(175 days)
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 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 EMG Device consists of a handheld electronic unit, a stimulator unit with steel electrodes and felt pads, and a footswitch.
The TeleEMG Focus EMG Device is intended for use by healthcare providers to perform nerve conduction and EMG studies, and for evoked potentials (EP) studies using electrical or sound stimulus.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a submission for a neurodiagnostic testing system (hardware and software) and not an AI/ML device making diagnostic claims, the acceptance criteria are based on compliance with established medical device safety and performance standards rather than specific diagnostic accuracy metrics. The "reported device performance" refers to the successful completion of these compliance tests.
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance |
|---|---|---|
| Electrical Safety | IEC 60601-1-1:2000 Medical electric equipment Part 1-1: Safety requirements for medical electrical systems | Successfully tested and meets the requirements. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2001 Medical electric equipment Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests | Successfully tested and meets the requirements. |
| Specific Safety for Electromyographs and Evoked Response Equipment | IEC 60601-2-40:1998 Medical electric equipment Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment | Successfully tested and meets the requirements. |
| Photobiological Safety | IEC 62471:2006 Photobiological safety of lamps and lamp systems (specifically for LED goggles) | The TeleEMG Focus EMG Device met IEC 62471:2006. LED goggles luminance is 1,203 cd/m², which is "much less than the admissible level 10,000 cd/m² specified in clause 4.1 of this standard." Therefore, additional spectral calculations were not required. |
| Software Level of Concern | FDA draft software guidance document ("Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices") | The TeleEMG Focus is categorized as a "moderate" level of concern and "meets the requirements set forth in the FDA draft software guidance document for a 'moderate' in the level of concern device." |
| Biocompatibility | Compatibility of patient-contacting surfaces (stainless steel electrodes and felt pads) | The electrodes and pads were previously cleared under the submission of the NC Stat, K060584. This indicates they are considered biocompatible based on prior FDA review. |
| Substantial Equivalence | Demonstrating that the device is as safe and effective as a legally marketed predicate device. | Based on the non-clinical performance testing and comparison to predicate devices, the Focus EMG Device is considered "substantially equivalent" to the cited predicate devices (Nemus System, K073415, and Synergy LT, K981405). The comparison table highlights that the proposed device has comparable intended use, warnings, contraindications, general design, user interface, patient inputs, signal acquisition, trigger features, stimulator types, and application modules to the predicate devices. |
| Functional Performance | Performance evaluation of features described in the user's manual. | "Performance evaluation of the features described in the Focus user's manual has been successfully completed utilizing hardware and software tests and validations." This implies that the device's functions (e.g., amplification, A/D conversion, filtering, stimulation parameters) operate as specified and are comparable to predicate devices as detailed in the "Side-by-Side Comparison of the Proposed Device with Cited Predicate Devices" table. |
2. Sample size used for the test set and the data provenance
The document explicitly states: "No clinical testing was conducted to support this submission."
Therefore, there is no test set in the sense of patient data for clinical evaluation, and no data provenance in that context. The testing was non-clinical (hardware, software, and safety standard compliance).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As no clinical testing was performed, there was no "test set" requiring expert-established ground truth. The acceptance criteria were based on engineering, safety, and performance standards.
4. Adjudication method for the test set
Not applicable. No clinical test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a diagnostic electromyograph machine, not an AI-assisted diagnostic tool that interprets or analyzes data to improve human reader performance. Its function is to acquire and display electrophysiological data for a healthcare provider to interpret.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a hardware and software system for data acquisition and display, designed for human-in-the-loop use by a healthcare provider. It does not perform standalone diagnostic interpretation.
7. The type of ground truth used
For the non-clinical performance testing, the "ground truth" would be the specifications defined by the relevant international standards (IEC 60601 series, IEC 62471) and the functional specifications and design requirements internally established for the device itself. For example, for noise levels, the ground truth is that the device noise should be less than 0.6 µVrms, or for the LED goggles, the luminance should be below the 10,000 cd/m² admissible limit.
8. The sample size for the training set
Not applicable. This device is not an AI/ML product that relies on a "training set" of data in the conventional sense. Its software performs signal acquisition, processing, and display based on established algorithms and embedded logic, not learned patterns from a large training dataset.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
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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
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
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- · 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:
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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
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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.
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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 |
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| 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 leftand Trace Marker Move right |
··
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(
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| 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
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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
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| Multiply Transducer Calibration | Supports up to 6 different transducerswith 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.
