(135 days)
No
The summary describes a standard evoked response testing device and does not mention any AI or ML capabilities.
No
The device is described as a "testing and diagnostic device" and is "indicated for use as a diagnostic aid and adjunctive tool." Its purpose is to measure and record evoked potential data and provide nerve stimulation/monitoring for diagnostic purposes, not to treat a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "SmartEP is an evoked response testing and diagnostic device" and "The product is indicated for use as a diagnostic aid and adjunctive tool in sensory related disorders".
No
The device description explicitly states that "additional hardware and software features have been added" and mentions various hardware components like electrodes, probes, and stimulators used for patient contact and data acquisition.
Based on the provided information, the SmartEP device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens taken from the human body. The SmartEP device works by applying stimuli to the patient (auditory, somatosensory, visual, or nerve stimulation) and measuring the body's electrical responses (evoked potentials) directly from the patient's body using electrodes. It does not analyze samples like blood, urine, or tissue.
- The intended use and device description clearly state it's an evoked response testing and diagnostic device. It measures physiological responses to external stimuli, which falls under the category of physiological monitoring and diagnostic devices, not IVDs.
- The anatomical sites of contact are the patient's body (scalp, limbs, ear canal, nerve tissue), not specimens.
Therefore, the SmartEP device is a medical device used for in-vivo physiological testing and diagnosis, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
SmartEP is an evoked response testing and diagnostic device, that is capable of eliciting, acquiring, and measuring auditory, somatosensory, and visual evoked potential data, as well as providing nerve stimulation and monitoring.
The intended use of the SmartEP device is to objectively record evoked responses from patients of all ages upon the presentation of sensory stimuli. The product is indicated for use as a diagnostic aid and adjunctive tool in sensory related disorders (i.e., auditory, somatosensory, visual) and in surgical procedures for inter-operative nerve monitoring.
The SmartEP system is intended to be used by trained personnel in a hospital, nursery, clinic. audiologist's, EP technologist's, surgeon's, or physician's office, operating room, or other appropriate setting.
Product codes
GWJ, GWF, GWF, GWE, ETN
Device Description
SmartEP is an evoked response system that is capable of eliciting, acquiring, and measuring auditory, somatosensory, and visual evoked potential data, as well as providing nerve stimulation/monitoring.
The feature modifications described in this 510(k) are to incorporate additional/expanded indications to the SmartEP device for somatosensory evoked potential, visual evoked potential, and nerve stimulation testing to the previously FDA cleared indications for auditory evoked potential testing.
Specifically, additional hardware and software features have been added to the original SmartEP device system to objectively acquire somatosensory/visual evoked potentials upon the presentation of a somatosensory/visual stimulus, and to provide nerve stimulation/monitoring functionality.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
The anatomical sites of contact for auditory evoked potential (AEP) testing are the patient's ear canal (with the contact object being a sound delivery eartip or headphone, or an ear probe and personal eartip, or earcup) and the patient's scalp and possibly other body sites (with the contact object being electrodes that are capable of measuring bio-potentials).
The anatomical sites of contact for somatosensory evoked potential (SEP) testing are the patient's upper/lower limbs and head (with the contact object being two metal prongs or skin-surface electrodes connected to a constant-current stimulator probe) and to the patient's scalp and possibly other body sites (with the contact object being electrodes that are capable of measuring bio-potentials).
The anatomical sites of contact for visual evoked potential (VEP) testing are the patient's scalp and possibly other body sites (with the contact object being electrodes that are capable of measuring bio-potentials).
The possible anatomical sites of contact for nerve stimulation and monitoring testing are the patient's nerve tissue (with the contact object being sterile monopolar or bipolar nerve stimulator probe tips), the patient's tympanic membrane and cochlear promontory (with the contact object being a sterile stimulation needle electrode), and the patient's scalp and possibly other body sites (with the contact object being electrodes that are capable of measuring bio-potentials).
