DE48-PLUS

K123915 · Grass Technologies, an Astro-Med, Inc. Product Gro · GXY · Apr 24, 2013 · Neurology

Device Facts

• Record ID: K123915
• Device Name: DE48-PLUS
• Applicant: Grass Technologies, an Astro-Med, Inc. Product Gro
• Product Code: GXY · Neurology
• Decision Date: Apr 24, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2

Intended Use

The Grass "DE-48-Plus Disposable Electrodes" are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials.

Device Story

DE-48-Plus Disposable Electrodes are non-invasive, cutaneous surface electrodes; used to acquire microvoltage physiological signals (EEG, EMG, Evoked Potentials) from skin surface. Device consists of ABS plastic cup coated with Ag/AgCl; connected to lead wire via tin-plated copper crimp; terminates in DIN 42-802 compliant connector. Applied to skin using conductive cream or gel. Signals transferred to external recording/monitoring equipment. Used in clinical settings by healthcare professionals. Provides raw signal acquisition for diagnostic monitoring; facilitates clinical decision-making by enabling visualization of physiological waveforms.

Clinical Evidence

Bench testing only. Performance characteristics including resistance, impedance, and frequency response were evaluated and compared to predicate devices to demonstrate substantial equivalence.

Technological Characteristics

Non-invasive cutaneous surface electrodes. Materials: ABS plastic cup, Ag/AgCl coating, 28AWG stranded tin copper conductor, soft PVC insulation, tin-plated copper crimp, brass/tin-plated terminal. Dimensions: 8.5-10mm cup. Connectivity: DIN 42-802 compliant connector. Passive device; no energy source or software.

Indications for Use

Indicated for non-invasive acquisition of physiological signals (EMG, EEG, Evoked Potentials) for monitoring and recording purposes in patients requiring such diagnostic or monitoring procedures.

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

• Rhythmlink Disc Electrodes (K061148)
• Grass Technologies' Gold Electrodes

Submission Summary (Full Text)

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## APR 2 4 2013

## 510(k) SUMMARY (as required by 21 CFR 807.92)

Device Name:

DE-48-Plus Disposable Electrodes

12 123915

COMPANY:

Grass Technologies Division of Astro-Med, Inc. 53 Airport Park Drive Rockland, MA 02370 Establishment Registration Number: 1218414

CONTACT:

Steven G. Holbrook 401-828-4000 (phone) 401-822-2430 (fax)

[e-mail]

TRADE NAME: DE-48-Plus Disposable Electrodes COMMON NAME: Non-invasive Disc Electrodes CLASSIFICATION NAME: Electrode, Cutaneous REGULATION NUMBER: 882.1320 PRODUCT CODE: GXY

#### SUBSTANTIAL EQUIVALENCE

Grass Technologies believes that the DE-48-Plus Disposable Electrodes are substantially equivalent to the Rhythmlink Disc Electrodes as marketed under K061148 by Rhythmlink International, FDA Reg# 1067162 and to Grass Technologies' Gold Electrodes as marketed by Grass Technologies in the US prior to 1976.

#### DEVICE DESCRIPTION

The Grass Technologies DE48-Plus Disposable Electrodes (various lengths) are noninvasive, cutaneous devices, applied directly to the skin, and used in the acquisition of physiological signals for the purpose of montoring and recording Electroencephalograph (EEG), PSG and similar physiological parameters.

Non-invasive, disposable surface electrode discs (Cutaneous Electrodes), as included in this submission, are applied to the skin using a cream or gel for adhesion. Their purpose is to pick up and transfer microvoltage signals, as generated by the body, to recording equipment, for the purpose of monitoring and recording associated with electroencephalography and electromyography. The new Grass DE-48-Plus electrodes, as with the BNT predicate, are manufactured with a circular, raised cup body molded from ABS plastic and coated with silver chloride (Ag/AgCl). The disc is adhered to a lead wire which is covered with heat shrink tubing and terminates with a molded

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connector that conforms to DIN 42-802 for electrical safety. Grass DE-48-Plus Electrodes connect to, and work with, any EEG equipment, without special attachments.

The DE-48-Plus electrodes are made up of the following materials (same or equivalent to the Rhythmlink predicate).

Cup Disk: ABS Plastic with an Aq/AqCl coating which is nominally measured at 10mm (8.5 to 10mm).

The connecting wire which is manufactured from 28AWG stranded Tin Copper conductor with soft PVC insulation.

Wire crimped to Cup Electrode using Tin plated copper tubing.

Terminal connected with Alex crimp type, 24-30AWG Brass, Tin plated, Molded in Palprene.

## INDICATIONS FOR USE

The Grass "DE-48-Plus Disposable Electrodes" are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials.

#### TECHNOLOGICAL CHARACTERISTICS (compared to Predicate(s)

The Grass and Predicate Surface Disk Electrodes are non-invasive, cutaneous devices used for the acquisition of signals from the body for the purpose of monitoring and recording EEG, EMG and Evoked Potentials (EP). The Grass DE-48-Plus Disk electrodes are manufactured from ABS Plastic with an AG/AgCl coating; with lead wire manufactured from 28AWG stranded tin copper conductor with soft PVC insulation; electrode to wire crimp with tin plated copper tubing; and an Alex crimp type terminal (24-30 AWG Brass, tin plated, molded in Palprene) which conforms to DIN 42-802 for electrical safety and is the same/equivalent design as the predicate Disc Electrodes. Skin contact materials do not include the use of any color additives.

## PERFORMANCE DATA

Product performance characteristics [Resistance, Model Surface, Impedance and Frequency Response] of the Grass DE-48-Plus electrode was found, through appropriate testing to be substantially equivalent to the predicate Grass Gold and the Rhythlink BNT Disk Electrodes.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

April 24,2013

Public Health Service

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

Grass Technologies, Inc. Mr. Phillio Soares 53 Airport Park Drive Rockland, MA 02370

Re: K123915

Trade/Device Name: DE48-Plus Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: January 27, 2013 Received: February 21, 2013

Dear Mr. Soares:

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 (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 53)-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Phillip Soares

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address: http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Joyce M. Whang -S

for Victor Krauthamer, Ph.D. Acting 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): K123915

Device Name: _DE48-Plus Disposable Electrodes

Indications For Use:

The Grass "DE-48-Plus Disposable Electrodes" are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials.

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

K123915 510(k) Number

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