Disposable Adhesive Surface Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of stimulating/recording of biopotential signals. Electrodes are applied in the study of biopotentials such as electroencephalograph (EEG), surface Electromyography (EMG) and Evoked Potential sigmals (EP). The electrodes are non-sterile and for single use only.

Disposable Adhesive Surface (Ring) Electrodes are intended to be used with diagnostic electromyography equipment that deliver an electrical stimulus and record electromyography signals for neurodiagnostic purposes. The electrodes are nonsterile and for single use only.

Disposable/Reusable Cup Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials (EP).

Device Description

Not Found

AI/ML Overview

I am sorry, but this document contains general correspondence regarding an FDA 510(k) premarket notification for "Disposable Adhesive Surface Electrodes" and "Disposable/Reusable Cup Electrodes."

The document does not describe "acceptance criteria" for a study, nor does it present any "study that proves the device meets acceptance criteria" in the way one would analyze a medical device's performance in clinical or diagnostic tasks.

Instead, the document primarily focuses on:

Regulatory classification: Class II (Special Controls) for Cutaneous Electrodes.
Substantial equivalence: A determination that the device is substantially equivalent to legally marketed predicate devices.
General regulatory requirements: Information about annual registration, labeling, manufacturing practices, etc.
Indications for Use: What the electrodes are intended for (e.g., recording and monitoring biopotential signals like EEG, sEMG, EP).

Therefore, I cannot provide the requested information, which typically pertains to performance metrics (sensitivity, specificity, AUC), sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies for AI/CADe devices. This document is related to a much simpler, non-AI medical device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 1, 2016

Bio Protech, Inc. % Kevin Han Manager Bio Protech USA, Inc. Tustin, California 92780

Re: K153019

Trade/Device Name: Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: February 15, 2016 Received: February 16, 2016

Dear Mr. Han:

This letter corrects our substantially equivalent letter of March 21, 2016.

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 misleading.

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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely. Michael J. Hoffmann -A

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K153019

Device Name

Disposable Adhesive Surface Electrodes Disposable/Reusable Cup Electrodes

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Regulation Number and Section

§ 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).