(180 days)
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. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.
The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the 3D Auto TV (Tricuspid Valve) software application onto the EPIQ Series Diagnostic Ultrasound Systems.
The 3D Auto TV software enables semi-automated quantification of the tricuspid valve. At a high level, this is accomplished through automatically derived measurements from a segmented model of the tricuspid valve annulus formed by the software through model-based segmentation of the acquired ultrasound images.
The 3D Auto CFQ software provides semi-automated quantification of Mitral Requrgitation (MR) volume and peak flow rate based on 3D color flow images. This application uses a known fluid dynamic model of flow that is adapted to the acquired color information. This allows quantitative assessment of mitral valve leakage during systole. The derived result supports the assessment of mitral regurgitation volume and peak flow rate.
No hardware changes to the EPIQ systems are required when using the 3D Auto TV and 3D Auto CFQ, and existing, cleared Philips transducer(s) are used for the software applications.
The software applications are supported by all EPIQ models running software version 11.0 or higher including EPIQ CVx/CVxi. EPIQ Elite Advanced. EPIQ 7. EPIQ 5. The software applications are both associated with the cardiac adult indication.
The provided text describes two software applications, 3D Auto TV and 3D Auto CFQ, for the Philips EPIQ Series Diagnostic Ultrasound System. It details their acceptance criteria and the studies conducted to demonstrate their performance.
1. Table of Acceptance Criteria & Reported Device Performance
| Feature/Metric | Acceptance Criteria | 3D Auto TV Reported Performance | 3D Auto CFQ Reported Performance |
|---|---|---|---|
| 3D Auto TV | |||
| LoA for Annulus Size | Within ± 46% (for TEE/TTE combined) | Confidence intervals for the limits of agreement were within ± 46% | N/A |
| LoA for Annulus Shape | Within ± 52% (for TEE/TTE combined) | Confidence intervals for the limits of agreement were within ± 52% | N/A |
| Relative Bias (Distance) | Within +/- 17.37% | Met (within +/- 17.37%) | N/A |
| Relative Bias (Circumference) | Within +/- 23.68% | Met (within +/- 23.68%) | N/A |
| In-silico Phantom Mean Error | Within +/- 1% | Mean relative error of measurement primitives: within +/- 1% | N/A |
| In-silico Phantom LoA | Within +/- 5% | Limits of agreement of measurement primitives: within +/- 5% | N/A |
| 3D Auto CFQ | |||
| Maximum Allowable Difference (Δ) for Regurgitant Volume LoA | 61.6 ml | N/A | Lower LoA: -49.29; Upper LoA: 25.09. 95% CI for LoA: Lower end (-58.37 - -40.20), Upper end (16.01 - 34.18). The largest absolute difference is 58.37 mL, which is within the 61.6 mL acceptance criteria. |
| Mean Difference (Bias) | Within +/- 19.2 ml | N/A | Met. |
| Pearson's Correlation vs 2D PISA (Peak Regurgitant Flow) | > 0.8 (for both fully-automated and semi-automated modes) | N/A | Upper and lower bounds of the 95% confidence interval for Pearson's correlation exceeded > 0.8. |
2. Sample Size for Test Set and Data Provenance
- 3D Auto TV: The text does not explicitly state the numerical sample size (number of patients or clips) used for the test set. It mentions "cardiac clips were used" and "Subjects whose clips contributed to the study represented a broad range of demographics, body habitus, and their severity of tricuspid regurgitation." The provenance is not explicitly stated (e.g., country of origin), but it is implied to be clinical data (transthoracic and transesophageal echocardiography (TTE, TEE) cardiac clips). It is a retrospective study, as pre-recorded clips were used.
- 3D Auto CFQ: The text does not explicitly state the numerical sample size (number of patients or clips) used for the test set. The provenance is not explicitly stated (e.g., country of origin), but it is implied to be clinical data. It is a retrospective study, as the results were compared to pre-existing Cardiac Magnetic Resonance Imaging (CMR) data.
3. Number of Experts and Qualifications for Ground Truth
- 3D Auto TV:
- Number of Experts: 3 clinical experts (reviewers).
- Qualifications: Not explicitly stated beyond "clinical experts (reviewers)."
- 3D Auto CFQ: The ground truth was Cardiac Magnetic Resonance Imaging (CMR) regurgitant volume (RVol). No human experts were used to establish this specific ground truth; rather, it's considered a gold standard imaging modality. For comparison to the PISA method, clinical experts would have performed the PISA measurements, but their number and qualifications are not specified here.
