(58 days)
EPIQ: The intended use of EPIQ Ultrasound Diagnostic System is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), intra-luminal, intra-cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung. Modes of operation include: B Mode, M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode . Power Doppler and Harmonic Imaging. The clinical environments where EPIQ Series Diagnostic Ultrasound Systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients. When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live echo quidance. The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.
Affiniti: The intended use of Affiniti Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use. Abdominal, Cardiac Adult, Cardiac Other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung. Modes of operation include: B Mode, M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode , Power Doppler and Harmonic Imaging. The clinical environments where the Affiniti diagnostic ultrasound systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients. The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.
The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the change in AutoMeasure V3 software application onto the EPIQ Series Diagnostic Ultrasound Systems and Affiniti Series Diagnostic Ultrasound Systems. Philips AutoMeasure feature provides the end user semi-automated 2D, Doppler and M-mode measurements with an adult cardiology transthoracic transducer and acquisitions that includes an electrocardiogram (ECG). The Auto Measure feature is designed to provide semi-automated and editable measures during an echocardiography. When Auto Measure is enabled, the healthcare professional performs an echocardiography with a workflow that provides the user with a semiautomated measurement that can be edited, accepted, or rejected. AutoMeasure is available in the Adult Echo analysis applications with ECG. Availability is also controlled by transducer and preset via the EPM. The software applications are supported by all EPIQ and Affiniti models running software version 13.0 or higher.
Here's an analysis of the acceptance criteria and study proving the device meets those criteria, based on the provided FDA 510(k) summary for Philips AutoMeasure V3 software.
Overview of the Device and Study:
The Philips AutoMeasure V3 software is an optional feature for EPIQ and Affiniti Series Diagnostic Ultrasound Systems. It provides semi-automated 2D, Doppler, and M-mode measurements during adult transthoracic echocardiography (TTE) using an AI-algorithm trained via machine learning. The study aimed to evaluate the performance of AutoMeasure V3 compared to standard of care (SOC) measurements.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list a table of acceptance criteria in numerical ranges for specific performance metrics (e.g., "accuracy > X%"). Instead, it describes a general acceptance methodology:
Acceptance Criteria for AutoMeasure V3 Software:
"meeting the pre-defined acceptance criteria for the study. Taken together, the results of the study demonstrated clinically reasonable, relevant and meaningful performance of the AutoMeasure V3 software supporting automation of measurements during cardiac TTE exams. Specifically, success on the hypotheses testing for AutoMeasure V3 agreement with ground truth measurements indicate that the safety and effectiveness of the proposed software is acceptable and aligns with previously reported agreement for cardiac assessment. Since the acceptance criteria were based on inter-observer data for echocardiographic measurements, the AutoMeasure V3 performance supports the conclusion that the algorithm behaves like any average human observer. Therefore, the clinical acceptability of AutoMeasure V3 is met."
This implies that the acceptance criteria for each of the 32 tested hypotheses were based on achieving agreement within the confidence intervals typically observed between human observers for echocardiographic measurements. The specific numerical thresholds for these confidence intervals are not provided in the summary.
Reported Device Performance:
The study concluded: "The results of the 32 hypotheses tested, demonstrated high agreement of AutoMeasure V3 software with Standard of Care Measurements (ground truth) obtained during initial subject exam, by producing confidence intervals for the limits of agreement, for each parameter (hypothesis) tested, meeting the pre-defined acceptance criteria for the study."
This indicates that for all 32 tested parameters, the AutoMeasure V3's performance was within the pre-defined limits of agreement, deemed comparable to human inter-observer variability.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 7127 transthoracic echocardiography (TTE) cardiac clips from 3964 subjects.
- Data Provenance: Retrospective, multi-institutional.
- Country of Origin: USA, Asia, and Europe.
- Retrospective/Prospective: "Subjects were enrolled at institutions between 2015 and June 2024, and the timeframes varied for different hospitals." This indicates retrospective data collection from existing patient records/imaging archives.
