(83 days)
Not Found
Not Found
No
The summary describes a standard audiometer with electroacoustic testing capabilities and does not mention any AI or ML features.
No
The device is used for diagnostic hearing evaluations and assisting in the diagnosis of disorders, not for treating them.
Yes
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."
No
The device description explicitly states it is an "electroacoustic test instrument" that "produces controlled levels of test tones and signals," indicating it includes hardware components for generating and delivering sound and measuring responses, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders." This involves testing the function of the ear and hearing system in vivo (within the living body).
- Device Description: The description reinforces this by mentioning "tympanometry, acoustic reflex and air conduction audiometry," all of which are tests performed on a living patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests in vitro (outside the living body).
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. This device operates directly on the patient to assess their hearing.
N/A
Intended Use / Indications for Use
The Interacoustics AT22t Automatic 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)
77 ETY, 77 EWO
Device Description
The Interacoustics AT22t Automatic 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
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.
Interacoustics Automatic Impedance Audiometer
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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MAY 17 1999
Page 1 of 2
510(k) SUMMARY
PREPARED BY:
International Distributors of Electronics for Medicine, Inc. (IDEM) 4814 East Second St. Benicia, CA 94510
CONTACT PERSON:
TELEPHONE:
DATE ON WHICH THE SUMMARY WAS PREPARED:
NAME OF DEVICE:
COMMON NAME:
PREDICATE DEVICE:
800-947-6334
Donna Ward, President
February 19, 1999
Interacoustics Automatic Impedance Audiometer Model AT22t
Impedance Audiometer
Interacoustics Automatic Impedance Audiometer
DESCRIPTION OF DEVICE:
The Interacoustics AT22t Automatic 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.
1
Page 2 of 2 Comparison of the Interacoustics Model AT22t Automatic Impedance Audiometer and the Interacoustics Automatic Impedance Audiometer.
Indication for use - Identical for both units.
Similarities and differences:
| Interacoustics AT22t Automatic
Impedance Audiometer | Interacoustics Automatic Impedance
Audiometer |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Display Description: Digital | Digital |
| Available Frequencies:
250 Hz, 500 Hz, 1kHz, 2kHz, 3kHz,
4kHz, 6kHz, and 8kHz | |
| Probe Tone Frequency: 226Hz ± 3% | Same |
| Probe Tone Intensity: 85dB SPL ± 3dB | Same |
| Pressure Range: +200 to -300daPa | Same |
| Compliance Range: 0,1 to 5 ml | Same |
| Transducers: TDH39 Single
Contralateral Earphone, Probe with
Probe Tip | Same |
| Patient response unit: Handheld Push
Button Switch | Same |
| Compatible Windows Software:
IABase95 Database program, Printview
for On-line PC Monitoring and Printing,
IA-NOAH-IMP Module for Interfacing
to NOAH | laBase Database program only |
| Tests: Tympanometry, Acoustic Reflex
and Air Conduction Audiometry | Same |
| Calibration: Impedance: ANSI S 3.39-
1987, IEC 1027-1991 | |
| Audiometer: ISO/R 389-1991 | Same |
| Power: 100-120 V or 220-240V | Same |
| Size and Weight: 14" x 16" x 6": 15.5 lbs | Same |
SAFETY AND EFFECTIVENESS:
The Interacoustics AT22t Automatic Impedance Audiometer is in compliance with the following performance and safety standards:
Audiometer: ANSI 3.6- 1989 IEC 645-1-1992 Type 4 Impedance: ANSI 3.39-1987 IEC 1027-1991 Type 2 Safety: IEC 601-1-1988
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The caduceus is depicted with three lines forming the wings, and the overall design is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 17 1999
Ms. Donna Ward President IDEM 4814 East Second Street Benicia, CA 94510
Re: K990585
Device: Interacoustics AT22t Automatic Impedance Audiometer Dated: February 23, 1999 Received: March 1, 1999 Classification Regulation: 77 ETY Auditory Impedance Tester, 21 CFR 874.1090 77 EWO Audiometer, 21 CFR 874.1050 Regulatory Class: II
Dear Ms. Ward:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
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Page 2 - Ms. Donna Ward
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on.the.promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Interacoustics AT22t Automatic Impedance Audiometer Devicc Name:
Indications For Use:
バ
The Interacoustics AT22t Automatic 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.
| (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 Devices | |
| 510(k) Number | K990585 |
| 7/1/99 |
Prescription Use ﺳﮯ 是 (Per 21 CFR 801.109) OR
Over-The-Counter Use