SMARTEP-ASSR, MODEL M811007

K031051 · Intelligent Hearing Systems · GWJ · Feb 20, 2004 · Neurology

Device Facts

• Record ID: K031051
• Device Name: SMARTEP-ASSR, MODEL M811007
• Applicant: Intelligent Hearing Systems
• Product Code: GWJ · Neurology
• Decision Date: Feb 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1900
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The intended use of the SmartEP-ASSR product is for the recording of auditory steady-state evoked potential data. The product is intended to be used as a diagnostic aid in auditory and hearing related disorders and as an adjunctive tool in the estimation of behavioral hearing thresholds. SmartEP-ASSR can be used for patients of all ages. It is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's office or other appropriate setting.

Device Story

SmartEP-ASSR is an auditory evoked potential testing system; measures auditory steady-state responses (ASSR). Inputs: physiological signals via 1-4 optically isolated channels; auditory stimuli (clicks, pure tones, multifrequency) via transducers (earphones, bone conduction, OAE probe). System processes signals using programmable artifact rejection and user-selectable digital filters; outputs ASSR data for clinical interpretation. Used in hospitals, clinics, or audiologist offices by trained personnel. Provides diagnostic aid for hearing disorders; assists in estimating behavioral hearing thresholds. Benefits patients by enabling objective hearing assessment across all ages.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparison of technical specifications.

Technological Characteristics

Evoked response auditory stimulator; 1-4 optically isolated channels; 16-bit A/D resolution. Stimuli: clicks, pure tones, multifrequency (500Hz-8kHz). Connectivity: USB interface. Software runs on Windows 98SE/ME/2000/XP. Features programmable artifact rejection, variable gain (30k-300k), and user-selectable digital filters (1-5k Hz).

Indications for Use

Indicated for patients of all ages with auditory or hearing-related disorders to record auditory steady-state evoked potential (ASSR) data and estimate behavioral hearing thresholds.

Regulatory Classification

Identification

An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.

Predicate Devices

• Bio-logic MASTER Evoked Response System (K021895)

Submission Summary (Full Text)

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K031051

FEB 2 0 2004

## 510(k) Summary

| Prepared By: | Intelligent Hearing Systems<br>7356 SW 48th Street<br>Miami, FL 33155 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | [phone] |
| FAX: | [phone] |
| Contact Person: | Edward Miskiel, Ph.D. |
| Date Summary prepared: | February 13, 2004 |
| Name of the Device: | SmartEP-ASSR |
| Common Name: | Evoked Response System |
| Classification Name: | Evoked Response Auditory Stimulator (per CFR 874.1900) |
| Predicate Device: | Bio-logic MASTER Evoked Response System (K021895) |
| Device Description: | SmartEP-ASSR is a auditory evoked potential testing device<br>that is capable of measuring auditory steady state responses<br>(ASSR). |
| Intended Use: | The intended use of the SmartEP-ASSR product is for the<br>recording of auditory steady-state evoked potential data.<br>The product is intended to be used as a diagnostic aid in<br>auditory and hearing related disorders and as an adjunctive<br>tool in the estimation of behavioral hearing thresholds.<br>SmartEP-ASSR can be used for patients of all ages. It is<br>intended to be used by trained personnel in a hospital,<br>nursery, clinic, audiologist's office or other appropriate<br>setting. |
| Technological Characteristics: | The SmartEP-ASSR device is similar to the predicate device<br>in its intended use and data processing methodologies. |

# INTELLIGENT HEARING SYSTEMS

· Miami, Florida 33155 · Telephone: [phone] · FAX: [phone] S.W. 48th Street Email Address: [e-mail] = www.ihsys.com Page E1

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### Substantial Equivalence Based on Assessment of Performance Data:

The SmartEP-ASSR is substantially equivalent to the Bio-logic MASTER Evoked Response System device marketed by Bio-logic Systems Corp. with FDA 510(k) clearance number K021895. Comparisons of technical parameters are shown in the table below.

