GSI Audera Pro

K193033 · Grason Stadler · GWJ · Apr 24, 2020 · Neurology

Device Facts

• Record ID: K193033
• Device Name: GSI Audera Pro
• Applicant: Grason Stadler
• Product Code: GWJ · Neurology
• Decision Date: Apr 24, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1900
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Audera Pro is intended to be used for the stimulation, recording and measurement of auditory evoked potentials, vestibular evoked myogenic potentials, auditory steady state responses and otoacoustic emissions. The device is indicated for use in the evaluation, identification, documentation and diagnosis of auditory and vestibular disorders. The device is intended to be used on patients of any age. The Audera Pro is intended to be used by qualified medical personnel such as an audiologist, physician, hearing healthcare professional, or trained technician. The Audera Pro is intended to be used in a hospital, clinic, or other healthcare facility with a suitable quiet testing environment. The anatomical sites of contact for auditory evoked potential (AEP) testing are the patient's ear canal (with the contact object being a sound delivery eartip or headphone, or an ear probe and eartip) and the patient's scalp and possibly other body sites (with the contact object being a bone transducer or electrodes that are capable of measuring bio-potentials). The anatomical sites of contact for vestibular evoked myogenic potential (VEMP) testing are the patient's ear canal (with the contact object being a sound delivery eartip or headphone, or an ear probe and eartip) and the patient's head and neck and possibly other body sites (with the contact object being a bone transducer or electrodes that are capable of measuring bio-potentials). The anatomical sites of contact for otoacoustic emission (DPOAE, TEOAE) testing are the patient's ear canal (with the contact object being an ear probe and eartip).

Device Story

Audera Pro is a configurable platform for auditory/vestibular testing; inputs include bio-potentials from scalp/neck electrodes and acoustic responses from ear canal probes. System comprises a laptop PC (Windows 10 Pro) connected to a specialized hardware interface. Device delivers auditory stimuli (clicks, tones, chirps) via headphones, insert earphones, or bone vibrators; records evoked responses (AEP, VEMP, ASSR, OAE). Used in hospitals/clinics by audiologists, physicians, or technicians. Software controls hardware, collects/analyzes signals, and displays results for clinician review. Output aids in diagnosing sensory-neural/hearing conditions and estimating behavioral hearing thresholds. Benefits include objective assessment of cochlear/auditory nerve/brainstem function.

Clinical Evidence

No clinical data. Bench testing only. Performance verified using simulators to compare Audera Pro output against predicate (K163326) across all modules (EP, ASSR, DPOAE, TEOAE). Electrical safety, EMC, and usability testing performed per IEC 60601-1, 60601-1-2, 60601-2-40, 60645-1/3/6/7, and 62366 standards.

Technological Characteristics

PC-based system with external hardware interface. Connectivity: USB. Power: AC line. Display: Laptop LCD. Software: Windows 10 Pro. Sensing: EEG amplifier (2 channels, >10 MΩ impedance, ≥110 dB CMRR). Stimuli: Clicks, tones, chirps (125Hz-12kHz). Transducers: Headphones, insert earphones, bone vibrators. Sterilization: N/A (disposable electrodes).

Indications for Use

Indicated for evaluation, identification, documentation, and diagnosis of auditory and vestibular disorders in patients of any age.

Regulatory Classification

Identification

An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.

Predicate Devices

• SmartEP (Duet platform) (K163326)
• Smart USBLite (K061443)

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 Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Grason-Stadler Inc. % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct. Naples, Florida 34114

Re: K193033

Trade/Device Name: GSI Audera Pro Regulation Number: 21 CFR 882.1900 Regulation Name: Evoked Response Auditory Stimulator Regulatory Class: Class II Product Code: GWJ Dated: March 27, 2020 Received: March 31, 2020

Dear Daniel Kamm:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K193033

Device Name GSI Audera Pro

### Indications for Use (Describe)

The Audera Pro is intended to be used for the stimulation, recording and measurement of auditory evoked potentials, vestibular evoked myogenic potentials, auditory steady state responses and otoacoustic emissions. The device is indicated for use in the evaluation, identification, documentation and diagnosis of auditory and vestibular disorders. The device is intended to be used on patients of any age.

The Audera Pro is intended to be used by qualified medical personnel such as an audiologist, physician, hearing healthcare professional, or trained technician. The Audera Pro is intended to be used in a hospital, clinic, or other healthcare facility with a suitable quiet testing environment.

The anatomical sites of contact for auditory evoked potential (AEP) testing are the patient's ear canal (with the contact object being a sound delivery eartip or headphone, or an ear probe and eartip) and the patient's scalp and possibly other body sites (with the contact object being a bone transducer or electrodes that are capable of measuring bio-potentials). The anatomical sites of contact for vestibular evoked myogenic potential (VEMP) testing are the patient's ear canal (with the contact object being a sound delivery eartip or headphone, or an ear probe and eartip) and the patient's head and neck and possibly other body sites (with the contact object being a bone transducer or electrodes that are capable of measuring bio-potentials). The anatomical sites of contact for otoacoustic emission (DPOAE, TEOAE) testing are the patient's ear canal (with the contact object being an ear probe and eartip).

