(257 days)
No
The summary describes standard signal processing and statistical analysis for evaluating test results, with no mention of AI or ML techniques.
No.
The device is for hearing screening, diagnostics, and vestibular diagnostics, aiding in the diagnosis of conditions, rather than providing therapy.
Yes
The "Intended Use / Indications for Use" explicitly states that the device offers methods for "hearing screening or diagnostics and vestibular diagnostics." Additionally, the "Summary of Performance Studies" states that the device "can be considered suitable for the recording of VEMPs to assist ENT Doctors in a diagnosis of deficiencies in the vestibular system."
No
The device description explicitly states that Sentiero is an audiometric examination platform consisting of a Sentiero device with a touch screen display and various accessories (mains adapter, OAE probes, headphones, bone conductor, electrode cable, ear coupler cable, patient response switch). This indicates it is a hardware device with accompanying software/firmware, not a software-only medical device.
Based on the provided information, the Sentiero device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body.
- Sentiero's Function: The Sentiero device performs tests on the patient's body to assess hearing and vestibular function. It uses psycho-acoustical methods (requiring patient response) and physiological modules (measuring responses like VEMP). These are direct measurements of the body's responses, not tests on samples taken from the body.
- Lack of Sample Analysis: The description focuses on the device's interaction with the patient (headphones, probes, electrodes) and the analysis of signals generated by the patient's body in response to stimuli. There is no mention of analyzing biological samples.
Therefore, the Sentiero device falls under the category of a medical device used for diagnostic purposes, but specifically for in-vivo (within the living body) testing, not in-vitro testing.
N/A
Intended Use / Indications for Use
Devices of the Seniero device families offer different test methods which can be configured to fit the professional's needs for hearing screening or diagnostics and vestibular diagnostics (Sentiero Advanced only),
Available psycho-acoustical methods on Sentiero devices are especially indicated for use with cooperative patients starting at the age of two years or adequate development age, which enables them to do play/interactive audiometry. Physiological modules which require active paticipation (e.g. VEMP) are indicated for use with cooperative patients who are mentally and physically able to perform the required task. All other physiological modules are suitable to be used for all ages elder than infants from 34 weeks (gestational age) that are ready for discharge from the hospital.
Product codes (comma separated list FDA assigned to the subject device)
EWO, GWJ, ETY
Device Description
Sentiero is an audiometric examination platform which consists of the Sentiero device with a touch screen display together with different accessories such as mains adapter, OAE probes, headphones, bone conductor, electrode cable, ear coupler cable, patient response switch. These accessories can be connected to Sentiero based on a special plug, which holds the information about the connected transducer / cable. Therefore, the firmware can make use of this information and adapt the measurement procedures accordingly or provide information to the user via its display.
Furthermore, each model can be configured to allow different test methods and features (modules) by a license key in the device. Sentiero is based on configurable modules. Sentiero can have one single module or a combination of multiple.
The measurement application is controlled from a self-contained firmware. The measurement flow is menu guided on a touch screen. Evaluation of test results is based on signal statistics (if available for the test method). Besides that, wave forms and result information are displayed for the user's evaluation.
The patient/test data can be transferred from the device to a PC via a USB connection and the accompanied data management and archiving software MRA. Patient/test data on the PC software can be password- protected so that unauthorized access is prohibited.
Compared to the original 510(k) submission of the Sentiero in its predicate state, the Sentiero now offers a VEMP test module. Vestibular evoked myogenic potential (VEMP) is a short latency muscle reflex driven by otolithic organs that play a major role for detecting the orientation, static balance and linear acceleration of the head. Vestibular dysfunctions arise from various different regions along the vestibular pathway. Vestibular neuritis, vestibular schwannoma, multiple sclerosis or Meniere's disease will be indicated by the decrease or absence of VEMP responses.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear, Vestibular system, Middle ear, Outer ear
Indicated Patient Age Range
Cooperative patients starting at the age of two years or adequate development age. All other physiological modules are suitable to be used for all ages elder than infants from 34 weeks (gestational age) that are ready for discharge from the hospital.
Intended User / Care Setting
Audiologists, ear-nose-throat (ENT) doctors, and other hearing/ENT health care professionals and personnel trained on the available test modules in a medical environment. Sentiero is intended for indoor-use only.
