(210 days)
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No
The document does not mention AI, ML, or related concepts, and the described functionality is based on established otoacoustic emission testing methods.
No.
The device is used to measure or determine cochlear function for diagnostic purposes, not to provide therapy.
Yes
This device measures cochlear function to differentiate normal and hearing-impaired subjects, which is a diagnostic purpose.
No
The device description explicitly states it is an "Addition to the Scout Otoacoustic Emissions (OAE) Test Instrument" and "The system still uses the Etymotic ER-10C probe," indicating it is a software feature added to existing hardware, not a standalone software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device function: The description clearly states that the device measures otoacoustic emissions (OAEs) to determine cochlear function. This is a non-invasive test performed directly on the patient's ear, not on a sample taken from the body.
Therefore, this device falls under the category of a medical device but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the current Scout Otoacoustic Emissions Test Instrument is to measure or determine cochlear function either by measuring and recording transient (click evoked) otoacoustic emissions or by measuring and recording distortion product otoacoustic emissions utilizing continuous pure tones. The intended use of this new software feature is essentially the same as that of the predicate device. It provides for an additional test methodology which measures DPOAE threshold instead of the more-routine DPOAE amplitude test. The threshold test (also called the Input/Output (1/0) function) involves varying the stimulus intensity levels while keeping the frequencies constant. Both test methods can be effectively used to differentiate normal and hearing- impaired subjects, but the amplitude test is usually preferred because it usually requires a shorter testing time. However, in cases where the amplitude test results in a DP-gram with a low DP response (close to the noise floor) at specific frequencies, the I/O function test can be used to determine if there is an improved response at other stimulus frequencies. Therefore, the I/O function test offers the potential to improve the identification of patients with normal hearing.
Product codes
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Device Description
Addition to the Scout Otoacoustic Emissions (OAE) Test Instrument. Modification and Software Feature. The device measures or determines cochlear function by measuring and recording transient (click evoked) otoacoustic emissions or by measuring and recording distortion product otoacoustic emissions utilizing continuous pure tones. This modification adds a new software feature for an additional test methodology that measures DPOAE threshold (Input/Output (I/O) function) by varying stimulus intensity levels while keeping frequencies constant. The hardware design remains unchanged.
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
Cochlea (ear)
Indicated Patient Age Range
Adults, children and infants.
Intended User / Care Setting
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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
To establish the safety and effectiveness of the software which Input/Output feature, the system was validated in accordance with the IEEE Standards for Software Engineering, as well as Bio-logic internal software development policies and procedures modeled after the IEEE Standards. Changes to the standard Scout PC computer program necessary to generate new test sequences and the presentation of this data were all developed and tested as specified in these procedures. The system, for which this application is submitted, was verified and validated; it was found to perform in accordance with specifications.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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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
MAY 1 3 1997
Biologic One Bio-logic Plaza Mundelein, Illinois 60060-3700 1-800-323-8326 Fax: 847-949-8615
SUMMARY AND CERTIFICATION SECTION 2:
510 (K) SUMMARY
SAFETY AND EFFECTIVENESS SUMMARY
Safety and effectiveness information concerning this modification to the Scout OAE device is summarized below.
Because this is not a CLASS III device, the special certification defined for this section is not required.
| PREPARED BY: | Bio-logic Systems Corp |
|---|---|
| One Bio-logic Plaza | |
| Mundelein, IL 60060 |
TELEPHONE :
(847) -949-5200
CONTACT PERSON :
Norman E. Brunner
DATE ON WHICH THE SUMMARY October 7, 1996 WAS PREPARED:
NAME OF DEVICE:
Addition to the Scout Otoacoustic Emissions (OAE) Test Instrument.
Modification and Software Feature
COMMON NAME : Otoacoustic Emissions Test Instrument
CLASSIFICATION NAME: Audiometer (per CFR 874.1050).
