(18 days)
Not Found
No
The device description and performance studies focus on the physical and electrical properties of the electrodes, with no mention of AI or ML.
Yes
The device functions as an interface for electrical stimulators such as TENS and EMS, which are therapeutic modalities for pain relief and muscle stimulation.
No
The device is described as a conductive adhesive interface for electrical stimulators (TENS, EMS, etc.) and is solely for delivering electrical stimulation, not for detecting, monitoring, or diagnosing medical conditions.
No
The device description clearly outlines a physical, multi-layer electrode with specific material components and construction, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the EZ-STIK Electrodes are for use as a conductive interface between the patient's skin and an electrical stimulator. This is a therapeutic or physical therapy application, not a diagnostic one.
- Device Description: The description details the physical construction of the electrodes and how they function to conduct electrical signals to the skin. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) which is the core function of an IVD.
- Performance Studies: The performance studies focus on biocompatibility and electrical/physical performance of the electrodes in their intended use with electrical stimulators. There are no studies related to the accuracy or reliability of diagnosing a condition based on the device's output.
- Lack of IVD Characteristics: The description does not mention any reagents, assays, or analytical methods typically associated with IVD devices.
In summary, the EZ-STIK Electrodes are designed to deliver electrical stimulation to the body for therapeutic purposes, not to diagnose a disease or condition by examining samples taken from the body.
N/A
Intended Use / Indications for Use
The EZ-STIK Electrodes are intended for use as a disposable, conductive adhesive interface between the patient's skin and the electrical stimulator. The EZ-STIK Electrodes are designed and intended to be used with marketed electrical stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscle Stimulation), IF (Inferential), or PGF (Pulsed Galvanic Stimulation). The electrode is for OTC (Over-the-Counter) or Prescription Use.
Product codes
GXY
Device Description
EZ-STIK Electrodes have a basic 3-layer construction of non-woven polyester material or soft PVC foam, carbon film coated with silver and conductive hydrogel. EZ-STIK Electrodes are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application.
First layer: Insulating backing material- non-woven polyester material or soft PVC foam coated with biocompatible medical adhesive tape
Second layer: Conductive carbon-carbon film or Carbon film/Carbon film coated with silver film
Third layer: Biocompatible self-adhesive conductive hydrogel
The electrodes are designed for single-patient/multiple application use. Because of the biocompatible conductive hydrogel's adhesive nature, no securing materials are required to secure the device to the patient's skin. The electrode is connected to the electrical stimulator by lead wire, with a standard .080" female socket connector. By design, the insulated outer jacket prevents the conductive connection to earth or hazardous voltages. Wire assembly complies with FDA performance standard 21 CFR Part 898.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals and lay persons (for OTC use)
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
The biocompatibility evaluation for the EZ-STIK Electrodes was conducted in accordance with International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests: Cytotoxicity, Sensitization, and Irritation. The EZ-STIK Electrode is considered direct tissue contacting for a duration of less than 24 hours.
To verify the safety and performance of the EZ-STIK Electrode, the subject device was tested in the same method as the previously cleared EZ-STIK Electrode (K050469), including electrical performance test, pull and peel test, and shelf-life test.
No clinical data were necessary for this submission.
For all electrical and physical performance tests conducted, the subject device results were shown to be within the acceptance range generated from direct testing of predicate device. The test results and information contained in this submission demonstrate that any differences in technological characteristics do not raise any new questions of safety or effectiveness. Thus, the subject EZ-STIK Electrodes are substantially equivalent to the predicate EZ-STIK Electrodes.
Key Metrics
Not Found
Predicate Device(s)
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in a blue box. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 3, 2023
South Dakota Partners % Dave Yungvirt Official Correspondent Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K223775
Trade/Device Name: EZ-STIK Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: December 14, 2022 Received: December 16, 2022
Dear Dave Yungvirt:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Heather L. Dean -S
Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223775
Device Name EZ-STIK Electrodes
Indications for Use (Describe)
The EZ-STIK Electrodes are intended for use as a disposable, conductive adhesive interface between the patient's skin and the electrical stimulator. The EZ-STIK Electrodes are designed and intended to be used with marketed electrical stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscle Stimulation), IF (Inferential), or PGF (Pulsed Galvanic Stimulation). The electrode is for OTC (Over-the-Counter) or Prescription Use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| [X] Prescription Use (Part 21 CFR 801 Subpart D) | |
| 区 Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image is a logo for South Dakota Partners, a Salona Global Medical Device Company. The words "South Dakota" and "Partners" are in a bold, blue font. Below the words is the phrase "A Salona Global Medical Device Company" in a smaller, green font. To the right of the text is a graphic of a sun with green leaves.
