(90 days)
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Not Found
No
The summary describes a device that measures sound signals and noise levels, but there is no mention of AI, ML, or any learning algorithms used for analysis or interpretation.
No
The device is for diagnostic purposes, specifically for determining the distortion product response of the human cochlea to assess cochlear function. It is not described as providing treatment or therapy.
Yes
The device is described as determining the distortion product response of the human cochlea and measuring the noise level present during the test, with the purpose of determining cochlear function. This indicates it is used to identify or assess a physiological condition, which aligns with the definition of a diagnostic device.
Unknown
The provided text describes the intended use and function of the device, which involves delivering sound signals and recording responses. However, it lacks a "Device Description" section, which is crucial for determining if the device is purely software or includes hardware components for sound delivery and recording. Without this information, it's impossible to definitively classify it as software-only.
Based on the provided information, the SmartOAE 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.
- SmartOAE Function: The SmartOAE device works by delivering sound signals into the outer ear and recording sound responses from the cochlea. This is a non-invasive test performed directly on the patient's body, not on a sample taken from the body.
Therefore, the SmartOAE device falls under the category of a medical device used for diagnostic purposes, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SmartOAE device is intended to be used for the purpose of determining the distortion product response of the human cochlea. The device is intended to be used by hearing health professionals to determine cochlear function. The test administered by the device does not require any patient behavioral response, such as pushing a button switch. The device delivers sound signals into the outer ear and subsequently records the sound in the outer ear which contain sounds produced by normal cochleas. The device also measures the level of sound near the distortion product frequency to estimate the noise level present while the test was performed.
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
human cochlea, outer ear
Indicated Patient Age Range
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Intended User / Care Setting
hearing health professionals
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
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)
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Intelligent Hearing Systems c/o Edward Miskiel, Ph.D. President 10689 N. Kendall Drive, Suite 315 Miami, FL 33176
Re: K964426 Trade/Device Name: SmartOAE Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: II Product Code: EWO Dated: November 18, 1996 Received: November 20, 1996
JUN - 1 2012
Dear Dr. Miskiel:
This letter corrects our substantially equivalent letter of February 3, 1997.
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 (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 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
1
Page 2 - Edward Miskiel, Ph.D.
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Melvin R. Field, M.D.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
(964426
510(k) Number (if known): K964426
Device Name: SmartOAE
Indications for Use:
The SmartOAE device is intended to be used for the purpose of determining the distortion product response of the human cochlea. The device is intended to be used by hearing health professionals to determine cochlear function. The test administered by the device does not require any patient behavioral response, such as pushing a button switch. The device delivers sound signals into the outer ear and subsequently records the sound in the outer ear which contain sounds produced by normal cochleas. The device also measures the level of sound near the distortion product frequency to estimate the noise level present while the test was performed.
X Prescription Use (Per 21 CFR 801.109)
Over-the-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation
Ch. G.
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
X Prescription Use (Per 21 CFR 801.109)
K964426 510(k) Number