Sera

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. February 14, 2018 Interacoustics A/S Amy Yanta Director of Regulatory Affairs Audiometer Alle 1 Middelfart, 5500 Dk Re: K173567 Trade/Device Name: Sera™ Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO. GWJ Dated: November 20, 2017 Received: November 20, 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K173567 Device Name Sera™M #### Indications for Use (Describe) The Sera™ with DPOAE is intended for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emissions. The target population for Sera with DPOAE includes all ages. The Sera™ with TEOAE is intended for use in the audiologic evaluation and documentation of ear disorders using Transient Evoked Otoacoustic Emissions. The target population for Sera with TEOAE includes all ages. The Sera™ with ABRIS 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 Sera with ABRIS is newborns. The Sera™ 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. The device should not be used without the necessary knowledge and training to understand its use and how results should be interpreted. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> <span style="font-family: Wingdings;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> | <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> <span style="font-family: Wingdings;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> | # CONTINUE ON A SEPARATE PAGE IF NEEDED. 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FDA 510(k) K173567 Sera Summary as required by 21 CFR 807.92. #### Administrative Information Submitter: Interacoustics A/S Audiometer Allé 1 5500 Middelfart Denmark Tel: +45 6371 3555 Fax: +45 6371 3522 Contact Person: Amy Yanta Director of Regulatory Affairs 10393 West 70th Street Eden Prairie, MN 55344 952-947-6097 amyy@diagnostic-group.us Date Summary Prepared: August 25, 2017 #### Device Identification Trade Name: Sera™ Common Name: otoacoustic emission device/evoked response auditory stimulator and measurements Device Classification Name: Audiometer/Stimulator, Auditory, Evoked Response Device classification: Class II Panel: Ear Nose & Throat / Neurology Classification Regulation: 874.1050/882.1900 Product Code: EWO/GWJ Predicate Device: easyScreen, cleared on 08/29/2017 via K171506 Device Description The device is audiometric equipment used for assisting of inner ear and auditory brainstem abnormalities. Sera™ features a touch-screen display and user-friendly software in a compact hardware design. Sera™ can be purchased with various licenses allowing you to perform different hearing screening tests. Sera™ uses auditory brainstem response (ABRIS) 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. Auditory brainstem response (ABRIS) 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. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Interacoustics. The logo consists of a stylized globe symbol above the word "Interacoustics" in a bold, sans-serif font. Below the company name is a tagline in a smaller font, but the text is not legible. The logo is in black and white. The EEG is processed and analyzed automatically using the Sera™'s respons a response is detected, the screening is stopped automatically and a Pass result is assig ear. When no response is detected after 3 minutes of EEG activity has been processed, a Refer result is assigned. 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. ### Device Intended Use The Sera™ with DPOAE is intended for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emissions. The target population for Sera™ with DPOAE includes all ages. The Sera™ with TEOAE is intended for use in the audiologic evaluation and documentation of ear disorders using Transient Evoked Otoacoustic Emissions. The target population for Sera™ with TEOAE includes all ages. The Sera™ with ABRIS 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 Sera™ with ABRIS is newborns. The Sera™ 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. The device should not be used without the necessary knowledge and training to understand its use and how results should be interpreted. # Technological Characteristics The Sera™ 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. 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. | Description | Predicate: easyScreen<br>(K171506) | Device: Sera™ | |-------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------| | Type | Audiometer/ Auditory<br>Brainstem Response –<br>Audiometric equipment | Audiometer/ Auditory Brainstem<br>Response – Audiometric<br>equipment | Equivalence Predicate Chart 1: {5}------------------------------------------------ | | | Image: Interacoustics logo | |-----------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------| | Regulation Number | 21 CFR 874.1050<br>(otoacoustic emission device)<br>21 CFR 882.1900<br>(Evoked response auditory<br>stimulator) | 21 CFR 874.1050<br>(otoacoustic emission device) 21<br>CFR 882.1900<br>(Evoked response auditory<br>stimulator) | | Classification Product Code | EWO, GWJ | EWO, GWJ | | Regulatory Class | Class II | Class II | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Interacoustics. The logo consists of a stylized globe above the word "Interacoustics". The word "Interacoustics" is in a bold, sans-serif font. There is a line underneath the word "Interacoustics". | Indications for Use | | Interacoustics | |---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The device DPOAE and TEOAE<br>modules are intended for use in<br>the audiologic evaluation and<br>documentation of ear disorders<br>using Distortion Product<br>Otoacoustic Emissions or<br>Transient Otoacoustic Emissions<br>technology. The target<br>population for the modules<br>includes all ages. | The Sera™ with DPOAE is<br>intended for use in the<br>audiologic evaluation and<br>documentation of ear disorders<br>using Distortion Product<br>Otoacoustic Emissions. The<br>target population for Sera™<br>with DPOAE includes all ages. | | | The device ABR module is<br>intended for use in the<br>audiologic evaluation and<br>documentation of ear and nerve<br>disorders using auditory evoked<br>potentials from the inner ear,<br>the auditory nerve and the<br>brainstem. The target<br>population for the ABR module<br>is newborns and infants up to 6<br>months of age. | The Sera™ with TEOAE is<br>intended for use in the<br>audiologic evaluation and<br>documentation of ear disorders<br>using Transient Evoked<br>Otoacoustic Emissions. The<br>target population for Sera™<br>with TEOAE includes all ages.