(79 days)
No
The device description and intended use clearly define the product as electrodes for electrical stimulation, with no mention of AI or ML capabilities. The performance studies focus on material equivalence to predicate devices, not algorithmic performance.
No
Explanation: The device is an electrode, which is a component used with electrical stimulators (like TENS or EMS devices). The electrical stimulators themselves are therapeutic devices, but the electrodes are accessories that facilitate the function of those therapeutic devices, rather than being therapeutic devices on their own.
No
The device, electrodes, acts as an interface between the patient's skin and an electrical stimulator. Its purpose is to conduct electrical stimulation to the patient, not to gather information or diagnose a condition.
No
The device is described as electrodes, which are physical components intended for electrical stimulation, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the electrodes are for use as a "conductive adhesive interface between the patient's skin and the Electrical Stimulator." This describes a device that facilitates the delivery of electrical stimulation to the body, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The device is described as "Electrodes, Cutaneous," which aligns with devices used for external electrical stimulation, not in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
Therefore, the NAImco, inc. EZ-stik electrodes fall under the category of devices used for electrical stimulation, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The NAImco, inc. EZ-stik electrodes are intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. NAlmco's reusable electrodes are designed and intended to be used with marketed, Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation).
Product codes
GXY
Device Description
Electrodes, Cutaneous
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
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)
Non-clinical Testing: The (critical) components used in NAlmco, Inc. EZ-stik electrodes (Amgel 703 or Amgel 702 and Conductive Plastic Film) are the same as used in the predicate device. Therefore there is no reason to believe that the NAlmco, Inc. EZ-stik electrodes will perform any different than the predicate device.
Clinical Testing: Not Applicable
Conclusions: The NAlmco, Inc. EZ-stik electrodes are substantially equivalent to those of predicate device and any difference between the devices do not pose new questions of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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).
0
MAY 1 8 2005
www.naimco.com
1/2
Plant: 888-549-4945 Fax: 423-648-7735
510(k) Summary
| Submitter's Information: | Robert L. McClure, Jr., FAIC
NAlmco, Inc.
4120 South Creek Road
Chattanooga, TN 37406 |
|--------------------------|------------------------------------------------------------------------------------------------|
| Date of Preparation: | February 21, 2005 |
| Proprietary Name: | EZ-stik Electrodes |
| Common Name: | Neurostimulation Electrodes |
| Classification Name: | Electrodes, Cutaneous |
| Phone: | 888-549-4945 |
|---|---|
| Fax: | 423-648-7735 |
| Predicate Device: | K945676 (Selective Med Components)
K970426 (Axelgaard Manufacturing)
K012463 (Everyway Medical) |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description of Device: | Electrodes, Cutaneous |
| Intended Use: | The NAImco, Inc. EZ-stik electrodes are intended for use as a
disposable, conductive adhesive interface between the
patient's skin and the Electrical Stimulator. NAImco's reusable
electrodes are designed and intended to be used with
marketed, Electrical Stimulators, i.e. TENS (Transcutaneous
Electrical Nerve Stimulation), EMS (Electrical Muscular
Stimulation), IF (Interferential) or PGF (Pulsed Galvanic
Stimulation). |
| Technological Comparison: | The NAImco, Inc. EZ-stik electrodes exhibit technological
characteristics that are substantially equivalent to those of the
predicate device, as determined by both component usage and
physical testing. |
| Labeling Comparison: | The labeling of NAImco, Inc. EZ-stik electrodes is substantially
equivalent to those of predicate device. |
Image /page/0/Picture/6 description: The image shows a logo for North American Industrial manufacturing company. The logo features the letters 'NA' stacked on top of each other, with the letters 'mco' to the right. Above the letters 'NA' is a black circle. The text 'North American Industrial manufacturing company' is written below the letters 'NA'.
4120 South Creek Road
Chattanooga, TN 37406
A
1
| K050469 | |
|---|---|
| Non-clinical Testing: | The (critical) components used in NAlmco, Inc. EZ-stik |
| electrodes (Amgel 703 or Amgel 702 and Conductive Plastic | |
| Film) are the same as used in the predicate device. Therefore | |
| there is no reason to believe that the NAlmco, Inc. EZ-stik | |
| electrodes will perform any different than the predicate device. | |
| Clinical Testing: | Not Applicable |
| Conclusions: | The NAlmco, Inc. EZ-stik electrodes are substantially |
| equivalent to those of predicate device and any difference | |
| between the devices do not pose new questions of safety and | |
| effectiveness. |
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized depiction of an eagle or bird with three curved lines forming its wings and body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 3 2005
Mr. Robert L. McClure Naimco, Inc. 4120 South Creek Road Chattanooga, Tennessee 37406
Re: K050469
Trade/Device Name: EZ-Stik Electrodes Regulation Numbers: 21 CFR 882.1320 Regulation Names: Cutaneous electrode Regulatory Class: II Product Code: GXY Dated: May 2, 2005 Received: May 6, 2005
Dear Mr. McClure:
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 for use stared in the 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, de nees mat have been revat 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 read haly and 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 If your device to such additional controls. Existing major regulations affecting your device can may be subject to basil as a sateral 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 r rouse be actived 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 or uny I 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 OFF in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quint on control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 – Mr. Robert L. McClure
This letter will allow you to begin marketing your device as described in your Section 510(k) This icticle will anow you to organ miling of substantial equivalence of your device to a legally premarket notification: "The Pro 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 adrive 101-your as (240) 276-0120 . Also, please note the regulation entitled, Comace the Office of Companiet notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Stupt Rlurch
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
K0S0469
Device Name:
EZ-Stik Electrodes
Indications For Use:
The NAImco, inc. EZ-stik electrodes are intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. NAlmco's reusable electrodes are designed and intended to be used with marketed, Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation).
Prescription Use
(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 In Vitro Diagnostic Devices (OND)
taty Rlurlu
Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
Page 1 of
510(k) Number: K050464