(98 days)
Not Found
No
The description mentions an "automatic" response detection algorithm, but there is no mention of AI, ML, or any learning or adaptive capabilities. The algorithm appears to be based on pre-defined criteria for detecting a response.
No.
The device is used for evaluation and documentation of ear disorders and hearing loss, which are diagnostic purposes, not therapeutic.
Yes
The device's intended use and description explicitly state its purpose is for "audiologic evaluation and documentation of ear disorders" and "testing of inner ear and auditory brainstem abnormalities" using various technologies like OAE and ABR to detect or screen for hearing loss. This clearly indicates a diagnostic function.
No
The device description explicitly states it consists of a "compact hardware design," a "handheld unit that utilizes a touchscreen display and a rechargeable battery," and uses electrodes and a microphone, indicating it is a hardware device with integrated software.
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: This device performs audiometric evaluations using technologies like Otoacoustic Emissions (OAE) and Auditory Brainstem Response (ABR). These methods involve presenting stimuli to the ear and measuring physiological responses directly from the patient's body (acoustic emissions from the inner ear, electrical activity from the auditory pathway).
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It interacts directly with the patient's auditory system.
Therefore, while it is a medical device used for diagnosis, it falls under the category of in vivo diagnostic equipment rather than in vitro diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
EWO, GWJ
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 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 Bluetoothcommunication with a label printer for the purpose of printing screening results.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear and hearing nerves / Ear
Indicated Patient Age Range
The device DPOAE and TEOAE modules: all ages.
The device ABR module: newborns and infants up to 6 months of age.
Intended User / Care Setting
Intended Users: audiologists, ENTs, hearing healthcare professionals, or other trained technicians.
Care Setting: hospital, clinic, healthcare facility or other suitable quiet environment as defined in standard ISO 8253-1.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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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.
1
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 for | ||
| use in the audiologic evaluation and | |||
| documentation of ear disorders |
using Transient Evoked Otoacoustic
Emissions.
The target population for Titan with
TEOAE440 includes all ages. | 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. | |
| Target Population | The devices are suitable for all
populations including new-born infants | Same | |
| Intended User | The Titan System is to be used by
trained personnel only such as
audiologists, ENT surgeons, doctors,
hearing healthcare professionals or
personnel with a similar level of
education. | Same (or trained user with
supervision of a professional) | |
| TEOAE Stimulus | | | |
| Frequency Range | 500 to 5500Hz | same | |
| Stimuli Type | Non-Linear and Linear
Short duration signal (Click) According
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
PASS-REFER | Yes | same | |
| Description | Titan
(K103760) | | easyScreen |
| | With ABRIS440 | With DPOAE440 | |
| Type | Auditory Brainstem
Response -
Audiometric equipment | Audiometer | Same |
| Regulation Number | 21 CFR 882.1900
(Evoked response auditory
stimulator) | 21 CFR 874.1050
(otoacoustic emission
device) | Same |
| Classification
Product Code | GWJ | EWO | Same |
| Regulatory Class | Class II | Class II | Same |
| Indications for Use | The Titan with ABRIS440 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 Titan with DPOAE440
is intended for use in the
audiologic evaluation and
documentation of ear
disorders using Distortion
Product Otoacoustic
Emissions. | 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. |
| | | | |
| 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