FDA Drafts 510(k) Guidance for Arthroscopy Pump Tubing Sets
The US Food and Drug Administration (FDA) on Monday issued draft guidance explaining its expectations for premarket notification (510(k)) submissions for arthroscopy pump tubing sets intended for multiple patient use.According to FDA, during arthroscopy procedures, “clinicians often use a single source of irrigation fluid for multiple patients without replacing the source of irrigation fluid or replacing/reprocessing the irrigation tubing system between patients.” This practice, FDA says, creates a risk for cross-contamination between patients if fluids backflow through the irrigation tubing.
As such, the guidance focuses on recommendations to mitigate the risk of patient infection through labeling, sterilization and reprocessing considerations, as well as design and testing considerations for mitigating cross-contamination risk.
Specifically, the 20-page guidance discusses design considerations, risk mitigation strategies and testing recommendations for Class II arthroscopy pump tubing sets regulated under product code HRX and marketed either as part of an arthroscopy pump system or sold separately as accessories.
The guidance also provides a set of definitions that FDA recommends arthroscopy pump tubing set manufacturers adopt in their labeling and submissions “to ensure consistency in the use and premarket review of these devices.”
FDA specifies that arthroscopy tubing systems should state that they have been designed and validated for multiple patient use in the indications for use and specify the validated use time or use lives (e.g., 24-hour use or number of procedures).
FDA says that submissions should describe all integral device components and “other design features intended to reduce the risk of backflow for allowing multiple patient use,” including backflow-prevention valves, connectors, tubing and the pump(s) the tubing is intended to be used with.
The guidance also stresses that any validated reprocessing instructions should be provided for any components that are intended to be reused, noting that Section 3059 of the 21st Century Cures Act requires sponsors to provide reprocessing validation data and validated reprocessing instructions for 510(k) submission for devices under product code HRX if there are any design features that “may pose a challenge to adequate reprocessing.”
Some of the design considerations discussed in the guidance include a recommendation for “at least one backflow-prevention valve or other feature that prevents the backflow of fluids into the irrigation system,” and for all components in the distal irrigation system to be single-use.
FDA, Federal Register Notice