Search Results

The Venue is a general purpose diagnostic ultrasound system for use by qualified healthcare professionals. The clinical environments where the Venue can be used include critical care and emergency room environments, as well as point-of care areas in offices, clinical and hospital settings for diagnosis of patients.

The Venue is intended for ultrasound imaging, measurement and analysis of the human body and fluid for multiple clinical applications including: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/Organ (including breast, testes, thyroid). Peripheral vascular, neonatal and adult cephalic, musculoskeletal (conventional and superficial), cardiac (adults and pediatric), Transvaginal, Transesophageal, and imaging guidance of interventional procedures (e.g. Nerve block, vascular access).

The proposed Venue system is a general-purpose, Track 3, diagnostic ultrasound device, intended for ultrasound imaging, measurement and analysis of the human body and fluid that provides digital acquisition, processing and display capabilities. Venue can be used in offices, clinical areas and hospitals. The Venue is a mobile system with a small footprint that easily fits into tight spaces and positioned to accommodate the sometimes-awkward work settings of the point of care user. The Venue has a high resolution color LCD monitor, with a simple, multi-touch user interface that makes the system intuitive. The single surface screen can be cleaned with disinfectants. Articulated monitor arm enables flexible display positions in order to be accessible and clearly visible in both user-standing and sitting positions.

The proposed Venue has the capability for displaying the patient's ECG trace synchronized to the scanned image. This allows the user to view an image from a specific time of the ECG signal. The ECG signal can be input directly from the patient or as an output from an ECG monitoring device. ECG is not intended for monitoring or diagnosis.

The Venue has a battery that allows for scanning without the need to plug in to an electrical outlet. The system is capable of wireless communication and a barcode reader is available to be used as an input device. System meets DICOM requirements to support users image storage and archiving needs and allows for output to printing devices. The user documentation is available via electronic media.

The Venue utilizes a variety of linear, convex, and phased array transducers which provide high imaging capability, supporting all standard acquisition modes. Some biopsy kits are available for needle-guidance procedures. The system includes several automated tools designed to simplify and shorten the workflow time of the healthcare professional for some common assessments.

The provided document does not describe an acceptance criterion or a study to prove a device meets acceptance criteria related to clinical performance or algorithm accuracy.

Instead, this document is a 510(k) premarket notification for the GE Venue ultrasound system, asserting its substantial equivalence to previously cleared predicate devices. The review focuses on:

• Intended Use and Indications for Use: Defining the clinical applications and environments where the Venue can be used.
• Technological Characteristics: Comparing the Venue's technology (imaging modes, transducers, automated features, ECG module) to predicate devices.
• Safety and Effectiveness: Demonstrating compliance with voluntary standards for acoustic output, biocompatibility, cleaning/disinfection, and electrical/mechanical safety through non-clinical tests.

The document explicitly states: "The subject of this premarket submission, Venue, did not require clinical studies to support substantial equivalence." This means that for the purpose of this 510(k) submission, the device's performance was not evaluated against specific clinical acceptance criteria in a study that would involve metrics like sensitivity, specificity, or reader performance.

Therefore, I cannot provide the requested information from the given text. The device's "performance" in this context refers to its technological capabilities and safety features, which are demonstrated through compliance with established standards and comparison to predicate devices, rather than through a clinical performance study with defined acceptance criteria.

Ask a specific question about this device