(263 days)
The Uro-N Cystoscope is intended for direction of therapeutic agents and solutions into target areas of the bladder and the lower urinary tract via a cystoscope.
The UroViu Uro-N Cystoscope System consists of (1) a hand-held, battery operated portable endoscope contained within a reusable handle and (2) a disposable cannula with an injection needle. The fully assembled Uro-N system has overall length of 522 mm (~21 inches). The disposable cannula working length is 269 mm (~11 inches) and total length is 388 mm (~15 inches). The injection needle is 23 Ga (OD 0.635mm, ID 0.318mm). The combined handle and cannula weigh less than 1 pound. The reusable handle has a connector and locking mechanism for attaching and detaching the cannula. The catheter is sterilized by electron beam and is intended for single use only.
The provided text is a 510(k) summary for the Uro-N Cystoscope, demonstrating its substantial equivalence to predicate devices rather than proving it meets specific acceptance criteria through a standalone study with performance metrics. Therefore, many of the requested sections regarding acceptance criteria, performance, sample sizes, expert ground truth, and comparative effectiveness against human readers are not directly addressed in this document.
However, I can extract information related to the device's testing and safety/effectiveness claims based on comparison to its predicates.
Here's the summary based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not provide a table of quantitative acceptance criteria with corresponding device performance metrics. Instead, it relies on demonstrating substantial equivalence to predicate devices, implying that if it functions similarly and passes specified engineering and biocompatibility tests, it meets the necessary safety and effectiveness profiles.
The performance evaluation is primarily comparative and based on the established safety and effectiveness of the predicate devices.
| Aspect | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Summary) |
|:--------------------------------|:--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------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| Biocompatibility | Meets ISO 10993 requirements for medical devices with less than 24 hours of patient tissue contact. Materials must be biocompatible (e.g., stainless steel for the needle). | The Uro-N Cystoscope and cannula are made from materials reviewed and cleared in K171500. The only new material, stainless steel for the needle, passed cytotoxicity testing. |
| Electrical Safety | Compliance with IEC 60601-1 (medical electrical equipment - general requirements for basic safety and essential performance), specifically Class I, Type CF, defibrillation proof. | The device complies with IEC 60601-1, as reviewed and cleared in K171500 (predicate device). |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 (medical electrical equipment - electromagnetic disturbances - requirements and tests). | The device complies with IEC 60601-1-2, as reviewed and cleared in K171500 (predicate device). |
| Software Verification and Validation | Software should be verified and validated to ensure proper function and safety. The software level of concern is "Moderate." | No change was made to the software from the predicate device (K171500), which was previously reviewed and cleared. |
| Mechanical Performance | The device should be mechanically sound, withstand simulated use, and maintain structural integrity (e.g., resistance to bending, pulling, torque, and leaks). It should also maintain acceptable temperature at the tip surface, field of view, direction of view, and image quality comparable to the predicate diagnostic cystoscope. | Mechanical testing included: simulated use testing, mechanical testing (bending, pulling, torque, and presence of leaks), temperature at the surface of the tip testing, field of view testing, direction of view testing, and image quality testing. The results of these tests are not provided in detail, but the conclusion states "The information submitted... confirms that the Uro-N Cystoscope raises no new questions of safety and effectiveness and that it is substantially equivalent to the predicate devices." |
| Sterility | Disposable components (cannula, needle) must achieve a Sterility Assurance Level (SAL) of 10^-6. | Disposable cannula and needle are sterile following exposure to ethylene oxide (EO) with an SAL of 10^-6. |
| Cleanability (Reusable Handle) | The reusable handle, not provided sterile, must be cleanable and disinfectable according to company instructions to prevent cross-contamination. | The handle is cleaned and disinfected following company instructions (implies this is met). |
| Duration of Use | Less than 24 hours for patient contact components. | Less than 24 hours. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of collected patient data or images for performance evaluation. The substantial equivalence argument relies on engineering and bench testing, as well as the prior clearance of the predicate devices.
- Sample Size: Not applicable as no clinical or image-based test set was used for de novo performance evaluation against acceptance criteria.
- Data Provenance: Not applicable. The testing was laboratory/bench-based.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. As no clinical test set requiring expert interpretation was used for de novo performance evaluation, no experts were involved in establishing ground truth in this context.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring adjudication was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was reportedly done. The submission is a 510(k) for substantial equivalence, not a clinical efficacy study involving human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The Uro-N Cystoscope is a medical device, not an AI algorithm. Its performance is evaluated through physical, electrical, and materials testing, and by demonstrating equivalence in function and safety to predicate devices.
7. Type of Ground Truth Used
The "ground truth" for the device's acceptable performance is based on demonstrating compliance with regulatory standards (e.g., ISO, IEC), confirmed biocompatibility, and functional equivalence to legally marketed predicate devices through various engineering and bench tests. There is no biological or diagnostic "ground truth" (like pathology or outcomes data) established for a test set in this summary.
8. Sample Size for the Training Set
Not applicable. The Uro-N Cystoscope is a physical device, not an AI/machine learning model, so there is no training set in the context of data for algorithm development.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 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.