Search Results

Peritoneal Dialysis Coil Catheter with Spi-Argent™II, for the transport of dialysate solution to and from the peritoneal cavity for treatment of renal failure; suitable for CAPD (Continuous Ambulatory Peritoneal Dialysis)

Peritoneal Dialysis Coil Catheter with Spi-Argent™II, for the transport of dialysate solution to and from the peritoneal cavity for treatment of renal failure; suitable for CAPD (Continuous Ambulatory Peritoneal Dialysis). Peritoneal Dialysis Coil Catheter with Spi-Argent™ll is the same as the Peritoneal Dialysis Coil Catheter, K850247 except for the Spi-Argent™ II option offering. Spi-Argent™ II is the same surface treatment as the K942709, Mediastinal Drain with Spi-Argent™ II. The Spi-Argent™II surface treatment provides a lubricious surface to ease insertion and removal of the catheter.

The provided text is a 510(k) summary for the Sil-Med Corporation's Peritoneal Dialysis Coil Catheter with Spi-Argent™ II. This document describes the device, its intended use, and its predicate devices for the purpose of demonstrating substantial equivalence to the FDA.

Crucially, this document does NOT contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

510(k) submissions typically focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance studies with acceptance criteria in the same way a PMA (Premarket Approval) submission would. While the sponsor would have conducted internal testing to ensure the device performs as intended, the provided summary does not include the specifics of such testing, acceptance criteria, or performance data.

Therefore, I cannot provide accurate answers to your questions based solely on the provided text. The requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details are not present in this document.

Ask a specific question about this device