(176 days)
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).
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.
The provided FDA 510(k) summary for the GSI Audera Pro describes acceptance criteria and studies primarily through comparison to predicate devices and adherence to international standards.
Here's the information broken down as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The device's acceptance criteria are framed in terms of meeting the requirements of various international standards and demonstrating comparability to predicate devices. The "Reported Device Performance" column reflects the conclusions drawn from the testing against these standards or the comparison to the predicates.
| Acceptance Criteria (Objective of Testing/Evaluation) | Reported Device Performance |
|---|---|
| Electrical Safety (ES): Demonstrate that the basic safety and essential performance requirement of the device are satisfied to ensure safe use. | Satisfied (based on compliance with IEC 60601-1) |
| Electromagnetic Compatibility (EMC): Demonstrate that the basic safety and essential performance of the device is maintained in the presence of electromagnetic disturbances. | Maintained (based on compliance with IEC 60601-1-2) |
| Electromyographs (EMG): Demonstrate that the basic safety and essential performance for electromyographs (myofeedback equipment, as supported by the device system) is maintained. | Maintained (based on compliance with IEC 60601-2-40) |
| Calibration and Test Signal: Demonstrate that the device satisfies general requirements with respect to determining relative to standard reference threshold levels established by means of psychoacoustic test methods. | Satisfied (based on compliance with IEC 60645-1, IEC 60645-3, ISO 389-2, ISO 389-6, validated for various transducers) |
| Otoacoustic Emissions (OAE): Ensure that measurements made under comparable test conditions are consistent, with respect to methods for testing and routine calibration for measurement of otoacoustic emissions. | Ensured (based on compliance with IEC 60645-6, by demonstrating accuracy of required frequencies and amplitudes, harmonic distortion, measurement accuracy, and presentation of results) |
| EP (ABR): Ensure that measurements made under comparable test conditions are consistent with respect to characteristics and performance requirements for measurement of auditory evoked potential from the inner ear, auditory nerve, and brainstem, evoked by acoustic stimuli of short duration. | Ensured (based on compliance with IEC 60645-7, by evaluating measuring system, stimulus types, test quality assuring system, frequency accuracy, hearing level control linearity, stimulus pulse, SPL accuracy levels, and maximum transducer output level for various transducers) |
| Usability: Demonstrate that process used to analyze, specify, design, verify and validate usability as it relates to basic safety and essential performance of the device is in compliance with the IEC 62366 standard. | Compliant (based on compliance with IEC 60601-1-6) |
| Module Comparison: Demonstrate that performance of device in comparison to the primary predicate device (K163326) is comparable. | Comparable (Bench testing using simulator, with evaluation of device output upon activation of each module. Results indicated that end-to-end performance of device system is comparable to predicate despite observed differences in performance, using Bland-Altman analyses and correlation coefficient comparison). |
| Software Verification and Validation: As recommended by the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (effective 5/11/05). | Satisfied (for a Moderate Level of Concern (LOC)) |
| Cybersecurity Risk Management: With implementation of modifications to procedures and labeling, as recommended by the Guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (effective 10/2/2014). | Satisfied |
| Mechanical Requirements Evaluation: To demonstrate that functional mechanical product design requirements are satisfied. | Satisfied |
2. Sample size used for the test set and the data provenance
The document does not specify a "sample size" in terms of patient data or clinical cases for a test set. The studies described are primarily non-clinical bench testing and comparative technical assessments against predicate devices and international standards. Therefore, there's no mention of data provenance (e.g., country of origin) as clinical data was not used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As clinical testing was not performed and the studies were non-clinical bench tests and comparisons to predicate devices, there was no need for experts to establish ground truth in the context of patient diagnoses or outcomes. The "ground truth" for these tests would be the established specifications and performance characteristics defined by the relevant international standards and the predicate devices.
