(85 days)
No
The summary describes standard signal processing techniques (filtering, averaging, normalization) and biofeedback, but does not mention AI or ML.
No.
The device is intended to assist in the assessment and diagnosis of vestibular function and disorders, not for treatment.
Yes
The "Intended Use / Indications for Use" states that the device provides "testing that is intended to assist in the assessment of vestibular function." The "Device Description" section elaborates that VEMP "is a non-invasive test that is used for diagnosis of vestibular disorders" and lists specific conditions it can diagnose ("superior canal dehiscence, Menier's disease, vestibular neuritis, and, among others"). It also explicitly mentions that "The primary diagnostic component of a VEMP measurement is the comparison of the amplitude of the primary peak of the VEMP response between right and left sides, defined as an asymmetry ratio, where a significant amount of asymmetry is indicative of a vestibular disorder." These statements clearly indicate its use in diagnosing medical conditions.
No
The device description explicitly states that the device is a "PC based device which uses the same hardware and similar software" as the predicate device, and lists specific hardware components (VivoLink, transducers, CV-Amp, computer).
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Integrity with VEMP is a device that measures physiological responses (muscle activity evoked by auditory/vibratory stimulation) directly from the patient's body. It does not analyze samples taken from the body.
- Intended Use: The intended use is to assist in the assessment of vestibular function by measuring evoked potentials, not by analyzing biological samples.
- Device Description: The description details the hardware and software used to stimulate the patient and record electrical signals from electrodes placed on the skin. This is a direct physiological measurement, not an in vitro test.
Therefore, the Integrity with VEMP falls under the category of a medical device that performs physiological measurements, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Integrity with VEMP provides testing that is intended to assist in the assessment of vestibular function. The target patient population ranges from school age children to geriatric adults who can complete the testing tasks. The Integrity with VEMP is intended to be used by a variety of professionals, such as clinical practitioners specialized in balance disorders, Audiologists, and Otolaryngologists (ENT doctors) with prior knowledge of the medical and scientific knowledge about the VEMP procedure.
Product codes
GWJ
Device Description
VEMP (Vestibular Evoked Myogenic Potential) is a short latency response generated either from sternocleidomastoid muscle (cVEMP) or oblique muscle (oVEMP) which is typically evoked by high level acoustic or vibratory stimulation. VEMP is a non-invasive test that is used for diagnosis of vestibular disorders such as superior canal dehiscence, Menier's disease, vestibular neuritis, and, among others. VEMP test can be done in clinics (ENT/audiology) and hospitals provided that the users have adequate knowledge and background about underlying process of VEMP and recording auditory evoked responses.
The Integrity V500 is indicated for auditory evoked potential testing. "Integrity with VEMP" (this submission) is the addition of the VEMP test modality to the Integrity V500. The Integrity V500 is an auditory evoked auditory system response and Integrity with VEMP is an auditory evoked vestibular system response. Since the vestibular system is connected to the auditory system, a loud stimulus to the auditory system also simultaneously stimulates the vestibular system. However, the evoked signals are measured at different electrode sites. It is important to note that the methods of stimulation and data acquisition are the same for the VEMP modality as for the ABR modality (one of the Integrity V500's auditory evoked testing modalities), with differences being in electrode montage and patient's physical state. As such, it is possible to also get a VEMP response while testing in the Integrity V500's ABR modality.
Integrity with VEMP is a PC based device which uses the same hardware and similar software for evoking the stimulus, collecting the response, processing the data, and displaying the outcome on the screen as does the Integrity V500. The hardware used are: a VivoLink (patient interface device), air and bone conduction transducers (to stimulate the vestibular system), CV-Amp (bio-amplifier), and a computer. The response from the muscle is picked up by a bio-amplifier attached to the neck (for cVEMP) or under eyes (for oVEMP) and forehead with electrodes. The data is the VivoLink for pre-processing and then transferred to the PC via Bluetooth connection for full processing using the algorithm designed for VEMP processing. Through the test, the processed sweeps are filtered using the filter setting defined by the user and the averaged response is shown on the screen.
