(28 days)
Yes
The device description explicitly states that Smart View Select uses a "Deep Learning Al interface engine" and Segmental Wall Motion uses "machine learning algorithms".
No
The intended use of the EPIQ and Affiniti systems, as described, is "diagnostic ultrasound imaging and fluid flow analysis." The device description and indications for use consistently focus on diagnostic purposes, such as assisting with image guidance during treatment, classifying images, and evaluating segmental wall function. There is no mention of treating or curing any disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the "EPIQ Ultrasound Diagnostic System" and "Affiniti Series Diagnostic Ultrasound Systems" are for "diagnostic ultrasound imaging and fluid flow analysis of the human body". The document then details the integration of new software applications (Smart View Select and Segmental Wall Motion) onto these existing diagnostic systems, further supporting their diagnostic intent.
No
The device is described as software applications (Smart View Select and Segmental Wall Motion) that are introduced onto existing, cleared hardware systems (EPIQ and Affiniti Series Diagnostic Ultrasound Systems). While the submission focuses on the software, the device's functionality is dependent on and integrated with the ultrasound hardware. The predicate devices are also ultrasound systems, not standalone software.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The tests are performed outside of the living body.
- Device Description: The EPIQ and Affiniti systems, even with the new software features, are described as diagnostic ultrasound imaging and fluid flow analysis systems of the human body. They use ultrasound waves to create images and analyze flow within the living body.
- Intended Use/Indications for Use: The listed indications for use (Abdominal, Cardiac, Fetal/Obstetric, etc.) all involve imaging and analysis of internal structures and functions of the human body in vivo.
- Clinical Environment: The clinical environments mentioned (clinics, hospitals, clinical point-of-care) are where patients are directly examined using the ultrasound system.
- No Specimen Analysis: There is no mention of collecting or analyzing biological specimens. The device directly interacts with the patient's body.
The software features (Smart View Select and Segmental Wall Motion) are image processing and analysis tools that operate on the ultrasound data acquired from the patient's body. They do not involve the analysis of in vitro specimens.
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), Transvaginal, Lung.
The clinical environments where EPIQ Series Diagnostic Ultrasound Systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.
When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image quidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live echo guidance.
The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.
Affiniti:
The intended use of Affiniti Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:
Abdominal, Cardiac Adult, Cardiac Other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.
The clinical environments where the Affiniti diagnostic ultrasound systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.
The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX, QIH, OBJ
Device Description
The purpose of this Special 510(k) Pre-Market Notification is to introduce the Smart View Select (SVS) software application onto the EPIQ Series Diagnostic Ultrasound Systems and to introduce the Segmental Wall Motion software application onto both the EPIQ and Affiniti Series Diagnostic Ultrasound Systems.
Smart View Select is an automated software feature that assists the user in selection of images for analysis with the existing Philips AutoStrain LV or 2D Auto LV application in Adult Echo Transthoracic (TTE) examination. This feature automatically classifies each acquired image by view and selects an appropriate set of images for left ventricle (LV) analysis. The classification is based on a Deep Learning Al interface engine; the selection is a non-Al algorithm that considers the view classification and image depth to select the optimal set of images.
The Segmental Wall Motion software automatically evaluates the segmental (regional) function of the left ventricle (LV) from adult TTE echo examinations. For input, the SWM algorithm uses 3 apical views (A4C, A2C and A3C) and performs border detection and tracking to identify each of the LV segments based on the three views. The application then provides segmental wall motion scores for each of the 17 segments of the LV by using machine learning algorithms and an overall wall motion score index (WMSI) is calculated as the average of the segmental scores.
No hardware changes to the EPIQ or Affiniti systems are required when using SVS or SWM, and existing, cleared Philips TTE transducers are used with these software applications.
The SVS feature is supported by all EPIQ models running software version 11.0 or higher including EPIQ CVx/CVxi, EPIQ Elite Advanced, EPIQ Elite, EPIQ 7, EPIQ 5. The SWM feature is supported by the same EPIQ models running software version VM11.0 or higher, as well as all Affiniti models including Affiniti CVx, Affiniti 70, Affiniti 50, and Affiniti 30. The SVS and SWM software are associated with the cardiac adult indication.
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), Transvaginal, Lung.
Indicated Patient Age Range
Adult, Fetal, Pediatric, Neonatal. The specific age ranges for these categories are not explicitly defined in the document.
Intended User / Care Setting
Intended User: Trained healthcare professionals: sonographers, physicians, and biomedical engineers who operate and maintain your product.