4. Adjudication method for the test set
Not applicable. Given that the studies were non-clinical bench tests and comparisons to predicate devices, there was no independent adjudication of results in the way it would be done for a clinical study with multiple human readers. The evaluation methods included "Bland-Altman analyses and correlation coefficient comparison" for the module comparison, which are statistical methods rather than adjudication by experts.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was performed. The device is not an AI-assisted diagnostic tool that would typically involve human readers interpreting results. It is an "Evoked Response Auditory Stimulator" used for physiological measurements.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This concept doesn't directly apply because the device is hardware and software for stimulation, recording, and measurement of biological responses, not an algorithm providing a diagnosis or interpretation in a standalone capacity that would typically interface with human practitioners in an AI context. The performance evaluations described are of the device's ability to accurately generate and measure these physiological signals.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical studies described:
- International Standards: The primary "ground truth" for electrical safety, EMC, EMG, calibration, OAE, and ABR measurements are the specifications and performance requirements detailed within the referenced IEC and ISO standards (e.g., IEC 60601-1, IEC 60645 series).
- Predicate Device Performance: For the module comparison, the performance characteristics of the legally marketed predicate devices (K163326 and K061443) served as the benchmark for demonstrating comparability.
- Product Design Requirements: For software, cybersecurity, and mechanical evaluations, the established design requirements and FDA guidance documents served as the "ground truth" or criteria for successful performance.
8. The sample size for the training set
Not applicable. This device is not an AI/ML model that undergoes a training phase with a dataset. It is a medical device system built on established principles of electronics, signal processing, and audiometry.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: 952 278-4402
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:K163326Predicate for ASSR,DPOAE, and TEOAE: K061443 | Audera Pro: K193033 | |
|---|---|---|
| Photo | Image: Predicate for AEP and VEMP | Image: Audera Pro |
| Predicate for AEP and VEMP:K163326Predicate for ASSR,DPOAE, and TEOAE: K061443 | Audera Pro: K193033 | |
| Indications forUse: | SmartEP is an evoked response testing anddiagnostic device, that is capable of eliciting,acquiring, and measuring auditory,somatosensory, visual, and vestibular evokedmyogenic potential data, as well as providingnerve stimulation and monitoring. The intendeduse of the SmartEP device is to objectively recordevoked responses from patients of all ages uponthe presentation of sensory stimuli. The product isindicated for use as a diagnostic aid and adjunctivetool in sensory related disorders (i.e., auditory,somatosensory, visual, and vestibular) and insurgical procedures for inter-operative nervemonitoring. The SmartEP system is intendedto beused by trained personnel in a hospital, nursery,clinic, audiologist's, EP technologist's, surgeon's,or physician's office, operating room, or otherappropriate setting. The intended use of the SmartUSBLite device system is for the recording ofauditory evoked potential, otoacoustic emissions,& auditory steady-state evoked potential data. Theproduct is intended to be used as a diagnostic aidin auditory and hearing related disorders, as anobjective measure of cochlear function, and as anadjunctive tool in the estimation of behavioralhearing thresholds on patients of all ages | The Audera Pro is intended to be used for thestimulation, recording and measurement ofauditory evoked potentials, vestibular evokedmyogenic potentials, auditory steady stateresponses and otoacoustic emissions. The deviceis indicated for use in the evaluation,identification, documentation and diagnosis ofauditory and vestibular