(29 days)
No
The description focuses on signal acquisition, amplification, conversion, and transmission. There is no mention of AI or ML algorithms for analysis or interpretation of the signals.
No
The device is described as an amplifier for acquiring and transmitting neurophysiology signals; it does not directly treat or alleviate a medical condition.
Yes
The device is intended for the acquisition of various physiological signals (EEG, polygraphy, polysomnography, evoked potentials, electromyography), which are used by physicians for neurophysiology examinations and sleep analysis. This signal acquisition is a crucial step in the diagnostic process.
No
The device description explicitly details hardware components like an amplifier box, headbox, PC interface, and AC/DC adapter, indicating it is not software-only.
Based on the provided information, the Sandman SD20 Amplifier is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the acquisition and transmission of physiological signals (EEG, polygraphy, polysomnography) from the human body during neurophysiology examinations. This involves measuring electrical activity and other physical parameters directly from the patient.
- 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 analysis by a host computer. This is a process of acquiring and processing signals from the living body.
- Lack of In Vitro Activity: An IVD device is specifically designed to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease. The Sandman SD20 Amplifier does not perform any analysis on such specimens. It directly interacts with the patient's body to capture signals.
The device falls under the category of medical devices used for physiological monitoring and diagnosis based on signals acquired in vivo (within the living body).
N/A
Intended Use / Indications for Use
The Sandman SD20 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 Sandman SD20 Amplifer is a fully programmable system which provides a total of 22 analog input channels cach 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 601-1 requirements, which feeds a +15VDC. Internally, the +15VDC is further isolated by a dedicated DC/DC CF type converter.
The Sandman SD20 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), Electromyography (EMG), Polysomnography (Sleep Analysis) and General Polygraphy.
The Sandman SD20 Amplifier contains a Pulse Oximeter module. The data measured from this module is passed to the host computer together with the other channels' data. The MP100 Pulse Oximeter module, developed by Nellcor Puritan Bennett, is substantially equivalent to Nellcor Puritan Bennett's MP400 Pulse Oximeter module cleared with EB Neuro's Mizar Amplifier via K003154.
The host computer must use one of the following Operating Systems: Microsoft Windows 98, Microsoft Windows NT or Microsoft Windows XP.
The Sandman SD20 Amplifier system consists of four interconnected units: the headbox, the amplifier box, the PC interface (BE Net/Sandman eLink) and the AC/DC adapter.
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)
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
Ko40113
場
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR1807.92(a).
807.92(a)(1)
. . . . . .
Submitter Information
Colleen J. Hittle-Densmore, Official Corresondent The Anson Group 7992 Castleway Drive Indianapolis, Indiana 46250
(317) 849-1916 Phone: (317) 577-9070 Facsimile:
Contact Person: Colleen J. Hittle-Densmore
January 14, 2004 Date:
807.92(a)(2)
Trade Name: Sandman SD20 Amplifier
Physiological Signal Amplifier Common Name:
Physiological Signal Amplifier Classification Name(s):
Classification Number: 84GWL
807.92(a)(3)
.
Predicate Device(s)
| EB Neuro, S.p.A. | Mizar Amplifier | K003 154 |
|---|---|---|
| ------------------ | ----------------- | ---------- |
Additional Substantial Equivalence Information is provided in the following Substantial Equivalence Comparison Table.
1
Device Description
The Sandman SD20 Amplifer is a fully programmable system which provides a total of 22 analog input channels cach 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 601-1 requirements, which feeds a +15VDC. Internally, the +15VDC is further isolated by a dedicated DC/DC CF type converter.
The Sandman SD20 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), Electromyography (EMG), Polysomnography (Sleep Analysis) and General Polygraphy.
The Sandman SD20 Amplifier contains a Pulse Oximeter module. The data measured from this module is passed to the host computer together with the other channels' data. The MP100 Pulse Oximeter module, developed by Nellcor Puritan Bennett, is substantially equivalent to Nellcor Puritan Bennett's MP400 Pulse Oximeter module cleared with EB Neuro's Mizar Amplifier via K003154.
The host computer must use one of the following Operating Systems: Microsoft Windows 98, Microsoft Windows NT or Microsoft Windows XP.
The Sandman SD20 Amplifier system consists of four interconnected units: the headbox, the amplifier box, the PC interface (BE Net/Sandman eLink) and the AC/DC adapter.
807.92(a)(5)
Intended Use(s)
The Sandman SD20 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.
2
807 92(a)(6)
:
Technological Characteristics
| Item | EB Neuro
MIZAR Amplifier
K003154 | EB Neuro
SD 20 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 | 19 (16 monopolar + 3 bipolar) |
| DC channel | 32/40 | 3 (+3 dedicated ) |
| 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) |
| CMMR | >100dB | >100dB |
| Noise |