(84 days)
Iontophoresis drug delivery systems are 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 Dupel® Buffered Iontophoresis Electrode System consists of an active drug delivery electrode and a passive return electrode. Both electrodes have buffering capability for up to a 160mA min treatment session. These electrodes are designed for single patient, one application use. There are multiple sizes and shapes of drug delivery electrodes to accommodate placement at different body sites. The size of the return electrode is the same for all drug delivery electrode sizes.
The provided text describes non-clinical tests for the "Duple B.L.U.E Small Iontophoresis Electrode" (referred to as "the device" or "small electrode") and a performance evaluation (clinical test) comparing it to a predicate electrode.
Here's an analysis of the acceptance criteria and the study as described:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Parameter | Reported Device Performance |
|---|---|
| Primary Dermal Irritation Index Score (for non-irritant or barely perceptible irritation) | For the small electrode (current submission) and the currently marketed small electrode (predicate), when administered 2% lidocaine hydrochloride and epinephrine 1:100,000, both were rated as a "non-irritant or irritation barely perceptible after the 1st treatment." This implies the device met the criteria of being a non-irritant or minimally irritating. |
| Electrical Resistance | Verified. The results "demonstrate that the product meets requirements." |
| pH Buffering Ability | Verified. The results "demonstrate that the product meets requirements." |
| Fill Rate | Verified. The results "demonstrate that the product meets requirements." |
| Material Biocompatibility | Verified. The results "demonstrate that the product meets requirements." |
| Clinical Performance (irritation, maximum comfortable current, conformance, adherence, and leakage) | Based on preliminary results, the small electrode (current submission) is "similar to the predicate electrode" in terms of irritation, maximum comfortable current, conformance, adherence, and leakage. This indicates it met the criteria of performing comparably to the predicate device in these aspects. |
2. Sample Size Used for the Test Set and Data Provenance
- Non-Clinical Animal Tests: A "standard Primary Dermal Irritation Index scores" was used. The text states "the small electrode and the currently marketed small electrode was rated as a non-irritant or irritation barely perceptible after the 1st treatment". No specific number of animals is provided, but it implies a standardized animal model study. This would be a prospective study. The country of origin is not specified but would likely be the USA, where Empi, Inc. is located.
- Clinical Tests: A "performance evaluation of the new small electrode was conducted." The results are described as "preliminary results." No specific sample size (number of human subjects) is given. This was a prospective clinical study. The country of origin is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Non-Clinical Animal Tests: It states "rated as a non-irritant or irritation barely perceptible". This implies evaluation by trained personnel, likely a veterinarian or toxicologist, interpreting the Primary Dermal Irritation Index scores. No specific number or qualifications are given in the document.
- Clinical Tests: "Preliminary results" were used to assess similarity to the predicate electrode. This assessment likely involved healthcare professionals evaluating the observed irritation, comfortable current, conformance, adherence, and leakage. No specific number or qualifications of these "experts" are provided.
4. Adjudication Method for the Test Set
- The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for either the non-clinical or clinical tests. The evaluation seems to be based on direct observation and measurement against predefined criteria.
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
- No, an MRMC comparative effectiveness study was not done. The device is an iontophoresis electrode, not an AI-assisted diagnostic tool. The "clinical tests" compare the new small electrode to a predicate electrode, not to human readers, and no AI is mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable as this is a medical device (electrode), not an algorithm or AI system. The non-clinical tests evaluate the device's physical and chemical properties in a standalone manner.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Non-Clinical Animal Tests: The "ground truth" was established by standardized evaluation using the Primary Dermal Irritation Index scores. This is a well-established, objective scoring system for dermal irritation.
- Clinical Tests: The "ground truth" for comparison appears to be the performance characteristics of the predicate electrode. The new electrode's performance was compared to this established baseline for irritation, comfortable current, conformance, adherence, and leakage. This comparison doesn't rely on a "ground truth" in the diagnostic sense (like pathology), but rather on directly observed and measured performance characteristics relative to a benchmark.
8. The Sample Size for the Training Set
- Not applicable. The document describes a medical device undergoing pre-market evaluation, not an AI or machine learning model that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for an AI model.
§ 890.5525 Iontophoresis device.
(a)
Iontophoresis device intended for certain specified uses —(1)Identification. An iontophoresis device is a device that is intended to use a direct current to introduce ions of soluble salts or other drugs into the body and induce sweating for use in the diagnosis of cystic fibrosis or for other uses if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug. When used in the diagnosis of cystic fibrosis, the sweat is collected and its composition and weight are determined.(2)
Classification. Class II (performance standards).(b)
Iontophoresis device intended for any other purposes —(1)Identification. An iontophoresis device intended for any other purposes is a prescription device that is intended to use a current to introduce ions of drugs or non-drug solutions into the body for medical purposes other than those specified in paragraph (a) of this section, meaning that the device is not intended for use in diagnosis of cystic fibrosis, or a specific drug is not specified in the labeling of the iontophoresis device.(2)
Classification. Class II (special controls). The device is classified as class II. The special controls for this device are:(i) The following performance testing must be conducted:
(A) Testing using a drug approved for iontophoretic delivery, or a solution if identified in the labeling, to demonstrate safe use of the device as intended;
(B) Testing of the ability of the device to maintain a safe pH level; and
(C) If used in the ear, testing of the device to demonstrate mechanical safety.
(ii) Labeling must include adequate instructions for use, including sufficient information for the health care provider to determine the device characteristics that affect delivery of the drug or solution and to select appropriate drug or solution dosing information for administration by iontophoresis. This includes the following:
(A) A description and/or graphical representation of the electrical output;
(B) A description of the electrode materials and pH buffer;
(C) When intended for general drug delivery, language referring the user to drug labeling approved for iontophoretic delivery to determine if the drug they intend to deliver is specifically approved for use with that type of device and to obtain relevant dosing information; and
(D) A detailed summary of the device-related and procedure-related complications pertinent to use of the device, and appropriate warnings and contraindications, including the following warning:
Warning: Potential systemic adverse effects may result from use of this device. Drugs or solutions delivered with this device have the potential to reach the blood stream and cause systemic effects. Carefully read all labeling of the drug or solution used with this device to understand all potential adverse effects and to ensure appropriate dosing information. If systemic manifestations occur, refer to the drug or solution labeling for appropriate action.(iii) Appropriate analysis/testing must demonstrate electromagnetic compatibility, electrical safety, thermal safety, and mechanical safety.
(iv) Appropriate software verification, validation, and hazard analysis must be performed.
(v) The elements of the device that may contact the patient must be demonstrated to be biocompatible.
(vi) The elements of the device that may contact the patient must be assessed for sterility, for devices labeled as sterile.
(vii) Performance data must support the shelf life of the elements of the device that may be affected by aging by demonstrating continued package integrity and device functionality over the stated shelf life.