(162 days)
Yes.
The device description explicitly states "The R-Trigger AI software feature on Philips EPIQ and Affiniti Ultrasound System" and "R-trigger AI based software".
No.
The intended use of the device is "diagnostic ultrasound imaging and fluid flow analysis of the human body." It is not designed to treat, cure, or mitigate a 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 device in question, the "R-Trigger algorithm software feature," is implemented on these diagnostic ultrasound systems and supports their clinical applications.
No
The device is described as "The R-Trigger algorithm software feature on Philips EPIQ and Affiniti Ultrasound System". The predicate and reference devices are ultrasound systems, which are hardware devices. The description explicitly states, "There are no hardware changes to the EPIQ and Affiniti systems due to change to the introduction of the R-Trigger software application." This indicates that the software is an additional feature or component of an existing, integrated hardware system, not a standalone software-only medical device.
No.
This device is an ultrasound system with an AI software feature for diagnostic imaging and fluid flow analysis, which are in-vivo diagnostic procedures, not in-vitro.
No
The letter does not state that the FDA has reviewed and cleared or approved a PCCP for this device. There is no mention of PCCP in the provided text.
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 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.
Modes of operation include: B Mode, M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode , Power Doppler, and Harmonic Imaging.
Product codes
IYN, IYO, ITX, QIH, OBJ
Device Description
The R-Trigger algorithm software feature on Philips EPIQ and Affiniti Ultrasound System is intended to support detection of R-wave peak (R-trigger) as an input to certain TTE clinical applications, initially including AutoStrain LV, AutoEF, 2D Auto LV (collectively referred to as "AutoStrain"), and AutoMeasure applications. The R-trigger algorithm is planned to be implemented as workflow enhancement for transthoracic clinical applications on EPIQ and Affiniti Ultrasound Systems in the VM13 software release.
The Auto-Measure and AutoStrain features, cleared on Philips EPIQ and Affiniti systems (K211597, K190913 resp.) support users during B-mode (2D), CW-, PW- and TDI-Doppler measurements by automating some of the measurements needed to complete a routine transthoracic echo (TTE) exam for adult patients.
The current AutoMeasure and AutoStrain applications require input from physio signal (ECG) using electrodes, because the modules and their detectors work on single cardiac cycles, starting and ending with the End Diastole (ED) or more precisely with delimiting R-trigger events as a good approximation. Determining the R-triggers is currently done on the EPIQ and Affiniti Ultrasound Systems by a dedicated physio board. However, in some cases, the physio signal is not available, either because it was never obtained or because the data were not saved. To enable clinical users to be able to use AutoMeasure and AutoStrain application without the R-trigger (ECG based) input, R-trigger feature (non-ECG-based) has been developed.
There are no hardware changes to the EPIQ and Affiniti systems due to change to the introduction of the R-Trigger software application.
The software application is 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 ("adult patients" mentioned for AutoMeasure and AutoStrain), Neonatal (Cephalic Neonatal), Pediatric (Cardiac Pediatric, Pediatric). The age range in the study demographics is 18.00 to 100.00 years.
Intended User / Care Setting
Trained healthcare professionals (sonographers, physicians, and biomedical engineers); Clinics, hospitals, and clinical point-of-care.
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
A retrospective data analysis study was executed to evaluate the performance of R-trigger AI based software in detection of R-wave time stamp and subsequent input of the time stamp into AutoMeasure and AutoStrain applications' clinical outputs. The study was executed on cardiac TTE clips acquired with Philips Ultrasound systems from a diverse set of subject demographics, body habitus and parameters' distribution. Total of 7309 cardiac clips from 3964 were used for analysis of R-trigger AI-based algorithm covering the 3 endpoints.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Retrospective data analysis study
Sample Size: 7309 cardiac clips from 3964 subjects.
Standalone Performance: Not explicitly stated as standalone performance, but primary endpoint #1 evaluated the performance of the R-Trigger (non-ECG) algorithm in isolation.
