(134 days)
The AFX Introducer System facilitates the introduction of guidewires, and other medical devices into the vasculature and minimizes blood loss associated with such introduction.
The Endologix AFX Introducer System consists of an Introducer Sheath (45 cm working length) and two Dilators. The system is enclosed in a sterile package. During clinical use, the system will allow introduction of a standard 0.035" guidewire within its inner lumen.
Introducer Sheath: The Introducer Sheath provides a conduit for introducing other interventional devices, including guidewires and interventional catheters, into the vasculature. The main components of this assembly are a hydrophilically-coated, PTFE lined, 55D Pebax introducer sheath, acrylobutylstyrene (ABS) hemostasis valve housing with butyl rubber valve, and silicone gasket assembly, 3 way stopcock/valve, and sideport diethylhexyl phthalate (DEHP)-free polyvinylchloride (PVC) tubing. The Pebax introducer sheath also includes an embedded stainless steel braid for increased strength and kink resistance, and embedded Vectran® strands for increased longitudinal strength. The distal tip of the introducer sheath includes an embedded radiopaque marker composed of 90% Platinum/10% Iridium.
Dilators: The dilators for the system are used to provide support and stability to the Introducer Sheath during deployment into the vasculature. The dilators are designed specifically for the Endologix AFX Introducer System and can accommodate a 0.035" guidewire through the central lumen. Two dilators are included with the AFX Introducer System. Both dilators are included within the package. One dilator is a single lumen device and one dilator is a dual lumen device. Both dilators are composed of 63D Pebax with 20% Barium Sulfate (BaSO4) for radiopacity and include a hydrophilic coating on the outer surface. These dilators are designed in diameter and length to be placed within the AFX Introducer Sheath component. The dilators have a tapered, atraumatic distal tip. The proximal end of the dilators includes a luer port. The dilators provide stiffness to the assembly so that the introducer sheath can be placed within the vasculature during a standard vascular access.
The provided document describes the Endologix AFX Introducer System, an introducer sheath and dilator system. The information outlines various tests conducted to demonstrate the device's substantial equivalence to predicate devices, focusing on regulatory and performance aspects.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents several tables detailing various tests performed on the Endologix AFX Introducer System. The "Result (Pass/Fail)" column serves as the reported device performance against the implied acceptance criteria for each test.
| Test Category | Specific Test / Acceptance Criteria Description | Reported Device Performance (Result) |
|---|---|---|
| Sterilization | Validation of the ethylene oxide sterilization cycle in accordance with ISO 11135-1 to verify that the ethylene oxide sterilization process provides a SAL of 10^-6 | Pass |
| Shelf-Life Packaging Validation | Visual inspection of the packaging to identify any anomalies that could impact integrity | Pass |
| Bubble Emission (ASTM F2096-04) for detecting gross leaks | Pass | |
| Dye Penetration (ASTM F1929-98 (2004)) for detecting seal leaks | Pass | |
| Peel Test (ASTM F88M-09) for seal strength of flexible barrier materials | Pass | |
| Biocompatibility | Cytotoxicity (ISO 10993-5) using MEM Elution | Pass |
| Sensitization (ISO 10993-10) - Murine Local Lymph Node Assay | Pass | |
| Intracutaneous Reactivity (ISO 10993-10) - Intracutaneous Irritation Test | Pass | |
| Acute Systemic Toxicity (ISO 10993-11) - Acute Systemic Injection Test | Pass | |
| Hemocompatibility (ISO 10993-4): Complement Activation, Hemolysis Assay, Partial Thromboplastin Time, Platelet and Leukocyte Counts | Pass (for each sub-test) | |
| Pyrogenicity (USP ) - Rabbit Pyrogen Test | Pass | |
| Performance Testing (ISO 10555-1) | Leak Testing (connection fittings and valve seal do not leak liquid when tested at 3.0 PSI) | Pass |
| Bond and Component Tensile Strength (break force meets or exceeds requirements) | Pass | |
| Particle Size (USP requirements: 10-25μm 25μm |
§ 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).