(95 days)
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No
The provided text describes a system for measuring auditory functions (ABR and TEOAE) with features like automatic recording and manual programmability. There is no mention of AI, ML, or related concepts in the intended use, device description, or other sections.
No
The intended use describes the device as assisting in the evaluation, documentation, and recording of auditory functions (specifically ABR and TEOAE), which are diagnostic procedures, not therapeutic.
Yes
The intended use states that the devices "are intended to assist in the evaluation, documentation and the automatic recording of ABR waveforms" and "for determining Cochlear function." These functions are consistent with diagnostic purposes.
No
The description refers to "systems" (EP15 and EP25) and their function in recording ABR waveforms and using click stimuli for TEOAE. This strongly implies the presence of hardware components (e.g., electrodes, transducers, amplifiers) necessary to acquire these physiological signals and deliver stimuli, which are not solely software functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as assisting in the evaluation, documentation, and recording of auditory responses (ABR and TEOAE). This involves measuring physiological signals from the patient's ear and brainstem in response to stimuli.
- Lack of IVD Characteristics: An IVD is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of this device does not mention the analysis of any such specimens.
- Focus on Physiological Measurement: The device's function is centered around measuring the body's response to external stimuli, which falls under the category of physiological monitoring or diagnostic equipment, not in vitro diagnostics.
Therefore, based on the provided text, the Interacoustics EP systems and TEOAE25 system are not IVDs.
N/A
Intended Use / 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. The automatic recording of ABR waveforms makes it well suited for waveform based recording and specific threshold test to operating room applications and cochlear implant tests. The EP15/25 is a 2 channel ABR and the manual programmability options makes it ideal for the Auditory Brainstem Response (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, audiologists and other health professionals concerned with measuring auditory functions.
Product codes
EWO, GWJ
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
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Intended User / Care Setting
Ear, Nose, and Throat doctors, audiologists and other health professionals; operating room applications
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
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
1
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 (301) 827-8910. 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 (800) 638-2041 or (301) 443-6597 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
2
Eclipse System 510k Notification
Image /page/2/Picture/1 description: The image shows a logo for "interacoustics". The logo features a globe-like design with lines representing longitude and latitude. The word "interacoustics" is written in a sans-serif font across the center of the globe. The logo is black and white.
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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