(88 days)
to maintain a fluid-tight seal around interventional and diagnostic devices while allowing control/manipulation of such devices during use
Not Found
The provided document is a 510(k) clearance letter from the FDA for a device called "Disposable Hemostatic Y-Connectors." This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific details requested in the prompt.
The letter explicitly states that it is a review of the premarket notification and a determination of substantial equivalence to previously marketed predicate devices. It does not include the actual study data or the specific performance metrics used to make that determination.
Therefore, I cannot provide the requested information from this document. The information you are looking for would typically be found in the 510(k) submission itself, not in the clearance letter.
§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.