Indicated Patient Age Range
The intended use of the SmartEP device is to objectively record evoked responses from patients of all ages upon the presentation of sensory stimuli.
Intended User / Care Setting
The SmartEP system is intended to be used by trained personnel in a hospital, nursery, clinic. audiologist's, EP technologist's, surgeon's, or physician's office, operating room, or other appropriate setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
IHS SmartEP (K904926), Nicolet Viking II (K890495), Medtronic XOMED NIM-Response (K982595)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1900 Evoked response auditory stimulator.
(a)
Identification. An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle faces right and appears to be in flight. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
OCT 1 0 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Intelligent Hearing Systems % Mr. Edward Miskiel, Ph.D President & CEO 6860 SW 81st Street Miami, Florida 33143
RE: K070608 Trade/Device Name: SmartEP M010000 Regulation Number: 21 CFR 882.1900 Regulation Name: Evoked response auditory stimulator Regulatory Class: II Product Code: GWJ, GWF, GWF, GWE, ETN Dated: June 28, 2007 Received: June 29, 2007
Dear Dr. Miskiel:
This letter corrects our substantially equivalent letter of July 18, 2007.
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 (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 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.
1
Page 2 - Edward Miskiel, Ph.D.
This letter will allow you to continue marketing your device as described in your Section 510(k) I his letter will anow you to commal mag of substantial equivalence of your device to a legally premarket notification. The PDA miding of basetantial of 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
s and the many and consember of the collection and the received If you desire specific advice for your do not on the many please note the regulation entitled, whitely comaci the Office of Comphand at (210) 276 - 13 - 17 - 17 807.97). You may obtain "Misoraliung by icierches to promanteriouslited.com the Act from the Division of Small other gelleral information on your response at toll-free number (800) 638-2041 or Manufacturers, International and Consultip://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark M Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): K070608
Device Name: Smartille (with Additional/Expanded Indications for Somatosensory SmartEP (with Additional/Expanded Potential Testing, & Nerve Stimulation/Monitoring)
Indications for Use:
Smartise an evoked response testing and diagnostic devices potential data, as well as SmartBP is and measuring auditory, somatoresory, and visual evoked potential data, as well as
acquiring, and measuring and moritarian acquiring, and measuration and monitoring.
provious is ve claiment and objectively record evoked responses from patiented for use as a diegnostic The intended use of the Simation of semany stimuli. The product is indication for use as a diagnostic
all ages upon the presentation of semsers states is to . anditors, some all ages upon the presentation of sensory clasted disorters (i.e., auditory, somatosensory, visual) and in
aid and adjunctive tool in sensory than enversentians surgical procedures for inter-operative nerve monitoring.
The SmartEP system is intended to be used by trained persomel in a hospital, or other The SmartEP system is intended to be used by tramed personnel in a belging, and or other appropriate setting.
appropriously sites of contact for auditory ovoked potential (ABP) testing are the patient's ear The andomical sites of contact of contact of the processions of hedgebend. Or an ear probe and canal (with the coutect object beatly and possibly of them body sites (with the contact)
personal cartip, or earcup) and the patient's scelp and possibly of personal carap, or earcup) and the panelly of measuring bio-potentials).
Object other and contact for somatosensory evoked potential (SEP) testing are the patient is The anatomical sites of contact for somer object being two mestl proget or sein-surface cleotrodos comected to a constant-current stimulator probo) and to the patient's sealp and cleorodos comected to a constant-current stimulator proboty and is are capable of massuring bio-potentials).
The anatomical sites of contact for visual evoked potential (VEP) testing are the patient's scalps) The anatomical sites of outlast for visual evoked polential (VDI ) contact and control of the one of of of
and possibly other body sites (with the contact object being electr measuring bio-potentials).