4. Adjudication Method for the Test Set
- The text does not explicitly state an adjudication method (e.g., 2+1, 3+1). For 3D Auto TV, the ground truth was established by "manual measurements by the same reviewers performed within 4D Cardio-View application (K213544)." This implies individual or consensus measurements, but a formal adjudication process is not detailed.
- For 3D Auto CFQ, the primary ground truth was CMR, which does not involve human adjudication in the same way. When compared to the 2D PISA methodology, it's implied that such measurements were collected.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No explicit MRMC comparative effectiveness study demonstrating improved human reader performance with AI assistance vs. without AI assistance was reported. The studies described focus on the standalone performance of the AI software against human manual measurements or other gold standard modalities.
6. Standalone (Algorithm Only) Performance Study
- Yes, standalone performance studies were conducted for both 3D Auto TV and 3D Auto CFQ.
- 3D Auto TV: The study evaluated the "automation performance of the 3D Auto TV software" and compared its results to manual measurements (ground truth) performed within the 4D Cardio-View application.
- 3D Auto CFQ: The study evaluated the "performance of the 3D Auto CFQ software" by comparing its regurgitant volume output to CMR (ground truth) and its peak flow rate output to the 2D PISA methodology.
7. Type of Ground Truth Used
- 3D Auto TV: Manual measurements performed by 3 clinical experts using the 4D Cardio-View application (K213544). This can be classified as expert consensus/manual measurement from a predicate device.
- 3D Auto CFQ:
- For regurgitant volume: Cardiac Magnetic Resonance Imaging (CMR) regurgitant volume (RVol), which is considered a clinical gold standard.
- For peak flow rate: 2D PISA methodology. While PISA is a widely accepted method in echocardiography, it is also a measurement based on assumptions and manual input, thus falling under a blend of accepted clinical methodology and manual measurement.
8. Sample Size for the Training Set
- The provided document does not specify the sample size for the training set for either 3D Auto TV or 3D Auto CFQ. It only states that the algorithms use "machine learning algorithm without user interaction" for contour generation.
9. How the Ground Truth for the Training Set Was Established
- The provided document does not explicitly describe how the ground truth for the training set was established for either 3D Auto TV or 3D Auto CFQ. It mentions "model-based segmentation" for 3D Auto TV and "machine learning algorithm" for both, implying a supervised learning approach where annotated data would have been used for training, but the specifics of that annotation process are not detailed.
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October 7, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Philips Ultrasound LLC Michael Chambers Senior Regulatory Affairs Specialist 22100 Bothell Everett Hwy Bothell, WA 98021
Re: K240980
Trade/Device Name: EPIQ Series Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX, QIH, OBJ Dated: April 10, 2024 Received: August 19, 2024
Dear Michael Chambers:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Yanna S. Kang -S
Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
EPIQ Series Diagnostic Ultrasound System
Indications for Use (Describe)
The intended use of EPIQ Ultrasound Diagnostic System is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:
Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), intra-luminal, intra-cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transvaginal, Lung.
The clinical environments where EPIQ Series Diagnostic Ultrasound Systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.
When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live echo guidance.
The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This summary of safety and effectiveness information is submitted in accordance with 21 CFR § 807.92.
510(k) Number: K240980
Date Prepared: August 16, 2024
l. Submitter
| Manufacturer Name andAddress | Philips Ultrasound LLC22100 Bothell Everett HwyBothell, 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, Regulatory AffairsPhilips Ultrasound LLC22100 Bothell Everett HwyBothell, WA 98021-8431 USA+1 (617) 798-8092 |
II. Device
EPIQ Series Diagnostic Ultrasound System
Common Name
Proprietary Name
Regulation Description
Diagnostic Ultrasound System and Transducers
| Classification Description | 21 CFR § | Product Code |
|---|---|---|
| Primary | ||
| System, imaging, pulsed doppler,ultrasonic | 892.1550 | IYN |
| Secondary | ||
| System, imaging, pulsed echo,ultrasonic | 892.1560 | IYO |
| Transducer, ultrasonic, diagnostic | 892.1570 | ITX |
| Automated Radiological ImageProcessing Software | 892.2050 | QIH |
| Diagnostic Intravascular Catheter | 870.1200 | OBJ |
| Device Class | Class II |
|---|---|
| Review Panel | Radiology |
| Predicate Device | K233788; Philips EPIQ Series Diagnostic Ultrasound System |
| Reference Devices | K213544; TOMTEC-ARENA, TOMTEC Imaging Systems GmbHK200974; QLAB Advanced Quantification Software |
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111. Device Description
The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the 3D Auto TV (Tricuspid Valve) software application onto the EPIQ Series Diagnostic Ultrasound Systems.