- Nature of Data: "Patients referred for clinical TTE as well as healthy volunteers were invited to participate."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not explicitly stated as a specific number of unique experts who reviewed the test set for adjudication. The document states "Standard of Care (SOC) measurements obtained during initial subject visit, performed by qualified healthcare professional(s)." This implies that the ground truth was established by the original healthcare professional(s) performing the TTE exam in clinical practice.
- Qualifications of Experts: "qualified healthcare professional(s)". Specific qualifications (e.g., radiologist, cardiologist, sonographer, years of experience) are not detailed beyond "qualified". Given the context of echocardiography, these would likely be sonographers or cardiologists.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly described. The ground truth was based on "Standard of Care (SOC) measurements obtained during initial subject visit." This suggests a single reader paradigm where the initial clinical measurement serves as the ground truth, rather than a multi-reader consensus process specifically for the study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, a traditional MRMC comparative effectiveness study where multiple human readers systematically re-read cases with and without AI assistance was not explicitly described. The study focused on the agreement between the AI's measurements and existing Standard of Care human measurements.
- Effect Size of Human Improvement with AI Assistance: Not applicable, as this type of MRMC study was not performed. The study aimed to show that the AI's measurements were comparable to typical human variability.
6. If a Standalone (Algorithm Only) Performance Study Was Done
- Standalone Performance: Yes, implicitly. The "Performance Validation Study" evaluated "the performance of the AutoMeasure V3 software... compared to ground truth." While the user can edit the semi-automated measurements, the study's focus on "agreement of AutoMeasure V3 software with Standard of Care Measurements" suggests an evaluation of the algorithm's initial output before human intervention, establishing its standalone capability. The document states, "AutoMeasure V3 is created semi-automatically using machine learning algorithm without user interaction."
7. The Type of Ground Truth Used
- Type of Ground Truth: Expert consensus (implicitly, as SOC measurements by "qualified healthcare professional(s)"). More specifically, it is "Standard of Care (SOC) measurements obtained during initial subject visit". This suggests reliance on clinical practice measurements rather than a separate, dedicated "gold standard" panel review or pathological confirmation.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not explicitly stated in this 510(k) summary. The document mentions "training via machine-learning techniques" but does not give the size of the dataset used for this training.
9. How the Ground Truth for the Training Set Was Established
- Training Set Ground Truth Establishment: Not explicitly stated in this 510(k) summary. However, it's highly probable that the training data's ground truth was also established by human expert annotation or existing clinical measurements, similar to how the test set ground truth was derived.
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February 6, 2025
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 the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Philips Ultrasound LLC Deval Patel Principal Regulatory Affairs Specialist 22100 Bothell Everett Hwy Bothell, Washington 98021
Re: K243794
Trade/Device Name: EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX, OBJ, OIH Dated: December 10, 2024 Received: December 10, 2024
Dear Deval Patel:
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.
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-regulatory
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
YANNA S. KANG -S
Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
EPIQ Series Diagnostic Ultrasound System Affiniti Series Diagnostic Ultrasound System
Indications for Use (Describe)
Eblo:
The intended use of EPIQ Ultrasound Diagnostic System is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:
Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), intra-luminal, intra-cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.
Modes of operation include: B Mode, M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode . Power Doppler and Harmonic Imaging.
The clinical environments where EPIQ Series Diagnostic Ultrasound Systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.
When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live echo quidance.
The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.
Affiniti:
The intended use of Affiniti Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use.
Abdominal, Cardiac Adult, Cardiac Other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.
Modes of operation include: B Mode, M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode , Power Doppler and Harmonic Imaging.
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The clinical environments where the Affiniti diagnostic ultrasound systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.
The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.
