(28 days)
Not Found
No
The description focuses on signal acquisition, amplification, and digital conversion, with no mention of AI or ML for analysis or interpretation.
No
The device is used for acquisition and transmission of biological signals for diagnostic purposes (EEG, polygraphy, polysomnography), not for treating or rehabilitating a condition.
Yes
The device is described as an amplifier for acquiring EEG, polygraphy, and polysomnography signals for neurophysiology examinations, which are used to diagnose neurological conditions. It amplifies and converts bioelectric signals from the human body for analysis, indicating its role in diagnosis.
No
The device description explicitly details hardware components such as an amplifier box, PC interface (PCMCIA or BE Net), and an AC/DC adapter, indicating it is not solely software.
Based on the provided information, the BE Plus / AURA-LTM64 Amplifier is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the acquisition and transmission of bioelectric signals (EEG, polygraphy, polysomnography) from the surface of the human body during neurophysiology examinations. This involves directly interacting with the patient's body to capture signals.
- Device Description: The device amplifies and filters bioelectric signals captured via leads or transducers on the surface of the human body. It converts these signals to digital form for processing by a host computer.
- Lack of In Vitro Activity: IVD devices are intended for the examination of specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not process or analyze such specimens. It directly measures physiological signals from the living body.
Therefore, the BE Plus / AURA-LTM64 Amplifier falls under the category of a medical device used for physiological monitoring and recording, not an IVD.
N/A
Intended Use / Indications for Use
The BE Plus / AURA-LTM64 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 BE Plus / AURA-LTM64 Amplifier is a fully programmable system which provides a total of 64 analog input channels each of which can be configured, amplified and converted to digital form (analog to digital conversion). The amplifier receives its power from a dedicated AC/DC adapter, meeting the IEC 60601-1 requirements, which feeds a +15VDC. Internally, the +15VDC is further isolated by a dedicated DC/DC CF type converter.
The BE Plus / AURA-LTM64 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 form and passes it on to a host computer running appropriate amplification software. Typical fields of application will be: Electroencephalograph (EEG), Evoked Potentials (EP), Polysomnography (Sleep Analysis) and General Polygraphy.
The BE Plus / AURA-LTM64 Amplifier does not contains 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 BE Plus / AURA-LTM64 Amplifier system consists of three interconnected units: the amplifier box, the PC interface (PCMCIA interface or BE Net) 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 bodi
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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. BE Plus / AURA-LTM64 Amplifier
JAN 2 4 2006
053606
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 Correspondent
The Anson Group
11460 N. Meridian St.
Suite 150
Carmel, IN 46032
| Phone: | (317) 569-9500 x 103 |
|---|---|
| Facsimile: | (317) 569-9520 |
| Contact Person: | Carri Graham |
| Date: | December 22, 2005 |
807.92(a)(2)
| Trade Name: | BE Plus / AURA-LTM64 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 |
|---|---|---|
| EB Neuro, S.p.A. | NIC36 Amplifier | K041198 |
Additional Substantial Equivalence Information is provided in the following Substantial Equivalence Comparison Table.
f. 1 of 5
10
1
510(k) Summary EB Neuro, S.p.A. BE Plus / AURA-LTM64 Amplifier
807.92 (a)(4)
Device Description
The BE Plus / AURA-LTM64 Amplifier is a fully programmable system which provides a total of 64 analog input channels each of which can be configured, amplified and converted to digital form (analog to digital conversion). The amplifier receives its power from a dedicated AC/DC adapter, meeting the IEC 60601-1 requirements, which feeds a +15VDC. Internally, the +15VDC is further isolated by a dedicated DC/DC CF type converter.
The BE Plus / AURA-LTM64 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 form and passes it on to a host computer running appropriate amplification software. Typical fields of application will be: Electroencephalograph (EEG), Evoked Potentials (EP), Polysomnography (Sleep Analysis) and General Polygraphy.
The BE Plus / AURA-LTM64 Amplifier does not contains 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 BE Plus / AURA-LTM64 Amplifier system consists of three interconnected units: the amplifier box, the PC interface (PCMCIA interface or BE Net) and the AC/DC adapter; optionally the system may be completed by a led visual stimulator.
807.92(a)(5)
Intended Use(s)
The BE Plus / AURA-LTM64 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.
5 2015 11
2
807.92(a)(6)
Technological Characteristics
| Item | EB Neuro
MIZAR Amplifier
K003154 | EB Neuro
Nic36 Amplifier
K041198 | EB Neuro
BE Plus / AURA-
LTM64 Amplifier
This Submission |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Acquisition of EEG, polygraphy and polysomnography signals and transmission of these to a PC during recording of neurophysiology examinations | Acquisition of EEG, polygraphy and polysomnography signals and transmission of these to a PC during recording of neurophysiology examinations | Acquisition of EEG, polygraphy and polysomnography signals and transmission of these 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) | 64 monopolar (128 with the double Amplifier configuration expansion) |
| DC channel | 32/40 | 4 | 4 |
| A/D conversion | 16 bit Sigma-Delta A/D effectively transferred to host | 16 bit SAR effectively transferred to host | 16 bit SAR effectively transferred to host |
| Sampling rate | User selectable (128, 256, 512 ... up to 32KHz/Channel) | User selectable (128, 256, 512... up to 8192 Hz/Channel) | User selectable (128, 256, 512... up to 4096 Hz/Channel) |
| CMRR | >100dB | >100dB | >100dB |
| Noise |