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For endoscopic access and examination of the lower urinary tract including the bladder and, using additional accessories, to perform various diagnostic and therapeutic procedures.

The device system described in this 510(k) consists of a flexible, fiberoptic cystoscope and sterile, single use protective sheath.

The provided text is a 510(k) summary for a medical device (Vision-Sciences Flexible Cystoscope with EndoSheath® System). It describes the device, its intended use, and its classification relative to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it provide details about any performance testing that would generate such data.

The document states: "This submission is a Special 510(k): Device Modification as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Vision-Sciences has provided certification of compliance to 21 CFR 820.30 Design Control requirements, and a description of the internal Risk Analysis procedure. V & V activities included modified device labeling, and was addressed through Design Validation and Verification planning."

This indicates that internal validation and verification (V&V) activities were performed, but the details of these activities, including specific acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert involvement, are not included in this publicly available 510(k) summary. These details would typically be found in the full 510(k) submission, which is not publicly disclosed.

Therefore, I cannot provide the requested information based on the input text.

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