(106 days)
The GE EchoPAC workstation is indicated for diagnostic review and analysis of ultrasound images acquired under various modes of operation including B, M, Color M modes, Color, Power, Pulsed & CW Doppler modes, Coded Pulse, Harmonic and Realtime 3D. Clinical applications include: Fetal; Abdominal (including renal and GYN); Urology (including prostate); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-skeletal Conventional; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).
The device may include EchoPliot reporting software which provides guidance to support the quality of the echocardiography examination and report. It compares patient data, user entered clinical data and measurements to generally accepted guidelines and studies, and helps to identify mismatches, inconsistencies and unusual or missing data. It can generate a preliminary data analysis that can be used as basis for the examination report.
GE EchoPAC provides image processing, annotation, analysis, measurement, report generation, communication, storage and retrieval of ultrasound images that are acquired via GE Vivid family of ultrasound scanners, primarily for cardiology ultrasound applications but also for general imaging. The EchoPAC software is an integral component of each Vivid system, providing the postacquisition image management and reporting functions of the scanner. EchoPAC will be offered as SW-only to be installed directly on customer PC hardware, or as an accessory to selected 3rd party image management workstations. EchoPAC is DICOM compliant, transferring images and data via LAN between scanners, hard copy devices, file servers and other workstations. The modified or added software features for GE EchoPAC are substantially equivalent to the predicate device and functionality cleared on GE EchoPAC K123894.
The provided document is a 510(k) Premarket Notification for the GE EchoPAC device. It outlines modifications to an existing device, rather than introducing a new software feature that necessitates a robust clinical study with specific acceptance criteria.
Based on the content of the document, the device did not require clinical studies to support its substantial equivalence. Therefore, there is no information provided regarding acceptance criteria for device performance, nor a study proving the device meets such criteria.
The document states:
- "The subject of this premarket submission, EchoPAC, did not require clinical studies to support substantial equivalence." (Page 2, "Summary of Clinical Tests" section).
- "GE Healthcare considers the EchoPAC to be as safe, as effective, and performance is substantially equivalent to the predicate device." (Page 2, "Conclusion" section).
The focus of this 510(k) submission is on demonstrating "substantial equivalence" of the modified device to a previously cleared predicate device (K123894). The modifications are primarily related to existing features (e.g., 4D Strain, 2D Strain) and the introduction of a new plug-in feature that was "originally cleared in its own right by their OEM manufacturer."
Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details about a clinical study as none were conducted or deemed necessary for this specific submission to demonstrate substantial equivalence.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).