(55 days)
The CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
The sheath curve can be visualized when used with compatible CARTO® EP Navigation Systems.
The CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac anatomy.
The steerable sheath is fitted with a hemostatis valve to minimize blood loss during catheter introduction and/or exchange. A sideport
with three-way stopcock is provided for air or blood aspiration, and fluid infusion. A handle equipped with a rotating collar to deflect the
tip clockwise ≥ 180° and counterclockwise ≥ 180°. The steerable sheath features distal vent holes to facilitate aspiration and minimize
cavitation and a radiopaque tip marker to allow fluoroscopic visualization. The steerable sheath is coated with silicone lubricant on the
entire shaft and dilator surface to help minimize friction at the insertion site.
The sheath has electrodes on the outer surface to allow interface with compatible CARTO® 3 EP Navigation Systems.
Based on the provided text, the device in question is a CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath. It is a catheter introducer. The submission is not for a new AI/ML device but rather a modification to the Instructions For Use (IFU) of an existing device to allow for additional imaging guidance and to update labeling based on FDA guidance. Therefore, the detailed questions about AI model acceptance criteria, ground truth, training and test sets, and multi-reader studies are not applicable to this submission.
Here's a breakdown of why this is the case based on the provided document:
- Device Type: This is a physical medical device (catheter introducer), not a software or AI/ML diagnostic tool.
- Purpose of Submission: The 510(k) summary explicitly states: "The sole purpose of this submission is to revise the instructions for use (IFU) to (1) allow for the use of direct imaging guidance, such as fluoroscopy or ultrasound, during catheter manipulation, and (2) to adhere to FDA Guidance 'Intravascular Catheters, Wire, and Delivery Systems with Lubricious Coatings -Labeling Considerations' (October 2019)."
- Technological Comparison: "The CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath is identical in technological characteristics with the predicate device, as there are no changes in the materials, design, or other from those of the CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath cleared under K170997."
- Clinical Study Data (Mentioned): The text mentions: "The safety and performance of the CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath with the additional workflow has been validated through clinical study data." And "The clinical study data demonstrated that the CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath is as safe and effective as the predicate device." However, no details about this "clinical study data" (e.g., sample size, design, endpoints) are provided in the excerpt. This study would not be for an AI model.
Therefore, it is impossible to answer the specific questions about AI/ML acceptance criteria, test sets, ground truth establishment, or MRMC studies because the submission is not for an AI/powered device. The acceptance criteria for this type of submission would relate to demonstrating that the change in IFU does not negatively impact the safety or effectiveness of the physical device, likely through non-clinical (bench) testing and review of existing clinical data, rather than AI model performance metrics.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).