(84 days)
No
The description mentions "analyzes the emissions and mathematically separates noise from cochlear emissions" and "evaluation is based upon signal statistics," which are standard signal processing techniques, not necessarily AI/ML. There is no mention of AI, ML, or related terms in the document.
No.
The device is used for diagnostic screening to assess cochlear function by detecting otoacoustic emissions, not to treat or modify a disease or health condition.
Yes
The device analyzes otoacoustic emissions to determine cochlear function, indicating whether the cochlea is operating normally, which is a diagnostic assessment of an individual's physiological state.
No
The device description explicitly states it is a "hand-held instrument with an attached probe" and mentions a "microphone in the probe," indicating it includes physical hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Echo-Screen Otoacoustic Emissions Test Instrument works by emitting sound into the ear canal and detecting the body's response (otoacoustic emissions). It does not analyze a specimen taken from the body.
- Anatomical Site: The device interacts with the outer ear canal, which is a part of the body, not a specimen.
Therefore, the Echo-Screen is a diagnostic device, but it falls under the category of in vivo (within the living body) diagnostic devices, not in vitro.
N/A
Intended Use / Indications for Use
The purpose of the device is the reliable and earliest possible detection of hearing disorders due to cochlear dysfunction. It can be used beginning from neonates to adults.
The Echo-Screen Otoacoustic Emissions Test Instrument is a hand-held instrument with an attached probe (that is placed in the outer ear canal) which emits sound that evokes otoacoustic emissions. A microphone in the probe picks up the emissions if any are present, and the device then analyzes the emissions and mathematically separates noise from cochlear emissions. The presence of these emissions indicates cochlear function in adults, infants and children. The instrument requires no active participation from the patient.
Otoacoustic emissions (OAEs) are low-level audio-frequency sounds that are generated by the outer hair cells of the cochlea in response to sound input. The presence of OAEs is an indication of cochlear function. If the Echo-Screen signals a "pass" reading as it analyzes the presence of OAEs, the clinician can determine that the cochlea is operating normally.
Product codes
77 EWO
Device Description
The Fischer-Zoth Audiologic System model 'Echo-Screen' is based upon Otoacoustic Emissions and it is similar to the Grason Stadler Inc. GSI70 AudioPath Screener and the Otodynamics OAE Analyser, model ILO88. The 'echo-screen' is a handheld, automated OAE-based screeming-system which is easy to use. The measurement flow is menu guided and the evaluation is based upon signal statistics.
- Probe: miniature probe easy to apply even for premature infants
- Hardware:
Hand held device : size 21,5x10x5,4cm , weight 600g. Battery powered : 6V/1000mAh, rechargeable Stimulus Rate: 40 ... 100Hz Signal Bandwidth : 1,4KHz to 4KHz - Software: echo-screen evaluation SW
Automated stimulus adjustment and online control
Signal statistical criterion for 'PASS' condition
Additional hints to measurement quality (stimulus stability and artefact rate)
The Echo-Screen Otoacoustic Emissions Test Instrument is a hand-held instrument with an attached probe (that is placed in the outer ear canal) which emits sound that evokes otoacoustic emissions. A microphone in the probe picks up the emissions if any are present, and the device then analyzes the emissions and mathematically separates noise from cochlear emissions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
outer ear canal, cochlea
Indicated Patient Age Range
neonates to adults, infants and children
Intended User / Care Setting
trained personnel in a medical or school environment, trained personnel in a medical or clinical 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)
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
OCT 21 1998
'510 (k) Summary' Summary and safety effectiveness
Submitter's Name & Address: Fischer-Zoth Audiologic Systems 11309 South Brandon Park Dr. 3 Sandy, Utah, 84092
Contact person & Telephone: Mr. Michael Soerensen (801) 253 0704
May 5, 1998 Data summary prepared:
Device name: Classification Name - Audiometer Common/Usual Name - Screening Audiometer Proprietary name - Echo-Screen
Predicate Device: Grason Stadler Inc. model GS170 AudioPath Screener (ref. 510(k) #K974237) and Otodynamics LTD. model ILO88 (ref. 510(k) #K962995,
Device description , intended Use & Effectiveness:
The Fischer-Zoth Audiologic System model 'Echo-Screen' is based upon Otoacoustic Emissions and it is similar to the Grason Stadler Inc. GSI70 AudioPath Screener and the Otodynamics OAE Analyser, model ILO88. __ ____________________________________________________________________________________________________________________________________
The purpose of the device is the reliable and earliest possible detection of hearing disorders due to cochlear dysfunction. It can be used beginning from neonates to adults.
The 'echo-screen' is a handheld, automated OAE-based screeming-system which is easy to use . The measurement flow is menu guided and the evaluation is based upon signal statistics.
It is intended to be used by trained personnel in a medical or school environment. The echo-screen is not intended for use in prescribing or fitting assisstive listening devices such as hearing aids or cochlea implants.
