(22 days)
The MBA Hemostasis Valves are designed for use during percutaneous transluminal angioplasty (PTA) and other intravascular therapeutic procedures that utilize a guiding catheter.
The MBA™ is a Dual Seal Hemostasis Valve with an integral introducer
The provided text describes a 510(k) summary for the MBA™ Hemostasis Valves and a letter from the FDA regarding its clearance. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, or adjudication methods that would typically be found in a study proving a device meets acceptance criteria.
The document primarily focuses on:
- Identifying the device and its predicate.
- Stating its intended use and device use.
- Confirming biocompatibility.
- Asserting substantial equivalence to a predicate device (Merit Passage Hemostasis Valves, K925419).
- The FDA's clearance of the device based on substantial equivalence.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or comparative effectiveness. The text explicitly states, "Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act," which further indicates that specific performance criteria and a study to meet them are not detailed in this submission.
§ 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.