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: K243794
Date Prepared: October 10, 2024
Date of Revision: February 5, 2025
| I. | Submitter | |
|---|---|---|
| Manufacturer Name andAddress | Philips Ultrasound LLC22100 Bothell Everett HwyBothell, WA 98021-8431 USA | |
| Contact Information | Deval PatelPrincipal Regulatory Affairs Specialist22100 Bothell Everett HwyBothell, WA 98021-8431 USA+1 (949) 502-1823 | |
| Secondary Contact | Erdit GremiDirector, Regulatory AffairsPhilips Ultrasound LLC22100 Bothell Everett HwyBothell, WA 98021-8431 USA+1 (617) 798-8092 |
II. Device
| Proprietary Name | EPIQ Series Diagnostic Ultrasound SystemAffiniti Series Diagnostic Ultrasound System |
|---|---|
| Common Name | Diagnostic Ultrasound System and Transducers |
| Regulation Description | Classification Description | 21 CFR § | Product Code |
|---|---|---|---|
| Primary | |||
| System, imaging, pulsed doppler,ultrasonic | 892.1550 | IYN | |
| Secondary | |||
| System, imaging, pulsed echo,ultrasonic | 892.1560 | IYO | |
| Transducer, ultrasonic, diagnostic | 892.1570 | ITX | |
| Medical image management andprocessing system | 892.2050 | QIH | |
| Diagnostic Intravascular Catheter | 870.1200 | OBJ | |
| Device Class | Class II |
| Review Panel | Radiology |
|---|---|
| -------------- | ----------- |
Predicate Device K240850; Philips EPIQ Series Diagnostic Ultrasound System and Philips Affiniti Series Diagnostic Ultrasound System
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| Predicate RegulationDescription | Classification Description | 21 CFR § | Product Code |
|---|---|---|---|
| Primary | System, imaging, pulsed doppler,ultrasonic | 892.1550 | |
| Secondary | System, imaging, pulsed echo,ultrasonic | 892.1560 | IYO |
| Transducer, ultrasonic, diagnostic | 892.1570 | ITX | |
| Medical image management andprocessing system | 892.2050 | QIH | |
| Diagnostic Intravascular Catheter | 870.1200 | OBJ |
III. Device Description
The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the change in AutoMeasure V3 software application onto the EPIQ Series Diagnostic Ultrasound Systems and Affiniti Series Diagnostic Ultrasound Systems.
Philips AutoMeasure feature provides the end user semi-automated 2D, Doppler and M-mode measurements with an adult cardiology transthoracic transducer and acquisitions that includes an electrocardiogram (ECG). The Auto Measure feature is designed to provide semi-automated and editable measures during an echocardiography. When Auto Measure is enabled, the healthcare professional performs an echocardiography with a workflow that provides the user with a semiautomated measurement that can be edited, accepted, or rejected. AutoMeasure is available in the Adult Echo analysis applications with ECG. Availability is also controlled by transducer and preset via the EPM.
The software applications are supported by all EPIQ and Affiniti models running software version 13.0 or higher.
IV. Intended Use and Indications for Use
EPIQ Intended Use
The intended use of EPIQ Ultrasound Diagnostic System is diagnostic ultrasound imaging and fluid flow analysis of the human body.
EPIQ Indications for Use:
The intended use of EPIQ Ultrasound Diagnostic System is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:
Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), intra-luminal, intra-cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.
Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler and Harmonic Imaging.
The clinical environments where EPIQ Series Diagnostic ultrasound Systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.
When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live echo guidance.
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The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.
Affiniti Intended Use
The intended use of Affiniti Ultrasound Diagnostic ultrasound imaging and fluid flow analysis of the human body.
Affiniti Indications for Use:
The intended use of Affiniti Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:
Abdominal, Cardiac Adult, Cardiac Other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaqinal, Lunq.
Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler and Harmonic Imaging.
The clinical environments where the Affiniti diagnostic ultrasound systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.
The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information.
Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.
