(15 days)
Not Found
No
The device description focuses on the physical components and materials of the electrodes, and there is no mention of AI, ML, or any software-based signal processing that would typically involve these technologies. The intended use is for signal acquisition, not analysis or interpretation using AI/ML.
No.
The device is described as electrodes intended for non-invasive use with recording and monitoring equipment for Electromyography (EMG), Electroencephalograph (EEG), and Evoked Potentials, which are diagnostic/monitoring functions rather than therapeutic.
Yes
The device is intended for use with recording and monitoring equipment of Electromyography (EMG), Electroencephalograph (EEG), and Evoked Potentials, which are diagnostic tests used to assess neurological function.
No
The device description clearly details physical components such as discs made of various materials, lead wires, heat shrink tubes, and connectors, indicating it is a hardware device, not software-only.
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 "non-invasive use with recording and monitoring equipment" for physiological signals (EMG, EEG, Evoked Potentials). This involves measuring electrical activity from the body's surface.
- Device Description: The description reinforces this by describing the physical components of the electrodes designed for cutaneous application to acquire these signals.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a physiological state, health, disease, or congenital abnormality. This device does not interact with or analyze such specimens.
The device is a medical device used for physiological monitoring, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Rhythmlink Disc Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials.
Product codes (comma separated list FDA assigned to the subject device)
GXY
Device Description
Rhythmlink Disc Electrodes are non-invasive, Cutaneous devices are used in the acquisition of signals for the purpose of monitoring and recording Electroencephalograph (EEG), Electroencephalography (EEG), and Evoked Potentials (EP). Rhythmlink Disc electrodes have a disc manufactured with a variety of materials which include; silver, Ag/AgCL, ABS Molded Gold Plated and Gold. See appendix "C" for part numbers and descriptions. The disc is permanently adhered to a lead wire. The joint is then covered by a heat shrink tube or is molded into the disc so as not allow exposed lead wires and provide a strain relief. The lead wires are covered using polyurethane (PU), polyvinylchloride (PVC), Silicone or Teflon cover. The lead wires terminate using a molded touch proof connector that conforms to DIN 42-802 for electrical safety.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
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).
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11. 510(k) Summary
| Company Name: | Rhythmlink International, LLC
1256 First Street South Extension
Columbia, SC 29209
Phone: (803) 252-1222
Owner Operator #: 9052354
Establishment Registration #: 1067162 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact Person: | James M. Mewborne |
| | Engineering & Regulatory Manager |
| Summary Date: | May 12, 2005 |
| Device Identification: | Proprietary Device Name:
Rhythmlink Disc Electrodes |
| | Generic Device Name:
Cutaneous Electrodes |
| | Regulatory Class: Class II |
| | Classification Name: Cutaneous Electrodes |
| | Panel: 882 Neurological Devices, 882.1320
Cutaneous Electrodes |
| | Product Code: GXY |
| | This device has not been previously submitted to the FDA. |
| Predicate Device(s): | Neurolink TM 510(k) Number: K942921
Neuro Supplies 510(k) Number: K991772 |
Device Description:
Rhythmlink Disc Electrodes are non-invasive, Cutaneous devices are used in the acquisition of signals for the purpose of monitoring and recording Electroencephalograph (EEG), Electroencephalography (EEG), and Evoked Potentials (EP). Rhythmlink Disc electrodes have a disc manufactured with a variety of materials which include; silver, Ag/AgCL, ABS Molded Gold Plated and Gold. See appendix "C" for part numbers and descriptions. The disc is permanently adhered to a lead wire. The joint is then covered by a heat shrink tube or is molded into the disc so as not allow exposed lead wires and provide a strain relief. The lead wires are covered using polyurethane (PU), polyvinylchloride (PVC), Silicone or Teflon cover. The lead wires
1
terminate using a molded touch proof connector that conforms to DIN 42-802 for electrical safety.
Intended Use:
The Rhythmlink Disc Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials.
This concludes the 510(k) summary.
Revised: 8/15/2005
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 10 2006
Rhythmlink International, LLC c/o Mr. James M. Mewborne 1256 First Street South Extension Columbia, South Carolina 29209
Re: K061148
Trade/Device Name: Rhythmlink Disc Electrodes Regulation Name: Cutaneous Electrodes Regulatory Class: II Product Code: GXY Dated: April 24, 2006 Received: April 25, 2006
Dear Mr. Mewborne:
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 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
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Page 2- Mr. Mark W. Sheehan
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 (240) 276-0120. 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.gov/cdrh/industry/support/index.html.
Sincerely yours,
Hulst Lemmer no
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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8. Indications for Use
510(k) Number (if known):
Rhythmlink Disc Electrodes Device Name:
:
Indications for Use: The Rhythmlink Disc Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials.
AND/OR Prescription Use x (Part 21 CFR 801 Subpart D)
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 Device Evaluation (ODE)
Hubert Lemmons
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K061148
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Revised &/19/2005