(19 days)
The Serranator® PTA Serration Balloon Catheter is intended for dilatation of lesions in the illac, femoral, and poplited arteries for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
The Serranator® PTA Serration Balloon Catheter is an Over-The-Wire (OTW) balloon dilatation catheter designed to perform Percutaneous Transluminal Angioplasty (PTA) for peripheral indications as described in the Indication for Use statement. The Serranator® has a nylon semicompliant balloon with embedded external metal strips or scoring elements. The unique scoring elements are serrated, designed to modify the plaque by creating linear, interrupted scoring along the endoluminal surface. This occurs during balloon inflation and is designed to aid arterial expansion.
The provided text is a 510(k) Premarket Notification for a medical device called the Serranator® PTA Serration Balloon Catheter. It discusses the device's indications for use, description, and comparison to predicate and reference devices to demonstrate substantial equivalence. Crucially, this document does not contain information about clinical acceptance criteria (e.g., sensitivity, specificity, accuracy) or the results of a clinical study that proves the device meets these criteria.
The "NON-CLINICAL TESTING/PERFORMANCE DATA" section states that "bench tests were performed" and "In vitro bench testing demonstrated that the subject device performed as intended and similar to the predicate device." This refers to laboratory tests, not human clinical trials. There is no mention of an AI component, human readers, or ground truth establishment relevant to AI performance.
Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than proving clinical performance against specific acceptance criteria in a human study.
§ 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).