Note: There are no changes to the EPIQ and Affiniti Ultrasound System Indications for Use due to the introduction of the AutoMeasure software applications
V. Comparison of Technological Characteristics with the Predicate
The purpose of the submission is to introduce the change to AutoMeasure V3 software applications to the EPIQ Series Diagnostic Ultrasound System and Affiniti Series Diagnostic Ultrasound System. The subject device is substantially equivalent to the predicate device (K240850).
The following tables provide an overview of the comparison of similarities and differences between the proposed device and the predicates.
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DHILIPS
Table 1: Comparison to Predicate for modification of AutoMeasure V3 onto EPIQ
| Feature | EPIQ Series Diagnostic Ultrasound SystemFeature: AutoMeasure V3Proposed Device | EPIQ Series Diagnostic Ultrasound SystemK240850Predicate Device | Comparison |
|---|---|---|---|
| Indications forUse | 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, PeripheralVessel, Small Organ (Breast, Thyroid, Testicle),Transesophageal (Cardiac), Transrectal, Transvaginal,Lung. | Identical to predicate |
| Intended Users | Trained healthcare professionalsIntended for sonographers, physicians, andbiomedical engineers who operate andmaintain your product.Before use of the system and userinformation, the user must be familiar withultrasound techniques. Sonography trainingand clinical procedures are not included inthe User Manual or with the EPIQ SeriesDiagnostic Ultrasound System. | Trained healthcare professionalsIntended for sonographers, physicians, and biomedicalengineers who operate and maintain your product.Before use of the system and user information, the usermust be familiar with ultrasound techniques.Sonography training and clinical procedures are notincluded in the User Manual or with the EPIQ SeriesDiagnostic Ultrasound System. | Identical to predicate |
| Intended UserEnvironment | Clinics, hospitals, and clinical point-of-carefor diagnosis of patients. | Clinics, hospitals, and clinical point-of-care fordiagnosis of patients. | Identical to predicate |
| USA FDAClassification | Class II | Class II | Identical to predicate |
| Primary ProductCode | IYN | IYN | Identical to predicate |
| PrimaryRegulation Name | System, Imaging, Pulsed Doppler, Ultrasonic | System, Imaging, Pulsed Doppler, Ultrasonic | Identical to predicate |
| Feature | EPIQ Series Diagnostic Ultrasound SystemFeature: AutoMeasure V3Proposed Device | EPIQ Series Diagnostic Ultrasound SystemK240850Predicate Device | Comparison |
| PrimaryRegulationNumber | 21 CFR 892.1550 | 21 CFR 892.1550 | Identical to predicate |
| SecondaryProduct Codes | ITXIYOOBJQIH | ITXIYOOBJQIH | Identical to predicate |
| SecondaryRegulation Name | Diagnostic ultrasonic transducerUltrasonic pulsed echo imagingsystemDiagnostic intravascular catheterAutomated Radiological ImageProcessing Software | Diagnostic ultrasonic transducerUltrasonic pulsed echo imagingsystemDiagnostic intravascular catheterAutomated Radiological ImageProcessing Software | Identical to predicate |
| SecondaryRegulationNumber | 21 CFR 892.157021 CFR 892.156021 CFR 870.120021 CFR 892.2050 | 21 CFR 892.157021 CFR 892.156021 CFR 870.120021 CFR 892.2050 | Identical to predicate |
| Reusable-Systems andTransducers | Yes | Yes | Identical to predicate |
| Duration of use | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Identical to predicate |