Technological Characterisitics: see also Attachment A
-
Probe: miniature probe easy to apply even for premature infants - Hardware:
-
Hardware:
Hand held device : size 21,5x10x5,4cm , weight 600g. Battery powered : 6V/1000mAh, rechargeable Stimulus Rate: 40 ... 100Hz Signal Bandwidth : 1,4KHz to 4KHz
- Software: echo-screen evaluation SW
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 required Sound Pressure level: 70-85 dB SPL maximum
1
Safety:
The 'Echo-Screen' Screening System is designed to provide electrical safety to the patient as well as the user. The system is designed to meet the following standards related electrical safety: IEC601-1, UL2601 and VDE750 (German MedGv).
The echo-screen is a stand alone-system. It is battery powered with a 6V battery. During operation there are no connections to the mains. There are no conductive connections to the patient or to the user during measurement.
To prevent excessive tone levels within the ear, the echo-screen system continiously controls the level of the output tone or click-burst. The max. output level is controlled via Software to 85dB SPL (sound pressure level) and the electronic hardware is build in such a way, that the speakers within the probe are incapable of producing enough decibels to permanently damage the ear.
The system will also be certified according to the following standards:
- ISO 9001 (EN29001) Quality Management System
- EN46001 Class I or Class IIa device
- Group 1 (medical equipment, conducted and radiated emissions) - EN 25011
- IEC801-3 Radiated Electromagnetic Field Susceptibility
- Conforms the provisions of Eruopean council Directive 93/42EEC - CE Mark concerning medical devices.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Summary of Effectiveness:
The 'echo-screen' is a portable OAE based screening system.
Its aim is to detect and track hearing loss and abnormal cochlear conditions as early as possible in the child's life. The automated test makes it easy to use by trained personnel in a medical or clinical environment.
2
Attachement A
i
۰ -----
| Technological
| Specification | GSI70 | echo-screen |
|---|---|---|
| Power source | Powered by rechargeable | |
| battery | Powered by rechargeable | |
| battery | ||
| Battery Low | ||
| Indication | Battery low indicator | Battery low indicator |
| Safety Compliance | IEC 601-1 and UL2601-1 | IEC601-1 and UL2601-1 |
| Computer interface | IRDA communication | none, during measurement |
| Audiometry | Tones are presented to a | |
| miniature speaker within the | ||
| probe which perceived is | ||
| indicated by the patient using a | ||
| response switch. Tone quality | ||
| and frequency specified per | ||
| ANSIS3.6 | Tones (clicks) are presented to a | |
| miniature speaker within the | ||
| probe and controlled via SW. | ||
| The response from the cochlea is | ||
| received and registrated. | ||
| Click tone quality and amplitude is | ||
| controlled via SW and HW and is | ||
| limited to a max. output level | ||
| 85dB SPL. | ||
| OAE probe design | Two speakers and a | |
| microphone present and | ||
| record response from | ||
| cochlea of ear. | One speaker and a microphone | |
| present and record response | ||
| from cochlea of ear. | ||
| SW | GSI 60 SW | Echo-screen Automated Evaluation SW |
| Supporting SW | Windows based SW that | |
| shows result., allows export | ||
| of data, and updating of | ||
| patient ID | C-based SW, that shows evaluation results, | |
| artefact rate, stimulus stability. | ||
| After measurement export of test-result | ||
| and patient data are possible |
3
Image /page/3/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name encircling an emblem. The emblem is a stylized image of an eagle with three overlapping profiles, suggesting a sense of community or collaboration. The overall design is simple and professional, reflecting the department's role in public health and human services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 21 1998
David G. Wood, Esq. Fischer-Zoth Audiologic System, Inc. 11309 Brandon Park Drive Sandy, Utah 84092
Re:
K982642 Echo-Screen Dated: July 27, 1998 Received: July 29, 1998 Regulatory class: II 21 CFR 874.1050/Procode: 77 EWO
Dear Mr. Wood:
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 (Special Controls) or class III (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 (QS) 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 531 through 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 programs 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/odff/dsmaldsmam.html".
Sincerely yours,
Lillian Yin, 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
4
| 510(k) Number (if known): | K982642 |
|---|---|
| Device Name: | ECHO-SCREEN |
| Indications For Use: |
The Echo-Screen Otoacoustic Emissions Test Instrument is a hand-held instrument with
an attached probe (that is placed in the outer ear canal) which emits sound that evokes
otoacoustic emissions. A microphone in the probe picks up the emissions if any are
present, and the device then analyzes the emissions and mathematically separates noise
from cochlear emissions. The presence of these emissions indicates cochlear function in
adults, infants and children. The instrument requires no active participation from the
patient.
Otoacoustic emissions (OAEs) are low-level audio-frequency sounds that are generated by
the outer hair cells of the cochlea in response to sound input. The presence of OAEs is an
indication of cochlear function. If the Echo-Screen signals a "pass" reading as it analyzes
the presence of OAEs, the clinician can determine that the cochlea is operating normally.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K982642
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
(Optional Format 1-2-96)