(244 days)
No
The summary describes standard audiometric and evoked potential testing equipment and procedures. There is no mention of AI or ML in the device description, intended use, or performance studies. The device performs physical measurements and protocols are created in software, but this does not indicate AI/ML.
No
The device is intended for diagnostic purposes (vestibular evoked myogenic potential testing to assist in the assessment of vestibular function) and does not provide therapy or treatment.
Yes
The device is intended for "vestibular evoked myogenic potential testing to assist in the assessment of vestibular function" and "assist medical practitioners in the diagnosis of various balance disorders." This clearly indicates its role in diagnosing medical conditions.
No
The device description explicitly states that the Eclipse with VEMP consists of a hardware platform, a preamplifier, stimulation transducers, and recording electrodes, in addition to the PC-based software modules.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Eclipse with VEMP performs physiological measurements by stimulating the auditory system and recording evoked potentials from muscles. It does not analyze biological specimens.
- Intended Use: The intended use is for "vestibular evoked myogenic potential testing to assist in the assessment of vestibular function." This involves directly testing the patient's physiological response, not analyzing a sample taken from the patient.
- Device Description: The description clearly states it's "audiometric equipment intended to perform various Otoacoustic Emissions (OAEs) and Auditory Evoked Potential evaluations." These are all physiological tests.
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any biological specimens.
Therefore, the Eclipse with VEMP falls under the category of a physiological measurement device rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Eclipse with VEMP (Vestibular Evoked Myogenic Potential) is intended for vestibular evoked myogenic potential testing to assist in the assessment of vestibular function. The target population for Eclipse with VEMP includes patients aged from 8 years and up.
The device is to be used only by qualified medical personnel with prior knowledge of the medical and scientific facts underlying the procedure.
Product codes
GWJ
Device Description
The Eclipse with VEMP is audiometric equipment intended to perform various Otoacoustic Emissions (OAEs) and Auditory Evoked Potential evaluations. The Eclipse is operated solely from PC based software modules. The Eclipse platform performs the physical measurements. The protocols are created in the software modules. The Eclipse consists of a hardware platform, a preamplifier, stimulation transducers and recording electrodes.
VEMP evaluations are tests of the vestibular portion of the inner ear and acoustic nerve, evoked with an auditory stimulation. The evoked response results in a potential recorded from the sternocleidomastoid (neck) muscles or the inferior oblique (eye) muscles. VEMP is not a test of the neck or eye musculature directly; the clinician is interested in the vestibular anatomy which triggers the response. The cervical Vestibular Evoked Myogenic Potential (cVEMP) is an evoked potential measured from the sternocleidomastiod (SCM) muscle and the ocular VEMP (oVEMP) is an evoked potential measured from the inferior oblique muscle. Both tests are used to assess the otolith organs (saccule and utricle) of the vestibular system and their afferent pathways and assist medical practitioners in the diagnosis of various balance disorders.
Summary: VEMP is Auditory Evoked Potentials like ABR obtained using any commercially available EP system. The addition of the VEMP module to Eclipse will make it possible for clinicians to conduct VEMP tests while using EMG (electromyography) monitoring and scaling. The VEMP function of the Eclipse with VEMP does not make a diagnosis. It only assists the medical professional.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Examination of Ear, hearing nerves and vestibular functions
Indicated Patient Age Range
patients aged from 8 years and up.
Intended User / Care Setting
The device is to be used only by qualified medical personnel with prior knowledge of the medical and scientific facts underlying the procedure.