disorders. The device isintended to be used on patients of any age.The Audera Pro is intended to be used byqualified medical personnel such as anaudiologist, physician, hearing healthcareprofessional, or trained technician. The AuderaPro is intended to be used in a hospital, clinic, orother healthcare facility with a suitable quiettesting environment.The anatomical sites of contact for auditoryevoked potential (AEP) testing are the patient'sear canal (with the contact object being a sounddelivery eartip or headphone, or an ear probe andeartip) and the patient's scalp and possibly otherbody sites (with the contact object being a bonetransducer or electrodes that are capable ofmeasuring bio-potentials). The anatomical sites ofcontact for vestibular evoked myogenic potential(VEMP) testing are the patient's ear canal (withthe contact object being a sound delivery eartip orheadphone, or an ear probe and eartip) and thepatient's head and neck and possibly other bodysites (with the contact object being a bonetransducer or electrodes that are capable ofmeasuring bio-potentials). The anatomical sites ofcontact for otoacoustic emission (DPOAE, TEOAE)testing are the patient's ear canal (with thecontact object being an ear probe and eartip).DIFFERENCE: Does not support Somatosensoryand Visual Evoked Potential and Nerve Stimulationmodules |
| Tests Performed/AssociatedpredicateClearance | AEP Auditory Evoked Potentials K163326 ASSR Auditory Steady-State Response K061443 VEMP Vestibular Evoked MyogenicPotential K163326 TEOAE Transient Evoked OtoacousticEmissions K061443 DPOAE Distortion Products OtoacousticEmissions K061443 Plus: The SEP, VEP, and nerve stimulation | AEP Auditory Evoked Potentials K163326 ASSR Auditory Steady-State Response K061443 VEMP Vestibular Evoked Myogenic PotentialK163326 TEOAE Transient Evoked Otoacoustic EmissionsK061443 DPOAE Distortion Products OtoacousticEmissions K061443 DIFFERENCE: Does not support Somatosensory andVisual Evoked Potential and Nerve Stimulationmodules |
| Predicate for AEP and VEMP:K163326 | Audera Pro: K193033 | |
| Predicate for ASSR,DPOAE, and TEOAE: K061443 | ||
| Configuration | PC-based system with external hardwareplatform and external hardware peripherals(USB interface) | SAME |
| HardwareImplementation | PC-based system with external hardwareplatform and peripherals (USB interface) | SAME |
| Technological Characteristics | ||
| Preamplifier/Amplifier | Gain: 5K to 200K (8 steps)HPF cutoffs: 0.1 Hz to 300 Hz (8 steps)LPF cutoffs: 30 Hz to 500 Hz (8 steps)Impedance test capable | SAME |
| EEG AmplifierChannels | TWO | SAME |
| StimulatorFrequencies(In Hz) | 125, 250 500 750 1000 2000 30004000 6000 8000, 16,000, Tone Burst, Click | SAME |
| Stimulatortransducers | Headphones InsertEarphones BoneConductor Probe EarTips | SAME |
| Patientelectrode | Self stick single use disposable | SAME |
| OAEProbe | Two channels of acquisition; Two speakers | One channel of acquisition;One speaker |
| DIFFERENCE: Can performsame testing, but with eachear individually | ||
| InterfaceConnectors | Headphones DIN Boneoscillator DIN Speakers DINOAE Probe DINPatient Connection 6 pin custom USB:USB A | Headphones 2 x ¼ inchphone (DIFFERENCE)Bone oscillator 1 x ¼ inchphone (DIFFERENCE) |
| Speakers 2 x RCA phono(DIFFERENCE) OAE Probe HDMI(DIFFERENCE) | ||
| Patient Connection 6 pincustom (SAME) | ||
| USB: USB A (SAME) | ||
| Data Acquisition | Sampling Rate 40 kHz A/Dresolution 16 bit | SAME |
| Filtering and Artifact Rejection | ||
| ArtifactRejection | User Selectable - 0-100% | SAME |
| Filter Slope | - 6 dB/Octave | SAME |
| Notch Filter | User Selectable, 50/60 Hz | SAME |
| Predicate for AEP and VEMP:K163326 | Audera Pro: K193033 | |
| Predicate for ASSR,DPOAE, and TEOAE: K061443 | ||
| Noise Level | ||
| InputImpedance | > 10 ΜΩ | SAME |
| Common ModeRejection Ratio | ≥ 110 dB @ 1 kHz, 50/60 Hz | SAME |
| Auditory Stimuli | ||
| Transducers | ||
| Types | Clicks, Tones, Chirps | SAME |
| Duration | 100 µsec click default, adjustable; Tonesadjustable to 500 msec | SAME |
| Envelopes | Rectangular, Hann, Blackman, and Gaussian,Trapezoidal, Extended Cosine, Barlett,Cosine Cubed, Exact Blackman | Rectangular, Hann, Blackman, andGaussian, Trapezoidal, Extended CosineDIFFERENCE: Does not include Barlett,Cosine Cubed and Exact Blackmanenvelopes |
