(176 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of the device and its functions does not mention any AI or ML capabilities.
No.
The device is intended for stimulation, recording, and measurement of evoked potentials and emissions to aid in the evaluation, identification, documentation, and diagnosis of auditory and vestibular disorders. It is a diagnostic device, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The device is indicated for use in the evaluation, identification, documentation and diagnosis of auditory and vestibular disorders."
No
The device description explicitly states that the system consists of a laptop PC with software and a specialized hardware implementation interface (platform) to which transducers and accessories connect. This indicates the presence of significant hardware components beyond just a standard computer.
Based on the provided text, the Audera Pro is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body.
- Audera Pro's Function: The Audera Pro directly interacts with the patient's body (ear canal, scalp, head, neck) to stimulate and measure physiological responses (auditory evoked potentials, vestibular evoked myogenic potentials, auditory steady state responses, and otoacoustic emissions). This is an in vivo (within the living body) measurement.
- Intended Use: The intended use describes the device as being used for "stimulation, recording and measurement of auditory evoked potentials, vestibular evoked myogenic potentials, auditory steady state responses and otoacoustic emissions." This involves direct interaction with the patient's sensory and nervous systems, not the analysis of bodily fluids or tissues.
Therefore, the Audera Pro falls under the category of a diagnostic device that performs measurements directly on the patient, rather than an In Vitro Diagnostic device that analyzes specimens.
N/A
Intended Use / Indications for 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.
Product codes
GWJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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).
Indicated Patient Age Range
patients of any age.
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Bench testing was performed using a simulator, with evaluation of device output upon activation of each module. Evaluation of results performed alongside Bland-Altman analyses and correlation coefficient comparison. Results indicated that end-to-end performance of device system is comparable to predicate, despite observed differences in performance.
Other testing included:
- 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
- Mechanical Requirements Evaluation to demonstrate that functional mechanical product design requirements are satisfied.
Clinical testing was not performed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
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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3
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
4
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:
K163326
Predicate for ASSR,
DPOAE, and TEOAE: K061443 | Audera Pro: K193033 |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Photo | Image: Predicate for AEP and VEMP | Image: Audera Pro |
| | Predicate for AEP and VEMP:
K163326
Predicate for ASSR,
DPOAE, and TEOAE: K061443 | Audera Pro: K193033 |
| Indications for
Use: | SmartEP is an evoked response testing and
diagnostic device, that is capable of eliciting,
acquiring, and measuring auditory,
somatosensory, visual, and vestibular evoked
myogenic potential data, as well as providing
nerve stimulation and monitoring. The intended
use of the SmartEP device is to objectively record
evoked responses from patients of all ages upon
the presentation of sensory stimuli. The product is
indicated for use as a diagnostic aid and adjunctive
tool in sensory related disorders (i.e., auditory,
somatosensory, visual, and vestibular) and in
surgical procedures for inter-operative nerve
monitoring. The SmartEP system is intendedto be
used by trained personnel in a hospital, nursery,
clinic, audiologist's, EP technologist's, surgeon's,
or physician's office, operating room, or other
appropriate setting. The intended use of the Smart
USBLite device system is for the recording of
auditory evoked potential, otoacoustic emissions,
& auditory steady-state evoked potential data. The
product is intended to be used as a diagnostic aid
in auditory and hearing related disorders, as an
objective measure of cochlear function, and as an
adjunctive tool in the estimation of behavioral
hearing thresholds on patients of all ages | 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).
