(169 days)
The BioGuard EUS Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure.
The BioGuard EUS Suction Valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure.
The BioGuard EUS Air/Water Valve and the BioGuard EUS Suction Valve are accessories to an echoendoscope. The EUS Air/Water valve allows the end user to control air or CO2 insufflation down the endoscope's accessory channel, control water used to wash the lens of the endoscope and insufflate a balloon at the distal end of the echoendoscope.
The EUS Suction valve allows the user to control suction through the echoendoscope's accessory channel and suction to the balloon at the distal end of the echoendoscope.
Both devices are single use devices, supplied sterile.
The provided text is a 510(k) summary for a medical device (BioGuard EUS Air/Water and Suction Valves). It describes the device's technical characteristics, intended use, and comparison with a predicate device to demonstrate substantial equivalence. However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-based device.
The document discusses functional bench and simulated use testing for the physical valves to ensure they control air/CO2 and water supply/evacuation. This is standard for mechanical devices but is not related to the acceptance criteria or study methodologies typically used for AI/ML-driven medical devices (e.g., performance metrics like sensitivity, specificity, AUC).
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance: The document does not define such criteria or report AI/ML performance metrics.
- Sample size for test set and data provenance: Not applicable as no AI/ML study is mentioned.
- Number of experts used to establish ground truth and qualifications: Not applicable.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for training set: Not applicable.
- How ground truth for training set was established: Not applicable.
The document's conclusion states that "The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device." This refers to mechanical and functional performance, not AI/ML performance.
In summary, the provided text describes the regulatory clearance process for mechanical medical valves and does not contain the information requested regarding AI/ML device acceptance criteria or performance studies.
§ 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.