Search Results
Found 1 results
510(k) Data Aggregation
(109 days)
DUPEL II BUFFERED IONTOPHORESIS ELECTRODES
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.
Here's an analysis of the provided text based on your request:
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.
Ask a specific question about this device
Page 1 of 1