(121 days)
Not Found
Not Found
No
The summary describes a physical electrode for recording physiological signals and does not mention any software or processing capabilities that would involve AI/ML.
No
The device is described as a recording or stimulating electrode for electroencephalography (EEG), which focuses on diagnostic or monitoring functions rather than applying therapy to treat a disease or condition.
Yes
The device is described as recording physiological signals during electroencephalography, which is a diagnostic procedure used to assess brain activity.
No
The device description clearly states it is a "Subdermal Needle Electrode," which is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The Electrode Store™ Subdermal Needle Electrode is used for recording physiological signals or applying electrical stimulation directly to the body (subdermally) during an EEG. It is not used to analyze samples taken from the body.
Therefore, based on its intended use and how it interacts with the patient, this device falls under the category of a medical device used for physiological measurement and stimulation, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Electrode Store™ Subdermal Needle Electrode for Electroencephalography (EEG) is intended for single-use, subdermal application to record physiological signals or to apply electrical stimulation. It is indicated for use with adult or pediatric patients as a recording or stimulating electrode during electroencephalography.
Product codes
GXZ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subdermal
Indicated Patient Age Range
adult or pediatric patients
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1350 Needle electrode.
(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by a series of curved lines that suggest feathers or wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
The Electric Store Carl Youngmann, PhD, RAC c/o R.A. Associates 936-11th Avenue East Seattle, Washington 98102
(JUL 1 9 2002
Re: K020910
Trade/Device Name: Subdermal Needle Electrode for Electroencephalograpy Regulation Number: 882.1350 Regulation Name: Needle Electrode Regulatory Class: II Product Code: GXZ Dated: June 6, 2002 Received: June 11, 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. Iisting 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.
1
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 your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,
Hipt Rhode
Celia 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
2
THE ELECTRODE STORE™ Subdermal Needle Electrode for EEG 510(k)
Indications for Use Statement
510(k) Number: KO20910
The Electrode Store™ Subdermal Needle Electrode for Electro-Device Name: encephalography (EEG)
Indications for Use:
The Electrode Store™ Subdermal Needle Electrode for Electroencephalography (EEG) is intended for single-use, subdermal application to record physiological signals or to apply electrical stimulation. It is indicated for use with adult or pediatric patients as a recording or stimulating electrode during electroencephalography.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Hyt Quorln
of General, Restorative and Neurological Devices
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR §801.109)
Over-The-Counter Use
510(k) Number.
Indications for Use Statement