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NAImco, Inc. Iontophoresis Drug Delivery Electrodes are indicated to introduce ions of soluble salts or other drugs into the body.

The Naimco, Inc. 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 Naimco, Inc. 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/AgCI) 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.

The provided text is a 510(k) summary for Naimco, Inc. Iontophoresis Drug Delivery Electrodes, which is a regulatory submission to the FDA. This type of document is concerned with demonstrating substantial equivalence to predicate devices for market approval rather than presenting a detailed study with specific acceptance criteria and performance metrics for a novel medical device.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as it relates to performance endpoints derived from clinical or technical studies. The document only states that the Naimco electrodes have "technological characteristics equivalent to those of the predicate devices, including comparable performance specifications."

Here's why the requested information cannot be extracted:

• Acceptance Criteria and Device Performance: The document lists predicate devices and claims "comparable performance specifications" but does not define these specifications or provide quantitative data on how the Naimco device performs against them. This type of information would typically be detailed in a separate test report or clinical study summary, not necessarily in the 510(k) summary itself, which focuses on equivalence.
• Study Details (Sample size, data provenance, expert ground truth, adjudication, MRMC, standalone, training set): None of these details are present because the submission hinges on demonstrating equivalence to existing devices rather than presenting a novel study to establish new performance benchmarks. The "study" here is essentially the comparison to predicate devices, and the "proof" is the FDA's determination of substantial equivalence.

In summary, this document is a regulatory filing for an iontophoresis electrode product, focusing on its equivalence to previously approved devices. It does not contain the detailed clinical or technical study data (performance metrics, study design, ground truth establishment, sample sizes, etc.) that would typically be associated with a description of acceptance criteria and the evidence proving a device meets them for a novel or significantly modified device.

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