The primary diagnostic component of a VEMP measurement is the comparison of the amplitude of the primary peak of the VEMP response between right and left sides, defined as an asymmetry ratio, where a significant amount of asymmetry is indicative of a vestibular disorder. The amplitude of the vestibular response peaks is also dependent on the contraction level of the muscles involved in the recording. To minimize the muscular response biasing the result, it is important to have equal contraction levels for both sides; this is especially physically challenging to generate equivalent neck contractions needed for cVEMP. To overcome this issue, two key features were added to the Integrity with VEMP compared to Integrity V500: a biofeedback EMG monitor (which displays real-time muscular activity) and VEMP response normalization (scaling based on muscular contraction levels). The EMG monitors can be used as a guidance to the clinicians and patients for the level of muscle contraction. Normalization automatically scales the recorded sweeps based on the energy of the corresponding EMG which helps to compensate for imbalance contraction from the two sides.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Neck (for cVEMP), Under eyes and forehead (for oVEMP)
Indicated Patient Age Range
school age children to geriatric adults
Intended User / Care Setting
Clinical practitioners specialized in balance disorders, Audiologists, and Otolaryngologists (ENT doctors) with prior knowledge of the medical and scientific knowledge about the VEMP procedure.
Care settings: Clinics (ENT/audiology), Hospitals.
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
Study 1:
- Sample Size: 13 normal adult participants for cVEMP and 9 adult participants for oVEMP.
- Data Source: Not explicitly stated, implied to be directly from the participants using the Integrity VEMP and Interacoustics Eclipse devices.
- Annotation Protocol: Latencies (P1, N1) and amplitudes (P1-N1) were analyzed for both cVEMP and oVEMP. Reliability was analyzed using intraclass correlation (ICC) coefficient analysis.
Study 2:
- US site: 33 normal hearing adults for cVEMP tests (30 male, 3 female) and 17 normal hearing adults for oVEMP test (2 male, 15 female) with air conduction transducer (AC).
- Canada Site: 9 school-age normal hearing children for cVEMP subjects with bone conduction transducer (BC) and 8 pre-school age normal hearing children for cVEMP subjects with air conduction transducer (AC).
- Data Source: Data collected at two sites (one in Canada and one in the United States).
- Annotation Protocol: Not explicitly stated beyond collecting data to assess test-retest reliability and reproducibility based on waveform correlations. Mean, median, and IQR values of the tested populations correlation between VEMP waveforms were analyzed for test-retest reliability (in one session) and reproducibility (in two sessions separated by 24 to 72 hours).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study 1:
- Study Type: Clinical comparison study to prove substantial equivalency between Integrity with VEMP and its predicate device (Interacoustics Eclipse K162037).
- Sample Size: 13 normal adult participants for cVEMP and 9 adult participants for oVEMP.
- Key Results:
- cVEMP latencies (P1, N1) for Integrity VEMP (P1: 15.6 ± 1.3 ms Right, 15.8 ± 1.4 ms Left; N1: 23.5 ± 1.6 ms Right, 23.9 ± 1.5 ms Left) and Interacoustics Eclipse (P1: 14.7 ± 1.2 ms Right, 15.1 ± 1.5 ms Left; N1: 23.6 ± 1.4 ms Right, 23.7 ± 1.8 ms Left) were consistent with literature norms (11 to 17 ms for P1, 18 to 27ms for N1).
- cVEMP amplitude (P1-N1) for Integrity VEMP (209.6 ± 105.3 microV Right, 198.7 ± 106 microV Left) and Interacoustics Eclipse (195.5 ± 54.4 microV Right, 168.8 ± 48.8 microV Left) were consistent with literature norms (28 to 300 microV).
- ICC for cVEMP P1 was 0.72 (Right) and 0.91 (Left); for N1 was 0.95 (Right) and 0.80 (Left); for P1-N1 was 0.67 (Right) and 0.71 (Left).
- oVEMP latencies (N1, P1) for Integrity VEMP (N1: 11.2 ± 0.8 ms Right, 11.4 ± 0.9 ms Left; P1: 15.9 ± 1.7 ms Right, 16.3 ± 1.6 ms Left) and Interacoustics VEMP (N1: 10.2 ±1.1 ms Right, 10.4 ±1.1 ms Left; P1: 15.2 ± 1.7 ms Right, 15.2 ±1.6 ms Left) were consistent with literature norms (9 to 19 ms for N1, 12 to 22 ms for P1).
