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The EG-3870UTK, Ultrasound Video Gastroscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to the organs, tissues, and subsystems: Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: Endoscopy

PENTAX EG-3870UTK Ultrasound Video Gastroscope + HI VISION PREIRUS are the endoscopic ultrasound system consists of an ultrasound endoscope with a curved linear array type ultrasound transducer, video processor, and Hitachi ultrasound scanner. This modified new system configuration is to work together with the already cleared latest Hitachi HI VISION PREIRUS Diagnostic Ultrasound Scanner (K093466).

The provided text is a 510(k) summary for a medical device called "PENTAX EG-3870UTK Ultrasound Video Gastroscope (Curved Linear Array Type) + HI VISION PREIRUS". It describes a modification to an already cleared system. This document is a regulatory submission for premarket notification, not a clinical study report detailing acceptance criteria and performance data for a device.

Therefore, I cannot provide the requested information about acceptance criteria and device performance based on the provided text for the following reasons:

• This is a Special 510(k) submission for a modification, not a de novo clearance or a typical 510(k) requiring detailed performance data against acceptance criteria. The submission explicitly states: "There are no software or hardware changes between the PENTAX EG-3870UTK Ultrasound Video Gastroscope subject and predicate device in connecting with the new Hitachi HI VISION PREIRUS Diagnostic Ultrasound Scanner. In addition, there are no change in technology, including features, materials, and principles of operation." The modification is simply a change in the ultrasound scanner used with the endoscope.
• The justification for clearance is "substantial equivalence" to a predicate device, not demonstration of meeting specific performance acceptance criteria through a clinical study. The document states: "The system configuration modification does not impact the intended use, safety and/or effectiveness. The modified system configuration has been verified and validated according to the company's design control activities as certified in this Special 510(K) Submission's declaration of conformity with design control to ensure the compatibility between the PENTAX EG-3870UTK Ultrasound Video Gastroscope and the HITACHI HI VISION PREIRUS Ultrasound Scanner." This implies compatibility testing, not a formal clinical trial with acceptance criteria for diagnostic performance.
• No clinical study to demonstrate "device performance" in terms of sensitivity, specificity, accuracy, etc., is described. The document focuses on the equivalence of the modified system.

In summary, the provided document does not contain the information required to populate the requested table and answer the questions about acceptance criteria, study details, sample sizes, ground truth, experts, or comparative effectiveness studies. This type of information is typically found in full clinical study reports, which are usually not part of a Special 510(k) for a system configuration change like this.

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The EG-3870UTK, Ultrasound Video Gastroscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to the organs, tissues, and subsystems: Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for 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-3870UTK, Ultrasound Video Gastroscope, must be used with a Pentax Video processor (a software controlled device) and must be used with an Ultrasound Scanner (a software controlled device). The endoscope has a flexible insertion tube, a control body, PVE umbilical connector, and ultrasound scanner umbilical connector. The PVE connector will be attached to the Video Processor and has connections for illumination, video signals, air/ water/ and suction. The ultrasound umbilical connector will be attached to the ultrasound scanner unit. The control body includes controls for up/ down/ left/ right angulation, air/ water delivery, and an accessory inlet port. The endoscope contains light carrying bundles to illuminate the body cavity, a charge couple device (CCD) to collect endoscopic image data, and a linear 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 video processor contains a lamp that provides white light and is focused at the PVE connector light guide prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collects endoscopic image data. 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 the signals are passed to the ultrasound scanner for processing and 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 related to a 510(k) premarket notification for the "EG-3870UTK, Ultrasound Video Gastroscope." It describes the device, its intended use, and its comparison to predicate devices. However, the submission explicitly states that "The substantial equivalence is not based on an assessment of clinical performance data."

Therefore, the document does not contain information about:

• Acceptance criteria for device performance.
• Any study (clinical or otherwise) that proves the device meets acceptance criteria.

The core of this submission is a claim of substantial equivalence to existing legally marketed predicate devices, primarily based on design specifications, standard components, and a comparison table, rather than new performance data.

Consequently, none of the specific information requested in your prompt (such as sample sizes, ground truth establishment, expert qualifications, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance) is present in the provided text. The device's clearance is based on its similarity to previously cleared devices, implying that its performance is expected to be equivalent, but no new performance studies are detailed in this document.

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