(180 days)
Yes
The "Mentions AI, DNN, or ML" section explicitly states that a "3D surface model is created semi-automatically using machine learning algorithm without user interaction."
No
Explanation: The intended use of the device is explicitly stated as "diagnostic ultrasound imaging and fluid flow analysis." There is no mention of treating or preventing diseases or conditions, which characterizes therapeutic devices.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The intended use of EPIQ Ultrasound Diagnostic System is diagnostic ultrasound imaging and fluid flow analysis of the human body." It further specifies that the systems can be used "for diagnosis of patients" in various clinical environments.
No
The device is described as software applications (3D Auto TV and 3D Auto CFQ) that are introduced onto existing, cleared Philips EPIQ Series Diagnostic Ultrasound Systems. While the software itself doesn't require hardware changes, it functions as a component of a larger hardware system (the ultrasound machine) and relies on the hardware for image acquisition and processing. Therefore, it is not a standalone software-only medical device.
Based on the provided information, the EPIQ Ultrasound Diagnostic System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- EPIQ System's Function: The EPIQ Ultrasound Diagnostic System uses ultrasound technology to create images and analyze fluid flow within the human body. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states "diagnostic ultrasound imaging and fluid flow analysis of the human body."
- Device Description: The description focuses on software applications that process ultrasound images acquired from within the body to quantify anatomical structures and fluid flow.
Therefore, the EPIQ Ultrasound Diagnostic System falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
No
The letter does not state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
The intended use of EPIQ Ultrasound Diagnostic System is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:
Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), intra-luminal, intra-cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), 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.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX, QIH, OBJ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Ultrasound
Anatomical Site
Abdominal, Cardiac (Adult, Fetal, Pediatric), Cerebral Vascular, Cephalic (Adult, Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular, Cardiac), intra-luminal, intra-cardiac echo, Musculoskeletal (Conventional, Superficial), Ophthalmic, Urology, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.
Specific to the new features: Tricuspid Valve, Mitral Valve
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained healthcare professionals. Intended for sonographers, physicians, and biomedical engineers who operate and maintain the product. Before use of the system and user information, the user must be familiar with ultrasound techniques. Sonography training and clinical procedures are not included in the User Manual or with the EPIQ Series Diagnostic Ultrasound System.
Clinical environments: clinics, hospitals, and clinical point-of-care for diagnosis of patients.
Description of the training set, sample size, data source, and annotation protocol
Not Found (The document states "3D surface model is created semi-automatically using machine learning algorithm without user interaction." and "the only difference is the algorithm is trained on tricuspid valve images, where the reference device was trained using mitral valve images." but does not provide details on the training set characteristics.)
Description of the test set, sample size, data source, and annotation protocol
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 contributed to the study represented a broad range of demographics, body habitus, and their severity of tricuspid reguration were representative of the intended population.
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. Further, the peak regurgitant flow output from 3D Auto CFQ was also validated against 2D PISA methodology on the same subjects.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
For 3D Auto TV:
Study Type: Performance Validation Study to evaluate automation performance.
Sample Size: Not explicitly stated, but involved cardiac clips from subjects representing broad demographics, body habitus, and severity of tricuspid regurgitation.
Standalone Performance: Not explicitly stated as standalone, but compared against 4D Cardio-View software (K213544) as ground truth.
Key Results: 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:
Study Type: Performance Validation Study to evaluate performance.
Sample Size: Not explicitly stated, but involved subjects.
Standalone Performance: Not explicitly stated as standalone, but compared against cardiac magnetic resonance imaging (CMR) regurgitant volume (RVol) as ground truth and 2D PISA methodology.
Key Results: The 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, 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
For 3D Auto TV:
- Agreement with ground truth (4D Cardio-View) within confidence intervals for limits of agreement: ± 46% (annulus size), ± 52% (annulus shape).
- Relative bias based on inter-observer variability: +/- 17.37% (distance), +/- 23.68% (circumference).
- Mean relative error of measurement primitives on in-silico phantoms: +/- 1%.
- Limits of agreement for in-silico phantoms: +/- 5%.