DIFFERENCE: Does not support Somatosensory
and Visual Evoked Potential and Nerve Stimulation
modules |
| Tests Performed/
Associated
predicate
Clearance | AEP Auditory Evoked Potentials K163326 ASSR Auditory Steady-State Response K061443 VEMP Vestibular Evoked Myogenic
Potential K163326 TEOAE Transient Evoked Otoacoustic
Emissions K061443 DPOAE Distortion Products Otoacoustic
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
K163326 TEOAE Transient Evoked Otoacoustic Emissions
K061443 DPOAE Distortion Products Otoacoustic
Emissions K061443 DIFFERENCE: Does not support Somatosensory and
Visual Evoked Potential and Nerve Stimulation
modules |
| | Predicate for AEP and VEMP:
K163326 | Audera Pro: K193033 |
| | Predicate for ASSR,
DPOAE, and TEOAE: K061443 | |
| Configuration | PC-based system with external hardware
platform and external hardware peripherals
(USB interface) | SAME |
| Hardware
Implementation | PC-based system with external hardware
platform 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 Amplifier
Channels | TWO | SAME |
| Stimulator
Frequencies
(In Hz) | 125, 250 500 750 1000 2000 3000
4000 6000 8000, 16,000, Tone Burst, Click | SAME |
| Stimulator
transducers | Headphones Insert
Earphones Bone
Conductor Probe Ear
Tips | SAME |
| Patient
electrode | Self stick single use disposable | SAME |
| OAE
Probe | Two channels of acquisition; Two speakers | One channel of acquisition;
One speaker |
| | | DIFFERENCE: Can perform
same testing, but with each
ear individually |
| Interface
Connectors | Headphones DIN Bone
oscillator DIN Speakers DIN
OAE Probe DIN
Patient Connection 6 pin custom USB:
USB A | Headphones 2 x ¼ inch
phone (DIFFERENCE)
Bone oscillator 1 x ¼ inch
phone (DIFFERENCE) |
| | | Speakers 2 x RCA phono
(DIFFERENCE) OAE Probe HDMI
(DIFFERENCE) |
| | | Patient Connection 6 pin
custom (SAME) |
| | | USB: USB A (SAME) |
| Data Acquisition | Sampling Rate 40 kHz A/D
resolution 16 bit | SAME |
| | Filtering and Artifact Rejection | |
| Artifact
Rejection | 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 | |
| Input
Impedance | > 10 ΜΩ | SAME |
| Common Mode
Rejection Ratio | ≥ 110 dB @ 1 kHz, 50/60 Hz | SAME |
| | Auditory Stimuli | |
| | Transducers | |
| Types | Clicks, Tones, Chirps | SAME |
| Duration | 100 µsec click default, adjustable; Tones
adjustable to 500 msec | SAME |
| Envelopes | Rectangular, Hann, Blackman, and Gaussian,
Trapezoidal, Extended Cosine, Barlett,
Cosine Cubed, Exact Blackman | Rectangular, Hann, Blackman, and
Gaussian, Trapezoidal, Extended Cosine
DIFFERENCE: Does not include Barlett,
Cosine Cubed and Exact Blackman
envelopes |
| Intensity | 150 dB attenuator range | SAME |
| Repetition Rate | 0.1-100/sec | SAME |
| Test
Frequencies | 125Hz to 16kHz | 125Hz to 12kHz
DIFFERENCE: Shorter
frequency range |
| Presentation | Right, Left, Both | SAME |
| Polarity | Rarefaction, Condensation, Alternating | SAME |
| Masking | White Noise | SAME |
| | Analysis/Measurement Parameters | |
| | Sweeps | |
| Analysis
Window | -2.5 sec to +2.5 sec (maximum) | SAME |
| Artifact
Rejection
Threshold | 1 – 2000 μV | SAME |
| | Other | |
| | Size/Weight | |
| | Predicate for AEP and VEMP:
K163326
Predicate for ASSR,
DPOAE, and TEOAE: K061443 | Audera Pro: K193033 |
| Computer
Operating
System | Windows 10 Pro | SAME |
| Power | AC line | SAME |
| Display | Laptop LCD | SAME |
| Data Display | Single/split screen, multiple pages | SAME |
5
6
7
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VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
| Testing/Ev-
aluation
Performed | Objective
of
Testing/Ev-
aluation | Product Design
Requirements
Evaluated | Standards
used for
Testing/Evalu
ation (as
applicable) |
|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical
Safety (ES)
and
Electromag
netic
compatibility (EMC) | ES:
Demonstrate that the
basic safety
and
essential
performance
requirement
of the device
are satisfied
to ensure
safe use
EMC:
Demonstrate that the
basic safety
and
essential
performance
of the device
is
maintained
in the
presence of
electromagnetic
disturbances | ES: Electrical leakage, insulation, safety
of applied parts
EMC: Conducted and Radiated
Emissions (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 (Third
Edition) +
CORR.1 (2006)
- CORR.2
(2007+ AMI1
(2012)) (or IEC
60601-1: 2012
reprint):
Medical
electrical
equipment –
Part 1: General
Requirements
for basic safety
and essential
performance
EMC: IEC 60601-1-2:
2015: Medical
electrical equipment
– Part 1-2: General
Requirements for
basic safety and
essential
performance –
Collateral Standard:
Electromagnetic
Disturbances –
Requirements and
Tests. |
| Electromyographs
(EMG) | Demonstrate that the
basic safety and
essential performance
for electromyographs
(myofeedback
equipment, as
supported by the
device system) is
maintained | Marking, electrical and mechanical
hazards, excessive temperatures,
accuracy of controls and instruments
and protection against hazardous
outputs, stimulators default to off on
electrical interruption | IEC 60601-2-40: 2016:
Medical electrical
equipment – Part 2-40:
Particular Requirements
for the Safety of
Electromyographs and
Evoked Response
Equipment.
