ILO292 DP ECHOPORT PLUS OAE SYSTEM by OTODYNAMICS, LTD.

The Otodynamics ILO292 DP ECHOPORTplus system performs an auditory screening function by objectively testing for normal function of the cochlea. It is a new concept in OAE screening and analysis since it operates in standalone mode, without a PC. It is based on the DP ECHOPORT Instrument but with added built-in processor and graphic display.

Otodynamics ILO292 DP ECHOPORTplus system provides DPOAE facilities in addition to all the screening and TEOAE functions of the ECHOPORT plus. Both TEOAE's and DPOAE's are useful as screening tests for cochlear function in infants, children and adults. They are particularly useful when the patient is unable to respond

DPOAE's are useful with older patients, as the method can tolerate sub-clinical depression of cochlear activity. DPOAE's are also of use to test the higher frequency region of the cochlea.

Device Description

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) letter and the "Indications for Use" section does not contain the detailed information necessary to answer your request regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications.

The documents provided are primarily a 510(k) clearance letter (K983351) for the Otodynamics ILO292 DP ECHOPORTplus OAE System, confirming its substantial equivalence to a predicate device. It states the indications for use of the device for auditory screening but does not include:

A table of acceptance criteria and reported device performance.
Sample sizes for test sets or data provenance.
Number or qualifications of experts for ground truth.
Adjudication methods.
Information about MRMC comparative effectiveness studies.
Details of standalone performance studies.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

This type of detailed study information is typically found in the 510(k) submission itself, which is a much larger document than what has been provided here. The clearance letter only summarizes the FDA's decision based on the submitted information.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 1 1998

Otodynamics, LTD C/O Smith Associates E.J. Smith Consultant P.O. Box 4341 Crofton, MD 21114

Re: K983351

IL0292DP ECHOPORT plus OAE System Dated: September 23, 1998 Received: September 23, 1998 Regulatory class: II 21 CFR 874.1050/Procode: 77 EWO

Dear Mr. Smith:

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 (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 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/odri/dsma/dsmamain.html".

Sincerely yours,

Lillian Yiu, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known:

Device Name: ILO292 DP ECHOPORTplus OAE System

Classification Panel:

Indications for Use:

DPOAE's are useful with older patients, as the method can tolerate sub-clinical depression of cochlear activity. DPOAE's are also of use to test the higher frequency region of the cochlea.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓	or	Over the Counter Use
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(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number	K983351
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Regulation Number and Section

§ 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.