| ApplicationDescription | Auto Measure is an optional software featureon the EPIQ Series Diagnostic UltrasoundSystem that provides the end user withsemiautomated adult echocardiography 2D,Doppler or M-mode measurements throughan Al-algorithm, training via machine-learningtechniques.It is intended to be used with an AdultCardiology Transthoracic transducer andacquisitions that include an ECG. Thesemeasurements are routinely collected duringa transthoracic ECG.2D modes include the following:IVSdLVIDdLVPWdLVIDsAsc Ao DiamLA Vol, A2CsLA Vol, A4CsLA Diameter a.p. (PLAX)RA Volume | Auto Measure is an optional software feature on theEPIQ Series Diagnostic Ultrasound System thatprovides the end user with semiautomated adultechocardiography 2D and Doppler measurementsthrough an Al-algorithm, training via machine-learningtechniques.It is intended to be used with an Adult CardiologyTransthoracic transducer and acquisitions that includean ECG. These measurements are routinely collectedduring a transthoracic ECG.2D modes include the following:IVSdLVIDdLVPWdLVIDSAsc Ao DiamDoppler modes include the following:MV Peak E Vel,MV Peak A Vel MV Inflow (MV Dec Time, MV Peak EVel, MV Peak A Vel) LVOT VTI, LVOT Vmax AV VTI,AV Vmax PV VTI, PV Vmax TR Vmax Lat E' Vel, Lat A' | Similar to the reference device features.The functionality and workflow of theAutoMeasure V3 software is Identical topredicate where Auto Measure quantifiesimage data acquired on the Philips EPIQUltrasound System through an Al basedalgorithm that used a trained machine-learning model.Compared to predicate only newmeasurements and detectors are added tothe existing measurements. Clinicalperformance studies were completed, andthe results showed safety and effectiveness |
| Feature | EPIQ Series Diagnostic Ultrasound SystemFeature: AutoMeasure V3Proposed Device | EPIQ Series Diagnostic Ultrasound SystemK240850Predicate Device | Comparison |
| AoR Diam(2D) = Ao Annlus diamDoppler modes include the following:MV Peak E Vel,MV Peak A Vel MV Inflow (MV Dec Time, MVPeak E Vel, MV Peak A Vel) LVOT VTI,LVOT Vmax AV VTI, AV Vmax PV VTI, PVVmax TR Vmax Lat E' Vel, Lat A' Vel Lat Vel(Lat E' Vel, Lat A' Vel) Med E' Vel, Med A'Vel Med Vel (Med E' Vel, Med A' Vel) RV SVel, MR VTITR VTIM-Modes include the following: TAPSE | Vel Lat Vel (Lat E' Vel, Lat A' Vel) Med E' Vel, Med A'Vel Med Vel (Med E' Vel, Med A' Vel) RV S Vel | ||
| Semi-AutomationTechnology | AutoMeasure V3 is created semi-automatically using machine learningalgorithm without user interaction. Semi-automated adult echocardiography 2D,Doppler and M-mode measurements aregenerated using an artificial intelligence (AI)detection algorithm without userinteraction. After measurement is generated,the user can edit (manually adjust the caliperpositions), accept, or reject themeasurements. | AutoMeasure V3 is created semi-automatically usingmachine learning algorithm without user interaction.Semi-automated adult echocardiography 2D andDoppler measurements are generated using an artificialintelligence (AI) detection algorithm without userinteraction. After measurement is generated, the usercan edit (manually adjust the caliperpositions), accept, or reject the measurements. | Subject device uses identical method forcontour generation as the reference deviceK240850. The only difference is thealgorithm is new M-mode measurement isadded, new detectors are added, andexisting detectors are re-trained based onnew literature available. |
| User Interface | User selects an adult echocardiography 2D,Doppler or M-mode measurement to performthen the caliper positions are initialized basedon the output of the Al detection algorithm.The user can edit, accept, or reject themeasurements. | User selects an adult echocardiography 2D or Dopplermeasurement to perform then the caliper positions areinitialized based on the output of the Al detectionalgorithm.The user can edit, accept, or reject themeasurements. | Similar. The proposed AutoMeasure V3software allows very similar semi-automatemeasurements as the reference softwareapplication AutoMeasure.The proposed Auto Measure V3 softwareadds additional M-mode measurement andnew detectors to the existing measurements(2D and Doppler). |