- oVEMP amplitude (N1-P1) for Integrity VEMP (17.4 ± 8.5 microV Right, 17.3 ± 8.3 microV Left) and Interacoustics VEMP (16.7 ± 10.6 microV Right, 14.1 ± 6.6 microV Left) were consistent with literature norms (2 to 45 microV).
- ICC for oVEMP N1 was 0.63 (Right) and 0.78 (Left); for P1 was 0.89 (Right) and 0.76 (Left); for N1-P1 was 0.90 (Right) and 0.91 (Left).
- Conclusion: Both systems' results are consistent with literature and statistical analysis shows good to excellent reliability, meeting substantial equivalency criteria.
Study 2:
- Study Type: Clinical study to prove reliability and reproducibility of the Integrity with VEMP according to industry-accepted standards.
- Sample Size: US site: 33 normal hearing adults for cVEMP tests (air conduction) and 17 normal hearing adults for oVEMP test (air conduction). Canada Site: 9 school-age normal hearing children for cVEMP (bone conduction) and 8 pre-school age normal hearing children for cVEMP (air conduction).
- Key Results:
- Test-Retest Reliability (correlation of waveforms in one session):
- cVEMP (Air Conduction): Mean (mu) = 0.92, Median = 0.94, IQR = 0.07.
- oVEMP (Air Conduction): Mean (mu) = 0.89, Median = 0.89, IQR = 0.08.
- cVEMP (Bone Conduction): Mean (mu) = 0.92, Median = 0.92, IQR = 0.12.
- All mean values were >= 0.879. Air conduction IQR values were = 0.879 and air conduction IQR values were
- Test-Retest Reliability (correlation of waveforms in one session):
§ 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).
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December 19, 2024
Vivosonic Inc Trevor Rocheleau Regulatory and Quality Assurance Manager 222-5535 Eglinton Avenue West Toronto, ON M9C 5K5 Canada
Re: K242954
Trade/Device Name: Integrity V500 ("Integrity", "Integrity with VEMP") Regulation Number: 21 CFR 882.1900 Regulation Name: Evoked Response Auditory Stimulator Regulatory Class: Class II Product Code: GWJ Dated: September 25, 2024 Received: September 25, 2024
Dear Trevor Rocheleau:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
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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,
Shuchen Peng -S
Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K242954
Device Name Integrity V500 ("Integrity", "Integrity with VEMP")
Indications for Use (Describe)
The Integrity with VEMP provides testing that is intended to assist in the assessment of vestibular function. The target patient population ranges from school age children to geriatric adults who can complete the testing tasks. The Integrity with VEMP is intended to be used by a variety of professionals, such as clinical practitioners specialized in balance disorders, Audiologists, and Otolaryngologists (ENT doctors) with prior knowledge of the medical and scientific knowledge about the VEMP procedure.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| X Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY K242954
1. SUBMISSION INFORMATION
| Date of preparation: | September 24, 2024 |
|---|---|
| Submitter Information: | Vivosonic Inc |
| 222-5535 Eglinton Avenue West | |
| Toronto, ON, M9C 5K5 | |
| Canada | |
| Telephone: +1 (416) 231-9997 | |
| Fax: +1 (416) 231-2289 | |
| Contact Person: | Mr. Trevor Rocheleau |
| Regulatory and Quality Assurance Manager | |
| Telephone: +1 (416) 231-9997 ext 227 | |
| Email: trevor.rocheleau@vivosonic.com |
2. DEVICE INFORMATION
| Device Name: | Integrity V500 |
|---|---|
| Device Trade Name: | Auditory Evoked Response Stimulator |
| Device Identification | |
| Codes: | V500 |
| Classification Name: | Stimulator, Auditory, Evoked Response |
| Device Class | Class II (According to 21 CFR 882.1900 |
| Product Code Class | GWJ |
3. PREDICATE DEVICE
| Predicate Device: | Eclipse with VEMP |
|---|---|
| Manufacturer: | Interacoustics |
| 510(k) No. | K162037 |
| Date Cleared | March 23, 2017 |
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4. REFERENCE DEVICE
| Predicate Device: | Integrity, Model V500 |
|---|---|
| Manufacturer: | Vivosonic Incorporate |
| 510(k) No. | K043396 |
| Date Cleared | January 24, 2005 |
5. DEVICE DESCRIPTION
VEMP (Vestibular Evoked Myogenic Potential) is a short latency response generated either from sternocleidomastoid muscle (cVEMP) or oblique muscle (oVEMP) which is typically evoked by high level acoustic or vibratory stimulation. VEMP is a non-invasive test that is used for diagnosis of vestibular disorders such as superior canal dehiscence, Menier's disease, vestibular neuritis, and, among others. VEMP test can be done in clinics (ENT/audiology) and hospitals provided that the users have adequate knowledge and background about underlying process of VEMP and recording auditory evoked responses.
