(22 days)
The TriSalus TriGuide Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The TriSalus TriGuide is intended to be used in the peripheral vascular system.
The TriSalus TriGuideTM Guiding Catheter provides a pathway to introduce and facilitate the advancement of devices into the peripheral vascular system. Its principle of operation is therefore to provide a patent pathway for compatible accessories as described within its labeling.
TriSalus TriGuideTM Guiding Catheter is a single-lumen, braided, fixed-length 5F catheter with a soft distal tip and a proximal Luer-Lock hub and strain relief. The TriSalus TriGuide Catheter has a three-layer construction, consisting of a PTFE inner liner, stainless steel braid mid-layer, and an extruded Pebax polymer outer shaft jacket. The Pebax extruded polymer is filled with barium suffate (BaSO4) as a radiopacifier, to provide visibility of the TriSalus TriGuideTM Guiding Catheter under fluoroscopy.
The TriSalus TriGuideTM Guiding Catheter are 65 cm in length in three pre-shaped tip designs including Axis, Sim 1, and Cobra to accommodate access and positioning in a range of peripheral vascular anatomies. The distal tip is rounded for atraumatic vessel tracking.
The provided text is a 510(k) summary for the TriSalus TriGuide™ Guiding Catheter, which is a medical device and not an AI/ML-enabled device. Therefore, the information requested in the prompt, which is typically relevant to the performance and validation of AI/ML software as a medical device, is not applicable to this submission.
Specifically, the document focuses on demonstrating substantial equivalence to a predicate device through comparisons of indications for use, design, dimensions, materials, packaging, labeling, sterilization, and mechanical performance via bench and animal testing. It does not involve any AI/ML components, and thus "acceptance criteria" in this context refers to engineering specifications and performance benchmarks for a physical device, not AI model metrics.
Therefore, I cannot provide the requested information about acceptance criteria for an AI model, sample sizes for test sets (in the context of AI validation), expert qualifications for ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, types of ground truth for AI, or training set details. These concepts do not apply to the TriSalus TriGuide™ Guiding Catheter as described in this FDA submission.
§ 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).