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510(k) Data Aggregation
(68 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 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 of the Reinforced Infusion Catheter is indicated by distal and proximal radiopaque markers to facilitate fluoroscopic visualization. The Reinforced Infusion Catheters are available in a variety of infusion lengths.
Here's a breakdown of the acceptance criteria and study information for the Micro Therapeutics, Inc. Reinforced Infusion Catheter, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Criteria | Device Performance |
|---|---|
| Biocompatibility (in accordance with ISO 10993-1 for external communicating, blood contact, limited exposure (<24 hrs) device) | Test results confirmed biocompatibility of the catheter. |
| In-vitro Performance Testing: | |
| - Dimensional Inspection | Yielded acceptable results. |
| - Tensile Strength Tests | Yielded acceptable results. |
| - Burst Pressure Tests | Yielded acceptable results. |
| - Flow Rate Tests | Yielded acceptable results. |
| - Performance under Simulated Conditions | Yielded acceptable results. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective) for any of its performance testing. The description is quite general about "in-vitro performance testing" and biocompatibility.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
This information is not provided in the document. The tests performed are laboratory-based physical and biological evaluations, rather than those requiring expert interpretation of clinical data.
4. Adjudication Method for the Test Set
This information is not applicable and is not provided. The testing described does not involve expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document focuses on the physical and biological characteristics of the device, not its use by human readers in a diagnostic capacity.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone algorithm performance study was not done. This device is a physical medical catheter, not an AI algorithm.
7. The Type of Ground Truth Used
For the biocompatibility testing, the "ground truth" was established based on the criteria outlined in ISO 10993-1. For the in-vitro performance testing (dimensional inspection, tensile strength, burst pressure, flow rate, simulated conditions), the "ground truth" would be the predetermined engineering specifications and performance requirements for a safe and effective catheter.
8. The Sample Size for the Training Set
No training set is mentioned as this device is not an AI/machine learning product.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is mentioned.
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