(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.
§ 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).