ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS.

K052562 · Interacoustics AS · EWO · Dec 23, 2005 · Ear, Nose, Throat

Device Facts

• Record ID: K052562
• Device Name: ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS.
• Applicant: Interacoustics AS
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Dec 23, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2

Intended Use

The Interacoustics EP systems, EP15 and EP25, are intended to assist in the evaluation 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 specific threshold test to operating room applications and cochlear implant tests. The E. 1915 a bacil unk allowing 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, and other health professionals concerned with measuring auditory functions.

Device Story

Eclipse system (EP15, EP25, TEOAE25) functions as an audiometer for auditory assessment. EP15/25 captures ABR waveforms via 2-channel input; provides automatic recording and manual programmability for threshold testing, OR applications, and cochlear implant monitoring. TEOAE25 uses click stimuli to assess cochlear function via transient evoked otoacoustic emissions. Operated by ENT physicians and audiologists in clinical or OR settings. Output consists of auditory potential waveforms and diagnostic data, assisting clinicians in identifying ear disorders and measuring auditory function.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Audiometer system (Class II, 21 CFR 874.1050). Features 2-channel ABR recording (EP15/25) and TEOAE click-stimuli measurement. System supports automatic waveform recording and manual programmability. Connectivity and specific hardware specs not detailed.

Indications for Use

Indicated for human patients requiring evaluation and diagnosis of ear disorders, including auditory function assessment, ABR waveform screening, threshold testing, and cochlear function determination via TEOAE. Intended for use by ENT doctors and health professionals.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 3 2005

Interacoustics AS c/o Daniel Eggan Interacoustics USA 7625 Golden Triangle Drive Eden Prairie, MN 55344

Re: K052562

Trade/Device Name: Eclipse (Cabinet name), TEOAE25, EP15, EP25 or the combination of Systems Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO, GWJ Dated: November 29, 2005 Received: November 30, 2005

Dear Mr. Eggan:

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 for association 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 r your device 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

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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 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/industry/support/index.html.

Sincerely yours,

David M. Whipple

Acting 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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Eclipse System 510k Notification

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## Indications for Use

510(k) Number (if known):

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 r the interdoodotios and diagnosis of ear disorders on human beings. evaluation, documentation and the automatic recording of ABR waveforms makes it
EP15/25 is a 2 channel ABR and the automatic recording of ABR waveforms makes it EF 15/2013 a 2 channon ADA and the manual programmability options well suited for waverom baood occorning and and and and specific threshold test to operating room applications and cochlear implant tests.

operating foom applications and over over of the Auditory Brainstem Response The E. 1915 a bacil unk allowing 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, Doll of these byotone are of paist and other health professionals concerned with measuring auditory functions.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Use

Prescription Use (Per 21 CFR 801.109)

Larrilu

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

Author Eivind Christensen

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