(218 days)
The Bravo Multi-Modality System is intended to record and display EEG, EP, EMG and TCD data in the clinic and hospital (including the hospital room, operating room, emergency room, intensive care unit, neuro intensive care unit, critical care unit, etc.), and to import and display data from third-party monitoring devices such as vital signs monitors. It is intended to aid the diagnosis and monitoring of potential disorders of the central and peripheral nervous system and muscles.
The Bravo Multi-Modality System is a personal computer-based digital data recorder for continuously monitoring various types of neurological information, including: (i) neuroelectric and neuromuscular data pertaining to the patient's central and peripheral nervous system and muscles, and (ii) neurovascular data pertaining to blood flow in the patient's brain and related blood vessels. The intended use of this device is to record and display EEG, EMG, EP and TCD signals; and to import and display data from third-party monitoring devices, such as vital signs monitors. EEG signals are passively recorded using electrically-conductive electrodes that are placed in electrical contact with the patient's skin or nervous system. EMG and EP signals are recorded using electrically-conductive electrodes that are placed in electrical contact with the patient's skin, nervous system or muscles. EMG signals are passively recorded, while EP signals are evoked using a light source, a sound source, or an electrical stimulator. TCD signals are actively recorded using a non-invasive ultrasound transducer that emits and records ultrasound energy. The ultrasound energy is applied externally to the skin, passes through the skin and body tissues, reflects off blood molecules moving in the blood stream, passes back through the body tissues and skin, and returns to the transducer. Movement of the blood molecules causes a frequency or "Doppler" shift in the returned ultrasound energy, which is detected and converted into a signal representing the velocity of the blood from which the ultrasound energy was reflected. Third-party monitoring devices, such as vital signs monitors, acquire and display a variety of physiological data from the patient. Importing and displaying such data is done by taking an output signal directly from such monitoring devices without any additional connections to the patient. Data obtained from the monitoring device is then displayed, analyzed or stored by the Bravo Multi-Modality System independently of how the third-party device handles the data.
The provided document does not contain acceptance criteria or detailed study results for the Bravo Multi-Modality System.
Instead, the document is a 510(k) summary and a subsequent FDA substantial equivalence letter for the device. It focuses on demonstrating equivalence to predicate devices rather than presenting performance data against defined acceptance criteria.
Here's a breakdown of why the requested information is not available in the provided text:
- Acceptance Criteria and Reported Device Performance (Table): The document states only that "nonclinical tests consist of various tests to verify program function" and that "tests are ongoing, but indicate that the performing as expected." It then says "Test results are summarized below" but no summary or table of results is present in the provided text.
- Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): The document explicitly states: "Clinical tests will be used to validate the device's performance under simulated or actual use conditions. Because each of the individual modalities was derived from an existing from an existing the decided data will be a primary validation tool. To provided for an existing and to vill be ev the device will be evaluated at different health care sites to solicit can annound with the mainting valiation, which in the studion, which is and and to was over of ovaluated at different health care sites to solicit common". This fragmented sentence indicates that clinical validation will be used, suggesting that detailed clinical study results (including specifics like sample sizes, ground truth establishment, expert qualifications, etc.) are either not yet finalized or not part of this 510(k) summary. The emphasis is on the fact that the modalities are "derived from an existing" (predicate) device, implying that the performance is expected to be similar, rather than requiring extensive new performance studies for substantial equivalence.
In summary, the provided text serves as a regulatory submission for substantial equivalence based on technological similarity to existing devices, and it does not detail specific acceptance criteria or the results of a primary study proving device performance against such criteria.
§ 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).