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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### 510(K) Summary

Image /page/3/Picture/2 description: The image shows the logo for Grason-Stadler, also known as GSI. The logo features a stylized blue sound wave graphic to the left of the letters "gsi" in bold, black font. Below the letters "gsi" is the text "Grason-Stadler" in a smaller, thinner font, also in black.

#### SUBMITTER 1.

Grason-Stadler Inc. 10395 West 70th Street Eden Prairie, MN 55344

Tel: [phone]

Contact Person: Brent Nissly, General Manager/COO Date Prepared: February 28, 2020

#### DEVICE II.

Name of Device: GSI Audera Pro™ Common or Usual Name: Audera Pro Classification Name: Evoked Response Auditory Stimulator (21 CFR 882.1900) Regulatory Class: Class II Product Code: GWJ

#### III. PREDICATE DEVICE

K163326, Predicate for: Hardware platform for all modules, Software platform for VEMP and AEP modules Manufacturer: Intelligent Hearing Systems Trade/Device Name: SmartEP (Duet platform) Classification Name: Evoked Response Auditory Stimulator (21 CFR 882.1900) Regulatory Class: Class II Product Code: GWJ, GWF, GWF, GWE, ETN

K061443, Predicate for: ASSR, DPOAE, and TEOAE modules Trade/Device Name: Smart USBLite (with SmartEP, SmartScreener, SmartOAE, SmartTrOAE, & SmartEP-ASSR) Classification Name: Audiometer (21CFR 874.1050) Regulatory Class: Class II Product Code: GWJ; EWO; GWL

#### IV. DEVICE DESCRIPTION

The device is a configurable platform used to aid in the screening and diagnosis of sensory-neural and hearing conditions. It is capable of performing the following procedures: Auditory Evoked Potentials (EP), Auditory Steady-State Response (ASSR), Distortion Products Otoacoustic Emissions (DPOAE), Transient Evoked Otoacoustic Emissions (TEOAE), and vestibular evoked myogenic potentials (VEMP). The device system consists of a laptop PC with Windows 10 Pro, placed on top of or beside a specialized hardware implementation interface (i.e. platform) for the procedures. Software in the laptop controls the specialized hardware and collects and analyzes the resulting signals. Transducers and various accessories connect to the specialized hardware via connectors on the back of the hardware package.

#### INDICATIONS FOR USE V.

The Audera Pro is intended to be used for the stimulation, recording and measurement of auditory evoked potentials, vestibular evoked myogenic potentials, auditory steady state responses and otoacoustic emissions. The device is

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indicated for use in the evaluation, identification, documentation and diagnosis of auditory and vestibular disorders. The device is intended to be used on patients ofany age.

The Audera Pro is intended to be used by qualified medical personnel such as an audiologist, physician, hearing healthcare professional, or trained technician. The Audera Pro is intended to be used in a hospital, clinic, or other healthcare facility with a suitable quiet testing environment. The anatomical sites of contact for and the title (AEP) testing are the patient's ear canal (with the contact object being a sound delivery eartip or headphone, or an ear probe and eartip) and the patient's scalp and possibly other body sites (with the contact object being a bone transducer or electrodes that are capable of measuring bio-potentials).

The anatomical sites of contact for vestibular evoked myogenic potential (VEMP) testing are the patient's ear canal (with the contact object being a sound delivery eartip or headphone, or an ear probe and eartip) and the patient's head and neck and possibly other body sites (with the contact object being a bone transducer or electrodes that are capable of measuring bio-potentials). The anatomical sites of contact for otoacoustic emission (DPOAE, TEOAE) testing are the patient's ear canal (with the contact object being an ear probe and eartip)

#### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The following technological differences exist between the GSI Audera Pro™ MEG and the predicate devices. In addition, changes made to the USB Jr. Duet hardware platform include:

- Changes to the connectors on the chassis have been changed to mate with accessories;
- . Changes to the equalization circuit for the OAE probe to match probe model; and
- Reduction of earphone and bone vibrator impedance (from 300 to 10Ω)