The 3D Auto TV software enables semi-automated quantification of the tricuspid valve. At a high level, this is accomplished through automatically derived measurements from a segmented model of the tricuspid valve annulus formed by the software through model-based segmentation of the acquired ultrasound images.
The 3D Auto CFQ software provides semi-automated quantification of Mitral Requrgitation (MR) volume and peak flow rate based on 3D color flow images. This application uses a known fluid dynamic model of flow that is adapted to the acquired color information. This allows quantitative assessment of mitral valve leakage during systole. The derived result supports the assessment of mitral regurgitation volume and peak flow rate.
No hardware changes to the EPIQ systems are required when using the 3D Auto TV and 3D Auto CFQ, and existing, cleared Philips transducer(s) are used for the software applications.
The software applications are supported by all EPIQ models running software version 11.0 or higher including EPIQ CVx/CVxi. EPIQ Elite Advanced. EPIQ 7. EPIQ 5. The software applications are both associated with the cardiac adult indication.
IV. Intended Use and Indications for Use
EPIQ Intended Use
The intended use of EPIQ Ultrasound Diagnostic System is diagnostic ultrasound imaging and fluid flow analysis of the human body.
EPIQ Indications for Use:
The intended use of EPIQ Ultrasound Diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:
Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), intra-luminal, intra-cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.
The clinical environments where EPIQ Series Diagnostic ultrasound Systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.
When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live echo guidance.
The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.
Note: There are no changes to the EPIQ Ultrasound System Indications for Use due to the introduction of the 3D Auto TV or 3D Auto CFQ software applications. Both are associated with the Cardiac Adult indication.
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V. Comparison of Technological Characteristics with the Predicate
The purpose of the submission is to introduce the 3D Auto TV and 3D Auto CFQ software applications to the EPIQ Series Diagnostic Ultrasound System. The subject device is substantially equivalent to the predicate device (K233788).
The following tables provide an overview of the comparison of similarities and differences between the proposed device and the predicates. Details are provided in Attachment 005 of the submission.
| Feature | EPIQ Series DiagnosticUltrasound SystemFeature: 3D Auto TVProposed Device | EPIQ Series DiagnosticUltrasound SystemK233788Predicate Device | TOMTEC-ARENAFeature: 4D CARDIO-VIEWK213544Reference Device | QLAB AdvancedQuantification SoftwareFeature: 3D Auto MVK200974Reference 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, SmallOrgan (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, SmallOrgan (Breast, Thyroid,Testicle).Transesophageal(Cardiac), Transrectal,Transvaginal, Lung. | Quantification andreporting ofcardiovascular, fetal,and abdominalstructures and functionsof patients withsuspected disease tosupport the physician inthe diagnosis. | QLAB Quantification softwareis a software applicationpackage. It is designed to viewand quantify image dataacquired on Philips ultrasoundsystems | Identical to predicate |
| IntendedUsers | Trained healthcareprofessionalsIntended forsonographers,physicians, andbiomedical engineerswho operate andmaintain your product.Before use of thesystem and userinformation, the usermust be familiar withultrasound techniques.Sonography training andclinical procedures arenot included in the UserManual or with the EPIQSeries DiagnosticUltrasound System. | Trained healthcareprofessionalsIntended forsonographers,physicians, andbiomedical engineerswho operate andmaintain your product.Before use of thesystem and userinformation, the usermust be familiar withultrasound techniques.Sonography training andclinical procedures arenot included in the UserManual or with the EPIQSeries DiagnosticUltrasound System. | Licensed medicalpractitioners or assistantmedical technicians | Trained healthcareprofessionals | Identical to predicate |
| Feature | EPIQ Series DiagnosticUltrasound SystemFeature: 3D Auto TVProposed Device | EPIQ Series DiagnosticUltrasound SystemK233788Predicate Device | TOMTEC-ARENAFeature: 4D CARDIO-VIEWK213544Reference Device | QLAB AdvancedQuantification SoftwareFeature: 3D Auto MVK200974Reference Device | Comparison |
