(90 days)
Not Found
No
The 510(k) summary describes simple reusable neurostimulation electrodes and does not mention any AI or ML capabilities.
No
This device is an accessory to therapeutic devices (Electrical Stimulators like TENS, EMS, etc.), acting as an interface. It is not a therapeutic device itself.
No
The device is described as an interface between the patient's skin and an electrical stimulator (TENS, EMS, etc.), which are used for therapy, not diagnosis. The "intended use" section clearly states its role in delivering electrical stimulation for therapy.
No
The device description clearly states it is "Electrodes, cutaneous," which are physical hardware components. The intended use also describes a physical interface between the patient's skin and an electrical stimulator.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the electrodes are a "conductive adhesive interface between the patient's skin and the Electrical Stimulator." They are used for delivering electrical stimulation to the body for therapeutic purposes (TENS, EMS, etc.).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not involve testing samples from the body.
- Device Description: "Electrodes, cutaneous" further reinforces that it's a device applied to the skin, not a diagnostic test.
The information provided describes a medical device used for therapy, not for diagnosing conditions.
N/A
Intended Use / Indications for Use
Electromed Reusable Neurostimulation Electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Electromed 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) of 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
Federal Law restricts this device to sale by or on the order of a physician.
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)
Bench testing demonstrated that the characteristics or Electromed are substantially equivalent to that of the predicate device.
The Electromed is substantially equivalent in electrical output to the predicate device and any differences between the devices do not pose new questions of safety.
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
'JUN 1 1 2003
KO 30800
11_Appendix_D_510(K)Summary
510(k) Summary
| Submitter's Information: | Lydia Baynes
Electromed
4938 Hampden Lane
#750
Bethesda, MD 20814 | Phone: 1-703-448-9644
FAX: 1-703-356-2182 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Date of preparation: | March 11, 2003 | |
| Proprietary Name: | Electromed Reusable Neurostimulation Electrodes | |
| Common Name: | Neurostimulation Electrodes | |
| Classification Name: | Electrodes, cutaneous | |
| Predicate Device: | K963125 (M & R Manufacturing, Inc.)
K932849 (Pepin Mfg., Inc.) | |
| Description of Device: | Electrodes, cutaneous | |
| Intended Use: | Electromed Reusable Neurostimulation Electrodes are intended for use as the
disposable, conductive adhesive interface between the patient's skin and the
Electrical Stimulator. Electromed 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) of PGF (Pulsed Galvanic Stimulation). | |
| Technological Comparison: | The Electromed has technological characteristics that are substantially
equivalent to those of the predicate device, as determined criteria specified in the
Tripartite Biocompatibility Guidance for Medical Devices. | |
| Labeling Comparison: | The labeling of the Electromed is substantially equivalent to that of the predicate
device. | |
| Nonclinical Testing: | Bench testing demonstrated that the characteristics or Electromed are
substantially equivalent to that of the predicate device. | |
| Clinical Testing: | Not applicable. | |
| Conclusions from Testing: | The Electromed is substantially equivalent in electrical output to the predicate
device and any differences between the devices do not pose new questions of safety. | |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing right, arranged in a cascading manner. These profiles are depicted in black and are positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the profiles.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 1 2003
Ms. Lydia Baynes ElectroMed, Inc. 4938 Hampden Lane #750 Bethesda, MD 20814
Re: K030800
Trade/Device Name: ElectroMed Reusable Neurostimulation Electrodes ™ sizes - 32mm round, 54x34mm, 50x90mm, 40x60mm oval, and 50x100mm oval Regulation Numbers: 21 CFR 882.1320 Regulation Names: Cutaneous electrodes Regulatory Class: Class II Product Codes: GXY Dated: March 11, 2003 Received: March 13, 2003
Dear Ms. Baynes
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
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Page 2 - Ms. Lydia Baynes:
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 contact the Office of Compliance at (301) 594-4659 . 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Millman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use 4
510(k) Number:
Device Name: Electromed Reusable Neurostimulation Electrodes™
030800
Indications for Use:
Electromed Reusable Neurostimulation Electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Electromed 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) of PGF (Pulsed Galvanic Stimulation).
These electrodes will include the precaution statement: Federal Law restricts this device to sale by or on the order of a physician.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE AS NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Mark A. Milburn
Division Sign-Off of Ceneral. Restorative nd Neurological Devices
510(k) Number K030820
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