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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the SmartEP device, seeking expanded indications for Somatosensory Evoked Potential (SEP), Visual Evoked Potential (VEP), and Nerve Stimulation/Monitoring. The core of the information regarding acceptance criteria and supporting studies is based on demonstrating substantial equivalence to predicate devices.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the equivalence of key specifications and intended use to legally marketed predicate devices. The "reported device performance" is a demonstration that the SmartEP's characteristics meet or are comparable to those of the predicate devices. The tables provided (Table E-1 and Table E-2) serve as the primary evidence for this.

Table 1: Acceptance Criteria and Reported Device Performance for SEP & VEP (Summarized from Table E-1)

Parameter	Acceptance Criteria (Predicate Device: Nicolet Viking II K890495)	Reported SmartEP Performance (Device Under Review)
Intended Use	SEP: Stimulate, record, and process somatosensory evoked potentials. VEP: Stimulate, record, and process visual evoked potentials.	Same
Indications for Use	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 RS232 connection.	External box housing circuitry connected to personal computer via a USB connection. (Note: This is a design difference, but implied functionally equivalent).
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 (specifically for SEP Stimulator Probe: Type-302 stainless steel, meets ISO-10993)
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 - Type	Constant Current or Voltage	Constant Current
Somatosensory Stimuli - Current Levels	0 - 100 mA, 0 - 400V (into 4000 Ohms load)	0 - 100 mA (400 Volt maximum) (into 4000 Ohms load)
Visual Stimuli - Output Illumination	None Specified	Red LED Light (Class I AEL Level), Peak Wavelength: 625 nm, Max Accessible Power: < 0.43 microWatts (at 30cm)
Visual Stimuli - Repetition Rate	0.1 - 30 Hz	0.1 - 100 Hz

Table 2: Acceptance Criteria and Reported Device Performance for Nerve Stimulation/Monitoring (Summarized from Table E-2)

Parameter	Acceptance Criteria (Predicate Device: NIM-Response K982595)	Reported SmartEP Performance (Device Under Review)
Intended Use	Stimulate, record, and process evoked nerve responses.	Same
Indications for Use	Nerve stimulation & monitoring.	Same
Target Population	All Ages	Same
Design	Main hardware receiver/monitor unit with touch-screen display (control test setup, monitoring, storage), connects to separate isolated Patient Interface Unit (input amplifier channels & output stimulator channels).	External hardware receiver unit which connects to a separate isolated battery-powered Low-Current Stimulation Box for stimulation, a separate isolated bio-amplifier unit for acquisition, and a personal computer (via a USB connection) for test setup, processing, monitoring, and storage through software. (Note: Design difference, but claimed functionally equivalent).
Sterility	Requires use of sterile nerve stimulator probe (monopolar or bipolar) and sterile subdermal/needle electrodes for patient contact.	Same (Nerve stimulator probe provided by outside vendor pre-packaged and sterile).
Biocompatibility	Completely Biocompatible (meeting ISO-10993 for soft tissue contact).	Same
Anatomical Sites	Patient's exposed nerve/soft tissue, intramuscular, subdermal, skin, scalp, and possibly other body sites.	Same
Energy Delivery	Stimulation of exposed nerve tissue with low-current electrical signals.	Same
Where Used	Intra-Operative/Surgical Setting.	Same
Safety	Complies with IEC 60601-1, UL2601-1, CSA22.2 No.601, AS3200.	Complies with EN 60601-1.
Patient Isolation	Type BF (IEC/EN 60601-1), 4000Vpp 60Hz dielectric withstand (power). Main Unit Fuse: TypeF 250V, 2-4 A. Stimulator Fuse: TypeF 250V, 32mA.	Type BF (IEC 60601-1), 4000Vdc, 10 MegaOhms (power). Medical-grade power supply, Fiber Optic Signal Link (amplifier). Stimulator Fuse: 15.6 mA (1500ohm load impedance), Battery-powered stimulator, Isolation amplifier.
Nerve Stimuli - Type	Constant Current, Pulsed.	Same
Nerve Stimuli - Shape	Monophasic pulses.	Mono- or Biphasic pulses. (Note: This is a difference, but likely considered equivalent or enhanced functionality within the scope of intended use).
Nerve Stimuli - Repetition Rate	1, 4, 7, & 10 Hz.	1 - 10 Hz. (Note: Wider range described for SmartEP, functionally equivalent).
Nerve Stimuli - Current Levels	0 - 3 mA (12 Volt maximum).	0 - 5 mA (10 Volt maximum). (Note: Higher current range for SmartEP, within safety limits).

