(109 days)
The Dupel® II Buffered Iontophoresis Electrodes are designed for use with the Dupel Iontophoresis System (K903093) which is indicated for the local administration of ionic solutions into the body for medical purposes and can be used as an alternative to injections.
The Dupel® II 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 160mAmin 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.
This document describes the safety and effectiveness information for the Dupel® II Buffered Iontophoresis Electrode System.
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1. Table of Acceptance Criteria and Reported Device Performance
The document states that the modified Dupel® II electrode was compared to the predicate Empi Buffered Iontophoresis Electrode (K912015). The performance was assessed against product specifications.
| Acceptance Criterion (Specification) | Reported Device Performance (Dupel® II) |
|---|---|
| pH Buffering Ability | Remains the same as predicate |
| Fill Rate | Remains the same as predicate |
| Active Area | Essentially the same as predicate |
| Material Biocompatibility | Same level as predicate |
| Electrical Resistance | Lowered specification compared to predicate |
| Fill Volume | Increased slightly compared to predicate |
Note: The document explicitly states, "The results of the functional testing were analyzed against product specifications and demonstrate that the product meets requirements, is acceptable for its intended use and is equivalent to the predicate electrodes."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document refers to "functional testing" and "design qualification tests" but does not provide specific numbers for units tested.
- Data Provenance: The study was conducted as part of the 510(k) submission by Empi, Inc., based in St. Paul, Minnesota, USA. It is a retrospective analysis comparing a modified device to a previously cleared predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This is not a study involving human interpretation of medical images or data where expert ground truth is typically established. The testing focused on technical performance parameters of an electrode.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring adjudication of expert opinions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study is typically used for diagnostic or screening devices where human readers interpret medical data. This study is an engineering and functional performance assessment of an electrode.
6. Standalone (Algorithm Only) Performance Study
No. This device is an electrode, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.
7. Type of Ground Truth Used
The ground truth or reference standard for this study was product specifications and the performance of the predicate device. The modified device was evaluated against these established benchmarks for equivalence.
8. Sample Size for the Training Set
Not applicable. This is a medical device performance study, not an AI/Machine Learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device study.
§ 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.