The Integrity V500 is indicated for auditory evoked potential testing. "Integrity with VEMP" (this submission) is the addition of the VEMP test modality to the Integrity V500. The Integrity V500 is an auditory evoked auditory system response and Integrity with VEMP is an auditory evoked vestibular system response. Since the vestibular system is connected to the auditory system, a loud stimulus to the auditory system also simultaneously stimulates the vestibular system. However, the evoked signals are measured at different electrode sites. It is important to note that the methods of stimulation and data acquisition are the same for the VEMP modality as for the ABR modality (one of the Integrity V500's auditory evoked testing modalities), with differences being in electrode montage and patient's physical state. As such, it is possible to also get a VEMP response while testing in the Integrity V500's ABR modality.
Integrity with VEMP is a PC based device which uses the same hardware and similar software for evoking the stimulus, collecting the response, processing the data, and displaying the outcome on the screen as does the Integrity V500. The hardware used are: a VivoLink (patient interface device), air and bone conduction transducers (to stimulate the vestibular system), CV-Amp (bio-amplifier), and a computer. The response from the muscle is picked up by a bio-amplifier attached to the neck (for cVEMP) or under eyes (for oVEMP) and forehead with electrodes. The data is the VivoLink for pre-processing and then transferred to the PC via Bluetooth connection for full processing using the algorithm designed for VEMP processing. Through the test, the processed sweeps are filtered using the filter setting defined by the user and the averaged response is shown on the screen.
The primary diagnostic component of a VEMP measurement is the comparison of the amplitude of the primary peak of the VEMP response between right and left sides, defined as an asymmetry ratio, where a significant amount of asymmetry is indicative of a vestibular disorder. The amplitude of the vestibular response peaks is also dependent on the contraction level of the muscles involved in the recording. To minimize the muscular response biasing the result, it is important to have equal contraction levels for both sides; this is especially physically challenging to generate equivalent neck contractions needed for
6
cVEMP. To overcome this issue, two key features were added to the Integrity with VEMP compared to Integrity V500: a biofeedback EMG monitor (which displays real-time muscular activity) and VEMP response normalization (scaling based on muscular contraction levels). The EMG monitors can be used as a guidance to the clinicians and patients for the level of muscle contraction. Normalization automatically scales the recorded sweeps based on the energy of the corresponding EMG which helps to compensate for imbalance contraction from the two sides.
6. INDICATIONS OF USE
The Integrity with VEMP provides testing that is intended to assist in the assessment of vestibular function. The target patient population ranges from school age children to geriatric adults who can complete the testing tasks. The Integrity with VEMP is intended to be used by a variety of professionals, such as clinical practitioners specialized in balance disorders, and Otolaryngologists (ENT doctors) with prior knowledge of the medical and scientific knowledge about the VEMP procedure.
7. TECHNOLOGICAL CHARACTERISTICS
The Integrity with VEMP consists of a battery-operated patient-interface device (Vivolink), Bio-amplifier, transducer, electrodes, and PC (laptop). Stimulus and data collection is done via Vivolink, while processing of the data is done through the VEMP software on the PC.
