Who is the manufacturer of NEMUS SYSTEM; NEMUS PC PERIPHERAL?

Eb Neuro S.P.A. filed the 510(k) submission for NEMUS SYSTEM; NEMUS PC PERIPHERAL (K073415).

What is the FDA product code for NEMUS SYSTEM; NEMUS PC PERIPHERAL?

IKN. It is classified under 21 CFR 890.1375 as a Class 2 device in the Physical Medicine panel.

What is the regulatory pathway for NEMUS SYSTEM; NEMUS PC PERIPHERAL?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like NEMUS SYSTEM; NEMUS PC PERIPHERAL?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

NEMUS SYSTEM; NEMUS PC PERIPHERAL

Q: What are the predicate devices for NEMUS SYSTEM; NEMUS PC PERIPHERAL?

Esaote Biomedica PHASIS (K922488); Oxford Instruments PLC Sinergy LT (K981405).

K073415 · Eb Neuro S.P.A. · IKN · May 23, 2008 · Physical Medicine

Device Facts

Record ID	K073415
Device Name	NEMUS SYSTEM; NEMUS PC PERIPHERAL
Applicant	Eb Neuro S.P.A.
Product Code	IKN · Physical Medicine
Decision Date	May 23, 2008
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 890.1375
Device Class	Class 2
Attributes	Pediatric

Intended 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).

Device Story

NeMus system and NeMus PC Peripheral are diagnostic electromyographs used in hospitals and clinical environments by physicians. The device detects bioelectric signals from peripheral nerves and skeletal muscles via isolated preamplifiers. It provides electrical or sound stimuli for evoked response (EP) measurements. The system consists of an amplifier (NeMus 1), host PC, and management software (GALILEO NT/MYTOWIN). It performs analog-to-digital conversion of signals, which are then processed, recorded, and displayed on a digital monitor. The system supports various clinical protocols including nerve conduction studies, spontaneous activity, single fiber EMG, and motor unit analysis. Clinicians use the displayed data to aid in the diagnosis and prognosis of neuromuscular diseases. The system is available in a complete cart-based configuration or as a PC peripheral kit.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, including electrical safety (IEC 60601-1, 60601-1-1, 60601-2-26, 60601-2-40, 60601-1-2) and performance comparison of acquisition parameters (CMRR, noise, impedance, filter ranges) against predicate devices.

Technological Characteristics

Class II electromyograph. Components: NeMus 1 amplifier, host PC, optional cart. Connectivity: LAN Ethernet 100 Mbit. Power: 110-240 VAC via isolation transformer. Patient circuitry: Optic isolation. A/D conversion: 24-bit Sigma-Delta. Sampling rate: 4.194 MHz. Input impedance: >1000 MOhm. CMRR: >100 dB. Noise: <0.3 µVrms. Stimulators: Constant current electrical (up to 100 mA) and audio (125-8000 Hz). Software: GALILEO NT/MYTOWIN running on Microsoft Windows. Sterilization: Not applicable (non-invasive).

Indications for Use

Indicated for pediatric through adult patients for the diagnosis and prognosis of neuromuscular diseases via EMG and evoked response measurements (EP). Contraindicated for use in the presence of flammable anesthetics or in conjunction with defibrillation equipment.

Regulatory Classification

Identification

A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.

Predicate Devices

Esaote Biomedica PHASIS (K922488)
Oxford Instruments PLC Sinergy LT (K981405)

Related Devices

K133517 — NEMUS 2 SYSTEM · Eb Neuro S.P.A. · Feb 26, 2014
K242832 — NExT Station; NExT Station Advanced · Eb Neuro S.P.A. · Dec 12, 2024
K120397 — MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM · Nihon Kohden Corp. · Sep 19, 2012
K172743 — Natus VikingQuest · Natus Neurology Incorporated · Dec 19, 2017
K102610 — FOCUS EMG DEVICE · Teleemg, LLC USA · Mar 4, 2011

Submission Summary (Full Text)

