Who is the manufacturer of FOCUS EMG DEVICE?

Teleemg, LLC USA filed the 510(k) submission for FOCUS EMG DEVICE (K102610).

What is the FDA product code for FOCUS EMG DEVICE?

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 FOCUS EMG DEVICE?

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

Who can help prepare an FDA 510(k) submission like FOCUS EMG DEVICE?

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.

FOCUS EMG DEVICE

Q: What are the predicate devices for FOCUS EMG DEVICE?

Nemus System (K073415); Synergy LT (K981405).

K102610 · Teleemg, LLC USA · IKN · Mar 4, 2011 · Physical Medicine

Device Facts

Record ID	K102610
Device Name	FOCUS EMG DEVICE
Applicant	Teleemg, LLC USA
Product Code	IKN · Physical Medicine
Decision Date	Mar 4, 2011
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 890.1375
Device Class	Class 2

Intended Use

The Focus is intended for use by a healthcare provider to perform nerve conductions and EMG studies as an aid in the evaluation of patients with diseases of muscle and nerves. The machine can also use electrical stimulus or sound stimulus for evoked potentials (EP) studies.

Device Story

Focus EMG Device is a 2-channel neurodiagnostic system for recording, displaying, and documenting electrophysiological signals (biopotentials) from human nervous and muscular systems. Used in clinical environments by healthcare providers, the device performs nerve conduction studies, needle EMG, and evoked potentials (EP) using electrical or sound stimuli. Input signals from electrodes are amplified, quantized via ADC, and processed by microcontrollers (MC1-MC4) before transmission to a Windows-based PC. The system includes a handheld electronic unit, stimulator unit (steel electrodes/felt pads), and footswitch. The GUI allows clinicians to adjust settings, customize protocols, and review traces. Output data assists clinicians in diagnosing neuro-muscular diseases. The device benefits patients by providing reliable diagnostic data for evaluating central and peripheral nervous system symptoms.

Clinical Evidence

No clinical testing was conducted to support this submission. Substantial equivalence is based on bench testing, hardware/software validation, and adherence to recognized international safety standards (IEC 60601 series).

Technological Characteristics

2-channel neurodiagnostic system; stainless steel electrodes/felt pads (cleared under K060584); USB-connected electronic unit; 16-bit ADC; sampling rate 200-80,000 Hz; CMRR >100 dB; input impedance >100 MOhm; Windows-based software; galvanic isolation; electrical/auditory/photic stimulation; IEC 60601-1, 60601-1-2, 60601-2-40, 62471 compliance.

Indications for Use

Indicated for use by healthcare providers to perform nerve conduction, EMG, and evoked potential (EP) studies to aid in the evaluation of patients with muscle and nerve diseases.

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

Nemus System (K073415)
Synergy LT (K981405)

