(182 days)
The LAGUNA" Softip® diagnostic catheter is designed for delivering radiopaque media to selected sites in the vascular system.
The LAGUNA" diagnostic catheter is manufactured in three French sizes (5 FR, 6 FR and 7. FR) and multiple distal stem configurations and lengths. In addition, within each French size, catheters will be offered with differing handling characteristics to allow flexibility in meeting physician preferences.
The provided 510(k) summary for the LAGUNA™ Softip® diagnostic catheter does not include information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of an AI/ML medical device.
This document describes a traditional medical device (a diagnostic catheter) and its technological characteristics and equivalence to predicate devices through physical tests. It does not involve any AI/ML components, image analysis, or performance metrics like sensitivity, specificity, or AUC that would be associated with AI/ML device studies.
Therefore, I cannot fulfill your request as the required information (acceptance criteria for an AI/ML device, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, etc.) is entirely absent from the provided text.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).