(234 days)
The Flexible CMOS Video-Cysto-Urethroscope is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of the lower urinary tract including the bladder and urethra.
The Flexible CMOS-Video-Cysto-Urethroscope system consists of an endoscope and a monitor. The endoscope is a single device and can be said to be made up of an instrument handle, a shaft and a video connector cable. The handle has three camera control buttons, a deflection control lever and a luer connector to the working channel. An LED located in the handle and is use to provide the illumination for visualization of the anatomy under examination. The light is transmitted from the LED to the distal tip via glass fiber light bundles, where it is used to illuminate the body cavity under examination. The CMOS imaging sensor is located at the distaltip of the endoscope shaft captures the reflected light and converts it to a standard NTSC video signal. The luer connector and working channel are used as an introduction port for irrigation fluid and endoscopic instruments. The 8402ZX monitor provides visualization of the image being captured by the CMOS chip in the endoscope. During the procedure, the physician can use the control buttons on the monitor to perform functions, such as video and single image capture.
The KARL STORZ Flexible CMOS-Video-Cysto-Urethroscope is a medical device designed for visualizing and providing operative access during diagnostic and therapeutic endoscopic procedures of the lower urinary tract, including the bladder and urethra. The submission does not explicitly list acceptance criteria in a table format with performance metrics. However, it states that "Testing demonstrated that the device is as safe & effective and performs as well as or better than the predicate devices." The predicates are KARL STORZ Video-Urethro-Cystoscope System (K062918) and KARL STORZ Flexible Fiber Optic Cystoscope (K945185).
Therefore, the implicit acceptance criteria are that the device meets or exceeds the safety and effectiveness of these predicate devices. The study conducted to prove this involves various non-clinical performance and safety tests.
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit acceptance criteria are not provided in a quantifiable table, the table below reflects the comparison to predicate devices, which serves as the basis for substantial equivalence.
| Parameter | Acceptance Criteria (Performance equivalent to or better than predicate devices) | Reported Device Performance (Flexible CMOS-Video-Cysto-Urethroscope) |
|---|---|---|
| Mechanical Performance | Equivalent to predicate devices | Verified through bench testing |
| Optical Performance | Equivalent to predicate devices | Verified through bench testing |
| Illumination Performance | Equivalent to predicate devices | Verified through bench testing |
| Basic Safety & Performance | Conformance to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18 | Conforms to specified IEC standards |
| Cleaning Validation | Effective cleaning as per instructions | Validated for cleaning instructions in IFU |
| Disinfection Validation | High-level disinfection (HLD) with Resert XL to SAL of 10⁻⁶ | Validated for HLD with Resert XL to SAL of 10⁻⁶ |
| Sterilization Validation | Sterilization with STERRAD 100NX to SAL of 10⁻⁶ | Validated for sterilization with STERRAD 100NX to SAL of 10⁻⁶ |
| Biocompatibility | Patient-contacting parts comply with ISO 10993-1:2009 | Evaluated per ISO 10993-1:2009 |
| Risk Analysis | In accordance with ISO 14971 | Performed in accordance with ISO 14971 |
| Software Validation | Software performs as intended | Software verified through testing |
| Intended Use | Identical to predicate devices | Identical: Visualization and operative access during diagnostic and therapeutic endoscopic procedures of the lower urinary tract including the bladder and urethra |
| Technological Characteristics | Comparable to predicate devices | Shows similar key specifications (Distal Tip, Shaft, Working Channel, Working Length, Deflection) with some updates (CMOS chip, LED illumination) |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes bench testing (non-clinical) and does not mention human subject testing or specific data sets in terms of images or patient cases. Therefore, there is no information on a "test set" in the context of image analysis or algorithm performance, nor is there information on data provenance (country of origin, retrospective/prospective). The testing focused on physical, electrical, and material performance of the device itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The study is based on bench testing of the device's physical and functional properties against engineering standards and comparison to predicate devices, not on interpretation of outputs by human experts to establish ground truth.
4. Adjudication Method for the Test Set
Not applicable, as no human expert adjudication of a test set is described.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not applicable. The submission does not describe a MRMC study or any study comparing human readers with AI assistance versus without. The device itself is an endoscope, not an AI-powered diagnostic tool requiring human-in-the-loop analysis.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The device is an endoscope, which is a tool for visualization and access, not a standalone algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Conformance to recognized international standards such as IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, ISO 8600-1, ISO 8600-3, ISO 8600-4.
- Results from bench testing for mechanical, optical, and illumination performance.
- Successful validation studies for cleaning, disinfection, and sterilization protocols.
- Biocompatibility testing per ISO 10993-1:2009.
- Software verification testing.
- The intended use and technological characteristics being substantially equivalent to legally marketed predicate devices.
8. Sample Size for the Training Set
Not applicable. This device is an endoscope, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this device.
§ 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.