Care Setting: 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The first study was conducted to evaluate the performance of the SVS workflow enhancement algorithm. Three reviewers (clinical experts) participated in the manual selection of clips from subject exam and subsequent semi-automated processing of the clips with AutoStrain LV software to evaluate GLS and EF, which served as ground truth (average across reviewers for each output). The same exams were processed through the SVS software for automatic selection of appropriate clips and subsequent, un-edited evaluation of GLS and EF with AutoStrain LV. GLS and bi-plane EF results for each subject evaluated by the reviewers (averaged across reviewers= ground truth) were compared to the automatically obtained GLS and EF results with SVS selected clips.
The co-primary endpoints for the study were defined as agreements between GLS/EF measured via manual clip selection and compared to SVS clip selection and GLS/EF output using AutoStrain LV software. Agreement was measured as correlation for each output, separately for GLS and EF (coprimary endpoints). A review of the published literature and previous regulatory submissions (K130779, K232500) informed the acceptance criteria for the study to be defined as Lower Confidence Bound for the Pearson's correlation coefficient to be >0.8.
The results of the co-primary endpoints analysis demonstrated very strong correlation for GLS and EF outputs when manually selected clips were compared to SVS selected clips for the same subject exams. Specifically, for the Pearsons' correlation coefficient was 0.911 (95%Cl 0.855.0.946) and 0.941 (95%Cl 0.903.0.965), for GLS and EF, respectively. The lower confidence bounds were 0.855 for GLS and 0.903 for EF, thereby meeting the predefined acceptance criteria for the study.
A separate study was conducted to assess the use of Segmental Wall Motion (SWM), a machine learning-based feature in quantification of Wall Motion Score Index (WMSI) in transthoracic (TTE) ultrasound clips obtained from subjects referred for clinical TTE exam. The study evaluated the performance of the integrated SWM algorithm compared to LVivo SWM (DiA Imaging Analysis) application (ground truth) in the quantification of WMSI for the same subjects' exams. The study was executed in 2 phases with a 7-day washout period between the phase 1, three reviewers (clinical experts) participated in the manual selection of representative clips from subject TTE exams and subsequent processing of the clips with LVivo application for WMSI output, which served as ground truth in the study (average across reviewers). In phase 2, the manually selected clips as well as SVS selected clips (clips selected by the SVS workflow algorithm from subject exams used in phase1) were processed by the same 3 reviewers with the integrated (subject) SWM algorithm for WMSI output, in a random order.
A review of published literature within the cardiac assessment space and previous regulatory submissions (K130779, K223771, K232500) informed the acceptance criteria for the study to be defined as Lower Confidence Bound for the Pearson's correlation coefficient to be >0.8 for each endpoint. Acceptance criteria were defined prior to study execution.
The results of the co-primary endpoints analysis demonstrated very strong correlation for manual and SVS selected clips and assessed for WMSI of the subject SWM algorithm when compared to the ground truth. Specifically, the Pearsons' correlation coefficient was 0.957 (95%C) 0.933,0.972) and 0.913 (95%Cl 0.857,0.948), for the manual and SVS workflows, respectively. The lower confidence bounds were 0.933 for manual workflow and 0.857 for SVS workflow, thereby meeting the predefined acceptance criteria for the study.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Pearson's correlation coefficient:
SVS study:
GLS: 0.911 (95% CI 0.855-0.946), lower confidence bound 0.855
EF: 0.941 (95% CI 0.903-0.965), lower confidence bound 0.903
SWM study:
Manual workflow: 0.957 (95% CI 0.933-0.972), lower confidence bound 0.933
SVS workflow: 0.913 (95% CI 0.857-0.948), lower confidence bound 0.857
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.
K233788; Philips EPIQ Series Diagnostic Ultrasound System, K233788; Philips Affiniti Series Diagnostic Ultrasound System
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.
K212466; LVivo Seamless, K161382; LVivo Software Application with LVivo SG
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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April 24, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Philips Ultrasound LLC Michael Chambers Sr. Regulatory Affairs Specialist 22100 Bothell Everett Highway BOTHELL WA 98021
Re: K240850
Trade/Device Name: EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX, QIH, OBJ Dated: March 25, 2024 Received: March 27, 2024
Dear Michael Chambers:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Yanna S. Kang -S
Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Submission Number (if known)
Device Name
EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
Indications for Use (Describe)
EPIQ:
The intended use of EPIQ Ultrasound Diagnostic System is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:
Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), intra-luminal, intra-cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transvaginal, Lung.
The clinical environments where EPIQ Series Diagnostic Ultrasound Systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.
When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image quidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live echo guidance.
The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.
