(182 days)
BMSI 5000 (Nicolet), Ceegraph (Bio-Logic), EMU 128 (XLTek)
Not Found
No
The description focuses on standard signal processing and recording functionalities without mentioning AI or ML.
No
The device is described as being for "recording and monitoring of brain electrical activity," indicating a diagnostic rather than therapeutic purpose.
Yes
Explanation: The device is intended for "recording and monitoring of brain electrical activity," which is a fundamental aspect of diagnosis in neurology, even if it doesn't explicitly state "diagnosis." The monitoring provides data that would be interpreted by a clinician to assess a patient's condition.
No
The device description explicitly lists multiple hardware components (Patient Cable, Amplifier, CPU, Display monitor) as part of the system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "recording and monitoring of brain electrical activity." This is a physiological measurement taken directly from the patient's body (in vivo).
- Device Description: The device components and functions are focused on acquiring, amplifying, and displaying electrical signals from the brain.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, or disease. This device does not process such specimens.
Therefore, the NeuroPort™ NSP System is a medical device for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NeuroPort™ NSP System is intended for temporary (
§ 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).
0
| Submitter Name: | Cyberkinetics, Inc. |
|---|---|
| Submitter Address: | 100 Foxborough Boulevard, Suite 240 |
| Foxboro, MA 02035 | |
| Contact Person: | Nandini Murthy, V.P. Regulatory Affairs and Quality Systems |
| Phone Number: | (508) 549-9981, Extn 103 |
| Fax Number: | (508) 549-9985 |
| Date Prepared: | Sept 24, 2004 |
| Device Trade Name: | NeuroPort™ NSP System |
| Device Common Name: | Neural Signal Amplifier |
| Predicate Devices: | BMSI 5000 (Nicolet), Ceegraph (Bio-Logic) and EMU 128 |
| (XLTek) | |
| Device Description: | The Neuroport Neural Signal Processing (NSP) System is |
| intended for recording and monitoring. Its functionality includes | |
| routine brain activity recording, monitoring, retrieval and replay. | |
| The Neuroport supports up to 96 channels of recording and is | |
| comprised of the following hardware components: Patient Cable, | |
| Amplifier, CPU and a Display monitor. The Neuroport System | |
| also includes the following software functions: acquisition, | |
| amplification and display. | |
| Intended Use: | The NeuroPort™ NSP System is intended for temporary ( |