(66 days)
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Not Found
No
The summary describes a standard tympanometer and lacks any mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No
This device is for detection/diagnosis of disorders, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for ... the detection of possible otologic disorders associated with the functioning of the middle ear." The term "detection" strongly implies a diagnostic purpose.
No
The device is described as a "Tympanometer," which is a hardware device used to measure acoustic impedance. The description focuses on the function of a physical instrument, not a software application.
Based on the provided information, the Maico Diagnostics model MI 44 Tympanometer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description states the device measures the acoustic impedance of the ear canal to detect possible otologic disorders. This is a physical measurement of a bodily function, not an analysis of a biological specimen.
- Intended Use: The intended use describes a diagnostic process performed directly on the patient's ear, not on a sample taken from the patient.
Therefore, the Maico Diagnostics model MI 44 Tympanometer falls under the category of a diagnostic device but not specifically an In Vitro Diagnostic (IVD) device.
N/A
Intended Use / Indications for Use
The Maico Diagnostics model MI 44 Tympanometer is intended for use by trained operators in hospitals, ENT clinics and audiologist offices for the detection of possible otologic disorders associated with the functioning of the middle ear. This is accomplished by measuring the acoustic impedance of the ear canal under various conditions.
Product codes
EWO
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Ear
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained operators in hospitals, ENT clinics and audiologist offices
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 5 2006
Maico-Diagnostics c/o Daniel Eggan Manager of Regulatory Affairs / QA 7625 Golden Triangle Drive Eden Prairie, MN 55344
Re: K060885
Trade/Device Name: MI 44 Tympanometer Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO Dated: March 30, 2006 Received: April 3, 2006
Dear Mr. Eggan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA), 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 - Daniel Eggan
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Everette T. Buup PhD
Malvina B. Eydelman, M.D.
Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Section A
Indications for Use Statement
510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Maico Diagnostics model MI 44 Tympanometer is intended for use by trained operators in hospitals, ENT clinics and audiologist offices for the detection of possible otologic disorders associated with the functioning of the middle ear. This is accomplished by measuring the acoustic impedance of the ear canal under various conditions.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | |
|---|---|
| ------------------------------------------ | -- |
| (Division Sign-Off) | |
|---|---|
| Division of Ophthalmic Ear, Nose and Throat Devises |
| 510(k) Number | K060885 |
|---|---|
| --------------- | --------- |