Used in conjunction with
IEC 60601-1: 2005,
CORR1: 2006, CORR2:
2007, AMD1: 2012 |
| Calibration and Test
Signal | IEC 60645-1: Demonstrate
that the device satisfies
general requirements with
respect to determining | Audiometric requirements as specified
by referenced standards
Transducers 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 methods
IEC 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 methods
ISO 389-2 and ISO 389-6: Evaluate the ability to accurately generate calibration and test signals | Radio Ear DD45 Supra Aural Headset
Radio Ear IP30 Insert Phones
Radio Ear B81 Bone Vibrator
Radio Ear SP90A
Free Field speaker system | IEC 60645-3:2007:
Electroacoustics - Audiometric equipment - Part 3: Test signals of short duration
ISO 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 earphones
ISO 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-
aluation
Performed | Objective
of
Testing/Ev-
aluation | Product Design
Requirements
Evaluated | Standards
used for
Testing/Evalu
ation (as
applicable) |
| | respect
to
character
istics and
performa
nce
requirme
ns for
measure
ment of
auditory
evoked
potential
from the
inner
ear,
auditory
nerve
and
brainste
m,
evoked
by
acoustic
stimuli of
short
duration | Radio Ear IP30 Insert Phones
Radio Ear B81 Bone Vibrator
Radio Ear SP90A
Free Field speaker
system | auditory
brainstem
responses |
| Usability | To
demonst
rate that
process
used to
analyze,
specify,
design,
verify
and
validate
usability
as it
relates to
basic
safety
and
essential
performa
nce of
the
device is
in
complian
ce with
the IEC
62366
standard | Usability Requirements, with respect to
establishment and maintenance of a
usability engineering process addressing
user interactions with the device | IEC 60601-
1-6: 2010,
AMD1:
2013:
Medical
Electrical
Equipment
- Part 1-6:
General
Requireme
nts for
basic safety
and
essential
performanc
e –
Collateral
Standard:
Usability |
| Testing/Ev-
aluation
Performed | Objective
of
Testing/Ev-
aluation | Product Design
Requirements
Evaluated | Standards
used for
Testing/Evalu
ation (as
applicable) |
| | including
amended
definitions.
Excludes
production and
post-
production
monitoring and
maintenance of
the
Usability
Engineering
Process. | | |
| Module Comparison | Demonstrate that
performance of
device in
comparison to the
primary
predicate
device
(K163326
) is
comparable | Software (EP, ASSR, DPOAE and TEOAE
modules)
Hardware (USB Jr. Duet platform,
connected transducers, accessories and
components used for each module) | N/A
Bench
testing
performed
using
simulator,
with
evaluation
of device
output
upon
activation
of each
module.
Evaluation
of results
performed
alongside
Bland-
Altman
analyses
and
correlation
coefficient
comparison
. Results
indicated
that end-to-end
performance of device
system is
comparable
to
predicate |
| Testing/Ev-
aluation
Performed | Objective
of
Testing/Ev-
aluation | Product Design
Requirements
Evaluated | Standards
used for
Testing/Evalu
ation (as
applicable) |
| | | | despite
observed
differences
in
performance |
10
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12
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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.