(77 days)
Not Found
No
The summary describes a standard tympanometer/audiometer with a printer and makes no mention of AI or ML capabilities.
No
The device is used for diagnosis and evaluation of disorders, not for treatment.
Yes
The device's intended use explicitly states "assisting in the diagnosis of possible otologic disorders."
No
The device description explicitly states it is a "combination device" with an "integral printer," indicating it includes hardware components beyond just software.
Based on the provided information, the American Electromedics Quik Tymp 2 (QT2) Tympanometer/Audiometer With Integral Printer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The intended use of the QT2 is to conduct hearing evaluations and assist in the diagnosis of possible otologic disorders by interacting directly with the patient's ear. It does not analyze biological samples.
- The device description and intended use clearly indicate it's a diagnostic tool for hearing and ear health. Tympanometry and audiometry are methods of measuring the function of the middle ear and hearing ability, respectively, through physical interaction with the patient.
Therefore, the QT2 falls under the category of a diagnostic device used for in-vivo measurements, not in-vitro analysis of specimens.
N/A
Intended Use / Indications for Use
The device is intended to be used in conducting hearing evaluations and assisting in the diagnosis of possible otologic disorders.
The American Electromedics Quik Tymp 2 (QT2) Tympanometer/Audiometer With Integral Printer is intended to be used in conducting hearing evaluations and assisting in the diagnosis of possible otologic disorders.
Product codes
77ETY, 77EWO
Device Description
The American Electromedics Quik Tymp 2 (QT2) Tympanometer/Audiometer With Integral Printer is a combination device which can be used as a tympanometer or as an audiometer.
The American Electromedics Quik Tymp 2 (QT2) Tympanometer/ Audiometer With Integral Printer is a combination device which can be used as a tympanometer or as an audiometer, and 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
§ 874.1050 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
NOV 17 1998
510(k) SUMMARY
-
American Electromedics Corporation A. Manufacturer: 13 Columbia Drive Suite 5 Amherst, NH 03031
Ferguson Medical Submitted By: Consultant to American Electromedics Corporation -
(603) 880-6300 B. Contact Information: Phone: FAX: (603) 880-8977
-
Auditory Impedance Tester, and C. Classification Name: Audiometer
Tympanometer/Audiometer Common/usual Name:
American Electromedics Quik Tymp 2 Proprietary Name: (QT2) Tympanometer/Audiometer With Integral Printer
- D. Classification Number: 77ETY and 77EWO
- E. Substantial Equivalence: Car Tympanometer With Race Audiometer and Quik Tymp2, and Quik Tymp1, American Electromedics Corporation (K970279)
- Electromedics Quik F. The American Device Description: Tymp 2 (QT2) Tympanometer/Audiometer With Integral Printer is a combination device which can be used as a tympanometer or as an audiometer.
- 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 Quik Tymp 2 (QT2) Electromedics Tympanometer/ Audiometer With Integral Printer is a combination device which can be used as a tympanometer or as an audiometer, and has a built-in printer.
1
Image /page/1/Picture/2 description: The image shows a logo and the date November 17, 1998. The logo is for the Department of Health & Human Services. The date is written in a simple, sans-serif font and is located below the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
American Electromedics Corporation c/o Ferguson Medical Frank Ferguson 2581 California Park Drive, Suite 269 Chico, CA 95928
Re:
K983048 American Electromedics Ouik Tymp 2 (OT2) Tympanometer/Audiometer with Integral Printer Dated: August 1, 1998 Received: September 1, 1998 Regulatory class: II 21 CFR 874.1050/Procode: 77 EWO 21 CFR 874.1090/Procode: 77 ETY
Dear Mr. Ferguson:
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 (OS) 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.
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/cdrividsmadsmam.html".
Sincerely yours,
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Thro and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (If known):
American Electromedics Quik Tymp 2 (QT2) Tympanometer/ Device Name: Audiometer With Integral Printer
Indications For Use:
The American Electromedics Quik Tymp 2 (QT2) Tympanometer/Audiometer With Integral Printer is intended to be used in conducting hearing evaluations and assisting in the diagnosis of possible otologic disorders.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Vinilla Sevens
Sir. OFF.
ision Sign-Off) Division of Rone motive, Abdominal, Bidi, and Radicles 510(k) Numuu
Prescription Use
(Per 21 CFR 801.109) $\checkmark$
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)