Affiniti:
The intended use of Affiniti Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:
Abdominal, Cardiac Adult, Cardiac Other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.
The clinical environments where the Affiniti diagnostic ultrasound systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.
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
3
operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
2HIL
Special 510(k) Summary
This summary of safety and effectiveness information is submitted in accordance with 21 CFR § 807.92.
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Date Prepared: March 27, 2024
l. Submitter
| Manufacturer Name and
Address | Philips Ultrasound LLC
22100 Bothell Everett Hwy Bothell,
WA 98021-8431 USA |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information | Mike Chambers
Senior Regulatory Affairs Specialist
22100 Bothell Everett Hwy
Bothell, WA 98021-8431 USA
+1 (315) 262-7702 |
| Secondary Contact | Erdit Gremi
Director, Requlatory 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 |
| | Automated Radiological Image
Processing Software | 892.2050 | QIH |
| | Diagnostic Intravascular Catheter | 870.1200 | OBJ*
*EPIQ only |
| Device Class | Class II | | |
| Review Panel | Radiology | | |
| Predicate Device | K233788; Philips EPIQ Series Diagnostic Ultrasound System
K233788; Philips Affiniti Series Diagnostic Ultrasound System | | |
| Reference Devices | K212466; LVivo Seamless
K161382; LVivo Software Application with LVivo SG | | |
5
III. Device Description
The purpose of this Special 510(k) Pre-Market Notification is to introduce the Smart View Select (SVS) software application onto the EPIQ Series Diagnostic Ultrasound Systems and to introduce the Segmental Wall Motion software application onto both the EPIQ and Affiniti Series Diagnostic Ultrasound Systems.
Smart View Select is an automated software feature that assists the user in selection of images for analysis with the existing Philips AutoStrain LV or 2D Auto LV application in Adult Echo Transthoracic (TTE) examination. This feature automatically classifies each acquired image by view and selects an appropriate set of images for left ventricle (LV) analysis. The classification is based on a Deep Learning Al interface engine; the selection is a non-Al algorithm that considers the view classification and image depth to select the optimal set of images.
The Segmental Wall Motion software automatically evaluates the segmental (regional) function of the left ventricle (LV) from adult TTE echo examinations. For input, the SWM algorithm uses 3 apical views (A4C, A2C and A3C) and performs border detection and tracking to identify each of the LV segments based on the three views. The application then provides segmental wall motion scores for each of the 17 segments of the LV by using machine learning algorithms and an overall wall motion score index (WMSI) is calculated as the average of the segmental scores.
No hardware changes to the EPIQ or Affiniti systems are required when using SVS or SWM, and existing, cleared Philips TTE transducers are used with these software applications.
The SVS feature is supported by all EPIQ models running software version 11.0 or higher including EPIQ CVx/CVxi, EPIQ Elite Advanced, EPIQ Elite, EPIQ 7, EPIQ 5. The SWM feature is supported by the same EPIQ models running software version VM11.0 or higher, as well as all Affiniti models including Affiniti CVx, Affiniti 70, Affiniti 50, and Affiniti 30. The SVS and SWM software are associated with the cardiac adult indication.
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.
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.
Note: There are no changes to the EPIQ Ultrasound System Indications for Use due to the introduction
6
of the SVS or SWM software applications. These software applications are associated with the Cardiac Adult indication.
Affiniti Intended Use:
The intended use of Affiniti Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body.
Affiniti Indications for Use:
The intended use of Affiniti Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:
Abdominal, Cardiac Adult, Cardiac Other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.
The clinical environments where the Affiniti diagnostic ultrasound systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.
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 Affiniti Ultrasound System Indications for Use due to the introduction of the SWM software application. This software applications is associated with the Cardiac Adult indication.
7
PHILIPS
V. Comparison of Technological Characteristics with the Predicate
The purpose of the submission is to introduce the SVS software application feature to the EPIQ Series Diagnostic Ultrasound System and the SWM software application to both EPIQ and Affiniti. The subject device is substantially equivalent to the predicate device (K233788).
