(123 days)
The coraCross Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral and/or coronary vasculature. It may be used to facilitate placement and exchange of guidewire and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic contrast.
The coraCross Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral and/or coronary vasculature. The device consists of a support catheter, with a concealed radiopaque beveled guide-tip, and activating handle. The through-lumen of the device can serve as a conduit for the delivery of diagnostic contrast.
This document is an FDA 510(k) Premarket Notification summary for the coraCross Catheter. It focuses on demonstrating substantial equivalence to a predicate device, not on proving performance against specific acceptance criteria for an AI/ML-based device or diagnostic study.
Therefore, the requested information regarding acceptance criteria, study design parameters (sample size, data provenance, expert adjudication, MRMC studies, standalone performance), and ground truth establishment for a device performance study (especially one involving AI/ML) is not available in the provided text.
The document primarily describes:
- Device Name: coraCross Catheter
- Intended Use: Used with steerable guidewires to access peripheral/coronary vasculature, facilitate placement/exchange of guidewires/interventional devices, and provide a conduit for saline/contrast.
- Predicate Device: Wingman 14C Crossing Catheter (K190393)
- Technological Comparison: States the coraCross Catheter is "nearly identical" to the predicate, listing identical technological elements (over-the-wire, through lumen, smooth inner lumen, polymer catheter shaft) and minor differences (inner catheter leveraged from another device, beveled tip attachment method, hydrophilic coating length).
- Nonclinical Tests: Lists various performance tests conducted (Simulated Use Testing, Leak, Kink Resistance, Corrosion, Bond, Component Integrity, Particulate, Torque, Catheter Flow/Burst, Lubricity Testing).
- Conclusion: The device "met all specified criteria and did not raise new safety or performance questions" and "was found to be equivalent to the predicate device."
In summary, there is no information in this document that directly addresses the specific points requested for a study proving a device meets acceptance criteria related to AI/ML or diagnostic performance. The submission is for a medical device (catheter) based on substantial equivalence to an existing predicate, and the "acceptance criteria" referred to are likely engineering and performance specifications for the catheter itself, rather than diagnostic accuracy metrics.
§ 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).