(71 days)
The Teleport microcatheters are indicated for:
supporting and facilitating the placement of guidewires in the coronary and peripheral vasculature.
exchanging guidewires in the coronary and peripheral vasculature.
the delivery of contrast media into the coronary, peripheral, and abdominal vasculature.
The Teleport family of microcatheters are single lumen catheters, offered in two shaft sizes (2.0F and 2.1F) with working lengths of 135cm or 150cm, designed for use in the coronary, peripheral, and abdominal vasculature. The shaft profiles gradually decrease from 2.6F (0.034") to 2.0F (0.0265") for the 2.0F configuration (Teleport), and 2.7F (0.036") to 2.1F (0.0275") for the 2.1F configuration (Teleport Control) respectively. The catheter consists of four sections: body shaft, proximal tip shaft, distal tip shaft, and a radiopaque tip. The distal most 60cm of the outer surface is coated with a hydrophilic polymer to increase lubricity and the lumen of the catheter is lined with a fluoropolymer to facilitate movement of the guidewire. The catheter is compatible with a standard 0.014 inch (0.36mm) guidewire.
The provided text describes a 510(k) summary for the Teleport Microcatheter, focusing on its substantial equivalence to a predicate device. However, it does not contain a detailed study proving the device meets specific acceptance criteria in the format requested. Instead, it lists the types of performance tests conducted and a general statement that "The Teleport microcatheter test results met all acceptance criteria and were similar to the predicate and reference devices."
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth used, or training set details as these are not present in the provided document.
The document confirms that standalone performance testing was done for the device, as indicated by the list of "Performance Testing" conducted, which did not involve human readers (e.g., flow rate, burst pressure, torque strength).
Ground truth for these engineering and material performance tests would be established through predefined engineering specifications and standards (e.g., a specific flow rate must be achieved, a certain pressure must be withstood before burst).
§ 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).