(58 days)
No
The device description explicitly states that the electrodes "do not contain active electronics, software or firmware" and connect to the user's electronic device. There is no mention of AI or ML in the intended use, device description, or any other section.
Yes
The device is described as an electrode for applying electrical stimulation for therapeutic purposes such as TENS for pain relief and electrical muscle stimulation (EMS), which are forms of therapy. The device description also references its use as "cutaneous electrotherapy electrodes".
No
The device is described as "cutaneous electrotherapy and recording electrodes" used to apply electrical stimulation or record physiological signals, which are typically used for therapy or monitoring, not for diagnosing a condition. Its function is to facilitate the connection between a patient's skin and "electrotherapy (electrical stimulation) and recording devices," but it does not inherently perform diagnostic analysis.
No
The device is explicitly described as electrodes, which are hardware components, and it states that it does not contain software or firmware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- Device Function: The description clearly states the electrodes are used to apply electrical stimulation to the patient's skin or record physiological signals from the patient's skin. This is an external application and recording, not an analysis of a specimen taken from the body.
- Intended Use: The intended uses listed (TENS, EMS, FES, etc.) are all forms of electrotherapy applied to the body's surface.
- Classification: The device is classified under 21 CFR 882.1320, which is for "Cutaneous electrode," a classification for devices applied directly to the skin for stimulation or recording. This classification is not for IVD devices.
Therefore, the device described is a cutaneous electrode used for electrotherapy and recording, which falls under the category of medical devices used externally on the body, not IVD devices.
N/A
Intended Use / 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).
Product codes
GXY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K932849, K010431, K983097, K023347
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo for Pepin Manufacturing Inc. The logo consists of the letters "PMI" in large, bold, black font on the left side of the image. To the right of the letters, the words "PEPIN MANUFACTURING INC." are stacked vertically in a smaller, thinner font.
510(k) Summary
MAY 2 3 2007
| Company Name: | Pepin Manufacturing, Inc.
1875 Highway 61 South
Lake 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 Electrodes
21 CFR 882.5890 Transcutaneous Electrical Nerve Stimulators for Pain Relief | |
| Predicate Device(s): | | |
| | 510(k) Number:
Manufacture:
Trade Name: | K932849
Pepin Manufacturing Incorporated
PMI TENS Electrodes |
| | 510(k) Number:
Manufacture:
Trade Name: | K010431
Lead-Lok
Lead-Lok Reusable TENS/NMES Electrodes |
| | 510(k) Number:
Manufacture:
Trade Name: | K983097
Uni-Patch, Inc.
TENS/FES/FMES Electrodes |
| | 510(k) Number:
Manufacture:
Trade Name: | K023347
Chattanooga Group
Vital 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 .
1
-
- 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.
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
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.
2
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.
3
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
5
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) | |
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| Division of General, Restorative, | |
| and Neurological Devices | |
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