(54 days)
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.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.