| Feature | Affiniti Series Diagnostic Ultrasound SystemFeature: AutoMeasure V3Proposed Device | Affiniti Series Diagnostic Ultrasound SystemK240850Predicate Device | Comparison |
| Indications forUse | 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. | Identical to predicate |
| Intended Users | Trained healthcare professionalsIntended for sonographers, physicians, andbiomedical engineers who operate andmaintain your product.Before use of the system and userinformation, the user must be familiar withultrasound techniques. Sonography trainingand clinical procedures are not included inthe User Manual or with the Affiniti SeriesDiagnostic Ultrasound System. | Trained healthcare professionalsIntended for sonographers, physicians, andbiomedical engineers who operate and maintainyour product.Before use of the system and user information,the user must be familiar with ultrasoundtechniques. Sonography training and clinicalprocedures are not included in the User Manualor with the Affiniti Series Diagnostic UltrasoundSystem. | Identical to predicate |
| Intended UserEnvironment | Clinics, hospitals, and clinical point-of-care fordiagnosis of patients. | Clinics, hospitals, and clinical point-of-care fordiagnosis of patients. | Identical to predicate |
| USA FDAClassification | Class II | Class II | Identical to predicate |
| Primary ProductCode | IYN | IYN | Identical to predicate |
| PrimaryRequlation Name | System, Imaging, Pulsed Doppler, Ultrasonic | System, Imaging, Pulsed Doppler, Ultrasonic | Identical to predicate |
| Feature | Affiniti Series Diagnostic Ultrasound SystemFeature: AutoMeasure V3Proposed Device | Affiniti Series Diagnostic Ultrasound SystemK240850Predicate Device | Comparison |
| PrimaryRegulationNumber | 21 CFR 892.1550 | 21 CFR 892.1550 | Identical to predicate |
| SecondaryProduct Codes | ITXIYOOBJQIH | ITXIYOOBJQIH | Identical to predicate |
| SecondaryRegulation Name | Diagnostic ultrasonic transducerUltrasonic pulsed echo imagingsystemDiagnostic intravascular catheterAutomated Radiological ImageProcessing Software | Diagnostic ultrasonic transducerUltrasonic pulsed echo imagingsystemDiagnostic intravascular catheterAutomated Radiological ImageProcessing Software | Identical to predicate |
| SecondaryRegulationNumber | 21 CFR 892.157021 CFR 892.156021 CFR 870.120021 CFR 892.2050 | 21 CFR 892.157021 CFR 892.156021 CFR 870.120021 CFR 892.2050 | Identical to predicate |
| Reusable-Systems andTransducers | Yes | Yes | Identical to predicate |
| Duration of use | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Identical to predicate |
| ApplicationDescription | Auto Measure is an optional software featureon the Affiniti Series Diagnostic UltrasoundSystem that provides the end user withsemiautomatedadult echocardiography 2D, Doppler or M-mode measurements through an Al-algorithm, trainingvia machine-learning techniques.It is intended to be used with an AdultCardiology Transthoracic transducer andacquisitions that include an ECG. Thesemeasurements are routinely collected duringa transthoracic ECG.2D modes include the following:IVSdLVIDdLVPWdLVIDs | Auto Measure is an optional software feature onthe Affiniti Series Diagnostic Ultrasound Systemthat provides the end user with semiautomatedadult echocardiography 2D or Dopplermeasurements through an Al-algorithm, trainingvia machine-learning techniques.It is intended to be used with an AdultCardiology Transthoracic transducer andacquisitions that include an ECG. Thesemeasurements are routinely collected during atransthoracic ECG.2D modes include the following:IVSdLVIDdLVPWdLVIDsAsc Ao Diam | Similar to the reference device features.The functionality and workflow of theAutoMeasure V3 software is Identical topredicate where AutoMeasure quantifies imagedata acquired on the Philips Affiniti UltrasoundSystem through an Al based algorithm that useda trained machine-learningmodel.Compared to predicate only new measurementsand detectors are added to the existingmeasurements. Clinical performance studieswere completed, and the results showed safetyand effectiveness |