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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 useby a healthcare provider toperform nerve conductions andEMG studies as an aid in theevaluation of patients withdiseases of muscle and nerves.The machine can also useelectrical stimulus or soundstimulus for evoked potentials(EP) studies. | The NEMUS system isintended to monitor,record and display thebioelectric signal produced bythe muscles, to stimulateperipheral nerves, andto monitor, record and displaythe electrical activity producedby nerves to aid the clinician inthe diagnosis and prognosis ofneuro-muscular diseases(EMG). The device may useelectrical stimulus or soundstimulus for use in evokedresponse measurements (EP). | 2 channel electromyographwhich provides facilities forEMG and Evoked Potentialstesting for a range of clinicalapplication. Synergy LT isdesigned to enable reliablerecording display anddocumentation ofelectrophysiologicalinformation from the humannervous and muscular system ina 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 andindicated use limitations, suchas not for use in the presence offlammable anesthetics or inconjunction with defibrillationequipment. | Items related to design andindicated use limitations, suchas not for use in the presence offlammable anesthetics or inconjunction with defibrillationequipment. | Items related to design andindicated use limitations, suchas not for use in the presence offlammable anesthetics |
| Design - General | |||
| General systemapproach | Computer based equipmentwith dedicated hardwareperipherals/components | Computer based equipmentwith dedicated hardwareperipherals/components | Computer based equipmentwith dedicated hardwareperipherals/components |
| User input device | Microsoft Windowsmouse/keyboard driven graphicinterface. Built-in keyboard | Microsoft Windows mousekeyboard driven graphicinterface. Dedicated externalkeyboard (optional) | Microsoft Windowsmouse/keyboard driven graphicinterface. |
| User output device | Digital color displayCommercial printers | Digital color displayCommercial printers | Digital color displayCommercial printers |
| Patient inputs | 2 channels preamplifiers,isolated | 2 channels preamplifiers,isolated | 2 channels preamplifiers,isolated |
| Signal acquisition | Analog-to-digital conversion atvariable sampling rate | Analog-to-digital conversion atvariable sampling rate | Analog-to-digital conversion atvariable sampling rate |
| Trigger input(synchronization toexternal events) | Yes | Yes | Yes |
| Trigger output(synchronization forexternal devices) | Yes | Yes | Yes |
| Footswitch for hands-free operation | Yes | Yes (Optional) | Yes |
| Use of standardsoftware platform(Operating System) | YES - Microsoft Windows | YES - Microsoft Windows | YES - Microsoft Windows |
| PRODUCTFEATURES | FOCUS EMG DEVICENEUROSOFT, LTD.PROPOSED | NEMUS SYSTEMEBNEURO S.P.A.K073415 | SYNERGY LTOXFORD INSTRUMENTSK981405 |
| Customization ofclinical 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 | 60601-1-1-200060601-1-2-200160601-1-2-40-199862471-2006 | IEC 60601-1IEC 60601-1-1IEC 60601-2-26IEC 60601-2-40IEC 60601-1-2 | IEC 60601-1 |
| Patient circuitryisolation | Optic/transformer | Optic | Optic |
| System Components | Focus EMG DeviceUSB CableFootswitchElectrical StimulatorNotebook PC based system | Nemus I Base Unit(Amplifier) HostComputer (PC) Printer(optional) Cart (optional)Dedicated Keyboard(optional) | Headbox (Amplifier)Computer (PC)CartPrinter (optional) |
| Amplifier- Computerinterface | USB | LAN Ethernet 100 Mbit | Proprietary |
| System Power Supply | Electronic unit: 5V DC Systemwith 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 medicalapproved AC/DC converter | Internal power supply |
| Size (H/W/D) mm | Electronic Unit:90x270x50 mm | Nemus System:1250/750/850 (completesystem, with cart, monitor, arm) | 500/209/321(cart : 720/640/780 ) |
| Weight (completesystem-kg) | Electronic Unit: 0.35System: 3.5 | Nemus System: 90(complete system, withcart, 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, 10000Hz | 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 currentN. output 1Max output: 100 mA Pulsewidth: 0.1 - 5 ms Mode: single,train (50 Hz) | Type: constant currentN. output 1Max output: 100 mA Pulsewidth: 0.05 - 1 ms Mode:single, train | Type: constant current/voltageN. output : 1Max output: 100 mAPulse width: 0.05-1 ms Mode:single, double, train (200Hz) |
| Audio Stimulator | Output mode: click, toneSound pressure: 0-126 dB SPL(TDH 39)Phase: condens., raref, alternateSignal frequency: 1008000 HzClick width: 100-5000 usStimulus presen. Left, right,binauralHeadset: TDH 39 | Output mode: click, toneSound pressure: 0-132 dB SPLPhase: condens., raref, alternateSignal frequency: 1258000 HzPlateau time: 1-200 msRise/fall time: 1-100 ms Masklevel: -40 + 10 dB (relative)Click width: 1-100 us Stimuluspresen. Left, right, binauralHeadset: TDH 39 | Output mode: click, pip, toneSound pressure: 0-122 dB SPLPhase: condens., raref, alternateSignal frequency: 1258000 HzPlateau time: 1-999 msRise/fall time: 1-255 ms Masklevel: -40 + 10 dB (relative)Click width: 0.05 - 1 msStimulus presen. Left, rightbinauralHeadset: TDH 39 |
