PRESSON ELECTRODE

K121347 · Rhythmlink International, LLC · GXZ · Jul 12, 2012 · Neurology

Device Facts

• Record ID: K121347
• Device Name: PRESSON ELECTRODE
• Applicant: Rhythmlink International, LLC
• Product Code: GXZ · Neurology
• Decision Date: Jul 12, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1350
• Device Class: Class 2

Intended Use

The PressOn™ Electrode is intended for use in the recording of the Electroencephalogram (EEG), Evoked Potential (EP), or as Ground and Reference in an EEG or EP recording.

Device Story

Persyst PressOn™ Electrode is a passive electrode used for recording electroencephalogram (EEG) and evoked potential (EP) signals. It functions as a conductive interface between the patient's scalp and EEG/EP recording equipment. The device serves as a signal acquisition component for EEG/EP, ground, or reference leads. It is intended for use in clinical settings by trained healthcare professionals. The electrode facilitates the transmission of electrical brain activity to diagnostic monitoring systems, aiding clinicians in the assessment of neurological function.

Clinical Evidence

Bench testing only.

Technological Characteristics

Passive electrode for EEG/EP signal acquisition. Conductive interface. Class II device (21 CFR 882.1350).

Indications for Use

Indicated for patients requiring EEG or EP monitoring. Used for recording EEG/EP signals or as ground/reference electrodes. No specific age or disease state contraindications provided.

Regulatory Classification

Identification

A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of an eagle.

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

Rhythmlink International, LLC c/o Mr. James M. Mewborne Manager of Regulatory Affairs 1140 First Street South Columbia, SC 29209

Re: K121347

Trade/Device Name: Persyst PressOn™ Electrode Regulation Number: 21 CFR 882.1350 Regulation Name: Needle Electrode Regulatory Class: Class II Product Code: GXZ Dated: April 24, 2012 Received: May 01, 2012

Dear Mr. Mewborne:

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.

JUL 12 2012

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## Page 2 - Mr. James M. Mewborne

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

Peter Thomson

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## · Indications for Use Statement

## Indications for Use Statement

: 510(k) Number

Ki21347

Device Name Persyst PressOn Electrode

Indications for Use

The PressOn™ Electrode is intended for use in the recording of the Electroencephalogram (EEG), Evoked Potential (EP), or as Ground and Reference in an EEG or EP recording.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write below this line – Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

John Grimes, Ph.D.

(Division Sign-Off) (Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K121347