Related Devices

K070109 — NEUROMETRIX ADVANCE · Neurometrix, Inc. · Apr 25, 2008
K133517 — NEMUS 2 SYSTEM · Eb Neuro S.P.A. · Feb 26, 2014
K965065 — TECA. MILLENNIUM · Medelec , Ltd. · Jun 20, 1997
K120979 — CAREFUSION NICOLET EDX · Carefusion 209, Inc. · Apr 25, 2012
K120397 — MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM · Nihon Kohden Corp. · Sep 19, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ # 510(k) Summary for the TeleEMG, LLC ### Focus (per 21 CFR 807.92 and http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm) ## 1. SUBMITTER/510(K) HOLDER TeleEMG, LLC 65 Arlington Road Woburn, MA 01801, USA Contact Person: Joe F. Jabre, M.D. Telephone: 617-840-3253 Date Prepared: August 10, 2010 # 2. DEVICE NAME | Proprietary Name: | Focus EMG Device | |----------------------|----------------------------| | Common/Usual Name: | Diagnostic Electromyograph | | Classification Name: | Diagnostic Electromyograph | | Product Code: | IKN, JXE | ## 3. PREDICATE DEVICES - · Nemus System, K073415 - · Synergy LT, K981405 ### 4. DEVICE DESCRIPTION ### Physical Description The Focus is a 2-channel neurodiagnostic testing system designed to enable reliable recording, display and documentation of electrophysiological information from the human nervous and muscular systems in a clinical environment. The system enables the healthcare provider to perform evoked potentials, nerve conductions and needle EMG studies as an aid in the evaluation of patients with central and peripheral nervous system symptoms. The device provides functionality for the Electromyography (EMG), Nerve Conduction Studies (NCS), and Evoked Potential (EP) testing for a range of clinical applications and has a fast, intuitive and flexible graphical user interface (GUI) that conforms to a Windows philosophy. The Focus provides the healthcare professional with: TeleEMG LLC, Traditional 510(k) - Focus K102610 {1}------------------------------------------------ - · A means of adjusting or activating all of the unit's settings and controls. - · Multiple ways in which a user can carry a task, such as from a menu, using the mouse or the keyboard or by double-clicking on an icon. - · Configurable function keys and fields that enable the user to customize the interface to meet their requirements. - · Single-stroke keyboard function keys for key tasks carried out during a patient examination. In addition to using the GUI, key tasks can be carried out via control switches on the Control Panel, Patient Interface Unit, Amplifiers, and Footswitch. ### Intended Use The Focus is intended for use by a healthcare provider to perform nerve conductions and EMG studies as an aid in the evaluation of patients with diseases of muscle and nerves. The machine can also use electrical stimulus or sound stimulus for evoked potentials (EP) studies. ## How the Device Functions The device's principle of operation is based on the recording and input of electrical physiological signals (biopotentials) to a computer with the purpose of its analysis. The functional scheme of the device is represented in the figure below: {2}------------------------------------------------ Image /page/2/Figure/0 description: This image is a block diagram of a biopotential recording system. The diagram includes several components, such as a galvanically isolated amplifier unit, an auditory and photic stimulators unit, and a board of indication and keyboard. The diagram also shows the connections between the different components, as well as the input and output signals. The system is designed to record biopotentials from electrodes and stimulate the auditory and visual senses. Figure 5-1. Device Functional Scheme EMG biopotentials are amplified by the channels amplifier (CA) and quantized by time and level with the use of the analog-digital converter (ADC) under the control of microcontroller MC1. The commands of the microcontroller MC1 control are transferred from the microcontroller MC4 via the galvanic isolation device (GID), the counts of the input signal are delivered in the reverse direction. The microcontroller MC1 controls the gain and bandpass of EMG channels amplifiers, is used in the calibration procedures and electrode impedance measurement, and performs the internal diagnostic operations. The power supply of the amplifier unit is done via the galvanically isolated direct voltage transducer DVT1. The microcontroller MC4 controls the DVT1. The galvanically isolated electrical