(29 days)
The AngioSculpt PTA Scoring Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal, and infra popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
The AngioSculpt catheter is a standard two-lumen catheter with a scoring balloon near the distal tip. The distal end of the catheter has a conventional nylon-blend balloon with a nitinol scoring element that wraps around the balloon. The sconng element creates focal concentrations of dilating force which minimizes balloon slippage and assists with luminal expansion of stenotic arteries. The balloon has radiopaque markers to aid in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at a specific pressure.
This document is a 510(k) summary for the AngioSculpt PTA Scoring Balloon Catheter (K091966). It does not contain the detailed acceptance criteria or the study results that would be needed to fill out a table of acceptance criteria and reported device performance. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting novel clinical study data against defined acceptance criteria.
Therefore, I cannot provide the requested information from the given text. The provided document states:
- No specific acceptance criteria are listed. The document focuses on demonstrating substantial equivalence to predicate devices.
- No specific study is described with performance metrics. The document mentions "Design verification and validation testing demonstrated adequate device performance," but does not detail the nature, sample size, or specific results of these tests, particularly in a way that aligns with "device performance" as might be measured in a clinical study (e.g., success rates, complication rates).
The remaining sections of your request (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, how training set ground truth was established) require information that would typically be found in a detailed clinical study report or a more comprehensive premarket submission, which is not present in this 510(k) summary.
A 510(k) summary is a high-level overview intended to demonstrate substantial equivalence, not a full clinical study report.
§ 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).