(287 days)
The Disposable Endoscope Valves Set is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials. It includes an air/water valve, a suction valve, a biopsy valve and a water connector.
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Disposable Air/Water Valves: 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.
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Disposable Suction Valves: This unit is intended to be fitted to an endoscope suction channel to control the operations of suction, whilst preventing inflow of air.
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Disposable Biopsy Valves: This unit is intended to be fitted to an endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure.
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Disposable Endoscope Water Connectors: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.
The Disposable Endoscope Valves Set B is a collection of sterile device intended to be fitted to multiple endoscope working channels/ports to enable an endoscope operator control the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It includes a suction valve. This is a single-use device.
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Air/Water Valves: This device is intended to be fitted to an endoscope air/water channel to enable the operator to control inflow of medical gases and water, whilst preventing backflow.
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Suction Valves: The device is intended to be fitted to an endoscope suction channel to enable the operator to control suction whilst preventing inflow of air.
The Disposable Endoscope Valves Set is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials. It includes an air/water valve, a suction valve, a biopsy valve and a water connector.
The Disposable Endoscope Valves Set B is a collection of sterile device intended to be fitted to multiple endoscope working channels/ports of Pentax GI Video Endoscopes to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It includes a suction valve, an air/water valve.
The provided text describes the regulatory clearance for "Disposable Endoscope Valves Set" and "Disposable Endoscope Valves Set B" and compares them to predicate devices, but does not contain information related to software or AI performance, or any studies involving human readers or ground truth determination in the context of diagnostic accuracy.
Therefore, I cannot fulfill the request for information regarding AI acceptance criteria, device performance tables, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details as these concepts are not addressed in the provided document.
The document focuses on the substantial equivalence of the physical medical device to legally marketed predicate devices, primarily based on:
- Indications for use: Similar intended purposes.
- Technological characteristics: Similar design, sterilization method, single-use nature, and environment of use. Differences in compatible endoscopes and materials are discussed but deemed not to alter suitability, supported by performance testing and biocompatibility.
- Performance data: Bench testing to demonstrate functionality and biocompatibility testing.
However, I can extract information related to the general performance testing conducted:
1. A table of acceptance criteria and the reported device performance:
The document lists performance tests but does not explicitly provide a table of acceptance criteria with corresponding reported performance values in a structured quantitative comparison format. Instead, it states that "All evaluation acceptance criteria were met" for biocompatibility and that "bench testing to support substantial equivalence" was performed for various functional aspects.
| Device Component | Test Performed | Acceptance Criteria (Implied: Met) | Device Performance (Details not provided beyond "met acceptance criteria") |
|---|---|---|---|
| All components | Biocompatibility (Cytotoxicity, Irritation, Sensitization) | In accordance with ISO 10993-1 | Met |
| Disposable Air/Water Valves WS-VO-01 | Time of inflation of 8KPa air | Not explicitly stated | Met (supporting substantial equivalence) |
| Time of injection of 10g water | Not explicitly stated | Met (supporting substantial equivalence) | |
| Disposable Suction Valves WS-VO-02 | Time of suction of 200g water | Not explicitly stated | Met (supporting substantial equivalence) |
| Disposable Biopsy Valves WS-M-01S | Plug-in performance: Depression force, pull out force | Not explicitly stated | Met (supporting substantial equivalence) |
| Sealing performance: Leakage test, flush open force | Not explicitly stated | Met (supporting substantial equivalence) | |
| Fitting test | Not explicitly stated | Met (supporting substantial equivalence) | |
| Disposable Endoscope Water connectors WS-VO-03 | Leakage test under 80Kpa forward pressure | Not explicitly stated | Met (supporting substantial equivalence) |
| Leakage test under 30Kpa reverse pressure | Not explicitly stated | Met (supporting substantial equivalence) | |
| Disposable Air/Water Valves WS-VP-01 | Amount of water feeding | Not explicitly stated | Met (supporting substantial equivalence) |
| Amount of air feeding | Not explicitly stated | Met (supporting substantial equivalence) | |
| Depression force | Not explicitly stated | Met (supporting substantial equivalence) | |
| Sealing performance | Not explicitly stated | Met (supporting substantial equivalence) | |
| Disposable Suction Valves WS-VP-02 | Amount of suction | Not explicitly stated | Met (supporting substantial equivalence) |
| Depression force | Not explicitly stated | Met (supporting substantial equivalence) | |
| All components | Sterilization validation (ISO11135) | In accordance with ISO 11135 | Validated |
| All components | Shelf-life (accelerated aging test) | 3-year shelf-life | Evaluated (and presumably met, as it supports substantial equivalence) |
The remaining points (2-9) cannot be answered. The document does not describe a study involving algorithms, AI, human readers, or diagnostic accuracy. It's a clearance document for physical medical devices (endoscope valves) based on substantial equivalence to existing devices.
§ 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.