(62 days)
The Vericor Support Catheter is intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures, including peripheral use.
The Vericor Support Catheter with hydrophilic coating is a braided, kink-resistant catheter designed to facilitate wire guide exchange, wire guide support and to provide a conduit for the delivery of saline solutions or diagnostic contrast agents. The Vericor Support Catheter will be available in three catheter lengths which are 90 cm, 135 cm and 150 cm. The proposed device is a single-lumen catheter. The hub of the catheter incorporates standard luer adapter to facilitate the attachment of accessories. The outer surface of the distal catheter has a hydrophilic coating. The catheter has three radiopaque markers at the distal end to facilitate fluoroscopic visualization. The device is provided in single use and sterile.
This document, a 510(k) Summary, describes the Vericor Support Catheter and its substantial equivalence to a predicate device. This is a medical device, not an AI/ML product, so the questions regarding AI/ML clinical studies are not applicable.
Here's the breakdown of the acceptance criteria and the study (non-clinical) that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) Summary details numerous non-clinical tests. The column "Test Method Summary" indirectly describes the acceptance criteria by outlining what the test aims to demonstrate (e.g., "To demonstrate that the device meets the corrosion resistance"). The "Results and Conclusion" column reports that the device met these criteria.
| Test | Acceptance Criteria (Implied from "Test Method Summary") | Reported Device Performance |
|---|---|---|
| Visual inspection | No structural or mechanical damage under x2.5 magnification | The catheter met acceptance criteria. |
| Corrosion Resistance | Meets ISO 10555-1:2013 corrosion resistance requirements | Corrosion resistance met acceptance criteria. |
| Dimensional verification | Meets specified dimensions | Size verification met acceptance criteria. |
| Flowrate determination test | Meets ISO 10555-1:2013 flowrate requirements | The flowrate of the Vericor catheter size verification met acceptance criteria. |
| Compatibility test | Can be used as intended with compatible devices in a vascular model | The device can be used as intended. |
| Simulated use | Can be used as intended in a vascular model | The device can be used as intended. |
| Power injection | Free of leakage, rupture, or other failure modes during power injection | The catheters were free of leakage, rupture or other failure modes during power injection test, and the test result met acceptance criteria. |
| Torque transmission | Meets torque transmission requirements | Torque transmission met acceptance criteria. |
| Air leakage | No air leakage during hub aspiration | No air leakage |
| Liquid leakage | No liquid leakage under pressure | No liquid leakage |
| Static burst pressure | Meets burst pressure requirements (greater than maximum injection pressures) | Burst pressure met acceptance criteria. |
| Friction of coating | Acceptable change in coating friction before and after use | Friction met acceptance criteria |
| Coating integrity | No coating defects with magnification after simulated use | Coating integrity met acceptance criteria. |
| Flexibility | Meets ASTM F2606-2008 flexibility requirements | Tip flexibility met acceptance criteria. |
| Kink resistance | Meets kink resistance requirements (implied by method) | Kink resistance met acceptance criteria |
| Peak tensile force | Meets maximum tensile force acceptance criteria | Peak tensile force met acceptance criteria. |
| Catheter tip twist to damage test | Meets tip twist acceptance criteria (e.g., no deformation/failure under specified rotation) | Tip twist met acceptance criteria |
| Radiopacity | Radiopaque marker on the catheter tip divisible under X-ray | The radiopaque marker on the catheter tip is visible under X - ray. |
| Catheter body axial compression test | Meets catheter body axial force acceptance criteria | Catheter body axial force met acceptance criteria. |
| Delivery and retrieval forces test | Meets FDA Guidance delivery and retrieval requirements | Deliver and retrieval force met acceptance criteria. |
| Particulate testing | Quantity and size of generated particles meet acceptance criteria after simulated use | The number and size of the particles met acceptance criteria. |
| Connector performance | Meets ISO 80369-7 requirements for small bore connectors | Connector performance met acceptance criteria. |
| Cytotoxicity | No cytotoxicity | No cytotoxicity |
| Skin Sensitization | No skin sensitization | No skin sensitization |
| Intracutaneous Reactivity | No irritation | No irritation |
| Systemic Toxicity | No systemic toxicity | No systemic toxicity |
| Pyrogen | No pyrogen | No pyrogen |
| Complement Activation | No significant difference to control group | No significant difference to control group |
| In Vivo Thromboresistance | Minimal thrombosis | Minimal thrombosis |
| Hemolysis | No hemolysis | No hemolysis |
| Partial Thromboplastin Time | No significant difference to control group | No significant difference to control group |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample sizes for each non-clinical test. It generally states that "Non clinical tests were conducted to verify that the proposed device met all design specifications." The data provenance is not applicable in terms of country of origin or retrospective/prospective for these non-clinical, laboratory-based tests. The tests were performed on the Vericor Support Catheter itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This is not applicable as the studies are non-clinical, laboratory-based performance tests, not studies involving human interpretation or clinical data. Ground truth in this context is established by adherence to specified standards and measurement techniques.
4. Adjudication Method for the Test Set
Not applicable. The tests are based on objective measurements and adherence to established standards, not expert adjudication of subjective interpretations.
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 conventional medical device (support catheter), not an AI/ML diagnostic or assistive device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Not applicable. This device does not involve an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For these non-clinical tests, the "ground truth" is defined by the objective criteria within the referenced international and national standards (e.g., ISO 10993, ISO 10555-1, ASTM standards, USP). Performance is measured against these established technical specifications and benchmarks.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML system that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device does not involve a training set.
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).