(98 days)
The device DPOAE and TEOAE modules are intended for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emissions or Transient Otoacoustic Emissions technology. The target population for the modules includes all ages.
The device ABR module is intended for use in the audiologic evaluation and documentation of ear and nerve disorders using auditory evoked potentials from the inner ear, the auditory nerve and the brainstem. The target population for the ABR module is newborns and infants up to 6 months of age.
The easyScreen is intended to be used by audiologists, ENTs, hearing healthcare professionals, or other trained technicians in a hospital, clinic, healthcare facility or other suitable quiet environment as defined in standard ISO 8253-1.
The device is audiometric equipment used for testing of inner ear and auditory brainstem abnormalities.
easyScreen features a touch-screen display and user-friendly software in a compact hardware design. easyScreen can be purchased with various licenses allowing you to perform different hearing screening tests.
easyScreen uses auditory brainstem response (ABR) technology to screen patients for hearing loss. A modified click stimulus, the CE-Chirp , of 35 dB nHL is delivered into the patient's ear while electrodes placed on the patient's head measure EEG activity.
The EEG is processed and analyzed automatically using the easyScreen's response detection algorithm. When a response is detected, the screening is stopped automatically and a Pass result is assigned to the test ear. When no response is detected after 3 minutes of EEG activity has been processed, a Refer result is assigned.
Auditory brainstem response (ABR) test produces a short acoustic stimulus and measures via transcutaneous electrodes the auditory evoked potentials from the inner ear, the auditory nerve and the brainstem.
Distortion product otoacoustic emissions (DPOAE) technology uses pairs of pure tones presented in sequence to screen patients for cochlear hearing loss. Responses to the stimulus are predictable and therefore can be measured via a sensitive microphone placed in the patient's ear canal.
Transient otoacoustic emissions (TEOAE) technology uses a click stimulus to screen patients for cochlear hearing loss. Responses to the stimulus are predictable and therefore can be measured via a sensitive microphone placed in the patient's ear canal. The response can be divided into frequency bands for assessment.
The easyScreen consists of a handheld unit that utilizes a touchscreen display and a rechargeable battery. A simple cradle is included to support charging of the device's battery. The device supports Bluetooth communication with a label printer for the purpose of printing screening results.
The provided document does not contain an acceptance criterion table or a detailed study description with specific performance metrics. It's a 510(k) clearance letter and associated summary information for the "easyScreen" audiometric device, establishing substantial equivalence to predicate devices rather than providing detailed performance study results against specific criteria.
However, based on the information provided, here's what can be extracted regarding the device and its assessment:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of acceptance criteria with numerical performance targets (e.g., sensitivity, specificity, accuracy) for a study. Instead, the equivalence charts compare technical specifications and features of the easyScreen to its predicate devices, implying that meeting these comparable specifications is the "performance" considered for substantial equivalence.
Implied Performance Benchmarks from Predicate Comparison:
| Feature/Characteristic | Predicate Device (Titan) Performance/Specification | easyScreen (New Device) Performance/Specification | Note on "Acceptance" (Implied) |
|---|---|---|---|
| TEOAE Stimulus | |||
| Frequency Range | 500 to 5500Hz | same | Equivalent |
| Stimuli Type | Non-Linear and Linear Short duration signal (Click) According to IEC 60645-3 | same | Equivalent |
| Level | 30 to 90 dB peSPL | same | Equivalent |
| Level Step | 1 dB SPL | same | Equivalent |
| TEOAE Recording | |||
| A/D Resolution | 24 bit | same | Equivalent |
| Artifact Reject System | 0 -> +60 dB SPL or off | same | Equivalent |
| Automatic test with display of PASS-REFER | Yes | same | Equivalent |
| ABR Stimulus | |||
| Stimulus | Click and Chirps | same | Equivalent |
| Stimulus Rate | 90/s | same | Equivalent |
| Stimulus Level | 30, 40 and 45dB HL | same | Equivalent |
| Masking | None | same | Equivalent |
| ABR Electrode Features | |||
| Electrode quality check | YES | same | Equivalent |
| Impedance Test | Before recording: Electrode impedance is measured if they are above 10kOhm, below 10 kOhm or below 3 kOhm. | Similar impedance test; acceptable impedance <40kOhm. | Considered comparable |
| Preamplifier channels | 1 | same | Equivalent |
| Preamplifier Gain | 64 dB (fixed) + 64dB (Variable) | same | Equivalent |
| DPOAE Stimulus | |||
| Stimulus | 2 pure tones | same | Equivalent |
| Frequency range | 500Hz – 10kHz | same | Equivalent |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states in Section VII, "Summary of Clinical Testing," that "Not applicable. Not required to establish substantial equivalence." This indicates that no clinical testing with a specific test set was performed for this 510(k) submission. The evaluation was based on non-clinical testing and comparison to predicates.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Since no clinical testing was performed on a test set, no experts were used to establish ground truth for such a set in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set was used.