The possible anatomical started for news shipst heing greating are the patient's nerve tissue (with the contact object beting sectile momontant of bigently probe tips), the patient's tympanic membrate and cochear promotory (vita the contact object object object being a sterile stimulation necdle electrode), and the possibly other body sites
being a sterile stimulation necdle clecked and the possibly other body sites (with the contact object being electrodes that are capable of measuring blo-potentials).
Over-the-Counter Use OR Prescription Use (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence Di 200 11 1 211 Division of General, Restorative, and Neurological Devices
510(k) Number_
Page D1
3
ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ
Image /page/3/Picture/1 description: The image shows the logo for Intelligent Hearing Systems. The logo features a stylized sound wave graphic on the left, followed by the words "INTELLIGENT HEARING" in bold, black capital letters. Below "INTELLIGENT HEARING" are the letters "S Y S T E M S" each in a black square.
510(k) Summary
| Prepared By: | Intelligent Hearing Systems
6860 SW 81st Street
Miami, FL 33143 | JUL 1 8 2007 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Telephone: | (305) 668-6102 | |
| FAX: | (305) 668-6103 | |
| Contact Person: | Edward Miskiel | |
| Date Summary prepared: | February 26, 2007 | |
| Name of the Device: | SmartEP (with Additional/Expanded Indications for
Somatosensory Evoked Potential, Visual Evoked Potential, &
Nerve Stimulation/Monitoring Testing) | |
| Common Name: | Evoked Response System, Nerve Stimulator/Monitor | |
| Classification Name: | Electrical Evoked Response Stimulator (per CFR 882.1870)
Photic Evoked Response Stimulator (per CFR 882.1890)
Nerve Stimulator/Monitor (per CFR 874.1820)
Auditory Evoked Response Stimulator (per CFR 882.1900) | |
| Predicate Device(s): | IHS SmartEP (K904926),
Nicolet Viking II (K890495),
Medtronic XOMED NIM-Response (K982595) | |
| Device Description: | SmartEP is an evoked response system that is capable of
eliciting, acquiring, and measuring auditory, somatosensory, and
visual evoked potential data, as well as providing nerve
stimulation/monitoring.
The feature modifications described in this 510(k) are to
incorporate additional/expanded indications to the SmartEP
device for somatosensory evoked potential, visual evoked
potential, and nerve stimulation testing to the previously FDA
cleared indications for auditory evoked potential testing.
Specifically, additional hardware and software features have
been added to the original SmartEP device system to objectively
acquire somatosensory/visual evoked potentials upon the
presentation of a somatosensory/visual stimulus, and to provide
nerve stimulation/monitoring functionality, | |
| Intended Use: | The SmartEP device is intended to be used as a diagnostic aid
and adjunctive tool in sensory related disorders and nerve
stimulation/monitoring on patients of all ages. This is the same
intended use as that of the predicate device(s). | |
:
4
Technological Characteristics:
The Intelligent Hearing Systems (IHS) family of products is intended to be used for recording and analysis of human physiological data for the purpose of diagnosis, screening, and treatment of sensory disorders and nerve monitoring.
Evoked response systems provide a means to elicit and acquire signals evoked in response to appropriate stimuli, and can be used for different kinds of tests: Auditory evoked potentials (AEP), somatosensory evoked potentials (SEP), visual evoked potentials (VEP), nerve stimulation/monitoring, cochlear promontory stimulation (transtympanic eABR), etc. These testing variations are called "modalities", and each modality has its own unique hardware/software requirements.
The feature modifications described in this 510(k) are to incorporate additional/expanded indications to the SmartEP device for SEP, VEP, and Nerve Stimulation/Monitoring to the previously FDA cleared indications for AEP testing (refer to FDA 510(k) #K904926). Specifically, additional hardware and software features have been added to the original SmartEP device system to objectively acquire somatosensory/visual evoked potentials upon the presentation of a somatosensory/visual stimulus, as well as to provide nerve stimulation and monitoring functionality.
