GSI Novus

K172403 · Grason-Stadler, Inc. · EWO · Oct 20, 2017 · Ear, Nose, Throat

Device Facts

• Record ID: K172403
• Device Name: GSI Novus
• Applicant: Grason-Stadler, Inc.
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Oct 20, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The GSI Novus is intended to be used for the measurement and automated analysis of auditory evoked responses (auditory brainstem responses, ABR) and/or otoacoustic emissions (distortion product, DPOAE and transient evoked, TEOAE). These measures are useful in the screening evaluation, identification, documentation and diagnosis of auditory and hearing related disorders. The auditory evoked response (ABR) measurement is intended for newborns and infants up to 6 months of age. The otoacoustic emissions (DPOAE and/or TEOAE) measurement is intended for use in patients of all ages. The GSI Novus is intended to be used by a healthcare professional such as an ENT doctor, nurse or audiologist or by a trained technician under the supervision of a professional. The device is intended to be used in a hospital, clinic, or other facility with a suitable quiet testing environment.

Device Story

Handheld audiometric device for screening inner ear and auditory brainstem abnormalities; utilizes touchscreen interface. Inputs: EEG activity via transcutaneous electrodes (ABR) or acoustic responses via ear canal microphone (DPOAE/TEOAE). ABR uses 35 dB nHL CE-Chirp stimulus; DPOAE uses pure tone pairs; TEOAE uses click stimulus. Device processes signals via automated detection algorithm; assigns Pass/Refer result based on response detection. Used in hospitals/clinics by ENT doctors, nurses, audiologists, or trained technicians. Output displayed on screen; supports Bluetooth label printing and USB data transfer to PC. Facilitates clinical decision-making by providing objective screening results for hearing loss. Benefits include rapid, automated assessment of auditory function in infants and patients of all ages.

Clinical Evidence

No clinical testing performed. Substantial equivalence established via bench testing, including design verification and validation against international standards for OAE (IEC 60645-6) and ABR (IEC 60645-7) measurements, EMC, and electrical safety (IEC 60601-1).

Technological Characteristics

Handheld unit with touchscreen and rechargeable battery. Sensing: transcutaneous electrodes (ABR) and ear canal microphone (OAE). Connectivity: Bluetooth (printer) and USB (PC data transfer). Standards: IEC 60601-1 (safety), IEC 60645-6 (OAE), IEC 60645-7 (ABR). Software: Moderate level of concern. Sterilization: Not applicable (non-invasive).

Indications for Use

Indicated for screening, identification, documentation, and diagnosis of auditory and hearing-related disorders. ABR measurement indicated for newborns and infants up to 6 months. OAE (DPOAE/TEOAE) measurement indicated for patients of all ages.

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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 20, 2017

Grason-Stadler Inc. Amy Yanta Director of Regulatory Affairs 10395 West 70th Street Eden Prairie, MN 55344

Re: K172403

Trade/Device Name: GSI Novus Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO, GWJ Dated: August 9, 2017 Received: August 9, 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.

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.

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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 device-related 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 (DICE) 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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

# Srinivas Nandkumar -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) K172403

Device Name GSI Novus

#### Indications for Use (Describe)

The GSI Novus is intended to be used for the measurement and automated analysis of auditory evoked responses (auditory brainstem responses, ABR) and/or otoacoustic emissions (distortion product, DPOAE and transient evoked, TEOAE). These measures are useful in the screening evaluation, documentation and diagnosis of auditory and hearing related disorders. The auditory evoked response (ABR) measurement is intended for newborns and infants up to 6 months of age. The otoacoustic emissions (DPOAE and/or TEOAE) measurement is intended for use in patients of all ages.

The GSI Novus is intended to be used by a healthcare professional such as an ENT doctor, nurse or audiologist or by a trained technician under the supervision of a professional. The device is intended to be used in a hospital, clinic, or other facility with a suitable quiet testing environment.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------|---------------------------------------------|
| X 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 Grason-Stadler, a company that specializes in audiology equipment. The logo features a stylized sound wave graphic in light blue on the left. To the right of the sound wave is the company's acronym "gsi" in bold, black letters. Below the acronym is the full company name, "Grason-Stadler," in a smaller, sans-serif font.

