(28 days)
Not Found
No
The summary describes a standard audiometer and does not mention any AI or ML capabilities.
No
The device is used for diagnosis ("assisting in the diagnosis of possible otologic disorders") and does not provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states "The Interacoustics Model AD226 Diagnostic Audiometer is indicated for use... assisting in the diagnosis of possible otologic disorders." The "Device Description" also refers to it as a "Diagnostic Audiometer."
No
The device description explicitly states it is an "electroacoustics instrument" that "produces... tones and signals," indicating it is a hardware device that generates sound, not solely software.
Based on the provided text, this device 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 Description: The description clearly states the device is an "electroacoustics instrument that produces... tones and signals intended for acc in conductions of possible otologic disorders." This describes a device that interacts with the patient's ear directly using sound, not by analyzing a biological sample.
- Intended Use: The intended use is "assisting in the diagnosis of possible otologic disorders," which are disorders of the ear. This is consistent with an audiometer, which tests hearing function.
Therefore, the Interacoustics Model AD226 Diagnostic Audiometer is a diagnostic device, but it operates in vivo (on the living body) rather than in vitro (outside the body).
N/A
Intended Use / Indications for Use
The Interacoustics Model AD226 Diagnostic Audiometer is indicated for use in the Interacoustics Model AB220 Diagnostic and assisting in the diagnosis of possible otologic disorders.
Product codes
77 EWO
Device Description
The interacoustics Model AD226 Diagnostic Audiometer is an The Interacoustics Model AD220 Diagnitudes controlled levels of test electroacoustics instrument that produces and as a diagnectic hostring electroacousiic test instrument until processible stallegic disording tones and signals intended for acc in conductions of possible otologic disorders.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Beltone Model 110 Audiometer
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.1050 Audiometer.
(a)
Identification. An audiometer or automated audiometer is an electroacoustic device 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.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.
0
17981327
Page 1 of 2
MAY | | 1998
510(k) SUMMARY
PREPARED BY:
INTERNATIONAL DISTRIBUTORS OF ELECTRONICS FOR MEDICINE, INC. (IDEM) 4814 East Second Street Benicia, CA 94510
CONTACT PERSON:
TELEPHONE:
DATE ON WHICH THE SUMMARY WAS PREPARED:
March 25, 1998
707-746-8597
Donna Ward, President
NAME OF DEVICE
Interacoustics Diagnostic Audiometer Model AD226
COMMON NAME:
Audiometer
PREDICATE DEVICE:
Beltone Model 110 Audiometer
DESCRIPTION OF THE DEVICE
The interacoustics Model AD226 Diagnostic Audiometer is an The Interacoustics Model AD220 Diagnitudes controlled levels of test
electroacoustics instrument that produces and as a diagnectic hostring electroacousiic test instrument until processible stallegic disording tones and signals intended for acc in conductions of possible otologic disorders.
Comparison of the Interacoustics Model AD226 Acoustic audiometer and the Beltone Model 110 Audiometer follows:
Indication for use - Identical for both units.
Similarities and differences:
| Model AD226 Audiometer | Beltone Model 110 Audiometer |
|---|---|
| Digital Display. | Analog and Digital Display. |
| Available Frequencies (Hz): 125, 250, | |
| 500, 750, 1000, 1500, 2000, 3000, | Identical. |
1
| 4000, 6000, 8000 | |
|---|---|
| Masking: Narrow Band Noise /White | |
| Noise. | Narrow Band Noise, Speech Weighted |
| Noise, and White Noise. | |
| Transducers: TDH 39 Headset; Ear- | |
| Tone 3A Insert Phones and B71 Bone | |
| Conductor. | TDH 50P Headset; B71 Bone |
| Conductor. | |
| Patient response unit: Hand held push- | |
| button switch. | Hand held push-button switch. |
| Compatible Windows Software: | |
| IaBase95 database program; PrintView | |
| for on-line PC Monitoring and printing; | |
| NOAH hearing aid fitting software. | |
| Connex hearing aid fitting software. | |
| Power: 100-115 or 230 V. | 105-125 VAC, 50-60 Hz; : Optional : |
| 208-250 VAC ,50-60 Hz. | |
| Size and Weight; Audiometer alone: | |
| 12x9x4 inches. Weight 2.9 lbs. | Audiometer alone: 16-1/8x9-3/4x 6-1/8 |
| inches. Weight: 6lb 1oz. | |
| External Power supply: 1.8 lbs. |
SAFETY AND EFFECTIVENESS:
The Interacoustics Model AD226 Diagnostic Audiometer is in compliance with the following performance and safety standards:
Audiometers IEC 645-1 Type 3 ANSI 3.6-1989 and Safety: EN 60601-1:1990 EMC: EN60601-1-2:1993
2
Public Health Service
Image /page/2/Picture/15 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle symbol.
MAY | |-1998
Donna Ward President International Distributors of Electronics for Medicine, Inc. (IDEM) 4814 East Second Street Benicia, CA 94510
Dear Ms. Ward:
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K981327 Interacoustics Diagnostic Audiometer Model AD226 Dated: April 9, 1998 Received: April 13, 1998 Regulatory class: II 21 CFR 874.1050/Procode: 77 EWO
We have reviewed your Section 510%) 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 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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.
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/cdrb/dsmallsmamain.html".
Sincerely yours,
Kilian Yin
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
l'agc
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Interacoustics Model AD226 Diagnostic Device Name:
Audiometer
Indications For Use:
The Interacoustics Model AD226 Diagnostic Audiometer is indicated for use in The Interacoustics Model AB220 Diagnostic and assisting in the diagnosis of possible otologic disorders.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Vinit C. Seyson
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K981327
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)