(77 days)
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.
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.
The Interacoustics Model AZ26 Clinical Impedance Audiometer (K990652) is deemed substantially equivalent to the Interacoustics Clinical Impedance Audiometer Model AZ26 (predicate device) and thus meets its acceptance criteria by complying with relevant performance and safety standards.
Here's a breakdown of the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the device's compliance with established performance and safety standards, and its similarity to the predicate device. The performance is reported through comparison with the predicate device and explicit statements of compliance with standards.
| Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (Interacoustics Model AZ26) |
|---|---|
| Display Description | Digital |
| Available Frequencies | 250 Hz, 500 Hz, 1kHz, 2kHz, 3kHz, 4kHz, 6kHz, and 8kHz |
| Probe Tone Frequency | 226Hz ± 1% |
| Probe Tone Intensity | 85dB SPL ± 1.5dB |
| Harmonic Distortion | Less than 5% |
| Pressure Range | -600 to +300 daPa |
| Transducers | TDH39 Single Contralateral Earphone, Probe with Probe Tip |
| Patient response unit | Handheld Push Button Switch |
| Compatible Windows Software | IABase95, Printview, IA-NOAH-IMP Module |
| Tests Offered | Tympanometry, Acoustic Reflex, Eustachian Tube Test (Williams and Toynbee), Air Conduction Audiometry, and Gelle Test |
| Impedance Calibration Standard | ANSI S 3.39-1987, IEC 1027-1991 |
| Audiometer Calibration Standard | ISO/R 389-1991 |
| Pressure Release | Pressure Release Function |
| Size and Weight | 19" x 16" x 6"; 21 lbs. |
| Power | 100-120 V or 220-240V |
| Optional External Keyboard | Yes |
| Safety Standard (Audiometer) | ANSI S 3.6-1996 IEC 645-1-1992, Type 4 |
| Safety Standard (Impedance) | ANSI S 3.39-1987 IEC 1027-1991, Type 1 |
| General Safety Standard | IEC 601-1-1988 |
2. Sample size used for the test set and the data provenance
The document specifies the device is "in compliance with the following performance and safety standards" (listed above) and provides a "Comparison of the Interacoustics Model AZ26 Clinical Impedance Audiometer and the Interacoustics Clinical Impedance Audiometer Model AZ26". This suggests that the "testing" for acceptance was based on device specifications and adherence to recognized industry standards, rather than a clinical trial with a specific "test set" of patients or data.
Therefore, there is no explicit sample size or data provenance (country of origin, retrospective/prospective) for a clinical test set mentioned in this 510(k) summary, as it is a predicate-based submission relying on technical equivalence and compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
There is no mention of experts establishing ground truth for a test set, as the submission appears to rely on technical specifications and adherence to established industry standards for audiometric and impedance devices rather than a clinical ground truth established by experts.
4. Adjudication method for the test set
As there is no identified "test set" or clinical study described in the provided document, there is no adjudication method mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document does not describe an MRMC comparative effectiveness study, nor does it involve AI assistance. This device is a measurement instrument (audiometer), not an AI-powered diagnostic aid for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a clinical impedance audiometer, not an algorithm. Its performance is inherent to its design and calibration, not a standalone algorithmic output.
7. The type of ground truth used
The "ground truth" for this device's acceptance is its compliance with established international and national performance and safety standards (e.g., ANSI S 3.6-1996, IEC 645-1-1992 for audiometers; ANSI S 3.39-1987, IEC 1027-1991 for impedance; IEC 601-1-1988 for general safety). Additionally, the device demonstrated substantial equivalence to a legally marketed predicate device based on feature comparison. The performance parameters detailed in the comparison table essentially serve as the "ground truth" for its technical specifications matching or exceeding the predicate.
8. The sample size for the training set
This question is not applicable. The device is an electroacoustic test instrument, not a machine learning model. Therefore, there is no concept of a "training set" for its development or validation.
9. How the ground truth for the training set was established
This question is not applicable as there is no training set for this type of device.
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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.
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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 ClinicalImpedance Audiometer | Interacoustics Clinical ImpedanceAudiometer Model AZ26 (OLDERMODEL) |
|---|---|
| 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 PushButton Switch | Same |
| Compatible Windows Software:IABase95 Database program, Printviewfor On-line PC Monitoring and Printing,IA-NOAH-IMP Module for Interfacingto NOAH | IABase Database program only |
| Tests:Tympanometry (Manual or Automatic),Acoustic Reflex, Eustachian Tube Test(Williams and Toynbee), Air ConductionAudiometry, and Gelle Test | All except the Gelle Test and ToynbeeEustachian Tube Test |
| Calibration: Impedance: ANSI S 3.39-1987, IEC 1027-1991Audiometer: 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
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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
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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 .
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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,
ARalph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K990652 Interacoustics AZ26 Clinical Impedance Audiometer Device Name:
Indications For Use:
ﻨﻴﺔ
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(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
§ 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.