PREDICATE DEVICE: Bio-logic Scout OAE Instrument (K944735)
1
REVISED STATEMENT OF INTENDED USE FOR 510(k) #K964132
ي پريز جي ته ا
INTENDED USE: The intended use of the current Scout Otoacoustic Emissions Test Instrument is to measure or determine cochlear function either by measuring and recording transient (click evoked) otoacoustic emissions or by measuring and recording distortion product otoacoustic emissions utilizing continuous pure tones. The intended use of this new software feature is essentially the same as that of the predicate device. It provides for an additional test methodology which measures DPOAE threshold instead of the more-routine DPOAE amplitude test. The threshold test (also called the Input/Output (1/0) function) involves varying the stimulus intensity levels while keeping the frequencies constant. Both test methods can be effectively used to differentiate normal and hearing- impaired subjects, but the amplitude test is usually preferred because it usually requires a shorter testing time. However, in cases where the amplitude test results in a DP-gram with a low DP response (close to the noise floor) at specific frequencies, the I/O function test can be used to determine if there is an improved response at other stimulus frequencies. Therefore, the I/O function test offers the potential to improve the identification of patients with normal hearing.
DPOAE threshold is the lowest stimulus intensity level which produces a DPOAE response amplitude that is distinguishable from the level of system distortion and from the noise floor. DPOAE threshold is expressed in much of the published literature as the lowest intensity of the F2 stimulus that generates a clear DPOAE response. DPOAE threshold does not equate to and should not be confused with audiometric or auditory threshold. Whereas auditory threshold measures assess the integrity of the entire auditory system from outer ear to cortex, DPOAE threshold measures are limited to assessment of outer hair cell function in the cochlea only.
(This statement replaces the text on pages 8 and 11 of the original 510(k) submission. )
2
Modification and Feature Addition to Bio-logic Scout Otoacoustic Emissions (OAE) Test Instrument
PATIENT POPULATION: Adults, children and infants.
SAFETY AND EFFECTIVENESS:
No changes have been made to the hardware design of the Scout product Therefore, the Scout product which incorporates this new line. software feature does not present any safety issues which have not already been addressed in the predicate Scout 510(k) notifications. Also, the Scout software modules which are used to control the hardware have not been changed. This new feature only changes the sequence in which tones of varying intensity and frequency are Instead of keeping stimulus qenerated when conducting a test. intensity constant and varying frequency, the frequencies are kept constant and the stimulus intensity is varied. Therefore, this new feature does not affect the safety of the Scout product.
To establish the safety and effectiveness of the software which Input/Output feature, the system was validated in accordance with the IEEE Standards for Software Engineering, as well as Bio-logic internal software development policies and procedures modeled after the IEEE Standards. Changes to the standard Scout PC computer program necessary to generate new test sequences and the presentation of this data were all developed and tested as specified in these The system, for which this application is submitted, was procedures. verified and validated; it was found to perform in accordance with specifications.
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Modification and Feature Addition to Bio-logic Scout Modiffication Emissions (OAE) Test Instrument
The following comparison is provided as a summary of technological
characteristics relative to the predicate device society characteristics that the addition of this new Input/Output software is
demonstrates that the addition of this new Input/Output software affect product safety and effectiveness.
| Parameter for comparison. | Similarity or Difference. |
|---|---|
| Intended Use | No differences. |
| Population | No differences. |
| Hardware Configuration | No differences. |
| Computer Control Software | Only differences are changes to Scout |
| software required to support the new | |
| Input/Output feature addition. There | |
| are no differences in software test | |
| algorithms. | |
| Ear Probe System | No differences. The system still |
| uses the Etymotic ER-10C probe. | |
| Performance | The time to perform a DPOAE I/O |
| (threshold) test is somewhat longer | |
| than that required for the more | |
| routine DPOAE amplitude test. | |
| However, the I/O test can provide | |
| additional information which the | |
| routine test cannot easily provide, | |
| which can, in some cases, be | |
| clinically useful. | |
| Safety Characteristics | No difference. There is no direct |
| electrical connection to the patient | |
| in any Bio-logic OAE system. |
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