5 10(k) Summary

EB Neuro, S.p.A.
(073 5
Nemus MAY 2 320

510(k) Summary
The following 5 10(k) summary has been prepared pursuant to requirements specified in
2 1 CFR¶807.92(a).

807.92(a)(1)
Submitter Information

Allison Scott
Official Correspondent
The Anson Group
11460 N. Meridian St.
Suite 150
Carmel, IN 46032

Phone: (317) 569-9500 x 106

Facsimile: (317) 569-9520

Contact Person: Allison Scott

Date: December 3, 2007

807.92(a)(2~)

Trade Names: Nemus System

Nemus PC Peripheral

Common Name: Electromyograph

Classification Name(s): Electromyograph

Classification Number: IKN

807.92(a)(3)
Predicate Device(s)
Esaote Biomedica PHASIS K922488
Oxford Instruments PLC Sinergy LT K98 1405

Additional Substantial Equivalence Information is provided in the following Substantial

Equivalence Comparison Table.
510(k) Summary
EB Neuro, S.p.A.
Nemus

807.92 (a)(4)
Device Description

There are two configurations of NeMus: NeMus System and NeMus PC Peripheral.

The "Nemus system" is a complete system provided with a cart (expressly designed for this
device and equipped with isolation transformer, the base unit support mobile arm, places for
computer, keyboard, footswitch, printer, and dedicated keyboard and so on. The complete system
provided of all the part ordered by the customer is completely wired, assembled and tested in
factory before to ship to the final user. Like the hardware parts, all the needed software is
installed and configured in factory.

The "Nemus PC Peripheral" is a base kit (constituted by the NeMus 1 Amplifier the AC/DC
adapter, cables and GALILEO NT management software) which, by adding a Personal
Computer, becomes a digital electromiograph system. This configuration is developed and
verified in order to allow a Distributor or the User to "build" an acquisition/processing EMG
signal system by using the NeMus 1 acquisition module, the GALILEO NT/MYTOWIN
management software and their own Personal Computer (and peripherals). However the PC must
be compliant with EBNeuro specified minimum requirements. Of course the "system builder"
must follow all the indications detailed in the related User Manual provided withthe-system. In
this kind of system configuration, the "base kit" provided by EBNeuro is a sort of "peripheral" of
a PC system. This configuration allows the Distributor or the User to use its own PC, cart or
other "system" arrangement of its choice.

NeMus systems are diagnostic medical systems able to detect the electric signals produced by the
peripheral nerve system and by skeletal muscles.

The Nemus system is intended to monitor, record and display the bioelectric signal produced by
the muscles, to stimulate peripheral nerves, and to monitor, record and display the electrical
activity produced by nerves to aid the clinician in the diagnosis and prognosis of neuromuscular
diseases (EMG). The device may use electrical stimulus, visual stimulus or sound stimulus for
use in evoked response measurements (EP).

807.92(a)(5)
Intended Use(s)
NEMUS systems are diagnostic medical systems able to detect the electric signals produced by
the peripheral nerve system and by skeletal muscles.

The NEMUS system is intended to monitor, record and display the bioelectric signal produced by
the muscles, to stimulate peripheral nerves, and to monitor, record and display the electrical
activity produced by nerves to aid the clinician in the diagnosis and prognosis of neuromuscular
diseases (EMG). The device may use electrical stimulus or sound stimulus for use in evoked
response measurements (EP).
510(k) Summary
EB Neuro, S.p.A.
Nemus
807.92(a)(6)
Technological Characteristics
Substantial Equivalence Comparison Table

Product Nemus System, PHASIS SnryL

Characteristic (s lumision device) (predicate device)

Regulatory

Manufacturer EBNeuro S.p.A. Esaote Biomedica Oxford Instruments

plc
5 10(k) number Not assigned K922488 K981405

Device class Class II Class II Class II

Product code IKN IKN GMF
Device type Electromyograph Electromyograph Stimulator, Electrical,
Evoked response
Regulation Number 890.1375 890.1375 882.1870
510(k) Summary
EB Neuro, S.p.A.
Nemus