Key Results: The results of the 35 hypotheses demonstrated high agreement of R-trigger AI based algorithm in both technical and clinical assessments when compared to ECG-based R-trigger. The mean differences, inclusive of 95% confidence intervals, reported in the study for all endpoints fall within the clinical ranges, as such the clinical acceptability for the bias (mean difference) is also met. The study results produced confidence intervals for the limits of agreement and correlation, for each parameter (hypothesis) tested, meeting the pre-defined acceptance criteria for the study.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The study reports bias (mean difference) and 95% Confidence Intervals for Upper and Lower Limits of Agreement (LoA). It also reports Pearson's correlation coefficient (r). Specific metrics reported include:
- R-wave peak time stamp: Lower LoA -58.06ms (-59.34, -56.78), Upper LoA 69.69ms (68.41, 70.97)
- EF: Pearson's correlation coefficient (r) 0.892 (0.853,0.922)
- GLS: Pearson's correlation coefficient (r) 0.992 (0.990,0.994)
- Various AutoMeasure parameters (e.g., MV E Vel, LVIDd) with Lower and Upper LoA and 95% CI.
Predicate Device(s)
K240850; Philips EPIQ Series Diagnostic Ultrasound System and Philips Affiniti Series Diagnostic Ultrasound System
Reference Device(s)
K190913 (AutoStrain), K211597 (AutoMeasure)
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.
FDA 510(k) Clearance Letter - Philips Ultrasound Systems
Page 1
May 21, 2025
Philips Ultrasound LLC
Deval Patel
Principal Regulatory Affairs Specialist
22100 Bothell Everett Hwy
Bothell, Washington 98021
Re: K243793
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, QIH, OBJ
Dated: December 10, 2024
Received: May 8, 2025
Dear Deval Patel:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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K243793 - Deval Patel Page 2
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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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
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K243793 - Deval Patel Page 3
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-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,
Lora D. Weidner, Ph.D.
Assistant Director
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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K243793
Device Name
EPIQ Series Diagnostic Ultrasound System
Affiniti Series Diagnostic Ultrasound System
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), 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 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.
Modes of operation include: B Mode, M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode , Power Doppler, and Harmonic Imaging.
Page 5
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Page 6
510(k) Summary
This summary of safety and effectiveness information is submitted in accordance with 21 CFR § 807.92.
510(k) Number: K243793
Date Prepared: December 10, 2024
Date Modified: May 21, 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* |
*EPIQ only
| Device Class | Class II |
|---|---|
| Review Panel | Radiology |
| Predicate Device | K240850; Philips EPIQ Series Diagnostic Ultrasound System and Philips Affiniti Series Diagnostic Ultrasound System |
Page 7
III. Device Description
The R-Trigger algorithm software feature on Philips EPIQ and Affiniti Ultrasound System is intended to support detection of R-wave peak (R-trigger) as an input to certain TTE clinical applications, initially including AutoStrain LV, AutoEF, 2D Auto LV (collectively referred to as "AutoStrain"), and AutoMeasure applications. The R-trigger algorithm is planned to be implemented as workflow enhancement for transthoracic clinical applications on EPIQ and Affiniti Ultrasound Systems in the VM13 software release.
The Auto-Measure and AutoStrain features, cleared on Philips EPIQ and Affiniti systems (K211597, K190913 resp.) support users during B-mode (2D), CW-, PW- and TDI-Doppler measurements by automating some of the measurements needed to complete a routine transthoracic echo (TTE) exam for adult patients.
The current AutoMeasure and AutoStrain applications require input from physio signal (ECG) using electrodes, because the modules and their detectors work on single cardiac cycles, starting and ending with the End Diastole (ED) or more precisely with delimiting R-trigger events as a good approximation. Determining the R-triggers is currently done on the EPIQ and Affiniti Ultrasound Systems by a dedicated physio board. However, in some cases, the physio signal is not available, either because it was never obtained or because the data were not saved. To enable clinical users to be able to use AutoMeasure and AutoStrain application without the R-trigger (ECG based) input, R-trigger feature (non-ECG-based) has been developed.
There are no hardware changes to the EPIQ and Affiniti systems due to change to the introduction of the R-Trigger software application.
