(416 days)
The Flexor® Radial Hydrophilic Introducer Access Set is introduce diagnostic and interventional devices in radial arterv access procedures.
The Flexor Radial Hydrophilic Introducer Access Set is comprised of an introducer sheath, a dilator, a wire guide, and an access needle.
This document describes the Cook, Inc. Flexor® Radial Hydrophilic Introducer Access Set (K132592). It details the testing conducted to demonstrate substantial equivalence to predicate devices, focusing on the quality and performance of the device components.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dilator and introducer sheath tensile testing | Peak load values in accordance with applicable values of BS EN ISO 11070:1999. | The predetermined acceptance criteria were met. |
| Connecting tube to check-flo tensile testing | Connection between the valve body and the connecting tube meets predetermined acceptance criteria under proper clinical use. | The predetermined acceptance criteria were met. |
| Needle tensile testing | Peak load values in accordance with applicable values of BS EN ISO 11070:1999. | The predetermined acceptance criteria were met. |
| Needle tubing testing | Tubing resists breakage in accordance with EN ISO 9626:1995. | The predetermined acceptance criteria were met. |
| Check-Flo valve dislodgement testing | Check-Flo valve not dislodged during insertion and withdrawal when utilized according to intended use. | The predetermined acceptance criteria were met. |
| Check-Flo valve liquid leakage testing | Check-Flo valve does not experience excessive leakage when utilized according to intended use. | The predetermined acceptance criteria were met. |
| Dimensional verification | Each component meets dimensions within tolerances of predetermined acceptance criteria. | Each component met the dimensions within tolerances of the predetermined acceptance criteria. |
| Fluoroscopic visibility evaluation | Each component visible under fluoroscopy. | The predetermined acceptance criteria were met. |
| Design validation | Achieves design validation through simulated clinical use where predetermined acceptance criteria were met. | The predetermined acceptance criteria were met. |
| Insertion and extraction force evaluation | Insertion and extraction forces of the dilator through the check-flo valve meet predetermined acceptance criteria, where appropriate. | The predetermined acceptance criteria were met, where appropriate. |
| Dilator and introducer sheath coating slough-off | Hydrophilic coating meets requirements for durability. | The predetermined acceptance criterion was met. |
| Particulate evaluation | Particulate counts recorded in continuous flow loop. (Specific acceptance criteria not detailed in the provided text, but the nature of the test implies a limit on particulate generation.) | Particulate counts were recorded in continuous flow loop. (Implied that counts were within acceptable limits or characterized sufficiently to demonstrate safety, though specific criteria/results are not stated as "met.") |
| Introducer lubricity testing | Lubricity of the introducer shaft meets predetermined acceptance criterion. | The predetermined acceptance criterion was met. |
| Coating integrity testing | Surface of device, including hydrophilic coating, visually examined at multiple time points (implies no significant degradation or damage). | Surface of device, including the hydrophilic coating, was visually examined at multiple time points. (Implied that integrity was maintained, though specific criteria/results are not stated as "met.") |
| Wire guide testing | Meets predetermined acceptance criteria for resistance to fracture, resistance to damage by flexing, tensile, tip deflection, torque response and torque strength as recommended in BS EN ISO 11070:1999 and "Coronary and Cerebrovascular Guidewire Guidance," January 1995. | All predetermined acceptance criteria were met for resistance to fracture, resistance to damage by flexing, tensile, tip deflection, torque response and torque strength as recommended in BS EN ISO 11070:1999 and in "Coronary and Cerebrovascular Guidewire Guidance," January 1995. |
| Biocompatibility testing | Demonstrated as biocompatible in conformance with applicable sections of ISO 10993-1:2009 for tests including cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogen, hemocompatibility, complement activation, partial thromboplastin time, and thromboresistance. | Testing (i.e., cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogen, hemocompatibility, complement activation, partial thromboplastin time, and thromboresistance) demonstrated the device as biocompatible. In conformance with the applicable sections of ISO 10993-1:2009, the predetermined acceptance criteria were met. |
2. Sample size used for the test set and the data provenance:
The provided document details various performance and laboratory tests. However, it does not specify sample sizes for each test set, nor does it mention data provenance (e.g., country of origin, retrospective or prospective data). These tests appear to be bench and laboratory-based assessments of the device's physical and biological properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The tests described are primarily engineering and laboratory evaluations, not clinical studies requiring expert ground truth establishment in the traditional sense (e.g., for image interpretation).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable or not provided. The listed tests are objective, quantifiable physical and biological 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. This document describes a medical device (introducer access set), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study assessing human reader improvement with AI assistance is not relevant and was not conducted.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
No. This document describes a physical medical device. The concept of "standalone algorithm only" performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the tests performed is based on established engineering standards (e.g., BS EN ISO 11070:1999, EN ISO 9626:1995), biocompatibility standards (e.g., ISO 10993-1:2009), and internal predetermined acceptance criteria derived from the device's intended use and design specifications. These are objective measures rather than expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
This refers to a training set for machine learning or AI models. Since this is a physical medical device and not an AI/ML product, there is no "training set" in this context.
9. How the ground truth for the training set was established:
As there is no training set for an AI/ML model, this question is not applicable.
§ 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).