8. SAFETY AND EFFECTIVENESS-COMPARISON TO PREDICATE DEVICE AND REFERENCE DEVICE
Predicate Device
The Integrity V500 with VEMP and Interacoustics' Eclipse with VEMP (K162037) have the same intended use and similar technical characteristics in terms of stimulators and electrodes (i.e. patient contact). However, the Eclipse with VEMP is powered by mains whereas the Integrity is battery powered. They both have the biofeedback and waveform normalization.
Reference Device
The reference device is the previous iteration of Integrity V500 (K043396).
The Integrity V500 and the Integrity V500 with VEMP use the same physical hardware. As such, they have the same technical characteristics in terms of design, material, chemical composition, and energy source. The only difference is software functionalities, such as biofeedback (which can be done on an external monitor) and waveform normalization, based on muscle contraction, all of which are designed to streamline the VEMP testing itself.
9. PRODUCT COMPARISONS CHARTS SUMMARY
The primary comparison device used for this submission is Eclipse with VEMP (K162037) as the VEMP modality has the same indications for use as the Integrity with VEMP.
The reference device is the previous iteration of Integrity V500 (K043396). Integrity V500 is not indicated for vestibular testing. However, it is an AEP system that uses the same stimuli and data collection, just different electrode montage and patient position. Since it uses the same hardware as the Integrity V500 with VEMP, it is an appropriate device to support the technical characteristics and validation of the Integrity with VEMP.
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| Description | Integrity V500 with VEMP (K24954) | Predicate Device Eclipse with VEMP
(K162037) | Reference Device
Integrity V500
(K043396) | Equivalence |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Purpose | | | | |
| Indication for
use | The Integrity with VEMP provides
testing that is intended to assist in
the assessment of vestibular
function. The target patient
population ranges from school age
children to geriatric adults who can
complete the testing tasks. The
Integrity with VEMP is intended to
be used by a variety of
professionals, such as clinical
practitioners specialized in balance
disorders, Audiologists, and
Otolaryngologists (ENT doctors) with
prior knowledge of the medical and
scientific knowledge about the
VEMP procedure. | The Eclipse with VEMP 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. | Integrity V500 is
indicated to measure or
determine cochlear
function testing or
auditory evoked
potential testing as an
aid in detecting hearing
loss and lesions in
auditory pathway. | Similar
Clinical
performance
testing included
school aged
children. |
| Physiological Features | | | | |
| Bio Signal | Evoked Potential | Evoked Potential | Evoked Potential | Same |
| Electrode
Montage | cVEMP: non-inverting electrodes on
head, inverting electrodes on
sternocleidomastoid (left and right)
oVEMP: non-inverting electrodes on
head, inverting electrodes under the
2 eyes. | In total 4 electrodes:
1 in each SCM which is for both
recording and monitoring via the built-
in software EMG monitor, 1 at the
clavicle junction, 1 at lower forehead. | For Auditory evoked
potential, non-inverting
electrodes on head and
inverting electrodes on
mastoid/earlobe | The
configuration of
the electrodes
is subjective.
The differences
between the
two systems do
not raise any
safety or
effectiveness
issues. |
| Stimulation
Target | Vestibular System | Vestibular System | Auditory Pathway | Same |
| Hardware | | | | |
| Configuration
(Hardware) | Integrity V500 is a PC based system
with external hardware (Vivolink)
and accessories (amplifier,
transducers, electrodes). Plus, an
additional external monitor for
biofeedback. | Eclipse platform connected to PC (PC-
Based system with external hardware
platform and peripherals (USB
interface)). | Integrity V500 is a PC
based system with
external hardware
(Vivolink) and
accessories (amplifier,
transducers, electrodes) | There are
physical
differences
between eclipse
and Integrity.
But the
functionality is
the same.
Clinical
performance
testing
showed
similar
outcomes for
the eclipse
and integrity
devices. |
| Pre-Amplifier | 2 channels | 2 channels | 2 channels | Same |
| Photo | | | | Same
functionality |
| Biofeedback
Monitor | The visual monitor is used. Below
the range is shown in blue, within
the range in green, and above the
range in red.
Image: Biofeedback Monitor | A visual or acoustic VEMP monitor.
The visual VEMP monitor is displayed
on an external screen and indicates
below range (low), in range for
recording (good) and outside range
(high).
Image: Biofeedback Monitor | N/A | Similar
functionality
shows the
ranges in colors
between eclipse
and Vivosonic.