| Intended UserEnvironment | Clinics, hospitals, andclinical point-of-care fordiagnosis of patients. | Clinics, hospitals, andclinical point-of-care fordiagnosis of patients. | Inside and outside ofHospitals, Clinics, andPhysician's offices | Clinics, hospitals, and clinicalpoint-of-care for diagnosis ofpatients. | Identical to predicate |
| USA FDAClassification | Class II | Class II | Class II | Class II | Identical to predicate |
| PrimaryProduct Code | IYN | IYN | QIH | QIH | Identical to predicate |
| ApplicationDescription | The 3D Auto TVsoftware solution isintended for use with thePhilips EPIQ DiagnosticUltrasound Systems.The software enablessemi-automatedquantification of thetricuspid valve. At a highlevel, this isaccomplished throughautomatically derivedmeasurements from asegmented model of thetricuspid valve annulusformed by the softwarethrough model-basedsegmentation of theacquired ultrasoundimages. | The predicate EPIQSeries DiagnosticUltrasound System doesnot currently have adedicated softwareapplication forquantification of thetricuspid valve annulus.The subject of thissubmission is tointroduce the 3D AutoTV software onto thepredicate device. | 4D CARDIO-VIEW is anadvanced analysis toolfor 3D/4Dechocardiography data.Anatomical structurevisualization, volumemeasurements (LVand/or generic), andspecified or manualmeasurements arepossible for cardiacstructures including, butnot limited to, thetricuspid valve. Varioustools are available forrendering that display 2-and 3-dimensionalmorphology andfunction for definedstructures. | 3D Auto MV is a semi-automated softwareapplication intended for theanalysis of Mitral Valve (MV)anatomy and function. Thisapplication generates modelsof anatomical structures ofinterest such as the MVannulus, leaflets, and theclosure line, which allows forquantification of pre- and post-operative valvular function anda comparison of morphology. | Similar to the referencedevice features.The functionality andworkflow of the 3D AutoTV software is verysimilar to the 3D AutoMV tool, wheremeasurementparameters are derivedfrom models of themitral valve (in the caseof 3D Auto MV) andtricuspid valve (in thecase of 3D Auto TV).Manual measurementsare also able to beperformed on bothsoftware applications.Comparing 3D Auto TVto 4D CARDIO-VIEW,both software havefunctionality forquantifying the tricuspidvalve. The proposed 3DAuto TV allows for semi-automatedquantification, where thereference device is fullymanual. As wedemonstrate highagreement in themeasurement outputson the same patientswhen quantified usingthe proposed 3D AutoTV software and thereference 4D CARDIO-VIEW application, thereare no new questionsraised of safety oreffectiveness. |
| ContourGeneration | 3D surface model iscreated semi-automatically usingmachine learningalgorithm without userinteraction. User is ableto edit, accept, or rejectthe initial landmark | No standard tricuspidvalve (TV) quantificationparameters included aspart of the system. | 3D surface model iscreated based on userdefined anatomicallandmarks. User is ableto edit the contour of thesurface model beforeproceeding with theworkflow. | 3D surface model is createdsemi-automatically usingmachine learning algorithmwithout user interaction. Useris able to edit, accept, or rejectthe initial landmark proposalsof the mitral valve anatomicallocations. | Subject device usesidentical method forcontour generation asthe reference deviceK200974. The onlydifference is thealgorithm is trained ontricuspid valve images,where the reference |
| Feature | EPIQ Series DiagnosticUltrasound SystemFeature: 3D Auto TVProposed Device | EPIQ Series DiagnosticUltrasound SystemK233788Predicate Device | TOMTEC-ARENAFeature: 4D CARDIO-VIEWK213544Reference Device | QLAB AdvancedQuantification SoftwareFeature: 3D Auto MVK200974Reference Device | Comparison |
| valve anatomicallocations. | device was trained usingmitral valve images. | ||||
| Measurements Performed | Semi-auto annulusresults TV Ann Perimeter (3D) TV Ann Perimeter (2D) TV Ann Max Diam (2D) TV Ann Min Diam (2D) TV Ann Perimeter Derived Diam (2D) TV Ann Height (3D) TV Ann Area (2D) Manual device results TV Ann AP Diam (2D) TV Ann SL Diam (2D) Subvalvular 5 Plane SL Diam Subvalvular 5 Plane AP Diam Supravalvular C-Shaped Perimeter Supravalvular AV - AoCenter Diam | No standard tricuspidvalve (TV) quantificationparameters included aspart of the system. | TAVR results Ann-Ost left diam Ann-Ost right diam Annulus Area Annulus dmin Annulus dmax Ao Ring diam Ao SV diam Ao STJ diam Volume results (notrelated to TVquantification) EDV EF ESV GenVol Mass SV | Standard MV Parameters AP Diameter (cm) AL-PM