| Intensity | 150 dB attenuator range | SAME |
| Repetition Rate | 0.1-100/sec | SAME |
| TestFrequencies | 125Hz to 16kHz | 125Hz to 12kHzDIFFERENCE: Shorterfrequency range |
| Presentation | Right, Left, Both | SAME |
| Polarity | Rarefaction, Condensation, Alternating | SAME |
| Masking | White Noise | SAME |
| Analysis/Measurement Parameters | ||
| Sweeps | ||
| AnalysisWindow | -2.5 sec to +2.5 sec (maximum) | SAME |
| ArtifactRejectionThreshold | 1 – 2000 μV | SAME |
| Other | ||
| Size/Weight | ||
| Predicate for AEP and VEMP:K163326Predicate for ASSR,DPOAE, and TEOAE: K061443 | Audera Pro: K193033 | |
| ComputerOperatingSystem | Windows 10 Pro | SAME |
| Power | AC line | SAME |
| Display | Laptop LCD | SAME |
| Data Display | Single/split screen, multiple pages | SAME |
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VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
| Testing/Ev-aluationPerformed | ObjectiveofTesting/Ev-aluation | Product DesignRequirementsEvaluated | Standardsused forTesting/Evaluation (asapplicable) |
|---|---|---|---|
| ElectricalSafety (ES)andElectromagneticcompatibility (EMC) | ES:Demonstrate that thebasic safetyandessentialperformancerequirementof the deviceare satisfiedto ensuresafe useEMC:Demonstrate that thebasic safetyandessentialperformanceof the deviceismaintainedin thepresence ofelectromagneticdisturbances | ES: Electrical leakage, insulation, safetyof applied partsEMC: Conducted and RadiatedEmissions (CISPR 11)Electrostatic Discharge (IEC 61000-4-2)Radiated Susceptibility (IEC 61000-4-3)Transient Susceptibility (IEC 61000-4-4)Surge Susceptibility Test (IEC 61000-4-5)Conducted Immunity (IEC 61000-4-6)Power Magnetics Field (IEC 61000-4-8)Voltage Fluctuations (IEC 61000-4-11)Flicker (IEC 61000-3-3) | ES: IEC 60601-1: 2005 (ThirdEdition) +CORR.1 (2006)+ CORR.2(2007+ AMI1(2012)) (or IEC60601-1: 2012reprint):Medicalelectricalequipment –Part 1: GeneralRequirementsfor basic safetyand essentialperformanceEMC: IEC 60601-1-2:2015: Medicalelectrical equipment– Part 1-2: GeneralRequirements forbasic safety andessentialperformance –Collateral Standard:ElectromagneticDisturbances –Requirements andTests. |
| Electromyographs(EMG) | Demonstrate that thebasic safety andessential performancefor electromyographs(myofeedbackequipment, assupported by thedevice system) ismaintained | Marking, electrical and mechanicalhazards, excessive temperatures,accuracy of controls and instrumentsand protection against hazardousoutputs, stimulators default to off onelectrical interruption | IEC 60601-2-40: 2016:Medical electricalequipment – Part 2-40:Particular Requirementsfor the Safety ofElectromyographs andEvoked ResponseEquipment.Used in conjunction withIEC 60601-1: 2005,CORR1: 2006, CORR2:2007, AMD1: 2012 |
| Calibration and TestSignal | IEC 60645-1: Demonstratethat the device satisfiesgeneral requirements withrespect to determining | Audiometric requirements as specifiedby referenced standardsTransducers evaluated (IEC 60645-3 & | IEC 60645-1: 2001:Electroacoustics –Audiometric equipment –Part 1: Equipment for |
| Testing/Evaluation Performed | Objective of Testing/Evaluation | Product Design Requirements Evaluated | Standards used for Testing/Evaluation (as applicable) audiometry |
| relative to standard reference threshold levels established by means of psychoacoustic test methodsIEC 60645-3: Ensure that audiometric stimuli of short duration are specified and measured in same way, and that calibration of the device using such signals is carried out using defined methodsISO 389-2 and ISO 389-6: Evaluate the ability to accurately generate calibration and test signals | Radio Ear DD45 Supra Aural HeadsetRadio Ear IP30 Insert PhonesRadio Ear B81 Bone VibratorRadio Ear SP90AFree Field speaker system | IEC 60645-3:2007:Electroacoustics - Audiometric equipment - Part 3: Test signals of short durationISO 389-2:1994:Acoustics - Reference zero for the calibration of audiometric equipment - Part 2: Reference equivalent threshold sound pressure levels for pure tones and insert earphonesISO 389-6:2007:Acoustics - Reference zero for the calibration of audiometric equipment -- Part 6: Reference threshold of hearing for test signals of short duration | |
