EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE

K090406 · Interacoustics AS · EWO · Jul 22, 2009 · Ear, Nose, Throat

Device Facts

• Record ID: K090406
• Device Name: EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE
• Applicant: Interacoustics AS
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Jul 22, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Interacoustics EP systems, EP15 and EP25, are intended to assist in the evaluation, documentation and diagnosis of ear disorders on human beings. EP1 5/25 is a 2 channel ABR and the automatic recording of ABR waveforms makes it well suited for waveform based screening and the manual programmability options allow for comprehensive clinical use ranging from frequency specific threshold test to operating room applications and cochlear implant tests. The EP15 is a basic unit allowing only recording of the Auditory Brainstem Response (ABR), while the EP25 allows recording of the ABR and earlier and later potentials. The Interacoustics TEOAE25 system is intended for determining Cochlear function using Transient Evoked Otoaccoustic Emission click stimuli. Both of these systems are of particular interest to Ear, Nose, and Throat doctors, Neurology specialties, Audiologist and other health professionals concerned with measuring auditory functions.

Device Story

System measures auditory brainstem responses (ABR) and other evoked potentials via surface electrodes; inputs amplified by external preamplifier; digitized by ADC within Eclipse unit; processed by PC software. Features include automatic waveform recording for screening and manual programmability for clinical threshold testing, OR applications, and cochlear implant testing. Operators (ENTs, neurologists, audiologists) view processed waveforms on monitor for diagnosis; data stored on PC. Enhancements include Bayesian weighting, low-pass filtering, and new stimulus types (Chirp, NB Chirp, wave file clicks). Benefits include improved signal quality and expanded diagnostic capabilities for hearing disorders.

Clinical Evidence

Bench testing only. Validation performed on EABR protocol, new stimuli (chirp, NB chirp, wave file clicks), Bayesian weighting, and low-pass filtering. Results confirmed generated electrical output was consistent with mathematically predicted output. OS compatibility testing performed for Windows Vista.

Technological Characteristics

PC-based system; USB connectivity; external preamplifier with surface electrodes; 16-bit A/D resolution. Stimuli: Click, Tone burst, Chirp, NB Chirp. Signal processing: Bayesian weighting, low-pass filtering. Software runs on Windows OS. Improved CMRR and lower noise compared to predicate.

Indications for Use

Indicated for human patients, newborn to geriatric, requiring evaluation, documentation, and diagnosis of ear disorders and auditory function. Used by ENT, neurology, and audiology professionals for ABR, MLR, LLR, P300, MMN, EcochG, and EABR 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

• Eclipse (Cabinet name), TEOAE25, EP15, EP25 or the combination of the systems (K052562)

Submission Summary (Full Text)

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990406

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# Eclipse EP15/EP25 510(k) Summary

JUL 222009

#### Sponsor

Interacoustics A/S Drejervaenget 8 DK-5610 Assens Denmark

Phone: [phone] Fax:

· Contact person: Mrs. Hanne Nielsen Preparation date: 03 Feb. 09.

#### Device

Trade names: EP15 software module, EP25 software module. Common name: Audiometer Classification name: EWO, GWJ

#### Predicate device

Eclipse (Cabinet name), TEOAE25, EP15, EP25 or the combination of the systems. K052562

#### Device description

The EP15 and EP25 systems measure auditory brainstem responses picked up by skin electrodes and amplified by a pre amplifier. The data acquisition of the ABR recordings takes place from the surface electrodes mounted at specific recording points on the patient. The analogue ABR recordings are amplified in the external preamplifier connected to the electrodes. The amplified analogue ABR recordings are converted into a digital signal in the ADC (Analog to Digital Converter) inside the Eclipse. The digital ABR recordings undergo data processing handled by the PC to improve the ABR-recordings. The ABR-recordings are displayed on the monitor for the operator, for further examination and diagnosis. All ABR recordings are stored on the Laptop / Desktop computer hard drive for later examination and diagnosis.

#### Intended use

The Interacoustics EP systems, EP15 and EP25, are intended to assist in the evaluation, documentation and diagnosis of ear disorders on human beings. EP1 5/25 is a 2 channel ABR and the automatic recording of ABR waveforms makes it well suited for waveform based screening and the manual programmability options allow for comprehensive clinical use ranging from frequency specific threshold test to operating room applications and cochlear implant tests.

The EP15 is a basic unit allowing only recording of the Auditory Brainstem Response

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(ABR), while the EP25 allows recording of the ABR and earlier and later potentials.

The Interacoustics TEOAE25 system is intended for determining Cochlear function using Transient Evoked Otoaccoustic Emission click stimuli.

Both of these systems are of particular interest to Ear, Nose, and Throat doctors, Neurology specialties, Audiologist and other health professionals concerned with measuring auditory functions.

