(162 days)
EPIQ: The intended use of EPIQ Ultrasound Diagnostic System is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), intra-luminal, intra-cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.
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 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 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 R-trigger feature (non-ECG-based) has been developed to enable clinical users to use AutoMeasure and AutoStrain application without the R-trigger (ECG based) input, which is currently required. 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.
The provided FDA 510(k) clearance letter describes the R-Trigger software application on Philips EPIQ and Affiniti Ultrasound Systems, which aims to provide an alternative method for detecting R-wave peaks (R-triggers) for cardiac clinical applications like AutoStrain and AutoMeasure, especially when the ECG signal is unavailable or unusable.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The primary acceptance criteria for the R-Trigger algorithm are related to the agreement of its R-wave time stamp detection with the ground truth (ECG-based R-trigger) and the subsequent impact on the clinical outputs of AutoMeasure and AutoStrain. These are evaluated using Bland-Altman analysis (for agreement, specifically the Upper and Lower Limits of Agreement, LoA) and Pearson's correlation (for correlation, specifically the Lower Confidence Bound, LCB).
| Endpoint / Outcome Comparison | Measurement Type | Acceptance Criteria (Upper/Lower LoA or LCB) | Reported Device Performance (Upper/Lower LoA or Pearson's r with 95% CI) | Met Criteria? |
|---|---|---|---|---|
| Endpoint 1: R-trigger | ||||
| R-wave peak time stamp | Time Stamp | [-99.5ms, 99.5ms] | -58.06ms (-59.34, -56.78) to 69.69ms (68.41, 70.97) | Yes (-58.06 > -99.5, 69.69 0.8 |
| GLS | GLS (Correlation) | LCB > 0.8 | 0.992 (0.990, 0.994) | Yes (0.990 > 0.8) |
| Endpoint 2: AutoMeasure | ||||
| MV E Vel | Pw/cw Doppler velocity | [-25%, 25%] | -12.00 % (-13.17%, -10.84 %) to 12.98 % (11.81 %, 14.14%) | Yes (-12.00 > -25, 12.98 -30, 9.33 -30, 5.35 -29, 17.44 -29, 17.91 -30, 9.39 -25, 14.69 -30, 9.30 -30, 9.55 -29, 14.41 -30, 13.00 -28, 17.97 -28, 17.53 -25, 13.83 -29, 14.77 -30, 10.64 -34, 18.23 -30, 8.83 -46, 32.89 -46, 20.47 -46, 21.51 -28, 21.44 -28, 20.89 -28, 21.62 -40, 13.59 -35, 23.62 -40, 14.21 -30, 14.74 -30, 12.98 -30, 12.68 -30, 16.86 -29, 17.04 |
§ 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.