CUB DIS II DPOAE MEASUREMENT SYSTEM

K981460 · Mimosa Acoustics, Inc. · EWO · May 20, 1998 · Ear, Nose, Throat

Device Facts

• Record ID: K981460
• Device Name: CUB DIS II DPOAE MEASUREMENT SYSTEM
• Applicant: Mimosa Acoustics, Inc.
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: May 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2

Intended Use

The intended use of The CUB®DIS II™ DPOAE Measurement System is to determine the presence of cochlear function.

Device Story

CUBEDIS II DPOAE Measurement System provides acoustic stimuli to the ear canal to measure odd-order distortion product tones generated by the cochlea. The system utilizes a PCMCIA-based DSP card for signal processing and a probe interface cable (PIC) with an acoustic probe and ear-tips to capture emissions. It operates on a Windows 95 platform using Visual C++ and Visual Basic. The device is intended for clinical evaluation of cochlear function at audiometric frequencies between 500 and 8,000 Hz. It provides a low noise floor and high signal-to-noise ratio for clinicians. Output is displayed graphically, allowing healthcare providers to evaluate cochlear health and inform clinical decision-making regarding auditory function.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technical comparison of hardware specifications and software functionality.

Technological Characteristics

System utilizes a PCMCIA Type II DSP card for signal processing. Input/Output bandwidth is 20 kHz with 16-bit ADC/DAC resolution. Connectivity is via PCMCIA slot. The probe interface cable is designed based on the ER-10C DPOAE probe. Compliance with EN 55011B, EN 60601-1-2, IEC 801-2/3/4/5, and UL 2601-1/CAN/CSA-C22.2 No. 601.1-M90 standards.

Indications for Use

Indicated for the determination of cochlear function in patients requiring otoacoustic emission testing.

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

• Etymotic Research CUBEDIS Otoacoustic Emissions Test Instrument

Submission Summary (Full Text)

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K981460

510(k) Summary

MAY 20 1998

PREPARED BY:

Mimosa Acoustics, Inc. 382 Forest Hill Way Mountainside, NJ 07092

Patricia S. Jeng, President

TELEPHONE:

CONTACT PERSON:

DATE ON WHICH THE SUMMARY WAS PREPARED

NAME OF DEVICE:

COMMON NAME:

April 22, 1998

acoustic Emission

[phone]

CUBEDIS II TM DPOAE Measurement System

Etymotic Research CUBEDIS TM Oto-

Otoacoustic Emissions Test Instrument

PREDICATE DEVICE:

FUNCTION OF DEVICE:

The CUBEDIS II TM DPOAE Measurement system is designed to provide acoustic stimuli for, and rapid clinical measurement and evaluation of, odd order distortion product tones generated by the cochlea and measured in the ear canal, at the audiometric frequencies (or other frequencies, as desired), between 500 through 8,000 Hz with no known artifacts, a low noise floor system, and a high signal-to-noise ratio.

SAFETY:

The Mimosa Acoustic CUBEDIS II TM DPOAE Measurement System is in compliance with the following standards:

EN 55011B Emissions Test EN 60601-1-2 Immunity Test IEC 801-2 Electrostatic Discharge Test IEC 801-3 RF Electromagnetic Field Test IEC 801-4 Fast Transients Test IEC 801-5 Surge Test Standard for Medical Electrical Equipment, Part 1:

General Requirements for Safety - UL 2601-1, Second Edition

1

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Medical Electrical Equipment, Part 1: ical Electrical Equipment, Part 1.
General Requirements for Safety - CAN/CSA - C22.2 No. 601.1-M90.

COMPARISON of the Mimosa CUB®DIS II TM device to the Etymfic Research CUB®DIS TM unit:

Identical for both products INDICATION FOR USE:

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## Comaprision between Ariel_ DSP16+ and Mimosa DSP Boards

| | Computer<br>Software | Computer<br>Hardware | DSP Board | Probe Driver<br>&<br>Microphone<br>Pre-Amplifier | Acoustic Probe<br>&<br>Ear-tips | |
|--|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|----------------|
| | CUBDIS | Data Collections:<br>DOS in Fortran<br><br>Graphic displays<br>DOS Fortran Package<br><br>Signal Processing:<br>Fortran routines | DSP port<br><br>Uses ISA full-size<br>plug-in slot | Ariel DSP16 Plus<br><br>Etymotic Research<br>ER-10C DPOAE<br>Probe Driver-Preamp | Etymotic Research<br>ER-10C DPOAE<br>Low Noise Probe<br>&<br>ER10C14 series ear-tips | |
| | CUBDIS II | Data Collections:<br>Window95 Visual C++<br><br>Graphic displays<br>Window95 Visual C++<br>Window95 Visual Basic<br><br>Signal Processing:<br>Same routines as the<br>Fortran routines in<br>CUBDIS system. | Uses PCMCIA card<br>plug-in slot | MA DSP PC Card<br>(PCMCIA Card) | Mimosa Acoustics<br>Probe Interface<br>Cable (PIC)<br>designed after<br>ER-10C DPOAE<br>Probe Driver-Preamp<br>with Etymotic's help. | Same as above. |

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| Parameters | Ariel DSP16+ | Mimosa DSP |
|----------------------------------------------|-------------------------|--------------------------------------------|
| Size (Type) | ISA full-size DSP board | PC (PCMCIA) Type II DSP card |
| INPUT | | |
| Measurement Bandwidth | 20 kHz | Same |
| ADC Resolution | 16 bit | Same |
| ADC Differential Nonlinearity | - | $ \pm0.5 $ LSB |
| Instantaneous Dynamic Range -<br>Line Inputs | 88 dB | 85 dB |
| Total Harmonic distortion - Line<br>Inputs | 0.025 | 0.006 |
| Signal-to-Intermodulation distor-<br>tion | - | 90 dB (Typ) |
| Full Scale Input Voltage: | 20 Vpp | 2.9 Vpp |
| OUTPUT | | |
| Measurement Bandwidth | 20 kHz | Same |
| DAC Resolution | 16 bits | Same |
| DAC Differential Nonlinearity | - | $ \pm0.5 $ LSB |
| Total Dynamic Range | 88 dB | 95 dB |
| Total Harmonic Distortion | 0.025 | 0.01% |
| Signal-to-Intermodulation Distor-<br>tion | - | 85 dB |
| Full Scale Output Voltage | 20 Vpp | 2.8 Vpp |

## Comaprision between Ariel_ DSP16+ and Mimosa DSP Boards

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 0 1998

Patricia S. Jeng President Mimosa Acoustics, Inc. P.O. Box 1111 Mountainside, New Jersey 07092 Re:

K981460

The CUB® DIS II ™ DPOAE Measurement System Dated: April 22, 1998 Received: April 23, 1998 Regulatory class: II 21 CFR 874.1050/Procode: 77 EWO

Dear Ms. Jeng:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely yours,

Kiliaith

Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): \$9814 6.6 The CUB®DIS II™ DPOAE Measurement System Device Name:

Indications For Use:

1

The intended use of The CUB®DIS II™ DPOAE Measurement System is to determine the presence of cochlear function.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ehrich A. Reppert

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic

Radiological Devices
510(k) Number K981460

Prescription Use (Pcr 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Formal 1-2-96)