(188 days)
The Edwards Directional Catheter is indicated to facilitate the placement of guidewires in bifurcations or any sidebranch vasculature.
The Edwards Directional Catheter is 99 cm in length and 16F outer diameter. The body has two lumens, one for a deflectable spring, and the other to allow it to track on a 0.035" guidewire. The sheath on the subject device provides a smooth transition from the body to the tip of the catheter. The tip of the catheter is made from a soft material that offers flexibility. The body of the catheter is made from a higher durometer material that offers better torqueability. When the sheath of the device is retracted, the spring tip can be deflected using the knob located at the proximal end. The spring tip can be adjusted from approximately 0° to 180° by sliding the knob back and forth. There is also a port that allows a 0.035" guidewire to pass through the catheter and exit through the deflecting tip.
The provided 510(k) summary for the "Edwards Directional Catheter" indicates that clinical testing was not deemed necessary to establish substantial equivalence to predicate devices. Therefore, the document does not contain information related to acceptance criteria or a study proving the device meets said criteria in a clinical context.
Instead, the submission relies on the following non-clinical evaluations:
- Biocompatibility testing/chemical acceptability testing
- Physical and mechanical specification testing
- Sterilization testing
- Animal Studies
Based on the results of these non-clinical tests, Edwards Lifesciences concluded that the device's design and construction were acceptable for its intended use.
Consequently, the requested information elements related to clinical study acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be extracted from the provided text.
The 510(k) summary explicitly states:
"Summary of Clinical Tests and Conclusions: Clinical testing was not deemed necessary to establish the substantial equivalence of the subject device to the predicate devices."
§ 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).