Diameter (cm) Sphericity Index (AP / AL-PM) Intertrigonal Distance (cm) Commissural Diameter (cm) D-Shaped Annulus Perimeter (cm) Annulus Height (cm) Non-planar Angle (degrees) Tenting Volume (cm3) Coaptation Depth (mm) Tenting Area (cm2) Angle AAo-AP (degrees) Maximum Prolapse Height (mm) Maximum Open Coaptation Gap (mm) Maximum Open Coaptation Width (mm) Anterior Leaflet Area (cm2) Posterior Leaflet Area (cm2) Distal Anterior Leaflet Angle (degrees) Posterior Leaflet Angle (degrees) Anterior Leaflet Length (cm) Posterior Leaflet Length (cm) C-Shaped Annulus (cm) 2D MV Parameters D-Shaped Annulus Area (cm2) Annulus Area (cm2) Anterior Closure Line Length (cm) Posterior Closure Line Length (cm) 3D MV Parameters Saddle Shaped Annulus Area (cm2) Saddle Shaped Annulus Perimeter (cm) Total Open Coaptation Area (cm2) Anterior Closure Line Length (cm) Posterior Closure Line Length (cm) | Similar. The proposed3D Auto TV softwareallows very similar semi-automatedmeasurements as thereference softwareapplication 3D Auto MV,only applied to thetricuspid valve.The proposed 3D AutoTV software addsadditional TV annulusand devicemeasurements fromthose available in 4DCARDIO-VIEW tofurther define thetricuspid valve anatomy.Both the proposed 3DAuto TV and thereference 4D CARDIO-VIEW software allowmanual, free-formmeasurements of thetricuspid valve. |
| Feature | EPIQ Series DiagnosticUltrasound SystemFeature: 3D Auto CFQProposed Device | EPIQ Series DiagnosticUltrasound SystemK233788Predicate Device | QLAB Advanced QuantificationSoftwareFeature: 3D Auto MVK200974Reference Device | Comparison | |
| Indications forUse | Abdominal, Cardiac Adult,Cardiac other (Fetal), CardiacPediatric, 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, PeripheralVessel, 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), intra-luminal, intra-cardiac echo, Musculoskeletal(Conventional), Musculoskeletal(Superficial), Ophthalmic, Other:Urology, Pediatric, PeripheralVessel, Small Organ (Breast,Thyroid, Testicle),Transesophageal (Cardiac),Transrectal, Transvaginal, Lung. | QLAB Quantification software is asoftware application package. Itis designed to view and quantifyimage data acquired on Philipsultrasound systems | Identical to predicate | |
| Trained healthcare professionals | Trained healthcare professionals | Trained healthcare professionals | Identical | ||
| Intended for sonographers,physicians, and biomedicalengineers who operate andmaintain your product. | Intended for sonographers,physicians, and biomedicalengineers who operate andmaintain your product. | ||||
| Intended Users | 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 EPIQ Series DiagnosticUltrasound System. | 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 EPIQ Series DiagnosticUltrasound System. | |||
| Intended UserEnvironment | Clinics, hospitals, and clinicalpoint-of-care for diagnosis ofpatients. | Clinics, hospitals, and clinicalpoint-of-care for diagnosis ofpatients. | Clinics, hospitals, and clinicalpoint-of-care for diagnosis ofpatients. | Identical | |
| USA FDAClassification | Class II | Class II | Class II | Identical | |
| Primary ProductCode | IYN | IYN | QIH | Identical to predicate | |
| ApplicationDescription | 3D Auto CFQ is a new semi-automated quantification softwarewhich will be introduced on theEPIQ Ultrasound Systems fromsoftware version VM11.0. Theapplication provides semi-automated quantification of MitralRegurgitation (MR) volume andpeak flow rate by analyzing 3Dcolor flow images acquired duringtransesophagealechocardiography (TEE)examinations. | The Proximal Isovelocity SurfaceArea (PISA) methodology can beused currently on the predicatedevice to quantify valvularregurgitation. The techniqueutilizes 2D/Color and Dopplerimages to allow the user to makesimple, manual measurements ina cascading fashion to allowcalculation of peak flow rate andvolumetric regurgitation. | 3D Auto MV is a semi-automatedsoftware application intended forthe analysis of Mitral Valve (MV)anatomy and function. Thisapplication generates models ofanatomical structures of interestsuch as the MV annulus, leaflets,and the closure line, which allowsfor quantification of pre- and post-operative valvular function and acomparison of morphology. | Similar. The predicate devicefacilitates the quantification ofmitral regurgitation volumeand peak flow rate through agroup of measurements whichare performed in a cascadingfashion manually by the useraccording to the ProximalIsovelocity Surface Area(PISA) methodology. Theproposed 3D Auto CFQsoftware application allowsthe users to quantify the samemeasurements for mitralregurgitation volume and peakflow rate but in a semi- | |
