(86 days)
The BMC Coaxial Injectable Catheter is intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires.
BMC Coaxial Injectable Catheter
I am sorry, but the provided text is a scanned FDA 510(k) clearance letter for a medical device and does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth, or expert qualifications for AI/ML-based device evaluation.
The letter only states that the "BMC Coaxial Injectable Catheter" has been found substantially equivalent to a legally marketed predicate device for its stated indications for use. It outlines regulatory information regarding marketing, classification, and general controls.
Therefore, I cannot fulfill your request based on the provided input.
§ 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.