The minor
differences
don't have any
impact on
safety and
effectiveness. |
| Compatible
Transducers | Air Conduction (AC)
Bone Conduction (BC) | Air Conduction (AC)
Bone Conduction (BC) | Air Conduction (AC)
Bone Conduction (BC) | Same |
| Power | AC line for the PC.
Battery for the Vivolink | AC power | AC line for the PC.
Battery for the Vivolink | Same |
| Implementation Details | | | | |
| Environment
of Use | Clinics (Audiology/ENT)
Hospitals | Hospital/Clinics | Clinics (Audiology/ENT)
Hospitals | Same |
| Target
Population | School Age Children/Adult | From age 8 and up and adults. | Infant/Adult | Similar for
eclipse and
Vivosonic VEMP
Clinical
performance
testing included
school aged
children. |
| Tests
Performed | Vestibular Evoked Myogenic
Potential (VEMP) only in this module | 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) | Auditory Brainstem
Response (ABR)
Electrocochleography
(ECochg)
Cortical Middle
Latency/Late Latency
Response (MLR/LLR)
Auditory Steady State
Response (ASSR) | VEMP tests are
same between
eclipse and
Vivosonic |
| Polarity
(Stimulus) | Rarefaction, Condensation,
Alternating, Alternating-Split | Rarefaction, Condensation,
Alternating | Rarefaction,
Condensation,
Alternating, Alternating-
Split | Same |
| Stimulus Types | Click, Tone Burst | Click, Tone burst, Narrow Band Chirp,
Wide Band Chirp | Click, Chirp, Tone Burst | Same |
| Evaluation of
results | Manually / Subjective | Manually / Subjective | Manually / Subjective | Same |
| EMG Scaling | Yes | N/A | Yes | Same |
| Automatic
asymmetry
calculation | Yes | Yes | Yes (Interaural
differences table) | Same |
| Results
Interpretation | The device presents the results to
the ENT specialists or Audiologist.
No diagnosis is done by the device. | The device presents the results to the
ENT specialists or Audiologist. No
diagnosis is done by the device. | N/A | Same |
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It must be noted that there are some hardware differences between predicate device and the Vivosonic Integrity V500 with VEMP device. However, these differences do not affect safety and effectiveness.
With the Vivosonic system, the stimulation and the response detection (via electrodes) are handled by the batient interface module (Vivolink). The Vivolink communicates wirelessly (Bluetoth) with the clinicial (CV-Amp) is optimized for VEMP testing, including a fixed hardware gain and filtering.
With the predicate device, the stimulation and the response detection (via electrodes) are connected directly to the device's primary module. This module is directly powered by the mains and directly wired to the clinician's PC. Its bio-amplifier is general for all evoled response testing.
Although the software has the same functionality, the GUI for the Integrity's VEMP module is based on the Integrity's previous ABR module, whereas the predicate device is based on its own previous ABR module.
Performance testing was conducted to evaluate differences in hardware and the results support substantial equivalence between the two systems.
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10. SUMMARY OF NON-CLINICAL TESTING
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 reference device, the Integrity V500 (K043396). As such, there is no need for hardware bench testing. Software validation and risk analysis was performed to confirm the proper functions of the VEMP protocol. Risk management indicated that there are no critical tasks; as such a human factors study was not necessary to be performed.
11. SUMMARY OF CLINICAL TESTING
VEMP is a well-documented test for evaluating the vestibular functions. Integrity with VEMP includes biofeedback EMG monitor and VEMP response normalization feature which facilitate the control of the muscle contraction and compensate for imbalance contraction from the two sides. The objective of the clinical studies was to prove (a) the substantial equivalency between it and its predicate device (Interacoustics Eclipse (K162037)) and (b) shows its test-reliability and reproducibility.
Study 1 was conducted to prove substantial equivalency between Integrity with VEMP and FDA cleared device Interacoustics Eclipse (K162037) which is currently in the market. Study 2 was conducted to prove the reliability and reproducibility of the new Integrity with VEMP and to compare the data with industryaccepted standards.
