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The intended use for the PeriVac Kit is as follows: The PeriVac Kit is intended for use in pericardial aspiration and drainage in the presence of pericardial effusion and tamponade.

The PeriVac Kit is designed to provide all of the necessary components for site preparation, local anesthesia, puncture, aspiration and/or drainage, collection, and dressing for the completion of pericardial fluid aspiration. The kit is comprised of finished components and packaged to provide convenience for the user. The PeriVac Kit is comprised of 21 components pre-assembled and packaged to eliminate delays when initiating emergency pericardial aspiration of fluid. For customer convenience, the PeriVac Kit will be made available in four packaging configurations with the only difference between the kits being the catheter types and the inclusion of Lidocaine and Providone-Iodine solution. This submission addresses two components of the PeriVac Kit.

The provided text describes a 510(k) submission for a medical device, the PeriVac Kit, and its comparison to a predicate device. However, it does not contain information regarding acceptance criteria, study design, or performance metrics that would typically be associated with AI/ML device studies. This document is a regulatory submission for a traditional medical device (pericardiocentesis kit), not an AI/ML powered device.

Therefore, I cannot extract the requested information as it is not present in the provided text. The submission focuses on demonstrating substantial equivalence to a predicate device based on device characteristics and intended use, rather than presenting performance data from a clinical or non-clinical study in the context of acceptance criteria.

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