(15 days)
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.
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.
I am sorry, but the provided text from the K061148 submission only describes the device (Rhythmlink Disc Electrodes), its intended use, and the FDA's clearance letter. It does not contain any information about acceptance criteria or a study proving the device meets those criteria.
This type of submission (510(k)) primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy or meet specific performance metrics. The FDA's decision is based on comparing the new device to existing ones, often relying on engineering and performance standards rather than clinical study data.
Therefore, I cannot fulfill your request for the tables and details about a study, as that information is not present in the provided document.
{0}------------------------------------------------
11. 510(k) Summary
| Company Name: | Rhythmlink International, LLC1256 First Street South ExtensionColumbia, SC 29209Phone: (803) 252-1222Owner Operator #: 9052354Establishment 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, 882.1320Cutaneous Electrodes | |
| Product Code: GXY | |
| This device has not been previously submitted to the FDA. | |
| Predicate Device(s): | Neurolink TM 510(k) Number: K942921Neuro 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
{2}------------------------------------------------
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
{3}------------------------------------------------
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
{4}------------------------------------------------
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
Page 1 of 1
7
Revised &/19/2005
§ 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).