(141 days)
The Ureterorenoscope System consists of a sterile single-use disposable Flexible Ureteroscope to be introduced within the urinary tract and video processor for clinical image processing. The device is indicated for endoscopic examination in the urinary tract and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures.
The Ureterorenoscope System consists of a sterile single-use disposable Flexible Ureteroscope to be introduced within the urinary tract and endoscope operating system for clinical image processing.
The provided text describes a 510(k) premarket notification for a Ureterorenoscope System. It outlines the device, its indications for use, comparison with predicate devices, and performance data provided in support of substantial equivalence. However, it does not contain information related to acceptance criteria, specific study designs, or performance metrics in a way that would allow for a detailed response to all aspects of your request.
Specifically, the document discusses "performance data" in general terms, such as "Biocompatibility testing," "Sterilization and shelf life testing," "Electrical safety and electromagnetic compatibility (EMC)," "Software Verification and Validation Testing," "Optical performance testing," and "Mechanical performance testing." It states that "All evaluation acceptance criteria were met" for biocompatibility and that the system "complies with" various ISO and IEC standards for other tests, but it does not provide:
- A table of specific acceptance criteria and reported device performance values. It only gives broad statements of compliance.
- Sample sizes used for test sets or data provenance for these performance tests (e.g., country of origin, retrospective/prospective).
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, or any effect size. This type of study is more common for AI/diagnostic support systems, which this device is not described as.
- If a standalone (algorithm only) performance study was done. This is not an AI algorithm; it's a medical device.
- The type of ground truth used (e.g., pathology, outcomes data). While it mentions testing, it does not specify how "ground truth" was established for, say, optical or mechanical performance beyond compliance with standards.
- Sample size for the training set. This is not an AI device that would typically have a "training set" in the machine learning sense.
- How ground truth for the training set was established.
Therefore, based on the provided text, I can only extract the following limited information regarding acceptance criteria and performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Description of Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1:2009 for "Surface – Mucosal Membrane" contact ( |
§ 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.