For 3D Auto CFQ:
- Limits of Agreement (LoA) for regurgitant volume (compared to CMR): -49.29 (lower LoA) and 25.09 (upper LoA).
- 95% CI for LoA: (-58.37 - 40.20) for lower end, (16.01 - 34.18) for upper end.
- Acceptance criteria for maximum allowable difference (Δ): 61.6ml.
- Mean difference (bias) acceptance criteria: +/- 19.2ml.
- Pearson's correlation (compared to 2D PISA for peak flow rate): > 0.8 (acceptance criteria).
Predicate Device(s)
K233788; Philips EPIQ Series Diagnostic Ultrasound System
Reference Device(s)
K213544; TOMTEC-ARENA, TOMTEC Imaging Systems GmbH, K200974; QLAB Advanced Quantification Software
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
2
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
3
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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4
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 and
Address | Philips Ultrasound LLC
22100 Bothell Everett Hwy
Bothell, WA 98021-8431 USA |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information | Mike Chambers
Senior Regulatory Affairs Specialist
22100 Bothell Everett Hwy
Bothell, WA 98021-8431 USA
+1 (315) 262-7702 |
| Secondary Contact | Erdit Gremi
Director, Regulatory Affairs
Philips Ultrasound LLC
22100 Bothell Everett Hwy
Bothell, 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 Image | ||
| Processing 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 GmbH |
| K200974; QLAB Advanced Quantification Software |
5
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.
6
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 Diagnostic
Ultrasound System
Feature: 3D Auto TV
Proposed Device | EPIQ Series Diagnostic
Ultrasound System
K233788
Predicate Device | TOMTEC-ARENA
Feature: 4D CARDIO-
VIEW
K213544
Reference Device | QLAB Advanced
Quantification Software
Feature: 3D Auto MV
K200974
Reference Device | Comparison |
|-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | Abdominal, Cardiac
Adult, Cardiac other
(Fetal). Cardiac
Pediatric, Cerebral
Vascular, Cephalic
(Adult), Cephalic
(Neonatal),
Fetal/Obstetric,
Gynecological,
Intraoperative
(Vascular),
Intraoperative (Cardiac),
intra-luminal, intra-
cardiac echo,
Musculoskeletal
(Conventional),
Musculoskeletal
(Superficial).
Ophthalmic, Other:
Urology, Pediatric,
Peripheral Vessel, Small
Organ (Breast, Thyroid,
Testicle).
Transesophageal
(Cardiac), Transrectal,
Transvaginal, Lung. | Abdominal, Cardiac
Adult, Cardiac other
(Fetal), Cardiac
Pediatric, Cerebral
Vascular, Cephalic
(Adult), Cephalic
(Neonatal),
Fetal/Obstetric,
Gynecological,
Intraoperative
(Vascular),
Intraoperative (Cardiac),
intra-luminal, intra-
cardiac echo,
Musculoskeletal
(Conventional),
Musculoskeletal
(Superficial).
Ophthalmic, Other:
Urology, Pediatric,
Peripheral Vessel, Small
Organ (Breast, Thyroid,
Testicle).
Transesophageal
(Cardiac), Transrectal,
Transvaginal, Lung. | Quantification and
reporting of
cardiovascular, fetal,
and abdominal
structures and functions
of patients with
suspected disease to
support the physician in
the diagnosis. | QLAB Quantification software
is a software application
package. It is designed to view
and quantify image data
acquired on Philips ultrasound
systems | Identical to predicate |
| Intended
Users | Trained healthcare
professionals
Intended for
sonographers,
physicians, and
biomedical engineers
who operate and
maintain your product.
Before use of the
system and user
information, the user
must be familiar with
ultrasound techniques.
Sonography training and
clinical procedures are
not included in the User
Manual or with the EPIQ
Series Diagnostic
Ultrasound System. | Trained healthcare
professionals
Intended for
sonographers,
physicians, and
biomedical engineers
who operate and
maintain your product.
Before use of the
system and user
information, the user
must be familiar with
ultrasound techniques.
