(174 days)
No
The document describes a system for acquiring and transmitting EEG signals, focusing on hardware components and signal transmission methods. There is no mention of AI or ML algorithms for signal processing, analysis, or interpretation.
No.
The device is a neuro-monitoring system designed to locate EEG electrodes and present electrical signals for existing EEG recording, analysis, and archiving equipment, which is a diagnostic function, not a therapeutic one.
Yes
Explanation: The device is described as presenting electrical signals sensed by electrodes to existing EEG recording, analysis, and archiving equipment. EEG recording and analysis is a diagnostic procedure, and this device is an integral part of that process by acquiring and transmitting the necessary signals.
No
The device description explicitly lists multiple hardware components including Biosensor electrodes, e-Net headpiece, Patient Module, fiber optic interface, and DSP Interface Card. While software is likely involved in processing the signals, the device is clearly a system with physical hardware components.
Based on the provided text, the NeuroLink NeuroMonitoring System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "locate EEG electrodes according the 10-20 International System and present electrical signal sensed by the electrodes from the skin to existing EEG recording, analysis and archiving equipment." This describes a system for acquiring and transmitting physiological signals from the body surface (skin), not for examining specimens derived from the human body (like blood, urine, or tissue) outside of the body.
- Device Description: The components described are related to acquiring electrical signals from the skin (electrodes, headpiece, patient module) and transmitting them to EEG equipment. There is no mention of reagents, assays, or any components used for testing biological samples.
- Anatomical Site: The anatomical site is listed as "skin," which is a surface of the body, not a biological specimen.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device is focused on acquiring and transmitting electrical signals from the body itself.
N/A
Intended Use / Indications for Use
The NeuroLink NeuroMonitoring System has the same intended use as the predicate device, the HydroDot NeuroMonitoring System. Both are designed to locate EEG electrodes according the 10-20 International System and present electrical signal sensed by the electrodes from the skin to existing EEG recording, analysis and archiving equipment.
Product codes
21 CFR Part 882.1320, 21 CFR Part 882.1835
Device Description
The e-Net NeuroMonitoring System consists of a set of components that work together to acquire and present EEG signal to any existing EEG recording and analysis equipment. The components in the original submission included Biosensor electrodes, e-Net headpiece, Patient Module, fiber optic interface, Monitor Module, AC power supply, and EEG Adapter Cable. The components of this submission include Biosensor electrodes, e-Net headpiece, Patient Module, fiber optic interface, and DSP Interface Card (replaces Monitor Module). The AC power supply and EEG Adapter Cable have been eliminated.
The modified system discussed in this submission uses the same electrodes and headpiece for signal acquisition but has changes in the modules used to transmit signals to the existing EEG recording and analysis equipment.
The Patient Module is a small battery powered unit attached to the patient. Power is enabled when the Patient Module is plugged into the DSP Card via the fiber optic cable, the host digital EEG computer is in the powered state and the Patient Module is enabled by pressing the control button located on the Patient Module. A five meter fiber optic cable is standard. The fiber optic cable provides outstanding patient isolation and flexible patient EEG Record Station placement options. A connector located at the top end of the module attaches to our standard e-Net headpiece or optionally a mini-jack for interface to standard cup electrodes. Self test, calibration and impedance tests are remotely activated from the host Digital EEG Machine through the DSP Interface Card or locally by depressing the appropriate test button on the Patient Module. A visual indication of control button function, system status and out of range impedance can be provided on the LCD display as controlled from the host Digital EEG Machine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
NOV 25 1996
alle
Physiometrix, Inc. 510(k), Premarket Notification NeuroLink NeuroMonitoring System, Model 1310
SUMMARY OF SAFETY AND EFFECTIVENESS
| Date: | June 3, 1996 |
|---|---|
| Company: | Physiometrix, Inc. |
| Five Billerica Park | |
| 101 Billerica Avenue | |
| N. Billerica, MA 01862 | |
| Contact: | Dawn E. Frazer |
| Director, Regulatory Affairs & Quality Assurance | |
| (508) 670-2422 | |
| (800) 474-9746 | |
| Subject Device: | Model 1310, NeuroLink NeuroMonitoring System |
| Predicate Device: | K930080, HydroDot NeuroMonitoring System |
| Classification: | Class II, CFR 21 Part 882.1320, Cutaneous Electrodes |
| Class II, 21 CFR Part 882.1835, Physiological Signal Amplifier | |
| Description: | The e-Net NeuroMonitoring System consists of a set of components that work together to acquire and present EEG signal to any existing EEG recording and analysis equipment. The components in the original submission included Biosensor electrodes, e-Net headpiece, Patient Module, fiber optic interface, Monitor Module, AC power supply, and EEG Adapter Cable. The components of this submission include Biosensor electrodes, e-Net headpiece, Patient Module, fiber optic interface, and DSP Interface Card (replaces Monitor Module). The AC power supply and EEG Adapter Cable have been eliminated. |
| The modified system discussed in this submission uses the same electrodes and headpiece for signal acquisition but has changes in the modules used to transmit signals to the existing EEG recording and analysis equipment. | |
| The Patient Module is a small battery powered unit attached to the patient. Power is enabled when the Patient Module is plugged into the DSP Card via the fiber optic cable, the host digital EEG computer is in the powered state and the Patient Module is enabled by pressing the control button located on the Patient Module. A five meter fiber optic cable is standard. The fiber optic cable provides outstanding patient isolation and flexible patient EEG Record Station placement options. A connector located at the top end of the module attaches to our standard e-Net headpiece or optionally a mini-jack for interface to standard cup electrodes. Self test, calibration and impedance tests are |
1
remotely activated from the host Digital EEG Machine through the DSP Interface Card or locally by depressing the appropriate test button on the Patient Module. A visual indication of control button function, system status and out of range impedance can be provided on the LCD display as controlled from the host Digital EEG Machine.
Intended Use:
The NeuroLink NeuroMonitoring System has the same intended use as the predicate device, the HydroDot NeuroMonitoring System. Both are designed to locate EEG electrodes according the 10-20 International System and present electrical signal sensed by the electrodes from the skin to existing EEG recording, analysis and archiving equipment.