(108 days)
The Porti Physiological Amplifier is intended to be use by or under the directions of a physician for acquisition of EEG, polygraphy and polysomnography signals and transmission of the signals to a PC during recording of neuro-physical/physiological research and exams.
Polygraphy and polysmnography may besides EEG, include physiological information such as EMG, ECG, EGG, EGG, PH, Respiration, Temperature and Oxygen Saturation.
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This document is a 510(k) clearance letter for the Porti 7, a physiological signal amplifier, indicating it is substantially equivalent to legally marketed predicate devices. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. Therefore, I cannot provide the requested information based on the given text.
The document mainly focuses on the regulatory approval process by the FDA, including:
- Device Name: Porti 7
- Regulation Number: 21 CFR 882.1835
- Regulation Name: Physiological signal amplifier
- Regulatory Class: II
- Product Code: GWL
- Indications for Use: Acquisition of EEG, polygraphy, and polysomnography signals and transmission to a PC during recording of neuro-physical/physiological research and exams. This can include physiological information such as EMG, ECG, EGG, pH, Respiration, Temperature, and Oxygen Saturation.
To answer your request, I would need a different document that details the performance study conducted for the Porti 7 and its acceptance criteria.
§ 882.1835 Physiological signal amplifier.
(a)
Identification. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).(b)
Classification. Class II (performance standards).