(28 days)
The Rebar™ Micro Catheter is intended for the delivery of interventional devices or contrast media into the vasculature of the peripheral and neuro anatomy.
The Rebar" Micro Catheter is an endhole, single-lumen catheter designed to be introduced over a steerable guidewire into the vasculature. The proximal end of the catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter has a semi-rigid proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. Single or dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter is coated to increase lubricity.
The provided text does not describe a study involving a device that uses AI or machine learning. Instead, it describes a 510(k) premarket notification for a medical device called the "Rebar™ Micro Catheter." This submission is focused on demonstrating substantial equivalence to an existing predicate device based on material changes (e.g., to the hub material and adhesive) and associated non-clinical bench testing.
Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and a study proving an AI/ML device meets them, as the provided document pertains to a traditional, non-AI medical device clearance.
The document discusses:
- Device: Rebar™ Micro Catheter (a vascular microcatheter)
- Purpose: Delivery of interventional devices or contrast media into the vasculature.
- Regulatory Pathway: 510(k) premarket notification, aiming for substantial equivalence to a previously cleared Rebar™ Micro Catheter (K093750).
- Changes: Primarily changes to the material of the catheter hub (from Polypropylene to Trogamid) and the adhesive used.
- Proof of Equivalence: Non-clinical bench testing and biocompatibility data, rather than clinical trials or AI/ML performance studies.
The acceptance criteria listed are for physical and functional properties of the catheter (e.g., hub integrity, pressurization, tensile strength) and not related to AI/ML performance metrics like accuracy, sensitivity, or specificity. There is no mention of a test set, ground truth acquisition involving experts, MRMC studies, or training sets, as these concepts are not applicable to the type of device and study described.
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).