The software application is 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.
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.
Page 8
Affiniti Intended Use
The intended use of Affiniti Ultrasound Diagnostic System 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 (Superficial), 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 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 R-Trigger software application.
Page 9
V. Comparison of Technological Characteristics with the Predicate
The purpose of the submission is to introduce the R-Trigger software application 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.
Page 10
Table 1: Comparison to Predicate for introduction of R-Trigger onto EPIQ
| Feature | EPIQ Series Diagnostic Ultrasound System Feature: R-Trigger 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 |
| Primary Regulation Number | 21 CFR 892.1550 | 21 CFR 892.1550 | Identical to predicate |
Page 11
| Feature | EPIQ Series Diagnostic Ultrasound System Feature: R-Trigger Proposed Device | EPIQ Series Diagnostic Ultrasound System K240850 Predicate Device | Comparison |
|---|---|---|---|
| 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 |
| Device Track | Track 3 | Track 3 | Identical to predicate |
| Application Description | The R-Trigger AI software feature on Philips EPIQ and Affiniti Ultrasound System is intended to support detection of R-wave peak (R-trigger) as an input to AutoStrain and AutoMeasure applications, as well as other cardiac clinical applications. The R-trigger algorithm is planned to be implemented as workflow enhancement to the AutoStrain (previously cleared by FDA; K190913) and AutoMeasure (previously cleared by FDA; K211597) applications on EPIQ and Affiniti Ultrasound Systems in the VM13 software release. | The EPIQ ultrasound systems currently detects R-Trigger events by processing a patient's ECG signal using the on-cart physio board. | Similar. In the subject device, the R-Trigger algorithm will provide an additional method of determining R-Trigger events for a patient's acquired ultrasound clip. |
Currently, the Ultrasound System requires an ECG signal, which is processed by the on-cart physio board, to detect R-Trigger events in the cardiac cycle. These detected events are used as input into various cardiac clinical applications.
In the subject device, the R-Trigger algorithm will serve as a back-up for R-Trigger event detection.
Detecting events from the ECG signal on the system will still be the preferred method. In case the ECG signal is not usable or not available, the new R-Trigger algorithm will detect the events.
From a user perspective, their only difference is that they will be able to use certain cardiac clinical applications on acquired clips which do not have a usable ECG signal in the subject device. Otherwise, there are not able changes visible to the user as both methods work in the background. |
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Table 2: Comparison to Predicate for introduction of R-Trigger onto Affiniti
| Feature | Affiniti Series Diagnostic Ultrasound System Feature: R-Trigger 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), 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. | 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 |
| Primary Regulation Number | 21 CFR 892.1550 | 21 CFR 892.1550 | Identical to predicate |
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| Feature | Affiniti Series Diagnostic Ultrasound System Feature: R-Trigger Proposed Device | Affiniti Series Diagnostic Ultrasound System K240850 Predicate Device | Comparison |
|---|---|---|---|
| Secondary Product Codes | ITX | ||
| IYO | |||
| QIH | ITX | ||
| IYO | |||
| QIH | Identical to predicate | ||
| Secondary Regulation Name | Diagnostic ultrasonic transducer | ||
| Ultrasonic pulsed echo imaging system | |||
| Automated Radiological Image Processing Software | Diagnostic ultrasonic transducer | ||
| Ultrasonic pulsed echo imaging system | |||
| Automated Radiological Image Processing Software | Identical to predicate | ||
| Secondary Regulation Number | 21 CFR 892.1570 | ||
| 21 CFR 892.1560 | |||
| 21 CFR 892.2050 | 21 CFR 892.1570 | ||
| 21 CFR 892.1560 | |||
| 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 |
| Device Track | Track 3 | Track 3 | Identical to predicate |
| Application Description | The R-Trigger AI software feature on Philips EPIQ and Affiniti Ultrasound System is intended to support detection of R-wave peak (R-trigger) as an input to AutoStrain and AutoMeasure applications, as well as other cardiac clinical applications. The R-trigger algorithm is planned to be implemented as workflow enhancement to the AutoStrain (previously cleared by FDA; K190913) and AutoMeasure (previously cleared by FDA; K211597) applications on EPIQ and Affiniti Ultrasound Systems in the VM13 software release. |
The Affiniti ultrasound systems currently detects R-Trigger events by processing a patient's ECG signal using the on-cart physio board. | Similar. In the subject device, the R-Trigger algorithm will provide an additional method of determining R-Trigger events for a patient's acquired ultrasound clip.
