(86 days)
The Titan Micro Catheter is intended for the controlled selective infusion of physician-specified therapeutic agents or contrast media into the vasculature of the peripheral and neuro anatomy.
The MTI HD Injector is intended for the infusion of physician-specified fluids with the MTI Titan™ Micro Catheter.
The MTI Titan™ 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. The catheter is provided with a removable adapter for attachment to either standard luer fitting devices or the MTI HD Injector.
The HD Injector is a 1 mL syringe with threaded plunger and a vial septum-piercing needle. The connector at the distal end of the injector is threaded for connecting to the MTI Titan™ Micro Catheter.
The provided text describes a 510(k) submission for the MTI Titan™ Micro Catheter and MTI HD Injector, focusing on demonstrating substantial equivalence to predicate devices through in-vitro performance testing and biocompatibility verification.
Based on the provided information, here's an analysis of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The submission describes in-vitro performance testing for both the micro catheter and the injector. While specific numerical acceptance criteria (e.g., "burst pressure must exceed X psi") are not explicitly stated in the provided text, the text implies that the tests were conducted to demonstrate acceptable performance for intended use and substantial equivalence to predicate devices. The reported device performance is that the devices met these unstated criteria.
| Feature / Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| MTI Titan™ Micro Catheter | ||
| Dimensional Inspection | Conformance to design specifications | Met specifications |
| Tensile Strength Tests | Adequate strength for intended use (e.g., without breakage) | Adequately strong |
| Burst Pressure Tests | Ability to withstand internal pressure during infusion | Adequately resistant to burst |
| Flow Rate Tests | Acceptable flow characteristics for therapeutic agents/contrast media | Acceptable flow rates |
| Torque Tests | Adequate torque response for navigation and control | Acceptable torque performance |
| Performance under Simulated Conditions | Safe and effective operation in simulated anatomical environment | Performed safely and effectively |
| Biocompatibility | Conformance to ISO 10993-1 for external communicating, blood contact, limited exposure ( |
§ 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).