2. Sample Size Used for the Test Set and Data Provenance

The document does not report primary clinical data or a specific test set formed from human subjects for evaluating the performance of the SmartEP device with its expanded indications. Instead, the study relies on a comparative analysis of technical specifications and safety standards against legally marketed predicate devices.

Therefore:

Sample size for test set: Not applicable, as performance was not demonstrated through a traditional clinical study with a test set of patient data.
Data provenance: Not applicable. The "data" used for comparison are the technical specifications and regulatory compliance of the predicate devices and the modified SmartEP.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The ground truth, in this context, is the established safety and effectiveness profile of the predicate devices. This was determined by FDA clearance processes for those devices, not by new expert consensus for this 510(k). The current submission relies on the regulatory acceptance of the predicate devices as the benchmark for "ground truth" regarding safety and performance.

4. Adjudication Method for the Test Set

Not applicable, as no human subject test set or associated ground truth adjudication was performed as part of this 510(k) submission.

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 an evoked response testing and diagnostic system, not an AI-assisted diagnostic imaging or interpretation tool that would involve human readers or MRMC studies. Its function is to elicit, acquire, and measure physiological data, rather than interpret complex images or provide AI-driven assistance to human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a measurement instrument; its "performance" is assessed by its ability to accurately measure physiological responses within specified technical parameters, not by an algorithm's standalone diagnostic accuracy in the absence of human operation or interpretation.

7. The Type of Ground Truth Used

The ground truth used is the established safety, performance, and regulatory compliance of legally marketed predicate devices. The SmartEP device demonstrates substantial equivalence by comparing its technical characteristics, intended use, indications for use, and safety features directly against those of the Nicolet Viking II (for SEP and VEP) and the Medtronic XOMED NIM-Response (for Nerve Stimulation/Monitoring).

8. The Sample Size for the Training Set

Not applicable. The device is not a machine learning or AI algorithm that requires a training set of data. Its development and modification process involved engineering design, verification, and validation against specified requirements and safety standards, rather than data-driven machine learning.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this device.

Summary

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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.

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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

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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

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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 Systems6860 SW 81st StreetMiami, 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 forSomatosensory 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 ofeliciting, acquiring, and measuring auditory, somatosensory, andvisual evoked potential data, as well as providing nervestimulation/monitoring.The feature modifications described in this 510(k) are toincorporate additional/expanded indications to the SmartEPdevice for somatosensory evoked potential, visual evokedpotential, and nerve stimulation testing to the previously FDAcleared indications for auditory evoked potential testing.Specifically, additional hardware and software features havebeen added to the original SmartEP device system to objectivelyacquire somatosensory/visual evoked potentials upon thepresentation of a somatosensory/visual stimulus, and to providenerve stimulation/monitoring functionality,
Intended Use:	The SmartEP device is intended to be used as a diagnostic aidand adjunctive tool in sensory related disorders and nervestimulation/monitoring on patients of all ages. This is the sameintended use as that of the predicate device(s).

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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

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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

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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.

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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 "

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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.

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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.

