(241 days)
This instrument has been designed to be used with an Olympus light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and hepatic duct).
This endoscope is composed from eyepiece section, control section and flexible insertion tube, and equipped light fiber bundle for image transfer system. Besides, it has eyepiece frame on eyepiece section for eyepiece and video camera connection for endoscope.
URF-P6R has Identification marking for opposite bending direction on the control section and the bending section of the URF-P6R moves in the direction opposite to the conventional endoscopes, such as the URF-P6. This is the only different point between URF-P6 and URF-P6R.
The provided document is a 510(k) premarket notification from Olympus Medical Systems Corp. for their URF-P6/P6R uretero-reno fiberscope. This document does not describe an AI/ML-driven device or study that proves the device meets acceptance criteria related to AI/ML performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Olympus URF Type P2) through non-clinical testing for safety and effectiveness.
Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria, study details, sample sizes, expert involvement, or ground truth establishment, as the document does not contain this type of content.
The information in the document pertains to:
- Device identification: Ureter-reno fiberscope, Regulation Number 876.1500, Class II.
- Indications for Use: Endoscopic diagnosis and treatment within the ureter, kidney, and biliary tract.
- Comparison to predicate device (K912120 URF Type P2): Discusses minor changes in physical properties, patient-contact material, sterilization method (addition of hydrogen peroxide), and internal structure for durability.
- Non-clinical testing: Risk analysis (ISO 14971), biocompatibility (ISO 10993), performance testing, reprocessing validation, and electrical safety (IEC 60601 standards).
The document concludes that the Olympus URF-P6/P6R is substantially equivalent to the predicate device, with no significant changes affecting safety or effectiveness.
§ 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.