Hospitals and clinics
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
Testing was conducted at two sites (one in Denmark and one in the United States). Test subjects included 14 normal adults for cVEMP and oVEMP. The study evaluated test-retest reliability and reproducibility of VEMP measurements using the Eclipse with VEMP module. Collection parameters for both cVEMP and oVEMP tests included: Min number of runs per ear: 2 repeatable waveforms; Transducer: Insert phones; Stimulus: 500Hz tone burst (Blackman); Stimulus rate: 5.1/second; Stimulus level: 95dBnHL; High Pass Filter: 10Hz; Low Pass Filter: 1000Hz; # of sweeps: ~150 samples per waveform; EMG controlled stimulus (c VEMP only): 50.0uV RMS to 150uV RMS (subject to aim for 100uV).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Two internal clinical evaluations have been conducted to show the test-reliability and the reproducibility of the VEMP using the Eclipse with VEMP module.
Test subjects: 14 normal adults for cVEMP and oVEMP.
Study type: Test-retest reliability study & Reproducibility study.
Key results:
Correlation of the cVEMP waveform (5 – 35ms) for test-retest reliability: Mean 0.9374; Median 0.9562; IQR (75th – 25th percentile) 0.0547.
Correlation of the oVEMP waveform (4 – 20ms) for test-retest reliability: Mean 0.9095; Median 0.9280; IQR (75th – 25th percentile) 0.0738.
The mean and median values indicate a high degree of test-retest repeatability. The low IQR values indicate correlation coefficients clustered near the median.
Correlation of the cVEMP waveform (5 – 35ms) for reproducibility study: Mean 0.8794; Median 0.9235; IQR (75th – 25th percentile) 0.0955.
Correlation of the oVEMP waveform (4 – 20ms) for reproducibility study: Mean 0.8923; Median 0.9100; IQR (75th - 25th percentile) 0.1112.
The mean and median values indicate a high degree of reproducibility. While IQR values are higher than for test-retest, they are still relatively low. The increase in IQR is attributed to measurements being made on different days with slightly different electrode placements and by different testers.
The mean correlation values from both studies for the Eclipse with VEMP module are similar to or higher than those reported by the predicate device (GN Otometrics K143670).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation of cVEMP waveform (5 – 35ms) for test-retest reliability: Mean 0.9374, Median 0.9562, IQR 0.0547.
Correlation of oVEMP waveform (4 – 20ms) for test-retest reliability: Mean 0.9095, Median 0.9280, IQR 0.0738.
Correlation of cVEMP waveform (5 – 35ms) for reproducibility: Mean 0.8794, Median 0.9235, IQR 0.0955.
Correlation of oVEMP waveform (4 – 20ms) for reproducibility: Mean 0.8923, Median 0.9100, IQR 0.1112.
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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 23, 2017
Interacoustics A/S Mr. Erik Nielsen Director, Regulatory & Compliance Audiometer Allé 1 5500 Middelfart, Denmark
Re: K162037
Trade/Device Name: Eclipse with VEMP Regulation Number: 21 CFR 882.1900 Regulation Name: Evoked Response Auditory Stimulator Regulatory Class: Class II Product Code: GWJ Dated: February 08, 2017 Received: February 21, 2017
Dear Mr. Nielsen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Eric A. Mann -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K162037
Device Name Eclipse with VEMP
Indications for Use (Describe)
The Eclipse with VEMP (Vestibular Evoked Myogenic Potential) is intended for vestibular evoked myogenic potential testing to assist in the assessment of vestibular function. The target population for Eclipse with VEMP includes patients aged from 8 years and up.
The device is to be used only by qualified medical personnel with prior knowledge of the medical and scientific facts underlying the procedure.