205 Hwy 22 E Clear Lake, SD 57226 www.sdpartnersinc.com T: (800) 626-3098
510(k) Summary
21 CFR 807.92(a)(1)
| Applicant Name | South Dakota Partners | |
|---|---|---|
| Applicant Address | 205 Hwy 22 E | |
| Clear Lake, SD 57226 | ||
| United States | ||
| Applicant Contact | Mike Plunkett | |
| Applicant Contact Email | Mike.plunkett@sdpartnersinc.com | |
| Correspondent Name | Simbex | |
| Correspondent Address | 10 Water St Suite 410 | |
| Lebanon, NH 03766 | ||
| United States | ||
| Correspondent Contact Telephone | 504-432-8171 | |
| Correspondent Contact | Amaris Ajamil, PhD, RAC | |
| Correspondent Contact Email | aajamil@simbex.com |
Device Name
Contact Details
Device Trade Name Common Name Classification Name Regulation Number Product Code
EZ-STIK Electrodes EZ-STIK Electrodes Electrode, Cutaneous 21 CR 882.1320 GXY
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
|---|---|---|
| Predicate # | Predicate Trade Name | Product Code |
| K050469 | EZ-STIK Electrodes | GXY |
| K160138 | Adhesive Electrodes | GXY |
Device Description Summary
21 CFR 807.92(a)(4)
EZ-STIK Electrodes have a basic 3-layer construction of non-woven polyester material or soft PVC foam, carbon film coated with silver and conductive hydrogel. EZ-STIK Electrodes are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application.
First layer: Insulating backing material- non-woven polyester material or soft PVC foam coated with biocompatible medical adhesive tape
Second layer: Conductive carbon-carbon film or Carbon film/Carbon film coated with silver film
Third layer: Biocompatible self-adhesive conductive hydrogel
The electrodes are designed for single-patient/multiple application use. Because of the biocompatible conductive hydrogel's adhesive nature, no securing materials are required to secure the device to the
21 CFR 807.92(a)(2)
4
205 Hwv 22 E Clear Lake, SD 57226 www.sdpartnersinc.com T: (800) 626-3098
patient's skin. The electrode is connected to the electrical stimulator by lead wire, with a standard .080" female socket connector. By design, the insulated outer jacket prevents the conductive connection to earth or hazardous voltages. Wire assembly complies with FDA performance standard 21 CFR Part 898.
Intended Use/Indications For Use
The EZ-STIK Electrodes are intended for use as a disposable, conductive adhesive interface between the patient's skin and the electrical stimulator. The EZ-STIK Electrodes are designed and intended to be used with marketed electrical stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscle Stimulation), IF (Inferential), or PGF (Pulsed Galvanic Stimulation). The electrode is for OTC (Over-the-Counter) or Prescription Use.
Indications For Use Comparison
The subject and the predicate devices (K050469 and K160138) have the same intended use. The subject and predicate devices are cutaneous electrodes intended for use as a disposable, reusable, conductive adhesive interface between the patient's skin and the electrical stimulator. The subject and predicate devices are intended to be single patient reusable. The subject EZ-STIK electrode and predicate Adhesive Electrode (K160138) are indicated as OTC and prescription devices intended for use by healthcare professionals and lay persons, whereas the predicate EZ-STIK Electrode is indicated for prescription use only. As such, the subject EZ-STIK Electrode is substantially equivalent to the predicate device Adhesive Electrode with respect to intended use and indications for use.
Technological Comparison
At a high level, the subject and predicate devices (K050469 and K160138) are based on the same technological elements:
-
Use of three layers (insulating material, conductive carbon film with or without silver layer, biocompatible adhesive hydrogel)
-
Use of Leadwire for electrical connections
-
Provided non-sterile
-
Greater than 6lbf pull strength
The following technological differences exist between the subject and predicate devices:
- Use of different hydrogel material
Non-Clinical and/or Clinical Tests Summary & Conclusions
The following performance data were provided in support of the substantial equivalence determination.
The biocompatibility evaluation for the EZ-STIK Electrodes was conducted in accordance with International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:
Cytotoxicity, Sensitization, and Irritation. The EZ-STIK Electrode is considered direct tissue contacting for a duration of less than 24 hours.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
Use
tended for use as a disposable, reu
ne electrical stimulator. The EZ-S
Clear La
T: (8
21 CFR 807.92(b)
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Image /page/5/Picture/0 description: The image is a logo for South Dakota Partners, a Salona Global Medical Device Company. The words "South Dakota" and "Partners" are in a bold, blue font. Below the words is the phrase "A Salona Global Medical Device Company" in a smaller font. To the right of the words is a graphic of a sun with green leaves.
To verify the safety and performance of the EZ-STIK Electrode, the subject device was tested in the same method as the previously cleared EZ-STIK Electrode (K050469), including electrical performance test, pull and peel test, and shelf-life test.
No clinical data were necessary for this submission.
For all electrical and physical performance tests conducted, the subject device results were shown to be within the acceptance range generated from direct testing of predicate device. The test results and information contained in this submission demonstrate that any differences in technological characteristics do not raise any new questions of safety or effectiveness. Thus, the subject EZ-STIK Electrodes are substantially equivalent to the predicate EZ-STIK Electrodes.