(8 days)
The MTI Reinforced Infusion Catheter is intended to be used for the controlled selective infusion of physician-specified pharmacologic agents or radiopaque contrast media into the general vasculature.
The MTI TruLine™ Reinforced Infusion Catheter is a single-lumen plastic catheter designed to be introduced over a guidewire into the vasculature. Once positioned, various pharmacological agents may be delivered through a standard luer lock adapter at the proximal end. The infusion area is indicated by distal and proximal radiopaque markers to facilitate fluoroscopic visualization. The reinforced Infusion catheters are available in a variety of infusion lengths.
The provided text describes a Special 510(k) submission for the Micro Therapeutics, Inc. TruLine™ Reinforced Valved Infusion Catheter (K021139). This submission focuses on establishing substantial equivalence to a predicate device, which usually involves a different type of testing than what would be described for an AI/ML powered device, and therefore does not include detailed information on acceptance criteria and a study design in the way an AI/ML device would.
Based on the information provided, here's what can be extracted and what is not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific, quantifiable acceptance criteria and corresponding performance metrics in the way an AI/ML device submission would. Instead, it states that "All testing yielded acceptable results" for a range of physical and biocompatibility tests.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Confirmed in accordance with ISO 10993-1 as an external communicating, blood contact, limited exposure ( |
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).