(208 days)
The Cellvizio® 100 Series System with Confocal Miniprobes is a confocal laser system with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues.
The Uroflex™ B and CystoFlex™ F Confocal Miniprobes can be used within anatomical tracts, i.e., urinary, including, but not limited to, urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories.
| Confocal Miniprobes™ | Endoscope or accessory |
|---|---|
| UroFlex™ B | Cystoscope or ureteroscope with operating channel internal diameter ≥ 1.0mm (3 Fr) |
| CystoFlex™ F | Flexible Cystoscope with operating channel internal diameter ≥ 1.0mm (3 Fr) |
The subject devices, "Uroflex""B" and "CystoFlex""F" are identical in design and materials to the bundle and their reprocessing methods.
The provided text is a 510(k) summary for a medical device (Cellvizio® 100 Series System and Cellvizio® System with Confocal Miniprobes™). It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance.
Based on the provided text, there is no information present regarding specific acceptance criteria, a formal study proving the device meets acceptance criteria, or the details typically associated with AI/ML-based device performance studies.
The document states: "Verification and validation testing have shown that the Uroflex™B and CystoFlex™F Confocal Minigrobes are compatible with cystoscopes or endoscopic accessories with operating channels of diameter > 0.91 mm designed and commonly used to image the urinary tract during endoscopic procedures." However, this is a general statement and does not provide quantified acceptance criteria or detailed study results.
This submission is for a traditional medical device (confocal laser system with fiber optic probes), not an AI/ML-based device. Therefore, the questions related to AI/ML specific criteria (multi-reader multi-case studies, standalone algorithm performance, training data, ground truth establishment for training set) are not applicable to this document.
Since the requested information (acceptance criteria and study details) is not present in the provided text, I cannot complete the table or answer most of the specific questions.
§ 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.