(90 days)
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Not Found
No
The summary describes standard signal processing of otoacoustic emissions and does not mention AI, ML, or related concepts.
No
The device is used for evaluation and documentation of ear disorders, measuring auditory functions, which makes it a diagnostic device, not a therapeutic one.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the system is "for use in the audiologic evaluation and documentation of ear disorders." This clearly indicates its purpose is to diagnose ear conditions.
No
The description explicitly mentions an "OAE probe" and the "Eclipse" which are hardware components used in conjunction with the software to record and process the OAE response.
Based on the provided information, the Interacoustics DPOAE20 system is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description states the device uses an OAE probe placed in the ear canal to record responses directly from the ear. This is an in-vivo measurement, not an in-vitro examination of a specimen.
- The intended use is for audiologic evaluation and documentation of ear disorders. This involves assessing the function of the ear itself, not analyzing a biological sample to diagnose a condition.
The device is clearly intended for diagnostic purposes related to hearing function, but it does so through direct measurement of the ear's response, not by testing a sample outside the body.
N/A
Intended Use / Indications for Use
The Interacoustics DPOAE20 system is for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emission tone stimuli.
The presence of Otoacoustic emissions suggests normal outer hair cell function within cochlea, which in turn suggests normal hearing. OAEs are recorded using an OAE orobe which is placed in the ear canal. The OAE response from the ear is recorded and orocessed by the Eclipse and the DPOAE20 software and then displayed on the computer screen for evaluation.
This is of particular interest to Ear, Nose, and Throat doctors, Neurology specialists, Audiologist and other health professionals concerned with measuring auditory functions.
Product codes
EWO
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Ear
Indicated Patient Age Range
all ages
Intended User / Care Setting
Ear, Nose, and Throat doctors, Neurology specialists, Audiologist and other health professionals concerned with measuring auditory functions.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 874.1050 Audiometer.
(a)
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.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.
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Public Health Service
Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with three lines extending from its head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 0 2006
Interacoustics A/S, Assens c/o Mr. Daniel Eggan Interacoustics USA 7625 Golden Triangle Drive Eden Prairie, MN 55344
Re: K060539
Trade/Device Name: DPOAE20, Eclipse Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: II Product Code: EWO Dated: February 6, 2006 Received: March 24, 2006
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 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 – Mr. Daniel Eggan
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo tetel notification. The FDA finding of substantial equivalence of your device to a legally promation houring 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 in you a stato office of Compliance at (301) 827-8910. Also, please note the regulation entitled. "Misbranding by reference to premarket notifieation" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other gottorers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours;
M.B. Eckhaus, M.D.
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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DPOAE20 - Eclipse System 510k Notification
Revision A
Image /page/2/Picture/2 description: The image shows a logo for Interacoustics. The logo features a globe with lines of latitude and longitude. The word "interacoustics" is written across the center of the globe. The text is in lowercase letters.
Indications for Use
510(k) Number (if known):
Device Name: DPOAE20 Indications For Use:
The Interacoustics DPOAE20 system is for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emission tone stimuli.
The presence of Otoacoustic emissions suggests normal outer hair cell function within cochlea, which in turn suggests normal hearing. OAEs are recorded using an OAE orobe which is placed in the ear canal. The OAE response from the ear is recorded and orocessed by the Eclipse and the DPOAE20 software and then displayed on the computer screen for evaluation.
This is of particular interest to Ear, Nose, and Throat doctors, Neurology specialists, Audiologist and other health professionals concerned with measuring auditory functions.
The patient group includes all ages and sexes.
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)
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K660539
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Author Ejvind Christensen
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