(58 days)
The van Andel Dilatation Catheter is intended to facilitate percutaneous introduction of guide wires, and other devices into the femoral, popliteal, and infrapopliteal arteries during diagnostic and interventional procedures.
The van Andel Dilatation Catheter are intravascular dilation catheters comprised of polytetrafluoroethylene, designed for use in diagnostic and interventional procedures. The van Andel Dilatation Catheters are provided sterile and are meant for single use only. The van Andel Dilatation Catheter is available in 5.0, 6.3, 7.0, 8.0, and 9.0 French diameters and is manufactured in lengths of 60, 80, and 100 centimeters.
The provided text describes the 510(k) summary for the van Andel Dilatation Catheter. This document focuses on demonstrating substantial equivalence to predicate devices through various performance tests, not through clinical studies involving human readers or AI. Therefore, numerous requested sections related to AI performance, reader studies, and ground truth establishment are not applicable.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | Predetermined acceptance criteria as per ANSI AAMI ISO 10993-1:2009(R)2013 for cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogenicity, hemocompatibility, complement activation, and partial thromboplastin time. | The device is biocompatible. The predetermined acceptance criteria were met. |
| Tensile Testing of the Hub to Shaft Bond | Withstand peak load values specified in BS EN ISO 10555-1:2013 – Section 4.6 during proper clinical use. | The hub-to-shaft connection is expected to withstand peak load values. The predetermined acceptance criterion was met. |
| Liquid Leakage Testing | No liquid leakage during proper clinical use, as per BS EN ISO 10555-1:2013 - Section 4.7.1. | There shall be no liquid leakage. The predetermined acceptance criterion was met. |
| Dimensional Verification Testing | Outer diameter, inner diameter, taper length, and overall length of the device are within a specified tolerance. | The dimensions are within a specified tolerance. The predetermined acceptance criteria were met. |
| Exterior Surface Condition Testing and Distal Tip Inspection | Exterior surface of the device is smooth and free from any process defects. | The exterior surface was smooth and free from any process defects. The predetermined acceptance criteria were met. |
| Radiopacity Testing | Device is visible under fluoroscopic imaging in simulated clinical conditions. | The device would be visible under fluoroscopic imaging. The predetermined acceptance criterion was met. |
| Kink Radius Testing | Device would not kink under clinical conditions. | The device would not kink under clinical condition. The predetermined acceptance criteria were met. |
| Simulated Use Testing | Performance parameters are acceptable for clinical use. | The performance parameters were acceptable for clinical use. The predetermined acceptance criteria were met. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify the sample sizes used for each of the listed tests.
- The data provenance is not specified beyond being "applicable testing" conducted by the manufacturer, Cook Incorporated, in Bloomington, IN, USA. These are laboratory/bench tests, not clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. The tests conducted are physical and material property tests (e.g., tensile strength, leakage, dimensions, biocompatibility), not diagnostic interpretations requiring expert radiologists or similar medical professionals to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. These are objective engineering and material 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
- Not applicable. This is a medical device (catheter), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (catheter), not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the tests performed are established engineering and material standards and specifications (e.g., BS EN ISO 10555-1:2013, ANSI AAMI ISO 10993-1:2009(R)2013). These are objective criteria against which the device's physical properties and performance are measured.
8. The sample size for the training set
- Not applicable. This is a medical device, not a machine learning model; therefore, there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, this question is not relevant.
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).