<br><br>The Sera™ with ABRIS is<br>intended for use in the<br>audiologic evaluation and<br>documentation of ear and nerve<br>disorders using auditory evoked<br>potentials from the inner ear,<br>the auditory nerve and the<br>brainstem. The target<br>population for Sera™ with ABRIS<br>is newborns.<br><br>The Sera™ System is to be used<br>by trained personnel only, such<br>as audiologists, ENT surgeons,<br>doctors, hearing healthcare<br>professionals or personnel with<br>a similar level of education. The<br>device should not be used<br>without the necessary<br>knowledge and training to<br>understand its use and how<br>results should be interpreted.<br><br>The intended use differs<br>slightly because the Sera<br>separates each function's<br>intended use instead of<br>grouping. | {7}------------------------------------------------ | Intended User | populations including new-<br>born infants.<br>The patient group<br>includes all ages and sexes.<br>The easyScreen System is to be<br>used by trained personnel only<br>such as audiologists, ENT<br>surgeons, doctors, hearing<br>healthcare professionals or<br>personnel with a similar level<br>of education. (or trained user<br>with supervision of a<br>professional) | populations including new- born<br>infants.<br>The patient group<br>includes all ages and sexes.<br>The Sera™ System is to be used by<br>trained personnel only, such as<br>audiologists, ENT surgeons,<br>doctors, hearing healthcare<br>professionals or personnel with a<br>similar level of education. The<br>device should not be used without<br>the necessary knowledge and<br>training to understand its use and<br>how results should be interpreted<br>Intended user specifies further<br>intended user. | |----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Anatomical Sites | Examination of Ear and hearing<br>nerves | Examination of Ear and hearing<br>nerves | | Safety Standards | IEC 60601-1 | IEC 60601-1 | | Performance Standards | IEC 60645-7, IEC 60645-6 | IEC 60645-7, IEC 60645-6 | | Device Type | Screening device (PASS/REFER) | Screening device (PASS/REFER) | | System Configuration | 1 -channel ABR system<br>operated through a handheld<br>base unit. The base unit is<br>operated as a stand alone<br>device | 1 -channel ABR system operated<br>through a handheld base unit.<br>The base unit is operated as a<br>stand alone device | | Display Information | Noise status, detected<br>transducer, artifact %,<br>PASS/REFERstatus | Noise status, detected<br>transducer, artifact %,<br>PASS/REFER status | | Stimulus | Clicks and chirps, pure tones | Clicks and chirps, pure tones | | Electrode Quality Check | Yes | Yes | | Impedance Test | acceptable impedance<br><40kOhm. | acceptable impedance<br><40kOhm. | | Binaural screening | Yes | Yes | | Pre-amplifier channels | 1 | 1 | | Stimulus Rate | 90/s | 90/s | | Pre-amplifier Gain | ABRIS - 64 dB (fixed) + 64dB<br>(Variable) | ABRIS - 72dB<br>The higher dB allows for a higher<br>ceiling of sound to be exported<br>from sound source | | Stimulus Level | ABR - 30, 40 and 45db nHL/<br>DPOAE -30 dB SPL to 80 dB SPL | ABR - 30, 40 and 45db nHL/<br>DPOAE -30 dB SPL to 80 dB SPL | | Masking | NONE | NONE | | Transducers | OAE probe, RadioEar IP30 insert<br>earphone | OAE probe, RadioEar IP30 insert<br>earphone | | Frequency range (f2) | DPOAE 500Hz - 10kHz | DPOAE 500Hz - 10kHz | | TEOAE Stimulus | | | | Frequency Range | 500 to 5500Hz | 500 to 5500Hz | | | | Interacoustics | | Stimuli Type | Non-Linear and Linear<br>Short duration signal (Click)<br>According to IEC 60645-3 | Non-Linear<br>Short duration signal (Click)<br>According to IEC 606045-3<br><br>Default is only Non-linear | | Level | 30 to 90 dB peSPL | 30 to 90 dB peSPL | | Level Step | 1 dB SPL | 1 dB SPL | | Transducer | Dedicated OAE Probe | Dedicated OAE Probe | | Probe Detection | Auto detection | Auto detection | | Recording | | | | A/D Resolution | 24 bit | 24 bit | | Artifact Reject System | 0 -> +60 dB SPL or off | 0 -> +60 dB SPL or off | | Automatic test with display<br>of PASS-REFER | Yes | Yes | {8}------------------------------------------------ # 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 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. The OAE and ABRIS measurements were divided into 3 phases. Phase 1 included when optimization occurred and involved feedback to the operator so that they could adjust such as probe fit, electrode impedance, ambient electrical and acoustic noise etc. Once the pre-test conditions were optimized, phase 2 of data collection proceeded as rapid as possible to allow the maximum quantity of good quality data to be collected in the shortest possible time. Phase 3 proceeded into the data assessment and decision stage and this ran concurrently with Phase 2 once the predetermined minimum amount of data had been collected. Phase 3 then went into the algorithm descriptions for each TEOAE, DPOAE and ABRIS measurements modes and is provided in detail in Annex 16D of this submission. 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. ### Summary of Clinical Testing Not applicable. Not required to establish substantial equivalence. ### Conclusion We have compared the intended use and performance characteristics with the predicate device. The Sera™ 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 Sera™ conforms to the current standards. After analyzing bench testing, safety, EMC, and software validation (with risk analysis) testing we conclude that the Sera™ is found to be substantially equivalent to the predicate devices in technological characteristics and indications for use.