(61 days)
Olympus MH-246R Balloon Sheath have been designed to be used with the Olympus Ultrasonic Probe UM-2R/UM-3R, for intraluminal ultrasonic imaging of the urinary tract.
The MH-246R Balloon Sheath for urinary tract consists of two sections - insertion section and connector section. The insertion section is constructed of a balloon with the light shielding cover, insertion tube, and adapter. The connector section consists of a connector body, probe locking ring, sheath locking ring, and irrigation port. The insertion section is connector body through a sheath locking ring, while the ultrasonic probe in inserted into the balloon sheath through a probe locking ring. The water filled syringe is connected to the irrigation port via an extension tube and three-way stopcock. The insertion section with the balloon will be provided sterile and intended for single use only. The connector section can be reused after proper cleaning and sterilization as outlined in the instruction manual.
The provided text is a 510(k) Summary for the Olympus MH-246R Balloon Sheath. It describes the device, its intended use, and substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance metrics (such as accuracy, sensitivity, specificity), study design, sample sizes, ground truth establishment, or expert involvement for a study proving the device meets acceptance criteria.
Therefore, I cannot provide the requested table or detailed answers to questions 1-9 based on the given input. The document is primarily a regulatory submission outlining the device's description and intended use for substantial equivalence, not a performance study report.
§ 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.