SEP testing is performed by providing skin-surface (cutaneous) electrical stimulation to a patient's upper and lower limbs. A somatosensory stimulus (constant-current pulses, etc.) is presented to the subject's skin through the use of an SEP electrical stimulator probe which delivers the constant-current electrical stimulus through two metal prongs or skin-surface electrode connections. As in the case of AEP testing. the EEG response from the brain is recorded through the use of scalp electrodes placed on the patient, amplified/filtered, digitized, and averaged with multiple responses to obtain a final evoked response signal. SEP testing is useful to determine the integrity of the somatosensory pathways and how well the nerves that connect to the spinal cord are able to send and receive sensory information (such as pain, temperature, and touch), as well as to help diagnose the nature of any possible sensory impairment. The anatomical sites of contact for SEP testing are the patient's upper/lower limbs and head (with the contact object being two metal prongs or skin-surface electrodes connected to a constant-current stimulator probe) and the patient's scalp and possibly other body sites (with the contact object being electrodes that are capable of measuring bio-potentials).
VEP testing is performed by providing photic light stimulation to a patient's eyes. A visual stimulus (checker-board light patterns, light bars, etc.) is presented to the subject through the use of a visual stimulator light (or LED) array or monitor which delivers visual patterns covering a particular area of the field of view. As in the case of AEP testing, the EEG response from the brain is recorded through the use of scalp electrodes placed on the patient, amplified, and averaged with multiple responses to obtain a final evoked response signal. VEP testing is useful to determine the integrity of the visual pathways as well as to help diagnose the nature of any possible sensory impairment. VEP testing can help provide valuable diagnostic information about conditions such as optic neuritis, optic tumors, retinal disorders, and demyelineating diseases such as multiple sclerosis. The anatomical sites of contact for VEP testing are the patient's scalp and possibly other (with the contact object being electrodes that are capable of measuring bio-potentials).
Nerve Stimulation and Monitoring testing is performed by providing low-current electrical stimulation to a patient's nerve tissue during intra-operative/surgical procedures performed by a qualified surgeon. A low-current stimulus (constant-current pulses, etc.) is presented to the subject through the use of a sterile nerve stimulator probe (monopolar or bipolar) or needle electrode which delivers the constant-current electrical stimulus directly to the exposed tissue. The evoked nerve response is recorded through the use of various types of electrodes (sub-dermal, needle electrodes, etc.), amplified/filtered, and digitized (with possible use of averaging) to obtain an evoked response signal. Nerve Stimulation and Monitoring
5
testing is useful for nerve localization and integrity determination, intra-operative nerve monitoring during surgical procedures (facial, intra-cranial, peripheral, spinal, cochlear, etc.), direct stimulation for evoked responses (EP, EMG), and cochlear promontory stimulation (transtympanic eABR). The possible anatomical sites of contact for Nerve Stimulation and Monitoring testing are the patient's nerve tissue (with the contact object being sterile monopolar or bipolar nerve stimulator probe tips), the patient's tympanic membrane and cochlear promontory (with the contact object being a sterile stimulation needle electrode), and the patient's scalp and possibly other body sites (with the contact object being electrodes that are capable of measuring bio-potentials).
The modifications associated with this new SmartEP modified device only affect the operation of the SEP, VEP, and nerve stimulation/monitoring hardware and software functionality. There are no changes to any part of the AEP functionality. The modified SmartEP device is identical to the original SmartEP device in its intended use and methodologies for AEP testing, which have not changed as a result of modifications to the general or electrical specifications of the device, except with additional indications and capability for somatosensory evoked potential, visual evoked potential, and nerve stimulation/monitoring testing. Thus, the modified SmartEP device can be used to perform the same tests provided by the listed original SmartEP device (i.e., AEP testing), as well as SEP, VEP, and nerve stimulation/monitoring testing.
