(319 days)
The device has been developed to be used with endoscopic accessories such as a biopsy forceps and Endoscopic Video Image Processor for endoscopy and endoscopic surgery within urinary tract and interior of the ureter and kidney.
The Single-Use Video Flexible Ureterorenoscope System consists of a sterile Single-Use Video Flexible Ureterorenoscope (consists of handle and insertion portion) and an Endoscopic Video Image Processor (the video system, touch PC ) with its accessories power adapter, footswitch.The Ureterorenoscope is provided sterile (sterilized by EO) and intended to be single-use.The video system is powered by the main line.
The handle includes a deflection lever, a lever lock, and a Luer port for insertion of accessory devices and irrigation to the working channel. The insertion portion contains one working channel and wiring to transmit the image signals to the Video Image Processor. The distal bending section of the insertion portion controlled by the user via the deflection lever on the handle. The distal end of the insertion portion contains a CMOS sensor for capturing image and transmitting it to the Video Image Processor, LEDs for illumination, and the distal opening of the working channel. The video cable connects the endoscope handle to the Video Image Processor, which provides power and processes video signals from the endoscope.
Flexible Ureterorenoscope has the following physical and performance characteristics:
- Flexible insertion portion
- Camera and LED light source at the distal tip
The provided text describes a submission for a Single-Use Video Flexible Ureterorenoscope System seeking 510(k) clearance.
However, the document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does NOT present acceptance criteria or a study proving the device meets specific performance criteria through a clinical or performance study in the way typically seen for AI/ML devices or novel diagnostic tools.
Instead, the submission details a comparison of the subject device's technological characteristics to a legally marketed predicate device and summarizes various engineering and bench tests, along with biocompatibility and sterilization validations, to show that the new device performs similarly and is safe and effective for its intended use.
Therefore, many of the requested sections regarding acceptance criteria, device performance, sample sizes, ground truth, expert opinions, and MRMC studies are not applicable to the information provided in the given text.
Based on the provided text, here is what can be inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in the form of specific performance metrics (e.g., sensitivity, specificity, accuracy) with numerical targets. Instead, it indicates that the device's characteristics and performance were evaluated against established specifications and recognized standards, and compared to a predicate device.
| Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Predicate Comparison | Be similar to or better than the predicate device in technological characteristics (indications for use, anatomical site, target population, environment, flexible scope, CMOS imager, LED light source, deflection (at least 270°), 0° direction of view, 120° field of view, 3-50mm depth of field, system composition, patient-contacting materials, single-use, EO sterilized) to not raise new questions of safety and effectiveness. | Matches or is similar to the predicate device in all listed characteristics. Differences in deflection, insertion width, working length, and channel width are noted as either better or not raising new safety/effectiveness questions, confirmed by performance testing. For example, deflection is 275° (better), working length 670mm (longer). |
| Electrical Safety | Compliance with IEC 60601-1:2012, AAMI/ANSI ES60601-1:2005/(R)2012, IEC 60601-2-18:2009, and IEC 60601-1-2:2014 and A1:2020. | In compliance with the listed FDA recognized standards. |
| Photobiological Safety | Compliance with IEC 62471:2006. | Tested according to IEC 62471:2006. |
| Mechanical & Optical Performance | Compliance with ISO 8600-1:2015 (applicable parts), ISO 12233:2017, ISO 15739:2017, and internal specifications for water delivery, fatigue, stress of bending, tensile strength, insertion width, channel width, deflection, field of view, direction of view, resolution, depth of field, distortion, SNR, illumination, dynamic range, color performance. | The device was designed to comply, and performance measurements were performed according to, the listed standards. Bench test results claim "same or similar image quality, optical performance and mechanical performance" compared to the predicate. Specific numerical performance values are not provided. |
| Biocompatibility | Compliance with ISO 10993-1, -5, -10, -11 for "Surface – Mucosal Membrane" with "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.