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
Clinical Evaluation:
Test subjects: 16 normal hearing adults
Performed tests: cVEMP and oVEMP
Number of traces per day and VEMP modus: 2
Stimulus: Tone Burst Blackman 2-1-2, 65 dB HL
Transducer: Bone Conductor B81
Rate: 5.1 Hz
Polarity: Alternating
Frequency: 500Hz
Sweeps per trace: 150
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Evaluation Study:
Study Type: Clinical Evaluation
Sample Size: 16 normal hearing adults
Key Results:
Repeatability [Coefficient of variation]:
Day 1 [oVEMP] - P1 latency: 1.95%, N1 latency: 1.23%, Interpeak latency: 7.54%, Interpeak Amplitude: 8.02%
Day 2 [oVEMP] - P1 latency: 1.02%, N1 latency: 1.69%, Interpeak latency: 6.72%, Interpeak Amplitude: 12.14%
Day 1 [cVEMP] - P1 latency: 1.25%, N1 latency: 1.85%, Interpeak latency: 5.40%, Interpeak Amplitude: 11.48%
Day 2 [cVEMP] - P1 latency: 2.51%, N1 latency: 1.21%, Interpeak latency: 5.40%, Interpeak Amplitude: 7.08%
Reliability [Coefficient of variation]:
Day 1 & Day 2 [oVEMP] - P1 latency: 2.98%, N1 latency: 2.38%, Interpeak latency: 10.86%, Interpeak Amplitude: 23.64%
Day 1 & Day 2 [cVEMP] - P1 latency: 3.32%, N1 latency: 4.05%, Interpeak latency: 11.15%, Interpeak Amplitude: 18.80%
Overall, the EP system as implemented in the subject Sentiero with VEMP can be considered suitable for the recording of VEMPs to assist ENT Doctors in a diagnosis of deficiencies in the vestibular system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Repeatability [Coefficient of variation] for P1 latency, N1 latency, Interpeak latency, Interpeak Amplitude.
Reliability [Coefficient of variation] for P1 latency, N1 latency, Interpeak latency, Interpeak Amplitude.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 874.1050 Audiometer.
(a)
Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.
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June 22, 2022
Path Medical GmbH Johann Oswald Managing Director Landsberger Strasse 65 Germering, Bavaria 82110 Germany
Re: K213345
Trade/Device Name: Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced. NavPRO ONE Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO, GWJ, ETY Dated: May 17, 2022 Received: May 20, 2022
Dear Johann Oswald:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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,
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213345
Device Name Sentiero
Indications for Use (Describe)
Devices of the Seniero device families offer different test methods which can be configured to fit the professional's needs for hearing screening or diagnostics and vestibular diagnostics (Sentiero Advanced only),
Available psycho-acoustical methods on Sentiero devices are especially indicated for use with cooperative patients starting at the age of two years or adequate development age, which enables them to do play/interactive audiometry. Physiological modules which require active paticipation (e.g. VEMP) are indicated for use with cooperative patients who are mentally and physically able to perform the required task. All other physiological modules are suitable to be used for all ages elder than infants from 34 weeks (gestational age) that are ready for discharge from the hospital.
| 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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Image /page/3/Picture/0 description: The image is a logo for Path Medical. The logo consists of a red square with a white curved line running through it on the left side. To the right of the square is the word "PATH" in large, bold, black letters, with the word "MEDICAL" underneath it in smaller, black letters.