| Otoacoustic emissions (OAE) | Ensure that measurements made under comparable test conditions are consistent, with respect to methods for testing and routine calibration for measurement of otoacoustic emissions | Required frequencies and amplitudes, harmonic distortion, accuracy of measurements. Presentation of results for TEOAE and DPOAE, marking requirements | IEC 60645-6: 2009:Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of otoacoustic emissions |
| EP (ABR) | Ensure that measurements made under comparable test conditions are consistent with | Measuring system, stimulus types, test quality assuring system (i.e. impedance check, artifact rejection, presentation of results, instrument marking, safety, frequency accuracy, hearing level control linearity, stimulus pulse, SPL accuracy levels, maximum transducer output level.Transducers evaluated:Radio Ear DD45 Supra Aural Headset | IEC 60645-7: 2009:Electroacoustics - Audiometric equipment - Part 7: Instruments for the measurement of |
| Testing/Ev-aluationPerformed | ObjectiveofTesting/Ev-aluation | Product DesignRequirementsEvaluated | Standardsused forTesting/Evaluation (asapplicable) |
| respecttocharacteristics andperformancerequirmens formeasurement ofauditoryevokedpotentialfrom theinnerear,auditorynerveandbrainstem,evokedbyacousticstimuli ofshortduration | Radio Ear IP30 Insert PhonesRadio Ear B81 Bone VibratorRadio Ear SP90AFree Field speakersystem | auditorybrainstemresponses | |
| Usability | Todemonstrate thatprocessused toanalyze,specify,design,verifyandvalidateusabilityas itrelates tobasicsafetyandessentialperformance ofthedevice isincompliance withthe IEC62366standard | Usability Requirements, with respect toestablishment and maintenance of ausability engineering process addressinguser interactions with the device | IEC 60601-1-6: 2010,AMD1:2013:MedicalElectricalEquipment- Part 1-6:GeneralRequirements forbasic safetyandessentialperformance –CollateralStandard:Usability |
| Testing/Ev-aluationPerformed | ObjectiveofTesting/Ev-aluation | Product DesignRequirementsEvaluated | Standardsused forTesting/Evaluation (asapplicable) |
| includingamendeddefinitions.Excludesproduction andpost-productionmonitoring andmaintenance oftheUsabilityEngineeringProcess. | |||
| Module Comparison | Demonstrate thatperformance ofdevice incomparison to theprimarypredicatedevice(K163326) iscomparable | Software (EP, ASSR, DPOAE and TEOAEmodules)Hardware (USB Jr. Duet platform,connected transducers, accessories andcomponents used for each module) | N/ABenchtestingperformedusingsimulator,withevaluationof deviceoutputuponactivationof eachmodule.Evaluationof resultsperformedalongsideBland-Altmananalysesandcorrelationcoefficientcomparison. Resultsindicatedthat end-to-endperformance of devicesystem iscomparabletopredicate |
| Testing/Ev-aluationPerformed | ObjectiveofTesting/Ev-aluation | Product DesignRequirementsEvaluated | Standardsused forTesting/Evaluation (asapplicable) |
| despiteobserveddifferencesinperformance |
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Other testing performed included the following:
- Software verification and validation for a Moderate Level of Concern (LOC), as recommended by the Guidance ● for the Content of Premarket Submissions for Software Contained in Medical Devices (effective 5/11/05]1
- . Evaluation of cybersecurity risk management with implementation of modifications to procedures and labeling, as recommended by the Guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (effective 10/2/2014)2
- o Mechanical Requirements Evaluation to demonstrate that functional mechanical product design requirements are satisfied
Clinical testing was not performed.
VIII. Conclusion
Based on the non-clinical performance data, the GSI Audera Pro™ is found to have a safety and effectiveness profile that is comparable to the predicate device.
§ 882.1900 Evoked response auditory stimulator.
(a)
Identification. An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.(b)
Classification. Class II (performance standards).