLS/EF output using AutoStrain LV software. Agreement was measured as correlation for each output, separately for GLS and EF (coprimary endpoints). A review of the published literature and previous regulatory submissions (K130779, K232500) informed the acceptance criteria for the study to be defined as Lower Confidence Bound for the Pearson's correlation coefficient to be >0.8.

The results of the co-primary endpoints analysis demonstrated very strong correlation for GLS and EF outputs when manually selected clips were compared to SVS selected clips for the same subject exams. Specifically, for the Pearsons' correlation coefficient was 0.911 (95%Cl 0.855.0.946) and 0.941 (95%Cl 0.903.0.965), for GLS and EF, respectively. The lower confidence bounds were 0.855 for GLS and 0.903 for EF, thereby meeting the predefined acceptance criteria for the study.

A separate study was conducted to assess the use of Segmental Wall Motion (SWM), a machine learning-based feature in quantification of Wall Motion Score Index (WMSI) in transthoracic (TTE) ultrasound clips obtained from subjects referred for clinical TTE exam. The study evaluated the performance of the integrated SWM algorithm compared to LVivo SWM (DiA Imaging Analysis) application (ground truth) in the quantification of WMSI for the same subjects' exams. The study was executed in 2 phases with a 7-day washout period between the phase 1, three reviewers (clinical experts) participated in the manual selection of representative clips from subject TTE exams and subsequent processing of the clips with LVivo application for WMSI output, which served as ground truth in the study (average across reviewers). In phase 2, the manually selected clips as well as SVS selected clips (clips selected by the SVS workflow algorithm from subject exams used in phase1) were processed by the same 3 reviewers with the integrated (subject) SWM algorithm for WMSI output, in a random order.

A review of published literature within the cardiac assessment space and previous regulatory submissions (K130779, K223771, K232500) informed the acceptance criteria for the study to be defined as Lower Confidence Bound for the Pearson's correlation coefficient to be >0.8 for each endpoint. Acceptance criteria were defined prior to study execution.

The results of the co-primary endpoints analysis demonstrated very strong correlation for manual and SVS selected clips and assessed for WMSI of the subject SWM algorithm when compared to the ground truth. Specifically, the Pearsons' correlation coefficient was 0.957 (95%C) 0.933,0.972) and 0.913 (95%Cl 0.857,0.948), for the manual and SVS workflows, respectively. The lower confidence bounds were 0.933 for manual workflow and 0.857 for SVS workflow, thereby meeting the predefined acceptance criteria for the study.

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 SVS and SWM. 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 SVS and SWM.

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VIII. Clinical Data

There was no clinical investigation needed for this premarket submission of the EPIQ and Affiniti Series Diagnostic Ultrasound Systems with SVS and SWM software applications.

IX. Sterilization

Not applicable. The ultrasound transducers are not supplied sterile.

X. Conclusion

For testing, all pre-determined acceptance criteria were met. Results of these tests show that the proposed subject device meets its intended use support a determination that the proposed subject device does not raise new questions of safety or effectiveness.

Therefore, the subject device is substantially equivalent to the predicate device in terms of indications for use, design, technological characteristics, modes of operations, safety, and effectiveness.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
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.(b)
Classification. Class II.