Search Results

The TRANSDERM IONTO System is a powered iontophoresis drug delivery system that is indicated for the local administration of ionic drug solutions into the body for medical purposes and can be used as an alternative to injections.

The TRANSDERM IONTO System consists of a probe, power supply/support, and a disposable drug delivery cap clectrode. Flectrical pulses are produced by an electronic pulse generator that is able to generate bursts of pulses that are applied to the skin through electrodes applied to a plastic plate (the applicator). The design of the device provides one channel output. The TRANSDERM IONTO System requires a DC supply of 9 V, 1.0 A max. This power source is supplied by, the TRANS-BASE module which is connected to mains through a removable supply cord and is equipped with a proper connector receptacle to fit the connector malc mounted on TRANSDERM IONTO probe supply cable. The TRANS-BASE is equipped with a 15 w AC-DC switch mode power module. The drug delivery cap electrode is adhered to the patient's skin and then saturated with ionic solution. Once the drug delivery cap electrode is affixed to the patient's skin, the TRANSDERM IONTO probe's applicator head can be attached to the internal side of the drug delivery cap electrode.

This document describes a 510(k) premarket notification for the TRANSDERM IONTO System, an iontophoresis device. It's important to note that 510(k) submissions primarily demonstrate substantial equivalence to a predicate device rather than fulfilling specific, independent performance criteria based on a clinical study where the device's performance would be compared against a 'ground truth' developed by experts. As such, many of the typical acceptance criteria and study details for an AI/ML device (like those related to expert consensus, adjudication, and specific performance metrics like AUC, sensitivity, specificity, and F1 score) are not directly applicable or reported in this type of submission.

Therefore, the following table summarizes the information relevant to a 510(k) for a medical device aiming for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample size for the test set: Not directly applicable or explicitly stated in this 510(k) summary. Performance testing for a device like this would typically involve engineering and bench testing, potentially some in-vivo animal studies, or very limited human testing for specific parameters, but not a large-scale clinical trial with a "test set" in the sense of AI/ML evaluation.
• Data provenance: Not specified. Testing would likely be conducted in a laboratory or clinical setting, but details like country of origin or retrospective/prospective nature of data are not relevant for this type of submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This is not applicable for a 510(k) submission focused on substantial equivalence for an iontophoresis device. Ground truth, in the context of expert consensus, is typically used for diagnostic or screening AI/ML devices where human interpretation is the gold standard. For this device, "ground truth" would relate to objectively measurable physical or electrical parameters.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable. Adjudication methods are used in studies involving human interpretation or subjective assessments, often in diagnostic AI/ML contexts to establish a robust ground truth. This type of device's performance is evaluated by objective engineering and safety standards.

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. An MRMC study is relevant for diagnostic or screening devices where human readers (e.g., radiologists, pathologists) interpret cases with and without AI assistance. The TRANSDERM IONTO System is a drug delivery device, not a diagnostic imaging or screening tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not applicable. The TRANSDERM IONTO System is a physical device that delivers medication, not an algorithm. Its performance is inherent to its physical operation and electrical characteristics, rather than a separate "standalone algorithm."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The concept of "ground truth" as typically defined for AI/ML diagnostic studies is not applicable. Instead, the device's performance is assessed against established engineering standards (e.g., IEC 60601-1) and objective physical and electrical specifications derived from predicate devices or general medical device safety requirements. For instance, parameters like current output, voltage, safety mechanisms, and drug delivery capabilities would be measured against predefined benchmarks.

8. The sample size for the training set

• Not applicable. This device is hardware for drug delivery, not an AI/ML system that requires a "training set."

9. How the ground truth for the training set was established

• Not applicable. As the device is not an AI/ML system, there is no training set or associated ground truth.

Ask a specific question about this device