(79 days)
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).
Electrodes, Cutaneous
The provided document is a 510(k) summary for the Naimco EZ-stik Electrodes. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study design, and ground truth establishment is not present in this type of submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
Not applicable. The document does not define specific acceptance criteria based on performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it asserts substantial equivalence based on component usage and physical testing.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. No separate "test set" in the context of AI/machine learning or clinical performance evaluation is mentioned. The submission relies on "non-clinical testing" which refers to comparing the components of the proposed device to those of predicate devices.
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):
Not applicable. There is no mention of experts establishing ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No adjudication method is mentioned as there is no test set or expert review process described.
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/machine learning device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. "Ground truth" in the context of device performance is not explicitly discussed. The comparison is based on the characteristics of the device's components and physical testing, with the implicit "ground truth" being the established safety and effectiveness of the predicate devices.
8. The sample size for the training set:
Not applicable. No training set is mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
Not applicable. No training set is mentioned.
Summary of available information from the K050469 510(k) submission:
- Acceptance Criteria/Performance: The device (EZ-stik Electrodes) is deemed to meet acceptance criteria by demonstrating substantial equivalence to legally marketed predicate devices (K945676, K970426, K012463).
- Study Proving Acceptance: The study provided is a non-clinical testing comparison.
- Method: The submission states that the "critical components used in NAImco, Inc. EZ-stik electrodes (Amgel 703 or Amgel 702 and Conductive Plastic Film) are the same as used in the predicate device." Physical testing was also conducted, but no details are provided about the specifics of this testing or its results beyond the general statement of "technological characteristics that are substantially equivalent."
- Conclusion: "Therefore there is no reason to believe that the NAlmco, Inc. EZ-stik electrodes will perform any different than the predicate device."
- Clinical Testing: The document explicitly states "Clinical Testing: Not Applicable."
In essence, this 510(k) submission relies on the established safety and effectiveness of predicate devices and demonstrates that the new device is fundamentally the same in its critical components, thus inferring equivalent performance without requiring a new clinical study.
{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., FAICNAlmco, Inc.4120 South Creek RoadChattanooga, 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 adisposable, conductive adhesive interface between thepatient's skin and the Electrical Stimulator. NAImco's reusableelectrodes are designed and intended to be used withmarketed, Electrical Stimulators, i.e. TENS (TranscutaneousElectrical Nerve Stimulation), EMS (Electrical MuscularStimulation), IF (Interferential) or PGF (Pulsed GalvanicStimulation). |
| Technological Comparison: | The NAImco, Inc. EZ-stik electrodes exhibit technologicalcharacteristics that are substantially equivalent to those of thepredicate device, as determined by both component usage andphysical testing. |
| Labeling Comparison: | The labeling of NAImco, Inc. EZ-stik electrodes is substantiallyequivalent 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-stikelectrodes (Amgel 703 or Amgel 702 and Conductive PlasticFilm) are the same as used in the predicate device. Thereforethere is no reason to believe that the NAlmco, Inc. EZ-stikelectrodes will perform any different than the predicate device. |
| Clinical Testing: | Not Applicable |
| Conclusions: | The NAlmco, Inc. EZ-stik electrodes are substantiallyequivalent to those of predicate device and any differencebetween the devices do not pose new questions of safety andeffectiveness. |
{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
§ 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).