stimulator unit includes the electrical stimulus generator (ESG). The microcontroller MC1 specifies the pulse amplitude and duration for the electrical stimulus generator. ESG unit measures the value of the real stimulus current via a patient and transfers it to the microcontroller MC1. The control of the auditory stimulator, photic stimulator and checkerboard stimulator {3}------------------------------------------------ is performed via the corresponding auditory, photic, checkerboard pattern generators with the use of the microcontroller MC2 which receives the commands from the computer via MC4. The microcontroller MC3 performs the displaying of the information to the indicator and entering of information from the buttons, encoders, footswitch and patient button. The given block is located constructively on a separate board. The microcontroller MC4 also generates the synchro-signal input/output. The supply unit (SU) transforms the supplying voltage of USB bus to 3.3 V voltage which is required for MC4 operation. The device operates under control of a PC (IBM PC type) with the mouse, keyboard, laser or jet printer and an installed licensed Windows operational system. The electronic unit is attached to the USB connector of a computer via the interface cable. {4}------------------------------------------------ ## Significant Physical and Performance Characteristics of the Device, such as Device Design, Material Used, and Physical Properties The Focus EMG Device consists of a handheld electronic unit, a stimulator unit with steel electrodes and felt pads, and a footswitch. Image /page/4/Picture/2 description: The image shows a device with a variety of buttons and labels. The word "FOCUS" is prominently displayed in the center of the device. There are also labels such as "Tab", "Test", "Esc", and "NEUROSOFT" visible on the device. The device appears to be some sort of medical or scientific instrument. Figure 5-2. The Electronic Unit | | | Table 5-1. Controls for Handheld Unit | | |--|--|----------------------------------------|--| |--|--|----------------------------------------|--| | Button/Encoder | Menu Command/Action | |----------------|----------------------------------------------------------------------------| | Image: Z | Acquisition Impedance | | Image: Tab | Key [Tab] (intended for switching between input and traces review windows) | | Image: Test | Test Next, Test Previous | | Image: Trace | Trace Next | | Image: Sigma | Acquisition Accumulation/averaging | {5}------------------------------------------------ | Image: Diamond shape with pattern | Acquisition Stimulus protocol (autoincrement) | |----------------------------------------------------|-------------------------------------------------------| | Image: Hand clicking | | | Image: Oval shape with text Esc | Acquisition Cancel, same as [Esc] key | | Image: Circle shape | Acquisition Monitoring | | Image: Triangle shape | | | Image: Oval shape with dots | Acquisition Repetitive stimulation | | Image: Diamond shape with pattern | Acquisition Pause | | Image: Two parallel lines | | | Image: Circle shape with dot | Acquisition Start acquisition/stimulus | | Image: Diamond shape with pattern | Acquisition Stop | | Image: Square shape | | | Image: Circle shape with rotation arrow (rotation) | Trace Marker Move left and Trace Marker Move right | ·· ị ( {6}------------------------------------------------ | Button/Encoder | Menu Command/Action | |--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Image: Button with squiggly line | Selection of next marker | | (pressing) | | | Image: Button with H | View Sweep Increase and View Sweep Decrease | | (rotation) | | | Image: Button with I | View Sensitivity Increase and View Sensitivity Decrease | | (rotation) | | | Image: Button with squiggly line and arrow | Acquisition Stimulus Increase stimulus duration and Acquisition Stimulus Decrease Stimulus duration | | (rotation) | | | Image: Button with speaker icon | For tests with stimulation: Acquisition Stimulus Stimulus increase and Acquisition Stimulus Stimulus decrease. For tests without stimulation: Acquisition Sound Volume up and Acquisition Sound Volume down | | (rotation) | | | Image: Button with speaker icon | For tests without stimulation: Acquisition Sound Sound on/off | | (pressing) | | ## Table 5-1. Controls for Handheld Unit (Continued) The connectors that attach electrodes for measuring potentials are shown in Figure 5-3. Image /page/6/Figure/3 