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The Activatek ActivaPatch ET Intophoresis Patch is intended to be used for the administration of soluble salts into the body for medical purposes and as an alternative to hypodermic injection.

The Activatek ActivaPatch ET Iontophoresis Patch consists of a self-contained, disposable single-use iontophoresis patch, instructions for use, and an alcohol prep pad containing 70% isopropyl alcohol.

The ActivaPatch ET lontophoresis Patch contains an electronic module, an Active Electrode, and a Return Electrode. These elements are incorporated under an adhesive non-woven fabric covering which adheres the device to the skin. The overall dimensions of the ActivaPatch ET are 5.7 inches (length), 3.4 inches (width), and 0.2 inches (thickness).

Principle of Operation: Iontophoresis is a process that uses an electrical field across intact skin to propel charged ions into the skin and underlying tissue. The electrodes (Active and Return) are applied directly to the skin to transit the electric field. If the ion is negatively charged, then the negative electrode is designated the Active Electrode and the positive electrode is the Return Electrode. The total dose of all ions transported through the skin is proportional to the total current passed between the electrodes. Units of iontophoresis dosages are conventionally given in terms of mAmp*min, calculated by multiplying the amount of current by the time of application of the current.

The provided text describes a 510(k) summary for the ActivaPatch ET Iontophoresis Patch. While it outlines the device's specifications and its comparison to predicate devices, it does not contain information regarding a study that proves the device meets specific performance acceptance criteria based on clinical outcomes or a comparative effectiveness study with human readers.

The "Performance Data" section explicitly states: "There are no applicable Guidance Documents specifically associated with this type of medical device." This indicates that the regulatory submission primarily relies on substantial equivalence to predicate devices rather than new performance studies demonstrating achievement of specific metrics.

Therefore, I cannot populate the requested tables and information fields related to acceptance criteria and performance study details from the provided text.

Here's a breakdown of why the information is missing:

• Acceptance Criteria & Reported Device Performance: This device is undergoing a 510(k) pathway, which primarily focuses on demonstrating substantial equivalence to a predicate device, not necessarily meeting a set of pre-defined performance acceptance criteria from new clinical trials. The text only compares its specifications (dosage, voltage) to predicate devices, not clinical performance metrics against specific targets.
• Study Details (Sample Size, Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): The document does not describe any clinical study that was conducted to assess the performance of the ActivaPatch ET Iontophoresis Patch against a set of acceptance criteria. The information provided is primarily about the device's technical specifications and its similarity to existing devices.

In summary, the provided document is a 510(k) submission focused on demonstrating substantial equivalence, not a report of a performance study with defined acceptance criteria and results.

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