(27 days)
The Oscar Peripheral Multifunctional Catheter system is indicated for percutaneous transluminal interventions in the peripheral vasculature to provide support during access into and to dilate stenoses in femoral, popliteal and infrapopliteal arteries.
The product is also intended for injection of radiopaque contrast media for the purpose of angiography.
The Oscar Peripheral Multifunctional Catheter system is an intravascular balloon catheter system, supplied with a retractable sheath (Oscar Support Catheter), a flexible catheter (Oscar Dilator) and a PTA balloon (Oscar PTA balloon), allowing a variable guide wire support and injection of fluids, and adjustable length inflatable balloon up to 180 mm.
The over the wire (OTW) catheter has a retractable sheath allowing the balloon to be inflated at various lengths as determined by the physician. The balloon lengths are graduated with evenly spaced radiopaque markers.
The Oscar Peripheral Multifunctional Catheter system is a 4F and 6F catheter system with a shaft working length of 60 cm or 120 cm, compatible with 0.014″ (Oscar 4F) and 0.018″ (Oscar 6F) quide wires.
The device uses a semi-compliant balloon with a size dependent rated burst pressure and an indicated clinical use range of 6 atm to 16 atm. The balloon expands to a set nominal diameter (2.0, 2.5, 3.0, 4.0, 5.0, 6.0 and 7.0 mm). If required, separate PTA balloon catheters in same size range are also available separately.
This document, a 510(k) summary for the Oscar Peripheral Multifunctional Catheter System, does not describe an acceptance criteria and study as defined in the request. This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device, rather than a clinical study evaluating diagnostic performance and establishing new acceptance criteria.
Therefore, I cannot provide the requested information. The document focuses on bench testing and mechanical properties rather than clinical performance metrics with human readers or standalone AI 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).