(58 days)
Not Found
Yes
The document explicitly states that the AutoMeasure V3 software uses an "AI-algorithm, training via machine-learning techniques" and a "machine learning algorithm" to generate semi-automated measurements.
No.
The intended use of the device is "diagnostic ultrasound imaging and fluid flow analysis of the human body" for "diagnosis of patients," not for therapy.
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" and "The intended use of Affiniti Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body." It also mentions that the systems "can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients."
No
The device description explicitly states that the software application is introduced onto the EPIQ Series Diagnostic Ultrasound Systems and Affiniti Series Diagnostic Ultrasound Systems, which are hardware ultrasound systems. The software is an optional feature that runs on these existing hardware platforms.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The EPIQ and Affiniti systems, even with the AutoMeasure V3 software, are described as diagnostic ultrasound imaging and fluid flow analysis systems. They use ultrasound waves to create images of internal structures and analyze fluid flow within the human body.
- Intended Use: The intended use clearly states "diagnostic ultrasound imaging and fluid flow analysis of the human body." It lists various anatomical sites and clinical environments where the systems are used for diagnosis of patients.
- No Specimen Analysis: There is no mention of the device analyzing any specimens taken from the body. The input is ultrasound data acquired directly from the patient.
While the device uses AI and machine learning to assist in interpreting the ultrasound images and performing measurements, this processing is applied to in vivo (within the living body) data, not in vitro (in glass, i.e., outside the body) specimens.
Therefore, the EPIQ and Affiniti systems, as described, fall 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
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.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX, OBJ, QIH
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Ultrasound
Anatomical Site
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.
Indicated Patient Age Range
Adult Subjects (18 years of age and above)
Intended User / Care Setting
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.
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
Description of the test set, sample size, data source, and annotation protocol
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).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
The subjects whose TTE clips were used in the study were:
Age (years): 59.00±16.66 (3964);(18.00;100.00)
Gender: Male 48.56% (1925/3964), Female 51.44% (2039/3964)
Race: 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 (age, 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 algorithm generated measurements and outputs based on their clinical expertise.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
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.
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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.
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.
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
2
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.
4
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 and | ||
| Address | Philips Ultrasound LLC | |
| 22100 Bothell Everett Hwy | ||
| Bothell, WA 98021-8431 USA | ||
| Contact Information | Deval Patel | |
| Principal Regulatory Affairs Specialist | ||
| 22100 Bothell Everett Hwy | ||
| Bothell, WA 98021-8431 USA | ||
| +1 (949) 502-1823 | ||
| 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
| Proprietary Name | EPIQ Series Diagnostic Ultrasound System
Affiniti 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 and | |||
| processing 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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Image /page/6/Picture/0 description: The image shows the word "PHILIPS" in blue, block letters. The letters are bold and sans-serif. The background is a light gray or white color. The word is centered in the image.
| Predicate Regulation
| Description | 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 and | |||
| processing 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.
7
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 System
Feature: AutoMeasure V3
Proposed Device | EPIQ Series Diagnostic Ultrasound System
K240850
Predicate 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. | 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. | Identical to predicate |
| 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. | Identical to predicate |
| USA FDA
Classification | Class II | Class II | Identical to predicate |
| Primary Product
Code | IYN | IYN | Identical to predicate |
| Primary
Regulation Name | System, Imaging, Pulsed Doppler, Ultrasonic | System, Imaging, Pulsed Doppler, Ultrasonic | Identical to predicate |
| Feature | EPIQ Series Diagnostic Ultrasound System
Feature: AutoMeasure V3
Proposed Device | EPIQ Series Diagnostic Ultrasound System
K240850
Predicate Device | Comparison |
| Primary
Regulation
Number | 21 CFR 892.1550 | 21 CFR 892.1550 | Identical to predicate |
| Secondary
Product Codes | ITX
IYO
OBJ
QIH | ITX
IYO
OBJ
QIH | Identical to predicate |
| Secondary
Regulation Name | Diagnostic ultrasonic transducer
Ultrasonic pulsed echo imaging
system
Diagnostic intravascular catheter
Automated Radiological Image
Processing Software | Diagnostic ultrasonic transducer
Ultrasonic pulsed echo imaging
system
Diagnostic intravascular catheter
Automated Radiological Image
Processing Software | Identical to predicate |
| Secondary
Regulation
Number | 21 CFR 892.1570
21 CFR 892.1560
21 CFR 870.1200
21 CFR 892.2050 | 21 CFR 892.1570
21 CFR 892.1560
21 CFR 870.1200
21 CFR 892.2050 | Identical to predicate |
| Reusable-
Systems and
Transducers | Yes | Yes | Identical to predicate |
| Duration of use | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Identical to predicate |
| Application
Description | Auto Measure is an optional software feature
on the EPIQ Series Diagnostic Ultrasound
System that provides the end user with
semiautomated adult echocardiography 2D,
Doppler or M-mode measurements through
an Al-algorithm, training via machine-learning
techniques.