| Feature | EPIQ Series Diagnostic
Ultrasound System
Features: SVS and SWM
Proposed Device | EPIQ Series Diagnostic
Ultrasound System
K233788
Predicate Device | LVivo Seamless
K212466
Reference Device | LVivo Software
Application
Feature: LVivo SG K161382
Reference Device | Comparison |
|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | Abdominal, Cardiac
Adult, Cardiac other
(Fetal), Cardiac
Pediatric, Cerebral
Vascular, Cephalic
(Adult), Cephalic
(Neonatal),
Fetal/Obstetric,
Gynecological,
Intraoperative
(Vascular),
Intraoperative
(Cardiac), intra-luminal,
intra-cardiac echo,
Musculoskeletal
(Conventional),
Musculoskeletal
(Superficial),
Ophthalmic, Other:
Urology, Pediatric,
Peripheral Vessel,
Small Organ (Breast,
Thyroid, Testicle),
Transesophageal
(Cardiac), Transrectal,
Transvaginal, Lung. | Abdominal, Cardiac
Adult, Cardiac other
(Fetal), Cardiac
Pediatric, Cerebral
Vascular, Cephalic
(Adult), Cephalic
(Neonatal),
Fetal/Obstetric,
Gynecological,
Intraoperative
(Vascular),
Intraoperative
(Cardiac), intra-luminal,
intra-cardiac echo,
Musculoskeletal
(Conventional),
Musculoskeletal
(Superficial),
Ophthalmic, Other:
Urology, Pediatric,
Peripheral Vessel,
Small Organ (Breast,
Thyroid, Testicle),
Transesophageal
(Cardiac), Transrectal,
Transvaginal, Lung. | LVivo platform is
intended for non-
invasive processing of
ultrasound images to
detect, measure, and
calculate relevant
medical parameters of
structures and function
of patients with
suspected disease. | LVivo platform is
intended for non-
invasive processing of
ultrasound images to
detect, measure, and
calculate relevant
medical parameters of
structures and function
of patients with
suspected disease. | Identical to predicate |
| | Trained healthcare
professionals | Trained healthcare
professionals | Trained healthcare
professionals | Trained healthcare
professionals | Identical to predicate |
| Intended Users | Intended for
sonographers,
physicians, and
biomedical engineers
who operate and
maintain your product. | Intended for
sonographers,
physicians, and
biomedical engineers
who operate and
maintain your product. | | | |
| | Before use of the
system and user
information, the user
must be familiar with
ultrasound techniques.
Sonography training
and clinical procedures
are not included in the
User Manual or with the
EPIQ Series Diagnostic
Ultrasound System. | Before use of the
system and user
information, the user
must be familiar with
ultrasound techniques.
Sonography training
and clinical procedures
are not included in the
User Manual or with the
EPIQ Series Diagnostic
Ultrasound System. | | | |
| Intended User
Environment | Clinics, hospitals, and
clinical point-of-care for
diagnosis of patients. | Clinics, hospitals, and
clinical point-of-care for
diagnosis of patients. | Professional healthcare
environments | Professional healthcare
environments | Identical to predicate |
| Feature | EPIQ Series Diagnostic
Ultrasound System
Features: SVS and SWM
Proposed Device | EPIQ Series Diagnostic
Ultrasound System
K233788
Predicate Device | LVivo Seamless
K212466
Reference Device | LVivo Software
Application
Feature: LVivo SG
K161382
Reference Device | Comparison |
| USA FDA
Classification | Class II | Class II | Class II | Class II | Identical to predicate |
| Primary
Product Code | IYN | IYN | QIH | LLZ | Identical to predicate |
| Primary
Regulation
Name | System, Imaging,
Pulsed Doppler,
Ultrasonic | System, Imaging,
Pulsed Doppler,
Ultrasonic | Automated Radiological
Image
Processing Software | Medical image
management and
processing system. | Identical to predicate |
| Primary
Regulation
Number | 21 CFR 892.1550 | 21 CFR 892.1550 | 21 CFR 892.2050 | 21 CFR 892.2050 | Identical to predicate |
| Secondary
Product Codes | ITX
IYO
OBJ
QIH | ITX
IYO
OBJ
QIH | N/A | N/A | 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 | N/A | N/A | 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 | N/A | N/A | Identical to predicate |
| Reusable-
Systems and
Transducers | Yes | Yes | No, software-only | No, software-only | Identical to predicate |
| Duration of use | Limited (≤ 24 hours) | Limited (≤ 24 hours) | N/A, software-only | N/A, software-only | Identical to predicate |
| Device Track | Track 3 | Track 3 | N/A, software-only | N/A, software-only | Identical to predicate |
| Application
Description | Smart View Select is an
automated software
feature that assists the
user in selection of
images for analysis
with the existing Philips
AutoStrain LV or 2D
Auto LV application in
Adult Echo
Transthoracic (TTE)
examination.
The SWM software
automatically evaluates
the segmental
(regional) function of
the left ventricle (LV)
from adult TTE echo
examinations.
