(135 days)
The Cardiva Catalyst™ III System with Protamine Sulfate is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression in heparinized patients. The Cardiva Catalyst™ III System is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures using 5F, 6F or 7F introducer sheaths.
The Cardiva Catalyst™ III System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Cardiva Catalyst III system includes a design modification which involves the addition of Protamine Sulfate to the existing Boomerang Catalyst II System coating to further minimize ocze from the tissue tract and promote the hemostasis process in heparinized patients. The Cardiva Catalyst III System maintains the same indication for use as the Boomerang Catalyst System family of devices.
The Cardiva Catalyst III System consists of a sterile disposable Cardiva Catalyst III wire and a sterile disposable Catalyst Clip. The Cardiva Catalyst III System is specifically designed for use with heparinized patients. In conjunction with manual compression, the Cardiva Catalyst III System provides temporary hemostasis at a femoral access site after femoral arterial catheterization while allowing continued distal perfusion. After completion of catheterization, the Cardiva Catalyst III wire is inserted into the artery through the existing introducer sheath. After insertion, the distal tip of the Cardiva Catalyst III wire is deployed, which opens the flat, low-profile Catalyst Disc within the lumen of the femoral artery. During dwell, natural recoil of the smooth muscle of the vessel wall occurs at the arteriotomy site. A biocompatible coating on the Cardiva Catalyst III Wire aides the body's natural hemostatic process and promotes ease of removal. Specifically, the Cardiva Catalyst III System's biocompatible coating includes a minimal amount of Protamine Sulfate to further aid the body's natural hemostatic process in heparinized patients. Following the procedure, the Catalyst Disc is collapsed and the Cardiva Catalyst III wire is completely removed from the artery. No part of the device is left behind. Final closure of the arteriotomy occurs by applying gentle manual or mechanical compression after removal of the Cardiva Catalyst III System.
The provided text does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The text is a 510(k) summary for the Cardiva Catalyst™ III System, focusing on its substantial equivalence to a predicate device and its intended use. It describes the device, its function, and the fact that "All necessary bench testing was conducted on the Cardiva Catalyst III System to support a determination of substantial equivalence to the predicate device." However, it does not provide details about the specific acceptance criteria for this testing, the results of the testing with respect to those criteria, nor any clinical study details such as sample size, ground truth, or expert involvement.
Therefore, I cannot provide the requested table or answer the specific questions based on the given input.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).