ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS

K031986 · Ics Medical · EWO · Jul 24, 2003 · Ear, Nose, Throat

Device Facts

• Record ID: K031986
• Device Name: ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS
• Applicant: Ics Medical
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Jul 24, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.1050
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The CHARTR® EP with ASSR System is indicated for auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway. The CHARTR® OAE is indicated for the determination of cochlear function in infants, children, and adults which provides information about hearing without subjective response from the individual being tested.

Device Story

System performs auditory evoked potential testing and otoacoustic emissions analysis. Inputs include EEG signals from electrodes and auditory stimuli (modulated continuous pure tones) via transducers. Device transforms EEG inputs using digital sampling and statistical algorithms to identify steady-state responses; software calculates confidence levels for response presence. Output is objective identification of auditory responses, replacing subjective audiologist interpretation. Used in clinical settings by audiologists/technicians. Benefits include objective hearing assessment without patient cooperation, enabling testing of infants and non-responsive individuals. System comprises audio board with daughter board for multi-tone modulation, running on Windows 98 PC platform.

Clinical Evidence

No clinical data provided. Device relies on established scientific principles of steady-state response detection in EEG and bench testing for electrical safety (EN 60601-1) and EMI compatibility (EN 60601-1-2).

Technological Characteristics

System utilizes modulated continuous pure tone stimuli (0-120 dB HL) and EEG electrode montage. Hardware includes an audio board with a daughter board for multi-tone AM/FM modulation. Operates on Windows 98 PC platform (MCU-90 tower or portable). Complies with EN 60601-1 and EN 60601-1-2 standards. Software implements objective statistical detection algorithms for steady-state response identification.

Indications for Use

Indicated for auditory evoked potential testing to detect hearing loss and auditory pathway lesions, and for determination of cochlear function in infants, children, and adults who cannot provide subjective responses.

Regulatory Classification

Identification

An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.

Predicate Devices

• CHARTR® EP and CHARTR OAE Systems (K002985)

Submission Summary (Full Text)

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# 231986

### JUL 2 4 2003

### 510(k) SUMMARY

| Submitted by: | ICS MEDICAL<br>125 Commerce Drive<br>Schaumburg, IL 60173-5329 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | (847)-534-2150 |
| Fax: | (847)-534-2151 |
| Contact Person: | Delmar F. Bloem, President |
| Date Summary Prepared: | June 26, 2003 |
| Trade Name of Device: | ICS Medical CHARTR® EP with<br>ASSR and CHARTR® OAE<br>Systems |
| Common Name: | Auditory Evoked Potential<br>System and Otoacoustic<br>Emissions Analyzer System. |
| Classification Name: | Auditory Evoked Potential<br>System and Audiometer |
| Substantial Equivalence: | The CHARTR® EP with ASSR<br>CHARTR® OAE Systems<br>Product is substantially<br>equivalent to the CHARTR® EP<br>and CHARTR OAE Systems<br>which has a cleared 510(k):<br>K002985. |

Intended Use:

The CHARTR® EP with ASSR System is indicated for auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway.

The CHARTR® OAE is indicated for the determination of cochlear function in infants, children, and adults which provides information about hearing without subjective response from the individual being tested

Scientific Principle:

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ASSR (Auditory Steady-State Response) testing is based on the longestablished principle that stimuli presented at fast rates evoke brain responses that overlap (so-called "steady-state" responses). The overlap results in a stable sinusoidal pattern in the patient's electroencephalogram (EEG). The pattern is detectable with computer algorithms, and is stable only in the EEG of patients whose auditory system responds to the stimulus.

With auditory stimuli, amplitude- and/or frequency-modulation of a sine wave (pure tone) results in a stimulus that is both relatively frequencyspecific and capable of evoking a detectable steady-state response. Research studies have demonstrated that when several such stimuli are presented to a patient simultaneously, the response to each stimulus can be extracted from the (composite) EEG, and the results are comparable to those obtained when the stimuli are presented sequentially. This technique enables assessment of hearing at several frequencies at once.

Responses are detected through analysis of digital samples of the patient's EEG. The analysis consists of two stages: estimation and statistical detection. Estimation involves calculations performed on the EEG samples to produce periodic values for amplitude and/or phase of each response sought. Estimates for each response are passed to a statistical algorithm that calculates the confidence, in percent, that the estimates are consistent with a stable response to the corresponding stimulus. The software declares a response to be present when the confidence reaches a predetermined threshold (i.e. 95%). If the confidence does not reach this threshold within a predetermined amount of time (i.e. 5 minutes of testing), the software declares that no response could be found.

Electrical Safety:

Both Systems are designed to meet EN 60601-1 standard for Medical devices.

EMI Compatibility:

Both Systems are designed to meet EN 60601-1-2 standard.

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| | CHARTR EP | CHARTR EP with ASSR |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Stimulus | Click or tone burst | Modulated continuous pure tone |
| Transducers | Insert, bone | Insert, bone, speaker |
| Intensity | 0-90 db HL | 0-120 dB HL |
| Electrode montage | Low forehead, high<br>forehead and both ears | Low forehead, high forehead and<br>one ear |
| Patient state | Sleeping or resting<br>quietly | Same |
| Interpretation | Audiologist subjectively<br>identifies responses | Algorithm objectively identifies<br>responses |
| Clinical purpose | Indicated for auditory<br>evoked potential testing<br>as an aid in detecting<br>hearing loss and lesions<br>in the auditory pathway | Same |
| Patient population | Adults, children, and<br>infants. | Same |
| Hardware<br>configuration | Audio board | Audio board with daughter board to<br>provide multiple AM/FM modulated<br>tones |
| Operating system | Win98 | Same |
| Software - protocol<br>with ASSR | No | Yes |
| Electrical Safety | Designed to comply with<br>EN 60601-1 (UL2601) | Same |
| EMI Compatibility | Designed to comply with<br>EN 60601-1-2 | Same |
| Computer System | MCU-90 (IBM<br>compatible tower) and<br>Portable (TFT active<br>matrix screen) computer | Same |
| Labeling | Identical for both units | Same |
| Operator Manual | Covers CHARTR EP<br>version 2.0 | Contains updates for EP versions<br>3.0 and 4.0 |

# Comparison Table for
CHARTR® EP vs. CHARTR® EP with ASSR

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Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol consisting of three curved lines above two wavy lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 4 2003

ICS Medical c/o Delmar F. Bloem, President 125 Commerce Drive Schaumburg, IL 60173-5329

Re: K031986

Trade/Device Name: ICS MEDICAL CHARTR® EP WITH ASSR AND CHARTR® OAE SYSTEMS

Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: II Product Code: EWO Dated: June 26, 2003 Received: June 27, 2003

Dear Mr. Bloem:

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.

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 - Delmar F. Bloem, President

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 [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 Manufacturers, 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,

A. halyi Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page_1_of_1

510(k) Number (if known):_Ko 3 1986

Device Name: ICS Medical CHARTR® EP with ASSR and CHARTR® OAE Systems Indications For Use:

The CHARTR® EP System is indicated for auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway.

The CHARTR® OAE is indicated for the determination of cochlear function in infants, children, and adults which provides information about hearing without subjective response from the individual being tested.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Orms K. Kan, Ph D
Division Sign-Off

Division of Ophthalmic Ear,
Nose and Throat Devices

510(k) Number K031582

(Optional Format 3-10-98)