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
Eclipse with VEMP
Submitter Information:
| Company Name | Interacoustics A/S |
|---|---|
| Address | Audiometer Allé |
| 5500 Middelfart | |
| Denmark | |
| Phone | +45 6371 3555 |
| erni@dgs.com | |
| Contact Person | Erik Nielsen, |
| Director, Regulatory & Compliance, | |
| Date Summary Prepared | July 18 2016 |
Device Identification:
| Trade Name | Eclipse with VEMP |
|---|---|
| Common Name | Auditory Evoked Response Stimulator |
| Classification Name | Stimulator, Auditory, Evoked Response |
| Product Code Class | GWJ |
| Panel | Neurology |
| Device Class | Class II (According to 21 CFR 882.1900) |
Predicate Device 1:
Predicate Device Manufacturer 510(k) No. Date Cleared
ICS CHARTR EP 200 WITH VEMP GN OTOMETRICS A/S7 K143670 10/23/2015
Predicate Device 2:
Predicate Device Manufacturer 510(k) No. Date Cleared
Eclipse with EP15, EP25 software modules Interacoustics A/S K090406 07/22/2009
4
Device Description
The Eclipse with VEMP is audiometric equipment intended to perform various Otoacoustic Emissions (OAEs) and Auditory Evoked Potential evaluations. The Eclipse is operated solely from PC based software modules. The Eclipse platform performs the physical measurements. The protocols are created in the software modules. The Eclipse consists of a hardware platform, a preamplifier, stimulation transducers and recording electrodes.
VEMP evaluations are tests of the vestibular portion of the inner ear and acoustic nerve, evoked with an auditory stimulation. The evoked response results in a potential recorded from the sternocleidomastoid (neck) muscles or the inferior oblique (eye) muscles. VEMP is not a test of the neck or eye musculature directly; the clinician is interested in the vestibular anatomy which triggers the response. The cervical Vestibular Evoked Myogenic Potential (cVEMP) is an evoked potential measured from the sternocleidomastiod (SCM) muscle and the ocular VEMP (oVEMP) is an evoked potential measured from the inferior oblique muscle. Both tests are used to assess the otolith organs (saccule and utricle) of the vestibular system and their afferent pathways and assist medical practitioners in the diagnosis of various balance disorders.
Summary: VEMP is Auditory Evoked Potentials like ABR obtained using any commercially available EP system. The addition of the VEMP module to Eclipse will make it possible for clinicians to conduct VEMP tests while using EMG (electromyography) monitoring and scaling. The VEMP function of the Eclipse with VEMP does not make a diagnosis. It only assists the medical professional.
Indications for Use
The Eclipse with VEMP (Vestibular Evoked Myogenic Potential) is intended for vestibular evoked myogenic potential testing to assist in the assessment of vestibular function. The target population for Eclipse with VEMP includes patients aged from 8 years and up.
Technological characteristics
The Eclipse with VEMP consists of a hardware platform, a preamplifier, stimulation transducers and recording electrodes. The Eclipse VEMP is solely operated from a PC with VEMP software
5
Product Comparisons charts summary
We have chosen to compare Eclipse with VEMP with the currently cleared Eclipse with EP15, EP25 and the currently cleared Chartr EP200 for the following reasons.
- Chartr EP200 has the same medical purpose as Eclipse with VEMP and is intended as the . primary predicate for VEMP functionality
- . Eclipse with EP15, EP25 supports identical hardware as Eclipse with VEMP and provide identical technical characteristics
| Description | Predicative K143670
Chartr EP 200 with VEMP | Modified K162037
Eclipse with VEMP | Equivalence |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for use | The ICS Chartr EP 200 with VEMP is
indicated for auditory evoked
potential testing as an aid in
assessing hearing loss and lesions in
the auditory pathway. The
Vestibular Evoked Myogenic
Potential is indicated for vestibular
evoked potential testing as an aid in
assessing vestibular function in
adult patients. The device is to be
used only by qualified medical
personnel with prior knowledge of
the medical and scientific facts
underlying the procedure. | The Eclipse with VEMP (Vestibular
Evoked Myogenic Potential) is
intended for vestibular evoked
myogenic potential testing to assist in
the assessment of vestibular function.
