OTODYNAMICS OTOPORT

K072033 · Otodynamics, Ltd. · EWO · Nov 13, 2007 · Ear, Nose, Throat

Device Facts

• Record ID: K072033
• Device Name: OTODYNAMICS OTOPORT
• Applicant: Otodynamics, Ltd.
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Nov 13, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Otoport can perform Transient Evoked (TE) and Distortion Product (DP) Oto-Acoustic Emission (OAE) measurements on ears via an ear piece or "probe" fitted into the ear canal.

Device Story

Otoport is a handheld, battery-powered otoacoustic emission (OAE) analyzer; used to screen cochlear function in newborns, children, and adults. Device inputs acoustic signals via an ear probe inserted into the ear canal; performs high-performance signal analysis to detect Transient Evoked (TE) or Distortion Product (DP) emissions. Provides robust indications of cochlear function with high immunity to extraneous noise. Features include real-time data display, programmable test protocols, and probe identity checks. Output is viewed on an integral LCD screen or printed via a portable printer; data can be transferred to an IBM-compatible PC via USB or Bluetooth for storage and analysis. Used in clinical settings by healthcare professionals to assess hearing health; results assist in identifying potential cochlear dysfunction, facilitating early intervention.

Clinical Evidence

Bench testing only. The device performance was validated through technical specifications comparison, including frequency range, signal-to-noise ratio, and harmonic/intermodulation distortion metrics, demonstrating equivalence to the predicate devices.

Technological Characteristics

Handheld, battery-powered (3.6v rechargeable) OAE analyzer. Features LCD screen, built-in keypad, and probe interface. Connectivity via USB and Bluetooth. Signal processing includes TE and DP OAE analysis. Frequency range: 500-6,000Hz (TEOAE) and 500-10,000Hz (DPOAE). Level increments: 1dB steps. Includes latency artifact check and probe identity check. Software-based signal analysis.

Indications for Use

Indicated for newborn, child, and adult populations for screening cochlear function via Transient Evoked and Distortion Product Oto-Acoustic Emission measurements.

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

• Otodynamics LTD ILO292DP Echoport (K983350)
• Otodynamics LTD ILO2088 Echocheck (K983352)

Submission Summary (Full Text)

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# Section 5: 510(k) Summary

Otodynamics LTD 30-38 Beaconsfield Road AL10 8BB Hatfield Herts 108 GB Phone: [phone] Fax: [phone]

NOV 1 3 2007

Contact: John Morgan

Summary Prepared: April 25, 2007

Trade Name : Otocheck

Common Name :

Classification Name : Audiometer

#### Predicate Device Identification:

CFR21: Product Code: EWO Device Class:II Legally Marketed Device: Otodynamics LTD ILO292DP Echoport & ILO2088 Echocheck Manufacturer: Otodynamics LTD K#: K983350 & K983352

### Description:

The Otoport is a compact, sclf-contained, handheld Otoacoustic emission analyzer which has integral. rechargeable batteries for use.

The Otoport can screen for cochlear function using either Transicnt Evoked or Distortion Product Otacoustic Emissions (TE or DPOAEs). It uses state-of-the-art technology and high performance signal analysis to provide robust indications of cochlear function and high immunity to extraneous noise.

The Otoport has a high degree of connectivity, being capable of immediate connection to any IBM compatible PC via either USB port or Bluctooth wireless technology. The instrument will acccpt probes that are already in use with other products in the Otodynamics range of otoacoustic emission analyzer instruments. There is 100% compatibility between data recorded on the Otoport and data recorded on other Otodynamics OAE products.

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## Intended Use:

The Otoport can perform Transient Evoked (TE) and Distortion Product (DP) Oto-Acoustic Emission (OAE) measurements on ears via an ear piece or "probe" fitted into the ear canal.

| | Otodynamics<br>ILO2088 Echocheck | Otodynamics ILO292<br>DP EchoportPlus | Otodynamics<br>Otoport |
|----------------------------------------------------|--------------------------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| 510(k) Number | K983352 | K983350 | This 510(k) |
| Target population | Newborn, child,<br>adult | Newborn, child, adult | Newborn, child,<br>adult |
| Intended use | Transient Evoked<br>otoacoustic<br>screening technique | Distortion Product and<br>Transient Evoked<br>otoacoustic screening<br>technique | Distortion Product<br>and Transient<br>Evoked otoacoustic<br>screening technique |
| Physiological<br>Measurement<br>Technique employed | Non-invasive | Non-invasive | Non-invasive |

