(152 days)
The Flexible Video Cystoscope is used for visualizing body cavities and organs via natural passages. For examination, diagnosis and/or therapy in conjunction with endoscopic accessories/ auxiliary instruments through in scone's working should co scope's working channel. The scope is used in the medical disciplines of Urology (urogenital tract, cystoscopy, nephroscopy), Surgery (choledochoscopy)
The submitted flexible video cystoscopes and choledochoscopes are a modification of the Richard Wolf flexible fiber-cystoscopes. The flexible video cystoscopes have a CCD video image sensor for generating a video image with a camera controller instead of an image fiber light guide. The video cystoscopes connect to the Richard Wolf camera system 5520. The videoscopes have similar dimensions, working channels and design as the Richard Wolf flexible fiber-cystoscopes. Both cystoscopes are designed with a control lever for locking the tip in any angled position. Two different control directions are available, is . the endoscope is deflected either upward or downward upon activating the control lever proximally or distally. The tips are angled approximately 45° and angled. This makes the insertion into the urethra easier and more comfortable for male patients. The adapter with instrument port, irrigation and drain stopcocks and optional biopsy valve is removable. The new style ergonomic handle is equipped with two remote control buttons that control the camera function.
Here's an analysis of the provided information regarding the acceptance criteria and study for the Flexible Video-Endoscope (Models 7308.061, 7308.066):
The provided document (K051176) is a 510(k) summary for a medical device seeking clearance based on substantial equivalence to predicate devices. In such submissions, the "acceptance criteria" and "study proving it meets acceptance criteria" are typically defined by demonstrating compliance with recognized standards and substantial equivalence rather than a new clinical trial with specific performance metrics like sensitivity/specificity for AI models.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Standard | Reported Device Performance |
|---|---|
| Safety Standards | |
| IEC601-1 / UL2601-1 | Designed to meet the standard |
| IEC601-1-2 | Designed to meet the standard |
| Effectiveness (Substantial Equivalence) | |
| Similar dimensions to predicate flexible fiber-cystoscopes | The videoscopes have similar dimensions, working channels, and design as the Richard Wolf flexible fiber-cystoscopes. |
| Similar working channels to predicate flexible fiber-cystoscopes | The videoscopes have similar dimensions, working channels, and design as the Richard Wolf flexible fiber-cystoscopes. |
| Similar design to predicate flexible fiber-cystoscopes | The videoscopes have similar dimensions, working channels, and design as the Richard Wolf flexible fiber-cystoscopes. |
| Control lever for tip angling | Both cystoscopes are designed with a control lever for locking the tip in any angled position. Two different control directions are available. |
| Tip angled approximately 45° for easier insertion | The tips are angled approximately 45°, which makes insertion into the urethra easier and more comfortable for male patients. |
| Removable adapter with instrument port, irrigation, drain stopcocks, and optional biopsy valve | The adapter with instrument port, irrigation and drain stopcocks and optional biopsy valve is removable. |
| Ergonomic handle with remote control buttons for camera function | The new style ergonomic handle is equipped with two remote control buttons that control the camera function. |
Summary of the study that proves the device meets the acceptance criteria:
The study proving the device meets its acceptance criteria is not a "study" in the traditional sense of a clinical trial with statistical endpoints for performance. Instead, it's a demonstration of compliance with recognized safety standards and substantial equivalence to legally marketed predicate devices.
The document explicitly states: "No special clinical tests performed." This is common for 510(k) submissions, especially for devices that are modifications of existing technology and do not raise new questions of safety or effectiveness.
The core of the "proof" relies on:
- Design Compliance: The device is designed to meet the safety standards IEC601-1/ UL2601-1 and IEC601-1-2.
- Substantial Equivalence Argument: The submission argues that the new technological characteristics (CCD video image sensor instead of an image fiber light guide, ergonomic handle with remote controls) have not diminished safety or effectiveness compared to the predicate devices. The devices retain similar dimensions, working channels, and functional design (e.g., control lever for tip angling).
Additional Information - Based on the Provided Document:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- No formal "test set" in the context of a performance study (like an AI model) is described. The assessment is based on design specifications and comparison to predicate devices, not on data from a specific test set of patients or images.
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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):
- Not applicable. There was no "ground truth" to establish for a test set in the way an AI model would require. The assessment is based on engineering design, manufacturing standards, and clinical consensus regarding the safety and effectiveness of similar devices.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set was used that would require adjudication.
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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:
- Not applicable. This device is an endoscope, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with/without AI assistance was not performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a manual tool, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" implicitly used for this type of 510(k) clearance is the established safety and effectiveness of the identified predicate devices and compliance with recognized international and national safety standards for medical electrical equipment.
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable.
§ 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.