Currently, the Ultrasound System requires an ECG signal, which is processed by the on-cart physio board, to detect R-Trigger events in the cardiac cycle. These detected events are used as input into various cardiac clinical applications.
In the subject device, the R-Trigger algorithm will serve as a back-up for R-Trigger event detection.
Detecting events from the ECG signal on the system will still be the preferred method. In case the ECG signal is not usable or not available, the new R-Trigger algorithm will detect the events.
From a user perspective, their only difference is that they will be able to use certain cardiac clinical applications on acquired clips which do not have a usable ECG signal in the subject device. Otherwise, there are not able changes visible to the user as both methods work in the background. |
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VI. Safety Considerations
The proposed EPIQ Series Diagnostic Ultrasound System and Affiniti Series Diagnostic Ultrasound System, including R-Trigger software application, 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 R-Trigger software application. 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 R-Trigger software application.
A retrospective data analysis study was executed to evaluate the performance of R-trigger AI based software in detection of R-wave time stamp and subsequent input of the time stamp into AutoMeasure and AutoStrain applications' clinical outputs. The study was executed on cardiac TTE clips acquired with Philips Ultrasound systems from a diverse set of subject demographics, body habitus and parameters' distribution. There were 3 primary endpoints in the study. Primary endpoint #1 evaluated the performance of the R-Trigger (non-ECG) algorithm in isolation, primary endpoints #2 and #3 evaluated the clinical impact of the R-Trigger algorithm outputs, which were used as an input to the AutoMeasure and AutoStrain clinical application, respectively. Total of 35 hypotheses covering 3 endpoints were tested in this study in a pre-defined hierarchical order with pre-defined acceptance criteria. A total of 7309 cardiac clips from 3964 were used for analysis of R-trigger AI-based algorithm covering the 3 endpoints. The demographic for the subjects associated with the clips included in the study are presented in the tables below and additionally refer to Table 6 and Table 7 for detail different market regions stratified by demographics and age and BMI stratification by modes:
Table 1: AutoMeasure Subjects' Demographics
| 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 |
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| Asian | 2.70% (107/3964) |
|---|---|
| Black or African American | 45.18% (1791/3964) |
| White | 30.25% (1199/3964) |
| Other/Mixed | 21.85% (866/3964) |
| Unknown | 0.03% (1/3964) |
| BMI (kg/ m2) | 28.85±7.06 (3964);(12.40;63.60) |
Table 2: AutoStrain Subjects' Demographics
| Subjects | (mean ± SD (n) (min, max) or % (n/N) ) |
|---|---|
| Age (years) | 48.87±18.60 (82) (20.00, 86.00) |
| Gender | |
| Male | 45.12% (37/82) |
| Female | 54.88% (45/82) |
| Race | |
| Asian | 24.39% (20/82) |
| Black or African American | 7.32% (6/82) |
| White | 36.59% (30/82) |
| Other/Mixed | 31.71% (26/82) |
| BMI (kg/ m2) | 24.37±3.47 (82) (16.40, 33.80) |
Table 3: R-trigger Time Stamp Subjects' Demographics
| Subjects | (mean ± SD (n) (min, max) or % (n/N) ) |
|---|---|
| Age (years) | 58.51±17.00 (1894); (18.00;100.00) |
| Gender | |
| Male | 47.31% (896/1894) |
| Female | 52.69% (998/1894) |
| Race | |
| Asian | 3.27% (62/1894) |
| Black or African American | 42.77% (810/1894) |
| White | 31.36% (594/1894) |
| Other/Mixed | 22.60% (428/1894) |
| BMI (kg/ m2) | 28.51±6.81(1894); (12.40;69.50) |
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 35 hypotheses demonstrated high agreement of R-trigger AI based algorithm in both technical and clinical assessments when compared to ECG-based R-trigger. The mean differences, inclusive of 95% confidence intervals, reported in the study for all endpoints fall within the clinical
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ranges, as such the clinical acceptability for the bias (mean difference) is also met.