Note: Per FDA | The predicate EPIQ
Series Diagnostic
Ultrasound System
does not currently have
a dedicated software
application containing
the functionality
introduced in the
subject submission for
(1) automatic selection
of 4CH,2CH, and 3CH
views for left ventricle
(LV) analysis or (2)
(semi-) automated
segmental wall motion
evaluation of the left
ventricle (LV). | The LVivoSeamless
software is a
standalone application
that extends the LVivo
Platform and runs
offline on a server. The
system accepts echo
examination that are
sent from the US
device using DICOM
communication. The
examinations contain
clips in DICOM format.
The LVivoSeamless
scans the entire
examination and
selects automatically
4CH,2CH and 3CH
views for EF and GLS
evaluation and runs the
LVivoEF and the | The LVivoSG is a
decision support
system (software) for
automated segmental
wall motion evaluation
of the left ventricle (LV).
The LVivoSG is based
on a proprietary
algorithm for LV
regional motion
parameters calculation
and wall motion
classification.
The LVivoSG uses the
LVivo platform to detect
the LV inner borders
(endocard) from which
the wall motion
parameters are
calculated. As part of
the LVivoSG | The subject EPIQ Series
Diagnostic Ultrasound
System integrates the LVivo
Seamless algorithm of the
K212466 reference device
as "Smart View Select" and
the LVivo SWM module of
the LVivo SG K161382
reference device as
"Segmental Wall Motion".
Minor changes have been
made to the reference
LVivo Seamless and LVivo
SG software applications in
the subject SVS and SWM
applications, as described
below. |
| | EPIQ Series Diagnostic
Ultrasound System
Features: SVS and
SWM
Proposed Device | EPIQ Series Diagnostic
Ultrasound System
K233788
Predicate Device | LVivo Seamless
K212466
Reference Device | LVivo Software
Application
Feature: LVivo SG
K161382
Reference Device | Comparison |
| Feature | Performance
Assessment of
Quantitative Imaging in
Radiological Device
Premarket
Submissions, the SWM
software is a semi-
automated quantitative
imaging algorithm, as
users are generally
expected to review and
concur with the
initialization and
generated results. The
users can also edit
algorithm generated
segmental wall motion
scores for individual
segments based on
their clinical expertise. | | results are sent back
using DICOM
communication to the
PACS server and
become part of the
study. The clinician that
reviews the
examinations at the
PACS workstation will
be able view the output
of the LVivoEF and
LVivoStrain as part of
the study review. | platform supports also
edge detection and
tracking in additional
plane, the apical long
(3CH). The LVivoSG
provides fully
automated
measurements of the
regional left ventricular
systolic function from
three apical views the
four chamber (4CH),
two chamber (2CH)
and long (3CH). | |
| Deep Neural
Network utilized
for optimal
triplet selection | LVivo Seamless AI
neural network | Not applicable - does
not contain functionality
for optimal triplet
selection | LVivo Seamless Al
neural network | Not applicable - does
not contain functionality
for optimal triplet
selection | The subject SVS software
application utilizes the
identical, unchanged deep
neural network for view
identification and optimal
triplet (A4C, A2C, and A3C)
selection for subsequent LV
analysis |
| Scan depth
considered for
optimal triplet
selection? | Yes - the subject SVS
software application
uses an additional
heuristic logic step, after
the deep neural network
identifies the views and
determines a list of 3 clip
combinations (triplets),
to preferentially select
triplets of shallower scan
depths, provided the
depth exceeds 10cm
and the variation of
depths of each clips is
1 cm or less | Not applicable - does
not contain functionality
for optimal triplet
selection | Not applicable - scan
depth is not considered
in the selection of the
optimal triplets for the
user | Not applicable - does
not contain functionality
for optimal triplet
selection | The subject SVS software
application adds an
additional heuristic logic
step for preferentially
selecting certain scan
depths from the reference
LVivo Seamless. The
Neural Network of the
reference device is
unchanged, as described
above. Performance testing
has demonstrated very
strong correlation between
the LV analysis outputs
(EF, GLS) from clips
selected by the subject SVS
software application and
clips manually selected by
clinical users. Therefore,
the additional heuristic logic
step of the subject SVS
software does not raise new
or different questions of
safety or effectiveness in
comparison to the reference
device K212466. |
| Border
initialization
algorithm(s)
utilized for
segmental wall
motion | Primary - from K161382
Secondary - from
cleared AutoStrain LV
(K190913) | Not applicable - does
not contain functionality
for segmental wall
motion | Not applicable - this
application does not
contain functionality for
segmental wall motion | From K161382 | Subject device
preferentially utilizes
identical border initialization
algorithm as reference
device K161382.
