(240 days)
The Electrode Store™ Sterile Cutaneous Electrode is indicated for use as a recording (active/reference) or stimulating electrode during electromyography (EMG), including nerve conduction studies (NCS) and evoked potential (EP) recordings. It is provided packaged and labeled as a sterile device for single patient use.
Not Found
I am sorry, but the provided text does not contain the information requested in the prompt regarding acceptance criteria and a study proving a device meets them. The document is a 510(k) clearance letter from the FDA for "Sensory Nerve Electrodes-Two Finger Rings, Stimulator Probe Electrodes-Facial" and "Sterile Cutaneous Electrode."
It mentions:
- Device Names: Sensory Nerve Electrodes-Two Finger Rings, Stimulator Probe Electrodes-Facial, and The Electrode Store™ Sterile Cutaneous Electrode.
- Regulation Number and Name: 21 CFR 882.1320, Cutaneous Electrode
- Regulatory Class: II
- Product Code: GXY
- Indications for Use: The Electrode Store™ Sterile Cutaneous Electrode is indicated for use as a recording (active/reference) or stimulating electrode during electromyography (EMG), including nerve conduction studies (NCS) and evoked potential (EP) recordings. It is provided packaged and labeled as a sterile device for single patient use.
However, it does not provide details about:
- A table of acceptance criteria or reported device performance.
- Sample sizes or data provenance for any test set.
- Number or qualifications of experts for establishing ground truth.
- Adjudication methods.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document is primarily an FDA clearance letter confirming substantial equivalence to a predicate device, not a detailed study report.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the logo.
Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993-0002
AUG 1 4 2009
The Electrode Store, Inc. c/o Carl Youngmann, Ph.D., RAC Designated Regulatory and Quality Affairs Representative 1530 Holcomb St. Port Townsend, WA 98368
Re: K083758
Trade/Device Name: Sensory Nerve Electrodes-Two Finger Rings, Stimulator Probe Electrodes-Facial ·
Regulation Number: 21 CFR 882.1320
Regulation Name: Cutaneous Electrode Regulatory Class: II Product Code: GXY Dated: June 30, 2009 Received: July 2, 2009
Dear Dr. Youngmann:
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 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 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.
{1}------------------------------------------------
Page 2 - Carl Youngman, Ph.D., RAC
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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Kesia Alexander for
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
{2}------------------------------------------------
Section IV-Indications for Use Statement
K083758 510(k) Number:
The Electrode Store™ Sterile Cutaneous Electrode Device Name:
Indications for Use:
The Electrode Store™ Sterile Cutaneous Electrode is indicated for use as a recording (active/reference) or stimulating electrode during electromyography (EMG), including nerve conduction studies (NCS) and evoked potential (EP) recordings. It is provided packaged and labeled as a sterile device for single patient use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Harry L. Kacen
(Division Sign-Off) Division of Ophthalmic, Neurological and Ea Nose and Throat Devices
510(k) Number K083758
Prescription Use (Per 21 CFR §801 subpart D) OR
Over-The-Counter Use (Per 21 CFR §801 subpart C)
Section IV-Indications for Use Statement
Page IV-1
Company Confidential
§ 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).