The study results produced confidence intervals for the limits of agreement and correlation, for each parameter (hypothesis) tested, meeting the pre-defined acceptance criteria for the study. The results for all three primary endpoints are shown below:
Table 4: Relative Bland-Altman Analysis for R-trigger AI-based workflow vs Ground Truth
| Endpoint | Order of Hypothesis Testing | Outcomes Comparison | Lower LoA (95% CI) | Upper LoA (95% CI) | Measurement Type | Acceptance Criteria |
|---|---|---|---|---|---|---|
| Endpoint 1: R-trigger | 1 | R-wave peak time stamp | -58.06ms (-59.34, -56.78) | 69.69ms (68.41, 70.97) | Time Stamp | [-99.5ms, 99.5ms] |
| Endpoint 3: AutoStrain* | N/A | EF | -6.64% (-7.60%, -5.68%) | 6.52% (5.56%, 7.49%) | EF | [20%, 20%] |
| N/A | GLS | -5.25% (-5.72%, -4.79%) | 4.63% (4.16%, 5.10%) | GLS | [7%, 7%] | |
| Endpoint 2: AutoMeasure | 4 | MV E Vel | -12.00 % (-13.17%, -10.84 %) | 12.98 % (11.81 %, 14.14%) | Pw/cw Doppler velocity | [-25%, 25%] |
| 5 | LVIDd | -9.33 % (-9.84%, -8.81 %) | 9.33 % (8.82 %, 9.85%) | Distance | [-30%, 30%] | |
| 6 | RVLd | -8.60 % (-9.57 %, -7.62 %) | 5.35 % (4.38 %, 6.33%) | Distance | [-30%, 30%] | |
| 7 | TR VTI | -12.26 % (-15.15 %, -9.37 %) | 17.44 % (14.54 %, 20.33%) | Pw/cw Doppler VTI | [-29%, 29%] | |
| 8 | PV VTI | -13.73 % (-15.87 %, -11.59 %) | 17.91 % (15.78 %, 20.05%) | Pw/cw Doppler VTI | [-29%, 29%] | |
| 9 | LA Diameter a.p. (PLAX) | -8.05 % (-9.41 %, -6.70 %) | 9.39 % (8.03 %, 10.74%) | Distance | [-30%, 30%] | |
| 10 | MV A Vel | -15.95 % (-17.44 %, -14.47 %) | 14.69 % (13.20 %, 16.17%) | Pw/cw Doppler velocity | [-25%, 25%] | |
| 11 | Ao SV diam | -7.60 % (-8.42 %, -6.77 %) | 9.30 % (8.47 %, 10.12%) | Distance | [-30%, 30%] | |
| 12 | LVOT diam | -9.84 % (-10.51 %, -9.16 %) | 9.55 % (8.87 %, 10.22%) | Distance | [-30%, 30%] | |
| 13 | LVOT VTI | -10.97 % (-12.66 %, -9.28 %) | 14.41 % (12.72 %, 16.09%) | Pw/cw Doppler VTI | [-29%, 29%] | |
| 14 | AoR Diam(2D) = Ao Annlus diam | -13.02 % (-14.60 %, -11.44 %) | 13.00 % (11.42 %, 14.58%) | Distance | [-30%, 30%] | |
| 15 | RV S'(l) | -16.11 % (-17.59 %, -14.63 %) | 17.97 % (16.49 %, 19.45%) | TDI velocity | [-28%, 28%] |
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| Endpoint | Order of Hypothesis Testing | Outcomes Comparison | Lower LoA (95% CI) | Upper LoA (95% CI) | Measurement Type | Acceptance Criteria |
|---|---|---|---|---|---|---|
| 16 | LV A'(s) | -15.85 % (-18.53 %, -13.17 %) | 17.53 % (14.85 %, 20.22%) | TDI velocity | [-28%, 28%] | |
