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510(k) Data Aggregation
(233 days)
The Micropuncture® Introducer Set is intended for the placement of wire guides up to 0.038 inch diameter into the peripheral vascular system when a small 21 gage needle stick is desired.
The Micropuncture® Introducer Set is intended for the placement of wire guides up to 0.038 inch diameter into the peripheral vascular system when a small 21 gage needle stick is desired. The device is utilized to gain access to the vasculature using the Seldinger technique. These introducer sets are comprised of either 4.0 French outer introducer and 3.0 French inner dilator coaxial pair, a 21 gage percutaneous entry needle, and a 0.018 inch mandrel wire guide with a distal coil tip. The dilator of these sets can come with a stainless steel stiffening cannula embedded in the shaft. These sets are supplied sterile and are intended for one-time use.
Here's a breakdown of the acceptance criteria and study information for the Micropuncture Introducer Set, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | Conformance with ANSI AAMI ISO 10993-1:2009(R)2013 | Met predetermined acceptance criteria (passed Cytotoxicity, Pyrogen, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Complement Activation, and Hemocompatibility testing). |
| Liquid Leakage Testing | No leakage under proper clinical use (BS EN ISO 11070:2014, Annex D and E) | Met predetermined acceptance criteria. |
| Tensile Test of the Hub to Shaft Bond | Hub of outer introducer, inner dilator, and needle would not loosen or separate (BS EN ISO 11070:2014) | Met predetermined acceptance criteria. |
| Tensile Test of the Sideported Section | Sideported section of the outer introducer shaft would not separate under clinically relevant conditions | Met predetermined acceptance criterion. |
| Dimensional Verification Testing | Met dimensional requirements for overall length, inner diameter, outer diameter, and component compatibility | Met predetermined acceptance criteria. |
| Evaluation of Corrosion Resistance | Metallic components would resist corrosion | Met predetermined acceptance criteria. |
| Insertion Force Test | Simulated percutaneous insertion force through a simulated skin membrane met criteria | Met predetermined acceptance criteria. |
| Wire Fracture Test | Wire guide would show no signs of fracture when subjected to testing | Met predetermined acceptance criteria. |
| Wire Tensile Test | Distal tip of the wire guide would not separate under clinically relevant conditions | Met predetermined acceptance criteria. |
| Radiopacity Testing | Wire guide would be detectable under fluoroscopy | Met predetermined acceptance criteria. |
| Resistance to Damage by Flex Testing | Wire guide would not show any damage or defects when subjected to repeated flexing | Met predetermined acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each individual test. It only states that "Testing verified..." and "The predetermined acceptance criteria were met."
The data provenance is from benchtop testing conducted by Cook Incorporated. The country of origin for the data is not explicitly stated, but Cook Incorporated is located in Bloomington, Indiana, USA, suggesting the testing likely occurred in the US or under the company's direct supervision. The studies are retrospective in the sense that they are laboratory tests performed on finalized device designs rather than prospective clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The tests described are primarily engineering and material science tests, not clinical evaluations requiring expert interpretation of ground truth in the same way an AI diagnostic device would. The "ground truth" for these tests is based on established engineering standards and specifications.
4. Adjudication Method for the Test Set
This information is not applicable as the tests performed are objective physical and material performance tests, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance?
No, an MRMC comparative effectiveness study was not done. This document describes the clearance of a physical medical device (introducer set), not an AI diagnostic or assistive technology. Therefore, there is no discussion of human reader improvement with or without AI assistance.
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 instrument, not a software algorithm.
7. The Type of Ground Truth Used
The ground truth used for these tests is based on established engineering standards, material specifications, and regulatory requirements (e.g., ISO standards). For example, for biocompatibility, the ground truth is conformance with ANSI AAMI ISO 10993-1. For leakage, it's conformance with BS EN ISO 11070:2014.
8. The Sample Size for the Training Set
This information is not applicable. This device is not an AI/ML product and does not involve a "training set" in the computational sense. The testing described is verification and validation for a manufactured product.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as point 8.
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