(77 days)
Not Found
Not Found
No
The 510(k) summary describes a standard audiometer with electroacoustic testing capabilities and does not mention any AI or ML features. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is used for diagnosis and evaluation, not for treatment.
Yes
The "Intended Use / Indications for Use" 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, which is not characteristic of a software-only device.
Based on the provided information, the Interacoustics AZ26 Clinical Impedance Audiometer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The description of the AZ26 clearly states it's an "electroacoustic test instrument" that produces "test tones and signals" to evaluate hearing. It interacts with the patient directly, not with a biological sample taken from the patient.
- The intended use is for conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. This involves measuring the patient's response to sound and the function of their middle ear, not analyzing biological markers in a sample.
- The features listed (tympanometry, acoustic reflex, air conduction audiometry) are all methods of testing the auditory system directly.
Therefore, the AZ26 falls under the category of a diagnostic medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Interacoustics AZ26 Clinical 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
Our device, the Model AZ26 Clinical 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
Not Found
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 Model Clinical Impedance Audiometer AZ26
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.
0
MAY 17 1999
K990652
510(k) SUMMARY
PREPARED BY:
INTERNATIONAL DISTRIBUTORS OF ELECTRONICS FOR MEDICINE, INC. (IDEM) 4814 East Second Street Benicia, CA 94510
CONTACT PERSON:
Donna Ward, President
TELEPHONE:
707-746-6334
DATE ON WHICH THE SUMMARY WAS PREPARED:
February 23, 1999
NAME IF DEVICE:
Interacoustics Model AZ26 Clinical Impedance Audiometer
COMMON NAME:
Clinical Impedance Audiometer
PREDICATE DEVICE:
Interacoustics Model Clinical Impedance Audiometer AZ26
DESCRIPTION OF DEVICE:
Our device, the Model AZ26 Clinical 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
Comparison of the Interacoustics Model AZ26 Clinical Impedance Audiometer
Status County County City Learner Audiometer Model AZ26 Comparison of the interacousucs Model A226 Chineaning
and the Interacoustics Clinical Impedance Audiometer Model AZ26
Indication for use - Identical for both units.
Similarities and differences:
| Interacoustics AZ26 Clinical
Impedance Audiometer | Interacoustics Clinical Impedance
Audiometer Model AZ26 (OLDER
MODEL) |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Display Description: Digital | Digital |
| Available Frequencies:
250 Hz, 500 Hz, 1kHz, 2kHz, 3kHz,
4kHz, 6kHz, and 8kHz | Same |
| Probe Tone Frequency:
226Hz ± 1% | Same |
| Probe Tone Intensity: 85dB SPL ±
1.5dB | Same |
| Harmonic Distortion:
Less than 5% | Same |
| Pressure Range:
-600 to +300 daPa | 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 | IABase Database program only |
| Tests:
Tympanometry (Manual or Automatic),
Acoustic Reflex, Eustachian Tube Test
(Williams and Toynbee), Air Conduction
Audiometry, and Gelle Test | All except the Gelle Test and Toynbee
Eustachian Tube Test |
| Calibration: Impedance: ANSI S 3.39-
1987, IEC 1027-1991
Audiometer: ISO/R 389-1991 | Same |
| Pressure Release:
Pressure Release Function | None |
| Size and Weight: 19" x 16" x 6"; 21 lbs. | Same |
| Power: 100-120 V or 220-240V | Same |
| Opt. External Keyboard: yes | no |
INTERNATIONAL DISTRIBUTORS OF ELECTRONICS FOR MEDICINE, INC.
CONSULTIONAL DISTRIBUTORS OF EFFECT PENICIA CA 94510 USA TIONAL DISTRIBUTORS OF ELECTION, CA 94510 USA
2
SAFETY AND EFFECTIVENESS:
The Interacoustics Model AZ26 Clinical Impedance Audiometer is in compliance with the following performance and safety standards:
Audiometer: ANSI S 3.6-1996 IEC 645-1-1992, Type 4 Impedance: ANSI S 3.39-1987 IEC 1027-1991, Type 1 Safety: IEC 601-1-1988
3
Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" written around the top half of the circle. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, with flowing lines suggesting movement or energy.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 7 1999
Ms. Donna Ward President IDEM 4814 East Second Street Benicia, CA 94510
Re: K990652
Device: Interacoustics Model AZ26 Clinical 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 .
4
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,
ARalph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): K990652 Interacoustics AZ26 Clinical Impedance Audiometer Device Name:
Indications For Use:
ﻨﻴﺔ
The Interacoustics AZ26 Clinical Impedance Audiometer is an electroacoustic test interacoustics AL20 Official impodatios its test tones and signals intended test instrument that produces controlled forely and assisting in the diagnosis of
for use in conducting diagnostic hearing evaluations and assisting in the program and pir for use in Conducting diagnostic nearing oversially 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) | 5/17/99 |
|---|---|
| Division of Ophthalmic Devices | |
| 510(k) Number | K990652 |
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter Use