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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Interacoustics A/S Eclipse with VEMP, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in terms of predefined numerical thresholds for performance metrics. Instead, it presents the results of internal clinical evaluations (test-retest reliability and reproducibility studies) and compares them to similar reported values in a predicate device. The implicit acceptance criterion is that the device demonstrates comparable or better reliability and reproducibility than the predicate device.

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance (Eclipse with VEMP)	Predicate Device (K143670) Performance (for comparison)
cVEMP Test-Retest Reliability:	High correlation between repeated measurements	Mean: 0.9374Median: 0.9562IQR: 0.0547	N/A (No direct predicate comparison for test-retest in this doc)
oVEMP Test-Retest Reliability:	High correlation between repeated measurements	Mean: 0.9095Median: 0.9280IQR: 0.0738	N/A (No direct predicate comparison for test-retest in this doc)
cVEMP Reproducibility (Different Days, Testers, Electrode Placements):	High correlation between measurements on different days	Mean: 0.8794Median: 0.9235IQR: 0.0955	Mean: 0.9146 (R) / 0.9162 (L)
oVEMP Reproducibility (Different Days, Testers, Electrode Placements):	High correlation between measurements on different days	Mean: 0.8923Median: 0.9100IQR: 0.1112	Mean: 0.926 (R) / 0.93 (L)

Conclusion from document: The mean and median values for both test-retest reliability and reproducibility are high, indicating good performance. For reproducibility, the Eclipse with VEMP's mean correlation values are "similar to or higher than" those reported by the predicate device (GN Otometrics K143670).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: 14 normal adults (for both cVEMP and oVEMP).
Data Provenance: The studies were conducted at two internal sites: one in Denmark and one in the United States. They appear to be prospective internal evaluations specifically for this device and its VEMP module.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of diagnostic accuracy. The studies evaluated the reliability and reproducibility of the device's measurements, not its diagnostic accuracy against a separate, definitive truth. The VEMP module "does not make a diagnosis" but "only assists the medical professional." Therefore, there isn't a stated ground truth established by experts for these specific studies.

4. Adjudication Method for the Test Set

Not applicable. As noted above, these studies focused on the intrinsic reliability and reproducibility of the device's waveform measurements, not diagnostic outcomes requiring expert adjudication. The analysis involved correlation of waveforms.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study involving human readers with/without AI assistance was not mentioned or performed in the provided document. The device itself is an "Evoked Response Auditory Stimulator," a diagnostic tool that assists medical professionals, rather than an AI-powered diagnostic system that interprets images or data.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The studies performed evaluate the device's ability to consistently acquire and output VEMP waveforms. The device itself is a data acquisition system. While it has software for processing signals (e.g., filtering, averaging), the "performance" described is the consistency of the recorded physiological responses, not an algorithm's standalone diagnostic interpretation. The document explicitly states the VEMP module "does not make a diagnosis."

7. The Type of Ground Truth Used

There is no traditional "ground truth" (like pathology or clinical outcomes) used in these studies. The studies aimed to establish the test-retest reliability (consistency of measurements taken repeatedly within a short timeframe) and reproducibility (consistency of measurements taken on different occasions, potentially by different operators with slightly different setups) of the VEMP waveforms produced by the device. The comparison point is the device's own prior measurement or the measurement from a different session.

8. The Sample Size for the Training Set

The document describes internal clinical evaluations, not the training of a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for an AI/ML algorithm mentioned in the document.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K162037

Device Name Eclipse with VEMP

Indications for Use (Describe)

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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510(K) SUMMARY

Eclipse with VEMP

Submitter Information:

Company Name	Interacoustics A/S
Address	Audiometer Allé
	5500 Middelfart
	Denmark
Phone	+45 6371 3555
e-mail	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

