(273 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 and an image system OTU-A. The single-use cystoscope is comprised of a control body with articulation controls and accessory access ports, and a flexible insertion tube with an on-tip camera module and LED lighting source.
The provided text describes the WiScope® Digital Cystoscope System, which is a medical device. The document is a 510(k) premarket notification summary submitted to the FDA.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists numerous tests conducted, and for all of them, the result is "All tests were passed" or "All evaluation acceptance criteria were met." Specific numerical acceptance criteria are not detailed in the provided text, but the claim of passing suggests they were defined and met.
| Test Item | Acceptance Criteria/Standard | Reported Device Performance |
|---|---|---|
| Electrical Safety | IEC 60601-1, IEC 60601-2-18 | All evaluation acceptance criteria were met. |
| Electromagnetic Compatibility | IEC 60601-1-2 | All evaluation acceptance criteria were met. |
| Biocompatibility | ISO 10993-1 (Cytotoxicity, Sensitization, Intracutaneous reactivity test) | All tests were passed. |
| Shelf Life | ASTM F1980 (Performance test, Sterile Packaging Integrity) | All tests were passed. |
| Sterile Barrier Systems | ISO 11607-1:2019 | All tests were passed. |
| Sterilization Process | ISO 11135:2014 (SAL 10⁻⁶) | The WiScope® Single-Use Digital Flexible Cystoscope is sterile with a determination of lethal rate of the sterilization process to demonstrate achievement of the required SAL of 10⁻⁶. |
| Technological Characteristics (Performance Verification) | ISO8600, ISO 12233, and performance characteristics relevant to functions as intended (e.g., Appearance, Working length, Bending radius, Channel diameter, Outer diameter, Depth of field, Field of view, Direction of view, Distal Tip Temp, Tensile Force, Resolution, Illumination, Angulation range, Working channel leakage, Waterproof, Flow rate) | All tests were passed. |
| Noise and Dynamic Range | ISO 15739 | All evaluation acceptance criteria were met. |
| Simulated Shipping Distribution (aged devices) | ASTM D4169-16 | All tests were passed. |
| Photobiological Safety | IEC 62471:2006 | All tests were passed. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the sample sizes used for any of the non-clinical tests. It states that "These tests only used to evaluate non-clinical testing of the subject device." There is no mention of country of origin for the data or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable to the provided document. The studies described are non-clinical performance and safety tests, not studies requiring expert interpretation of medical images or diagnostic outcomes. Therefore, there is no mention of experts establishing ground truth in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable. As mentioned above, the studies are non-clinical performance and safety tests, not studies involving human interpretation or adjudication of medical results.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC comparative effectiveness study was done. The document explicitly states: "No clinical study is included in this submission." The submission focuses on demonstrating substantial equivalence through non-clinical testing and comparison to a predicate device. The device itself (a cystoscope) is an imaging tool, not an AI-powered diagnostic system that would typically be evaluated for reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The WiScope® Digital Cystoscope System is described as a physical medical device (an endoscope) for visualization and procedures, not an algorithm or AI system for standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The concept of "ground truth" as it relates to expert consensus or pathology is not applicable to the non-clinical tests described. The ground truth for these tests would be the established scientific standards, specifications, and physical properties specified in the referenced ISO and ASTM standards. For example, for "Working length of the shaft," the ground truth would be the defined manufacturing specification for the length, and the test verifies if the actual device meets that specification.
8. The sample size for the training set:
This information is not applicable as there is no mention of an algorithm or AI model requiring a training set in the document.
9. How the ground truth for the training set was established:
This information is not applicable for the reason stated in point 8.
§ 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.