(209 days)
For the introduction of various types of pacing or defibrillator leads and catheters.
The Thomas Medical Products, Inc. (TMP) Coronary Sinus Guide & Lateral Vein Introducer Kits (CSG/LVI) are intended to access the coronary venous system. either alone or in a telescopic assembly with other introducers. The CSG/LVI Introducers serve as a conduit to quide devices, including guidewires, pacemaker or defibrillator leads, and catheters, or to deliver contrast medium into specific branches of the coronary venous system. CSG/LVI introducers are intended to introduce left ventricular leads through their lumen. They have direct contact to the inner heart. CSG/LVI introducers come with various curve configurations and lengths to facilitate access to the coronary sinus OS and sub-selective access to angulated lateral vein branches. CSG/LVI introducers are designed as single use devices and for short term application (
The provided document describes the Coronary Sinus Guide & Lateral Vein Introducer Kits. The study presented focuses on demonstrating the substantial equivalence of the modified device to its predicate devices through various tests.
Here's an analysis of the acceptance criteria and study as per your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Test Description | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | USP Pyrogen Study, Material Mediated (XD-3050-00, Gen. III CSG Sheath) | Non-pyrogenic | Pass, non-pyrogenic |
| Cytotoxicity Study (ISO elution method) |
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).