(40 days)
The Pioneer Plus Catheter is intended to facilitate placement and positioning of catheters within the peripheral vasculature. The Pioneer Plus Catheter also provides an intraluminal cross-sectional ultrasound image of the area of interest to facilitate placement of guidewires beyond stenotic lesions (e.g., sub-total, total or chronic total occlusions) prior to additional intervention (i.e. PTCA, stent, etc.). The Pioneer Plus Catheter is not indicated for use in the coronary or cerebral vasculature.
The proposed device is a catheter which utilizes IVUS imaging and a hollow Nitinol needle to facilitate redirection and placement of a 0.014" OTW guidewire into peripheral vessels. The guidewire can then facilitate placement of subsequent devices. The device is a single use, sterile catheter.
The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. Instead, it is a 510(k) summary and FDA clearance letter for a medical device called the "Pioneer Plus Catheter."
The summary primarily focuses on establishing "substantial equivalence" to a predicate device (Pioneer Catheter, K072155) based on:
- Same indications for use: Facilitate placement and positioning of catheters and provide an intraluminal cross-sectional ultrasound image to facilitate guidewire placement beyond stenotic lesions in peripheral vasculature (not coronary or cerebral).
- Substantially equivalent performance, function, and device characteristics.
- Non-clinical data: In vitro and in vivo testing were completed to assess substantial equivalence in terms of indications, performance, function, device characteristics, materials, packaging, biocompatibility, sterilization, and stability.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study details as this type of information is not present in the provided document.
§ 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).