(30 days)
Not Found
No
The document explicitly states "There are no interpretations of results in the device" and there are no mentions of AI, ML, or related terms. The device is described as software-controlled with functions set and interpreted by the operator.
No
The device is described as a diagnostic tool used to conduct hearing evaluations and assist in the diagnosis of possible otologic disorders. It does not provide treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders." The "Device Description" further elaborates on its use to "evaluate the functional condition of the middle ear" and "determine abnormalities" related to hearing.
No
The device description explicitly states it is an "electroacoustic test instrument" and describes hardware components like a "probe (tone and pressure)" and a "built in display." While it is software-controlled, it is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Interacoustics AT235 Impedance Audiometer works by interacting directly with the patient's ear (external auditory canal and middle ear). It changes air pressure and measures the response of the tympanic membrane. This is an in vivo (within the living body) test.
- Lack of Specimen Analysis: The device does not analyze any biological specimens taken from the patient.
Therefore, based on the provided information, the Interacoustics AT235 Impedance Audiometer is a diagnostic device, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Interacoustics AT235 Impedance Audiometer is an electroacoustic test instrument 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. It features tympanometry, acoustic reflex and air conduction audiometry.
Product codes (comma separated list FDA assigned to the subject device)
ETY
Device Description
AT235 is an auditory impedance analyser. The device is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. The device is used to determine abnormalities in the mobility of the tympanic membrane due to stiffness, flaccidity, or the presence of middle ear pathologies. The device is also used to measure the acoustic reflex threshold which occurs due to contractions of the stapedial muscle following exposure to a strong stimulus. This test allow to assess between central and peripheral pathologies and to identify where the patients uncomfortable loudness level may reside. The uncomfortable loudness level is useful when providing rehabilitative amplification methods and determining the correct management process for the patient. The AT235 also includes basic audiometry functions. The instrument is software controlled. The software controls the probe (tone and pressure) stimuli, measures the result and presents the result on a built in display. All functions are set and interpreted by the operator (There are no interpretations of results in the device). The technological characteristics are substantially equivalent with predicate device. All technological characteristics are in compliance with the consensus standard ANSI S3.39 for auditory impedance testers
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear (external auditory canal, tympanic membrane, middle ear)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The AT235 tympanometer is intended to be used by an audiologist, hearing healthcare professional, or trained technician.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Following the design control procedure the design verification and validation were performed according to current standards for medical device safety and EMC and performance of impedance tester. The device was found in compliance with current standards and demonstrated substantial equivalence with the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 874.1090 Auditory impedance tester.
(a)
Identification. An auditory impedance tester is a device that is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. The device is used to determine abnormalities in the mobility of the tympanic membrane due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor followup treatment for inflammation of the middle ear.(b)
Classification. Class II (special controls). The device, when it is a tympanometer or auditory impedance tester that complies with FDA-recognized consensus standard ANSI S3.39, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract image of three human profiles facing to the right, with flowing lines above them that resemble hair or wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 15, 2015
Interacoustics A/S c/o Mr. Eric Nielsen Director, Regulatory & Compliance Drejervaenget 8 5610 Assens Denmark
Re: K151616
Trade/Device Name: AT235 Regulation Number: 21 CFR 874.1090 Regulation Name: Auditory Impedance Tester Regulatory Class: Class II Product Code: ETY Dated: June 11, 2015 Received: June 15, 2015
Dear Mr. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
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 of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Eric A. Mann -S
for 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)
Device Name AT235
Indications for Use (Describe)
The Interacoustics AT235 Impedance Audiometer is an electroacoustic test instrument 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. It features tympanometry, acoustic reflex and air conduction audiometry.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY
AT235
| Company Name |
|---|
| Address |
Telephone Fax e-mail Contact Person Interacoustics A/S Drejervaenget 8 5610 Assens Denmark +45 6371 3555 +45 6371 3522 erni@dgs.com Erik Nielsen, Director, Regulatory & Compliance, June 12, 2015
Date Summary Prepared
Device Identification:
- Trade Name Common Name Classification Name Product Code Panel Device Class
AT235 Audiometric equipment Tester, Auditory Impedance ETY Ear Nose & Throat Class II (According to 21 CFR 874.1090)
Predicate Devices:
Predicate Device Manufacturer 510(k) No. Date Cleared
AT235 Interacoustics K994254 03/14/2000
4
| Device Description | AT235 is an auditory impedance analyser. The device is intended to
change the air pressure in the external auditory canal and measure
and graph the mobility characteristics of the tympanic membrane
to evaluate the functional condition of the middle ear. The device is
used to determine abnormalities in the mobility of the tympanic
membrane due to stiffness, flaccidity, or the presence of middle ear
pathologies. The device is also used to measure the acoustic reflex
threshold which occurs due to contractions of the stapedial muscle
following exposure to a strong stimulus.
This test allow to assess between central and peripheral
pathologies and to identify where the patients uncomfortable
loudness level may reside. The uncomfortable loudness level is
useful when providing rehabilitative amplification methods and
determining the correct management process for the patient.
The AT235 also includes basic audiometry functions.
The instrument is software controlled. The software controls the
probe (tone and pressure) stimuli, measures the result and
presents the result on a built in display. All functions are set and
interpreted by the operator (There are no interpretations of results
in the device). The technological characteristics are substantially
equivalent with predicate device. All technological characteristics
are in compliance with the consensus standard ANSI S3.39 for
auditory impedance testers |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Interacoustics AT235 Impedance Audiometer is an
electroacoustic test instrument 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. It features tympanometry, acoustic reflex and
air conduction audiometry. |
| Intended operator | The AT235 tympanometer is intended to be used by an audiologist,
hearing healthcare professional, or trained technician. |
| Technological
Characteristics | The instrument is software controlled. The software controls the
probe (tone and pressure) stimuli, measures the result and
presents the result on a built in display. All functions are set and
interpreted by the operator (There are no interpretations of results
in the device). The technological characteristics are substantially
equivalent with predicate device. All technological characteristics
are in compliance with the consensus standard ANSI S3.39 for
auditory impedance testers |
| Nonclinical tests summary | Following the design control procedure the design verification and
validation were performed according to current standards for
medical device safety and EMC and performance of impedance |
5
tester. The device was found in compliance with current standards and demonstrated substantial equivalence with the predicate device.
Clinical tests None applicable The AT235 as a modification to the predicate device (the previous Conclusion cleared revision of AT235) uses the same or identical technology and has the same intended use as the predicate device. We trust that the verification and validation activities show substantial equivalence with the predicate device and that the modified AT235 is as safe and effective as the predicate device for its claimed purpose.