Product Nemus System PISSSinergy LT

Characteristic sumission devc)(rdct eie

Labeling

Intended use The NEMUS system is The PHASIS 2 channel

intended to monitor, electomyograph is electromyograph which
record and display the intended for medical provides facilities for
bioelectric signal purposes, such as to EMG and Evoked
produced by the muscles, monitor and display the Potentials testing for a
to stimulate peripheral bioelectric signals range of clinical
nerves, and to monitor, produced by muscles, to application.
record and display the stimulate peripheral Synergy LT is designed
electrical activity nerves, and to monitor and to enable reliable
produced by nerves to aid display the electrical recording display and
the clinician in the activity produced by documentation of
diagnosis and prognosis of nerves for the diagnosis electrophysiological
neuromuscular diseases and prognosis of information from the
(EMG). The device may neuromuscular disease human nervous and
use electrical stimulus or muscular system in a
sound stimulus for use in clinical environment.
evoked response
measurements (EP).
Warnings Items related to off- Items related to off- Items related to off-
label use. label use. label use.
Contraindication Items related to design Items related to design Items related to
and indicated use and indicated use design and indicated
limitations, such as not limitations, such as not use limitations, such
for use in the presence for use in the presence as not for use in the
of flammable of flammable presence of
anesthetics or in anesthetics flammable
conjunction with anesthetics.
defibrillation
equipment.
Target population Pediatric through adult Pediatric through adult Pediatric through
adult
Environment of use Hospitals, institutions, Hospitals, institutions, Hospitals,
or other test or other test institutions, or other
environments. environments test environments
Prescription status Available only on the Available only on the Available only on the
order of a physician. order of a physician. order of a physician.
User Service No user service allowed No user service allowed No user service allowed
510(k) Summary
EB Neuro, S.p.A.
Nemus

Product Nemus System PHAI inergy LT

Characteristic -(submission device) (preiatdec)

Design - General

Computer based Computer based Computer based

General system equipment with dedicated equipment with dedicated equipment with
approach hardware hardware dedicated hardware
peripherals/components peripherals/components peripherals/components

Microsoft Windows ASCII keyboard with Microsoft Windows

User input device mouse/keyboard driven application specific mouse/keyboard driven
graphic interface. function key. graphic interface.
Dedicated external Re-definable "soft" keys
keyboard (optional) with on-screen indication
User output device Digital color display Digital color display Digital color display
Commercial printers Commercial printers Commercial printers

Patient inputs 2 channels preamplifiers, 2-4 channels 2 channels

isolated preamplifiers, isolated preamplifiers, isolated
Signal acquisition Analog-to-digital Analog-to-digital Analog-to-digital
conversion at variable conversion at variable conversion at variable
sampling rate sampling rate sampling rate
Trigger input YES YES YES
(synchronization to
external events)

Trigger output YES YES YES

(synchronization for
external devices)

Footswitch for YES (optional) YES YES

hands-free
operation

Use of standard YES - Microsoft YES - Motorola Versados YES - Microsoft

software platform Windows Windows
(Operating System)

Customization of Via storage / retrieval of Via storage / retrieval of Via storage / retrieval
clinical protocols user-defined settings user-defined settings of user-defined settings

Application Via software update Via software update Via software update
flexibility /
expandability

Safety Standards IEC 60601-1 IEC 60601-1 IEC 60601-1

IEC 60601-1-1
IEC 60601-2-26
510(k) Summary
EB Neuro, S.p.A.
Nemus
IEC 60601-2-40
IEC 60601-1-2

Patient circuitry optic optic optic

isolation
Nemus I Base Unit Headbox (Amplifier) Headbox (Amplifier)
System (Amplifier) Computer Computer (PC)
Components Host Computer (PC) Cart Cart
Printer (optional) Printer (optional) Printer (optional)
Cart (optional)
Dedicated Keyboard
(optional)
Amplifier- LAN Ethernet 100 Mbit proprietary proprietary
Computer interface

System Power From mains (110-240 From mains (110-240 From mains (110-240
Supply VAC) trough isolation VAC) VAC)
transformer
Amplifier Power 15 VDC from medical Internal power supply Internal power supply
Supply approved AC/DC
converter
Size (H/W/D) mm 238/457/413 500/209/321
Nemus System: (cart: 720/640/780)
1250/750/850 (complete
system, with cart, monitor,
arm)

Weight 80 (with cart) 55 (with cart)

(complete system - Nemus System: 90
kg) (complete system, with
cart, monitor, arm)
5 10(k) Summary
EB Neuro, S.p.A.
Nemus

Product Nemnus System P7HAS

IS Siniergy LT
Characteristic (submission device) (predicatevce

Design - Acquisition

Number of channels 2 2/4 2

CMRR >100 dB >100 dB > 110 dB

Noise < 0.3 piVrms (0.1- 00 <0.9 [tVrms <0.7 ptVrms

Hz) (0.1 Hz - 10 kHz) (0.1 Hz - 10 kHz)
< 20 nV/Hz 2
( 10 Hz - 10 kHz)
Input impedance > 1000 MOhm / 8 pF > 100 MOhm / 15 pF > 1000 MOhm / 30 pF

Low pass filter 20 Hz- 16 kHz (15 10 Hz- 20 KHz (11 50 Hz- 16 kHz (10
step) step) step)
High pass filter 0.01 - 500 Hz (11 step) 0.01- 500 Hz (13 step) DC, 30 - 2000 Hz

