(199 days)
No
The description focuses solely on the physical components and function of a stimulating electrode, with no mention of AI or ML capabilities. The submission is for a labeling change to OTC use, not a technological change.
No
The device described is an electrode, which provides the conductive interface between a transcutaneous electrical stimulation device and the patient's skin. It is an accessory to a therapeutic device (the stimulator), but not a therapeutic device itself.
No
The device is an electrode that provides a conductive interface for transcutaneous electrical stimulation devices (TENS/NMES/FES). These therapies are for treatment (stimulation), not diagnosis.
No
The device description clearly outlines multiple physical components (cover, reinforcement film, lead wire, glue, silver print, conductive member, conductive hydrogel, pressure sensitive adhesive, release liner) and describes a physical mechanism of action (current delivery through these components to the skin). This indicates a hardware device, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a conductive interface between a transcutaneous electrical stimulation device and the patient's skin. This is a physical interaction with the body surface, not an analysis of biological samples (like blood, urine, or tissue) which is characteristic of IVDs.
- Device Description: The description details the physical components of an electrode designed for electrical stimulation applied to the skin. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The text does not mention any terms or concepts typically associated with IVDs, such as "in vitro," "diagnostic," "assay," "analyte," "sample," "laboratory," etc.
Therefore, the Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode is a medical device used for electrical stimulation applied to the body surface, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode is intended for over-the-counter use with transcutaneous electrical stimulation devices to provide the conductive interface between the stimulation device and the patient's skin. The starburst gradient pattern is designed to provide optimal current distribution during electrotherapy.
The Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode is indicated for use with transcutaneous electrical stimulation devices to provide the conductive interface between the stimulation device and the patient's skin.
Product codes
GXY
Device Description
The Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode is a transcutaneous electrical nerve stimulation (TENS), neuromuscular electrical stimulation (NMES), functional electrical stimulation (FES) electrode. It is composed of a cover, reinforcement film, lead wire, glue, silver print, conductive member, conductive hydrogel, pressure sensitive adhesive, and a release liner. During electrotherapy, current from the electrical stimulation device is delivered through the lead wire, silver printed conductive member, conductive hydrogel, and to the patient's skin. Four finished electrodes are placed into a protective pouch. The pouches are sealed and boxed for shipping.
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
Over-The-Counter 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
No performance data was required to support this premarket notification as the proposed OTC Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode has identical technological characteristics, including design and materials, as compared to the currently marketed predicate prescription Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode (K083350). This premarket notification supports a change to the product labeling only to allow the product to be sold for over-the-counter (OTC) use.
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
SEP 3 2010
510(K) SUMMARY
1. 510(k) Owner:
Covidien 15 Hampshire Street Mansfield, MA 02048 Telephone: (508) 261 - 6596 (508) 261 - 8461 Fax:
Contact: Mr. Wing Ng Title: Senior Regulatory Specialist Date Prepared: February 12, 2010
2. Device:
Trade Name: Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode Common Name: Electrode Classification Name: Cutaneous Electrode Regulation Number: 21 CFR 882.1320 Product Code: GXY Classification: Class II
3. Predicate Devices:
- Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating . Electrode (K083350)
- TENS Reusable Electrode (K902195) .
4. Device Description:
The Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode is a transcutaneous electrical nerve stimulation (TENS), neuromuscular electrical stimulation (NMES), functional electrical stimulation (FES) electrode. It is composed of a cover, reinforcement film, lead wire, glue, silver print, conductive member, conductive hydrogel, pressure sensitive adhesive, and a release liner. During electrotherapy, current from the electrical stimulation device is delivered through the lead wire, silver printed conductive member, conductive hydrogel, and to the patient's skin. Four finished electrodes are placed into a protective pouch. The pouches are sealed and boxed for shipping.
1
5. Intended Use:
The proposed Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode is intended for over-the-counter use with transcutaneous electrical stimulation devices to provide the conductive interface between the stimulation device and the patient's skin. The starburst gradient pattern is designed to provide optimal current distribution during electrotherapy.
6. Technological Characteristics:
The OTC Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode exhibits identical technological characteristics as compared to the predicate prescription Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode (K083350). The electrode is composed of a cover, reinforcement film, lead wire, glue, silver print, conductive member, conductive hydrogel, pressure sensitive adhesive, and a release liner.
7. Performance Data:
No performance data was required to support this premarket notification as the proposed OTC Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode has identical technological characteristics, including design and materials, as compared to the currently marketed predicate prescription Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode (K083350). This premarket notification supports a change to the product labeling only to allow the product to be sold for over-the-counter (OTC) use.
8. Conclusion:
Based on an evaluation of the labeling for the proposed and predicate devices, Covidien believes that the proposed OTC Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode is suitable for over-the-counter use.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Covidien Medical Supplies c/o Mr. Wing Ng 15 Hampshire St Mansfield, MA 02048
2010 SEP 3
Re: K100418
Trade/Device Name: Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrodes
Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: August 27, 2010 Received: August 30, 2010
Dear Mr. Ng:
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. Iisting 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.
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 (reporting of medical)
3
Page 2 - Mr. Wing Ng
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Kesia Alexander
Image /page/3/Picture/7 description: The image contains a handwritten word, "for", in cursive script. The letter "f" has a descending loop that extends below the baseline, and the "o" and "r" are connected with a smooth, flowing line. The writing appears to be done with a pen or marker, and the strokes are clear and defined.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K100418
Device Name: Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode
Indications For Use:
The Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode is indicated for use with transcutaneous electrical stimulation devices to provide the conductive interface between the stimulation device and the patient's skin.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use × (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aen.
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K100418