STATNET, MODEL 3100

K092828 · Hydrodot, Inc. · GXY · Jan 29, 2010 · Neurology

Device Facts

• Record ID: K092828
• Device Name: STATNET, MODEL 3100
• Applicant: Hydrodot, Inc.
• Product Code: GXY · Neurology
• Decision Date: Jan 29, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2

Intended Use

An Electroencepahlogram (EEG) electrode array intended for use in the ER, ICU and OR for recording of STAT EEGs in patients of 18 years of age and older.

Device Story

StatNet EEG Headpiece (Models 3100, 3110) is a cutaneous electrode array; used in ER, ICU, and OR settings for recording STAT EEGs. Device facilitates rapid placement of electrodes on patient scalp to acquire electrical signals for diagnostic monitoring. Operated by clinical staff; output used by physicians to assess neurological status and inform clinical decision-making. Benefits include rapid, standardized electrode application for urgent EEG acquisition.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Cutaneous electrode array; 21 CFR 882.1320; Class II; Product Code GXY. Form factor designed for rapid EEG signal acquisition.

Indications for Use

Indicated for patients 18 years and older requiring STAT EEG recordings in ER, ICU, or OR settings.

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.

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 consists of a stylized eagle-like symbol with three overlapping, curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

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

JAN 2 9 2010

HydroDot, Inc. c/o Ms. Kathleen M. Principe President 238 Littleton Road, Suite 202 Westford, Massachusetts 01886

Re: K092828

Trade/Device Name: StatNet, Models: 3100, 3110 Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: January 15, 2010 Received: January 19, 2010

Dear Ms. Principe:

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 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/ReportalProblem/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 yours.

Kesia Alexander for

Malvina B. Evdelman, 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

510(k) Number (if known):

Device Name:

Indications for Use:

K092828

StatNet EEG Headpiece

An Electroencepahlogram (EEG) electrode array intended for use in the ER, ICU and OR for recording of STAT EEGs in patients of 18 years of age and older.

Prescription Use × (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)

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

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510(k) Number k092828