| | Predicate for AEP and VEMP:<br>K163326<br>Predicate for ASSR,<br>DPOAE, and TEOAE: K061443 | Audera Pro: K193033 |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Photo | Image: Predicate for AEP and VEMP | Image: Audera Pro |
| | Predicate for AEP and VEMP:<br>K163326<br>Predicate for ASSR,<br>DPOAE, and TEOAE: K061443 | Audera Pro: K193033 |
| Indications for<br>Use: | SmartEP is an evoked response testing and<br>diagnostic device, that is capable of eliciting,<br>acquiring, and measuring auditory,<br>somatosensory, visual, and vestibular evoked<br>myogenic potential data, as well as providing<br>nerve stimulation and monitoring. The intended<br>use of the SmartEP device is to objectively record<br>evoked responses from patients of all ages upon<br>the presentation of sensory stimuli. The product is<br>indicated for use as a diagnostic aid and adjunctive<br>tool in sensory related disorders (i.e., auditory,<br>somatosensory, visual, and vestibular) and in<br>surgical procedures for inter-operative nerve<br>monitoring. The SmartEP system is intendedto be<br>used by trained personnel in a hospital, nursery,<br>clinic, audiologist's, EP technologist's, surgeon's,<br>or physician's office, operating room, or other<br>appropriate setting. The intended use of the Smart<br>USBLite device system is for the recording of<br>auditory evoked potential, otoacoustic emissions,<br>& auditory steady-state evoked potential data. The<br>product is intended to be used as a diagnostic aid<br>in auditory and hearing related disorders, as an<br>objective measure of cochlear function, and as an<br>adjunctive tool in the estimation of behavioral<br>hearing thresholds on patients of all ages | The Audera Pro is intended to be used for the<br>stimulation, recording and measurement of<br>auditory evoked potentials, vestibular evoked<br>myogenic potentials, auditory steady state<br>responses and otoacoustic emissions. The device<br>is indicated for use in the evaluation,<br>identification, documentation and diagnosis of<br>auditory and vestibular disorders. The device is<br>intended to be used on patients of any age.<br>The Audera Pro is intended to be used by<br>qualified medical personnel such as an<br>audiologist, physician, hearing healthcare<br>professional, or trained technician. The Audera<br>Pro is intended to be used in a hospital, clinic, or<br>other healthcare facility with a suitable quiet<br>testing environment.<br>The anatomical sites of contact for auditory<br>evoked potential (AEP) testing are the patient's<br>ear canal (with the contact object being a sound<br>delivery eartip or headphone, or an ear probe and<br>eartip) and the patient's scalp and possibly other<br>body sites (with the contact object being a bone<br>transducer or electrodes that are capable of<br>measuring bio-potentials). The anatomical sites of<br>contact for vestibular evoked myogenic potential<br>(VEMP) testing are the patient's ear canal (with<br>the contact object being a sound delivery eartip or<br>headphone, or an ear probe and eartip) and the<br>patient's head and neck and possibly other body<br>sites (with the contact object being a bone<br>transducer or electrodes that are capable of<br>measuring bio-potentials). The anatomical sites of<br>contact for otoacoustic emission (DPOAE, TEOAE)<br>testing are the patient's ear canal (with the<br>contact object being an ear probe and eartip).<br>DIFFERENCE: Does not support Somatosensory<br>and Visual Evoked Potential and Nerve Stimulation<br>modules |
| Tests Performed/<br>Associated<br>predicate<br>Clearance | AEP Auditory Evoked Potentials K163326 ASSR Auditory Steady-State Response K061443 VEMP Vestibular Evoked Myogenic<br>Potential K163326 TEOAE Transient Evoked Otoacoustic<br>Emissions K061443 DPOAE Distortion Products Otoacoustic<br>Emissions K061443 Plus: The SEP, VEP, and nerve stimulation | AEP Auditory Evoked Potentials K163326 ASSR Auditory Steady-State Response K061443 VEMP Vestibular Evoked Myogenic Potential<br>K163326 TEOAE Transient Evoked Otoacoustic Emissions<br>K061443 DPOAE Distortion Products Otoacoustic<br>Emissions K061443 DIFFERENCE: Does not support Somatosensory and<br>Visual Evoked Potential and Nerve Stimulation<br>modules |
| | Predicate for AEP and VEMP:<br>K163326 | Audera Pro: K193033 |
| | Predicate for ASSR,<br>DPOAE, and TEOAE: K061443 | |
| Configuration | PC-based system with external hardware<br>platform and external hardware peripherals<br>(USB interface) | SAME |
| Hardware<br>Implementation | PC-based system with external hardware<br>platform and peripherals (USB interface) | SAME |
| | Technological Characteristics | |
| Preamplifier/<br>Amplifier | Gain: 5K to 200K (8 steps)<br>HPF cutoffs: 0.1 Hz to 300 Hz (8 steps)<br>LPF cutoffs: 30 Hz to 500 Hz (8 steps)<br>Impedance test capable | SAME |
| EEG Amplifier<br>Channels | TWO | SAME |
| Stimulator<br>Frequencies<br>(In Hz) | 125, 250 500 750 1000 2000 3000<br>4000 6000 8000, 16,000, Tone Burst, Click | SAME |
| Stimulator<br>transducers | Headphones Insert<br>Earphones Bone<br>Conductor Probe Ear<br>Tips | SAME |
| Patient<br>electrode | Self stick single use disposable | SAME |
| OAE<br>Probe | Two channels of acquisition; Two speakers | One channel of acquisition;<br>One speaker |
| | | DIFFERENCE: Can perform<br>same testing, but with each<br>ear individually |
| Interface<br>Connectors | Headphones DIN Bone<br>oscillator DIN Speakers DIN<br>OAE Probe DIN<br>Patient Connection 6 pin custom USB:<br>USB A | Headphones 2 x ¼ inch<br>phone (DIFFERENCE)<br>Bone oscillator 1 x ¼ inch<br>phone (DIFFERENCE) |
| | | Speakers 2 x RCA phono<br>(DIFFERENCE) OAE Probe HDMI<br>(DIFFERENCE) |
| | | Patient Connection 6 pin<br>custom (SAME) |
| |…