(175 days)
The Olympic Brainz Monitor (OBM) is a three channel electroencephalograph (EEG) acquisition system intended to be used in a hospital environment to record, collect, display and facilitate manual marking of aEEG recordings.
- . The signals acquired from P3-P4, C3-P3 and C4-P4 channels are intended for use only with neonatal patients (defined as from birth to 28 days post delivery, and corresponding to a postconceptual age of 24 to 46 weeks) to display aEEG for monitoring the state of the brain.
- The signals acquired from P3-P4 channel is intended to assist in the prediction of and severity . of Hypoxic-Ischemic Encephalopathy and long-term outcome in full term neonates (postconceptual age of 37-46 weeks) who have suffered a hypoxic-ischemic event.
The Olympic Brainz Monitor does not provide any diagnostic conclusion about the patient's condition.
a three channel electroencephalograph (EEG) acquisition system intended to be used in a hospital environment to record, collect, display and facilitate manual marking of aEEG recordings.
This document, a 510(k) clearance letter for the Natus Medical Incorporated Olympic Brainz Monitor, does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.
The letter is the FDA's clearance, indicating substantial equivalence to a predicate device. However, it does not include:
- A table of acceptance criteria and reported device performance.
- Details about the sample size, data provenance, number/qualifications of experts, or adjudication method for a test set.
- Information on MRMC comparative effectiveness studies or human reader improvement data.
- Results from standalone algorithm performance studies.
- The type of ground truth used in a study.
- Sample size or ground truth establishment methods for a training set.
The letter primarily confirms that the device, an electroencephalograph acquisition system, is substantially equivalent to existing devices for its stated indications for use, which include recording, displaying, and facilitating manual marking of aEEG recordings in neonatal patients, and assisting in the prediction of and severity of Hypoxic-Ischemic Encephalopathy in full-term neonates.
To obtain the information requested, one would typically need to review the actual 510(k) submission document (K093949) to the FDA, which would contain the performance summary and details of any studies conducted to support the substantial equivalence claim.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 1 62010
Natus Medical Incorporated c/o Ms. Goldy Singh Excel-Tech Ltd. 2568 Bristol Circle Oakville, Ontario Canada L6H 5S1
Re: K093949
Trade/Device Name: Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMA Dated: May 4, 2010 Received: May 4, 2010
Dear Ms. Singh:
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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Page 2 - Ms. Goldy Singh
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
R. A. Thompson, Jr.
Malvina B. Eydelman, M. 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 Supplement 1
K093949 510(k) Number (if known):
Device Name: Olympic Brainz Monitor
Indications for Use:
The Olympic Brainz Monitor (OBM) is a three channel electroencephalograph (EEG) acquisition system intended to be used in a hospital environment to record, collect, display and facilitate manual marking of aEEG recordings.
- . The signals acquired from P3-P4, C3-P3 and C4-P4 channels are intended for use only with neonatal patients (defined as from birth to 28 days post delivery, and corresponding to a postconceptual age of 24 to 46 weeks) to display aEEG for monitoring the state of the brain.
- The signals acquired from P3-P4 channel is intended to assist in the prediction of and severity . of Hypoxic-Ischemic Encephalopathy and long-term outcome in full term neonates (postconceptual age of 37-46 weeks) who have suffered a hypoxic-ischemic event.
The Olympic Brainz Monitor does not provide any diagnostic conclusion about the patient's condition.
Prescription Use X (Per 21 CFR 801.109)
Over-The Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
SKD
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
(Optional Format 1-2-96)
510(k) Number K093949
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).