| 17 | TR Vmax | -9.66 % (-11.95 %, -7.38 %) | 13.83 % (11.54 %, 16.12%) | Pw/cw Doppler velocity | [-25%, 25%] | |
| 18 | AV VTI | -12.85 % (-14.06 %, -11.64 %) | 14.77 % (13.56 %, 15.98%) | Pw/cw Doppler VTI | [-29%, 29%] | |
| 19 | Ao Asc diam | -9.63 % (-10.49 %, -8.76 %) | 10.64 % (9.77 %, 11.50%) | Distance | [-30%, 30%] | |
| 20 | TAPSE | -19.65 % (-22.85 %, -16.44 %) | 18.23 % (15.02 %, 21.43%) | Distance (TAPSE/MAPSE) | [-34%, 34%] | |
| 21 | Ao STJ diam | -7.61 % (-8.26 %, -6.95 %) | 8.83 % (8.17 %, 9.49%) | Distance | [-30%, 30%] | |
| 22 | RA Volume (A4Cs) | -27.08 % (-29.52 %, -24.63 %) | 32.89 % (30.45 %, 35.33%) | Volume Contour | [-46%, 46%] | |
| 23 | LA Vol (A2Cs) | -21.72 % (-23.61 %, -19.82 %) | 20.47 % (18.58 %, 22.37%) | Volume Contour | [-46%, 46%] | |
| 24 | LA Vol (A4Cs) | -23.80 % (-25.88 %, -21.73 %) | 21.51 % (19.44 %, 23.58%) | Volume Contour | [-46%, 46%] | |
| 25 | LV A'(l) | -17.60 % (-20.15 %, -15.06 %) | 21.44 % (18.90 %, 23.98%) | TDI velocity | [-28%, 28%] | |
| 26 | LV E'(s) | -19.45 % (-21.25 %, -17.65 %) | 20.89 % (19.08 %, 22.69%) | TDI velocity | [-28%, 28%] | |
| 27 | LV E'(l) | -19.21 % (-21.04 %, -17.37 %) | 21.62 % (19.78 %, 23.45%) | TDI velocity | [-28%, 28%] | |
| 28 | LVPWd | -14.13 % (-14.89 %, -13.36 %) | 13.59 % (12.82 %, 14.35%) | Distance Short | [-40%, 40%] | |
| 29 | MV Dec. Time | -24.95 % (-26.87 %, -23.03 %) | 23.62 % (21.70 %, 25.54%) | Doppler Time Interval | [-35%, 35%] | |
| 30 | IVSd | -15.82 % (-16.65 %, -15.00 %) | 14.21 % (13.38 %, 15.04%) | Distance Short | [-40%, 40%] | |
| 31 | TV Ann diam ant-post | -14.91 % (-17.46 %, -12.37 %) | 14.74 % (12.20 %, 17.29%) | Distance | [-30%, 30%] | |
| 32 | LVIDs | -13.31 % (-14.27 %, -12.34 %) | 12.98 % (12.02 %, 13.95%) | Distance | [-30%, 30%] | |
| 33 | RVDd base (RVD1) | -12.60 % (-13.27 %, -11.92 %) | 12.68 % (12.00 %, 13.36%) | Distance | [-30%, 30%] |
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| Endpoint | Order of Hypothesis Testing | Outcomes Comparison | Lower LoA (95% CI) | Upper LoA (95% CI) | Measurement Type | Acceptance Criteria |
|---|---|---|---|---|---|---|
| 34 | RVDd mid (RVD2) | -20.45 % (-21.80 %, -19.11 %) | 16.86 % (15.51 %, 18.21%) | Distance | [-30%, 30%] | |
| 35 | MR VTI | -14.36 % (-15.90 %, -12.82 %) | 17.04 % (15.50 %, 18.58%) | Pw/cw Doppler VTI | [-29%, 29%] |
*EF/GLS were assessed via Pearson's Correlation for pre-specified hypothesis testing order. See table 5.
