(159 days)
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Not Found
No
The description focuses on the physical components and function of a standard electrode, with no mention of AI or ML capabilities.
No.
This device is an electrode that provides a conductive interface for transcutaneous electrical stimulation devices; it is not a therapeutic device itself.
No
The device is described as an electrode for use with transcutaneous electrical stimulation devices (TENS/NMES/FES), which are therapeutic, not diagnostic. Its function is to provide an interface for delivering electrical stimulation to the patient's skin, not to diagnose a condition.
No
The device description clearly outlines physical components like a top cover, reinforcement film, conductive member, hydrogel, release liner, and a wire, 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 the electrodes are for use with transcutaneous electrical stimulation devices (TENS/NMES/FES) to provide a conductive interface for stimulating the patient's skin. This is a therapeutic or diagnostic application involving direct interaction with the patient's body, not an in vitro test performed on samples outside the body.
- Device Description: The description details the physical components of an electrode designed for external application to the skin.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Superior Starburst Reusable Self-adhering TENS/NMES/FES Stimulating Electrodes are indicated for use with transcutaneous electrical stimulation devices as non-sterile. Latex free, reusable device for single patient use only. The electrodes provide the conductive interface between the stimulation device and the patient's skin. The starburst gradient pattern provides optimal current distribution.
Product codes (comma separated list FDA assigned to the subject device)
GXY
Device Description
The proposed electrode composes of a top cover, a reinforcement film, a conductive member with printed Silver, conductive hydrogel which contains Aloe Vera and green pigment, a release liner which protects the conductive hydrogel before use and during storage, and a wire secured in between reinforcement film and conductive member. The wire connects the electrode to the transcutaneous electrical stimulation devices. 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
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Input Imaging Modality
Not Found
Anatomical Site
patient's skin
Indicated Patient Age Range
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data for the proposed electrodes are compared to that of the predicate device. Results from biocompatibility study, physical and functional performance evaluation demonstrate that the proposed device is substantially equivalent to the legally marketed device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
Covidien, LP 15 HAMPSHIRE STREET, MANSFIELD, MASSACHUSETTS 02048 • (508) 261-80
510(k) Premarket Notification - Superior Starburst Reusable Self-adhering TENS/NMES/FES Stimulating Electrodes
Section B - 510(K) Summary
Date Summary Was Prepared: Submitter's Information:
November 11th, 2008
Covidien, LP 15 Hampshire Street Mansfield, MA 02048 Phone: 508-261-8000 APR 9 1 2009
Contact:
Wei Zhao Manager, Regulatory Affairs Covidien, LP Telephone: 508-261-8404 Fax: 508-261-8461
Device Trade
Name:
Superior Starburst Reusable Self-adhering TENS/NMES/FES Stimulating Electrodes
Device Common Name:
Cutaneous Electrode
Classification Panel:
Neurology
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
The proposed Covidien Superior Starburst Reusable Self-adhering TENS/NMES/FES Stimulating Electrodes are substantially equivalent to the currently marketed Covidien Reusable Self-adhering TENS/FES/NMES Stimulating Electrodes in intended use, physical characteristics, and performance characteristics. The predicate device is classified as Class II device.
Device Description:
The proposed electrode composes of a top cover, a reinforcement film, a conductive member with printed Silver, conductive hydrogel which contains Aloe Vera and green pigment, a release liner which protects the conductive hydrogel before use and during storage, and a wire secured in between reinforcement film and conductive member. The wire connects the electrode to the transcutaneous electrical stimulation devices. Four finished electrodes are placed into a protective pouch. The pouches are sealed and boxed for shipping.
Intended Use:
The Superior Starburst Reusable Self-adhering TENS/NMES/FES Stimulating Electrodes are indicated for use with transcutaneous electrical stimulation devices as non-sterile. Latex free, reusable device for single patient use only. The electrodes provide the conductive interface
000013
1
510(k) Premarket Notification – Superior Starburst Reusable Self-adhering TENS/NMES/FES Stimulating Electrodes
between the stimulation device and the patient's skin. The starburst gradient pattern provides optimal current distribution.
Performance Data:
Performance data for the proposed electrodes are compared to that of the predicate device. Results from biocompatibility study, physical and functional performance evaluation demonstrate that the proposed device is substantially equivalent to the legally marketed device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an image of an eagle.
Public Health Service
APR 2 1 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Covidien, LP % Ms. Wei Zhao 15 Hampshire Street Mansfield, Massachusetts 02048
Re: K083350
Trade/Device Name: Superior Starburst Reusable Self-adhering Stimulating Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: II Product Code: GXY Dated: April 9, 2009 Received: April 13, 2009
Dear Ms. Zhao:
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.
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2- Ms. Wei Zhao
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
Sincerely yours,
Mark N. Melkerson
Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known):K083350
Device Name:
Superior Starburst Reusable Self-adhering TENS/NMES/FES Stimulating Electrodes
Indication For Use:
The Superior Starburst Reusable Self-adhering TENS/NMES/FES Stimulating The Superior other of for use with transcutaneous electrical stimulation devices as non-sterile, Latex free, reusable device for single patient use only. The electrodes non blomb, and interface between the stimulation device and the patient's skin.
Prescription Use × (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(Please do NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Division Sign Off
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number L083350