(128 days)
The Catapult TM Guide Sheath is indicated to be used for introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature.
The Catapult ™ Guide Sheath consists of a coil reinforced introducer sheath with hemostasis valve and side port, as well as a dilator with a tapered tip and luer lock at the proximal end. The main introducer sheath tubing is connected at the proximal end to a hemostasis valve with side port tubing that is connected to a plastic color coded 3-way stopcock valve. The side port is used for flushing the introducer sheath. The sheath is introduced into the vascular system with the aid of the dilator. The hemostasis valve at the proximal end of the introducer sheath conforms and seals around guide wires and catheters to reduce blood leakage from the introducer sheath. A radiopaque marker helps identify the distal end of the introducer sheath. The introducer sheath has a lubricious hydrophilic coating on the outer surface of its distal 20cm.
The Catapult ™ Guide Sheath was previously cleared under K221914 in 4 French, 5 French, 7 French and 8 French sizes, each with effective lengths of 15 cm, 60 cm or 90 cm. This 510(k) adds a 130 cm length which is available in 4 French, 5 French and 6 French sizes.
The provided text does not contain information about the acceptance criteria and study proving a device meets them in the context of an AI/ML-driven device. Instead, it describes characteristics and performance tests for a conventional medical device, the "Catapult Guide Sheath," for which a 510(k) premarket notification was submitted.
The request asks for specific details related to AI/ML device studies (e.g., sample size for test set and training set, ground truth establishers, MRMC studies, standalone performance), which are not applicable to the non-AI device described in the document.
Therefore, I cannot fulfill the request as it pertains to an AI/ML device. The provided text details the 510(k) submission for a medical device that is not an AI/ML device.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).