Sonography training and
clinical procedures are
not included in the User
Manual or with the EPIQ
Series Diagnostic
Ultrasound System. | Licensed medical
practitioners or assistant
medical technicians | Trained healthcare
professionals | Identical to predicate |
| Feature | EPIQ Series Diagnostic
Ultrasound System
Feature: 3D Auto TV
Proposed Device | EPIQ Series Diagnostic
Ultrasound System
K233788
Predicate Device | TOMTEC-ARENA
Feature: 4D CARDIO-
VIEW
K213544
Reference Device | QLAB Advanced
Quantification Software
Feature: 3D Auto MV
K200974
Reference Device | Comparison |
| Intended User
Environment | Clinics, hospitals, and
clinical point-of-care for
diagnosis of patients. | Clinics, hospitals, and
clinical point-of-care for
diagnosis of patients. | Inside and outside of
Hospitals, Clinics, and
Physician's offices | Clinics, hospitals, and clinical
point-of-care for diagnosis of
patients. | Identical to predicate |
| USA FDA
Classification | Class II | Class II | Class II | Class II | Identical to predicate |
| Primary
Product Code | IYN | IYN | QIH | QIH | Identical to predicate |
| Application
Description | The 3D Auto TV
software solution is
intended for use with the
Philips EPIQ Diagnostic
Ultrasound Systems.
The 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 predicate EPIQ
Series Diagnostic
Ultrasound System does
not currently have a
dedicated software
application for
quantification of the
tricuspid valve annulus.
The subject of this
submission is to
introduce the 3D Auto
TV software onto the
predicate device. | 4D CARDIO-VIEW is an
advanced analysis tool
for 3D/4D
echocardiography data.
Anatomical structure
visualization, volume
measurements (LV
and/or generic), and
specified or manual
measurements are
possible for cardiac
structures including, but
not limited to, the
tricuspid valve. Various
tools are available for
rendering that display 2-
and 3-dimensional
morphology and
function for defined
structures. | 3D Auto MV is a semi-
automated software
application intended for the
analysis of Mitral Valve (MV)
anatomy and function. This
application generates models
of anatomical structures of
interest such as the MV
annulus, leaflets, and the
closure line, which allows for
quantification of pre- and post-
operative valvular function and
a comparison of morphology. | Similar to the reference
device features.
The functionality and
workflow of the 3D Auto
TV software is very
similar to the 3D Auto
MV tool, where
measurement
parameters are derived
from models of the
mitral valve (in the case
of 3D Auto MV) and
tricuspid valve (in the
case of 3D Auto TV).
Manual measurements
are also able to be
performed on both
software applications.
Comparing 3D Auto TV
to 4D CARDIO-VIEW,
both software have
functionality for
quantifying the tricuspid
valve. The proposed 3D
Auto TV allows for semi-
automated
quantification, where the
reference device is fully
manual. As we
demonstrate high
agreement in the
measurement outputs
on the same patients
when quantified using
the proposed 3D Auto
TV software and the
reference 4D CARDIO-
VIEW application, there
are no new questions
raised of safety or
effectiveness. |
| Contour
Generation | 3D surface model is
created semi-
automatically using
machine learning
algorithm without user
interaction. User is able
to edit, accept, or reject
the initial landmark | No standard tricuspid
valve (TV) quantification
parameters included as
part of the system. | 3D surface model is
created based on user
defined anatomical
landmarks. User is able
to edit the contour of the
surface model before
proceeding with the
workflow. | 3D surface model is created
semi-automatically using
machine learning algorithm
without user interaction. User
is able to edit, accept, or reject
the initial landmark proposals
of the mitral valve anatomical
locations. | Subject device uses
identical method for
contour generation as
the reference device
K200974. The only
difference is the
algorithm is trained on
tricuspid valve images,
where the reference |
| Feature | EPIQ Series Diagnostic
Ultrasound System
Feature: 3D Auto TV
Proposed Device | EPIQ Series Diagnostic
Ultrasound System
K233788
Predicate Device | TOMTEC-ARENA
Feature: 4D CARDIO-VIEW
K213544
Reference Device | QLAB Advanced
Quantification Software
Feature: 3D Auto MV
K200974
Reference Device | Comparison |
| | valve anatomical
locations. | | | | device was trained using
mitral valve images. |
| Measurement
s Performed | Semi-auto annulus
results 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 tricuspid
valve (TV) quantification
parameters included as
part 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 (not
related to TV
quantification) 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 proposed
3D Auto TV software
allows very similar semi-
automated
measurements as the
reference software
application 3D Auto MV,
only applied to the
tricuspid valve.
