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).

Device Description

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:

Sterile TENS electrodes variation will be commercially available.
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.

AI/ML Overview

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):

Commercial availability of sterile TENS electrodes.
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.

Summary

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K070807

510(k) Summary

MAY 2 3 2007

Company Name:	Pepin Manufacturing, Inc.1875 Highway 61 SouthLake City, MN 55041
Contact:	Jeff Solberg, President
Phone:	651 345-5655
Fax:	651 345-5656
Summary Date:	May 1, 2007
Trade Name:	Cutaneous Electrotherapy and Recording Electrodes; TENS Electrodes
Common Name:	Cutaneous electrode;Accessory TENS Electrode to Transcutaneous electrical nerve stimulator(TENS) for pain relief
Classification Name:	21 CFR 882.1320, Cutaneous Electrodes21 CFR 882.5890 Transcutaneous Electrical Nerve Stimulators for Pain Relief
Predicate Device(s):
	510(k) Number:Manufacture:Trade Name:	K932849Pepin Manufacturing IncorporatedPMI TENS Electrodes
	510(k) Number:Manufacture:Trade Name:	K010431Lead-LokLead-Lok Reusable TENS/NMES Electrodes
	510(k) Number:Manufacture:Trade Name:	K983097Uni-Patch, Inc.TENS/FES/FMES Electrodes
	510(k) Number:Manufacture:Trade Name:	K023347Chattanooga GroupVital Stim Electrodes

Description of Electrodes 1.0

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:

1875 HWY. 61 SOUTH · LAKE CITY, MINNESOTA, U.S.A. 55041 · (651) 345-5655 · FAX (651) 345-5656 િસ્પ www.pepinmfg.com .

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1. Sterile TENS electrodes variation will be commercially available.
1. 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."

2.0 Intended Use of Electrodes

The indication for use of the cutaneous electrotherapy and recording electrodes is consistent with the classification of cutaneous electrodes 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." and predicate cutaneous electrodes. The indication for use is:

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.
Functional electrical stimulation (FES). c)
Galvanic stimulation. d)
Microcurrent electrical nerve stimulation (MENS). e)
Interferential stimulation. f)
g) Neuromuscular electrical stimulation (NMES).

3.0 Technological Characteristics

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4.0 Conclusions

The Pepin Manufacturing, Inc. cutaneous electrotherapy and recording electrodes are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The symbol is positioned to the right of a circular arrangement of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" and is arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Quality & Regulatory Associates, LLC % Mr. Gary Syring Principal Consultant 800 Levanger Lane Stoughton, Wisconsin 53589

MAY 2 3 2007

K070807 Re:

Trade/Device Name: Cutaneous electrotherapy and recording electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrodes Regulatory Class: Class II Product Code: GXY Dated: May 10, 2007 Received: June 9, 2007

Dear Mr. Syring:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Gary Syring, Principal Consultant

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will and will and organismal equivalence of your device of your device to a legally promative newice results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please if you desire specific aarroliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other Convinctional and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson Director Division of General, Restorative Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K070807

Device Name: Cutaneous Electrotherapy and Recording Electrodes

Indications for Use:

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).

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

51	Page 1 of 1

Regulation Number and Section

§ 882.1320 Cutaneous electrode.

(a)
Identification. 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.(b)
Classification. Class II (performance standards).