The original SmartEP device (refer to FDA K904926) consists of the Universal Smart Box (the main hardware receiver unit containing electronic hardware) and external medical grade power supply, power cable, Opti-Amp bio-amplifier (refer to FDA K914876 and K052060), electrodes and leads, sound transducers, Universal Serial Bus cable, a laptop or desktop computer with a Universal Serial Bus port and Windows (2000, XP, Vista) operating system, along with SmartEP software.
For SEP testing, unlike the original SmartEP device, the modified SmartEP system also requires a separate SEP Electrical Stimulation Box and SEP Electrical Stimulator Probe to deliver a constant current electrical stimulus (through two metal prongs or skin-surface electrode connections) to the patient to elicit an evoked response. The metal prongs of the SEP Electrical Stimulator Probe are made of biocompatible Type-302 stainless steel, which meets the ISO-10993 standard. This commercially available grade of steel is commonly used for non-implant medical devices and dental appliances/prosthesis. The SEP Electrical Stimulation Box/Probe is powered by a medical grade power supply, and the patient is afforded protection and isolation transformer (rated up to 3500 volts DC, 10 TeraOhms). In addition, control hardware and software is used to limit the current stimulation to 0-100mA into a load less than or equal to 4000 Ohms (0-400V).
For VEP testing, unlike the original SmartEP device, the modified SmartEP system also requires a separate VEP Visual Stimulation Box with stimulator LED light array to deliver visual patterns to the patient to elicit an evoked response. In this case, there is no added electrical patient contact. The type of LEDs used for stimulation are commercially available, low-intensity, diffuse, red LEDs with a peak wavelength of 625 nm. The illumination provided by these LEDs is of an eye safe intensity and wavelength according to the FDA/CDRH 21 CFR 1040 Performance Standard for Light-Emitting Products. Considering the maximum radiant output condition with all of the LEDs on simultaneously, the system provides an average maximum accessible emission intensity level of approximately 0.43 microWatts at a distance of 30 cm (12 inches) from the test subject. Due to the narrowband characteristics of the LEDs, there is no significant emission of energy in the infraviolet (UV) region of the spectrum, and therefore no concern about this type of exposure.
For Nerve Stimulation and Monitoring testing, unlike the original SmartEP device, the modified SmartEP system also requires a separate Low-Current Stimulation Box to deliver a constant low-current electrical stimulus to the patient's exposed tissue to elicit an evoked nerve response. A separate nerve stimulator probe (monopolar or bipolar) or needle electrode which connects to the Low-Current Stimulator unit is
6
also required to provide direct stimulation to the patient, and is provided by an outside vendor prepackaged and sterile. The Low-Current Stimulation Box is powered by a 9V battery, and the patient is afforded additional protection and isolation via an isolation amplifier. In addition, control hardware/software is used to limit the current stimulation to 0-5mA into a load less than or equal to 1500 Ohms (0-10V), and the output channels are capacitively-coupled to prevent the unintended accumulation of direct current (DC) charge.
Figures E-1 and E-2 show simplified block diagrams for the original SmartEP system and the modified SmartEP system with SEP, VEP, and Nerve Stimulator/Monitoring testing functionality.
7
Safety and Effectiveness:
The modified SmartEP device with SEP, VEP, Nerve Stimulation/Monitoring testing functionality utilizes the same design principles, circuit designs, and operating principles as are used in the original SmartEP device. All of the modifications to the SmartEP device were designed in accordance with procedures that meet FDA QSR Design Control and ISO-13485:2003 specifications.
The same Hazard/Risk Analysis was performed for the modified SmartEP device using the same Fault Tree Analysis (FTA) approaches as in the original device. Also, the same validation, verification, and testing techniques for both hardware and software were performed for the modified SmartEP device.
The Class I Accessible Emission safety criteria outlined in the FDA/CDRH 21 CFR 1040 Performance Standard for Light-Emitting Products were followed in terms of the peak wavelength, exposure duration, and radiant intensity level of the light stimulus used for VEP testing. The light output of the device is of an eye safe intensity and wavelength, and meets Class I light product specifications which are not considered to be hazardous.