510(k) Summary
l. SUBMISSION INFORMATION
| Date of preparation: | June 15th, 2022 |
|---|---|
| 510(k) Submitter: | PATH MEDICAL GmbH |
| Landsberger Str. 65 | |
| 82110 Germering | |
| Germany |
Phone: ++49-89-80076502
Fax: ++49-89-80076503 |
| Contact Person: | Dr. Johann Oswald, Director
Landsberger Str. 65
82110 Germering
Germany
Phone: ++49-89-80076502
Fax: ++49-89-80076503
Email: oswald@pathme.de |
II. DEVICE INFORMATION
| Device Name: | SENTIERO |
|---|---|
| Device Trade Names: | Sentiero, Sentiero Screening, Sentiero |
| Diagnostic, Sentiero Advanced, Sentiero | |
| Desktop, AuDX, AuDX PRO, AuDX PRO FLEX, | |
| NavPRO ONE | |
| Device Identification Codes: | SOH1000098, SOH100360, SOD100497 |
| Common Name: | Evoked Response Auditory Stimulator |
| Classification Name: | Evoked Response Auditory Stimulator, |
| Audiometer, Auditory Impedance Tester | |
| FDA 21CFR882.1900 & 21CFR874.1050 & | |
| 21CFR874.1090 |
III. PREDICATE DEVICE
| SENTIERO | 510(k) Number: K133012 |
|---|---|
| ---------- | ------------------------ |
This device has not been subject to a recall.
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Image /page/4/Picture/0 description: The image contains the logo for Path Medical. The logo consists of a red square with a white curved line inside, and the words "PATH MEDICAL" in black text to the right of the square. The word "PATH" is in a larger font than the word "MEDICAL".
IV. REFERENCE DEVICE
| Eclipse with VEMP | 510(k) Number: K162037 |
|---|---|
| ------------------- | ------------------------ |
V. DEVICE DESCRIPTION
Sentiero is an audiometric examination platform which consists of the Sentiero device with a touch screen display together with different accessories such as mains adapter, OAE probes, headphones, bone conductor, electrode cable, ear coupler cable, patient response switch. These accessories can be connected to Sentiero based on a special plug, which holds the information about the connected transducer / cable. Therefore, the firmware can make use of this information and adapt the measurement procedures accordingly or provide information to the user via its display.
Furthermore, each model can be configured to allow different test methods and features (modules) by a license key in the device. Sentiero is based on configurable modules. Sentiero can have one single module or a combination of multiple.
The measurement application is controlled from a self-contained firmware. The measurement flow is menu guided on a touch screen. Evaluation of test results is based on signal statistics (if available for the test method). Besides that, wave forms and result information are displayed for the user's evaluation.
The patient/test data can be transferred from the device to a PC via a USB connection and the accompanied data management and archiving software MRA. Patient/test data on the PC software can be password- protected so that unauthorized access is prohibited.
Compared to the original 510(k) submission of the Sentiero in its predicate state, the Sentiero now offers a VEMP test module. Vestibular evoked myogenic potential (VEMP) is a short latency muscle reflex driven by otolithic organs that play a major role for detecting the orientation, static balance and linear acceleration of the head. Vestibular dysfunctions arise from various different regions along the vestibular pathway. Vestibular neuritis, vestibular schwannoma, multiple sclerosis or Meniere's disease will be indicated by the decrease or absence of VEMP responses.
INTENDED USE
Devices of the Sentiero device families offer different test methods which can be configured to fit the professional's needs for hearing screening or diagnostics and vestibular diagnostics (Sentiero Advanced only). Devices of the Sentiero device family provide standard psychoacoustical test procedures and additionally physiological test procedures including otoacoustic emissions (OAE) (e.g. transitory evoked otoacoustic emissions (TEOAE), distortion product otoacoustic emissions (DPOAE)), evoked potentials (e.g. auditory brainstem responses (ABR), auditory steady state responses (ASSR); vestibular evoked myogenic potentials (VEMP)) (Sentiero Advanced only), and auditory impedance and acoustic reflex measurements (Sentiero Desktop, Sentiero and Sentiero Advanced with tympanometry add-on).
Available psycho-acoustical methods on Sentiero devices are especially indicated for use with cooperative patients starting at the age of two years or adequate development age, which enables them to do
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Image /page/5/Picture/1 description: The image contains the logo for PATH Medical. The logo consists of a red square on the left side with a white, stylized design inside. To the right of the square is the word "PATH" in large, bold, black letters, with the word "MEDICAL" underneath in smaller, black letters.
play/interactive audiometry. Physiological modules which require active paticipation (e.g. VEMP) are indicated for use with cooperative patients who are able to mentally and physically perform the required task. All other physiological modules are suitable to be used for all ages elder than infants from 34 weeks (gestational age) that are ready for discharge from the hospital.