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 easyScreen is an audiometric screening device that provides PASS/REFER results programmatically, not a device requiring human readers or AI assistance in interpretation in the context of MRMC studies. The document also states "No clinical tests were performed."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is inherently a standalone algorithm-based screening device for ABR and OAE. The "easyScreen's response detection algorithm" processes and analyzes EEG for ABR, assigning "Pass" or "Refer" results automatically. Similarly, OAE technologies measure responses and categorize them. While not formally called a "standalone study" in the context of AI regulatory submissions, the non-clinical design verification and validation tests performed to assure the device meets its performance specifications (as per Section VI) would evaluate this algorithmic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical design verification and validation, the "ground truth" would be established by reference to engineering specifications, recognized international standards (IEC 60601-1 series, IEC 60645 series), and comparison to the known performance and characteristics of the predicate devices. There is no mention of clinical ground truth (e.g., confirmed hearing status by independent audiologist, pathology) because no clinical study was performed.
8. The sample size for the training set
The document does not mention a "training set" in the context of machine learning or AI development. The device's ABR response detection algorithm and OAE measurement capabilities are likely based on established physiological principles and signal processing, rather than being "trained" on a dataset in the modern AI sense. Therefore, no sample size for a training set is provided.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for machine learning. The algorithms are presumed to be developed based on audiological principles and validated against expected physiological responses and international standards.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 29, 2017
Maico Diagnostics GmbH Amy Yanta Director of Regulatory Affairs Sickingenstr. 70-71 Berlin, 10553 DE
Re: K171506 Trade/Device Name: Easyscreen Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO. GWJ Dated: Undated Received: July 27, 2017
Dear Amy Yanta:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Eric A. Mann -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171506
Device Name Easyscreen
Indications for Use (Describe)
The device DPOAE and TEOAE modules are intended for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emissions or Transient Otoacoustic Emissions technology. The target population for the modules includes all ages.
The device ABR module is intended for use in the audiologic evaluation and documentation of ear and nerve disorders using auditory evoked potentials from the inner ear, the auditory nerve and the brainstem. The target population for the ABR module is newborns and infants up to 6 months of age.
The easyScreen is intended to be used by audiologists. ENTs, hearing healthcare professionals, or other trained technicians in a hospital, clinic, healthcare facility or other suitable quiet environment as defined in standard ISO 8253-1.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the logo for MAICO. The logo consists of a stylized "M" symbol on the left, followed by the text "MAICO" in a sans-serif font. The color of the logo is a dark blue.
l. Administrative Information
Submitter: MAICO GmbH Sickingenstr 70-71 Berlin, Germany 10553
Tel: +4930-707146 Fax: +4930-70714699
Contact Person: Amy Yanta Director of Regulatory Affairs 10393 West 70th Street Eden Prairie, MN 55344 Tel: 952-947-6097 Email: amyy@diagnostic-group.us
Date Summary Prepared: May 10, 2017
II. Device Identification
Trade Name: easyScreen
Common Name: otoacoustic emission device/evoked response auditory stimulator and measurements Device Classification Name: Audiometer/Stimulator, Auditory, Evoked Response
Panel: Ear Nose & Throat / Neurology (874.1050/882.1900)
Device regulatory classification: Class II
Product Code: EWO/GWJ
Predicate Device 1: Titan (with DPOAE440 and ABRIS440), cleared on 05/05/2011 via K103760
Predicate Device 2: Titan (with TEOAE440), cleared on 06/20/2013 via K130795
III. Device Description
The device is audiometric equipment used for testing of inner ear and auditory brainstem abnormalities.
easyScreen features a touch-screen display and user-friendly software in a compact hardware design. easyScreen can be purchased with various licenses allowing you to perform different hearing screening tests.
easyScreen uses auditory brainstem response (ABR) technology to screen patients for hearing loss. A modified click stimulus, the CE-Chirp , of 35 dB nHL is delivered into the patient's ear while electrodes placed on the patient's head measure EEG activity.
The EEG is processed and analyzed automatically using the easyScreen's response detection algorithm. When a response is detected, the screening is stopped automatically and a Pass
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Image /page/4/Picture/1 description: The image shows the logo for MAICO. The logo is in blue and consists of a stylized "M" symbol on the left, followed by the word "MAICO" in a sans-serif font. The "M" symbol is made up of three connected, curved lines, resembling a sine wave. The letters in "MAICO" are bold and evenly spaced.
result is assigned to the test ear. When no response is detected after 3 minutes of EEG activity has been processed, a Refer result is assigned.
