(91 days)
The guiding catheter is intended for use for intravascular introduction of interventional / diagnostic devices into the coronary or peripheral vascular systems.
The VasCon Polaris™ Guiding Catheters are single lumen catheters, incorporating a nylon body reinforced with a stainless steel wire braid, a PTFE lubricious inner lumen, and a soft radiopaque tip to reduce potential vessel injury. They are available in 5Fr, 6Fr, 7Fr, and 8Fr, 100 cm in length, and in a variety of shapes. The technological characteristics are equivalent to the predicate device.
The provided 510(k) summary for the VasCon Polaris™ Guiding Catheter does not include information about specific acceptance criteria or an associated study conducted to prove the device meets these criteria in the context of AI/ML performance.
Instead, this submission is for a traditional medical device (a guiding catheter) and focuses on demonstrating substantial equivalence to a predicate device. The acceptance criteria and testing summary refer to engineering and biocompatibility tests, not studies related to AI/ML performance.
Therefore, I cannot populate the table or answer the subsequent questions related to AI/ML acceptance criteria and studies based on the provided text. The document clearly states:
- "Laboratory testing has been performed on the VasCon Polaris™ Guiding Catheters to assure compliance to the specifications."
- "In addition, laboratory testing has been performed on the materials to assure biocompatibility."
- "The technological characteristics are equivalent to the predicate device."
This indicates a focus on physical, mechanical, and biological properties, and substantial equivalence to a pre-existing non-AI 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).