All physiological test methods are especially indicated for use in defining the type and configuration of hearing loss particularly for individuals whose behavioral audiometric results are deemed unreliable or to assist in the diagnosis of otologic or vestibular disorders. Estimation of cochlear hearing thresholds (DPOAE Threshold) is possible at various frequencies without the need of cooperative interaction with the patient. Acoustic reflex and tympanometry are featured to evaluate the functional condition of the middle and outer ear. VEMP is featured to assist in the evaluation of the functional condition of the vestibular system. For each method, several protocols can be configured. The results can be used to make further recommendations regarding appropriate intervention strategies.
Devices of the Sentiero device family are intended for the following purposes:
- Diagnostics, monitoring and follow-up after newborn hearing screening
- . Pre-school, school, and adult hearing screening
- . ENT diagnostics based on measurement of
- a) Otoacoustic emissions
- Tympanometry and acoustic reflex (Sentiero Desktop, Sentiero and Sentiero Advanced with b) tympanometry add-on)
- c) Evoked potentials (Sentiero Advanced only)
Sentiero is intended for use by audiologists, ear-nose-throat (ENT) doctors, and other hearing/ENT health care professionals and personnel trained on the available test modules in a medical environment. Please consider local regulations regarding the qualification requirements for performing measurements with a specific test module.
Sentiero is not intended for operational use by the general public. All test procedures must be supervised or conducted by qualified personnel. In the United States of America, Federal law restricts this device to sale by or on the order of a licensed physician.
Sentiero is intended for indoor-use only and must be operated at defined environmental conditions. Sentiero is not intended for use in oxygen-rich environments.
Sentiero must not be used in cases of external otitis (outer ear canal infection) or in any case which yields to pain when inserting the ear probe or applying any other transducer. cVEMP on Sentiero Advanced must not be used in cases of neck, muscular and cervical injury problems and in cervical spine problems if the sternocleidomastoid muscle contraction cannot be maintained without further discomfort or pain.
VI. COMPARISONS
The Sentiero with VEMP will be compared to the predicate Sentiero ABR (without VEMP) due to the use of the same hardware, basic operating principle, and classification code (GWJ). For the parameters of the VEMP test module, the subject device will be compared to the reference device Eclipse with VEMP.
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COMPARISON TO PREDICATE DEVICE
For an easier comparison, the new VEMP module will be compared to predicate Sentiero's existing ABR module instead of all existing Sentiero test modules and their different operating principles. The new VEMP module and the existing ABR module use the same stimulus types, accessories and basic operating principle.
| | Sentiero ABR
(without VEMP) | Sentiero VEMP | Equivalency |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Purpose | | | |
| Intended use | Detection of otologic
disorders through
evoked potentials (EP) by
Audiologists, ear-nose-
throat (ENT) doctors, and
other hearing health
care professionals and
audiologically trained
technicians. | Detection of vestibular
disorders through evoked
potentials (EP) by
Audiologists, ear-nose-
throat (ENT) doctors, and
other hearing/ENT health
care professionals and
personnel trained on the
available test modules. | Similar, both detect
inner ear disorders
through Evoked
Potentials. Intended
User is the same. |
| Indications for Use | Devices of the Sentiero
device families offer
different test methods
which can be configured
to fit the professional's
needs for hearing
screening or diagnostics.
Available psycho-
acoustical methods on
Sentiero are especially
indicated for use with
cooperative patients
starting at the age of two
years or adequate
development age, which
enables them to do
play/interactive
audiometry. All other
physiological modules
are suitable to be used
for all ages elder than
infants from 34 weeks
(gestational age) that
are ready for discharge
from the hospital. | Devices of the Sentiero
device families offer
different test methods which
can be configured to fit the
professional's needs for
hearing screening or
diagnostics and vestibular
diagnostics (Sentiero
Advanced only).
Available psycho-acoustical
methods on Sentiero devices
are especially indicated for
use with cooperative
patients starting at the age
of two years or adequate
development age, which
enables them to do
play/interactive audiometry.