| Feature | EPIQ Series DiagnosticUltrasound SystemFeature: 3D Auto CFQProposed Device | EPIQ Series DiagnosticUltrasound SystemK233788Predicate Device | QLAB Advanced QuantificationSoftwareFeature: 3D Auto MVK200974Reference Device | Comparison | |
| The reference device does notcontain functionality forquantification of mitralregurgitation. | |||||
| ContourGeneration | 3D surface model is createdsemi-automatically usingmachine learning algorithmwithout user interaction. User isable to edit, accept, or reject theinitial landmark proposals of themitral valve anatomical locations. | No standard contour generationtechnology for the mitral valve,outside of 3D Auto MV, includedas part of the system. | 3D surface model is createdsemi-automatically usingmachine learning algorithmwithout user interaction. User isable to edit, accept, or reject theinitial landmark proposals of themitral valve anatomical locations. | Subject device uses identicalmethod for contour generationas the reference deviceK200974 | |
| QuantificationTechnology forMitralRegurgitation | The 3D Auto CFQ algorithmquantifies mitral regurgitationvolume and flow rate fromacquired 3D color flow images.The greyscale information fromthese images is used to generatea 3D model of the mitral valve,which is used as an input alongwith the 3D color data into the 3DAuto CFQ flow algorithm. The 3DAuto CFQ algorithm uses a fluiddynamic model of anincompressible fluid (blood)traveling through an irregular-shaped (i.e., nonround) orifice. Inits initial step, the algorithmgenerates a hypothetical modelof true blood flow velocities in theproximal convergence zonebased on all measured Dopplervelocities and the underlying fluiddynamics model. The truevelocity model is then convertedinto the corresponding apparentDoppler velocity model("synthetic apparent velocities")using ultrasound physics(projection along the axialdimension). These syntheticvelocities are subsequentlycompared to the acquiredvelocities in the Color Flow (CF)data set. Based on the outcomeof this comparison, the model isupdated and reiterated to getthe best fit between the acquiredvelocities and the generatedmodel. 3D Auto CFQ determinesthe resulting requrgitant flow ratefor this frame. This process isrepeated for each frame includedin the analysis, which in mostcases includes the entire systoliccycle. In each frame, the size andshape of theregurgitant orifice is not assumedbut is generated by this iterativeloop between the model and theCF data. | The PISA methodology usessequential acquisitions andmanual measurements, whichare manually performed by theuser:· MR Alias Velocity (from the2D/Color)· MR Radius (from the 2D/Color)· MR Vmax (from the continuouswave doppler)• MR VTI (from the continuouswave doppler)The outputs of thesemeasurements go into theequations for the derivedmeasurements including:· Mitral Regurgitant (MR) FlowRate· MR Effective RegurgitantOrifice (ERO)• MR Volume | N/A - does not containtechnology for mitral regurgitationquantification | Similar. The predicate deviceutilizes the PISA methodologyfor quantifying MR volumeand flow rate. Thismethodology utilizessequential measurementsperformed by the user and isbased on assumptionsincluding there being a single,round, constant flow orificeduring the entire systole.3D Auto CFQ operates using3D color to address the spatialcomplexities seen in mitralregurgitation and wasdeveloped to evaluate theregurgitant flow at every framein systole, where the PISAmethodology only assessesone frame during systole andassumes this frame appliesacross systole.The proposed 3D Auto CFQsoftware application allowsthe users to quantify the samemeasurements for mitralregurgitation volume and peakflow rate as PISA. Thedynamic flow algorithm is thenew technology introduced inthis submission. Everythingleading up to the calculationsby the dynamic flow model areexisting and cleared, includingthe transducer and imagingmodes (X8-2t transducer; 3DZoom, Full Volume 3D, or Live3D; K163120), and softwarefor mitral valve modelgeneration (reference deviceK200974). The dynamic flowmodel of the 3D Auto CFQsoftware application usesthese as inputs to arrive at theoutputs of mitral regurgitationvolume and peak flow rate.These outputs are the sameas in the predicate, only themethod to arrive at the | |
| Feature | EPIQ Series DiagnosticUltrasound SystemFeature: 3D Auto CFQProposed Device | EPIQ Series DiagnosticUltrasound SystemK233788Predicate Device | QLAB Advanced QuantificationSoftwareFeature: 3D Auto MVK200974Reference Device | Comparison | |
| measurements differs in thesubject device. | |||||