The proposed 3D Auto
TV software adds
additional TV annulus
and device
measurements from
those available in 4D
CARDIO-VIEW to
further define the
tricuspid valve anatomy.
Both the proposed 3D
Auto TV and the
reference 4D CARDIO-
VIEW software allow
manual, free-form
measurements of the
tricuspid valve. |
| Feature | EPIQ Series Diagnostic
Ultrasound System
Feature: 3D Auto CFQ
Proposed Device | EPIQ Series Diagnostic
Ultrasound System
K233788
Predicate Device | QLAB Advanced Quantification
Software
Feature: 3D Auto MV
K200974
Reference Device | Comparison | |
| Indications for
Use | Abdominal, Cardiac Adult,
Cardiac other (Fetal), Cardiac
Pediatric, Cerebral Vascular,
Cephalic (Adult), Cephalic
(Neonatal), Fetal/Obstetric,
Gynecological, Intraoperative
(Vascular), Intraoperative
(Cardiac), intra-luminal, intra-
cardiac echo, Musculoskeletal
(Conventional), Musculoskeletal
(Superficial), Ophthalmic, Other:
Urology, Pediatric, Peripheral
Vessel, Small Organ (Breast,
Thyroid, Testicle),
Transesophageal (Cardiac),
Transrectal, Transvaginal, Lung. | Abdominal, Cardiac Adult,
Cardiac other (Fetal), Cardiac
Pediatric, Cerebral Vascular,
Cephalic (Adult), Cephalic
(Neonatal), Fetal/Obstetric,
Gynecological, Intraoperative
(Vascular), Intraoperative
(Cardiac), intra-luminal, intra-
cardiac echo, Musculoskeletal
(Conventional), Musculoskeletal
(Superficial), Ophthalmic, Other:
Urology, Pediatric, Peripheral
Vessel, Small Organ (Breast,
Thyroid, Testicle),
Transesophageal (Cardiac),
Transrectal, Transvaginal, Lung. | QLAB Quantification software is a
software application package. It
is designed to view and quantify
image data acquired on Philips
ultrasound systems | Identical to predicate | |
| | Trained healthcare professionals | Trained healthcare professionals | Trained healthcare professionals | Identical | |
| | Intended for sonographers,
physicians, and biomedical
engineers who operate and
maintain your product. | Intended for sonographers,
physicians, and biomedical
engineers who operate and
maintain your product. | | | |
| Intended Users | Before use of the system and
user information, the user must
be familiar with ultrasound
techniques. Sonography training
and clinical procedures are not
included in the User Manual or
with the EPIQ Series Diagnostic
Ultrasound System. | Before use of the system and
user information, the user must
be familiar with ultrasound
techniques. Sonography training
and clinical procedures are not
included in the User Manual or
with the EPIQ Series Diagnostic
Ultrasound System. | | | |
| Intended User
Environment | Clinics, hospitals, and clinical
point-of-care for diagnosis of
patients. | Clinics, hospitals, and clinical
point-of-care for diagnosis of
patients. | Clinics, hospitals, and clinical
point-of-care for diagnosis of
patients. | Identical | |
| USA FDA
Classification | Class II | Class II | Class II | Identical | |
| Primary Product
Code | IYN | IYN | QIH | Identical to predicate | |
| Application
Description | 3D Auto CFQ is a new semi-
automated quantification software
which will be introduced on the
EPIQ Ultrasound Systems from
software version VM11.0. The
application provides semi-
automated quantification of Mitral
Regurgitation (MR) volume and
peak flow rate by analyzing 3D
color flow images acquired during
transesophageal
echocardiography (TEE)
examinations. | The Proximal Isovelocity Surface
Area (PISA) methodology can be
used currently on the predicate
device to quantify valvular
regurgitation. The technique
utilizes 2D/Color and Doppler
images to allow the user to make
simple, manual measurements in
a cascading fashion to allow
calculation of peak flow rate and
volumetric regurgitation. | 3D Auto MV is a semi-automated
software application intended for
the analysis of Mitral Valve (MV)
anatomy and function. This
application generates models of
anatomical structures of interest
such as the MV annulus, leaflets,
and the closure line, which allows
for quantification of pre- and post-
operative valvular function and a
comparison of morphology. | Similar. The predicate device
facilitates the quantification of
