(193 days)
No
The description explicitly states the evaluation is based upon "signal statistics," which is a traditional method and does not indicate the use of AI or ML. There are no mentions of AI, ML, or related terms like DNN.
No.
The device is described as a screening tool to help determine if a hearing loss may be present, and it explicitly states it is not intended for fitting assistive listening devices, which would be a therapeutic action.
Yes
The device is intended to screen hearing and determine if a hearing loss may be present, which aligns with the definition of a diagnostic device (identifying the presence or absence of a condition).
No
The device description explicitly states that the "Echo-Screen T" product family are "handheld, automated OAE- and ABR based hearing screening systems," indicating they are physical hardware devices that perform measurements.
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 taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Fischer-Zoth Audiologic Systems model family "Echo-Screen T" uses Otoacoustic Emissions (OAE) and Auditory Brainstem Response (ABR) technology. These are non-invasive physiological measurements taken directly from the patient's ear. They do not involve analyzing samples taken from the body.
- Intended Use: The intended use is to "screen hearing for newborns through adults," which is a functional assessment, not a diagnostic test performed on a biological sample.
Therefore, this device falls under the category of a medical device used for physiological measurement and screening, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Fischer-Zoth Audiologic Systems model family "Echo-Screen T" consisting of Echo-screen T, Echo-Screen TA, Echo-Screen TD, Echo-Screen TDA and Echo-Screen TC are based upon Otoacoustic Emissions (OAE) and Auditory Brainstem Response (ABR) technology.
The device is intended to screen hearing for newborns through adults, including geriatric patients. The device does not measure hearing per se, but helps to determine whether or not a hearing loss may be present.
The "Echo-Screen T" product family consists of handheld, automated OAE and ABR based hearing screening systems which are easy to use. The measurement flow is menu guided and the evaluation is based upon signal statistics. The "Echo-Screen T" devices are intended to be used by trained personnel in a medical or school environment. The "Echo-Screen T" models are not intended for fitting assistive listening devices such as hearing aids or cochlear implants.
Product codes
GWJ
Device Description
The Fischer-Zoth Audiologic Systems model family 'Echo-Screen T' consisting of Echoscreen T. Echo-Screen TA. Echo-Screen TD. Echo-Screen TDA. Echo-Screen TC are based upon Otoacoustic Emissions (OAE) and Auditory Brainstem Response (ABR) technology. Similar techniques and methods are - among others - used by the Fischer-Zoth model Echo-Screen and SLE Limited model SABRE.
The 'Echo-Screen T' product family are handheld, automated OAE- and ABR based hearing screening systems which are easy to be used. The measurement flow is menu guided and the evaluation is based upon signal statistics. They are intended to be used by trained personnel in a medical or school environment. The Echo-Screen T models are not intended for fitting assistive listening devices such as hearing aids or cochlea implants.
Technological Characterisitics: (also see Appendix B)
- Probe: miniature probe easy to apply even for premature infants -
- Electrodes: GXY, from Medicotest Inc. 510(k) #K931430 ・
- or other FDA-approved products
- Hardware: -
Hand held device : size 21,5x10x5,4cm , weight 600g. Battery powered : 6V/1500mAh, rechargeable Stimulus Rate: 40... 100Hz Signal Bandwidth : 1,4KHz to 4KHz - Software: echo-screen evaluation SW
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear
Indicated Patient Age Range
newborns through adults, including geriatric patients
Intended User / Care Setting
trained personnel in a medical or school environment.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1900 Evoked response auditory stimulator.
(a)
Identification. An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.(b)
Classification. Class II (performance standards).
0
JUN 1 4 2002
013977
"510 (k) Summary" Summary and safety effectiveness
Submitter's Name & Address: Fischer-Zoth
Audiologic Systems 1257 W. Margaret View Circle Riverton, UT 84065
Contact person & Telephone: Mr. Michael Sorensen (801) 541 1123
Data summary prepared: November 8th, 2001
Device name: Classification Name - Audiometer, Neurology Common/Usual Name - Screening Audiometer Proprietary name - Echo-Screen T. TA. TD. TDA. TC
Predicate Devices:
| Fischer-Zoth, model Echo-Screen: | 510(k) K982642 |
|---|---|
| SLE Limited, model SABRE: | 510(k) K993177 |
| see also: Appendix A |
Device description , intended Use & Effectiveness:
The Fischer-Zoth Audiologic Systems model family 'Echo-Screen T' consisting of Echoscreen T. Echo-Screen TA. Echo-Screen TD. Echo-Screen TDA. Echo-Screen TC are based upon Otoacoustic Emissions (OAE) and Auditory Brainstem Response (ABR) technology. Similar techniques and methods are - among others - used by the Fischer-Zoth model Echo-Screen and SLE Limited model SABRE.
The device is intended to screen hearing for newborns through adults, including geriatric patients. The device does not measure hearing per se, but helps to determine whether or not a hearing loss may be present.
The 'Echo-Screen T' product family are handheld, automated OAE- and ABR based hearing screening systems which are easy to be used. The measurement flow is menu guided and the evaluation is based upon signal statistics. They are intended to be used by trained personnel in a medical or school environment. The Echo-Screen T models are not intended for fitting assistive listening devices such as hearing aids or cochlea implants.
Technological Characterisitics: (also see Appendix B)
- Probe: miniature probe easy to apply even for premature infants -
- Electrodes: GXY, from Medicotest Inc. 510(k) #K931430 ・
- or other FDA-approved products
- Hardware: -
Hand held device : size 21,5x10x5,4cm , weight 600g. Battery powered : 6V/1500mAh, rechargeable Stimulus Rate: 40... 100Hz Signal Bandwidth : 1,4KHz to 4KHz
- Software: echo-screen evaluation SW
1
Automated stimulus adjustment and online control Signal statistical criterion for 'PASS' condition
Additional hints to measurement quality (stimulus stability and artefact rate) - Safety:
Battery powered, no connection to mains is possible during measurement Sound Pressure level: 70-85 dB SPL maximum
Current through electrodes limited to