Finally, we disagree with the applicant that the evidence for the VersaVue TM Single-Use Flexible Cystoscope is equivalent to that used for Uretero1 TM , and, as we previously explained in the CY 2024 and CY 2025 OPPS/ASC final rules with comment period for Ambu aScope TM 5 Broncho HD (88 FR 81736) and Ambu aScope TM Gastro (89 FR 94182), and as discussed in more detail in our responses to comment, we evaluate all evidence submitted for each device pass-through application as it applies to the nominated device
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For antimicrobial protection, avoid rubber closures, which can allow contamination through the hole where the needle passes, and may contain rubber additives
Both approaches can produce meaningful biological effects
The cumulative antioxidant activity could be very high with the reactivation of the carboxylic groups (e.g., glutathione or enzymes)
There's no peer reviewed level one data that tells us that these things work