(56 days)
The Catalyst II " System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Catalyst II System is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures using SF, 6F or 7F introducer sheaths.
The Catalyst™ III System with Protamine Sulfate is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression in heparinized patients. The 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 systems are intended to promote hemostasis at arteriotomy sites as adjuncts to manual compression and retain the same indication for use as the Boomerang Catalyst System family of devices. The Cardiva Catalyst systems consist of a sterile disposable Cardiva Catalyst 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 systems provide temporary hemostasis at a femoral access site after femoral arterial catheterization while allowing continued distal perfusion. After completion of catheterization, the Cardiva Catalyst wire is inserted into the artery through the existing introducer sheath. After insertion, the distal tip of the Cardiva Catalyst wire is deployed, which opens a 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 document is a 510(k) summary for the Cardiva Catalyst™ II and III systems, which are vascular clamps. It primarily discusses the device description, indications for use, and a comparison to predicate devices, stating that the subject device is identical to previously cleared devices with only an addition to contraindications.
This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or how ground truth was established for training sets.
Therefore, I cannot provide the requested table and information based on the input text. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies against acceptance criteria.
§ 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).