description: The image shows a diagram of a connector panel with labels and descriptions. The panel has two channels, labeled 1 and 2, each with a positive (+) and negative (-) touch-proof connector. There is also a ground connector in the center of the panel. The text provides descriptions for each connector, specifying whether it is for the anode or cathode of each channel. Figure 5-3. Panel View showing Electrode Connectors {7}------------------------------------------------ 300 V, 0+100 mA electrical stimulator connector. - connector for USB computer attachment. connector for photic or checkerboard stimulation pattern attachment. auditory stimulator connector. trig in/out connector. patient button connector. footswitch connector. View of the panel with connectors for the stimulators is given in Figure 5-4. Figure 5-4. Panel View showing Stimulator Connectors The electronic unit measures 92x167x46 mm and weighs .35kg. Image /page/7/Picture/4 description: The image shows a coiled cable with a connector on one end and some small metal parts near the other end. The cable appears to be a type of electrical or data cable, given the connector. The metal parts near the other end of the cable could be components used for connecting or securing the cable in a specific application. Figure 5-5. The Stimulator Unit The footswitch allows the operator to control the electronic unit. The footswitch measures 103x273x43 mm and weighs 1 kg. Image /page/7/Picture/7 description: In the image, there is a black electric griddle with three sandwiches on top of it. The sandwiches are rectangular and appear to be toasted. The griddle is plugged in with a cord visible on the right side of the image. The griddle has a curved shape and is sitting on a flat surface. Figure 5-6. Foot Switch The auditory stimulator is used for auditory Evoked Potentials testing. It is connected to the device via the auditory stimulator connection. TeleEMG LLC, Traditional 510(k) - Focus K102610 {8}------------------------------------------------ | Multiply Transducer Calibration | Supports up to 6 different transducers with saved calibration values | |---------------------------------|-------------------------------------------------------------------------| | Intensity | 0-126 dBSPL, 0-96dBHL | | Polarity | -ve, +ve or alternating | | Stimulation Frequency | 0.05-30 Hz | | Tone Frequency | 100-8000 Hz | | Click Duration | 0.1-6 ms | | Pips/Tone Bursts Intensity | 0-126 dBSPL, 0-96dBHL | | Presentation | Left / Right / Binaural | | Loudspeakers | External (computer) | Figure 5-6. Foot Switch The LED goggles are used in the "Flash Visual EP Test". They are connected via the connector for photic or checkerboard stimulation pattern. Image /page/8/Figure/3 description: The image shows a pair of LED goggles and a table of specifications. The goggles are black with a coiled wire and a strap. The table lists the maximum brightness of the LED goggles as (1100 ± 110) kd/m², the flash duration as 1-500 ms, the stimulation frequency as 0.05-50 Hz, and the presentation as Left / Right / Both. Figure 5-6. Technical Characteristics of the LED Goggles ## 5. INTENDED USE The Focus is intended for use by a healthcare provider to perform nerve conductions and EMG studies as an aid in the evaluation of patients with diseases of muscle and nerves. The machine can also use electrical stimulus or sound stimulus for evoked potentials (EP) studies. {9}------------------------------------------------ #### 6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE\PREDICATE DEVICE | PRODUCT | FOCUS EMG DEVICE | NEMUS SYSTEM | SYNERGY LT | |-------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | FEATURES | NEUROSOFT, LTD. | EBNEURO S.P.A. | OXFORD INSTRUMENTS | | | PROPOSED | K073415 | K981405 | | Intended Use | The Focus is intended for use by a healthcare provider to perform nerve conductions and EMG studies as an aid in the evaluation of patients with diseases of muscle and nerves. The machine can also use electrical stimulus or sound stimulus for evoked potentials (EP) studies. | 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 neuro-muscular diseases (EMG). The device may use electrical stimulus or sound stimulus for use in evoked response measurements (EP). | 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. | | Contraindications | 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 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 | | 