#### Summary

The technological characteristics of the predicate device and modified EP15/EP25 system are listed in the table below.

| | Predicate device | Modified device |
|-------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Name | Interacoustics Eclipse | Interacoustics Eclipse |
| Model | EP15/EP25 | EP15/EP25 |
| K-number | K052562 | Same as existing EP15/EP25 |
| Clinical purpose | Measuring evoked potentials to assist in<br>evaluation, documentation and diagnosis<br>of hearing disorders in human beings. | Same as existing EP15/EP25 |
| Patient group | New born to geriatric | Same as existing EP15/EP25 |
| Test types | ABR, MLR, LLR, P300, MMN, EcochG | Same as existing EP15/EP25 plus EABR |
| Stimulus | Click, Tone burst | Same as existing EP15/EP25 plus Chirp,<br>NB Chirp and click from wave file |
| Averaging | Standard averaging | Same as existing EP15/EP25 plus<br>Bayesian weighting and low pass filtering |
| Presentation | EEG, Normative latency, Latency, Latency<br>calculation. | Same as existing EP15/EP25 plus Residual<br>noise, FMP values, EcochG area |
| Result evaluation | Manually / subjective | Same as existing EP15/EP25 |
| Hardware system | Eclipse connected to Laptop through<br>USB, Insert earphones, external<br>preamplifier with surface electrodes | Same as existing EP15/EP25 |
| Transducers | Eartone ABR insert phone<br>TDH39 (Optional)<br>871 (Optional) | Same as existing EP15/EP25 |
| Electrodes | Surface electrodes on:<br>- Low forehead<br>- High forehead<br>- Both mastoids | Same as existing EP15/EP25 |
| Preamplifier | Channels: 1 or 2<br>A/D resolution: 16 bit | Same as existing EP15/EP25 but with<br>improved CMRR and lower noise. |
| Operating system | Windows 98<br>Windows XP<br>Windows 2000 | Same as existing EP15/EP25 plus<br>Windows Vista |

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| Predicate device | Modified device |
|---------------------------------------------------------|-----------------------------------------------------------------|
| Operators manual | Same as existing EP15/EP25 plus description of the new features |
| Covers the Eclipse EP15/EP25, TEOAE25, DPOAE20 and ASSR | |

#### Tests

The usefulness of the EABR protocol setup has been validated with a positive result. The correct implementation of the new stimuli, i.e. chirp, NB chirp and click from wave file, have been verified through bench testing which provided the expected results. The generated electrical output was consistent with the mathematically predicted output. The correct implementation of the Bayesian weighting and low pass filtering has also been verified through bench testing and the results were as predicted.

The EP15/EP25's ability to run under windows Vista® has also been tested and no abnormal behavior was detected.

#### Conclusion

Based on the design control, the tests performed and the validation of the modified device we conclude that the modified device is both as safe and effective and performs as good as or better than the predicate device.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 222009

Interacoustics A/S C/O Hanne Nielsen Drejervaenget 8 DK-5610 Assens Denmark

Re: k090406

Trade/Device Name: Eclipse EP15/EP25 ABR System Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO, GWJ Dated: May 29, 2009 Received: June 9, 2009

Dear Ms. Nielsen:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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#### Page 2 - Ms. Hanne Nielsen

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Malvina B. Eydelman, M.D.

Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/1 description: The image shows the logo for Interacoustics. The logo features the word "Interacoustics" in bold, sans-serif font. The word is placed inside of a globe. The globe is made up of curved lines.

## Indications for Use

510(k) Number (if known): K090406

Device Name: TEOAE25, EP15 or EP25, or the combination of systems

Indications For Use:

The Interacoustics EP systems, EP15 and EP25, are intended to assist in the evaluation, documentation and diagnosis of ear disorders on human beings. EP15/25 is a 2 channel ABR and the automatic recording of ABR waveforms makes it well suited for waveform based screening and the manual programmability options allow for comprehensive clinical use ranging from frequency specific threshold test to operating room applications and cochlear implant tests. The EP15 is a basic unit allowing only recording of the Auditory Brainstem Response (ABR), while the EP25 allows recording of the ABR and earlier and later potentials.

The Interacoustics TEOAE25 system is intended for determining Cochlear function using Transient Evoked Otoaccoustic Emission click stimuli.

Both of these systems are of particular interest to Ear, Nose, and Throat doctors, Neurology specialties, Audiologist and other health professionals concerned with measuring auditory functions.

X Prescription Use 801 Subpart C)

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

### Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
1 CFR 81 CFR 801 escription User 109)
Per 21 CFR 801.109)
Per 21 CFR 801.109

Shu Chen Peng

(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear,
Division of Ophthalmic, Neurological and Ear,
Devices Division of Throat Devices

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510(k) Number K090406