| Basic EMG Application Modules | |||
| Free run acquisition | Yes | Yes | Yes |
| Nerve conduction study | Yes | Yes | Yes |
| Self triggeredacquisition | 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 |
| H-Reflex analysis | Yes | No | Yes |
| Galvanic Skin ResponseAlso known asSympathetic SkinResponse (SSR) | Yes | No | Yes (Referred to asSympathetic Skin Response orSSR) |
| Basic EP Application Modules | |||
| Somatosensory EP | Yes | Yes | Yes |
| Auditory EP | Yes | Yes | Yes |
| Visual EP (flash) | Yes | No | Yes |
| P300 EP | Yes | No | Yes |
| Visual EP (pattern) | Yes | No | Yes |
Table 5-2. Side-by-Side Comparison of the Proposed Device with Cited Predicate Devices
TeleEMG LLC, Traditional 510(k) – Focus K102610
:
: : ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・
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Table 5-2. Side-by-Side Comparison of the Proposed Device with Cited Predicate Devices (Continued)
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Table 5-2. Side-by-Side Comparison of the Proposed Device with Cited Predicate Devices (Continued)
7. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
Performance Testing
Performance evaluation of the features described in the Focus user's manual has been successfully completed utilizing hardware and software tests and validations. Hardware qualification is performed using the following industry standards:
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- · IEC 60601-1-1:2000 Medical electric equipment Part 1-1: Safety requirements for medical electrical systems
- · IEC 60601-1-2:2001 Medical electric equipment Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility -Requirements and tests
- · IEC · 60601-2-40:1998 Medical electric equipment Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment
- · IEC 62471:2006 The TeleEMG Focus EMG Device has met the IEC 62471:2006: Photobiological safety of lamps and lamp systems. According to IEC 62471, our LED goggles luminance is 1,203 cd/m2 that is much less than the admissible level 10.000 cd/m2 specified in clause 4.1 of this standard. That is why it is not required to make additional spectral calculations according to IEC 62471.
The TeleEMG Focus is of a "moderate" level of concern according to the FDA draft software guidance document ("Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"), and meets the requirements set forth in the FDA draft software guidance document for a "moderate" in the level of concern device.
Biocompatibility Testing
The only patient contacting surfaces of the Focus EMG device are the stainless steel electrodes and felt pads applied during testing. The electrodes and pads were cleared under the submission of the NC Stat, K060584.
CLINICAL TESTING AS BASIS FOR SUBSTANTIAL 8. SUMMARY OF EQUIVALENCE
No clinical testing was conducted to support this submission.
9. SUMMARY OF OTHER INFORMATION
No other information is available.
10. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS
Based on the information and supporting documentation provided in the premarket notification, the Focus EMG Device is substantially equivalent to the cited predicate device. Testing demonstrates that the Focus EMG Device fulfills prospectively defined design and performance specifications.
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Image /page/13/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine. The text is written in a simple, sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
TeleEMG, LLC c/o Joe F. Jabre, M.D. 65 Arlington Road Woburn, MA 01801
MAR - 4 201
Re: K102610
Trade/Device Name: Focus EMG Regulation Number: 21 CFR 890.1375 Regulation Name: Diagnostic Electromyograph Regulatory Class: Class II · Product Code: IKN, JXE
Dated: January 22, 2011 Received: January 24, 2011
Dear Dr. Jabre:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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Page 2 - Joc F. Jabre, M.D.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K102610
Device Name: Focus EMG Device
Indications for 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.
Prescription Use X (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)
KRISTEN BOWSHER
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K102610
TeleEMG Traditional 510(k) K102610
Focus EMG Device
§ 890.1375 Diagnostic electromyograph.
(a)
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.(b)
Classification. Class II (performance standards).