Auditory brainstem response (ABR) test produces a short acoustic stimulus and measures via transcutaneous electrodes the auditory evoked potentials from the inner ear, the auditory nerve and the brainstem.
Distortion product otoacoustic emissions (DPOAE) technology uses pairs of pure tones presented in sequence to screen patients for cochlear hearing loss. Responses to the stimulus are predictable and therefore can be measured via a sensitive microphone placed in the patient's ear canal.
Transient otoacoustic emissions (TEOAE) technology uses a click stimulus to screen patients for cochlear hearing loss. Responses to the stimulus are predictable and therefore can be measured via a sensitive microphone placed in the patient's ear canal. The response can be divided into frequency bands for assessment.
IV. Indications for Use
The device DPOAE and TEOAE modules are intended for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emissions or Transient Otoacoustic Emissions technology. The target population for the modules includes all ages.
The device ABR module is intended for use in the audiologic evaluation and documentation of ear and nerve disorders using auditory evoked potentials from the inner ear, the auditory nerve and the brainstem. The target population for the ABR module is newborns and infants up to 6 months of age.
The easyScreen is intended to be used by audiologists, ENTs, hearing healthcare professionals, or other trained technicians in a hospital, clinic, healthcare facility or other suitable quiet environment as defined in standard ISO 8253-1.
V. Technological Characteristics
The easyScreen consists of a handheld unit that utilizes a touchscreen display and a rechargeable battery. A simple cradle is included to support charging of the device's battery. The device supports
Bluetoothcommunication with a label printer for the purpose of printing screening results.
A comparison between the new and predicate devices shows that the technological characteristics and indications for use are equivalent. The device employs similar technology to accomplish the same tasks as the predicates. A detailed table is provided below.
Equivalence
Predicate Chart 1:
| Description | Titan with TEOAE440 (K130795) | easyScreen | |
|---|---|---|---|
| Type | Audiometer | Same | |
| Regulation Number | 21 CFR 874.1050 | Same | |
| (otoacoustic emission device) | |||
| Classification Product Code | EWO | Same | |
| Regulatory Class | Class II | Same | |
| Indications for Use | The Titan with TEOAE440 is intended foruse in the audiologic evaluation anddocumentation of ear disordersusing Transient Evoked OtoacousticEmissions.The target population for Titan withTEOAE440 includes all ages. | The device DPOAE and TEOAEmodules are intended for usein the audiologic evaluationand documentation of eardisorders using DistortionProduct Otoacoustic Emissionsor Transient OtoacousticEmissions technology. Thetarget population for themodules includes all ages.The device ABR module isintended for use in theaudiologic evaluation anddocumentation of ear andnerve disorders using auditoryevoked potentials from theinner ear, the auditory nerveand the brainstem. The targetpopulation for the ABR moduleis newborns and infants up to 6months of age. | |
| Target Population | The devices are suitable for allpopulations including new-born infants | Same | |
| Intended User | The Titan System is to be used bytrained personnel only such asaudiologists, ENT surgeons, doctors,hearing healthcare professionals orpersonnel with a similar level ofeducation. | Same (or trained user withsupervision of a professional) | |
| TEOAE Stimulus | |||
| Frequency Range | 500 to 5500Hz | same | |
| Stimuli Type | Non-Linear and LinearShort duration signal (Click) Accordingto IEC 60645-3 | same | |
| Level | 30 to 90 dB peSPL | same | |
| Level Step | 1 dB SPL | same | |
| Transducer | Dedicated OAE Probe | same | |
| Probe Detection | Auto detection | same | |
| Recording | |||
| A/D Resolution | 24 bit | same | |
| Artifact Reject System | 0 -> +60 dB SPL or off | same | |
| Automatic test with display ofPASS-REFER | Yes | same | |
| Description | Titan(K103760) | easyScreen | |
| With ABRIS440 | With DPOAE440 | ||
| Type | Auditory BrainstemResponse -Audiometric equipment | Audiometer | Same |
| Regulation Number | 21 CFR 882.1900(Evoked response auditorystimulator) | 21 CFR 874.1050(otoacoustic emissiondevice) | Same |
| ClassificationProduct Code | GWJ | EWO | Same |
| Regulatory Class | Class II | Class II | Same |
| Indications for Use | The Titan with ABRIS440 isintended for use in theaudiologic evaluation anddocumentation ofear and nerve disordersusing auditory evokedpotentials from the innerear, the auditory nerveand the brainstem. | The Titan with DPOAE440is intended for use in theaudiologic evaluation anddocumentation of eardisorders using DistortionProduct OtoacousticEmissions. | The device DPOAE andTEOAE modules areintended for use in theaudiologic evaluationand documentation ofear disorders usingDistortion ProductOtoacoustic Emissionsor Transient OtoacousticEmissions technology.The target populationfor the modules includesall ages.The device ABR moduleis intended for use inthe audiologicevaluation anddocumentation of earand nerve disordersusing auditory evokedpotentials from theinner ear, the auditorynerve and thebrainstem. The targetpopulation for the ABRmodule is newborns andinfants up to 6 monthsof age. |
