Search Results

Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery Electrodes are intended to be used to introduce soluble salts and other drugs into the body as an alternative to hypodermic injection.
Selective Med Components, Inc., Buffered Iontophoresis Drug Delivery System Electrodes are indicated to introduce ions of soluble salts or other drugs into the body.

The Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery Electrode System consists of an active drug delivery electrode and a passive return electrode. These electrodes are designed for one use by a single patient for the local administration of ionic drug solutions into the body for medical purposes. There are multiple sizes and shapes of drug delivery electrodes to accommodate placement various sites on the body. The size of the return electrode is the same for all drug delivery electrode sizes. The SMC Buffered Iontophoresis Drug Delivery Electrodes have technological characteristics equivalent to those of the predicate devices, including comparable performance specifications, comparable materials including the same buffering agent (Ag/AgCl) and fiberous polyester reservoir materials on the active drug delivery electrodes and the same buffering, self-adhering polymer on the return electrode, multiple shapes and sizes of active the drug delivery electrodes, and equivalent packaging and labeling.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The document is a 510(k) summary for a medical device (Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery Electrodes), which primarily focuses on demonstrating substantial equivalence to already legally marketed predicate devices. It describes the device, its intended use, and lists predicate devices, but it does not include performance data or studies against specific acceptance criteria.

Therefore, I cannot fulfill your request for that information based on the provided input.

Ask a specific question about this device