(84 days)
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.
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.
The provided K982642 510(k) summary for the "Echo-Screen" device does not contain a specific study proving the device meets particular acceptance criteria through quantifiable performance metrics. Instead, it focuses on demonstrating substantial equivalence to predicate devices and adherence to safety standards.
Here's a breakdown of the information requested, based on the provided document:
1. Table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria for device performance (e.g., sensitivity, specificity for detecting hearing disorders). Instead, it establishes that the device's technological characteristics and intended use are similar to predicate devices and that it meets specified safety and quality standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Technological Equivalence (to predicates) | - Powered by rechargeable battery |
| - Battery low indicator | |
| - Safety Compliance: IEC 601-1 and UL2601-1 | |
| - Audiometry: Tones (clicks) presented to a miniature speaker, OAE response received and registered, click tone quality and amplitude controlled via SW and HW, limited to max 85dB SPL. | |
| - OAE probe design: One speaker and a microphone (vs. two speakers and a microphone for GSI70) | |
| - SW: Echo-screen Automated Evaluation SW (vs. GSI 60 SW) | |
| - Supporting SW: C-based SW for evaluation results, artifact rate, stimulus stability; export of test results and patient data possible. | |
| Safety Standards Compliance | - Designed to meet IEC601-1, UL2601, and VDE750. |
| - Max. output level controlled via Software to 85dB SPL. | |
| - Electronic hardware designed to prevent excessive decibels. | |
| Quality Management System Compliance | - Will be certified according to ISO 9001 (EN29001). |
| Medical Device Classification Compliance | - Will be certified according to EN46001 Class I or Class IIa device. |
| EMC Compliance | - Group 1 (medical equipment, conducted and radiated emissions) - EN 25011 |
| - IEC801-3 Radiated Electromagnetic Field Susceptibility | |
| Regulatory Compliance (EU) | - Conforms to provisions of European Council Directive 93/42EEC - CE Mark. |
2. Sample size used for the test set and the data provenance
The document does not describe a specific test set or clinical study with a sample size for evaluating performance. The submission relies on demonstrating substantial equivalence to predicate devices and compliance with relevant standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No performance study with a test set and ground truth established by experts is described.
4. Adjudication method for the test set
Not applicable. No performance study with a test set is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The "Echo-Screen" is an automated screening device, not an AI-assisted diagnostic tool that would involve "human readers" interpreting outputs in the way an MRMC study would typically evaluate.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is described as an "automated OAE-based screening system" with "Automated stimulus adjustment and online control" and "Signal statistical criterion for 'PASS' condition." This implies a standalone (algorithm only) performance in generating a "pass" or "refer" result for OAEs. However, the document does not present quantitative performance metrics (e.g., sensitivity, specificity) for this standalone performance. The "effectiveness" is primarily described in terms of its ability to detect OAEs and that their presence indicates cochlear function, similar to predicate devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state a type of ground truth used for performance validation. Given the device's nature as an OAE screener, the implied 'ground truth' for "effectiveness" would be the presence or absence of true OAEs, and indirectly, the presence or absence of cochlear function. However, no study measuring this against a gold standard (e.g., comprehensive audiological assessment) is presented.
8. The sample size for the training set
Not applicable. The document describes the device's design and technological characteristics, and its equivalence to predicate devices. It does not refer to an AI model that underwent a "training set." The "evaluation SW" is based on "signal statistics" rather than machine learning from a large training dataset.
9. How the ground truth for the training set was established
Not applicable. As there is no mention of a training set for an AI model, there is no description of how ground truth would have been established for it.
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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
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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.
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Attachement A
i
۰ -----
| TechnologicalSpecification | GSI70 | echo-screen |
|---|---|---|
| Power source | Powered by rechargeablebattery | Powered by rechargeablebattery |
| Battery LowIndication | 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 aminiature speaker within theprobe which perceived isindicated by the patient using aresponse switch. Tone qualityand frequency specified perANSIS3.6 | Tones (clicks) are presented to aminiature speaker within theprobe and controlled via SW.The response from the cochlea isreceived and registrated.Click tone quality and amplitude iscontrolled via SW and HW and islimited to a max. output level85dB SPL. |
| OAE probe design | Two speakers and amicrophone present andrecord response fromcochlea of ear. | One speaker and a microphonepresent and record responsefrom cochlea of ear. |
| SW | GSI 60 SW | Echo-screen Automated Evaluation SW |
| Supporting SW | Windows based SW thatshows result., allows exportof data, and updating ofpatient ID | C-based SW, that shows evaluation results,artefact rate, stimulus stability.After measurement export of test-resultand patient data are possible |
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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
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| 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)
§ 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.