| Target Population | Children and newborn | The patient group includes all ages and sexes. | Same |
| Anatomical Sites | Examination of Ear and hearing nerves | Examination of Ear | Same |
| Safety Standards | IEC 60601-1 | IEC 60601-1 | Same |
| Performance standard | IEC 60645-7 | IEC 60645-6 | Same |
| Device Type | Screening device (PASS/REFER) result | Screening and diagnostic | Same (PASS/REFER) |
| System Configuration | 1 -channel ABR system operated through a handheld base unit. The base unit can be operated stand alone or PC controlled through USB or Bluetooth. | 1 -channel ABR system operated through a handheld base unit. The base unit is operated as a stand alone device | |
| Display Information | PASS/REFER status, indicated with value between 0 and 100% where 100% indicates a pass. EEG peak or RMS value, rejection status, residual noise and what transducer(s) are detected. | Noise status, detected transducer, artifact %, PASS/REFER status | |
| Stimulus | Click and Chirps | 2 pure tones | same |
| Electrode quality check | YES | same | |
| Impedance Test | Before recording:Electrode impedance is measured if they are above 10kOhm, below 10 kOhm or below 3 kOhm. | Similar impedance test; acceptable impedance <40kOhm. | |
| Binaural screening | YES | same | |
| Pre-amplifier channels | 1 | same | |
| Stimulus rate | 90/s | same | |
| Pre-amplifier Gain | 64 dB (fixed) + 64dB (Variable) | same | |
| Stimulus Level | 30,40 and 45dB HL | 30 dB SPL to 80 dB SPL | same |
| Masking | None | same | |
| Transducers | Titan Probe (mono)Stereo headset: TDH39 and EAR3A | OAE probe,RadioEar IP30 insertearphone | |
| Frequency range | 500Hz – 10kHz | same |
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Image /page/5/Picture/1 description: The image shows the logo for MAICO. The logo is in blue and consists of the letter "M" with a sine wave design, followed by the letters "AICO" in a sans-serif font. The logo is simple and modern, and the blue color gives it a professional look.
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Image /page/6/Picture/1 description: The image shows the logo for MAICO. The logo consists of a stylized "M" symbol on the left, followed by the text "MAICO" in a sans-serif font. The color of the logo is a dark blue.
Equivalence Predicate Chart 2:
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Image /page/7/Picture/1 description: The image shows the logo for MAICO. The logo consists of a stylized "M" symbol on the left, followed by the text "MAICO" in a sans-serif font. The color of the logo is a dark blue.
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Image /page/8/Picture/1 description: The image shows the logo for MAICO. The logo consists of a blue symbol on the left and the word "MAICO" in blue letters on the right. The symbol on the left is a stylized "M" shape inside of a rounded square. The letters in "MAICO" are sans-serif and are connected to each other.
VI. Summary of Non-Clinical Testing
Design verification and validation were performed according to current standards for OAE and ABR to assure the device meets its performance specifications. EMC and Safety was performed in compliance with recognized standards IEC 60601-1 series, Medical Electrical Equipment - General requirements for basic safety and essential performance. The product meets the requirements from the international standard for OAE measurements IEC 60645 series. Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in medical Devices." The software for this device was considered as a "moderate" level of concern since a malfunction of, or a latent design flaw in, the Software Device could lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury. No clinical tests were performed, but based on the fulfillment of the international standards for OAE and ABR we believe the device is safe and effective. The auditory impedance testing characteristics and safety systems were compared and found to be comparable.
VII. Summary of Clinical Testing
Not applicable. Not required to establish substantial equivalence.
VIII. Conclusion
We have compared the intended use and performance characteristics with the predicate devices. The easyScreen was tested according to current standards and the differences found between the devices were related to functionality, not in relation to safety and efficiency. The easyScreen conforms to the current standards. After analyzing bench testing, safety, EMC, and software validation (with risk analysis) testing we conclude that the easyScreen is found to be substantially equivalent to the predicate devices in technological characteristics and indications for use.
§ 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.