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ActhyDerm is indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections.

ActhyDerm is a device that is a microprocessor controlled iontophoresis drug delivery system. The microprocessor bas four pre-set programs for penetration of the 1) epidermis, 2) dermis, 3) adipose, 4) muscle. It has a dispersive electrode and roller electrodes. An FDA approved conductive grounding pad is also required prior to its use. Introducing ions can be accomplished with ActhyDerm's Dispensing Electrode and roller using methods described with operator's manual: roller conducts current to the skin via the product to be delivered. The product has a positive charge, the current coming into the roller has a positive charge and when they meet the current are diffused into the skin are diffused into the skin.

The provided text describes the ActhyDerm iontophoresis device, its intended use, and its substantial equivalence to a predicate device (MesoDerm). However, it does not contain information on specific acceptance criteria for device performance, nor details of a study proving the device meets such criteria.

The document states that "The electrical performance of the ActhyDerm meets the requirements of the following standards: EN 60601-1 (1998), EN 62-24 (1997), 60601-1-2 (1998), ENS5011 (1999), EN 61000-4-2 (1998), EN 61000-4-3 (1997), EN 61000-4 (1998), En61000-4-2 (1998), EN 61000-4-3 (1997), EN 61000-4 (1998), EN550 (1998), EN 61000-4-3 (1997), EN 61000-4 (1998), En61000-4-5." This indicates adherence to electrical safety and electromagnetic compatibility standards, but not performance-based acceptance criteria related to its drug delivery function.

The FDA's decision is based on substantial equivalence to the predicate device, MesoDerm, due to identical intended use, materials, design, and technological characteristics. This means the ActhyDerm is considered as safe and effective as the legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria through a dedicated study.

Therefore, the requested information cannot be fully provided from the given text.

Here's a breakdown of what CANNOT be extracted from the document:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document only lists electrical safety standards that the device meets.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set or clinical study data is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set data requiring expert ground truth is presented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is an iontophoresis drug delivery system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the document serves as a 510(k) summary for a medical device (ActhyDerm) demonstrating substantial equivalence to a predicate device (MesoDerm) based on technical characteristics and intended use, and compliance with electrical safety standards. It does not include performance data from studies against specific acceptance criteria.

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