(26 days)
The Flexible Ureterorenoscope is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.
The Flexible Ureterorenoscope (Model: US31E-12-EU; US31E-12-US) is intended to be used with the Video Processor (cleared in K211169). The Flexible Ureterorenoscope is inserted through the natural orifice urethra and when used with the compatible Video Processor and monitor, the endoscope system can be operated as intended and indicated. The Flexible Ureterorenoscope is a single-use endoscope, which consists of a Handle, an Insertion Section, and an Endoscope Connector. The handle includes a deflection lever, a working channel port for accessory devices and a Luer port for irrigation. The insertion section contains one working channel and wiring to transmit the image signals to the Video Processor. The distal bending section of the insertion is controlled by the user via the deflection lever on the handle. The distal end of the insertion contains a CMOS sensor for capturing image and transmitting it to the Video Processor, LEDs for illumination, and the distal opening of the working channel. The endoscope connects the endoscope handle to the video processor, which provides power and processes video signals from the endoscope. Same as the predicate, the subject device is also provided in 2 deflection versions (US/EU deflection), which is the only difference between the two proposed models.
The provided text describes a 510(k) premarket notification for a medical device called "Flexible Ureterorenoscope." This document is a regulatory submission to the FDA proving substantial equivalence to a predicate device, not a study of an AI/ML algorithm. Therefore, many of the requested details, such as AI-specific acceptance criteria, test set Ground Truth establishment, MRMC studies, or training set information, are not applicable to this kind of device and its regulatory pathway.
The device discussed is a standard medical instrument, an endoscope, not an AI-powered diagnostic or therapeutic device. The "study" mentioned refers to non-clinical performance data and testing to demonstrate that the modified device performs comparably to its predicate and meets safety standards, not a clinical trial involving AI.
Here's an attempt to answer the questions based on the provided text, highlighting where the requested AI-specific information is not applicable:
1. A table of acceptance criteria and the reported device performance
The document states that the device passed all testing in accordance with internal requirements and applicable standards. The acceptance criteria are generally implied to be the successful demonstration that the device's characteristics (mechanical, optical, material, etc.) are equivalent to or better than the predicate device and meet relevant regulatory standards. Specific numerical acceptance criteria were not explicitly provided in the summary, but rather implied by the statement "passed all the testing in accordance with internal requirements and applicable standards to support substantial equivalence of the subject device."
| Test Category | Specific Tests | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | Tensile strength at joints/connections, coaxiality, deflection endurance, withstand of channel. | Met internal requirements and applicable standards. | Passed all tests. |
| Biocompatibility | Cytotoxicity (ISO 10993-5), Irritation (ISO 10993-10), Sensitization (ISO 10993-10), Acute Systemic Toxicity (ISO 10993-11), Material-mediated pyrogenicity (ISO 10993-11). | Met ISO 10993-1 and FDA Guidance requirements for Limited ( |
§ 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.