| Asc Ao DiamLA Vol, A2CsLA Vol, A4CsLA Diameter a.p. (PLAX) | Doppler modes include the following:MV Peak E Vel,MV Peak A Vel MV Inflow (MV Dec Time, MVPeak E Vel, MV Peak A Vel) LVOT VTI, LVOT | ||
| Feature | Affiniti Series Diagnostic Ultrasound SystemFeature: AutoMeasure V3Proposed Device | Affiniti Series Diagnostic Ultrasound SystemK240850Predicate Device | Comparison |
| RA VolumeAoR Diam(2D) = Ao Annulus diamDoppler modes include the following:MV Peak E Vel,MV Peak A Vel MV Inflow (MV Dec Time, MVPeak E Vel, MV Peak A Vel) LVOT VTI,LVOT Vmax AV VTI, AV Vmax PV VTI, PVVmax TR Vmax Lat E' Vel, Lat A' Vel Lat Vel(Lat E' Vel, Lat A' Vel) Med E' Vel, Med A' VelMed Vel (Med E' Vel, Med A' Vel) RV S Vel,MR VTITR VTI | Vmax AV VTI, AV Vmax PV VTI, PV Vmax TRVmax Lat E' Vel, Lat A' Vel Lat Vel (Lat E' Vel,Lat A' Vel) Med E' Vel, Med A' Vel Med Vel(Med E' Vel, Med A' Vel) RV S Vel | ||
| Semi-AutomationTechnology | M-Modes include the following: TAPSEAutoMeasure V3 is created semi-automatically using machine learningalgorithm without user interaction. Semi-automated adult echocardiography 2D,Doppler and M-mode measurements aregenerated using an artificial intelligence (AI)detection algorithm without userinteraction. After measurement is generated,the user can edit (manually adjust the caliperpositions), accept, or reject themeasurements. | AutoMeasure V3 is created semi-automaticallyusing machine learning algorithm without userinteraction. Semi-automated adultechocardiography 2D and Dopplermeasurements are generated using an artificialintelligence (AI) detection algorithm without userinteraction. After measurement is generated, theuser can edit (manually adjust the caliperpositions), accept, or reject the measurements. | |
| User Interface | User selects an adult echocardiography 2D,Doppler or M-mode measurement to performthen the caliper positions are initialized basedon the output of the AI detection algorithm.The user can edit, accept, or reject themeasurements. | User selects an adult echocardiography 2D orDoppler measurement to perform then thecaliper positions are initialized based on theoutput of the AI detection algorithm.The user can edit, accept, or reject themeasurements. | Similar. The proposed AutoMeasure V3 softwareallows very similar semi-automatedmeasurements as the reference softwareapplication AutoMeasure.The proposed AutoMeasure V3 software addsadditional M-mode measurement and newdetectors to the existing measurements (2D andDoppler). |
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Table 2: Comparison to Predicate for introduction of AutoMeasure V3 onto Affiniti
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VI. Safety Considerations
The proposed EPIQ Series Diagnostic Ultrasound System and Affiniti Series Diagnostic Ultrasound System, including AutoMeasure V3 software applications, and compatible transducers are all Track 3 Devices and comply with the referenced standards as well as the FDA ultrasound guidance document, Guidance for Industry and FDA Staff - Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, issued in February 2023.
VII. Nonclinical Performance Data
The proposed modification of the EPIQ Series Diagnostic Ultrasound System and Affiniti Series Diagnostic Ultrasound 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 AutoMeasureV3 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 AutoMeasure V3 software applications.