## Section 5: 510(k) Summary as required by 21 CFR 807.92.

#### Administrative Information

- Submitter: Grason-Stadler Inc. 10395 West 70th Street Eden Prairie, MN 55344 Tel: [phone] Fax: [phone]
Contact Person: Amy Yanta Director of Regulatory Affairs 10393 West 70th Street Eden Prairie, MN 55344 952-947-6097 [e-mail]

Date Summary Prepared: August 7, 2017

Device Identification

Trade Name: Novus 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 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

## Device Description

The device is audiometric equipment used for testing of inner ear and auditory brainstem abnormalities.

Novus features a touch-screen display and user-friendly software in a compact hardware design. Novus can be purchased with various licenses allowing you to perform different hearing screening tests.

Novus 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 Novus'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.

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Image /page/4/Picture/1 description: The image shows the logo for Grason-Stadler, a company that specializes in audiology equipment. The logo features a stylized sound wave graphic in blue, followed by the letters "gsi" in bold, black font. Below the letters, the words "Grason-Stadler" are written in a smaller, sans-serif font, also in black. The logo is clean and modern, reflecting the company's focus on technology and innovation in the field of audiology.

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.

# Device Intended Use

The GSI Novus is intended to be used for the measurement and automated analysis of auditory evoked responses (auditory brainstem responses, ABR) and/or otoacoustic emissions (distortion product, DPOAE and transient evoked, TEOAE). These measures are useful in the screening evaluation, identification, documentation and diagnosis of auditory and hearing related disorders.

The auditory evoked response (ABR) measurement is intended for newborns and infants up to 6 months of age. The otoacoustic emissions (DPOAE and/or TEOAE) measurement is intended for use in patients of all ages.

The GSI Novus is intended to be used by a healthcare professional such as an ENT doctor, nurse or audiologist or by a trained technician under the supervision of a professional. The device is intended to be used in a hospital, clinic, or other facility with a suitable quiet testing environment.

# Technological Characteristics

The Novus 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 | Titan with TEOAE440 (k130795) | Novus |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type | Audiometer | Audiometer |
| Regulation Number | 21 CFR 874.1050<br>(otoacoustic emission device) | 21 CFR 874.1050<br>(otoacoustic emission device) |
| Classification Product Code | EWO | EWO |
| Regulatory Class | Class II | Class II |
| Indications for Use | The Titan with TEOAE440 is intended<br>for use in the audiologic evaluation<br>and documentation of ear disorders | The GSI Novus is intended to<br>be used for the measurement<br>and automated analysis of |
| | using Transient Evoked Otoacoustic<br>Emissions.<br>The target population for Titan with<br>TEOAE440 includes all ages. | auditory evoked responses<br>(auditory brainstem<br>responses, ABR) and/or<br>otoacoustic emissions<br>(distortion product, DPOAE<br>and transient evoked, TEOAE).<br>These measures are useful in<br>the screening evaluation,<br>identification, documentation<br>and diagnosis of auditory and<br>hearing related disorders.<br>The auditory evoked response<br>(ABR) measurement is<br>intended for newborns and<br>infants up to 6 months of age.<br>The otoacoustic emissions<br>(DPOAE and/or TEOAE)<br>measurement is intended for<br>use in patients of all ages.<br>The GSI Novus is intended to<br>be used by a healthcare<br>professional such as an ENT<br>doctor, nurse or audiologist or<br>by a trained technician under<br>the supervision of a<br>professional. The device is<br>intended to be used in a<br>hospital, clinic, or other facility<br>with a suitable quiet testing<br>environment.<br>Intended use differs due to<br>the device encompassing all<br>functions into one device. |
| Target Population | The devices are suitable for all<br>populations including new-born<br>infants | The device are suitable for all<br>populations including new-<br>born infants |
| 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. | To be used by trained<br>personnel only such as<br>audiologists, ENT surgeons,<br>doctors, hearing healthcare<br>professionals or personnel<br>with similar level of education.<br>(or trained user with<br>supervision of a professional) |
| TEOAE Stimulus | | |
| Frequency Range | 500 to 5500Hz | 500 to 5500Hz |
| Stimuli Type | Non-Linear and Linear<br>Short duration signal (Click)<br>According to IEC 60645-3 | Non-Linear and Linear<br>Short duration signal (Click)<br>According to IEC 60645-3 |
| 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 |

Equivalence Predicate Chart 1:

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Image /page/5/Picture/1 description: The image shows the logo for Grason-Stadler, a company that specializes in audiology equipment. The logo features a stylized sound wave graphic in blue, followed by the letters "gsi" in bold, black font. Below the letters, the words "Grason-Stadler" are written in a smaller, lighter font.

