(231 days)
The Spectranetics Support Catheter is a coronary intravascular catheter used to support a guidewire, to assist in guidewire exchange or placement in distal vessels, and to provide a conduit for the delivery of saline solutions or diagnostic contrast agents. It is designed for patients needing vascular intervention.
The Spectranetics Support Catheter is a coronary intravascular catheter used to support a guidewire, to assist in guidewire exchange or placement in distal vessels, and to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
The provided text is a 510(k) summary for the Spectranetics Support Catheter, which is a regulatory submission to the FDA. It details the device's intended use and its substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria, study methodologies (like sample sizes, ground truth establishment, or expert qualifications), or performance results from a clinical or analytical study in the format you requested.
The document states that the manufacturer performed testing to assure safety and effectiveness, including "tensile strength, bond joints, tracking, visibility, flow rate, wire movement, sterility and biocompatibility including hemolysis, MEM cytotoxicity and dermal sensitization." It then concludes that "Testing performed for the Spectranetics Support Catheter provides reasonable assurance that the devices will perform in a safe and effective manner when used as indicated."
Therefore, I cannot provide the detailed table and study information you requested because it is not present in the provided text. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and a broad statement about various types of non-clinical testing performed, rather than specific performance metrics and study results typically found in a clinical study report.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).