(29 days)
The Wingman Crossing 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 Crossing 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 Wingman Crossing Catheter product line is being extended to add a .018" diameter device configuration.
The provided document is a 510(k) premarket notification for a medical device, the Wingman Crossing Catheter. It focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study proving its fulfillment is not explicitly available in this document.
However, I can extract what is present and highlight what is missing based on your request.
Here's a breakdown of the information, with explanations for what cannot be provided from this particular document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from tests) | Reported Device Performance |
|---|---|
| Simulated Use: Device performs as intended in simulated clinical scenarios. | Met all specified criteria. |
| Tensile Strength: Device withstands specified tensile forces without failure. | Met all specified criteria. |
| Torque: Device can be torqued without adverse effects. | Met all specified criteria. |
| Pressure Test: Device maintains integrity under specified pressure. | Met all specified criteria. |
| Coating verification: Coating quality and integrity meet specifications. | Met all specified criteria. |
| Corrosion Test: Device resists corrosion under specified conditions. | Met all specified criteria. |
| Dimensional verification and visual inspections: Device dimensions and visual appearance meet specifications. | Met all specified criteria. |
Missing Information: The document states that the modified Wingman Crossing Catheter "met all specified criteria," but it does not explicitly define those criteria (e.g., specific tensile strength in Newtons, pressure limits in psi, or detailed visual inspection parameters). It also doesn't provide numerical results for the performance of the device against these criteria, only a qualitative statement of meeting them.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing Information: The document states "All testing was performed on test units representative of finished devices" but does not specify the sample size for each test, nor does it indicate the provenance of any data (e.g., country of origin, retrospective or prospective). This is typical for a 510(k) summary which focuses on demonstrating substantial equivalence rather than a full clinical study report.
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)
Missing Information: This type of information is not relevant to the engineering and performance testing described in this 510(k) summary. The tests performed (tensile strength, pressure, etc.) are objective physical tests, not evaluations requiring expert interpretation of clinical data or images to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing Information: Similar to point 3, adjudication methods are typically used in clinical studies involving human interpretation of data, which is not the type of testing described here. The performance tests are objective engineering measurements.
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
Missing Information: An MRMC comparative effectiveness study is designed for evaluating the impact of a device (often AI-powered) on human performance in diagnostic or interpretive tasks. This document is for a physical medical device (a catheter) and does not involve AI or human readers for its intended use. Therefore, no such study was conducted or reported here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Missing Information: As explained in point 5, this device is a physical catheter, not an algorithm. Therefore, no standalone algorithm performance study was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Missing Information: The "ground truth" for the engineering performance tests are the pre-defined specifications and industry standards for mechanical properties and material integrity. The document doesn't detail these specific standards or criteria, but implies their existence by stating "met all specified criteria."
8. The sample size for the training set
Missing Information: This concept is relevant for machine learning algorithms. The Wingman Crossing Catheter is a physical medical device, not an AI model. Therefore, there is no "training set" in the context of this device.
9. How the ground truth for the training set was established
Missing Information: As explained in point 8, this concept is not applicable to the device described.
Summary of the Study (as described in the document):
The "study" presented here is a series of in-vitro, non-clinical performance tests conducted to demonstrate that the modified Wingman Crossing Catheter (specifically, a new .018" diameter configuration) is substantially equivalent to its predicate devices.
- Test Set: "Test units representative of finished devices." The exact sample size for each test is not provided.
- Data Provenance: Not specified, but generally, such tests are conducted in a laboratory setting by the manufacturer. Not applicable to clinical retrospective/prospective data.
- Tests Conducted: Simulated Use, Tensile Strength, Torque, Pressure Test, Coating verification, Corrosion Test, Dimensional verification and visual inspections.
- Results: The document states that the device "met all specified criteria" for each of these tests and "did not raise new safety or performance questions."
- Ground Truth: The "ground truth" for these tests are the pre-established engineering specifications and performance criteria that define acceptable functionality and durability for percutaneous catheters. These criteria are not detailed in the document.
Conclusion:
This 510(k) summary provides evidence of substantial equivalence primarily through mechanical and performance testing. It lacks the detailed quantitative acceptance criteria and specific study parameters that would be found in a full test report or clinical study. The device is a physical catheter, not a diagnostic imaging tool or AI software, which explains why many of your detailed questions regarding human readers, AI, or specific types of ground truth (like pathology or expert consensus) are not applicable to the information provided.
§ 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).