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The Dynatron® Ion™ iontophoresis electrode is designed for clinical use to introduce soluble salts and other drugs into the body as an alternative to hypodermic injection.
The Dynatron® Ion™ iontophoresis electrode is indicated to introduce soluble salts and other drugs into the body as an alternative to hypodermic injection

The Dynatron® Ion™ iontophoresis electrode consists of an active drug delivery electrode and a return electrode. Electrodes are designed for single patient use.

This 510(k) submission does not contain a study to prove acceptance criteria were met. Instead, it relies on substantial equivalence to a predicate device.

Here's why and what information is available based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

There is no table of acceptance criteria or reported device performance for the Dynatron® Ion™ iontophoresis electrode in this document. The submission asserts "substantial equivalence" to a predicate device rather than presenting performance data against defined criteria.

2. Sample Size Used for the Test Set and Data Provenance:

No test set was used for this device as detailed in the submission. The submission relies on substantial equivalence.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. No test set was used for performance evaluation against ground truth.

4. Adjudication Method for the Test Set:

Not applicable. No test set requiring expert adjudication was conducted.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was conducted. The submission does not compare the new device's performance to human readers with or without AI assistance.

6. Standalone Performance Study:

No standalone (algorithm only without human-in-the-loop performance) study was conducted for the Dynatron® Ion™ iontophoresis electrode.

7. Type of Ground Truth Used:

Not applicable. No ground truth was established for a testing phase of this device, as its approval is based on substantial equivalence.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML device and therefore does not have a "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As above, this is not an AI/ML device and does not involve a training set with established ground truth.

Summary of the Submission's Approach:

The submission for the Dynatron® Ion™ iontophoresis electrode is a 510(k) premarket notification which seeks to demonstrate that the new device is substantially equivalent to a legally marketed predicate device (the North Coast Buffered Iontophoresis Electrode, cleared under K052019).

The core argument for safety and effectiveness is that:

• "The Dynatron® Ion™ iontophoresis electrode shares the same or similar basic characteristics, features and intended use as the predicate device"
• "There are no substantive differences between the product defined in this 510(k) submission and the predicate device."
• "They are similar to the technologies that are currently used in other similar medical devices."
• "The product is safe and effective when used as indicated in specific applications under a clinician's supervision/therapy program."

Therefore, no new studies or performance data are presented to establish acceptance criteria or demonstrate the device's performance against such criteria. The device's safety and effectiveness are inferred from its similarity to an already cleared device.

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