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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 DeviceNicolet Viking II (K890495)	Device Under Current 510(k)ReviewSmartEP (SEP & VEP)
Intended Use	SEP:Stimulate, record, and processsomatosensory evoked potentialsVEP:Stimulate, record, and process visualevoked potentials	Same
Indications for Use	The recording and analysis ofphysiological data necessary for thediagnosis of somatosensory andvisual related disorders.	Same
Target Population	All Ages	Same
Design	External box housing circuitryconnected to CPU via a RS232connection	External box housing circuitryconnected to personal computer via aUSB connection
Materials	Assorted electrical components,circuit boards, SEP electricalstimulation box, SEP electricalstimulator probe, video monitor, andelectrodes	Assorted electrical components,circuit boards, SEP electricalstimulation box, SEP electricalstimulator probe, visual stimulationLED array, and electrodes
Sterility	None Required	Same
Biocompatibility	Completely Biocompatible	Same
Anatomical Sites	SEP:Upper/lower limbs and headVEP:Scalp	Same
Energy Delivery	SEP:Stimulation of upper or lower limbswith surface electrical signalsVEP:Stimulation of eyes with visual lightpatterns	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 componentsmay only add up to 1 millisecond)
Stimulus IntensityLevels	Current: 0 - 100 mA,Voltage: 0 - 400V(Continuous adjustable level withuser selectable maximum range intoa 4000 Ohms load)	Current: 0 - 100 mA(400 Volt maximum)(Continuous adjustable level withuser selectable maximum range intoa 4000 Ohms load)
Biocompatibility	None Specified	SEP Stimulator Probe metal prongsmade 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 nmMaximum Accessible Power:< 0.43 microWatts (at a distance of30cm (12 inches))
Pattern Types	Checkerboard, Horizontal Bars,Vertical Bars	Same
Pattern Fields	User selectable:Full field, Half field, and Quarter-field	User selectable:Full field, Half field, Quarter-field, and Displacements
Pattern Presentation	User selectable:Pattern Reversal and Pattern Flash	User selectable:Pattern Reversal, Pattern Flash, andPattern Shift
Repetition Rate	0.1 - 30 Hz	0.1 - 100 Hz
Parameter	Predicate DeviceNIM-Response (K982595)	Device Under Current 510(k)ReviewSmartEP (Nerve Stimulation)
Intended Use	Stimulate, record, and processevoked nerve responses	Same
Indications for Use	Nerve stimulation & monitoring	Same
Target Population	All Ages	Same
Design	Main hardware receiver/monitor unitwith touch-screen display (to controltest setup, monitoring, and storage),which connects to a separate isolatedPatient Interface Unit (includinginput amplifier channels & outputstimulator channels) for stimulation& acquisition	External hardware receiver unitwhich connects to a separate isolatedbattery-powered Low-CurrentStimulation Box for stimulation, aseparate isolated bio-amplifier unitfor acquisition, and a personalcomputer (via a USB connection) fortest setup, processing, monitoring,and storage through software
Sterility	Requires use of sterile nervestimulator probe (monopolar orbipolar) and sterile subdermal/needleelectrodes for patient contact	Same
Biocompatibility	Completely Biocompatible	Same
Anatomical Sites	Patient's exposed nerve/soft tissue,intramuscular, subdermal, skin,scalp, and possibly other body sites	Same
Energy Delivery	Stimulation of exposed nerve tissuewith low-current electrical signals	Same
Where Used	Intra-Operative/Surgical Setting	Same
Safety	Complies with IEC 60601-1,UL2601-1, CSA22.2 No.601,AS3200	Complies with EN 60601-1
Patient Isolation	Type BF (IEC/EN 60601-1) ,4000Vpp 60Hz dielectric withstandfrom Line Connections to signalground (for power),Main Unit Fuse: TypeF 250V, 2-4 A1000VRMS 60Hz, 2MegaOhms(for amplifier),Stimulator Fuse: TypeF 250V, 32mA	Type BF (IEC 60601-1)4000Vdc, 10 MegaOhms (for power)Medical-grade power supplyFiber Optic Signal Link(for amplifier),Stimulator Fuse: 15.6 mA(1500ohm load impedance),Battery-powered stimulator,Isolation amplifier
Nerve Stimuli
Transducers	Nerve stimulator probe (monopolaror bipolar), Needle Electrodes	Same
Types	Constant Current, Pulsed	Same
Mode	Stimulus Train	User selectable:Single, Dual, or Stimulus Train
Shape	Monophasic pulses	Mono- or Biphasic pulses
Repetition Rate	1, 4, 7, & 10 Hz	1 - 10 Hz
Phase/Polarity	Negative	Positive, Negative, or Alternating
Duration/Pulse Width	50, 100, & 250 microseconds	10 - 200 microseconds
Stimulus IntensityLevels	Current: 0 - 3 mA(12 Volt maximum)	Current: 0 - 5 mA(10 Volt maximum)
Biocompatibility	Nerve stimulator probe and/orsubdermal/needle electrodescompletely biocompatible meetingISO-10993 standard for soft tissuecontact	Same
Sterility	Nerve stimulator probe and/orsubdermal/needle electrodesprovided pre-packaged and sterile	Same