mitral regurgitation volume
and peak flow rate through a
group of measurements which
are performed in a cascading
fashion manually by the user
according to the Proximal
Isovelocity Surface Area
(PISA) methodology. The
proposed 3D Auto CFQ
software application allows
the users to quantify the same
measurements for mitral
regurgitation volume and peak
flow rate but in a semi- | |
| Feature | EPIQ Series Diagnostic
Ultrasound System
Feature: 3D Auto CFQ
Proposed Device | EPIQ Series Diagnostic
Ultrasound System
K233788
Predicate Device | QLAB Advanced Quantification
Software
Feature: 3D Auto MV
K200974
Reference Device | Comparison | |
| | | | | The reference device does not
contain functionality for
quantification of mitral
regurgitation. | |
| Contour
Generation | 3D surface model is created
semi-automatically using
machine learning algorithm
without user interaction. User is
able to edit, accept, or reject the
initial landmark proposals of the
mitral valve anatomical locations. | No standard contour generation
technology for the mitral valve,
outside of 3D Auto MV, included
as part of the system. | 3D surface model is created
semi-automatically using
machine learning algorithm
without user interaction. User is
able to edit, accept, or reject the
initial landmark proposals of the
mitral valve anatomical locations. | Subject device uses identical
method for contour generation
as the reference device
K200974 | |
| Quantification
Technology for
Mitral
Regurgitation | The 3D Auto CFQ algorithm
quantifies mitral regurgitation
volume and flow rate from
acquired 3D color flow images.
The greyscale information from
these images is used to generate
a 3D model of the mitral valve,
which is used as an input along
with the 3D color data into the 3D
Auto CFQ flow algorithm. The 3D
Auto CFQ algorithm uses a fluid
dynamic model of an
incompressible fluid (blood)
traveling through an irregular-
shaped (i.e., nonround) orifice. In
its initial step, the algorithm
generates a hypothetical model
of true blood flow velocities in the
proximal convergence zone
based on all measured Doppler
velocities and the underlying fluid
dynamics model. The true
velocity model is then converted
into the corresponding apparent
Doppler velocity model
("synthetic apparent velocities")
using ultrasound physics
(projection along the axial
dimension). These synthetic
velocities are subsequently
compared to the acquired
velocities in the Color Flow (CF)
data set. Based on the outcome
of this comparison, the model is
updated and reiterated to get
the best fit between the acquired
velocities and the generated
model. 3D Auto CFQ determines
the resulting requrgitant flow rate
for this frame. This process is
repeated for each frame included
in the analysis, which in most
cases includes the entire systolic
cycle. In each frame, the size and
shape of the
regurgitant orifice is not assumed
but is generated by this iterative
loop between the model and the
CF data. | The PISA methodology uses
sequential acquisitions and
manual measurements, which
are manually performed by the
user:
· MR Alias Velocity (from the
2D/Color)
· MR Radius (from the 2D/Color)
· MR Vmax (from the continuous
wave doppler)
• MR VTI (from the continuous
wave doppler)
The outputs of these
measurements go into the
equations for the derived
measurements including:
· Mitral Regurgitant (MR) Flow
Rate
· MR Effective Regurgitant
Orifice (ERO)
• MR Volume | N/A - does not contain
technology for mitral regurgitation
quantification | Similar. The predicate device
utilizes the PISA methodology
for quantifying MR volume
and flow rate. This
methodology utilizes
sequential measurements
performed by the user and is
based on assumptions
including there being a single,
round, constant flow orifice
during the entire systole.
3D Auto CFQ operates using
3D color to address the spatial
complexities seen in mitral
regurgitation and was
developed to evaluate the
regurgitant flow at every frame
in systole, where the PISA
methodology only assesses
one frame during systole and
assumes this frame applies
across systole.