Physiological modules which
require active patient
participation (e.g. VEMP) are
indicated for use with
cooperative patients who
are mentally and physically
able to perform the required
task. All other physiological
modules are suitable to be | Similar. New
indications for use
also lists VEMP; both
diagnostics
performed by ENT
specialists to detect
inner ear disorders
through EPs. |
| | Sentiero ABR
(without VEMP) | Sentiero VEMP | Equivalency |
| | | used for all ages elder than
infants from 34 weeks
(gestational age) that are
ready for discharge from the
hospital. | |
| Physiological features | | | |
| Biosignal | Evoked potential | Evoked potential | Same |
| Electrode position | Head and neck | Head, neck and
sternoclavicular junction
(cVEMP) or extraocular
muscle (oVEMP) | Not exactly the
same positions but
similar |
| Stimulation target | Cochlea | Circular ducts | Similar, both are
structures of the
inner ear |
| Biosignal Generator | Auditory pathway | Myogenic system | Similar |
| Patient cooperation | Calm and relaxed
posture to minimize
myogenic noise. | Calm and relaxed posture to
minimize myogenic noise.
Patient should turn head to
contract
sternocleidomastoid muscle
(cVEMP) or keep an upward
gaze of 35° to contract
extraocular muscle (oVEMP). | Same. Movement
should be kept at a
minimum to reduce
noise. The turning of
the head or the
upward gaze is just
one additional part
of the initial setup. |
| Hardware | | | |
| Hardware | Sentiero Advanced | Sentiero Advanced | Same |
| Transducer | Headphone / Insert
phone, bone conductor,
ear coupler cable, or ear
probe | Headphone / Insert phone,
bone conductor | Same (subset) |
| Potential recording | EEG sensors and PATH
MEDICAL electrode cable | EEG sensors and PATH
MEDICAL electrode cable | Same |
| EEG recording
channels, number of
electrode contacts | 1, 3 | 1, 3 | Same |
| Communication
interfaces | USB connection to a PC; | USB connection to a PC; | Same |
| | Sentiero ABR
(without VEMP) | Sentiero VEMP | Equivalency |
| | Proprietary connector
(label printer only) | Proprietary connector (label
printer only) | |
| Applied standards | All relevant
biocompatibility,
electrical safety,
usability, audiological
and medical device
manufacturing standards | All relevant biocompatibility,
electrical safety, usability,
audiological and medical
device manufacturing
standards | Same |
| Implementation Details | | | |
| Stimuli | Click, Chirp, Tone Burst | Click, Chirp, Tone Burst | Same |
| Stimulus repetition
rate | 10-100 Hz | 2-10 Hz | Similar (adjacent
range) |
| Stimulus levels | 0-100 dB nHL | 20-110 dB nHL | Similar |
| Result representation | Time domain waveform
plot with wave I, III, V
markers, plot range: 0-
25 ms | Time domain waveform plot
with P1, N1 markers, plot
range: 40-100 ms | Similar (markers
have different
names, different plot
range) |
| Result interpretation | by ENT specialist | by ENT specialist | Same |
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Image /page/7/Picture/0 description: The image is a logo for Path Medical. The logo consists of a red square with a white curved line running through it on the left side. To the right of the square is the word "PATH" in large, bold, black letters, with the word "MEDICAL" in smaller, black letters underneath.
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Image /page/8/Picture/0 description: The image is a logo for Path Medical. The logo consists of a red square with a white curved line inside of it on the left side. To the right of the square, the word "PATH" is written in black, with the word "MEDICAL" written in a smaller font size below it.
COMPARISON TO REFERENCE DEVICE
| | Reference Device
Eclipse with VEMP | Subject Device
Sentiero VEMP | Equivalency |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | Devices of the Sentiero
device families offer
different test methods which
can be configured to fit the
professional's needs for
hearing screening or
diagnostics and vestibular
diagnostics (Sentiero
Advanced only).
Available psycho-acoustical
methods on Sentiero devices | Similar, both
devices are
(amongst others)
indicated for use
in vestibular
diagnostics. The
difference in
patient age does
not raise any
concerns
regarding safety
or effectiveness |
| | with prior knowledge of the
medical and scientific facts
underlying the procedure. | are especially indicated for
use with cooperative
patients starting at the age
of two years or adequate
development age, which
enables them to do
play/interactive audiometry.