{0}------------------------------------------------ K073 4/5 MAY 2 3 2008 # 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 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 IKN Classification Number: 807.92(a)(3) #### Predicate Device(s) | Esaote Biomedica | PHASIS | K922488 | |------------------------|------------|---------| | Oxford Instruments PLC | Sinergy LT | K981405 | Additional Substantial Equivalence Information is provided in the following Substantial Equivalence Comparison Table. {1}------------------------------------------------ 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 with the 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 of neuromuscular diseases (EMG). The device may use electrical 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). {2}------------------------------------------------ ## Technological Characteristics Substantial Equivalence Comparison Table | Product Characteristic | Nemus System (submission device) | PHASIS (predicate device) | Sinergy LT | |-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulatory | | | | | Manufacturer | EBNeuro S.p.A. | Esaote Biomedica | Oxford Instruments plc | | 510(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 | | Product Characteristic | Nemus System (submission device) | PHASIS (predicate device) | Sinergy LT | | Labeling | | | | | Intended use | 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). | The PHASIS electomyograph is intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves for the diagnosis and prognosis of neuromuscular disease | 2 channel electromyograph which provides facilities for EMG and Evoked Potentials testing for a range of clinical application. Synergy LT is designed to enable reliable recording display and documentation of electrophysiological information from the human nervous and muscular system in a clinical environment. | | Warnings | Items related to off- label use. | Items related to off- label use. | Items related to off- label use. | | Contraindication | Items related to design and indicated use limitations, such as not for use in the presence of flammable anesthetics or in conjunction with defibrillation equipment. | Items related to design and indicated use limitations, such as not for use in the presence of flammable anesthetics | Items related to design and indicated use limitations, such as not for use in the presence of flammable anesthetics. | | Target population | Pediatric through adult | Pediatric through adult | Pediatric through adult | | Environment of use | Hospitals, institutions, or other test environments. | Hospitals, institutions, or other test environments | Hospitals, institutions, or other test environments | | Prescription status | Available only on the order of a physician. | Available only on the order of a physician. | Available only on the order of a physician. | | User Service | No user service allowed | No user service allowed | No user service allowed | | Product Characteristic | Nemus System (submission device) | PHASIS (predicate device) | Sinergy LT | | Design - General | | | | | General system approach | Computer based equipment with dedicated hardware peripherals/components | Computer based equipment with dedicated hardware peripherals/components | Computer based equipment with dedicated hardware peripherals/components | | User input device | Microsoft Windows mouse/keyboard driven graphic interface. Dedicated external keyboard (optional) | ASCII keyboard with application specific function key. Re-definable "soft" keys with on-screen indication | Microsoft Windows mouse/keyboard driven graphic interface. | | User output device | Digital color display Commercial printers | Digital color display Commercial printers | Digital color display Commercial printers | | Patient inputs | 2 channels preamplifiers, isolated | 2-4 channels preamplifiers, isolated | 2 channels preamplifiers, isolated | | Signal acquisition | Analog-to-digital conversion at variable sampling rate | Analog-to-digital conversion at variable sampling rate | Analog-to-digital conversion at variable sampling rate | | Trigger input (synchronization to external events) | YES | YES | YES | | Trigger output (synchronization for external devices) | YES | YES | YES | | Footswitch for hands-free operation | YES (optional) | YES | YES | | Use of standard software platform (Operating System) | YES - Microsoft Windows | YES - Motorola Versados | YES - Microsoft Windows | | Customization of clinical protocols | Via storage / retrieval of user-defined settings | Via storage / retrieval of user-defined settings | Via storage / retrieval of user-defined settings | | Application flexibility / expandability | Via software update | Via software update | Via software update | | Safety Standards | IEC 60601-1 IEC 60601-1-1 IEC 60601-2-26 | IEC 60601-1 | IEC 60601-1 | | | IEC 60601-2-40 IEC 60601-1-2 | | | | Patient circuitry isolation | optic | optic | optic | | System Components | Nemus 1 Base Unit (Amplifier) Host Computer (PC) Printer (optional) Cart (optional) Dedicated Keyboard (optional) | Headbox (Amplifier) Computer Cart Printer (optional) | Headbox (Amplifier) Computer (PC) Cart Printer (optional) | | Amplifier- Computer interface | LAN Ethernet 100 Mbit | proprietary | proprietary | | System Power Supply | From mains (110-240 VAC) trough isolation transformer | From mains (110-240 VAC) | From mains (110-240 VAC) | | Amplifier Power Supply | 15 VDC from medical approved AC/DC converter | Internal power supply | Internal power supply | | Size (H/W/D) mm | Nemus System : 1250/750/850 (complete system, with cart, monitor, arm ) | 238/457/413 | 500/209/321 ( cart : 720/640/780 ) | | Weight (complete system - kg) | Nemus System : 90 (complete system, with cart, monitor, arm) | 80 (with cart) | 55 (with cart) | . · 1 {3}------------------------------------------------ · {4}------------------------------------------------ . {5}------------------------------------------------ : . {6}------------------------------------------------ | Product Characteristic | Nemus System (submission device) | PHASIS (predicate device) | Sinergy LT | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Design - Acquisition | | | | | Number of channels | 2 | 2/4 | 2 | | CMRR | >100 dB | >100 dB | > 110 dB | | Noise | <0.3 µVrms (0.1 - 00 Hz) $ < 20 nV/Hz^{\frac{1}{2}} $ (10 Hz - 10 kHz ) | <0.9 µVrms (0.1 Hz - 10 kHz) | <0.7 µVrms (0.1 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 step) | 10 Hz - 20 kHz (11 step) | 50 Hz - 16 kHz (10 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 µs 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, External | Recurrent, manual, self, external | Auto, Internal, External | | Signal delay (pre/post) | 0-5 div | 0-5 div | 0-9 div | | Ohmmeter | 0-100 kOhm (auto full scale) | 0-100 kOhm (auto full scale) | 0 - 32 kOhm | | Product Characteristic | Nemus System (submission device) | PHASIS (predicate device) | Sinergy LT | | Design - Stimulators | | | | | Somatosensory (electrical) Stimulator | Type: constant current N. output : 1 Max output : 100 mA Pulse width: 0.05 - 1ms Mode: single, train | Type: constant current/voltage N. output : 1 Max output:100 mA Pulse width: 0.01 - 1 ms Mode: single, recurrent, paired, trains | Type: constant current/voltage N. output : 1 Max output: 100 mA Pulse width: 0.05-1 ms Mode: single, double, train | | Audio Stilmulator | Output mode: click, tone Sound pressure: 0-132 dB SPL Phase: condens., raref., alternate Signal frequency: 125- 8000 Hz Plateau time: 1-200 ms Rise/fall time: 1-100 ms Mask level: -40 - +10 dB (relative) Click width: 1-100 μs Stimulus presen. Left, right, binaural Headset: TDH 39 | Output mode: click, pip, tone Sound pressure: 20-132 dB SPL Phase: condens., raref., alternate Signal frequency: 125- 8000 Hz Plateau time: 0-200 ms Rise/fall time: 0-200 ms Mask level: 0-90 dB Click width: 50-500 μs Stimulus presen. Left, right, binaural Headset: TDH 50P | Output mode: click. pip, tone Sound pressure: 0-122 dB SPL Phase: condens., raref., alternate Signal frequency: 125- 8000 Hz Plateau time: 1-999 ms Rise/fall time: 1-255 ms Mask level: -40 - +10 dB (relative) Click width: 0.05-1ms Stimulus presen. Left, right, binaural Headset: TDH 39 | | Basic EMG application modules : Free run acquisition Nerve conduction study Self triggered acquisition Spontaneous activity Single fiber EMG Motor Unit Analysis | YES YES YES YES YES YES | YES YES YES YES YES YES | YES YES YES YES YES YES | | F wave analysis Basic EP application modules Somatosensory EP Auditory EP | YES YES YES | YES YES YES | YES YES YES | | Visual EP (flash) | NO…