## Predicate Product Comparison Chart : .

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| Signal output: | | | |
|-------------------------------|-------------------------------------------------------------------------|-------------------------------------------------|------------------------------------------------------------------------|
| Frequency range:<br>TEOAE | 1,500 to 3,200Hz | 500 to 6,000Hz | 500 to 6,000Hz |
| DPOAE | N/A | 500 to 8,000Hz | 500 to 10,000Hz |
| Level range: TEOAE | 94 to 44dB SPL | 94 to 44dB SPL | 94 to 44dB SPL |
| DPOAE | N/A | 35 to 75dB SPL | 35 to 75dB SPL |
| Level increments:<br>TEOAE | 1.5dB steps +/-0.5 | 1.5dB steps +/-0.5 | 1dB steps +-0.5 |
| DPOAE | N/A | 1dB steps +/-0.5 | 1dB steps +/-0.5 |
| Signal to noise ratio | >85dB | >85dB | >85dB |
| Harmonic distortion:<br>TEOAE | N/A | N/A | N/A |
| DPOAE | N/A | <1% | <1% |
| Intermodulation<br>distortion | N/A | <-80dB | <-80dB |
| OAE Measurement system: | | | |
| Frequency range:<br>TEOAE | 1,500 to 3,200Hz | 500 to 8,000Hz | 500 to 8,000Hz |
| DPOAE | N/A | 500 to 10,000Hz | 500 to 10,000Hz |
| Amplitude range:<br>TEOAE | -10 to +94dB SPL | -10 to +94dB SPL | -10 to +94dB SPL |
| DPOAE | N/A | -20 to +80dB SPL | -20 to +80dB SPL |
| Other parameters: | | | |
| External input<br>voltage: | Via charger adaptor:<br>100v AC (@ 60Hz<br>for USA or 230v AC<br>@ 50Hz | 100v AC (@ 60Hz for<br>USA or 230v AC @<br>50Hz | Via charger adaptor<br>100v AC (@ 60Hz<br>for USA or 230v<br>AC @ 50Hz |

..............................................................................................................................................................................

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| Internal power<br>source: | 2.4v rechargeable<br>battery | 7.5v rechargeable<br>battery | 3.6v rechargeable<br>battery |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Hard copy output: | Dedicated battery<br>portable printer | Range of standard PC<br>printers | Dedicated battery<br>portable printer |
| Computer<br>compatibility | PC Pentium III, 1<br>GHz. Windows 98<br>SE/ME/2000/XP,<br>CD-ROM drive.<br>RS232<br>communications port | Recommended<br>minimum system:<br>Laptop PC, VGA or<br>better 486 33MHz<br>4MB RAM for DOS<br>usage. Pentium laptop<br>PC 8MB RAM for<br>Windows 95 usage | PC Pentium III, 1<br>GHz, Windows 98<br>SE/ME/2000/XP.<br>CD-ROM drive.<br>USB port. |
| DPOAE Resolution: | N/A | 1 point/octave to<br>8 points/octave | 1 point/octave to<br>8 points/octave |
| TEOAE Resolution: | 100Hz | 100Hz | 100Hz |
| Latency artefact<br>check: | Yes | Yes | Yes |
| Real time data<br>display: | No | Yes | Yes |
| Programmable test<br>protocol | No | Yes | Yes |
| Fully self<br>documented file<br>structure: | Yes | Yes | Yes |
| Self-test: | Yes | Yes | Yes |
| Probe identity<br>check: | No | Yes | Yes |
| Built-in keypad: | Yes (limited) | Yes | Yes |
| Built-in LCD screen<br>display: | LEDs only | Yes | Yes |

..

Kolzzo33
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird symbol made up of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Otodynamics Ltd. c/o E. J. Smith Smith Associates, Inc. 1676 Village Green, Suite A Crofton, Maryland 21114

NOV 1 3 2007

Re: K072033

Trade/Device Name: Otodynamics Otoport Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO Dated: October 15, 2007 Received: October 15, 2007

Dear Mr. Smith:

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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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours,

M.B. Egolins, mD

Malvina B. Eydelman, 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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# Indications for Use

510(k) Number (if known): _ KoJ2033

Device Name: Otodynamics Otoport

Indications for Use:

The Otoport can perform Transient Evoked (TE) and Distortion Product (DP) Oto-Acoustic Emission (OAE) measurements on ears via an ear piece or "probe" fitted into the ear canal.

Prescription Use V (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Quthen
(Division Sign-Off)

Division of Ophthalmic Ear, Nose and Throat Devises

510(k) Number K072033

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