(88 days)
The Opta5 catheters are intended for balloon dilatation of lesions in peripheral arteries (iliac, renal, popliteal, infra poplited, femoral and ilio femoral) and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
OPTA 5 PTA Catheters are designed for dilating stenoses in peripheral arteries (iliac, renal, popliteal, infra popliteal, femoral, and ilio femoral). OPTA 5 PTA Catheters are similar in design, construction, indications for use, and performance characteristics as compared to commercially available PTA Catheters.
The provided text is a 510(k) premarket notification for the Cordis Corporation OPTA 5 PTA Catheters from 1997. This document focuses on demonstrating substantial equivalence to predicate devices rather than conducting a de novo study to establish new acceptance criteria and prove device performance against them.
Therefore, the information required to populate the table and answer the specific questions about acceptance criteria, study details, expert involvement, and ground truth establishment, is not present in this document.
The document states:
- "Performance standards have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act."
- "OPTA 5 PTA Catheters are substantially equivalent to the predicate devices. OPTA 5 PTA Catheters are similar in design, construction, indications for use, and performance characteristics as compared to commercially available PTA Catheters."
This means the device's acceptance was based on its similarity to previously approved devices, not on meeting new, predefined performance metrics from a specific study outlined here.
Consequently, I cannot provide the requested table and answers based solely on the provided text.
§ 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).