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The Pepin Manufacturing, Inc. cutaneous electrotherapy and recording electrodes are intended to be used to apply electrical stimulation current to the patient's skin or record physiological signals.

Example electrical stimulation current applications of these electrodes are:

a) Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief.
b) Electrical muscle stimulation (EMS); Powered Muscle Stimulators.
c) Functional electrical stimulation (FES).
d) Galvanic stimulation.
e) Microcurrent electrical nerve stimulation (MENS).
f) Interferential stimulation.
g) Neuromuscular electrical stimulation (NMES).

Pepin Manufacturing Incorporated (PMI) has a 510(k) clearance for TENS Electrodes, reference 510(k) K932849. This 510(k) submission addresses two modifications to these electrodes:

1. Sterile TENS electrodes variation will be commercially available.
2. Use of these TENS electrodes as cutaneous electrotherapy electrodes consistent with the cutaneous electrode classification, 21 CFR 882.1320: "A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation."

The electrodes described by this 510(k) submission remain single patient use devices. The electrodes provide the patient contact device when connected to commercially available electrotherapy (electrical stimulation) and recording devices.

The cutaneous electrotherapy and recording electrodes do not contain active electronics, software or firmware. The cutaneous electrotherapy electrodes connect to the user's electronic device. The electrode construction is equivalent to the predicate devices.

This document is a 510(k) summary for a cutaneous electrotherapy and recording electrode, a device that does not perform diagnostic tasks or provide "performance" in the sense of AI/ML algorithms. Therefore, the questions related to acceptance criteria, study design, ground truth, and expert evaluation are not applicable.

The submission is for a medical device that physically contacts the patient's skin to apply electrical stimulation or record physiological signals, such as an EEG. The purpose of this 510(k) is to demonstrate substantial equivalence to existing predicate devices, rather than showcasing specific performance metrics of a novel algorithm.

Here's an breakdown of why many of the requested points are not applicable:

• 1. A table of acceptance criteria and the reported device performance: This device is compared for functional equivalence to predicate devices. There are no performance metrics like sensitivity, specificity, or AUC that would be typically found in an AI/ML or diagnostic device submission. The "performance" is its ability to conduct electricity and adhere to the skin, which is assumed to be equivalent to the predicate devices.
• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set or data of this nature is described, as it's not a data-driven device.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Ground truth as it pertains to diagnostic accuracy is not relevant here.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 is not an AI-assisted diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: Not applicable. There is no training set for an algorithm.
• 9. How the ground truth for the training set was established: Not applicable.

Summary of the K070807 510(k) Submission:

This 510(k) submission (K070807) from Pepin Manufacturing, Inc. is for "Cutaneous Electrotherapy and Recording Electrodes." The purpose of the submission is to obtain clearance for two modifications to their previously cleared TENS electrodes (K932849):

1. Commercial availability of sterile TENS electrodes.
2. Expanded indications to include use as general cutaneous electrotherapy electrodes, consistent with the classification 21 CFR 882.1320, for both applying electrical stimulation and recording physiological signals.

Technological Characteristics & Conclusion:

The device is a passive component; it "do[es] not contain active electronics, software or firmware." Its construction is stated to be "equivalent to the predicate devices."

The regulatory review concluded that the device is substantially equivalent to the predicate devices (K932849, K010431, K983097, K023347). The basis for this equivalence is that the modifications do not raise "new questions of safety or effectiveness."

Predicate Devices:

The submission lists four predicate devices:

• K932849: Pepin Manufacturing Incorporated, PMI TENS Electrodes (This is the company's own prior device that is being modified)
• K010431: Lead-Lok, Lead-Lok Reusable TENS/NMES Electrodes
• K983097: Uni-Patch, Inc., TENS/FES/FMES Electrodes
• K023347: Chattanooga Group, Vital Stim Electrodes

These predicates serve as the benchmark for "acceptance criteria" not in terms of performance metrics, but in terms of safety, fundamental design, and intended use as a cutaneous electrode. The study that "proves" the device meets acceptance criteria is primarily an engineering and materials comparison, alongside a demonstration that the sterility modification and expanded indications do not alter the fundamental safety or effectiveness established by the predicate devices.

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