(295 days)
The Disposable Endoscope Valve Sets 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 an Auxiliary Water Connector.
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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.
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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.
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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.
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Auxiliary Water Connector: 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 Valve Sets is a collection of several sterile units, it is intended for single-use and supplied sterile. The subject device is intended 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 an Auxiliary Water Connector.
- The Suction Valve component of the Disposable Endoscope Valve Sets is designed to be attached to the suction port of the endoscope, allowing the user to aspirate excess fluids or other debris obscuring the endoscopic image.
- The Air/Water Valve component of the Disposable Endoscope Valve Sets is designed to be attached to the air/ water port of the endoscope, the activation of the air/ water valve allows the user to control air and water flow to assist in cleansing the lens during procedures.
- The Biopsy Valve component of the Disposable Endoscope Valve Sets is intended to cover the endoscope biopsy port during an endoscopy procedure. In addition, the valve provides access for endoscopic device passage and exchange, helps maintain insufflation, and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.
- The Auxiliary Water Connector component of the Disposable Endoscope Valve Sets is designed to be attached to the auxiliary water port of the endoscopes. The auxiliary water connector consists of a backflow valve that prevents the backflow of water or biomaterials from the endoscope to the sterile water bottle.
The provided text is a 510(k) Summary for a medical device (Disposable Endoscope Valve Sets) submitted to the FDA. It does not include information about AI/ML models or their acceptance criteria and performance. Therefore, I cannot extract the requested information regarding AI/ML performance, study design, expert involvement, or ground truth establishment.
The document focuses on demonstrating substantial equivalence to a predicate device through bench testing for various functional aspects (e.g., flow rates, leakage, compatibility) and standard medical device testing (sterilization, biocompatibility, package integrity).
Here's what the document does provide regarding testing:
- Test Summary: Mentions bench testing to support substantial equivalence, including:
- Suction Valve: Endoscope Compatibility, Depression Force, Leakage Test, Suction Flow.
- Air/Water Valve: Endoscope Compatibility, Air flow rate, Water flow rate, Leakage Test, Depression Force, Backflow Performance Test.
- Biopsy Valve: Endoscope Compatibility, Leakage Test.
- Auxiliary Water Connector: Endoscope Compatibility, Leakage Test, Water flow rate, Backflow Performance Test.
- Sterilization: EO sterilization cycle validation to SAL of 10^-6, Ethylene Oxide residuals testing.
- Biocompatibility: In Vitro Cytotoxicity Test, Skin sensitization Test, Irritation or intracutaneous reactivity Test, compliant with ISO 10993 series.
- Package Integrity: Visual inspection, seal strength test (ASTM F88/F88M-2015), dye penetration testing (ASTM F1929-2015) after accelerated aging and simulated distribution.
- No Clinical Study: Explicitly states "No clinical study is included in this submission."
Therefore, I cannot fulfill the request for information on:
- A table of acceptance criteria and reported device performance (for an AI/ML model, as the document doesn't pertain to AI/ML).
- Sample size used for the test set and data provenance (in the context of an AI/ML model).
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- MRMC comparative effectiveness study or human reader improvement.
- Standalone (algorithm-only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML model.
- Sample size for the training set (as no AI/ML model is discussed).
- How the ground truth for the training set was established (as no AI/ML model is discussed).
§ 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.