(88 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 Empi Lead Wire Adapter will allow the use of currently marketed Dupel Electrodes with other commercially available iontophoresis devices.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Dupel Iontophoresis Lead Wire Adapter:
Missing Information Disclosure:
It's important to note that the provided documents are a 510(k) premarket notification summary and an FDA clearance letter. These types of documents typically summarize the rationale for substantial equivalence rather than providing a detailed technical report of a clinical study with granular data on acceptance criteria, reader performance, or ground truth establishment. Therefore, much of the requested information (especially quantitative details about studies, sample sizes, and expert qualifications) is not present in the provided text.
Acceptance Criteria and Device Performance:
The document states: "Qualification was performed to establish suitability of performance between Dupel electrodes and lead wire adapters with other commercially available iontophoresis devices." This indicates that the core acceptance criterion was the "suitability of performance" when the Dupel adapter was used with existing devices.
A table of specific numerical acceptance criteria and reported device performance is not provided in the document, as the focus is on substantial equivalence rather than a detailed performance study against pre-defined quantitative metrics.
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred) |
|---|---|
| Suitability of performance with other commercial iontophoresis devices | Deemed "substantially equivalent" to predicate devices, implying suitable performance |
Study Details (Based on available information):
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document refers to "Qualification" being performed, which is a non-clinical test.
- Data Provenance: The document does not specify a country of origin for any data or whether it was retrospective or prospective. Given it's a non-clinical qualification, it would likely be laboratory-based testing rather than patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not stated. The "qualification" appears to be a technical, non-clinical assessment of device compatibility and electrical performance, rather than a clinical study requiring expert ground truth in the medical sense.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not stated. This is typically relevant for clinical studies with subjective assessments.
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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 MRMC study was done. This device is an iontophoresis lead wire adapter, not an AI-powered diagnostic or assistive technology.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-based device. "Qualification was performed to establish suitability of performance" suggests engineering and compatibility testing rather than algorithm evaluation.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated, but for a "qualification" of a lead wire adapter, the "ground truth" would likely involve objective engineering and electrical parameters (e.g., conductivity, impedance, physical fit, current delivery consistency) verified against technical specifications or predicate device performance. It would not be medical ground truth like pathology or outcomes data.
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The sample size for the training set:
- Not applicable/Not stated. No "training set" is mentioned as this device does not involve machine learning or AI.
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How the ground truth for the training set was established:
- Not applicable. No training set for AI was used.
§ 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.