(39 days)
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No
The summary describes surface electrodes for recording physiological signals and does not mention any AI or ML capabilities.
No
The device is described as electrodes for recording physiological signals (electroencephalography), not for treating conditions.
Yes
The device is used for electroencephalography, biofeedback, sleep studies, and evoked potential recordings, all of which involve measuring physiological signals to provide information about the patient's health status, which is a diagnostic purpose.
No
The device is described as "Surface Electrodes for Electroencephalography," which are physical components used to record physiological signals. This indicates a hardware device, not a software-only 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 that the electrodes are for "non-invasive use as recording electrodes in studies of physiological signals" and specifically mentions "electroencephalography, including biofeedback, sleep studies and evoked potential recordings." These are all procedures that involve measuring electrical activity from the body surface, not analyzing samples outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
IVDs are devices used to examine specimens obtained from the human body to provide information for clinical diagnosis, monitoring, or screening. This device is used to directly measure electrical signals from the body surface.
N/A
Intended Use / Indications for Use
The Electrode Store™ Surface Electrodes for Electroencephalography are intended for non-invasive use as recording electrodes in studies of physiological signals. These devices are indicated for use with adult or pediatric patients during electroencephalography, including biofeedback, sleep studies and evoked potential recordings.
Product codes
GXY
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
adult or pediatric patients
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
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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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with a flowing design element above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 3 2002
The Electrode Store, Inc. Carl Youngmann, Ph.D. c/o Regulatory Affairs Associates 936 - 11" Avenue East Seattle, Washington 98102
Re: K022197
Trade/Device Name: Surface Electrode for Electroencephalography Regulation Number: 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: July 2, 2002 Received: July 5, 2002
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 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.
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Page 2 - Dr. Carl Youngmann
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 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
A. Hyat Rhodes
a M. Witten. Ph.D., M.D. Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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THE ELECTRODE STORE™ Surface Electrode for EEG 510(k)
Indications for Use Statement
510(k) Number: _ Ko22|97
The Electrode Store™ Surface Electrodes for Electroencephalo-Device Name: graphy
Indications for Use:
The Electrode Store™ Surface Electrodes for Electroencephalography are intended for non-invasive use as recording electrodes in studies of physiological signals. These devices are indicated for use with adult or pediatric patients during electroencephalography, including biofeedback, sleep studies and evoked potential recordings.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR §801.109) Over-The-Counter Use
Styph Rhodes
(Division Sign-Off) Division of General, Restorative and Neurological Devices
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Indications for Use Statement
510(k) Number_Ko22197