(14 days)
The EG-3630UR, Ultrasound Video Gastroscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Tract. The Upper Gastrointestinal Tract includes but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Small Bowel, and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for the procedure are observed in adult and pediatric patient populations.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Endoscopy
The EG-3630UR, Ultrasound Video Gastroscope, must be used with a Pentax Video Processor (software controlled device) and must be used with Ultrasound Scanner (software controlled device). The endoscope has a Flexible Insertion Tube, a Control Body, PVE Umbilical Connector, and Scanner Umbilical. The endoscope the PVE Connects to the Video Processor and has connections for illumination, video commoner and suction. The Scanner Connector is connected at the Ultrasound Scanner. The Control Body includes controls for up/ down/ left/ right angulation, air/water delivery, suction selection/ control, balloon insufflation, and an accessory inlet port. The device contains light carrying bundles to illuminate the body cavity, a marge couple device (CCD) to collect image data, and a radial array ultrasound transducer to collect ultrasonic image data. The instrument contains a working channel through which biopsy devices, or other devices, may be introduced (the instrument is supplied with two biopsy forceps) The Video Processor contains a lamp that provides white light that is filtered, via a Red, Green, and Blue color filter wheel, and is focused at the PVE Connector winte right the endoscope light carrying bundles present the color strobes to the body cavity and the CCD collects image data for each strobe of color. The Video Processor stores the CCD information until all three color eonbes mage are completed and a full color image frame is compiled. Image data and other screen display information are formatted and presented to the video outputs of the Video Processor for display. The ultrasound transducer delivers ultrasonic pulses, reflections of the pulses are received and signals are passed to the Ultrasound Scanner for display. The instrument is immersable (with the use of supplied cleaning accessories) except for the Ultrasound Scanner Connector (as described in the Endoscope operator Manual cleaning instructions).
The provided text is a 510(k) Summary for the EG-3630UR Ultrasound Video Gastroscope. It describes the device, its intended use, and its comparison to predicate devices for substantial equivalence.
However, the document explicitly states: "The submission for substantial equivalence was not based on an assessment of clinical performance data."
This means that a study proving the device meets specific acceptance criteria based on performance (e.g., accuracy, sensitivity, specificity) was not included or relied upon for this 510(k) clearance. Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets them because such a study was not presented in this submission.
The 510(k) process for this device focused on demonstrating substantial equivalence to legally marketed predicate devices primarily through comparison of specifications, standard components, and accessories, not through a clinical performance study. The FDA's clearance letter confirms this approach, stating, "We have determined the device is substantially equivalent... to legally marketed predicate devices."
Therefore, I cannot populate the table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for a clinical performance study.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.