(109 days)
WiScope® Digital Cystoscope System is intended to be used by physicians to access, visualize, and perform procedures in the bladder and lower ureter. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.
WiScope® Digital Cystoscope System is designed for physicians to access, visualize, and perform procedures in the bladder and lower ureter for diagnosis and treatment. This system includes a single-use digital cystoscope.
WiScope®Digital Cystoscope System has the same intended use to the predicate device. Both devices use the same CMOS image sensor technology, i.e., an CMOS image sensor at the scope tip, a back-end image/video processing system, and a cable connecting the CMOS sensor to the processing system. In addition, they have same mechanical functions, e.g., a handle with a deflection control and a two-way deflectable insertion tube.
WiScope®Single-Use Digital Flexible Cystoscope has the following 4 models:
OTU-C300S: Standard Deflection Model for OTU-C300 series
OTU-C300R: Reverse Deflection Model for OTU-C300 series
OTU-C310S: Standard Deflection Model for OTU-C310 series
OTU-C310R: Reverse Deflection Model for OTU-C310 series
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets the acceptance criteria:
Based on the provided text, the submission is a 510(k) for the WiScope® Digital Cystoscope System. The core of this submission is to demonstrate substantial equivalence to a previously cleared device (K212202) rather than proving novel performance against specific clinical acceptance criteria. Therefore, the information typically found in a clinical study seeking to establish performance against acceptance criteria for a new device is largely absent.
Here's the breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria for clinical performance with reported results in the same way a de novo device might. Instead, it relies on demonstrating that the proposed device is substantially equivalent to a predicate device (K212202). The "acceptance criteria" are implicitly met by showing that the differences between the proposed device and the predicate do not raise new questions of safety or effectiveness, which is supported by non-clinical testing.
The non-clinical testing performed includes evaluations of:
| Acceptance Criteria Category (Implicit) | Reported Device Performance / Evaluation Type |
|---|---|
| Biocompatibility | Evaluated in accordance with ISO 10993-1 |
| Sterilization | Validated in accordance with ISO 11135:2014 |
| EO/ECH Residuals | Performed according to ISO 10993-7:2008 |
| Shelf Life | Conducted based on ASTM F1980 |
| Packaging Integrity | Evaluated in accordance with ISO 11607-1:2019 and ASTM F1980-16 |
| Photobiological Safety | Performed based on IEC 62471:2006 (and stayed the same as K212202) |
| Electrical Safety | Evaluated in accordance with IEC 60601-1 and IEC 60601-2-18 |
| Electromagnetic Compatibility | Evaluated in accordance with IEC 60601-1-2 |
| Optical and Color Performance | Resolution, Depth of Field, Distortion, Signal-to-Noise Ratio, Dynamic Range, Image/Brightness Uniformity, Color performance |
Note: For the Optical and Color Performance, the document lists the parameters tested but does not provide specific numerical acceptance criteria or reported performance values (e.g., "Resolution > X lp/mm" or "Distortion
§ 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.