SPECIFICATIONS

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Table E-1: General and performance specifications of predicate device & current device under 510(k) review for Somatosensory & Visual Evoked Potential Testing.

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Table E-2: General and performance specifications of predicate device & current device under 510(k) review for Nerve Stimulation/Monitoring Testing.

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Product Labeling:

In this 510(k) application there are changes in the intended use, advertisements, and directions for use due to the type of modifications to the original SmartEP device marketed by Intelligent Hearing Systems with FDA 510(k) clearance numbers K904926. These changes only deal with the new Somatosensory Evoked Potential (SEP), Visual Evoked Potential (VEP), and Nerve Stimulation/Monitoring testing aspects of the device. The original Auditory Evoked Potential (AEP) testing aspects have not been changed.

The only changes in product labeling between the predicate device under current 510(k) review are in the additional electrical safety labels (which include the reference model numbers and the power specifications) for the SEP Electrical Stimulation Box, SEP Electrical Stimulator Probe, VEP Visual Stimulation Box, and Low-Current Stimulation Box. These changes are a result of the modifications mentioned in this 510(k). The electrical safety labels for the Universal Smart Box (USB), SEP Electrical Stimulation Box, SEP Electrical Stimulator Probe, VEP Visual Stimulation Box, and Low-Current Stimulation Box are shown in the figure below. Note that power is supplied to the SEP Electrical Stimulator Probe through the SEP Electrical Stimulation Box, and power is supplied to the VEP Visual Stimulation Box through the Universal Smart Box.

Image /page/15/Figure/3 description: The image shows five labels, each with the text "INTELLIGENT HEARING SYSTEMS Miami, FL USA" at the top. Each label also has the year "2006" and a reference number (REF) and serial number (SN). The labels are for different products: USB DSP BOX, SEP ELECTRICAL STIMULATION BOX, SEP ELECTRICAL STIMULATOR PROBE, VEP STIMULATOR BOX, and Low-Current Stimulation Box. The labels also include electrical specifications and safety symbols.

Figure E-3: Electrical safety labels for the A) Universal Smart Box (USB), B) SEP Electrical Stimulation Box, C) SEP Electrical Stimulator Probe, D) VEP Visual Stimulation Box, and E) Low-Current Stimulation Box.

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Declaration of Conformity:

As required by our risk analysis, all verification and validation activities have been performed for the modified SmartEP device by designated individuals at Intelligent Hearing Systems. The results have demonstrated that all predetermined acceptance criteria have been met, in accordance with our ISO-13485 quality system. All records, including Device Master Records and Design History Files, are available for review upon request.

Edward Miskiel, Ph.D. President & CEO

2/26/07

Date

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Image /page/17/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 8 2007

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 Dated: June 28, 2007 Received: June 29, 2007

Dear Dr. Miskiel:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Edward Miskiel, Ph.D.

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address: http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Melkerson

Director

Mark N. Melkerson
Director
Division of General, Restorative

and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K070608

Device Name: SmartEP (with Additional/Expanded Indications for Somatosensory Evoked Potential Testing, Visual Evoked Potential Testing, & Nerve Stimulation/Monitoring)

Indications for Use:

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.

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).

Prescription Use(Per 21 CFR 801.109)	X	OR	Over-the-Counter Use
------------------------------------------	---	----	----------------------	--

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence (Division Sign-Off) Office of Device Evaluation

Division of General, Restorative, and Neurological Devices

510(k) Number	11670605	Page D1
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Regulation Number and Section

§ 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).