(88 days)
Not Found
No
The summary describes a standard audiometer with features like tympanometry and acoustic reflex, which are traditional audiology tests. There is no mention of AI, ML, or any related concepts in the provided text.
No
The device is described as a diagnostic hearing evaluation instrument, not one that provides therapy or treatment.
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, which is not characteristic of a software-only device.
Based on the provided information, the Interacoustics AT235 Impedance Audiometer is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description clearly states that the AT235 is an "electroacoustic test instrument" that produces "test tones and signals" for "conducting diagnostic hearing evaluations." It measures the function of the middle ear (tympanometry and acoustic reflex) and hearing thresholds (air conduction audiometry).
- No sample analysis: The device does not analyze any biological samples taken from the patient. It interacts directly with the patient's ear using sound and pressure.
Therefore, the AT235 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 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
77ETY
Device Description
The Interacoustics AT235 Impedence 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
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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
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Key Metrics
Not Found
Predicate Device(s)
Interacoustics Impedance Audiometer
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Page 1 of 2
| MAR 1 4 2000 | |
|---|---|
| 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: | 800-947-6334 |
| DATE ON WHICH THE SUMMARY | |
| WAS PREPARED: | December 14,1999 |
| NAME OF DEVICE: | Interacoustics AT235 |
| Impedance Audiometer | |
| COMMON NAME: | Impedence Audiometer |
| PREDICATE DEVICE: | Interacoustics Impedance Audiometer |
DESCRIPTION OF DEVICE:
The Interacoustics AT235 Impedence 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 AT235 Impedance Audiometer and The Interacoustics AT22t Automatic Impedance Audiometer.
Indication for use - Identical for both units.
Similarities and differences:
| Interacoustics AT235 | Interacoustics AT22t Automatic |
|---|---|
| Impedance Audiometer | Impedance Audiometer |
| Display Description: Digital | Digital |
| Available Frequencies: | |
| 125 Hz, 250 Hz, 500 Hz, 1kHz, 2kHz, | |
| 3kHz, 4kHz, 6kHz, and 8kHz | 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: +300 to -600daPa | +200 to -300daPa |
| 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 | Same |
| 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 10" x 4"; 6 lbs. | 14" x 16" x 6"; 15.5 lbs. |
SAFETY AND EFFECTIVENESS:
The Interacoustics AT235 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 is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized graphic of a bird-like figure, possibly representing an eagle, with three curved lines forming its wings or body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 4 2000
Ms. Donna Ward President International Distributors of Electronics For Medicine, Inc. (IDEM) 4814 East Second Street Benicia, CA 94510
Re: K994254 Trade Name: Interacoustics AT235 Impedance Audiometer Regulatory Class: II CFR: 874.1090 Product Code: 77ETY Dated: December 15, 1999 Received: December 17, 1999
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 .
3
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
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Page 1 of 1
| 510(k) Number (if known): | K994254 |
|---|---|
| --------------------------- | --------- |
Interacoustics Model AT235 Impedance Audiometer Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Usc:
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Over-The-Counter Use_ OR Prescription Use (Pcr 21 CFR 801.109) Sign-Off)
is on of Ophthalmic
510(k) Number
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Formal 1-2-96)