(108 days)
The Wingman 18 Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral and/or coronary 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 agents.
The Wingman 18 Crossing Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral and coronary 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.
This document is a 510(k) Premarket Notification from the FDA regarding the "Wingman 18 Crossing Catheter." It focuses on demonstrating substantial equivalence to predicate devices, not on proving new clinical effectiveness or safety in a comprehensive standalone study like an AI algorithm would require.
Therefore, many of the requested elements for describing the acceptance criteria and the study that proves the device meets them (especially those pertaining to AI algorithms, clinical trials with human readers, and detailed ground truth establishment) are not applicable to this type of medical device submission.
Here's an attempt to answer the questions based on the provided document, highlighting where information is not available or not relevant to a 510(k) for a physical medical device like a catheter:
Acceptance Criteria and Device Performance for Wingman 18 Crossing Catheter (K160848)
As this is a 510(k) submission for a physical medical device (catheter) and not an AI algorithm, the "acceptance criteria" discussed are primarily related to demonstrating substantial equivalence to legally marketed predicate devices through engineering and performance testing, rather than complex clinical outcomes or AI performance metrics.
1. A table of acceptance criteria and the reported device performance
The document states:
"The Wingman 18 Crossing Catheter met all specified criteria and did not raise new safety or performance questions."
"Based on the performance testing the Wingman 18 Crossing Catheter was found to be equivalent to the predicate device."
"The design testing performed for the Wingman 18 Crossing Catheter demonstrated that the performance of the device is equal to the legally marketed predicate devices."
However, the specific quantitative acceptance criteria and detailed reported performance metrics are not provided in this summary document. Typically, these would be detailed in the full submission, but only the types of performance data are listed.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Material/Component Safety | Met all specified criteria. Did not raise new safety questions. |
| Functional Performance (e.g., crossing, guidewire support, patency) | Met all specified criteria. Performance found to be equivalent/equal to predicate devices. |
| Biocompatibility (Implied by standard medical device requirements) | Met all specified criteria. |
| Sterility (Implied by standard medical device requirements) | Met all specified criteria. |
| Particulate Characterization | Met all specified criteria. |
| Simulated Use | Met all specified criteria. |
| Predicate Device Comparison Evaluation | Performance found to be equivalent/equal to predicate devices. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes for the "Particulate Characterization," "Simulated Use," or "Predicate Device Comparison Evaluation."
Regarding data provenance: These are likely laboratory/engineering tests performed by the manufacturer, Reflow Medical, Inc., in the United States, as the company is based in San Clemente, California. The studies are prospective in the sense that they are conducted specifically to support this regulatory submission, testing the device under controlled conditions. This is not clinical data provenance in the sense of patient cohorts.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not applicable to this type of device submission. "Ground truth" established by experts (e.g., radiologists, pathologists) is relevant for diagnostic devices or AI algorithms that interpret medical images/data. For a physical device like a catheter, performance is evaluated through engineering bench testing and simulated use, not through expert interpretation of clinical "truths."
4. Adjudication method for the test set
This concept is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical trials, especially for medical imaging or AI studies, where human expert disagreement on interpretation needs a defined resolution process. For physical device performance testing, predefined engineering specifications and measurement techniques are used.
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, an MRMC comparative effectiveness study was not conducted and is not applicable for this device. This type of study is specifically designed for diagnostic aids, particularly AI algorithms, to measure their impact on human reader performance. The Wingman 18 Crossing Catheter is a physical interventional tool, not a diagnostic aid or AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done and is not applicable. This device is a physical catheter, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance relies on pre-defined engineering specifications, material properties, and functional benchmarks established through testing and comparison with predicate devices. This involves:
- Engineering specifications: Meeting dimensions, material strength, radiopacity, and other design parameters.
- Performance metrics: Demonstrating successful navigation, guidewire support, fluid delivery capability, and resistance to kinking or damage during simulated use.
- Predicate device equivalence: Showing that its performance is comparable to an established, legally marketed device for the same intended use.
It is not based on expert consensus, pathology, or clinical outcomes data in the way an AI diagnostic device would be.
8. The sample size for the training set
This concept is not applicable. "Training set" refers to data used to train machine learning models. This device is a physical product, not an AI, so there is no training set.
9. How the ground truth for the training set was established
This concept is not applicable as there is no training set for this physical device.
§ 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).