(71 days)
Guidion catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement and exchange of guide wires and other interventional devices.
The Guidion catheter is a single lumen rapid exchange catheter offered in sizes being compatible with 5F; 6F; 7F and 8F guide catheters and may be placed over an guide wire. The 150cm long device has a stainless steel shaft section. The stainless steel shaft is followed distally by a 25cm lumen section.
The Guidion catheter has a radiopaque distal end which enables visibility while using standard fluoroscopic methods. The device has two positioning marks located at 95cm and 105cm from the distal tip, respectively.
The Guidion catheter is delivered through a guiding catheter resulting in an inner diameter that is approximately 1 French smaller than the guide catheter. The Guidion catheter has a proximal hub which indicates guide catheter compatibility.
The provided document is a 510(k) summary for the Guidion Catheter, a medical device. It does not describe an AI/ML powered device, nor does it detail a study involving AI for diagnostic assistance. Therefore, it does not contain the information required to answer the prompt regarding acceptance criteria and a study proving an AI device meets those criteria.
The document discusses the substantial equivalence of the Guidion Catheter to a predicate device based on performance and biocompatibility tests. It lists the types of tests performed (e.g., kink resistance, radiopacity, bond strength, biocompatibility), but it does not provide specific acceptance criteria or detailed results of these tests. It simply states that "The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues."
Therefore, I cannot provide information for the following points as they are not present in the given text:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi reader multi case (MRMC) comparative effectiveness study was done
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
§ 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).