(59 days)
The Wingman Crossing Catheters (14/14C/18/3) are intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices, including facilitation of the intraluminal placement of diagnostic/ interventional devices beyond peripheral stenotic lesions (including chronic total occlusions [CTOs]) and provide a conduit for delivery of saline solutions or diagnostic/therapeutic agents.
The Wingman 14C Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for delivery of saline solutions or diagnostic/therapeutic agents.
The Wingman 14, 18, & 35 Crossing Catheter is contraindicated for use in the coronary and cerebral vasculature. The Wingman 14C Crossing Catheter is contraindicated for use in the cerebral vasculature.
The Wingman Crossing Catheter (14/18/35) is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral vasculature.
The Wingman Crossing Catheter (14C) is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the coronary vasculature and 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 Wingman Crossing Catheters. The summary includes information about the device, its intended use, and a brief discussion of a clinical study conducted to demonstrate the safety and effectiveness of the device for crossing Chronic Total Occlusions (CTOs) in infrainguinal arteries.
Here's a breakdown of the requested information based on the provided text, focusing on the clinical study that proves the device meets the acceptance criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Primary Endpoints) | Device Performance (Reported Results) |
|---|---|
| Effectiveness: Successful CTO crossing (lower 95% confidence limit sufficient) | 89.5% successful CTO crossing (77 out of 86 lesions). Lower 95% confidence limit: 82.5%. |
| Safety: 30-day rate of Major Adverse Events (MAE), perforation, embolization, or dissection (upper 95% confidence limit sufficient) | 4.8% (4 out of 83) 30-day rate of MAE, perforation, embolization, or dissection. Upper 95% confidence limit: 10.7%. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 85 subjects with 86 CTO lesions.
- Data Provenance: The study was "non-randomized, prospective, multi-center, single-arm." It was conducted "both in the United States and outside the United States in Germany and Austria."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The provided text does not specify the number of experts used to establish ground truth or their qualifications. The study focused on objective endpoints (successful CTO crossing, MAE rates) rather than subjective expert consensus on image interpretation.
4. Adjudication Method for the Test Set
The provided text does not specify an adjudication method. Given the objective nature of the primary effectiveness endpoint (successful crossing of the CTO) and the safety endpoint (occurrence of specific adverse events), a formal adjudication method by experts beyond clinical reporting might not have been implemented in the way it would for, say, image review.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
The provided text indicates this was a "non-randomized, prospective, multi-center, single-arm study." It does not describe an MRMC comparative effectiveness study comparing human readers with and without AI assistance. The study evaluated the device's performance in crossing CTOs, not its impact on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a physical medical device (catheter), not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable in this context. The study evaluates the catheter's ability to facilitate CTO crossing.
7. The Type of Ground Truth Used
The ground truth for the effectiveness endpoint was the objective observation of successful CTO crossing during the interventional procedure. For the safety endpoint, the ground truth was the occurrence of specific clinical events (MAE, perforation, embolization, or dissection) within 30 days, likely determined by clinical follow-up and medical records. This falls under outcomes data and clinical observation.
8. The Sample Size for the Training Set
The provided text describes a clinical study evaluating the device's performance. It does not mention a "training set" in the context of machine learning or AI models. This study is an evaluation of the device itself.
9. How the Ground Truth for the Training Set Was Established
As the device is a physical catheter and not an AI algorithm, the concept of a "training set" and its associated ground truth establishment is not applicable. The study evaluates the device's clinical performance.
§ 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).