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The Pentax Medical Valve Set is a collection of several sterile units. It is intended to be fitted to Pentax endoscopes' working channels/ports to control the flow of fluids, gases and other materials.

• Disposable Air/Water Valve: This unit is intended to be fitted to an endoscope air/water channel to control the inflow of medical gases and water, whilst preventing back-flow.
• Disposable Suction Valve: This unit is intended to be fitted to an endoscope suction channel to control the operations of suction, whilst preventing inflow of air.
• Disposable Biopsy Valve: This unit is intended to be fitted to an endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure.
• Disposable Water Jet Adapter: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.

The Pentax Medical Valve Set is a collection of several sterile units. It is intended to be fitted to Pentax endoscopes' working channels/ports to control the flow of fluids, gases and other materials. The sterile units may consist of Disposable Air/Water Valve, Disposable Suction Valve, Disposable Biopsy Valve and Disposable Water Jet Adapter. Disposable Endoscopy Adapter Set may be configured as single valve or multiple valves in any combination up to a maximum of 4 valves.

The provided document is a 510(k) Premarket Notification summary for the Pentax Medical Valve Set. This document is a regulatory submission for a medical device, which seeks to establish substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through a rigorous scientific study (like for AI/ML devices).

Therefore, the information required to answer the question about acceptance criteria and a study proving a device meets these criteria (especially in the context of AI/ML performance metrics like accuracy, sensitivity, specificity, or MRMC studies) is not present in this document.

Here's why and what information is present:

• Device Type: The Pentax Medical Valve Set is an endoscope accessory, a physical medical device. It is not an AI/ML software device.
• Regulatory Pathway: A 510(k) submission primarily focuses on demonstrating "substantial equivalence" to a predicate device already on the market. This involves comparing technological characteristics, intended use, and assessing any performance differences through bench testing, biocompatibility testing, and sterilization validation. It does not typically involve clinical performance studies in the way an AI/ML device would need to demonstrate its diagnostic or predictive accuracy.
• Non-clinical Performance Data: The document mentions "bench tests were performed on Pentax Medical Valve Set: Appearance, Physical properties. The results of all testing were passing." This implies the device met its internal design specifications for those physical attributes. However, these are not "acceptance criteria" for a diagnostic or predictive performance study as would be seen for AI/ML.
• Clinical Test Data: The document explicitly states: "No Clinical Study is included in this submission." This confirms that no study was conducted to demonstrate clinical performance (e.g., diagnostic accuracy, reader improvement).

In summary, this document does not contain the information required to fill out the table and answer the questions about AI/ML device performance and testing.

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