Notch filter 50/60 Hz selectable 50/60 Hz selectable 50/60 Hz selectable

A/D conversion 24 bit Sigma-Delta 16 bit 16 bit

Sampling rate 4.194 MHz 0.5 is max 50 kHz

Analysis time 5 ms - 10 s 1 ms - 20 s 5 ms- 10s

Time base Single Single, dual single

Trigger mode Free, Auto, Internal, Recurrent, manual, self, Auto, Internal, External
External external
Signal delay 0-5 div 0-5 div 0 -9 div
(pre/post)
Ohmmeter 0-100 kOhm (auto full 0-100 kOhm (auto full 0 - 32 kOhm
scale) scale)
510(k) Summary
EB Neuro, S.p.A.
Nemus

Product Niemus System PHASIS Sinergy LT

Characteristic 1 (submiission device) (Predicate device)

Design - Stimulators

Somatosensory
(electrical) Stimulator Type: constant current Type: constant Type: constant
current/voltage current/voltage
N. output: 1 N. output: 1 N. output: 1
Max output: 100 mA Max output:O00 mA Max output: 100 mA
Pulse width: 0.05- Pulse width: 0.01 - 1 ms Pulse width: 0.05-1 ms
lms Mode: single, recurrent, Mode: single, double,
Mode: single, train paired, trains train

Audio Stilmulator
Output mode: click, Output mode: click, pip, Output mode: click,
tone tone pip, tone
Sound pressure: 0-132 Sound pressure:20-132 Sound pressure: 0-122
dB SPL dB SPL dB SPL
Phase: condens., raref, Phase: condens., raref, Phase: condens., raref.,
alternate alternate alternate
Signal frequency: 125- Signal frequency: 125- Signal frequency: 125-
8000 Hz 8000 Hz 8000 Hz
Plateau time: 1-200 ms Plateau time: 0-200 ins Plateau time: 1-999 ms
Rise/fall time: 1-100 Rise/fall time: 0-200 ms Rise/fall time: 1-255 ms
ms Mask level: 0-90 dB Mask level: -40 - +10
Mask level: -40 - +10 dB (relative)
dB (relative) Click width: 50-500 Is Click width: 0. 05-1Ims
Click width: 1-100 Is Stimulus presen. Left, Stimulus presen. Left,
Stimulus presen. Left, right, binaural right, binaural
right, binaural Headset: TDH 50P Headset: TDH 39
Headset: TDH 39

Basic EMG application

modules:

Free run acquisition YES YES YES

Nerve conduction study YES YES YES
Self triggered acquisition YES YES YES
Spontaneous activity YES YES YES
Single fiber EMG YES YES YES
Motor Unit Analysis YES YES YES
F wave analysis YES YES YES

Basic EP application
modules

Somatosensory EP YES YES YES

Auditory EP YES YES YES
510(k) Summary
EB Neuro, S.p.A.
Nemus
Visual EP (flash) NO YES YES
Visual EP (pattern) NO YES YES
 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

%4 Food and Drug Administration

9200 Corporate Boulevard
Rockville MD 20850

Eb Neuro S.p.A MAY 2 3 2008

% The Anson Group
Ms. Allison Scott
Official Correspondent
11460 North Meridian Street, Suite 150
Carmel, Indiana 46032

Re: K073415
Trade/Device Name: Nemus System and Nemus PC Peripheral
Regulation Number: 21 CFR 890.1375
Regulation Name: Diagnostic Electromyograph
Regulatory Class: Class II
Product Code: IKN, GWF, GWJ, JXE
Dated: May 9, 2008
Received: May 12, 2008

Dear Ms. Scott:

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 to 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 either 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.
Page 2 - Ms. Allison Scott

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance
at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket
notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact
CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240)
276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting
(MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other
general information on your responsibilities under the Act from the Division of Small Manufacturers,
International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the
Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson
Director
Division of General, Restorative
and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure
 Indications for Use
510(k) Number (if known):

Device Name: NeMus system & NeMus PC Peripheral

Indications For Use:

NEMUS systems are diagnostic medical systems able to detect the electric signals produced by
the peripheral nerve system and by skeletal muscles.

The NEMUS system is intended to monitor, record and display the bioelectric signal produced
by the muscles, to stimulate peripheral nerves, and to monitor, record and display the
electrical activity produced by nerves to aid the clinician in the diagnosis and prognosis of
neuromuscular diseases (EMG). The device may use electrical stimulus or sound stimulus for
use in evoked response measurements (EP).

Prescription Use X AND/OR Over-The-Counter Use

(Part 21 CFR 801 Subpart D) (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)

(Division Sign-Off)
Division of General, Restorative.
and Neurological Devices

510(k) NumberJ§Ž7ILL5