Study 1
The parameters of the conducted tests were as follows
- 13 normal adult participants for cVEMP and 9 adult participants
- . Integrity VEMP and Interacoustics Eclipse was used to record and analyze cVEMP and oVEMP responses.
| Parameters | Values |
|---|---|
| Stimulus Level | 105 dB nHL |
| Stim rate | 4.7/sec |
| Filter (HP cutoff) | 10 Hz |
| Filter (LP cutoff) | 300 Hz |
| Type of window | Blackman (4 cycle) |
| Stimulus | TB 500 Hz |
| Polarity | Rarefaction |
| Transducer | Air Conduction |
| Number of stimuli | 0-200 |
| EMG Controlled Pre-Stim | 50 (minimum)-150 µV (maximum) rms |
| cVEMP only - Integrity with VEMP | |
| Biofeedback | Verbal instructions from the clinician |
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The latencies and amplitudes were analyzed for both the cVEMP and compared with literature norms. Reliability was analyzed using intraclass correlation (ICC) coefficient analysis.
| cVEMP | Integrity VEMP
$\mu \pm \sigma$ | | Interacoustics
$\mu \pm \sigma$ | | Norms from
Literature | ICC | |
|------------|------------------------------------|-------------|------------------------------------|--------------|--------------------------|-------|------|
| | Right | Left | Right | Left | (range) | Right | Left |
| P1 [ms] | 15.6 ± 1.3 | 15.8 ± 1.4 | 14.7 ± 1.2 | 15.1 ± 1.5 | 11 to 17 ms | 0.72 | 0.91 |
| N1 [ms] | 23.5 ± 1.6 | 23.9 ± 1.5 | 23.6 ± 1.4 | 23.7 ± 1.8 | 18 to 27ms | 0.95 | 0.80 |
| P1-N1 [μV] | 209.6 ± 105.3 | 198.7 ± 106 | 195.5 ± 54.4 | 168.8 ± 48.8 | 28 to 300 (μV) | 0.67 | 0.71 |
Comparing the performance of the cVEMP data recorded by Integrity with VEMP and Eclipse (Predicate device).
Comparing the performance of the oVEMP data recorded by Integrity with VEMP and Eclipse (Predicate device).
| oVEMP | Integrity VEMP
$\mu \pm \sigma$ | | Interacoustics VEMP
$\mu \pm \sigma$ | | Norms from
Literature
(range) | ICC | |
|------------|------------------------------------|------------|-----------------------------------------|------------|-------------------------------------|-------|------|
| | Right | Left | Right | Left | | Right | Left |
| N1 [ms] | 11.2 ± 0.8 | 11.4 ± 0.9 | 10.2 ±1.1 | 10.4 ±1.1 | 9 to 19 ms | 0.63 | 0.78 |
| P1 [ms] | 15.9 ± 1.7 | 16.3 ±1.6 | 15.2 ± 1.7 | 15.2 ±1.6 | 12 to 22 ms | 0.89 | 0.76 |
| N1-P1 [μV] | 17.4 ± 8.5 | 17.3 ± 8.3 | 16.7 ± 10.6 | 14.1 ± 6.6 | 2 to 45 (μV) | 0.90 | 0.91 |
The study 1 results meet our substantial equivalency criteria between the two systems. This is concluded based on (1) both systems' results are consistent with those found in the Literature, and (2) the statistical analysis between the two systems' results shows good to excellent reliability.
Study 2
Testing was conducted at two sites (one in Canada and one in the United States)
- . US site: 33 normal hearing adults for cVEMP tests (30 male, 3 female) and 17 normal hearing adults for oVEMP test (2 male, 15 female) with air conduction transducer (AC).
