(178 days)
M&R Reusable Electrodes are intended for singlepatient/multiple-application use in TENS ("traditional" TENS, NMES ("traditional" NMES , microcurrent TENS, etc.) or interferential, high-volt pulsed galvanic, functional electrical stimulation, etc.).
M&R Reusable Electrodes are laminated, flexible structures composed of materials commonly used in this application (e.g., various cloths, tapes, etc. with biocompatible adhesive, various electrical conductors, and various biocompatible conductive gels). The electrodes are available in models of various sizes with either direct pin lead wire connection or via an integral electrode "prewire" lead wire, and are compatible with all standard, marketed TENS and NMES stimulation devices.
This 510(k) submission (K963123) for the M&R Reusable Electrodes is a premarket notification for a Class II medical device, seeking to demonstrate substantial equivalence to a predicate device (Medi-Source, Inc. GeoHesive Reusable Electrodes K903402). The provided documents do not contain information about a study proving the device meets specific acceptance criteria in the sense of clinical performance or algorithm-driven metrics, as typically seen with AI/ML devices.
Instead, the acceptance criteria are implicit in the demonstration of substantial equivalence to the predicate device. For this type of device (reusable electrodes for TENS/NMES), substantial equivalence is primarily established by comparing device characteristics, materials, intended use, and safety features.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set) are not applicable to the type of submission provided.
Here's a breakdown based on the provided information:
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" here are the characteristics of the predicate device, and the "reported device performance" is how the M&R Reusable Electrodes compare to those characteristics. The submission aims to show that the new device is as safe and effective as the predicate.
| Acceptance Criteria (Predicate Device Characteristics - K903402) | Reported Device Performance (M&R Reusable Electrodes) |
|---|---|
| Number of Models: 3 models | Number of Models: 37 models (device offers more variety) |
| Electrode Sizes (in.)/Shapes: | Electrode Sizes (in.)/Shapes: (Significantly more sizes and shapes offered, including many similar to or encompassing the predicate's sizes. Some M&R models are 2-electrode assemblies.) |
| - 2.000 x 2.000 clover leaf | - 1.250 x 1.250 clover leaf |
| - 2.000 x 3.000 dog bone | - 1.875 x 1.875 clover leaf |
| - 2.000 x 6.000 dog bone | - 2.875 x 1.875 dog bone |
| - 1.875 x 1.875 square | |
| - 2.000 x 1.250 rectangle | |
| - 1.750 x 1.625 rectangle | |
| - 3.875 x 1.875 rectangle | |
| - 3.875 x 2.500 rectangle * | |
| - 6.000 x 3.875 butterfly | |
| - 1.875 dia. round | |
| - 2.750 dia. round | |
| Electrode Construction: | Electrode Construction: (M&R offers a broader range of materials commonly used in similar applications, indicating flexibility in design while maintaining biocompatibility and functionality. Many constructions incorporate common elements like adhesive, conductive film/strip, Ag/AgCl coating, and biocompatible gel.) |
| - Vinyl w/ adhesive | - Polyester w/ adhesive |
| - Lead wire assembly w/ conductive tab | - Polyester/polyester film laminate w/ adhesive |
| - Conductive film w/ Ag/AgCl coating | - Polyethylene foam w/ adhesive |
| - Biocompatible gel | - Tricot/polyester laminate w/ adhesive |
| - Polyester film w/adhesive | |
| (All M&R constructions include conductive rubber strip OR conductive film, and biocompatible gel. Many include Ag/AgCl coating and/or lead wire assembly, similar to predicate.) | |
| Stimulator Compatibility: Common, marketed TENS & NMES devices | Stimulator Compatibility: Common, marketed TENS & NMES devices (Direct equivalence) |
| Lead Wire Connector Types: Standard .080 in. female connection (built-in electrode lead with connector) | Lead Wire Connector Types: |
| - 1. Standard .080 in. female connection (built-in electrode lead with connector) (Direct equivalence) | |
| - 2. Standard .080 in. female connection (hole in conductive rubber strip) (New option, but uses standard connection type) | |
| Labeled as reusable or single-use disposable? Reusable/for single-patient, multiple-application use | Labeled as reusable or single-use disposable? Reusable/for single-patient multiple-application use (Direct equivalence) |
| Indications For Use: TENS and NMES | Indications For Use: TENS and NMES (Direct equivalence, broadens to include "microcurrent TENS, etc." or "interferential, high-volt pulsed galvanic, functional electrical stimulation, etc.", which are generally variations of TENS/NMES) |
| Stated potential adverse reactions: Skin irritation | Stated potential adverse reactions: Skin irritation (Direct equivalence) |
2. Sample size used for the test set and the data provenance
- Not Applicable. This submission does not describe a performance study with a test set of patient data. The "study" is a comparison of product characteristics to a legally marketed predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. There is no "ground truth" established by experts for a test set in this type of submission. Substantial equivalence relies on engineering and material comparisons, and adherence to known safety principles for transcutaneous electrical stimulation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or human adjudication for performance is described.
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. This device is an electrode, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This device is an electrode, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Implicit "Ground Truth": The "ground truth" for this submission is the established safety and effectiveness profile of the predicate device (Medi-Source GeoHesive Reusable Electrodes K903402) and generally accepted scientific principles for transcutaneous electrodes. The M&R Reusable Electrodes demonstrate substantial equivalence by using similar materials, having similar indications for use, and presenting similar safety characteristics.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.
9. How the ground truth for the training set was established
- Not Applicable. No training set as per AI/ML context.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" in this context is the substantive comparison presented in the "Device Comparison Chart" within the 510(k) submission. This chart systematically compares the M&R Reusable Electrodes to the predicate device (Medi-Source GeoHesive Reusable Electrodes K903402) across various critical characteristics:
- Number of Models: The M&R device offers significantly more models (37 vs 3), indicating broader options but not necessarily performance difference.
- Electrode Sizes/Shapes: M&R offers a wider variety of sizes and shapes, which fall within the same functional category as the predicate.
- Electrode Construction: Both devices utilize common materials (polyester, polyethylene foam, tricot, vinyl, conductive films with or without Ag/AgCl coating, biocompatible adhesive, biocompatible gel) that are well-established in the industry for such applications. The M&R device provides a broader range of material combinations but remains within accepted norms.
- Stimulator Compatibility: Both devices are compatible with "Common, marketed TENS & NMES devices," establishing functional equivalence.
- Lead Wire Connector Types: M&R offers the same standard connector type as the predicate and an additional standard type, ensuring compatibility.
- Labeled as reusable or single-use disposable?: Both are labeled as "Reusable/for single-patient, multiple-application use."
- Indications For Use: Both are intended for "TENS and NMES," with M&R specifying a broader range of common stimulation modalities falling under TENS/NMES.
- Stated potential adverse reactions: Both list "Skin irritation," indicating similar safety profiles.
Conclusion from the "Study": The comparison demonstrates that the M&R Reusable Electrodes are substantially equivalent to the predicate device. While they offer more variety in models, sizes, shapes, and construction materials, these differences do not raise new questions of safety or effectiveness. The fundamental technological characteristics, intended use, stimulator compatibility, reusability, and potential adverse reactions are either identical or functionally equivalent to the predicate, thus "proving" they meet the implicit acceptance criteria for safety and effectiveness for a Class II device of this type through the substantial equivalence pathway.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).