(77 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on the device's function as an impedance tympanometer.
No.
The device is used for diagnosis and evaluation, not for treating any condition.
Yes
The "Intended Use / Indications for Use" states that the device is intended for "assisting in the diagnosis of possible otologic disorders."
No
The device description explicitly states it is an "impedance tympanometer" and includes an "Integral Printer," indicating it is a hardware device with software components, not a software-only device.
Based on the provided information, the American Electromedics Race Car Tympanometer With Integral Printer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "conducting hearing evaluations and assisting in the diagnosis of possible otologic disorders." This involves evaluating the function of the ear, which is a physiological process, not analyzing a sample taken from the body (like blood, urine, or tissue) in vitro.
- Device Description: It's described as an "impedance tympanometer," which measures the impedance of the middle ear. This is a physical measurement, not a diagnostic test performed on a biological sample.
- Lack of IVD Characteristics: The description doesn't mention any of the typical characteristics of an IVD, such as analyzing biological samples, using reagents, or performing tests on specimens.
Therefore, based on the provided text, the device falls under the category of a diagnostic device used for physiological measurement rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The American Electromedics Race Car Tympanometer With Integral Printer is intended to be used in conducting hearing evaluations and assisting in the diagnosis of possible otologic disorders.
Product codes
77ETY
Device Description
The American Electromedics Race Car Tympanometer With Integral Printer is an impedance tympanometer. The American Electromedics Race Car Tympanometer With Integral Printer is an impedance tympanometer which has a built-in printer.
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)
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.
0
NOV 17 1998
510(k) SUMMARY
A. Manufacturer: American Electromedics Corporation 13 Columbia Drive Suite 5 Amherst, NH 03031
Submitted By: Ferguson Medical Consultant to American Electromedics Corporation
- B. Contact Information: Phone: (603) 880-6300 FAX: (603) 880-8977
- C. Classification Name: Auditory Impedance Tester
Common/usual Name: Tympanometer
Proprietary Name: American Electromedics Race Car Tympanometer With Integral Printer
- D. Classification Number: 77ETY
- E. Substantial Equivalence: Race Car Tympanometer, American Electromedics Corporation (K955289)
- F. Device Description: The American Electromedics Race Car Tympanometer With Integral Printer is an impedance tympanometer.
- G. Intended Use: The device is intended to be used in conducting hearing evaluations and assisting in the diagnosis of possible otologic disorders.
- H . Technological Characteristics: The American Electromedics Race Car Tympanometer With Integral Printer is an impedance tympanometer which has a built-in printer.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 7 1998
American Electromedics Corporation c/o Ferguson Medical Frank Ferguson Official Correspondent 2581 California Park Drive Suite 269 Chico, California 95928
Re:
American Electromedics Race Car Tympanometer with Integral Printer Dated: August 1, 1998 Received: September 1, 1998 Regulatory class: II 21 CFR 874.1090/Procode: 77 ETY
Dear Mr. Ferguson:
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 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 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 i 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 question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, piense 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 "https://www.fda.gov/cdrh/dsmadsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D.
Lillian Yin, Ph.D Director, Division of Reproductiv Abdominal, Ear, Nose and Thros and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (If known):
American Electromedics Race Car Tympanometer Device Name: With Integral Printer
Indications For Use:
The American Electromedics Race Car Tympanometer With Integral Printer is intended to be used in conducting hearing evaluations 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)
Clamil G. Sigman
(Division Sign Off)
(Division Sign-Off) Division of Reproductive, Abdominal, F and Radiological I 510(k) Number
Prescription Use
(Per 21 CFR 801.109) -√
Over-The-Counter Use _
(Optional Format 1-2-96)