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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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The Pepin Manufacturing, Inc. iontophoresis electrodes are intended to be used to introduce soluble salts and other dugs into the body.

Iontophoresis electrodes described in this application are single patient use, disposable, nonsterile devices. Fundamentally the iontophoresis electrodes consist of two skin contacting electrodes: a drug delivery electrode and a return electrode. When connected to the user's iontophoresis electronic device, the electrodes localize administration of ionic drug solutions into the body for medical purposes.

The electrodes provide the patient contact device. The electrodes are used under the supervision of a physician or other medical professional. The iontophoresis electrodes are intended for use only with approved drugs delivered by iontophoresis technology.

There are variations of sizes and shapes of the drug delivery electrode. The size of the return electrode is constant for all drug delivery electrode variations. The iontophoresis electrodes do not include lead wires. The electrode electrical contact is made by a snap on the electrode.

lontophoresis electrodes are used under the direct supervision of a physician or medical professional. The electrodes are placed in contact with the skin to support introduction of soluble salts and other dugs into the body.

The iontophoresis electrodes do not contain active electronics, software or firmware. The electrodes connect to the user's iontophoresis electronic device. The drug delivery electrode is a buffed gel covered carbon electrode. The return electrode is a buffered hydrogel material electrode. Electrode material biocompatibility is addressed in the submission.

This 510(k) summary (K060579) describes an Iontophoresis Drug Delivery System Electrodes by Pepin Manufacturing, Inc. However, it does not contain the specific information required to complete a comprehensive table of acceptance criteria and a detailed study report. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use.

Here's an analysis of what can be extracted and what is missing based on your request:

1. Table of acceptance criteria and the reported device performance

This information is not present in the provided text. The document states: "Verification of performance and labeling are provided in the submission," but the actual acceptance criteria or performance data itself is not included in this 510(K) summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not present in the provided text. No specific studies with test sets, sample sizes, or data provenance are described.

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)

This information is not present in the provided text. As no specific test studies are detailed, there is no mention of experts establishing ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not present in the provided text.

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

This information is not present in the provided text. The device is an iontophoresis electrode, not an AI or imaging device that would typically involve human readers or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not present in the provided text. The device is an electrode and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not present in the provided text.

8. The sample size for the training set

This information is not present in the provided text. This device is not an AI/ML algorithm that would typically have a "training set."

9. How the ground truth for the training set was established

This information is not present in the provided text.

Summary of available information regarding acceptance criteria and study:

The provided document (K060579) for the Pepin Manufacturing, Inc. Iontophoresis Drug Delivery System Electrodes is a 510(k) summary report. The general approach for this type of device (iontophoresis electrodes) to gain FDA clearance is through demonstrating substantial equivalence to already legally marketed predicate devices, rather than through extensive clinical trials with specific acceptance criteria and detailed study reports as might be required for novel or high-risk devices, especially those involving AI/ML.

The key acceptance criteria for this device, as implied by the submission, are:

• Technological Characteristics Equivalence: The electrodes must have equivalent technological characteristics to predicate iontophoresis electrodes, including performance specifications, materials, sizes, packaging, and labeling.
• Biocompatibility: The electrode materials must be biocompatible.
• Intended Use Equivalence: The intended use (introducing soluble salts and other drugs into the body) must be equivalent to predicate devices.
• Safety and Effectiveness: The device should not raise new questions of safety or effectiveness.

Study/Evidence presented in the document:

The "study" or evidence presented in this 510(k) is a comparison to predicate devices rather than a standalone performance study with detailed numerical results against acceptance criteria.

The document states:

• "The iontophoresis electrodes have the equivalent technological characteristics to predicate iontophoresis electrodes, including performance specifications, materials, sizes, packaging and labeling."
• "Verification of performance and labeling are provided in the submission." (However, the details are not in this summary.)
• "The Pepin Manufacturing, Inc. iontophoresis electrodes are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised."

The predicate devices listed are:

• K031053, Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery System Electrodes
• K914264, K925800, K933620, Iomed, Inc. Iontophoresis Drug Delivery Electrodes
• K040495, North American Industrial Manufacturing Company, Naimco, Inc. Iontophoresis Drug Delivery Electrodes

In conclusion, this 510(k) summary demonstrates substantial equivalence by asserting that the device shares the same fundamental principles and characteristics as established predicate devices, and that detailed performance verification was provided in the full submission, but the specific metrics and study details are not publicly available in this summary.

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