(276 days)
The Micropuncture Introducer Set is intended for the placement of wire guides up to .038 inch diameter into the peripheral vascular system when a small 21 gage needle stick is desired.
The Micropuncture Introducer Sets contains a coaxial catheter, a wire guide, and a needle. The device is utilized to gain access to the vasculature using the Seldinger technique.
Here's an analysis of the provided document regarding the acceptance criteria and supporting studies for the Micropuncture® Introducer Set:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a general statement that "The predetermined acceptance criteria were met" for each test. Specific numerical acceptance criteria were not detailed in this summary.
| Test Conducted | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Insertion force testing | Predetermined acceptance criteria (not specified numerically) | Met |
| Coaxial catheter tensile testing | Hub would not be dislodged during insertion and withdrawal (not specified numerically) | Met |
| Wire guide resistance to damage testing | No damage or defects after repeated flexing (not specified numerically) | Met |
| Wire guide resistance to fracture testing | No signs of fracture (not specified numerically) | Met |
| Wire guide tensile strength testing | Distal tip withstands 4.0N before failure | Met |
| Wire guide torque response and torque strength | Output rotation within 90 degrees of input rotation; withstands 10 rotations without failure | Met |
| Biocompatibility testing (various assays) | In conformance with ISO 10993-1:2009 (not specified numerically) | Met |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not provide information on the sample sizes used for any of the tests. The data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not applicable as the document describes performance testing for a medical device (introducer set), not a diagnostic algorithm or image analysis tool requiring expert ground truth for interpretation.
4. Adjudication Method for the Test Set
This information is not applicable for the same reason as point 3.
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 conducted. The document describes laboratory-based performance testing, not studies involving human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The device described is a physical medical instrument, not a software algorithm.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically applied to diagnostic algorithms is not directly applicable here. The tests performed are laboratory-based engineering and material science tests. The "ground truth" would be the direct measurement of physical properties (e.g., force, rotation, tensile strength) or biological responses (e.g., cytotoxicity).
8. The Sample Size for the Training Set
Not applicable. The device is a physical product, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reason as point 8.
§ 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).