Table 5: Pearson's Correlation for R-trigger AI-based workflow vs ground Truth
| Order of Hypothesis Testing | Outcomes Comparison | Pearson's correlation coefficient (r) (95% CI) | Acceptance Criteria |
|---|---|---|---|
| 2 | EF | 0.892 (0.853,0.922) | LCB >0.8 |
| 3 | GLS | 0.992 (0.990,0.994) | LCB >0.8 |
Table 6: The performance analysis of the detectors in different market regions stratified by demographics
| B-mode apical | B-mode PLAX | cw Doppler | pw Doppler | TDI | M-Mode | |
|---|---|---|---|---|---|---|
| Bias [ms] | Lower 95% LoA (with 97.5 CI) [ms] | Upper LoA (with 97.5% CI) [ms] | Bias [ms] | Lower 95% LoA (with 97.5 CI) [ms] | Upper LoA (with 97.5% CI) [ms] | |
| Ethnicity "black" | 17.7 | -60.6 | 96.1 | 12.5 | -60.3 | 85.3 |
| Ehnicity "other" | 20.5 | -53.0 | 94.1 | 20.6 | -52.1 | 93.3 |
| Ethnicity "white" | 17.3 | -53.7 | 88.2 | 21.5 | -45.4 | 88.3 |
| Cardially healthy | 21.9 | -35.9 | 79.7 | 24.9 | -33.6 | 83.5 |
| Patients with echo indication | 16.7 | -62.0 | 95.4 | 15.6 | -55.7 | 86.9 |
| Region North America (USA1, USA2, Canada, Mexico) | 17.0 | -56.7 | 90.6 | 16.3 | -52.9 | 85.5 |
| Region Rest of world | 26.2 | -38.2 | 90.5 | 28.0 | -35.1 | 91.2 |
¹ Due to sample size issues, global performance is reported instead of rest of world data
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Table 7: Performance results of the different age – and BMI groups.
| Age [years] | 2D ALAX | 2D PLAX | CWD | PWD | TDI | Mmode | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| mean [ms] | std [ms] | N | mean [ms] | std [ms] | N | mean [ms] | std [ms] | N | mean [ms] | std [ms] | N | mean [ms] | std [ms] | N | mean [ms] | std [ms] | N | |
| = 80 | 18,0821 | 50,1052 | 266 | 9,7551 | 41,2727 | 248 | 3,206 | 28,1476 | 760 | 12,4942 | 42,5802 | 306 | 21,6097 | 40,9872 | 472 | 10,9446 | 21,0323 | 18 |
| Total | 4578 | 3246 | 10448 | 6312 | 7404 | 596 |
| BMI [kg/m²] | 2D ALAX | 2D PLAX | CWD | PWD | TDI | Mmode | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| mean [ms] | std [ms] | N | mean [ms] | std [ms] | N | mean [ms] | std [ms] | N | mean [ms] | std [ms] | N | mean [ms] | std [ms] | N | mean [ms] | std [ms] | N | |
| = 40.0 | 21,3035 | 44,2133 | 164 | 11,6543 | 25,0333 | 164 | -10,5029 | 40,7001 | 538 | -3,3229 | 58,5367 | 372 | 6,2726 | 31,0726 | 326 | 12,1638 | 16,8775 | 44 |
| Total | 4578 | 3246 | 10448 | 6312 | 7404 | 596 |
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Total of 35 hypotheses covering 3 endpoints were tested in this study in a pre-defined order with pre-defined acceptance criteria. Study produced confidence intervals for the limits of agreement and correlation, for each parameter (hypothesis) tested, meeting the pre-defined acceptance criteria for the study. Lastly, both AutoMeasure and AutoStrain applications are semi-automated quantitative imaging tools and users are generally expected to review and concur with the initialization and generated results. The users can also edit the application(s) 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, electrical, 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 R-Trigger. 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 R-Trigger.
VIII. Clinical Data
There was no clinical investigation needed for this premarket submission of the EPIQ Series Diagnostic Ultrasound Systems and Affiniti Series Diagnostic Ultrasound Systems with R-Trigger software application.
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.