(45 days)
The Wingman Extendable Tip Support Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents.
The Wingman Extendable Tip Support Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral vasculature. The device consists of a support catheter, with a concealed radiopaque beveled guide-tip, and activating handle. The through-lumen of the device can serve as a conduit for the delivery of diagnostic and therapeutic agents.
The provided text describes a 510(k) summary for the ReFlow Medical Wingman Extendable Tip Support Catheter. It outlines the device's characteristics, intended use, and the testing performed to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Test Performed | Reported Device Performance |
|---|---|
| Simulated Use | Met specified criteria |
| Tensile Strength | Met specified criteria |
| Torque | Met specified criteria |
| Pressure Test | Met specified criteria |
| Coating/Plating verification | Met specified criteria |
| Corrosion Test | Met specified criteria |
| Dimensional verification | Met specified criteria |
| Visual inspections | Met specified criteria |
2. Sample Size Used for the Test Set and Data Provenance:
The document states that "All testing was performed on test units representative of finished devices." However, it does not specify the exact sample size for each test or the overall test set. The data provenance is not explicitly mentioned but can be inferred as originating from internal testing conducted by ReFlow Medical, a US-based company, as part of their 510(k) submission to the FDA. The testing is prospective as it's for a new or modified device to demonstrate performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable or provided in the context of this device. The tests performed are engineering and material science-based, not clinical studies requiring expert interpretation of medical images or data for ground truth.
4. Adjudication Method for the Test Set:
This information is not applicable or provided for the type of engineering and material performance tests described. Adjudication methods are typically relevant for clinical studies with subjective interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating the impact of an AI system on human reader performance, which is not relevant to the physical performance testing of a catheter.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a standalone performance study was not done. This device is a physical medical device (catheter), not an AI algorithm. The performance evaluation is based on its physical properties and function.
7. The Type of Ground Truth Used:
The "ground truth" for the tests performed is the pre-defined acceptance criteria or specifications for each engineering and material test (e.g., a specific tensile strength value, acceptable pressure resistance, etc.). The device's performance was compared directly against these established criteria.
8. The Sample Size for the Training Set:
This information is not applicable or provided. The concept of a "training set" is relevant for machine learning algorithms, which is not what this device is. The device's design and manufacturing likely involved iterative development and testing, but not in the context of machine learning training data.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable or provided as there is no "training set" in the context of this device's development and testing. The "ground truth" for the design and performance specifications would have been established through engineering principles, regulatory requirements, and industry standards for similar medical devices.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).