Easyscreen

K171506 · Maico Diagnostics GmbH · EWO · Aug 29, 2017 · Ear, Nose, Throat

Device Facts

• Record ID: K171506
• Device Name: Easyscreen
• Applicant: Maico Diagnostics GmbH
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Aug 29, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Handheld audiometric screening device; features touchscreen display; rechargeable battery; cradle charger. Performs DPOAE, TEOAE, and ABR testing. DPOAE/TEOAE: uses pure tone pairs or click stimuli; microphone in ear canal measures emissions. ABR: delivers CE-Chirp stimulus (35 dB nHL); transcutaneous electrodes measure EEG activity. Used in hospitals/clinics by audiologists, ENTs, or trained technicians. Automated response detection algorithm processes EEG; assigns Pass/Refer result. Bluetooth connectivity for label printing. Benefits: enables rapid, automated hearing screening for newborns and patients of all ages; facilitates early detection of hearing loss.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, safety/EMC compliance, and software verification/validation per FDA guidance.

Technological Characteristics

Handheld unit with touchscreen; rechargeable battery. Sensing: OAE microphone, transcutaneous EEG electrodes. Connectivity: Bluetooth (printer). Standards: IEC 60601-1 (safety), IEC 60645-6 (OAE), IEC 60645-7 (ABR). Software: Moderate level of concern. Automated PASS/REFER algorithm.

Indications for Use

Indicated for audiologic evaluation and documentation of ear disorders (DPOAE/TEOAE modules) in all ages, and ear/nerve disorders (ABR module) in newborns and infants up to 6 months of age.

Regulatory Classification

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.

Predicate Devices

• Titan (with DPOAE440 and ABRIS440) (K103760)
• Titan (with TEOAE440) (K130795)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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: [phone] Fax: [phone]

Contact Person: Amy Yanta Director of Regulatory Affairs 10393 West 70th Street Eden Prairie, MN 55344 Tel: [phone] Email: [e-mail]

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 for<br>use in the audiologic evaluation and<br>documentation of ear disorders<br><br>using Transient Evoked Otoacoustic<br>Emissions.<br>The target population for Titan with<br>TEOAE440 includes all ages. | The device DPOAE and TEOAE<br>modules are intended for use<br>in the audiologic evaluation<br>and documentation of ear<br>disorders using Distortion<br>Product Otoacoustic Emissions<br>or Transient Otoacoustic<br>Emissions technology. The<br>target population for the<br>modules includes all ages.<br><br>The device ABR module is<br>intended for use in the<br>audiologic evaluation and<br>documentation of ear and<br>nerve disorders using auditory<br>evoked potentials from the<br>inner ear, the auditory nerve<br>and the brainstem. The target<br>population for the ABR module<br>is newborns and infants up to 6<br>months of age. | |
| Target Population | The devices are suitable for all<br>populations including new-born infants | Same | |
| Intended User | The Titan System is to be used by<br>trained personnel only such as<br>audiologists, ENT surgeons, doctors,<br>hearing healthcare professionals or<br>personnel with a similar level of<br>education. | Same (or trained user with<br>supervision of a professional) | |
| TEOAE Stimulus | | | |
| Frequency Range | 500 to 5500Hz | same | |
| Stimuli Type | Non-Linear and Linear<br>Short duration signal (Click) According<br>to 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 of<br>PASS-REFER | Yes | same | |
| Description | Titan<br>(k103760) | | easyScreen |
| | With ABRIS440 | With DPOAE440 | |
| Type | Auditory Brainstem<br>Response -<br>Audiometric equipment | Audiometer | Same |
| Regulation Number | 21 CFR 882.1900<br>(Evoked response auditory<br>stimulator) | 21 CFR 874.1050<br>(otoacoustic emission<br>device) | Same |
| Classification<br>Product Code | GWJ | EWO | Same |
| Regulatory Class | Class II | Class II | Same |
| Indications for Use | The Titan with ABRIS440 is<br>intended for use in the<br>audiologic evaluation and<br>documentation of<br>ear and nerve disorders<br>using auditory evoked<br>potentials from the inner<br>ear, the auditory nerve<br>and the brainstem. | The Titan with DPOAE440<br>is intended for use in the<br>audiologic evaluation and<br>documentation of ear<br>disorders using Distortion<br>Product Otoacoustic<br>Emissions. | The device DPOAE and<br>TEOAE modules are<br>intended for use in the<br>audiologic evaluation<br>and documentation of<br>ear disorders using<br>Distortion Product<br>Otoacoustic Emissions<br>or Transient Otoacoustic<br>Emissions technology.<br>The target population<br>for the modules includes<br>all ages.<br>The device ABR module<br>is intended for use in<br>the audiologic<br>evaluation and<br>documentation of ear<br>and nerve disorders<br>using auditory evoked<br>potentials from the<br>inner ear, the auditory<br>nerve and the<br>brainstem. The target<br>population for the ABR<br>module is newborns and<br>infants up to 6 months<br>of 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:<br>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…