It is intended to be used with an Adult
Cardiology Transthoracic transducer and
acquisitions that include an ECG. These
measurements are routinely collected during
a transthoracic ECG.
2D modes include the following:
IVSd
LVIDd
LVPWd
LVIDs
Asc Ao Diam
LA Vol, A2Cs
LA Vol, A4Cs
LA Diameter a.p. (PLAX)
RA Volume | Auto Measure is an optional software feature on the
EPIQ Series Diagnostic Ultrasound System that
provides the end user with semiautomated adult
echocardiography 2D and Doppler measurements
through an Al-algorithm, training via machine-learning
techniques.
It is intended to be used with an Adult Cardiology
Transthoracic transducer and acquisitions that include
an ECG. These measurements are routinely collected
during a transthoracic ECG.
2D modes include the following:
IVSd
LVIDd
LVPWd
LVIDS
Asc Ao Diam
Doppler modes include the following:
MV Peak E Vel,
MV Peak A Vel MV Inflow (MV Dec Time, MV Peak E
Vel, 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 the
AutoMeasure V3 software is Identical to
predicate where Auto Measure quantifies
image data acquired on the Philips EPIQ
Ultrasound System through an Al based
algorithm that used a trained machine-
learning model.
Compared to predicate only new
measurements and detectors are added to
the existing measurements. Clinical
performance studies were completed, and
the results showed safety and effectiveness |
| Feature | EPIQ Series Diagnostic Ultrasound System
Feature: AutoMeasure V3
Proposed Device | EPIQ Series Diagnostic Ultrasound System
K240850
Predicate Device | Comparison |
| | AoR Diam(2D) = Ao Annlus diam
Doppler modes include the following:
MV Peak E Vel,
MV Peak A Vel MV Inflow (MV Dec Time, MV
Peak E Vel, MV Peak A Vel) LVOT VTI,
LVOT Vmax AV VTI, AV Vmax PV VTI, PV
Vmax 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 S
Vel, MR VTI
TR VTI
M-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-Automation
Technology | AutoMeasure V3 is created semi-
automatically using machine learning
algorithm without user interaction. Semi-
automated adult echocardiography 2D,
Doppler and M-mode measurements are
generated using an artificial intelligence (AI)
detection algorithm without user
interaction. After measurement is generated,
the user can edit (manually adjust the caliper
positions), accept, or reject the
measurements. | AutoMeasure V3 is created semi-automatically using
machine learning algorithm without user interaction.
Semi-automated adult echocardiography 2D and
Doppler measurements are generated using an artificial
intelligence (AI) detection algorithm without user
interaction. After measurement is generated, the user
can edit (manually adjust the caliper
positions), accept, or reject the measurements. | Subject device uses identical method for
contour generation as the reference device
K240850. The only difference is the
algorithm is new M-mode measurement is
added, new detectors are added, and
existing detectors are re-trained based on
new literature available. |
| User Interface | User selects an adult echocardiography 2D,
Doppler or M-mode measurement to perform
then the caliper positions are initialized based
on the output of the Al detection algorithm.
The user can edit, accept, or reject the
measurements. | User selects an adult echocardiography 2D or Doppler
measurement to perform then the caliper positions are
initialized based on the output of the Al detection
algorithm.
The user can edit, accept, or reject the
measurements. | Similar. The proposed AutoMeasure V3
software allows very similar semi-automate
measurements as the reference software
application AutoMeasure.
The proposed Auto Measure V3 software
adds additional M-mode measurement and
new detectors to the existing measurements
(2D and Doppler). |
| Feature | Affiniti Series Diagnostic Ultrasound System
Feature: AutoMeasure V3
Proposed Device | Affiniti Series Diagnostic Ultrasound System
K240850
Predicate 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. | 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 Affiniti 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 Affiniti Series Diagnostic Ultrasound
System. | Identical to predicate |
| 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. | Identical to predicate |
| USA FDA
Classification | Class II | Class II | Identical to predicate |
| Primary Product
Code | IYN | IYN | Identical to predicate |
| Primary
Requlation Name | System, Imaging, Pulsed Doppler, Ultrasonic | System, Imaging, Pulsed Doppler, Ultrasonic | Identical to predicate |
| Feature | Affiniti Series Diagnostic Ultrasound System
Feature: AutoMeasure V3
Proposed Device | Affiniti Series Diagnostic Ultrasound System
K240850
Predicate Device | Comparison |
| Primary
Regulation
Number | 21 CFR 892.1550 | 21 CFR 892.1550 | Identical to predicate |
| Secondary
Product Codes | ITX
IYO
OBJ
QIH | ITX
IYO
OBJ
QIH | Identical to predicate |
| Secondary
Regulation Name | Diagnostic ultrasonic transducer
Ultrasonic pulsed echo imaging
system
Diagnostic intravascular catheter
Automated Radiological Image
Processing Software | Diagnostic ultrasonic transducer
Ultrasonic pulsed echo imaging
system
Diagnostic intravascular catheter
Automated Radiological Image
Processing Software | Identical to predicate |
| Secondary
Regulation
Number | 21 CFR 892.1570
21 CFR 892.1560
21 CFR 870.1200
21 CFR 892.2050 | 21 CFR 892.1570
21 CFR 892.1560
21 CFR 870.1200
21 CFR 892.2050 | Identical to predicate |
| Reusable-
Systems and
Transducers | Yes | Yes | Identical to predicate |
| Duration of use | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Identical to predicate |
| Application
Description | Auto Measure is an optional software feature
on the Affiniti Series Diagnostic Ultrasound
System that provides the end user with
semiautomated
adult echocardiography 2D, Doppler or M-
mode measurements through an Al-
algorithm, training
via machine-learning techniques.