The proposed 3D Auto CFQ
software application allows
the users to quantify the same
measurements for mitral
regurgitation volume and peak
flow rate as PISA. The
dynamic flow algorithm is the
new technology introduced in
this submission. Everything
leading up to the calculations
by the dynamic flow model are
existing and cleared, including
the transducer and imaging
modes (X8-2t transducer; 3D
Zoom, Full Volume 3D, or Live
3D; K163120), and software
for mitral valve model
generation (reference device
K200974). The dynamic flow
model of the 3D Auto CFQ
software application uses
these as inputs to arrive at the
outputs of mitral regurgitation
volume and peak flow rate.
These outputs are the same
as in the predicate, only the
method to arrive at the | |
| Feature | EPIQ Series Diagnostic
Ultrasound System
Feature: 3D Auto CFQ
Proposed Device | EPIQ Series Diagnostic
Ultrasound System
K233788
Predicate Device | QLAB Advanced Quantification
Software
Feature: 3D Auto MV
K200974
Reference Device | Comparison | |
| | | | | measurements differs in the
subject device. | |
| Compatible
transducers | 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 CFQ software
application can analyze
transesophageal
echocardiography (TEE) images
acquired by the cleared X8-2t
transducer (K163120), which is
already commercially available
and compatible with the EPIQ
Ultrasound 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 software
application is compatible with the
following transducers: X7-2t, X8-
2t, X11-4t | Identical. There are no new
transducers introduced in this
510(k).
The 3D Auto CFQ software
application can analyze
transesophageal
echocardiography (TEE)
images acquired by the
cleared X8-2t transducer
(K163120), which is already
commercially available and
compatible with the EPIQ
Ultrasound System.
There are no impacts to the
indications for use or intended
use of the X8-2t transducer
when used for the purposes of
acquiring images for analysis
by the 3D Auto CFQ software
application. The 3D Auto CFQ
software application requires
images to be acquired in
either 3D Zoom, Full Volume
3D, or Live 3D imaging
modes. There are no changes
to these existing transducer
imaging modes. | |
| Measurements
Performed | Semi-automated measurements
performed by the 3D Auto CFQ
software application:
Mitral regurgitation (MR) volume
[mL];
Peak flow rate [mL/s] | Derived measurements which the
user can obtain through the PISA
methodology 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 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) | Similar. The measurements
performed by the proposed
3D Auto CFQ software
application can also be
obtained by a user on the
predicate device.
Substantiation of the
performance of the 3D Auto CFQ
software's regurgitant
volume output was performed
by comparison to cardiac
magnetic resonance imaging
(CMR) images with
acceptance criteria of
agreement within the limits of
agreement. While the PISA
methodology is a widely
accepted method for mitral
regurgitation quantification
and is a recommended
method by the American
Society of Echocardiography,
the outputs from 3D Auto CFQ
were compared to those from
CMR (as opposed to PISA) as
the former is considered a
gold standard for mitral
regurgitation quantification.
Acceptance criteria for 3D
Auto CFQ was based on | |
| Feature | EPIQ Series Diagnostic
Ultrasound System
Feature: 3D Auto CFQ
Proposed Device | EPIQ Series Diagnostic
Ultrasound System
K233788
Predicate Device | QLAB Advanced Quantification
Software
Feature: 3D Auto MV
K200974
Reference 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 Annulus
Perimeter (cm)
• Total Open Coaptation Area
(cm2)
• Anterior Closure Line Length
(cm)
• Posterior Closure Line Length
(cm) | agreement with CMR being
within predefined maximum
limits of agreement.
In addition to regurgitant
volume, the peak flow rate
output of 3D Auto CFQ was
validated in comparison to
manual PISA method, where
the correlation was very high.
The reference device
K200974 facilitates
anatomical measurements of
the mitral valve from the
generated model of the mitra
valve but does not perform
measurements for quantifying
mitral regurgitation. | |
Table 1: Comparison to Predicate for introduction of 3D Auto TV onto EPIQ
7
PHILIPS
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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
13
PHILIPS
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.