(265 days)
The Flexible Video-Choledo-Cysto-Ureteroscope System is indicated for endoscopic examination in the urinary tract and can be used percutaneously to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures. The Flexible Video-Choledo-Cysto-Ureteroscope System is also indicated for the examination of bile ducts surgically, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.
Flexible Video-Choledo-Cysto-Ureteroscope System is composed of sterile Flexible Video-Choledo-Cysto-Ureteroscope and an non-sterile Imaging Processor System (Including Light Source).The Flexible Video-Choledo-Cysto-Ureteroscope is composed of Control Section, Light-guiding Section, Connector Section, Insertion Tube and Distal End. The Control Section is pulled by the wire rope to control the bending direction of the Distal End.
The Light-guide section transmits the illumination light from the image processor to the Distal End. The Insertion Tube is used to guide it into other instruments or cavity of the body. The Distal End contains a camera system and a lighting system for illumination and observation.
Imaging Processor System (Including Light Source) is composed of lighting system, image processing board. The lighting system provides the light source for the endoscope probe at the back end. The image processing board receives electronic signals from the front-end camera module and processes them, and finally transmits them to the display through the video interface.
Flexible Video-Choledo-Cysto-Ureteroscope is a kind of medical electronic optical instrument, also known as optical camera, which can enter into the human bladder, ureter, biliary and pancreatic duct for observation and diagnosis. The operator delivers the optical camera system to the site of diagnosis and treatment by means of a mechanical part with a flexible insertion tube and a system of bends.
The product is equipped with tiny size digital imaging parts --photoelectric sensors "CMOS", on which the objects in human cavity will be transferred though lens optical system, and converts light signals into electrical signals. The electrical signal will be transferred to Imaging Processor System (Including Light Source) and display images on it's monitor output for doctor observation and diagnosis.
This document is a 510(k) Premarket Notification from the FDA for a medical device called the "Flexible Video-Choledo-Cysto-Ureteroscope System." As such, it does not contain the information requested regarding acceptance criteria, study details (sample sizes, expert involvement, ground truth methods), or the performance of an AI/algorithm.
The document primarily focuses on establishing substantial equivalence to a predicate device (Flexible Video-Uretero-Choledochoscope System, K142556) based on:
- Indications for Use: The current device has similar indications for endoscopic examination in the urinary tract and bile ducts.
- Technological Characteristics: Comparison of features like imaging technology (CMOS), illumination source (LED), distal end size, deflection, field of view, and imaging processor system capabilities.
- Non-clinical Performance Data: Mention of testing against ISO standards for function, performance, electrical safety (IEC 60601-1, IEC 60601-2-18), electromagnetic compatibility (IEC 60601-1-2), and biocompatibility (ISO 10993). Sterilization process and EO residual validations are also mentioned.
Crucially, Section 5.8 "Clinical Test Data" explicitly states: "No Clinical Study is included in this submission." This means there is no data presented here about human performance (with or without AI assistance), standalone algorithm performance, or a comparative effectiveness study.
Therefore, I cannot provide a response filling in the requested details about acceptance criteria or a study proving the device meets those criteria, as that information is not present in the provided text. The device approval here is based on substantial equivalence to a predicate, not on a clinical trial demonstrating performance against specific quantitative acceptance metrics.
§ 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.