(71 days)
The BSC Transend Steerable Guidewire with hydrophilic coating and accessories are intended for general intravascular use including the peripheral and neurovasculature.
The BSC Transend Steerable Guidewire with hydrophilic coating and accessories are intended for general intravascular use including the peripheral and neurovasculature. The devices will be provided sterile, and are intended for one procedure use only. Testing and evaluation included tip tensile, tip flexibility, torque strength, torque response, coating adherance, coating extraction, lubricity testing, biocompatibility and in vivo testing.
This document is a 510(k) Premarket Notification for a medical device (BSC Transend Guidewire) and not a study describing the acceptance criteria and performance of an AI/ML device. Therefore, the requested information based on AI/ML study characteristics (like sample size for test/training sets, expert ground truth, MRMC studies, etc.) cannot be extracted from the provided text.
The document discusses the safety and effectiveness of a traditional medical device (a guidewire) based on various mechanical, material, and in vivo tests. It does not involve any AI or algorithmic performance evaluation.
If you have a document describing an AI/ML device study, please provide that, and I will be able to answer your questions.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.