The target population for Eclipse with
VEMP includes patients aged from 8
years and up. | Same intended
use of assisting
in the
assessment of
vestibular
function, but
the Eclipse with
VEMP is
indicated for
children 8 years
and older and
substantial
equivalence
was established
using clinical
literature. |
| Tests
Performed | Auditory Brainstem Response (ABR)
Electrocochleography (ECochG)
Auditory Middle Latency Response
(AMLR)
Auditory Late Response (ALR)
P300 - optional
Auditory Steady State Response
(ASSR) — Optional
Vestibular Evoked Myogenic
Potential (VEMP) — optional | Auditory Brainstem Response (ABR)
Electrocochleography (ECochG)
Auditory Middle Latency Response
(AMLR)
Auditory Late Response (ALR)
P300/Mismatch Negativity (MMN)
Auditory Steady State Response (ASSR)
Vestibular Evoked Myogenic Potential
(VEMP) — optional | Same
The addition of
VEMP is the
subject of this
510(k |
| Anatomical
sites | Examination of Ear and hearing
nerves and vestibular functions | Examination of Ear, hearing nerves and
vestibular functions | Same |
| Environment
of use | Hospitals and clinics | Hospitals and clinics | Same |
| Evaluation of
results | Manually / subjective | Manually / subjective | Same |
| Description | Predicative K143670
Chartr EP 200 with VEMP | Modified K162037
Eclipse with VEMP | Equivalence |
| Photo | Image: Chartr EP 200 with VEMP | Image: Eclipse with VEMP | Similar
The physical
differences are
not appraised
to raise any
issues about
safety and
efficiency |
| System | Chartr EP 200 connected to a PC
(PC-based system with external
hardware platform and peripherals
(USB interface)) | Eclipse platform connected to PC (PC-
based system with external hardware
platform and peripherals (USB
interface)) | Similar
The physical
differences are
not appraised
to raise any
issues about
safety and
efficiency |
| VEMP
Monitor | Image: VEMP Monitor | A visual or acoustical VEMP monitor is
available. The visual VEMP monitor is
displayed on an external screen and
indicates below range (low), in range
for recording (good) and outside range
(high). | Similar.
Both methods
have three
ranges for
assessing the
EMG
monitoring. We
appraise the
difference in
presentation
does not raise
any issues
about safety
and efficiency |
| Electrode
montage | 2x on each SCM muscle one for
recording and one for EMG
monitoring on external device, 1 at
clavicle junction, 1 low forehead.
In total 6 electrodes | 1 on each SCM which is for both
recording and monitoring via the built
in software EMG monitor, 1 at clavicle
junction, 1 at low forehead.
In total 4 electrodes | Similar.
Both methods
measures at the
same anatomic
place. The
difference in
configurations
are not
appraised to
raise any issues
about safety
and efficiency |
| Description | Predicative K143670
Chartr EP 200 with VEMP | Modified K162037
Eclipse with VEMP | Equivalence |
| Preamplifier | 2 channels | 1 or 2 channels | Similar
(subset)
The differences
are appraised
not to raise any
issues about
safety and
efficiency |
6
7
| Description | Predictive K090406
Eclipse with EP15, EP25 | Modified K162037
Eclipse with VEMP | Equivalence |
|----------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Target
population | All ages and genders | From age 8 and up both genders. | Similar
(Subset)
The VEMP
functionality
has a more
narrow age
range |
| Stimulus | Click, Tone Burst, NB CE-Chirp, CE-
Chirp | Click, Tone Burst, NB CE-Chirp, CE-
Chirp | Same |
| Energy
Source | AC Power | AC Power | Same |
| Photo | Image: Predictive K090406 Eclipse with EP15, EP25 | Image: Modified K162037 Eclipse with VEMP | Same |
| System | Eclipse platform connected to PC (PC-
based system with external hardware
platform and peripherals (USB
interface)) | Eclipse platform connected to PC (PC-
based system with external hardware
platform and peripherals (USB
interface)) | Same |
8
Brief discussion of non-clinical tests
Bench verification and testing demonstrates compliance with system and software specifications. There are no changes to the hardware including electrical safety or EMC compared to the already cleared Eclipse platform (K090406). Software verification including risk analysis was performed to demonstrate compliance with the specifications
Brief discussion of clinical evaluations
VEMP, like ABR, is an evoked potential obtained using any commercially available EP system. The Eclipse with VEMP module has the ability to perform EMG monitoring during VEMP data collection. The VEMP module of the Eclipse does not make a diagnosis is made by a qualified medical professional. Testing the vestibular evoked myogenic potential (VEMP) is welldocumented in the literature.
