(111 days)
The Karl Storz Video-Urethro-Cystoscope System is intended for use by physicians in the visual examination and treatment of a variety of urological endoscopic procedures. The Video-Urethro-Cystoscope is intended to provide optical visualization via a video monitor and therapeutic access.
The KARL STORZ Flexible Video-Urethro-Cystoscope System is use of the Video-Urethro-Cystoscope with Karl Storz CCU and Karl Storz Light source. The body contact portions of the Video-Urethro-Cystoscope are composed of materials used in other Karl Storz devices which have a long history of biocompatibility for human use and are commonly used in medical devices for a wide range of applications.
The provided text is a 510(k) summary and FDA clearance letter for a medical device called the "Karl Storz Flexible Video-Urethro-Cystoscope System." This document aims to establish substantial equivalence to a predicate device, not to present a study proving the device meets specific acceptance criteria in the way an AI/ML device would. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not applicable or available in this type of submission.
Here's a breakdown based on the provided text, indicating where information is not present:
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A table of acceptance criteria and the reported device performance
- Not applicable / Not provided. This document is a 510(k) summary for substantial equivalence, not a performance study report with specific acceptance criteria and performance metrics. The submission asserts that "The minor differences between the Karl Storz Video-Urethro-Cystoscope System and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices." This statement implies that performance is considered equivalent to the predicate, but no specific performance criteria or data are presented.
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Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. No test set or associated data are mentioned for this type of submission.
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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 / Not provided. No ground truth establishment is described as this is not a study assessing diagnostic performance against a gold standard.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No test set or adjudication process is described.
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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 / Not provided. This is a hardware device (an endoscope system), not an AI/ML diagnostic aid, so an MRMC study related to AI assistance is not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This is a hardware device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. No ground truth is established for this type of submission. The device's "ground truth" is its functional equivalence to a predicate device for visual examination and therapeutic access in urological procedures.
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The sample size for the training set
- Not applicable / Not provided. No training set is relevant as this is a hardware device, not an AI/ML model.
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How the ground truth for the training set was established
- Not applicable / Not provided. No training set or associated ground truth establishment is mentioned.
Summary based on the provided text:
The submission confirms the device's intended use and describes its components, noting that body contact portions are made of materials with a "long history of biocompatibility for human use." The core of the submission is the claim of "Substantial Equivalence" to predicate devices, meaning it is considered equally safe and effective without raising new questions of safety or effectiveness. There is no performance study described with acceptance criteria in the traditional sense for an AI/ML or diagnostic performance claim. The FDA's clearance is based on this claim of substantial equivalence.
§ 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.