(137 days)
The Modified HD Guide Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary or neuro vascular systems. It may also be used as a diagnostic angiographic catheter.
The Modified HD Guide Catheter is a single-lumen, braided stiffness catheter with a radiopague marker on the distal end a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. The radiopague shaft and distal marker facilitate fluoroscopic visualization. Device dimensions and configuration are shown on the product label. A rotating hemostatic valve with side-arm adapter is provided with each catheter.
The provided document K080583 is a Special 510(k) for a device modification, focusing on establishing substantial equivalence to a predicate device rather than a comprehensive study for initial device approval. As such, it does not contain the detailed information typically found in a clinical study report or a detailed stand-alone performance study for a new AI medical device.
Specifically, the document states: "The results of verification and validation conducted on the Modified HD Guide Catheter demonstrate that it performs as designed and is suitable for its intended use." However, it does not provide the specific acceptance criteria, reported performance values, or details of the studies in the format requested.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document. I also cannot fulfill the requests for sample sizes, data provenance, number of experts, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set information since these are not present in the provided text.
This submission is primarily focused on demonstrating that "Any differences in technological characteristics between the Modified HD Guide Catheter and the predicate device do not raise any new issues of safety or effectiveness," which means the testing summarized would likely be engineering or bench performance tests rather than clinical or AI-specific performance evaluations against specific quantifiable metrics for decision support.
§ 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).