(87 days)
The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary and peripheral vascular systems.
The Vista Brite Tip Guiding Catheters are single lumen catheters which features a nylon body reinforced with a tightly wound stainless braid wire. The braid wire extends from the hub into the Brite Tip segment. The transition segments of the catheters are designed with nylons of different durometers (stiffness) to provide a gradual decrease in material stiffness from the catheter body to the tip. The Brite Tip segment, located at the catheters' tip, is pellethane with a radiopaque filler, this is the softest material in the catheter.
This document is a 510(k) premarket notification for a medical device cleared in 1996. It does not contain the information requested about acceptance criteria or a study proving device performance against such criteria.
The document primarily focuses on establishing substantial equivalence to a predicate device, which was the standard for regulatory clearance at that time. It lists:
- Device Name: Cordis Guiding Catheter (Proprietary Name: Cordis Vista Brite Tip®)
- Predicate Device: Cordis Vista Brite Tip (implying it's substantially equivalent to itself or a prior version of itself, which is unusual for a modern 510(k) but was sometimes seen, or it refers to an earlier cleared version).
- Indications for Use: Intravascular introduction of interventional/diagnostic devices into the coronary and peripheral vascular systems.
- Device Description: Single lumen catheter with a nylon body, stainless braid wire reinforcement, varying durometer nylons, and a radiopaque pellethane tip.
- Biocompatibility: States that "All appropriate biocompatibility tests for the guiding catheters were successfully completed."
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth provenance, expert qualifications, or AI performance, as this information is not present in the provided text.
The provided text belongs to an era of medical device regulation where the emphasis for devices like coronary catheters was more on demonstrating substantial equivalence to a legally marketed predicate device rather than comprehensive performance studies against pre-defined acceptance criteria, especially not in the way current AI/ML devices require. Clinical performance data, especially for standalone algorithm performance or human-in-the-loop improvements, would not typically be part of such a submission.
§ 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).