EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
Philips Ultrasound LLCThe EPIQ Series Diagnostic Ultrasound System and Affiniti Series Diagnostic Ultrasound System by Philips Ultrasound LLC are advanced ultrasound systems designed for diagnostic imaging and fluid flow analysis across multiple body regions. They include an AI software feature called R-Trigger that detects R-wave peaks from cardiac cycles without requiring ECG input, aiding automated cardiac measurements to simplify and improve workflow for clinicians during transthoracic echo exams.
Intended Use
Diagnostic ultrasound imaging and fluid flow analysis of the human body with indications including abdominal, cardiac (adult, fetal, pediatric), cerebral vascular, cephalic, fetal/obstetric, gynecological, intraoperative, musculoskeletal, ophthalmic, urology, peripheral vessel, small organs (breast, thyroid, testicle), transesophageal, transrectal, transvaginal, lung.
Technology
The device is a diagnostic ultrasound system with multiple imaging modes (B, M, PW Doppler, CW Doppler, Color Doppler, etc.) incorporating an AI-based R-Trigger software algorithm to detect the R-wave peak from ultrasound clips without ECG signal. This software supports AutoMeasure and AutoStrain clinical applications for cardiac assessment, replacing or supplementing the traditional ECG-based R-trigger detection. No hardware changes were made; the algorithm operates on systems running software version 13.0 or higher.
Performance
Nonclinical testing included software lifecycle processes, risk management, requirements review, and design review. A retrospective data analysis was performed on 7309 cardiac clips across diverse subject demographics assessing the R-trigger algorithm performance. The algorithm demonstrated high agreement to the ECG-based R-trigger in technical and clinical metrics, meeting pre-defined acceptance criteria for clinical use. No new safety issues were raised. Clinical investigations were not required.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/10/2024
5 months - 2
FDA Approval
5/21/2025
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