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Iontophoretic drug delivery devices are indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections. They are also indicated for iontophoretic dermal administration of IONTOCAINE® (Lidocaine HCl 2% and Epinephrine 1:100,000 Topical Solution).

An iontophoresis device is a device that is intended to use electrical current to introduce ions of water-soluble salts or drugs into the body for medical purposes. Iontophoresis technology is based on the principle that an electric potential will cause ions in solution to migrate according to their electrical charges. The quantity and distribution of a drug delivered into and across the skin by iontophoresis is dependent on the charge and molecular weight of the ion, the magnitude of the electrical current applied, patch composition, duration of current flow, and numerous other factors.

The IOMED, Inc. Champion integrated transdermal patch incorporates both a drug electrode and a return electrode. The patch is designed for a single-patient, oneapplication use and can only be used with IOMED's Champion dose controller. The Champion dose controller provides control of the current and therefore dosage delivered.

The Champion dose controller is a small, battery-powered, microprocessor-controlled iontophoretic device which delivers direct current (DC) to the integrated transdermal patch which is placed on intact skin.

The provided document, K063465, is a 510(k) premarket notification for the "Champion Iontophoresis Drug Delivery System." This submission focuses on establishing substantial equivalence to predicate devices and demonstrating general safety and effectiveness through in vitro drug delivery and biocompatibility testing. It is not a study describing acceptance criteria and device performance in the context of a typical algorithm or diagnostic device evaluation.

Therefore, many of the requested elements are not applicable or cannot be extracted from this document, as they pertain to clinical trials, algorithm performance metrics, or expert adjudication which are not relevant to the approval of this physical drug delivery device.

However, I can extract information related to the in vitro testing and safety assessments that were presented as part of the submission to demonstrate the device's functionality and safety.

Here's a breakdown of the available and unavailable information based on your request:

1. A table of acceptance criteria and the reported device performance

Note: The document does not explicitly state quantitative "acceptance criteria" in the format typically seen for algorithm performance (e.g., sensitivity, specificity thresholds). Instead, it describes tests performed and their outcomes which serve to demonstrate the device's functionality and safety in comparison to predicate devices and established standards.

Specifics: In vitro testing used dexamethasone sodium phosphate (negative) and lidocaine hydrochloride (positive) as model drugs. Quantified by radioassay (3H-dexamethasone and 14C-lidocaine) in skin and receptor solution. |
| Biocompatibility/Irritation: Materials used in the patch should be biocompatible and cause acceptable levels of dermal irritation, consistent with predicate devices and safety standards. (Implicit, based on predicate device history and industry standards for medical devices). The predicate device (RH-801/GS) showed acceptable irritation levels. | Acceptable Biocompatibility/Irritation: "The materials used in the Champion integrated transdermal patch are identical to those used in the RH-801/GS and the RH-950."

Predicate Device Performance (RH-801/GS):

• Rated as a mild irritant (0.5) during lidocaine administration (

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