| Parameter | Predicate Device<br>(Non-Prcamendmant Device)<br>Bio-Logic Master (K021895) | Device Under Current 510(k)<br>Review<br>SmartEP-ASSR |
|-----------------------|-----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Data Acquisition | | |
| A/D Resolution | 16 bit | 16 bit |
| Artifact Rejection | Programmable | Programmable |
| Amplifiers | | |
| Channels | 1 Channel Optically Isolated | 1-4 Channels Optically Isolated |
| Gain | 10k | Variable (30k-300k) |
| Filters | | |
| Slope | 12 dB/octave | 6 dB/octave |
| LP | 1.5k, 3k, 10k, 20k Hz | 30, 100, 300, 500, 1k, 1.5k, 3k, 5k<br>Hz |
| HP | 0.1, 0.3, 1, 3, 10, 30, 100, 300Hz | 1, 10, 30, 50, 100, 150, 300, 500 Hz |
| Notch | 50/60Hz | 50/60Hz |
| Digital Filters | 1-200Hz | User Selectable (1 -5k Hz) |
| Noise Level | 0.45 μV RMS (10-3k Hz) | 0.33 μV RMS (1-3k Hz) |
| Input Impedance | 100M Ohms | 5M Ohms |
| CMR Ratio | 110 dB at 50/60 Hz | 117 dB at 60 Hz and<br>110 dB at 1k Hz |
| Impedance Test | | |
| Signal | 20 Hz Sinewave | 1k Hz Sinewave |
| Auditory Stimuli | | |
| Presentation | Monaural or Binaural | Monaural or Binaural |
| Number of Frequencies | 1-4 | 1-8 |
| Test Frequencies | 500, 750, 1k, 1.5k, 2k, 3k, 4k, 6k, 8k<br>Hz | User Selectable: Clicks, Pure Tones<br>and Multifrequency Stimuli (500Hz-<br>8k Hz) |
| Types | Sinewave | Sinewave, Tone Burst |
| Envelopes | Linear, Blackman, Gaussian,<br>Hanning Envelopes | Linear, Blackman, Gaussian,<br>Hanning, Rectangular, Triangular,<br>Trapezoidal, Exact Blackman,<br>Cosine, Cosine Squared, Cosine<br>Cubed |
| Intensity | 0-125 dB SPL<br>(132 dB Optional) | 0-125 dB SPL |
| Masking | White Noise Programmable | White Noise Programmable |
| Transducers | TDH Earphones, Insert Earphones,<br>Bone Conduction, Sound Field | TDH Earphones, Insert Earphones,<br>Bone Conduction, Sound Field, OAE<br>Probe |
| Computer Requirements | | |
| Computer Type | Personal Computer | Personal Computer |
| Operating System | Microsoft Windows | Microsoft Windows 98SE, ME,<br>2000, XP |
| Interface Connection | Serial | USB (Universal Serial Bus) |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three horizontal bars that curve upwards, resembling a stylized human figure. The symbol is black, and the text is also black.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 0 2004

Edward Miskiel, Ph.D. President and CEO Intelligent Hearing Systems 7356 S.W. 48" Street Miami, Florida 33155

Rc: K031051

Trade/Device Name: SmartEP- ASSR Regulation Number: 21 CFR 882.1900 Regulation Name: Evoked response auditory stimulator Regulatory Class: II Product Code: GWJ Dated: December 18, 2004 Received: December 23, 2004

Dear Dr. Miskiel:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bootion of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreased 976, the enactment date of the Medical Device Amendments, or 10 commerce print to May 2017 - 7:37
devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de nees mat nave been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merelore, manes of the Act include requirements for annual registration, listing of general controls provisions and prohibitions against misbranding and adulteration.

If your device is classificd (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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I hat FDA has made a determination that your device complies with other requirements of the Act that I Dr Has Intact a and regulations administered by other Federal agencies. You must of any I edetar statutes and regirements, including, but not limited to: registration and listing (21 Cliff Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K I art 607), latoring (21 OS) regulation (21 CFR Part 820); and if applicable, the clectronic 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 begin marketing your device as described in your Section 510(k) I mis letter will and A yours finding of substantial equivalence of your device to a legally premarket notication: "The Presults 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 If you desire specific accept [phone]. 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 other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

Mark N Milken

elia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K031051

Device Name: SmartEP-ASSR

Indications For Use:

The intended use of the SmartEP-ASSR product is for the recording of auditory steadystate evoked potential data. The product is intended to be used as a diagnostic aid in auditory and hearing related disorders and as an adjunctive tool in the estimation of behavioral hearing thresholds.

SmartEP-ASSR can be used for patients of all ages. It is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's office or other appropriate setting.

Prescription Use _ × (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)

| | <div><img alt="signature" src="signature.png"/></div> |
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| | (Division Sign-Off) |
| | Division of General, Restorative, |
| | and Neurological Devices |

| 510(k) Number | K031051 |
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