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. Built-in keyboard | Microsoft Windows mouse keyboard driven graphic interface. Dedicated external keyboard (optional) | 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 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 | Yes (Optional) | Yes | | Use of standard software platform (Operating System) | YES - Microsoft Windows | YES - Microsoft Windows | YES - Microsoft Windows | | PRODUCT FEATURES | FOCUS EMG DEVICE NEUROSOFT, LTD. PROPOSED | NEMUS SYSTEM EBNEURO S.P.A. K073415 | SYNERGY LT OXFORD INSTRUMENTS K981405 | | 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 | 60601-1-1-2000 60601-1-2-2001 60601-1-2-40-1998 62471-2006 | IEC 60601-1 IEC 60601-1-1 IEC 60601-2-26 IEC 60601-2-40 IEC 60601-1-2 | IEC 60601-1 | | Patient circuitry isolation | Optic/transformer | Optic | Optic | | System Components | Focus EMG Device USB Cable Footswitch Electrical Stimulator Notebook PC based system | Nemus I Base Unit (Amplifier) Host Computer (PC) Printer (optional) Cart (optional) Dedicated Keyboard (optional) | Headbox (Amplifier) Computer (PC) Cart Printer (optional) | | Amplifier- Computer interface | USB | LAN Ethernet 100 Mbit | Proprietary | | System Power Supply | Electronic unit: 5V DC System with Personal Computer: 100- 120/200-240 V AC (50-60 Hz) System with Notebook: 100- 120/200-240 V AC (50-60 Hz) | From mains (110-240 VAC) trough isolation transformer | From mains (110-240 VAC) | | Amplifier Power Supply | 5V DC from USB | 15 VDC from medical approved AC/DC converter | Internal power supply | | Size (H/W/D) mm | Electronic Unit: 90x270x50 mm | Nemus System: 1250/750/850 (complete system, with cart, monitor, arm) | 500/209/321 (cart : 720/640/780 ) | | Weight (complete system-kg) | Electronic Unit: 0.35 System: 3.5 | Nemus System: 90 (complete system, with cart, monitor, arm) | 55 (with cart) | | Design - Acquisition | | | | | Number of channels | 2 | 2 | 2 | | CMRR | >100 dB | >100 dB | >110dB | | Noise | < 0. 6 $ \mu $ Vrms. | < 0.3 $ \mu $ Vrms (0.1 - 00 Hz) < 20 nV/ $ \sqrt{Hz} $ (10 Hz - 10 kHz ) | <0.7 $ \mu $ Vrms (0.1 Hz - 10 kHz) | | Input impedance | > 100 MOhm <25pF | > 1000 MOhm / 8 pF | > 1000 MOhm / 30 pF | | Low pass filter | (-12dB/octave) 10, 20, 35, 50, 75, 100, 150, 200, 300, 500, 1000, 2000, 3000, 5000, 10000 Hz | 20 Hz - 16 kHz (15 step) | 50 Hz - 16 kHz (10 step) | | High pass filter | (-6dB/octave) 0.05, 0.1, 0.2, 0.3, 0.5, 1, 2, 3, 5, 10, 20, 30, 50, 100, 200, 300, 500, 1000, 2000, 3000 Hz | 0.01 - 500 Hz (11 step) | DC, 30 - 2000 Hz | | Notch filter | 50/60 Hz selectable | 50/60 Hz selectable | 50/60 Hz selectable | | A/D conversion | 16 Bit ADC | 24 bit Sigma-Delta | 16 bit | | Sampling rate | 200-80000 Hz | 4.194 MHz | 50 kHz | | Analysis time | 2 ms - 5 min | 5 ms - 10 s | 5 ms - 10s | | Time base | Single | Single | Single | | PRODUCT | FOCUS EMG DEVICE | NEMUS SYSTEM | SYNERGY LT | | FEATURES | NEUROSOFT, LTD. | EBNEURO S.P.A. | OXFORD INSTRUMENTS | | | PROPOSED | K073415 | K981405 | | Trigger mode | Free, Auto, Internal, External | Free, Auto, Internal, External | Auto, Internal, External | | Signal delay (pre/post) | 0-10 s | 0-5 div | 0 - 9 div | | Ohmmeter | 0-100 kOhm | 0-100 kOhm (auto full scale) | 0-32 kOhm | | Design - Stimulators | | | | | Somatosensory (electrical ) Stimulator | Type: constant current N. output 1 Max output: 100 mA Pulse width: 0.1 - 5 ms Mode: single, train (50 Hz) | Type: constant current N. output 1 Max output: 100 mA Pulse width: 0.05 - 1 ms Mode: single, train | Type: constant current/voltage N. output : 1 Max output: 100 mA Pulse width: 0.05-1 ms Mode: single, double, train (200Hz) | | Audio Stimulator | Output mode: click, tone Sound pressure: 0-126 dB SPL (TDH 39) Phase: condens., raref, alternate Signal frequency: 1008000 Hz Click width: 100-5000 us Stimulus presen. Left, right, binaural Headset: TDH 39 | Output mode: click, tone Sound pressure: 0-132 dB SPL Phase: condens., raref, alternate Signal frequency: 1258000 Hz Plateau time: 1-200 ms Rise/fall time: 1-100 ms Mask level: -40 + 10 dB (relative) Click width: 1-100 us Stimulus presen. Left, right, binaural Headset: TDH 39 | Output mode: click, pip, tone Sound pressure: 0-122 dB SPL Phase: condens., raref, alternate Signal frequency: 1258000 Hz Plateau time: 1-999 ms Rise/fall time: 1-255 ms Mask level: -40 + 10 dB (relative) Click width: 0.05 - 1 ms Stimulus presen. Left, right binaural 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…