If the reference device's
algorithm is unsuccessful in
the subject SWM, it will use |
| Feature | EPIQ Series Diagnostic Ultrasound System Features: SVS and SWM
Proposed Device | EPIQ Series Diagnostic Ultrasound System K233788
Predicate Device | LVivo Seamless K212466
Reference Device | LVivo Software Application Feature: LVivo SG K161382
Reference Device | Comparison |
| SWM scoring adjustment | Users manually edit scores using a drop-down selection | Not applicable – does not contain functionality for segmental wall motion | Not applicable – this application does not contain functionality for segmental wall motion | Users must manually edit the borders to attempt to edit scores | the border initialization of the cleared AutoStrain LV (K190913) as a back-up.
Performance testing has demonstrated very strong correlation between the SWM scoring of the subject software application compared to the scoring of the reference device on the same clips. Therefore, there are no new or increased risks for the use of the AutoStrain LV border initialization in the subject SWM software application as a back-up.
In the cleared LVivo SG, users must manually adjust the chamber borders to influence the SWM scores. In the subject SWM on VM11, users may manually select different SWM scores for each segment using a drop-down menu. Any scores which are manually changed from those calculated by the software application will be indicated by an asterisk (*). This change in editing does not introduce new risks because it is providing a simpler way for the user to edit their segmental wall motion score(s) – instead of having to edit the border contours to influence the SWM score as on the cleared LVivo SG, user can directly edit each segment's |
| Feature | Affiniti Series Diagnostic
Ultrasound System
Feature: SWM
Proposed Device | Affiniti Series Diagnostic
Ultrasound System
K233788
Predicate Device | LVivo Software Application
Feature: LVivo SG
K161382
Reference Device | Comparison | |
| Indications for
Use | Abdominal, Cardiac Adult,
Cardiac Other (Fetal), Cardiac
Pediatric, Cerebral Vascular,
Cephalic (Adult),
Cephalic (Neonatal),
Fetal/Obstetric, Gynecological,
Intraoperative (Vascular),
Intraoperative (Cardiac),
Musculoskeletal (Conventional),
Musculoskeletal (Superficial),
Other: Urology, Pediatric,
Peripheral Vessel,
Small Organ (Breast, Thyroid,
Testicle), Transesophageal
(Cardiac), Transrectal,
Transvaginal, Lung. | Abdominal, Cardiac Adult,
Cardiac Other (Fetal), 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. | LVivo platform is intended for
non-invasive processing of
ultrasound images to detect,
measure, and calculate relevant
medical parameters of
structures and function of
patients with suspected
disease. | 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. | Trained healthcare
professionals | 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. | Professional healthcare
environments | Identical to predicate | |
| USA FDA
Classification | Class II | Class II | Class II | Identical to predicate | |
| Primary
Product Code | IYN | IYN | LLZ | Identical to predicate | |
| Primary
Regulation
Name | System, Imaging, Pulsed
Doppler, Ultrasonic | System, Imaging, Pulsed
Doppler, Ultrasonic | Medical image management
and processing system. | Identical to predicate | |
| Primary
Regulation
Number | 21 CFR 892.1550 | 21 CFR 892.1550 | 21 CFR 892.2050 | Identical to predicate | |
| Secondary
Product Codes | ITX
IYO
OBЈ
QIH | ITX
IYO
OBJ
QiH | N/A | Identical to predicate | |
| Secondary
Regulation
Name | Diagnostic ultrasonic transducer
Ultrasonic pulsed echo imaging
system
Diagnostic intravascular | Diagnostic ultrasonic transducer
Ultrasonic pulsed echo imaging
system
Diagnostic intravascular | N/A | Identical to predicate | |
| | Affiniti Series Diagnostic
Ultrasound System
Feature: SWM
Proposed Device | Affiniti Series Diagnostic
Ultrasound System
K233788
Predicate Device | LVivo Software Application
Feature: LVivo SG
K161382
Reference Device | Comparison | |
| Feature | Automated Radiological Image
Processing Software | Automated Radiological Image
Processing Software | | | |
| 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 | N/A | Identical to predicate | |
| Reusable-
Systems and
Transducers | Yes | Yes | No, software-only | Identical to predicate | |
| Duration of use | Limited (≤ 24 hours) | Limited (≤ 24 hours) | N/A, software-only | Identical to predicate | |
| Device Track | Track 3 | Track 3 | N/A, software-only | Identical to predicate | |
| Application
Description | The SWM software
automatically evaluates the
segmental (regional) function of
the left ventricle (LV) from adult
TTE echo examinations.
