(137 days)
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.
StatNet EEG Headpiece
The provided text is a 510(k) premarket notification letter from the FDA to HydroDot, Inc. regarding their StatNet, Models: 3100, 3110 device. This document primarily focuses on regulatory approval and does not contain the detailed technical information required to answer your request about acceptance criteria and device study results.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or their data provenance.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Details on standalone algorithm performance.
- Type of ground truth used.
- Sample size for training sets or how their ground truth was established.
The letter simply states that the FDA has reviewed the 510(k) and determined the device to be "substantially equivalent" to legally marketed predicate devices for its intended use as an EEG electrode array. It outlines general regulatory requirements but does not delve into the specific technical studies or performance metrics that underpinned this determination.
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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 (800) 638-2041 or (301) 796-7100 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:
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
§ 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).