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510(k) Data Aggregation
(208 days)
CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES; UROFLEX B AND CYSTOLFLEX F
The Cellvizio® 100 Series System with Confocal Miniprobes is a confocal laser system with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues.
The Uroflex™ B and CystoFlex™ F Confocal Miniprobes can be used within anatomical tracts, i.e., urinary, including, but not limited to, urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories.
| Confocal Miniprobes™ | Endoscope or accessory |
|---|---|
| UroFlex™ B | Cystoscope or ureteroscope with operating channel internal diameter ≥ 1.0mm (3 Fr) |
| CystoFlex™ F | Flexible Cystoscope with operating channel internal diameter ≥ 1.0mm (3 Fr) |
The subject devices, "Uroflex""B" and "CystoFlex""F" are identical in design and materials to the bundle and their reprocessing methods.
The provided text is a 510(k) summary for a medical device (Cellvizio® 100 Series System and Cellvizio® System with Confocal Miniprobes™). It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance.
Based on the provided text, there is no information present regarding specific acceptance criteria, a formal study proving the device meets acceptance criteria, or the details typically associated with AI/ML-based device performance studies.
The document states: "Verification and validation testing have shown that the Uroflex™B and CystoFlex™F Confocal Minigrobes are compatible with cystoscopes or endoscopic accessories with operating channels of diameter > 0.91 mm designed and commonly used to image the urinary tract during endoscopic procedures." However, this is a general statement and does not provide quantified acceptance criteria or detailed study results.
This submission is for a traditional medical device (confocal laser system with fiber optic probes), not an AI/ML-based device. Therefore, the questions related to AI/ML specific criteria (multi-reader multi-case studies, standalone algorithm performance, training data, ground truth establishment for training set) are not applicable to this document.
Since the requested information (acceptance criteria and study details) is not present in the provided text, I cannot complete the table or answer most of the specific questions.
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(87 days)
CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES
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