This study evaluated the performance of AutoMeasure V3 software in automation of measurement from cardiac TTE clips across a diverse set of subject demographics, body habitus and parameters' distribution. Adult subjects (18 years of age and above) from whom the study data were sampled were enrolled in hospital settings at multiple institutions, including USA, Asia and Europe. Subjects were enrolled at institutions between 2015 and June 2024, and the timeframes varied for different hospitals. Patients referred for clinical TTE as well as healthy volunteers were invited to participate. Data independence was ensured by adhering to Philips procedure related to consistent data handling and project documentation independent of the data scientist. The study evaluated the performance of the AutoMeasure V3 software, where 7127 transthoracic echocardiography (TTE) cardiac clips from 3964 subjects were used for assessment of AutoMeasure V3 parameters (measurements) and compared to ground truth. The ground truth for the study was defined as Standard of Care (SOC) measurements obtained during initial subject visit, performed by qualified healthcare professional(s).
| Subjects(mean ± SD (n) (min, max) or % (n/N) ) | |
|---|---|
| Age (years) | 59.00±16.66 (3964);(18.00;100.00) |
| Gender | |
| Male | 48.56% (1925/3964) |
| Female | 51.44% (2039/3964) |
| Race |
The subjects whose TTE clips were used in the study were:
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| Asian | 2.70% (107/3964) |
|---|---|
| Black or African American | 45.18% (1791/3964) |
| White | 30.25% (1199/3964) |
| Other/Mixed | 21.85% (866/3964) |
| Unknown | 0.03% (1/3964) |
| BMI (kg/ m²) | 28.85±7.06 (3964);(12.40;63.60) |
In addition, the performance of the software was accessed in analysis stratified by demographic variables (aqe, BMI, gender and race) and clinical status (healthy, suspected of disease).
The results of the 32 hypotheses tested, demonstrated high agreement of AutoMeasure V3 software with Standard of Care Measurements (ground truth) obtained during initial subject exam, by producing confidence intervals for the limits of agreement, for each parameter (hypothesis) tested, meeting the pre-defined acceptance criteria for the study.
Taken together, the results of the study demonstrated clinically reasonable, relevant and meaningful performance of the AutoMeasure V3 software supporting automation of measurements during cardiac TTE exams. Specifically, success on the hypotheses testing for AutoMeasure V3 agreement with ground truth measurements indicate that the safety and effectiveness of the proposed software is acceptable and aligns with previously reported agreement for cardiac assessment. Since the acceptance criteria were based on inter-observer data for echocardiographic measurements, the AutoMeasure V3 performance supports the conclusion that the algorithm behaves like any average human observer. Therefore, the clinical acceptability of AutoMeasure V3 is met. Lastly, the AutoMeasure V3 software is a semi-automated quantitative imaging algorithm, and users are generally expected to review and concur with the initialization and generated results. The users can also edit alqorithm generated measurements and outputs based on their clinical expertise.
Since this is a software-only change and no new hardware was added, no acoustic output, cleaning and disinfectants, thermal, electromagnetic, and mechanical safety testing were required. Biocompatibility testing is not needed for the subject EPIQ Series Diagnostic Ultrasound Systems and Affiniti Series Diagnostic Ultrasound with AutoMeasure V3. The transducer patient contact materials and manufacturing processes are not impacted by the release of the subject EPIQ Series Diagnostic Ultrasound System and Affiniti Series Diagnostic Ultrasound with AutoMeasure V3.
Clinical Data VIII.
There was no clinical investigation needed for this premarket submission of the EPIQ Series Diagnostic Ultrasound Systems and Affiniti Series Diagnostic Ultrasound Systems with AutoMeasure V3 software applications.
IX. Sterilization
Not applicable. The ultrasound transducers are not supplied sterile.
X. Conclusion
Results of the testing show that the proposed subject device meets its intended use support a determination that the proposed subject device does not raise new questions of safety or effectiveness.
Therefore, the subject device is substantially equivalent to the predicate device in terms of indications for use, design, technological characteristics, modes of operations, safety, and effectiveness.
§ 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.