The safe electrical design criteria outlined in the FDA Guidance Document for Evoked Response Stimulators were followed in terms of isolation, leakage current, and applied current specifications (i.e., pulse width, amplitude, and direct-current decoupling). The patient-connection hardware is basically the same as the original device. There are no newly-introduced hardware related methods by which the patient can be harmed or injured through use of the device. The same patient interface/isolation methods are used.
The modified SmartEP device will be evaluated and certified for both electromagnetic compatibility and electrical safety by a certified National Recognized Test Laboratory (NRTL), which will conduct the appropriate EMI/EMC testing for medical electrical equipment, to elements of the requirements of:
- EN60601-1:1990: "Medical Electrical Equipment, Part 1: General Requirements for Safety." .
- EN60601-1-2:2001: "Medical Electrical Equipment, Part 1: General Requirements for Safety.2.Collateral . Standard: Electromagnetic Compatibility -- Requirements and Tests"
- . EN55011:1998: "Industrial, Scientific, & Medical (ISM) Radio-Frequency Equipment – Radio Disturbances Characteristics – Limits & Methods of Measurements "
- . EN61000-3-2:1995: "Electromagnetic Compatibility (EMC) - Part 3-2:Limits for Harmonic Current Emissions "
- . EN61000-3-3:1995: "Electromagnetic Compatibility (EMC) Part 3-3: Limits of Voltage Fluctuations and Flicker in Low-Voltage Supply Systems for Equipment with Rated Current up to 16 A "
8
Image /page/8/Figure/0 description: The image is a block diagram of the Original SmartEP System. The diagram includes several components, such as electrodes connected to a pre-amplifier, a desktop or laptop computer, and a universal smart box. The pre-amplifier is labeled as (Opti-Amp) and includes 2 x 1.5 Volt AA Batteries, while the universal smart box (Hardware Receiver Unit) has AEP Amp and Stimulus Outputs.
Figure E-1: Simplified block diagram of the original SmartEP system.
9
Image /page/9/Figure/0 description: This image is a block diagram of a system for evoked potential (EP) testing. The diagram includes several components, such as electrodes, a pre-amplifier (Opti-Amp), a desktop or laptop computer, and a universal smart box (hardware receiver unit). The system also includes SEP electrical stimulation probe and box, and a low-current stimulation box. The diagram shows the connections between the different components and the flow of signals through the system.
SmartEP System with SEP, VEP, & Low-Current Stimulator Block Diagram
Simplified block diagram of modified SmartEP Figure E-2: system with SEP. VEP, & Nerve Stimulation/Monitoring testing functionality. This system uses an SEP Electrical Stimulation Box connected to an SEP Electrical Stimulator Probe unit (for SEP testing), a VEP Visual Stimulation Box unit (for VEP testing), and a Low-Current Stimulation Box unit (for Nerve Stimulation/Monitoring, transtympanic eABR testing). The SEP Electrical Stimulation Box/Probe is powered by a medical grade power supply, and the patient is afforded protection via an isolation transformer (rated up to 3500 volts DC, 10 TeraOhms). In addition, control hardware/software is used to limit the current stimulation to 0-100mA into a load less than or equal to 4000 Ohms (0-400V). The Low-Current Stimulation Box is powered by a 9 volt battery, and the patient is afforded additional protection via an isolation amplifier. In addition, control hardware/software is used to limit the current stimulation to 0-5mA into a load less than or equal to 1500 Ohms (0-10V), and the output channels are capacitively-coupled to prevent the unintended accumulation of direct current (DC) charge. The nerve stimulator probe (monopolar or bipolar) or needle electrode, which connects to the Low-Current Stimulator unit to stimulate the patient, is provided by an outside vendor pre-packaged and sterile.