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Image /page/6/Picture/1 description: The image shows the logo for Grason-Stadler. The logo features a stylized letter 'g' with three curved lines emanating from it, followed by the letters 'si' stacked on top of the words 'Grason-Stadler'. The letter 'g' and the letters 'si' are in black, while the curved lines are in blue.

# Equivalence Predicate Chart 2:

| | Titan (K103760) | | Novus | |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description | With ABRIS440 | With DPOAE440 | With ABRIS | With DPOAE |
| Type | Auditory Brainstem<br>Response -<br>Audiometric<br>equipment | Audiometer | Auditory Brainstem<br>Response -<br>Audiometric<br>equipment | Audiometer |
| Regulation<br>Number | 21 CFR 882.1900<br>(Evoked response<br>auditory<br>stimulator) | 21 CFR 874.1050<br>(otoacoustic<br>emission device) | 21 CFR 882.1900<br>(Evoked response<br>auditory<br>stimulator) | 21 CFR 874.1050<br>(otoacoustic emission<br>device) |
| Classification<br>Product Code | GWJ | EWO | GWJ | EWO |
| Regulatory<br>Class | Class II | Class II | Class II | Class II |
| Indications for<br>Use | The Titan with<br>ABRIS440 is<br>intended for use in<br>the audiologic<br>evaluation and<br>documentation of<br>ear and nerve<br>disorders using<br>auditory evoked<br>potentials from the<br>inner ear, the<br>auditory nerve and<br>the brainstem. | The Titan with<br>DPOAE440 is<br>intended for use in<br>the audiologic<br>evaluation and<br>documentation of<br>ear disorders using<br>Distortion<br>Product<br>Otoacoustic<br>Emissions. | The GSI Novus is<br>intended to be used<br>for the measurement<br>and automated<br>analysis of auditory<br>evoked responses<br>(auditory brainstem<br>responses, ABR)<br>and/or otoacoustic<br>emissions (distortion<br>product, DPOAE and<br>transient evoked,<br>TEOAE). These<br>measures are useful in<br>the screening<br>evaluation,<br>identification,<br>documentation and<br>diagnosis of auditory | The GSI Novus is<br>intended to be used<br>for the measurement<br>and automated<br>analysis of auditory<br>evoked responses<br>(auditory brainstem<br>responses, ABR)<br>and/or otoacoustic<br>emissions (distortion<br>product, DPOAE and<br>transient evoked,<br>TEOAE). These<br>measures are useful in<br>the screening<br>evaluation,<br>identification,<br>documentation and<br>diagnosis of auditory |
| | | | and hearing related | and hearing related |
| | | | disorders.<br>The auditory evoked | disorders.<br>The auditory evoked |
| | | | response (ABR)<br>measurement is | response (ABR)<br>measurement is |
| | | | intended for newborns<br>and infants up to 6 | intended for<br>newborns and infants |
| | | | months of age. The | up to 6 months of age. |
| | | | otoacoustic emissions<br>(DPOAE and/or | The otoacoustic<br>emissions (DPOAE |
| | | | TEOAE) measurement<br>is intended for use in | and/or TEOAE)<br>measurement is |
| | | | patients of all ages.<br>The GSI Novus is | intended for use in<br>patients of all ages. |
| | | | intended to be used by | The GSI Novus is |
| | | | a healthcare | intended to be used |
| | | | professional such as an<br>ENT doctor, nurse or | by a healthcare |
| | | | audiologist or by a | professional such as<br>an ENT doctor, nurse |
| | | | trained technician<br>under the supervision | or audiologist or by a |
| | | | of a professional. The<br>device is intended to | trained technician<br>under the supervision |
| | | | be used in a hospital,<br>clinic, or other facility | of a professional. The<br>device is intended to |
| | | | with a suitable quiet<br>testing environment. | be used in a hospital,<br>clinic, or other facility |
| | | | | with a suitable quiet<br>testing environment. |
| | | | Intended use differs<br>due to the device | |
| | | | encompassing all | Intended use differs |
| | | | functions into one | due to the device |
| | | | device. | encompassing all |
| | | | | functions into one |
| | | | | device. |
| Target | Children and | The patient group | Children and newborn | The patient group |
| Population | newborn | includes all ages | | includes all ages and |
| |…