DISPOSABLE PRE-GELLED SURFACE ELECTRODE

K142159 · Rochester Electro Medical, Inc. · GXY · Jun 3, 2015 · Neurology

Device Facts

• Record ID: K142159
• Device Name: DISPOSABLE PRE-GELLED SURFACE ELECTRODE
• Applicant: Rochester Electro Medical, Inc.
• Product Code: GXY · Neurology
• Decision Date: Jun 3, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2

Intended Use

The Rochester Electro-Medical Disposable Pre-gelled 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 signals (EP). Electrodes are non-invasive as they are applied to the patient's skin using a self-adhesive solid-gel surface. The electrodes are non-sterile and for single use only. The surface electrodes are placed cutaneously by a certified physician or a trained clinician or technologist by the order of a physician.

Device Story

Disposable pre-gelled surface electrode; captures biopotential signals (EEG, EMG, EP) from patient skin; conductive solid gel interface; silver/silver chloride (Ag/AgCl) plated eyelet; adhesive cloth substrate; lead wire with DIN 42802 touch-proof female socket; used in clinical settings by physicians, clinicians, or technologists; non-invasive; single-use; non-sterile; provides electrical connection between patient skin and diagnostic/monitoring equipment; facilitates signal acquisition for clinical decision-making.

Clinical Evidence

Bench testing only. Electrode impedance measurements performed using a 1kHz source and digital multimeter; gel uniformity inspected. Biocompatibility testing conducted per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (skin irritation and sensitization).

Technological Characteristics

Conductive solid gel (Tyco hydrogel RG-63); Ag/AgCl plated eyelet; adhesive cloth substrate; polystyrene release liner; DIN 42802 touch-proof female socket (0.60" diameter); non-sterile; single-use. Biocompatibility standards: ISO 10993-5, ISO 10993-10.

Indications for Use

Indicated for patients requiring recording, monitoring, or stimulation of biopotential signals including EEG, EMG, and EP. For use by physicians, clinicians, or technologists under physician order.

Regulatory Classification

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.

Predicate Devices

• Friendship Pre-gelled Ag/AgCl Surface Electrodes (K110289)

Submission Summary (Full Text)

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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 caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.

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

June 3, 2015

Rochester Electro-Medical, Inc. c/o Wayne Glover TechniReg, Inc. 19404 Pine Valley Drive Odessa. FL 33556

Re: K142159

> Trade/Device Name: Disposable Pre-gelled Surface Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: April 28, 2015 Received: May 5, 2015

Dear Mr. Glover,

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.

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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 [phone] or [phone] 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" (21 CFR 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 [phone] or [phone] or at its Internet address

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

Sincerely yours.

Felipe Aquel - S

Carlos L. Peña. PhD. MS for 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) K142159

Device Name

Disposable Pre-gelled Surface Electrode

Indications for Use (Describe)

The Disposable Pre-gelled Surface Electrodes are intended for recording/stimulation and monitoring of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potential (EP) signals.

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

|X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image is a logo for Rochester Electro-Medical. The logo features a stylized graphic of a medical device cable and plug inside of a circle. To the right of the graphic is the company name, "Rochester Electro-Medical", with "Rochester" on top of "Electro-Medical".

## 510(k) Summary

This 510(k) Summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.

| Summary Date: | August 1, 2014 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Rochester Electro-Medical, Inc.<br>4212 Cypress Gulch Drive<br>Lutz, FL 33559 |
| Telephone: | [phone] |
| Establishment<br>Registration No.: | 2126558 |
| Contact Person: | Mark C. Berkins<br>Vice President<br>Phone: [phone], Extension 221<br>Fax: [phone] |
| Trade Name: | Disposable Pre-gelled Surface Electrode[1] |
| | [1] This submission is intended to be filed as a Cutaneous Electrode (i.e. Common Name)<br>although referenced by the Trade Name throughout this submission. |
| Common Name: | Cutaneous Electrode |
| | Classification Name: 882.1320 Cutaneous Electrode, Class II (performance standards) |
| Product Code: | GXY |
| Equivalence /<br>Predicate Device: | Friendship Pre-gelled Ag/AgCl Surface Electrodes, 510(k) Number K110289 |
| Description: | A conductive solid gel electrode consisting of a conductive adhesive gel, a<br>silver/silver chloride plated eyelet, an adhesive cloth substrate, label, lead wire<br>with a 0.60" diameter touch-proof female socket per DIN 42802 and polystyrene<br>release liner. These are available in various lead lengths, lead configurations,<br>electrode styles/sizes, and wire colors. |
| Intended Use: | The Rochester Electro-Medical Disposable Pre-gelled Surface Electrodes are<br>intended for use with recording, monitoring and stimulation equipment for the<br>purpose of stimulating/recording of biopotential signals. Electrodes are applied<br>in the study of biopotentials such as Electroencephalograph (EEG), surface<br>Electromyography (EMG) and Evoked Potential signals (EP). Electrodes are non- |
| Rochester Electro-Medical | |
| | invasive as they are applied to the patient's skin using a self-adhesive solid-gel<br>surface. The electrodes are non-sterile and for single use only. |
| | The surface electrodes are placed cutaneously by a certified physician or a<br>trained clinician or technologist by the order of a physician. |
| Technical<br>Comparison: | The Rochester Disposable Adhesive Surface Electrodes are technologically<br>equivalent to the predicate device, K110289 Cutaneous Electrode manufactured<br>by Xian Friendship Medical. |
| | Physical and electrical characteristics evaluated during bench testing and in the<br>comparison chart of this submission demonstrate that the design, materials,<br>chemical composition, packaging, intended use, electrical performance and other<br>characteristics of the subject device are comparable to those of the predicate<br>device. |
| | Bench testing included electrode impedance measurements of the subject device<br>and the predicate using a 1kHz source and a Digital Multimeter, a method similar<br>to that used in K010431. Additionally gel uniformity was inspected. Details of<br>this testing and performance criteria are included in section 18 of this<br>submission, Performance Testing - Bench. |
| Biocompatibility: | The contact material is Tyco hydrogel RG-63 with slight proprietary variations<br>and has been previously tested for material safety and biocompatibility to:<br>Cytotoxicity study – ISO 10993-5 Skin irritation study - ISO 10993-10 Skin sensitization study - ISO 10993-10 |
| | There were no changes to the formulation for the new intended use. |
| Shelf Life: | 18 Months in unopened pouch. |
| Conclusions: | The Rochester Electro-Medical Disposable Pre-gelled Surface Electrodes are<br>substantially equivalent to the predicate device, Xian Friendship Medical<br>Electronics Co., Ltd. |
| | There are no new concerns regarding safety or effectiveness. |

4212 Cypress Gulch Drive Lutz, FL 33559 Ph: [phone]

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