← Product Code [GWL](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWL) · K040113 # SANDMAN SD20 AMPLIFIER (K040113) _Eb Neuro S.P.A. · GWL · Feb 18, 2004 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWL/K040113 ## Device Facts - **Applicant:** Eb Neuro S.P.A. - **Product Code:** [GWL](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWL.md) - **Decision Date:** Feb 18, 2004 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 882.1835 - **Device Class:** Class 2 - **Review Panel:** Neurology ## 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. ## Device Story Sandman SD20 Amplifier is a programmable system for acquiring bioelectric signals (EEG, EP, EMG, polysomnography, polygraphy) via surface leads/transducers. Device includes a headbox, amplifier box, PC interface (BE Net), and AC/DC adapter. It captures analog signals, performs A/D conversion, and transmits data to a host PC running amplification software. Includes an integrated Nellcor Puritan Bennett MP100 pulse oximeter module. Used in clinical settings under physician direction. Output is displayed on a PC for clinical review, aiding in neurophysiological diagnosis and sleep analysis. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics System consists of headbox, amplifier, and BE Net interface. Features 16-bit SAR A/D conversion, >100dB CMRR, and fiber optic isolation (CF type). Power via external IEC 601-1 AC/DC adapter. Connectivity via BE Net. Software is resident and runtime downloadable. Complies with IEC 601-1, IEC 601-1-2, and IEC 601-1-4 safety standards. ## Regulatory Identification A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram). ## Predicate Devices - Mizar Amplifier ([K003154](/device/K003154.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 | < 1.5 $\mu$ Vpp | <0.5 $\mu$ Vrms(AC) <7 $\mu$ Vrms(DC) | | Power Supply | External IEC 601-1 mains adapter (standard) Internal batteries (optional) | External IEC 601-1 mains adapter | | Internal Storage | N/A | N/A | | Amplifier - PC Interface | PCMCIA or BE Net | BE Net | | Other Interfaces | 128x64 graph LCD display 5 push buttons | Power on LED (amplifier) LED matrix Ohm Meter (headbox) | | Use standard sensors and electrodes | Yes (electrodes and sensors are not included with the Amplifer) | Yes (electrodes and sensors are not included with the Amplifier) | | Dimension | 25 x 17 x 6.5 cm | 3.5 x 13.5 x 10.5 cm (amplifier)
12.6 x 9.6 x 2.5 cm (headbox) | | Weight | 1.5 Kg | 0.3 Kg (amplifier);
< 0.3 Kg (headbox) | {3}------------------------------------------------ | Item | EB Neuro
MIZAR Amplifier
K003154 | EB Neuro
SD 20 Amplifier
This Submission | |-----------------------------------|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------| | Isolation | Fiber optic link
Patient isolation BF type | Fiber optic link
Patient isolation CF type | | Safety Standards | IEC 601-1-1
IEC 601-1-2
IEC 601-1-4 | IEC 601-1
IEC 601-1-2
IEC 601-1-4 | | System Components | Head box
Amplifier
AC/DC Adapter
PCMCIA or BE Net Interfaces | Head box
Amplifier
AC/DC Adapter
BE Net Interface | | Firmware | Resident and Runtime
downloadable | Resident and Runtime
downloadable | | Head box connection and
inputs | 32 monopolar; 8 bipolar; 1
Thermistor | 16 inputs - 16 plugs
3 inputs - 6 plugs
1 Thermistor dedicated input
1 Body position dedicated input
1 Pressure sensor dedicated input | | Pulse Oximetry Module | Nellcor Puritan Bennet MP404 | Nellcor Puritan Bennet MP100 | | DC Expansion Module | Yes | Yes | | Accessory | | | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. FEB 1 8 2004 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 EB Neuro, S.p.A. c/o Ms. Colleen Densmore The Anson Group 7992 Castleway Drive Indianapolis, Indiana 46250 Re: K040113 Trade/Device Name: Sandman SD20 Amplifier Regulation Number: 21 CFR 882.1835 Regulation Name: Physiological signal amplifier Regulatory Class: II Product Code: GWL Dated: January 14, 2004 Received: January 20, 2004 Dear Ms. Densmore: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or 10 devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {5}------------------------------------------------ Page 2 - Ms. Colleen Densmore This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely vours. sincerely yours, Mark N Mulhern Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ # Indications for Use 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K040113 SD20 Amplifier Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications For Use: The 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. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Mark N Milken (Division Sign-Off) Division of General, Restorative, and Heardlogical Devices 510 K040113 510 --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWL/K040113](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWL/K040113) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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