Two internal clinical evaluations have been conducted to show the test-reliability and the reproducibility of the VEMP using the Eclipse with VEMP module
A summary of the studies follows:
Testing was conducted at two sites (one in Denmark and one in the United States). Test subjects included 14 normal adults for cVEMP and oVEMP.
| Min number of runs per ear | 2 repeatable waveforms |
|---|---|
| Transducer | Insert phones |
| Stimulus | 500Hz tone burst (Blackman) |
| Stimulus rate | 5.1/second |
| Stimulus level | 95dBnHL |
| High Pass Filter | 10Hz |
| Low Pass Filter | 1000Hz |
| # of sweeps | ~150 samples per waveform |
| EMG controlled stimulus (c VEMP only) | 50.0uV RMS to 150uV RMS (subject to aim for 100uV) |
Collection parameters for both the cVEMP and oVEMP tests:
The correlation results for the test-retest reliability study were as follows:
Correlation of the cVEMP waveform (5 – 35ms)
| Mean | 0.9374 |
|---|---|
| Median | 0.9562 |
| IQR (75th – 25th percentile) | 0.0547 |
Correlation of the oVEMP waveform (4 – 20ms)
| Mean | 0.9095 |
|---|---|
| Median | 0.9280 |
| IQR (75th – 25th percentile) | 0.0738 |
9
Mean and median values indicate a high degree of test-retest repeatability of the cVEMP and oVEMP measurements. The IQR (75th – 25th percentile) values are low, indicating a large number of the correlation coefficients are clustered near the median. In practical terms, the spread in correlation coefficients is not so large indicating, alongside the high median value, that test-retest measurements are typically highly correlated with each other for both the cVEMP and oVEMP measurements.
The correlation results for the reproducibility study were as follows:
| Mean | 0.8794 |
|---|---|
| Median | 0.9235 |
| IQR (75th – 25th percentile) | 0.0955 |
Correlation of the cVEMP waveform (5 – 35ms)
Correlation of the oVEMP waveform (4 – 20ms)
| Mean | 0.8923 |
|---|---|
| Median | 0.9100 |
| IQR (75th - 25th percentile) | 0.1112 |
Mean and median values indicate a high degree of reproducibility for the cVEMP and oVEMP measurements recorded on different days. The IQR (75th – 25th percentile) values are higher than for the test-retest cVEMP and oVEMP measurements. They are still relatively low, indicating a large number of the correlation coefficients are clustered near the median. The reason for the increase in IQR is probably to be expected, as each of the cVEMP and oVEMP measurements were made on different days with slightly different electrode placements, by different testers.
In the GN Otometrics K143670 (510(k)) document, mean correlation values for both cVEMPs and oVEMPs are reported for a reproducibility study (see table below). The mean correlation values recorded with the Eclipse with VEMP module for both the test-retest reliability study and the reproducibility study are similar to or higher than those reported by GN Otometrics in their 510(k).
| Correlation values reported in K143670 (510(K)) | ||
|---|---|---|
| cVEMP (5 - 35ms) | oVEMP (4 - 20 ms) | |
| Mean | 0.9146 (R) / 0.9162 (L) | 0.926 (R) / 0.93 (L) |
Conclusion
We appraise that the results of this comparison, the clinical evaluations and literature review, demonstrates that the Eclipse with VEMP (the modified indications for use) is safe and efficient and is substantially equivalent to the marketed predictive devices.