Physiological modules which
require active patient
participation (e.g. VEMP) are
indicated for use with
cooperative patients who
are able to perform the
required task. All other
physiological modules are
suitable to be used for all
ages elder than infants from
34 weeks (gestational age)
that are ready for discharge
from the hospital. | as the limiting
factor has been
shown to be
patient
cooperation and
not age. Patient
cooperation is
ensured through
EMG Monitor and
trained,
professional
users. |
| EEG recording
channels, number of
electrode contacts | 2, 4 | 1, 3 | Similar, Sentiero
VEMP requires
sequential
testing if both
sides are tested. |
| Available transducers | Headphones, Insert
Earphones, bone conductor,
OAE probe, speakers | Headphone / Insert
Earphone, bone conductor | Similar, subset |
| EMG monitor | Range indicating the current
and optimal EMG readings. | Range indicating the current
and optimal EMG readings. | Same |
| Stimulus implementation | | | |
| Stimulus types | Click, Chirp, Tone Burst | Click, Chirp, Tone Burst | Same |
| Stimulus repetition rate | 0.1-100 Hz | 2-10 Hz | Different, both
cover the range
usually used for
VEMP. |
| Polarity | Rarefaction, Condensation,
Alternating | Rarefaction, Condensation,
Alternating, Randomized | Similar,
Randomized is
just one of the
other three |
| Frequency range | 125 Hz- 16000 Hz | 500 Hz - 4000 Hz | Smaller range,
covers the most
relevant |
| | | | frequency range
for VEMPs |
| Filter | Rectangular, Hann,
Blackman, Gaussian,
Trapezoidal, Extended
Cosine, Barlett, Cosine
Cubed, Exact Blackman | Linear, Blackman | Similar, subset |
| Presentation | Right, left, both sides | Right, left, both sides | Same |
| Results | | | |
| EMG scaling | Yes | Yes | Same |
| Result presentation | Time domain waveform plot
with P1, N1 markers | Time domain waveform plot
with P1, N1 markers | Same |
| Automatic asymmetry
calculation | Yes | Yes | Same |
| Result interpretation | Only presentation of
recorded potential and
asymmetry. No diagnosis by
the device. ENT specialist
interprets the results. | Only presentation of
recorded potential and
asymmetry. No diagnosis by
the device. ENT specialist
interprets the results. | Same |
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Safety and Effectiveness comparison to the predicate and reference device:
The Sentiero with VEMP module is identical in hardware and technological aspects to the predicate device.
With respect to the intended use, the new VEMP module extends the intended use with evoking and detecting vestibular myogenic evoked potentials for vestibular diagnostics.
The implementation of the VEMP test module is similar to the already cleared reference device Eclipse with VEMP.
Biocompatibility testing
The biocompatibility evaluation was conducted according to ISO 10993-1:2009. Following tests were considered applicable:
- Cytotoxicity ●
- Sensitization ●
- . Irritation
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The device and its accessories are classified as short-term contact with intact skin. No issues were found during biocompatibility testing.
Electrical safety and electromagnetic compatibility (EMC)
The Sentiero was tested according to and complies to following electrical safety and electromagnetic compatibility standards: IEC 60601-1:2005/AMD1:2012, IEC 60601-1-2:2014, IEC 60601-2-40:1998 and 2016.
Software Verification and Validation Testing:
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "minor" level of concern, since a failure or latent flaw in the software are unlikely to cause any injury to the patient or operator.
Mechanical and Acoustic Testing:
- Maximum possible sound level compliant to IEC 60601-1 and 60601-2-40. ●
- Push, Drop, and Mould Stress Relief test as part of IEC 60601-1 test for portable devices.
Clinical Evaluation
Obtaining VEMP is a well-documented procedure to detect possible dysfunctions of the vestibular system. The Sentiero with VEMP module offers the same transducers, stimulus types and frequency ranges typically found in academic papers on VEMP measurements. Additionally, it supports threshold estimation, cVEMP and oVEMP testing and interpeak amplitude comparison to provide assistance to ENT doctors for a diagnosis of the vestibular system. A detailed clinical evaluation was conducted to confirm that the implementation of VEMP in the Sentiero represents the current State of the Art.
Furthermore, the EP recording function of the predicate Sentiero, which was already in use for several years in its ABR modules, was again tested for overall performance as well as repeatability for the new use-case.
