(49 days)
No
The summary does not mention AI, ML, or any related concepts, and the device description focuses on standard otoacoustic emission measurement.
No.
The device measures otoacoustic emissions to assess cochlear function; it does not treat or cure any condition, making it a diagnostic tool rather than a therapeutic one.
Yes
Explanation: The device measures otoacoustic emissions to provide information on cochlear function, which is a diagnostic purpose.
No
The device description explicitly states it is an "otoacoustic emissions testing device" and mentions a "probe that is capable of measuring and delivering sound" which contacts the patient's ear canal. This indicates the device includes hardware components beyond just software.
Based on the provided information, the SmartTrOAE device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The SmartTrOAE device measures otoacoustic emissions directly from the patient's ear canal. It does not analyze blood, urine, tissue, or any other bodily fluid or sample.
- The intended use describes a direct measurement of a physiological function (cochlear function) in a living person. This is characteristic of a diagnostic device used in vivo (in the living body), not in vitro (in glass/outside the body).
Therefore, the SmartTrOAE device falls under the category of a diagnostic device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the SmartTrOAE device is to measure otoacoustic emissions, which allow the operator to get information on cochlear function without requiring a subjective response from the person being tested with the device. It is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's office or other appropriate setting.
Product codes
EWO
Device Description
SmartTrOAE is an otoacoustic emissions testing device that is capable of measuring transient and spontaneous otoacoustic emissions produced by the inner ear.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
The anatomical site of contact is the patient's outer ear canal(s) with the contact object being a probe that is capable of measuring and delivering sound.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
It is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's office or other appropriate setting.
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)
Otodynamics ILO88 (K962995), K890124
Reference Device(s)
Etymotic Research ER 10B (K930553), Etymotic Research ER 10D (K011114)
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.
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Image /page/0/Picture/1 description: The image shows the logo for Intelligent Hearing Systems. The words "Intelligent Hearing" are in large, bold, black letters. Below that, the word "Systems" is spelled out with each letter in a black square with white text.
JAN 0 8 2003
510(k) Summary
| Prepared By: | Intelligent Hearing Systems
7356 SW 48th Street
Miami, FL 33155 | |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Telephone: | (305) 668-6102 | |
| FAX: | (305) 668-6103 | |
| Contact Person: | Edward Miskiel | |
| Date Summary prepared: | December 17, 2002 | |
| Name of the Device: | SmartTrOAE | |
| Common Name: | Otoacoustic Emissions Test Instrument | |
| Classification Name: | Audiometer (per CFR 874.1050) | |
| Predicate Device: | Otodynamics ILO88 (K962995) | |
| Device Description: | SmartTrOAE is an otoacoustic emissions testing device that is
capable of measuring transient and spontaneous otoacoustic
emissions produced by the inner ear. | |
| Intended Use: | The intended use of the SmartTrOAE device is to measure
otoacoustic emissions, which allow the operator to get
information on cochlear function without requiring a subjective
response from the person being tested with the device. It is
intended to be used by trained personnel in a hospital, nursery,
clinic, audiologist's office or other appropriate setting. | |
| Technological Characteristics: | The SmartTrOAE device is similar to the predicate device in its
intended use and methodologies.
The SmartTrOAE device technologically differs from the
predicate device in that the electronic circuitry of SmartTrOAE
device is housed in an external box that is connected to personal
computer by a USB cable connection, whereas the electronic
circuitry of the predicate device is housed internally to the
computer and is connected to the computer by an interface bus. | |
INTELLIGENT HEARING SYSTEMS
7356 S.W. 48th Street
• Miami, Florida 33155 • • Telephone: 305-668-6102 • FAX: 305-668-6103
Email Address: info@ihsys.com • www.ihsys.com Email Address: info@ihsys.com • www.ihsys.com
K: 305-668-6103
Page E1
1
Substantial Equivalence Based on Assessment of Performance Data:
The SmartTrOAE is substantially equivalent to the ILO88 device marketed by Otodynamics Ltd. with FDA 510(k) clearance number K890124.
| Parameter | Predicate Device
(Non-Preamendmant Device)
ILO88
(K890124) | Device Under Current 510(k)
Review
SmartTrOAE | |
|---------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Stimulus | | | |
| Type | Click | Click or Tone | |
| Duration | 100 µsec | 25 - 5000 µsec | |
| Intensity | 90 dB SPL | 60 - 90 dB SPL | |
| Repetition Rate | 50 Hz | 1 - 50 Hz | |
| Microphone | Otodynamics | Etymotic Research ER 10B
(K930553) or
Etymotic Research ER 10D
(K011114) | |
| Measured Values | Stimulus Level (dB SPL)
Response Level (dB SPL)
Noise Level (dB SPL)
Signal to Noise Ratio (dB SPL) | Stimulus Level (dB SPL)
Response Level (dB SPL)
Noise Level (dB SPL)
Signal to Noise Ratio (dB SPL) | |
| Measurement
Parameters | Bandlimit Filter
Analysis Window
Freq. Spectrum | 500 - 5000 Hz
2.5 to 20 msec post stimulus
0 - 6000 Hz | 500 - 5000 Hz
2.5 - 22.5 msec post stimulus
0 - 6000 Hz |
| Analysis Parameters | Sweeps
Rejection Threshold | 1 - 260
User Selectable | 1 - 260
User Selectable |
2
Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, resembling a bird-like shape.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 0 8 2003
Intelligent Hearing Systems c/o Edward Miskiel, Ph.D. 7356 SW 48th Street Miami, FL 33155
Re: K023859
Trade/Device Name: Otoacoustic Emissions Test Instrument / SmarTrOAE Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO Dated: November 19, 2002 Received: November 20, 2002
Dear Dr. Miskiel:
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
3
Page 2 - Edward Miskiel, Ph.D.
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 (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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
J. Joseph Rosenthal
A. Ralph Rosenthal. M.D Director Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K023859
Device Name: SmartTrOAE
Indications For Use:
The intended use of the SmartTrOAE device is to measure otoacoustic emissions, which allow the operator to get information on cochlear function without requiring a subjective response from the person being tested with the device. It is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's office or other appropriate setting.
The anatomical site of contact is the patient's outer ear canal(s) with the contact object being a probe that is capable of measuring and delivering sound.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use
(Per 21 CFR 801.109)
Concurrence of CDRH, Office of Device Evaluation
Jams K. Kane, Ph.D.
Division Sign-Off
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K023859