It is intended to be used with an Adult
Cardiology Transthoracic transducer and
acquisitions that include an ECG. These
measurements are routinely collected during
a transthoracic ECG.
2D modes include the following:
IVSd
LVIDd
LVPWd
LVIDs | Auto Measure is an optional software feature on
the Affiniti Series Diagnostic Ultrasound System
that provides the end user with semiautomated
adult echocardiography 2D or Doppler
measurements through an Al-algorithm, training
via machine-learning techniques.
It is intended to be used with an Adult
Cardiology Transthoracic transducer and
acquisitions that include an ECG. These
measurements are routinely collected during a
transthoracic ECG.
2D modes include the following:
IVSd
LVIDd
LVPWd
LVIDs
Asc Ao Diam | Similar to the reference device features.
The functionality and workflow of the
AutoMeasure V3 software is Identical to
predicate where AutoMeasure quantifies image
data acquired on the Philips Affiniti Ultrasound
System through an Al based algorithm that used
a trained machine-learning
model.
Compared to predicate only new measurements
and detectors are added to the existing
measurements. Clinical performance studies
were completed, and the results showed safety
and effectiveness |
| | Asc Ao Diam
LA Vol, A2Cs
LA Vol, A4Cs
LA Diameter a.p. (PLAX) | Doppler modes include the following:
MV Peak E Vel,
MV Peak A Vel MV Inflow (MV Dec Time, MV
Peak E Vel, MV Peak A Vel) LVOT VTI, LVOT | |
| Feature | Affiniti Series Diagnostic Ultrasound System
Feature: AutoMeasure V3
Proposed Device | Affiniti Series Diagnostic Ultrasound System
K240850
Predicate Device | Comparison |
| | RA Volume
AoR Diam(2D) = Ao Annulus diam
Doppler modes include the following:
MV Peak E Vel,
MV Peak A Vel MV Inflow (MV Dec Time, MV
Peak E Vel, MV Peak A Vel) LVOT VTI,
LVOT Vmax AV VTI, AV Vmax PV VTI, PV
Vmax 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 S Vel,
MR VTI
TR VTI | Vmax AV VTI, AV Vmax PV VTI, PV Vmax 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 S Vel | |
| | Semi-Automation
Technology | M-Modes include the following: TAPSE
AutoMeasure V3 is created semi-
automatically using machine learning
algorithm without user interaction. Semi-
automated adult echocardiography 2D,
Doppler and M-mode measurements are
generated using an artificial intelligence (AI)
detection algorithm without user
interaction. After measurement is generated,
the user can edit (manually adjust the caliper
positions), accept, or reject the
measurements. | AutoMeasure V3 is created semi-automatically
using machine learning algorithm without user
interaction. Semi-automated adult
echocardiography 2D and Doppler
measurements are generated using an artificial
intelligence (AI) detection algorithm without user
interaction. After measurement is generated, the
user can edit (manually adjust the caliper
positions), accept, or reject the measurements. |
| User Interface | User selects an adult echocardiography 2D,
Doppler or M-mode measurement to perform
then the caliper positions are initialized based
on the output of the AI detection algorithm.
The user can edit, accept, or reject the
measurements. | User selects an adult echocardiography 2D or
Doppler measurement to perform then the
caliper positions are initialized based on the
output of the AI detection algorithm.
The user can edit, accept, or reject the
measurements. | Similar. The proposed AutoMeasure V3 software
allows very similar semi-automated
measurements as the reference software
application AutoMeasure.
The proposed AutoMeasure V3 software adds
additional M-mode measurement and new
detectors to the existing measurements (2D and
Doppler). |
9
Image /page/9/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and appear to be a sans-serif font. The background behind the letters is white, providing a clear contrast that makes the brand name easily readable.
10
11
Table 2: Comparison to Predicate for introduction of AutoMeasure V3 onto Affiniti
12
13
14
Image /page/14/Picture/0 description: The image shows the word "PHILIPS" in blue letters. The letters are bold and sans-serif. The background is white.
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:
15
| 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.