(190 days)
Not Found
Not Found
No
The description focuses on the physical components and function of a biopotential skin electrode, with no mention of AI or ML for data processing or analysis.
No
The device is used for the acquisition of biopotential signals (e.g., EEG, ECG), which are diagnostic in nature, and does not mention any therapeutic action or treatment.
No.
The device is described as an electrode used for the acquisition of biopotential signals (EEG, ECG, EMG, EOG), which are then measured and analyzed for diagnostic purposes, but the electrode itself is not performing the diagnosis.
No
The device description explicitly details physical components like electrodes, housing, wires, and connectors, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is the acquisition of surface biopotentials (EEG, ECG, EMG, EOG). This involves measuring electrical signals directly from the body surface.
- Device Description: The device is a biopotential skin electrode designed to make contact with the skin and transmit electrical signals. It uses an electroconductive gel to facilitate this contact.
- Lack of In Vitro Activity: IVDs are typically used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. This device interacts directly with the body surface to acquire signals, not to analyze a specimen in vitro.
Therefore, this device falls under the category of a medical device used for physiological signal acquisition, not an IVD.
N/A
Intended Use / Indications for Use
Biopotential skin electrodes will be used by the Bio Medical community in both clinical and research applications of the acquisition of all surface biopotentials, standards, and reference, i.e. Electroencephalograph (EEG), Electrocardiograph (ECG), Electromyography (EMG), Electrooculograph (EOG).
Product codes
GXY
Device Description
This specific device is comprised of a sintered Ag-AgCl electrode with a 99.99% Silver wire. Some of the electrodes are to be sold as bare electrodes. Some are set and sealed in an epoxy or silicone housing with a PVC, Silicone or other TPE insulated, tinseled copper lead wire attached. The device is then sealed with either silicone or Epoxy. They have a smooth, non-porous finish on all surfaces with no cracks, seams, or bubbles. It is then considered waterproof and cold sterilizable. There is a recess in the underside of the housing surrounding the exposed electrode surface to allow for the placement of an electroconductive gel. The gel establishes contact between the Ag-AgCl electrode and the subject surface to be measured. The gel improves electro conductivity between the subject surface and the Ag-AgCl electrode surface for a more sensitive and accurate reading of the Biopotential.
The lead wires are either unterminated or terminate with a 1.5 DIN safety socket, snap, or pinch connector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Bio Medical community in both clinical and research applications
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
§ 882.1320 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
SEP 2 6 2002
DOCXS LI Bio Medical products Ag-AgCl Electrodes Vascular Occluders
510(k) Summary -
Cutaneous Electrodes
Biopotential Electrodes, various types
Date of Application: 3/15/02
Company name: DocXS, LLC Address: 564 S. Dora, Unit A #1 Ukiah, CA 95482 Mailing Address: 12200 Pine Ave. Potter Valley, CA 95469 Phone: 707-743-1365 E-mail: DocXS@pacific.net FDA Reg. #: Submitted application and waiting for response Submitted by: Richard A. Rizzolo, Principle Address: 12200 Pine Ave., Potter Valley, CA 95469 Phone: 707-743-1365
Signature:
10+2
1
Description of Device
Product Description: Biopotential Electrodes, various types and models Proprietary Device name: B series electrodes Common\Generic Name: Biopotential electrodes, various types and models Trade Name: Cutaneous electrodes FDA Classification Name: Cutaneous electrodes Device Class: 2 Product Code: GXY Regulation Number: 882.1320 Medical Specialty/Panel: NEUROLOGY Manufacture of original device: NA Establishment Operations: manufacturer
This specific device is comprised of a sintered Ag-AgCl electrode with a 99.99% Silver wire. Some of the electrodes are to be sold as bare electrodes. Some are set and sealed in an epoxy or silicone housing with a PVC, Silicone or other TPE insulated, tinseled copper lead wire attached. The device is then sealed with either silicone or Epoxy. They have a smooth, non-porous finish on all surfaces with no cracks, seams, or bubbles. It is then considered waterproof and cold sterilizable. There is a recess in the underside of the housing surrounding the exposed electrode surface to allow for the placement of an electroconductive gel. The gel establishes contact between the Ag-AgCl electrode and the subject surface to be measured. The gel improves electro conductivity between the subject surface and the Ag-AgCl electrode surface for a more sensitive and accurate reading of the Biopotential.
The lead wires are either unterminated or terminate with a 1.5 DIN safety socket, snap, or pinch connector. Exasple . Je ctron
Labeling
Labeling: Package Label, see sample label below
- Instructions for use, Promotional material, Specific intended use statement, included with device, example page ... Section 4 page 3 $ 4
- Warnings, contradictions, or limitations: included with device, . example page... Sec ... Sec 4 -- 1 --Page 3 14
Sample Label:
| Manufactured by | DocXS, LLC |
|---|---|
| 564 S. Dora, Ukiah, CA 95482 707-743-1365 |
Biopotential Surface Electrodes
Contents: One Ag-AgCl electrode, 8mm X 1mm in Epoxy
Model: B-224-LS, 40" red
Indicated for use in acquisition of surface biopotentials
| Refer to instructions before use | Batch #: | non-sterile |
|---|---|---|
| ---------------------------------- | ---------- | ------------- |
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an abstract image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The seal is black and white and appears to be a scanned image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 6 2002
Mr. Richard Rizzolo DocXS, LLC 564 South Dora, Suite A-1 Ukiah, California 95482
Re: K020903
Trade/Device Name: DocXS B Series Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: August 13, 2002 Received: August 23, 2002
Dear Mr. Rizzolo:
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.
3
Page 2 – Mr. Richard Rizzolo
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,
A. Celia M. Witten, Ph.D., MD
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
EU,STFood and Drig Administration, Center for Devices and Radiotograaf Realithy
510(k) Number (if known): K020903
Device Name:
Indications for Use:
Biopotential skin electrodes will be used by the Bio Medical community in both clinical and research applications of the acquisition of all surface biopotentials, standards, and reference, i.e. Electroencephalograph (EEG), Electrocardiograph (ECG), Electromyography (EMG), Electrooculograph (EOG).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurence of CDRH, Office of Device Evaulation (ODE) (Division Sign-Off)
Division of General, Restorative and Neurological Devices
(Optional Format 3-10-98)
510(k) Number K070903