| Compatibletransducers | 3D9-3V, C5-1, C8-5, C9-2, C10-3V, C10-4ec, D2cwc, D2tcd,D5cwc, eL18-4, eL18-4 EMT,L12-3, L12-3 ERGO, L12-5 50,L15-7io, L18-5, mC7-2, mC12-3,mL26-8, S5-1, S7-3t, S8-3, S8-3t,S9-2, S12-4, V6-2, V9-2, VL12-5,X5-1, X5-1c, X6-1, X7-2, X7-2t,X8-2t, X11-4t, XL14-3The 3D Auto CFQ softwareapplication can analyzetransesophagealechocardiography (TEE) imagesacquired by the cleared X8-2ttransducer (K163120), which isalready commercially availableand compatible with the EPIQUltrasound System. | 3D9-3V, C5-1, C8-5, C9-2, C10-3V, C10-4ec, D2cwc, D2tcd,D5cwc, eL18-4, eL18-4 EMT,L12-3, L12-3 ERGO, L12-5 50,L15-7io, L18-5, mC7-2, mC12-3,mL26-8, S5-1, S7-3t, S8-3, S8-3t,S9-2, S12-4, V6-2, V9-2, VL12-5,X5-1, X5-1c, X6-1, X7-2, X7-2t,X8-2t, X11-4t, XL14-3 | The 3D Auto MV softwareapplication is compatible with thefollowing transducers: X7-2t, X8-2t, X11-4t | Identical. There are no newtransducers introduced in this510(k).The 3D Auto CFQ softwareapplication can analyzetransesophagealechocardiography (TEE)images acquired by thecleared X8-2t transducer(K163120), which is alreadycommercially available andcompatible with the EPIQUltrasound System.There are no impacts to theindications for use or intendeduse of the X8-2t transducerwhen used for the purposes ofacquiring images for analysisby the 3D Auto CFQ softwareapplication. The 3D Auto CFQsoftware application requiresimages to be acquired ineither 3D Zoom, Full Volume3D, or Live 3D imagingmodes. There are no changesto these existing transducerimaging modes. | |
| MeasurementsPerformed | Semi-automated measurementsperformed by the 3D Auto CFQsoftware application:Mitral regurgitation (MR) volume[mL];Peak flow rate [mL/s] | Derived measurements which theuser can obtain through the PISAmethodology include:Mitral regurgitation (MR) volume[mL];Peak flow rate [mL/s] | Standard MV Parameters• AP Diameter (cm)• AL-PM Diameter (cm)• Sphericity Index (AP / AL-PM)• Intertrigonal Distance (cm)• Commissural Diameter (cm)• D-Shaped Annulus Perimeter(cm)• Annulus Height (cm)• Non-planar Angle (degrees)• Tenting Volume (cm3)• Coaptation Depth (mm)• Tenting Area (cm2)• Angle AAo-AP (degrees)• Maximum Prolapse Height(mm)• Maximum Open CoaptationGap (mm)• Maximum Open CoaptationWidth (mm)• Anterior Leaflet Area (cm2)• Posterior Leaflet Area (cm2)• Distal Anterior Leaflet Angle(degrees)• Posterior Leaflet Angle(degrees)• Anterior Leaflet Length (cm)• Posterior Leaflet Length (cm)• C-Shaped Annulus (cm) | Similar. The measurementsperformed by the proposed3D Auto CFQ softwareapplication can also beobtained by a user on thepredicate device.Substantiation of theperformance of the 3D Auto CFQsoftware's regurgitantvolume output was performedby comparison to cardiacmagnetic resonance imaging(CMR) images withacceptance criteria ofagreement within the limits ofagreement. While the PISAmethodology is a widelyaccepted method for mitralregurgitation quantificationand is a recommendedmethod by the AmericanSociety of Echocardiography,the outputs from 3D Auto CFQwere compared to those fromCMR (as opposed to PISA) asthe former is considered agold standard for mitralregurgitation quantification.Acceptance criteria for 3DAuto CFQ was based on | |
| Feature | EPIQ Series DiagnosticUltrasound SystemFeature: 3D Auto CFQProposed Device | EPIQ Series DiagnosticUltrasound SystemK233788Predicate Device | QLAB Advanced QuantificationSoftwareFeature: 3D Auto MVK200974Reference Device | Comparison | |
| • D-Shaped Annulus Area (cm2)• Annulus Area (cm2)• Anterior Closure Line Length(cm)• Posterior Closure Line Length(cm)3D MV Parameters• Saddle Shaped Annulus Area(cm2)• Saddle Shaped AnnulusPerimeter (cm)• Total Open Coaptation Area(cm2)• Anterior Closure Line Length(cm)• Posterior Closure Line Length(cm) | agreement with CMR beingwithin predefined maximumlimits of agreement.In addition to regurgitantvolume, the peak flow rateoutput of 3D Auto CFQ wasvalidated in comparison tomanual PISA method, wherethe correlation was very high.The reference deviceK200974 facilitatesanatomical measurements ofthe mitral valve from thegenerated model of the mitravalve but does not performmeasurements for quantifyingmitral regurgitation. |
Table 1: Comparison to Predicate for introduction of 3D Auto TV onto EPIQ
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Table 2: Comparison to Predicate for introduction of 3D Auto CFQ onto EPIQ
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VI. Safety Considerations
The proposed EPIQ Series Diagnostic Ultrasound System, including 3D Auto TV and 3D Auto CFQ 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.