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Device Description

Indications for Use

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

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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 K143670Chartr EP 200 with VEMP	Modified K162037Eclipse with VEMP	Equivalence
Indicationsfor use	The ICS Chartr EP 200 with VEMP isindicated for auditory evokedpotential testing as an aid inassessing hearing loss and lesions inthe auditory pathway. TheVestibular Evoked MyogenicPotential is indicated for vestibularevoked potential testing as an aid inassessing vestibular function inadult patients. The device is to beused only by qualified medicalpersonnel with prior knowledge ofthe medical and scientific factsunderlying the procedure.	The Eclipse with VEMP (VestibularEvoked Myogenic Potential) isintended for vestibular evokedmyogenic potential testing to assist inthe assessment of vestibular function.The target population for Eclipse withVEMP includes patients aged from 8years and up.	Same intendeduse of assistingin theassessment ofvestibularfunction, butthe Eclipse withVEMP isindicated forchildren 8 yearsand older andsubstantialequivalencewas establishedusing clinicalliterature.
TestsPerformed	Auditory Brainstem Response (ABR)Electrocochleography (ECochG)Auditory Middle Latency Response(AMLR)Auditory Late Response (ALR)P300 - optionalAuditory Steady State Response(ASSR) — OptionalVestibular Evoked MyogenicPotential (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	SameThe addition ofVEMP is thesubject of this510(k
Anatomicalsites	Examination of Ear and hearingnerves and vestibular functions	Examination of Ear, hearing nerves andvestibular functions	Same
Environmentof use	Hospitals and clinics	Hospitals and clinics	Same
Evaluation ofresults	Manually / subjective	Manually / subjective	Same
Description	Predicative K143670Chartr EP 200 with VEMP	Modified K162037Eclipse with VEMP	Equivalence
Photo	Image: Chartr EP 200 with VEMP	Image: Eclipse with VEMP	SimilarThe physicaldifferences arenot appraisedto raise anyissues aboutsafety andefficiency
System	Chartr EP 200 connected to a PC(PC-based system with externalhardware platform and peripherals(USB interface))	Eclipse platform connected to PC (PC-based system with external hardwareplatform and peripherals (USBinterface))	SimilarThe physicaldifferences arenot appraisedto raise anyissues aboutsafety andefficiency
VEMPMonitor	Image: VEMP Monitor	A visual or acoustical VEMP monitor isavailable. The visual VEMP monitor isdisplayed on an external screen andindicates below range (low), in rangefor recording (good) and outside range(high).	Similar.Both methodshave threeranges forassessing theEMGmonitoring. Weappraise thedifference inpresentationdoes not raiseany issuesabout safetyand efficiency
Electrodemontage	2x on each SCM muscle one forrecording and one for EMGmonitoring on external device, 1 atclavicle junction, 1 low forehead.In total 6 electrodes	1 on each SCM which is for bothrecording and monitoring via the builtin software EMG monitor, 1 at claviclejunction, 1 at low forehead.In total 4 electrodes	Similar.Both methodsmeasures at thesame anatomicplace. Thedifference inconfigurationsare notappraised toraise any issuesabout safetyand efficiency
Description	Predicative K143670Chartr EP 200 with VEMP	Modified K162037Eclipse with VEMP	Equivalence
Preamplifier	2 channels	1 or 2 channels	Similar(subset)The differencesare appraisednot to raise anyissues aboutsafety andefficiency

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Description	Predictive K090406Eclipse with EP15, EP25	Modified K162037Eclipse with VEMP	Equivalence
Targetpopulation	All ages and genders	From age 8 and up both genders.	Similar(Subset)The VEMPfunctionalityhas a morenarrow agerange
Stimulus	Click, Tone Burst, NB CE-Chirp, CE-Chirp	Click, Tone Burst, NB CE-Chirp, CE-Chirp	Same
EnergySource	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 hardwareplatform and peripherals (USBinterface))	Eclipse platform connected to PC (PC-based system with external hardwareplatform and peripherals (USBinterface))	Same

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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

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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.

Regulation Number and Section

§ 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).