- . Canada Site: 9 school-age normal hearing children for cVEMP subjects with bone conduction transducer (BC) and 8 pre-school age normal hearing children for cVEMP subjects with air conduction transducer (AC).
| Parameters | Values |
|---|---|
| Min number of runs per ear 2 repeatable | |
| waveforms | Min number of runs per ear 2 repeatable |
| waveforms | |
| Stimulus Level | 95 dB nHL |
| Stim rate | 4.7/sec |
| Filter (HP cutoff) | 10 Hz |
| Filter (LP cutoff) | 300 Hz |
| Type of window | Blackman (4 cycle) |
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| Stimulus | TB 500 Hz |
|---|---|
| Polarity | Rarefaction |
| Transducer | Air Conduction |
| Number of stimuli | 0-200 |
| EMG Controlled Pre-Stim | |
| cVEMP only - Integrity with VEMP | 50 (minimum)-150 µV (maximum) rms |
The mean, median, and IQR (75th – 25th percentile) values of the tested populations correlation between the VEMP waveforms obtained from two tests (a) in one session (for test-retest reliability) and (b) in two sessions separated by 24 to 72 hours (for reproducibility) should be similar to those from other products in the industry ("510(K) document for Eclipse with VEMP (K162037)"). High mean and median values indicate a high degree of repeatability, whereas a low value for IQR also indicates a large number of correlation coefficients are clustered near the median ("510(K) document for Eclipse with VEMP (K162037)")
- . From "510(K) document for Eclipse with VEMP (K162037)", industry acceptable test-retest repeatability and reproducibility for air conduction VEMP is assumed for a mean of correlation values ≥ 0.879 and for an IQR ≤ 0.111.
| Test-Retest Reliability | cVEMP (5 – 35 ms)
Air Conduction | oVEMP (4 - 20 ms)
Air Conduction | cVEMP (5 – 35 ms)
Bone Conduction |
|------------------------------|-------------------------------------|-------------------------------------|--------------------------------------|
| Mean (μ) | 0.92 | 0.89 | 0.92 |
| Median | 0.94 | 0.89 | 0.92 |
| Standard Deviation (σ) | 0.05 | 0.05 | 0.05 |
| IQR (75th - 25th percentile) | 0.07 | 0.08 | 0.12 |
Test-Retest Reliability based on the correlation of waveforms taken from one session .
The mean values are all ≥ 0.879 and the air conduction values all have an IVR ≤ 0.111. The slight increase in IVR for bone conduction (IVR = 0.12) is understandable given the greater variability associated with bone conduction in general. As such, the Test-Retest Reliability is within industry standards ("510(K) document for Eclipse with VEMP (K162037)").
Test-Retest Reproducibility based on the correlation of waveforms taken from two sessions separated by 24 to 72 hours
| Reproducibility | cVEMP (5 – 35 ms)
Air Conduction | oVEMP (4 – 20 ms)
Air Conduction |
|------------------------------|-------------------------------------|-------------------------------------|
| Mean (μ) | 0.92 | 0.89 |
| Median | 0.93 | 0.87 |
| Standard Deviation (σ) | 0.05 | 0.06 |
| IQR (75th – 25th percentile) | 0.08 | 0.11 |
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The mean values are all ≥ 0.879 and the air conduction values all have an IVR ≤ 0.111. As such, the Test-Retest Reproducibility is within industry standards ("510(K) document for Eclipse with VEMP (K162037)"). Study 2 results meet our criteria to prove the reliability of the new Integrity VEMP device. This is concluded based on the reliability values and the reproducibility values by Integrity VEMP is similar to those from other products in the industry ("510(K) document for Eclipse with VEMP (K162037)"). We conclude that Integrity VEMP has good test-retest reliability and reproducibility.
12. CONCLUSIONS
Integrity with VEMP has the same intended use and similar indications for use as the predicate device, Eclipse with VEMP. Integrity with VEMP also has the similar technical characteristics as its reference device, Integrity with AEP. The addition of biofeedback EMG monitor and VEMP response normalization to its software helps to control the muscle contraction and compensate for imbalance contraction from the two sides during VEMP testing. Non-clinical testing of the reference device supports the safety and effectiveness of the Integrity with VEMP. Clinical performance testing demonstrates substantial equivalence with the predicate device, Eclipse with VEMP. It also demonstrates that test-retest reliability and reproducibility of Integrity with VEMP is within industry accepted values as inferred from the "510(K) document for Eclipse with VEMP (K162037)". Therefore, Integrity with VEMP can be considered substantially equivalent to the predicate devices. Integrity with VEMP is a clinical tool for healthcare professionals such as audiologists and ENT doctors to evaluate vestibular disorders using both cVEMP and oVEMP tests along with the other vestibular tests battery.