(81 days)
The MTI Nautica™ Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media. Not intended for use in the coronary vasculature.
The MTI Nautica™ Micro Catheter is an end-hole, single-lumen catheter designed to be introduced over a steerable guidewire into the vasculature. The catheter has a semi-rigid proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter is coated to increase lubricity.
This document is a 510(k) Pre-market Notification for a medical device called the MTI Nautica™ Micro Catheter, dated December 12, 2002. It outlines the device description, indications for use, and a summary of substantial equivalence to predicate devices. The document also includes the FDA's acceptance letter from March 7, 2003, confirming the substantial equivalence.
Based on the provided text, the acceptance criteria and the study proving the device meets those criteria are described as follows:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| In-vitro Performance Testing | |
| Dimensional Inspection | Performed and results presumably met internal specifications. (Specific values not provided in this summary) |
| Tensile Strength Tests | Performed and results presumably met internal specifications. (Specific values not provided in this summary) |
| Burst Pressure Tests | Performed and results presumably met internal specifications. (Specific values not provided in this summary) |
| Flow Rate Tests | Performed and results presumably met internal specifications. (Specific values not provided in this summary) |
| Torque Tests | Performed and results presumably met internal specifications. (Specific values not provided in this summary) |
| Performance under Simulated Conditions | Performed and results presumably met internal specifications. (Specific values not provided in this summary) |
| Biocompatibility | |
| Compliance with ISO 10993-1 | Verified in accordance with ISO 10993-1 (Biological Evaluation of Medical Devices). |
| Biocompatibility of an external communicating, blood contact, limited exposure ( |
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).