Nonclinical Performance Data VII.
The proposed modification of the EPIQ 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 3D Auto CFQ 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
- . Design Reviews
Non-clinical testing also included the Performance Validation Study for the proposed 3D Auto TV and 3D Auto CFQ software applications.
For 3D Auto TV, a study was conducted to evaluate the automation performance of the 3D Auto TV software, where transthoracic and transesophageal echocardiography (TTE, TEE) cardiac clips were used for TV annulus measurements by 3 clinical experts (reviewers) with the use of 3D Auto TV software and the results compared to manual measurements by the same reviewers performed within 4D Cardio-View application (K213544), used as a ground truth for the study. Subjects whose clips
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contributed to the study represented a broad range of demographics, body habitus, and their severity of tricuspid requration were representative of the intended population. The results of the primary endpoint analysis demonstrated high agreement of the automated performance of the 3D Auto TV software with the 4D Cardio-View software (ground truth). Confidence intervals for the limits of agreement were within the acceptance criteria ± 46% and ± 52% for annulus size and annulus shape, respectively, within TEE and TTE arms. Bias was also evaluated for automation performance, where relative bias based on inter-observer variability was met, specifically within +/- 17.37% for distance (size) and +/- 23.68% for circumference (shape). The accuracy and precision of the underlying measurement primitives were also evaluated through use of in silico phantoms with known dimensions. Mean relative error of the measurement primitives on the in-silico phantoms were within +/- 1%, with limits of agreement within acceptance criteria of +/- 5%.
For 3D Auto CFQ, a study was conducted to evaluate the performance of the 3D Auto CFQ software. The results were compared to cardiac magnetic resonance imaging (CMR) regurgitant volume (RVol), used as a ground truth for the study. This study produced limits of agreement (LoA) of -49.29 (lower LoA) and 25.09 (upper LoA) and associated confidence intervals: lower end of 95% LoA (-58.37-40.20) and upper end of 95% LoA (16.01.34.18). The acceptance criteria set for the study was defined as maximum allowable difference (Δ) of 61.6ml. Based on the results of the study, the lower end of the 95% Cl for LoA was -58.37 and the upper end of the 95% Cl for LoA was 34.18, therefore the primary endpoint acceptance criteria for maximum allowable difference were met. In addition, bias was assessed where the acceptance criteria for mean difference (bias) within +/- 19.2ml was met. Further, the peak regurgitant flow output from 3D Auto CFQ was also validated against 2D PISA methodology on the same subjects. For both fully-automated and semi-automated 3D Auto CFQ, the upper and lower bounds of the 95% confidence interval for Pearson's correlation exceeded the acceptance criteria of > 0.8 when compared to 2D PISA. All acceptance criteria for the studies were met, and the results of the study demonstrated clinically reasonable, relevant, meaningful performance of the 3D Auto CFQ software supporting clinicians' assessment of mitral valve regurgitant volume during cardiac TEE exam.
Since these are software-only changes 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 Series Diagnostic Ultrasound Systems with 3D Auto TV and 3D Auto CFQ. The transducer patient contact materials and manufacturing processes are not impacted by the release of the subject EPIQ Series Diagnostic Ultrasound Systems with 3D Auto TV and 3D Auto CFQ.
VIII. Clinical Data
There was no clinical investigation needed for this premarket submission of the EPIQ Series Diagnostic Ultrasound Systems with 3D Auto TV and 3D Auto CFQ software applications.
IX. Sterilization
Not applicable. The ultrasound transducers are not supplied sterile.
X. Conclusion
Results of the testing shows 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.
§ 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.