(64 days)
Adhesive Electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. It is intended to be used with U.S. legally marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).
Adhesive Electrodes
This document is a 510(k) premarket notification letter from the FDA regarding "Reno Medical Adhesive Electrodes". It focuses on the regulatory approval of the device based on substantial equivalence to existing predicate devices.
Based on the provided text, there is no information about acceptance criteria, a study proving the device meets acceptance criteria, or any of the detailed study parameters you've requested.
The letter explicitly states:
- "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..."
This indicates that the approval is based on a comparison to existing devices, not a new study demonstrating performance against specific acceptance criteria.
Therefore, I cannot provide a table of acceptance criteria or details about a study to prove device performance because this information is not present in the provided FDA letter.
The document is a regulatory approval letter, not a scientific study report.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Reno Medical Limited c/o Diana Hong General Manager Mid-link Consulting Co., Ltd. PO Box 237-023 Shanghai, 200237, China
DEC 2 2010
Re: K102842
Trade/Device Name: Reno Medical Adhesive Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name:Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: November 12, 1010 Received: November 15, 2010
Dear Ms. Hong:
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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misJeading.
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.
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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 (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 yours.
Kesia Alexander
for
Mr.
Dr.
Dr.
J 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
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Premarket Notification Traditional Section 510(k) Submission - Section II Indication for Use Statement
Sec. Il Indication for Use Statement
510(k) Number: Device Name: Adhesive Electrodes
DEC 2 2010
Indications for Use:
Adhesive Electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. It is intended to be used with U.S. legally marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
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Thomas C. Radner
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
K102842
510(k) Number
§ 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).