10
Substantial Equivalence Based on Assessment of Performance Data:
The modifications described in this 510(k) are only concerned with the Somatosensory Evoked Potential (SEP), Visual Evoked Potential (VEP), and Nerve Stimulation/Monitoring testing aspects of the modified SmartEP device. The auditory evoked potential (AEP) testing aspects have already been previously submitted and cleared by the FDA (refer to FDA 510(k) #K904926).
With respect to SEP and VEP testing, the modified SmartEP device with SEP and VEP functionality is substantially equivalent to the Nicolet Viking II somatosensory electrical stimulator and visual stimulator device marketed by Nicolet Biomedical with FDA 510(k) clearance number K890495. Comparisons of general and performance specification parameters are given in Table E-1.
With respect to Nerve Stimulation/Monitoring testing, the modified SmartEP device with Nerve Stimulation/Monitoring functionality is substantially equivalent to the NIM-Repsonse integrity monitor device marketed by Medtronic XOMED with FDA 510(k) clearance number K982595. Comparisons of general and performance specification parameters are given in Table E-2.
| Parameter | Predicate Device
Nicolet Viking II (K890495) | Device Under Current 510(k)
Review
SmartEP (SEP & VEP) |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | SEP:
Stimulate, record, and process
somatosensory evoked potentials
VEP:
Stimulate, record, and process visual
evoked potentials | Same |
| Indications for Use | The recording and analysis of
physiological data necessary for the
diagnosis of somatosensory and
visual related disorders. | Same |
| Target Population | All Ages | Same |
| Design | External box housing circuitry
connected to CPU via a RS232
connection | External box housing circuitry
connected to personal computer via a
USB connection |
| Materials | Assorted electrical components,
circuit boards, SEP electrical
stimulation box, SEP electrical
stimulator probe, video monitor, and
electrodes | Assorted electrical components,
circuit boards, SEP electrical
stimulation box, SEP electrical
stimulator probe, visual stimulation
LED array, and electrodes |
| Sterility | None Required | Same |
| Biocompatibility | Completely Biocompatible | Same |
| Anatomical Sites | SEP:
Upper/lower limbs and head
VEP:
Scalp | Same |
| Energy Delivery | SEP:
Stimulation of upper or lower limbs
with surface electrical signals
VEP:
Stimulation of eyes with visual light
patterns | Same |
| Where Used | Clinical Setting | Same |
| Safety | Conforms to UL544 & IEC 60601-1 | Meets EN 60601-1 |
| Patient Isolation | Type BF (IEC 60601-1) (for data),
Fiber Optic Signal Link | Type BF (IEC 60601-1) (for data),
Fiber Optic Signal Link (for amp),
Medical-grade power supplies,
4000Vdc, 10 MegaOhms (for power)
3500Vdc, 10 TeraOhms (for probe)
Isolation transformers,
Isolation amplifiers |
| Somatosensory Stimuli | | |
| Types | Constant Current or Voltage | Constant Current |
| Mode | User selectable:
Single, Dual, or Stimulus Train | Same |
| Shape | Mono or Biphasic pulses | Same |
| Repetition Rate | 0.1 - 100 Hz | Same |
| Phase/Polarity | Positive or Negative | Positive, Negative, or Alternating |
| Duration / Pulse Width | 10 - 1000 microseconds | 10 - 600 microseconds
(Total duration of all components
may only add up to 1 millisecond) |
| Stimulus Intensity
Levels | Current: 0 - 100 mA,
Voltage: 0 - 400V
(Continuous adjustable level with
user selectable maximum range into
a 4000 Ohms load) | Current: 0 - 100 mA
(400 Volt maximum)
(Continuous adjustable level with
user selectable maximum range into
a 4000 Ohms load) |
| Biocompatibility | None Specified | SEP Stimulator Probe metal prongs
made of Type-302 stainless steel,
which meets ISO-10993 standard |
| | | Visual Stimuli |
| Output Illumination | None Specified | Red LED Light (Class I AEL Level)
Peak Wavelength: 625 nm
Maximum Accessible Power: