(25 days)
Not Found
No
The description focuses on signal acquisition, amplification, conversion, and transmission. There is no mention of AI or ML algorithms being used for analysis or interpretation of the signals.
No
The device is described as an amplifier for acquiring and transmitting neurophysiology signals (EEG, polygraphy, polysomnography) for diagnostic purposes, not for treating a condition.
Yes.
The device's intended use clearly states it is for the "acquisition of EEG, polygraphy and polysomnography signals" for "neurophysiology examinations," which are diagnostic procedures. It amplifies and converts bioelectric signals into digital form for analysis, which is a key function of diagnostic devices.
No
The device description explicitly details hardware components like an amplifier box, PCMCIA or BE Net interface, and an AC/DC adapter, indicating it is not software-only.
Based on the provided information, the Nic36 Amplifier is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "acquisition of EEG, polygraphy and polysomnography signals and transmission of these signals to a PC during recording of neurophysiology examinations." This involves capturing bioelectric signals directly from the human body.
- Device Description: The description reinforces this by stating it amplifies and filters "bioelectric signals captured via a lead or transdaor on the surface of the human body."
- Definition of IVD: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
The Nic36 Amplifier is designed to interact directly with the patient's body to acquire signals, which is characteristic of a medical device used for physiological monitoring and diagnosis, but not an IVD.
N/A
Intended Use / Indications for Use
The Nic36 Amplifier is intended to be used by or under the direction of a physician for acquisition of EEG, polygraphy and polysomnography signals and transmission of these signals to a PC during recording of neurophysiology examinations.
Product codes
GWL
Device Description
The Nic36 Amplifer is a fully programmable system which provides a total of 36 analog input channels, each of which can be configured to perform bio-amplification and analog to digital conversion. The amplifier receives its power from a dedicated AC/DC adapter which feeds a +15VDC. Internally, the +15VDC is further isolated by a dedicated DC/DC CF type converter.
The Nic36 Amplifier is intended to be used to amplify and filter bioelectric signals captured via a lead or transducer on the surface of the human body. It captures the data, converts it into a digital format, and transmits it to a host computer running appropriate software. Typical fields of application will be: Electroencephalograph (EEG), Evoked Potentials (EP), Electromyography (EMG), Polysomnography (Sleep Analysis) and General Polygraphy.
The Nic36 Amplifier does not contain a Pulse Oximeter module.
The host computer must use one of the following Operating Systems: Microsoft Windows 98, Microsoft Windows NT or Microsoft Windows XP.
The Nic36 Amplifier system consists of three interconnected units: the amplifier box, the fiber optic cable, and the AC/DC adapter; optionally the system may be completed by a led visual stimulator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surface of the human body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
by or under the direction of a physician
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
510(k) Summary EB Neuro. S.p.A. Nic36 Amplitier
JUN - 1 2004
510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a).
807.92(a)(1)
Submitter Information
Carri Graham, Official Corresondent The Anson Group 7992 Castleway Drive Indianapolis, Indiana 46250
(317) 849-1916 Phone: (317) 577-9070 Facsimile:
Carri Graham Contact Person:
May 5, 2004 Date:
807.92(a)(2)
| Trade Name: | Nic36 Amplifier | |
|---|---|---|
| Common Name: | Physiological Signal Amplifier | |
| Classification Name(s): | Physiological Signal Amplifier | |
| Classification Number: | 84GWL | |
| 807.92(a)(3) | ||
| Predicate Device(s) | ||
| EB Neuro, S.p.A. | Mizar Amplifier | K003154 |
Additional Substantial Equivalence Information is provided in the following Technological Characteristics Table.
1
510(k) Summary EB Neuro. S.p.A. Nic36 Amplifier
807.92 (a)(4)
Device Description
The Nic36 Amplifer is a fully programmable system which provides a total of 36 analog The NiCSO Aniphier is a fully programmation of amplified and converted to digital form mput challiers cach of witch can '00 bonnigation's its power from a dedicated ACDC
(analog to digital conversion). The amplifier receives its power from a dedicated AC/DC (affalog to digital conversion). The amirements, which feeds a +15VDC. Internally, the +15VDC is further isolated by a dedicated DC/DC CF type converter.
The Nic36 Amplifier is intended to be used to amplify and filter bioelectric signals The NICJO Ampillier is Intended to the surface of the human body. It captures the data, capidled via a lead of thansdaor on assess it on to a host computer running appropriate converts it into a urgital fields of application will be: Electroencephalograph ampirication Soltware. Typted Ticlas or upportunians
(EEG), Evoked Potentials (EP), Electromyography (EMG), Polysomnography (Sleep Analysis) and General Polygraphy.
The Nic36 Amplifier does not contain a Pulse Oximeter module.
The host computer must use one of the following Operating Systems: Microsoft Windows 98, Microsoft Windows NT or Microsoft Windows XP.
The Nic36 Amplifier system consists of three interconnected units: the amplifier box, the The Nicholo Ampiriter System ocubists be AC/DC adapter; optionally the system may be completed by a led visual stimulator.
807.92(a)(5)
Intended Use(s)
The Nic36 Amplifier is intended to be used by or under the direction of a physician for The Nicov Timplifier to graphy and polysomnography signals and transmission of these signals to a PC during recording of neurophysiology examinations.
2
510(k) Summary
EB Neuro, S.p.A.
Nic36 Amplifier
807.92(a)(6)
Technological Characteristics
| Item | EB Neuro
MIZAR Amplifier
K003154 | EB Neuro
Nic36 Amplifier
This Submission |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Acquisition of EEG, polygraphy
and polysomnography signals and
transmission of these signals to a
PC during recording of
neurophysiology examinations | Acquisition of EEG, polygraphy
and polysomnography signals and
transmission of these signals to a
PC during recording of
neurophysiology examinations |
| EEG/Polygraphic channel | 32/40
(64/96/128 with expansion
boards) | 36 monopolar fixed - (no
expansion boards) |
| DC channel | 32/40 | 4 |
| A/D conversion | 16 bit Sigma-Delta A/D
effectively transferred to host | 16 bit SAR effectively transferred
to host |
| Sampling rate | User selectable (128, 256, 512..
.up to 32 KHz/Channel | User selectable (128, 256, 512...
up to 8192 Hz/Channel) |
| CMRR | >100dB | >100dB |
| Noise |