(64 days)
Lantern Delivery Microcatheter is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic devices, such as occlusion coils, to the peripheral and neuro vasculature.
Lantern Delivery Microcatheter is a single lumen intravascular catheter designed to aid physician in accessing distal vasculature. When used in conjunction with a guide catheter and guide wire, Lantern provides access to the target site. Once in place it provides a reinforcing conduit for other intravascular devices.
This document describes the Lantern™ Delivery Microcatheter and its substantial equivalence to a predicate device. The information provided focuses on the non-clinical data, specifically biocompatibility and bench-top testing, to demonstrate its safety and effectiveness.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance/Results |
|---|---|---|
| In vitro Cytotoxicity (MEM Elution) | Sample extracts must yield cell lysis grade $\le$ 2 | Grade: 1 (slight) - Met |
| Sensitization (Magnusson-Kligman Method) | Test Group shall yield Grade 10% in 3 or more animals | Non-toxic - Met |
| Material Mediated Rabbit Pyrogen | Sample extracts must not cause a total rise in body temperature of $\ge$ 0.5° C | Non-pyrogenic - Met |
| Hemolysis – Indirect Contact | Sample extracts must be nonhemolytic ($\le$ 2% hemolytic index) | Non-hemolytic - Met |
| Complement Activation | The concentrations of C3a and SC5b-9 in the test samples are statistically similar to the predicate control and statistically lower than the positive control for all exposure times | No greater biological response than corresponding control - Met |
| Thrombosis (Dog Thrombogenicity) | Device must be non-thrombogenic after 4 hours in vivo when compared to control device | Non-thrombogenic - Met |
| Bench-top Testing (various tests) | All predetermined requirements (specific criteria not detailed for each individual test in the document) | All established acceptance criteria were met. All testing met specification. - Met |
| Pyrogenicity (LAL validation) |
§ 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).