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The parameters of the conducted tests were as follows:
| Test subjects | 16 normal hearing adults |
|---|---|
| Performed tests | cVEMP and oVEMP |
| Number of traces per day and VEMP modus | 2 |
| Stimulus | Tone Burst Blackman 2-1-2, 65 dB HL |
| Transducer | Bone Conductor B81 |
| Rate | 5.1 Hz |
| Polarity | Alternating |
| Frequency | 500Hz |
| Sweeps per trace | 150 |
Results:
Repeatability [Coefficient of variation]:
| | P1 latency
[%] | N1 latency
[%] | Interpeak latency
[%] | Interpeak
Amplitude
[%] |
|---------------|-------------------|-------------------|--------------------------|-------------------------------|
| Day 1 [oVEMP] | 1.95 | 1.23 | 7.54 | 8.02 |
| Day 2 [oVEMP] | 1.02 | 1.69 | 6.72 | 12.14 |
| Day 1 [cVEMP] | 1.25 | 1.85 | 5.40 | 11.48 |
| Day 2 [cVEMP] | 2.51 | 1.21 | 5.40 | 7.08 |
Reliability [Coefficient of variation]:
| | P1 latency
[%] | N1 latency
[%] | Interpeak latency
[%] | Interpeak
Amplitude
[%] |
|-----------------------|-------------------|-------------------|--------------------------|-------------------------------|
| Day 1 & Day 2 [oVEMP] | 2.98 | 2.38 | 10.86 | 23.64 |
| Day 1 & Day 2 [cVEMP] | 3.32 | 4.05 | 11.15 | 18.80 |
The subject device produced results similar to the data typically found in academic literature. Repeatability and reliability tests showed a low variation in latency of the P and N marker and interpeak latency difference, and a medium variation in interpeak amplitude results. Overall, the EP system as implemented in the subject Sentiero with VEMP can be considered suitable for the recording of VEMPs to assist ENT Doctors in a diagnosis of deficiencies in the vestibular system.
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VII. SUMMARY
VEMP, like ABR, is an acoustically evoked potential which can be obtained using commercially available EP systems. The Sentiero VEMP module has the ability to perform EMG monitoring during VEMP data collection. The VEMP module of the Sentiero does not provide a diagnosis is made by a qualified medical professional, while the Sentiero device only collects these potentials and displays them analogue to the approach used for other AEP measurements like ABR or ASSR. Testing the vestibular evoked myogenic potential (VEMP) is well- documented in the literature.
VIII. Substantial Equivalency
The Sentiero with VEMP and the predicate Sentiero use the identical hardware and accessories. Additionally, the operating principle behind the measurement of VEMPs is identical to the ABR operating principle as both record an acoustically evoked potential for a diagnosis. The relevant differences are the increased stimulus level needed for VEMP and the change of the biosignal generator and subsequent change of Indications for Use.
Bench tests verified, that the maximum available stimulus level remains below possibly hazardous overexposure. Measuring VEMP is a well-documented procedure and was implemented similarly to the application in academic papers to account for the change in biosignal generators. Similar to the ABR module, the VEMP module only shows the recorded potentials and does not provide a diagnosis. Recording acoustically evoked potentials has been performed for years on the predicate device with the ABR module and has been tested for the VEMP module in a test-retest test, where sufficient repeatability was proven.
The implementation of the VEMP module has been found to be very similar in terms of available transducers, stimulus parameters and result presentation to the reference Eclipse with VEMP.
It can be concluded, that the Sentiero with VEMP does not affectiveness and introduces no significant technological changes, therefore it can be considered substantially equivalent to the Sentiero without VEMP.
IX. OVERALL CONCLUSION
The Sentiero with the addition of the VEMP module shows identical characteristics in biocompatibility, software design, electrical safety and compatibility, and user testing compared to the predicate Sentiero without VEMP module. The extension of the indicated use does not raise different questions of safety and effectiveness and only differs through addition of the VEMP module and the reference to vestibular diagnostics. Additionally, there were no changes of the hardware and technological characteristics. Therefore, the Sentiero with VEMP can be considered substantially equivalent to the predicate Sentiero without VEMP module.