(185 days)
The Ceres PTA Catheter is intended for dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal, and profunda arteries and native or synthetic arteriovenous dialysis fistulae.
The Ceres PTA catheter is a single-use, sterile balloon dilation catheter for angioplasty. A double lumen coaxial shaft features an inflatable balloon at its distal end. The proximal end provides a double hub connector, whose first port allows the attachment of an inflatable device which is used to inflate and deflate the balloon through the outer lumen. A second hub port allows the advance of a guidewire throughout the entire length of the catheter using the distally open inner lumen. Platinum radiopaque bands are used to locate the balloon under fluoroscopy.
The provided text describes a 510(k) summary for a medical device called the "Ceres PTA Catheter". This document focuses on establishing substantial equivalence to a predicate device, rather than presenting a study with acceptance criteria and device performance metrics in the way one would for an AI/ML powered device or a device with new performance claims.
Therefore, the requested information, particularly regarding acceptance criteria, reported device performance in a numerical table, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment, cannot be extracted from the provided text.
The document states:
- Non-clinical Performance: "Non-clinical testing was conducted to confirm the safe and effective performance of the Ceres PTA catheter. Non-clinical testing also demonstrated the biocompatibility of the subject device." This indicates that some testing occurred, but specific acceptance criteria or performance metrics are not detailed.
- Substantial Equivalence: "The Ceres PTA catheter is substantially equivalent to the Fox Plus PTA catheter because the indications for use are identical and the function, design and performance specifications are comparable." This is the primary "proof" mentioned, relying on comparison to a cleared predicate device rather than a de novo study with explicit acceptance criteria.
In summary, the provided text does not contain the detailed study information needed to fill out the requested table and answer the specific questions about acceptance criteria, performance, sample sizes, expert ground truth, or study methodologies typically associated with software or diagnostic device evaluations.
§ 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).