Note: Per FDA Guidance
Technical Performance
Assessment of Quantitative
Imaging in Radiological Device
Premarket Submissions, the
SWM software is a semi-
automated quantitative imaging
algorithm, as users are
generally expected to review
and concur with the initialization
and generated results. The
users can also edit algorithm
generated segmental wall
motion scores for individual
segments based on their clinical
expertise. | The predicate Affiniti Series
Diagnostic Ultrasound System
does not currently have a
dedicated software application
containing the functionality
introduced in the subject
submission for (semi-)
automated segmental wall
motion evaluation of the left
ventricle (LV). | The LVivoSG is a decision
support system (software) for
automated segmental wall
motion evaluation of the left
ventricle (LV). The LVivoSG is
based on a proprietary
algorithm for LV regional motion
parameters calculation and wall
motion classification.
The LVivoSG uses the LVivo
platform to detect the LV inner
borders (endocard) from which
the wall motion parameters are
calculated. As part of the
LVivoSG development, the
LVivo platform supports also
edge detection and tracking in
additional plane, the apical long
(3CH). The LVivoSG provides
fully automated measurements
of the regional left ventricular
systolic function from three
apical views the four chamber
(4CH), two chamber (2CH) and
long (3CH). | The subject Affiniti Series
Diagnostic Ultrasound
System integrates the LVivo
SWM module of the LVivo
SG K161382 reference
device as "Segmental Wall
Motion". The subject SWM
software application utilizes
the border initialization of
the cleared AutoStrain LV
software in the event that
the border initialization
algorithm from LVivo SG is
unsuccessful. Otherwise,
there is no difference
between the subject SWM
software application and the
reference LVivo SG's SWM
module and no changes
have been made to its
algorithms. | |
| Border
initialization
algorithm(s)
utilized for
segmental wall
motion | Primary - from K161382
Secondary - from cleared
AutoStrain LV (K190913) | Not applicable - does not
contain functionality for
segmental wall motion | From K161382 | Subject device
preferentially utilizes
identical border initialization
algorithm as reference
device K161382.
If the reference device's
algorithm is unsuccessful in
the subject SWM, it will use
the border initialization of
the cleared AutoStrain LV
(K190913) as a back-up.
Performance testing has
demonstrated very strong
correlation between the
SWM scoring of the subject
software application
compared to the scoring of
the reference device on the
same clips. Therefore, there
are no new or increased
risks for the use of the
AutoStrain LV border
initialization in the subject | |
| Feature | Affiniti Series Diagnostic
Ultrasound System
Feature: SWM
Proposed Device | Affiniti Series Diagnostic
Ultrasound System
K233788
Predicate Device | LVivo Software Application
Feature: LVivo SG
K161382
Reference Device | Comparison | |
| | | | | SWM software application
as a back-up. | |
| SWM scoring
adjustment | Users manually edit scores
using a drop-down selection | Not applicable - does not
contain functionality for
segmental wall motion | Users must manually edit the
borders to attempt to edit scores | In the cleared LVivo SG,
users must manually adjust
the chamber borders to
influence the SWM scores.
In the subject SWM on
VM11, users may manually
select different SWM scores
for each segment using a
drop-down menu. Any
scores which are manually
changed from those
calculated by the software
application will be indicated
by an asterisk (*). This
change in editing does not
introduce new risks
because it is providing a
simpler way for the user to
edit their segmental wall
motion score(s) - instead of
having to edit the border
contours to influence the
SWM score as on the
cleared LVivo SG, user can
directly edit each segment's
score with the drop-down | |
Table 1: Comparison to Predicate - EPIQ
8
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PHILIPS
10
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Table 2: Comparison to Predicate - Affiniti
12
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VI. Safety Considerations
The proposed EPIQ and Affiniti Series Diagnostic Ultrasound Systems, including SVS and SWM software applications, and compatible transducers are all Track 3 Devices and comply with the referenced standards as well as the FDA ultrasound guidance document, Guidance for Industry and FDA Staff - Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, issued in February 2023.
VII. Nonclinical Performance Data
The proposed modification of the EPIQ and Affiniti Series Diagnostic Ultrasound Systems was tested in accordance with Philips internal procedures. Philips Ultrasound tested the subject devices per the following standards to ensure the continued safe and effective performance:
- IEC 62304 Medical device software Software life cycle processes, 2006 + A 2015 ●
- IEC 62366-1 Medical devices Part 1: Application of usability engineering to medical devices . Edition 1.1 2020-06 CONSOLIDATED VERSION
- ISO 14971 Medical devices- Application of risk management to medical devices, 2019 ●
Non-clinical verification testing was conducted to address the change and performance test data were provided to support the introduction of the subject SVS and SWM software applications. The activities to assure the safe and effective performance of the software revision included, but are not limited to, the following:
- . Requirements Review
- . Risk Analysis and Management Review
- . Product Specification Review
14
. Design Reviews
In addition, two retrospective data analysis studies were performed to support the substantial equivalence of the SVS and SWM features integrated onto EPIQ and Affiniti:
The first study was conducted to evaluate the performance of the SVS workflow enhancement algorithm. Three reviewers (clinical experts) participated in the manual selection of clips from subject exam and subsequent semi-automated processing of the clips with AutoStrain LV software to evaluate GLS and EF, which served as ground truth (average across reviewers for each output). The same exams were processed through the SVS software for automatic selection of appropriate clips and subsequent, un-edited evaluation of GLS and EF with AutoStrain LV. GLS and bi-plane EF results for each subject evaluated by the reviewers (averaged across reviewers= ground truth) were compared to the automatically obtained GLS and EF results with SVS selected clips.
The co-primary endpoints for the study were defined as agreements between GLS/EF measured via manual clip selection and compared to SVS clip selection and GLS/EF output using AutoStrain LV software. Agreement was measured as correlation for each output, separately for GLS and EF (coprimary endpoints). A review of the published literature and previous regulatory submissions (K130779, K232500) informed the acceptance criteria for the study to be defined as Lower Confidence Bound for the Pearson's correlation coefficient to be >0.8.
The results of the co-primary endpoints analysis demonstrated very strong correlation for GLS and EF outputs when manually selected clips were compared to SVS selected clips for the same subject exams. Specifically, for the Pearsons' correlation coefficient was 0.911 (95%Cl 0.855.0.946) and 0.941 (95%Cl 0.903.0.965), for GLS and EF, respectively. The lower confidence bounds were 0.855 for GLS and 0.903 for EF, thereby meeting the predefined acceptance criteria for the study.
A separate study was conducted to assess the use of Segmental Wall Motion (SWM), a machine learning-based feature in quantification of Wall Motion Score Index (WMSI) in transthoracic (TTE) ultrasound clips obtained from subjects referred for clinical TTE exam. The study evaluated the performance of the integrated SWM algorithm compared to LVivo SWM (DiA Imaging Analysis) application (ground truth) in the quantification of WMSI for the same subjects' exams. The study was executed in 2 phases with a 7-day washout period between the phase 1, three reviewers (clinical experts) participated in the manual selection of representative clips from subject TTE exams and subsequent processing of the clips with LVivo application for WMSI output, which served as ground truth in the study (average across reviewers). In phase 2, the manually selected clips as well as SVS selected clips (clips selected by the SVS workflow algorithm from subject exams used in phase1) were processed by the same 3 reviewers with the integrated (subject) SWM algorithm for WMSI output, in a random order.
A review of published literature within the cardiac assessment space and previous regulatory submissions (K130779, K223771, K232500) informed the acceptance criteria for the study to be defined as Lower Confidence Bound for the Pearson's correlation coefficient to be >0.8 for each endpoint. Acceptance criteria were defined prior to study execution.
The results of the co-primary endpoints analysis demonstrated very strong correlation for manual and SVS selected clips and assessed for WMSI of the subject SWM algorithm when compared to the ground truth. Specifically, the Pearsons' correlation coefficient was 0.957 (95%C) 0.933,0.972) and 0.913 (95%Cl 0.857,0.948), for the manual and SVS workflows, respectively. The lower confidence bounds were 0.933 for manual workflow and 0.857 for SVS workflow, thereby meeting the predefined acceptance criteria for the study.
Since this is a software-only change and no new hardware was added, no acoustic output, cleaning and disinfectant, thermal, electromagnetic, and mechanical safety testing were required. Biocompatibility testing is not needed for the subject EPIQ and Affiniti Series Diagnostic Ultrasound Systems with SVS and SWM. The transducer patient contact materials and manufacturing processes are not impacted by the release of the subject EPIQ and Affiniti Series Diagnostic Ultrasound Systems with SVS and SWM.
15
VIII. Clinical Data
There was no clinical investigation needed for this premarket submission of the EPIQ and Affiniti Series Diagnostic Ultrasound Systems with SVS and SWM software applications.
IX. Sterilization
Not applicable. The ultrasound transducers are not supplied sterile.
X. Conclusion
For testing, all pre-determined acceptance criteria were met. Results of these tests show that the proposed subject device meets its intended use support a determination that the proposed subject device does not raise new questions of safety or effectiveness.
Therefore, the subject device is substantially equivalent to the predicate device in terms of indications for use, design, technological characteristics, modes of operations, safety, and effectiveness.