(257 days)
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 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.
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.
The provided text describes a 510(k) premarket notification for a medical device called Sentiero, specifically addressing the addition of a Vestibular Evoked Myogenic Potential (VEMP) module. The document focuses on demonstrating substantial equivalence to a predicate device and a reference device, rather than presenting a performance study with detailed acceptance criteria of an AI/ML powered device.
Therefore, many of the requested criteria for acceptance and proof of performance relating to AI/ML devices (e.g., sample size for test set with provenance, number of experts for ground truth, MRMC studies, standalone AI performance, etc.) are not applicable to this submission, as the Sentiero device and its VEMP module are described as audiometric examination platforms with physiological test procedures, and do not appear to incorporate AI/ML algorithms that would require such performance evaluations.
However, I can extract information related to the device's functional performance and its verification and validation.
Here's a breakdown of the available information based on your request, highlighting what is present and what is not applicable:
1. A table of Acceptance Criteria and the Reported Device Performance
The document does not explicitly state "acceptance criteria" in the typical sense of a target metric for an AI/ML algorithm's performance (e.g., "AUC must be > 0.90"). Instead, it demonstrates the device's appropriate functionality and reliability through testing.
The primary performance data provided is related to the repeatability and reliability of the VEMP measurements.
| Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Repeatability (oVEMP) | Low variation in P1/N1 latency and interpeak latency; Medium variation in interpeak amplitude. (Inferred from "low variation" and "medium variation" statements) | P1 latency: Day 1: 1.95%, Day 2: 1.02%N1 latency: Day 1: 1.23%, Day 2: 1.69%Interpeak latency: Day 1: 7.54%, Day 2: 6.72%Interpeak Amplitude: Day 1: 8.02%, Day 2: 12.14% |
| Repeatability (cVEMP) | Low variation in P1/N1 latency and interpeak latency; Medium variation in interpeak amplitude. (Inferred) | P1 latency: Day 1: 1.25%, Day 2: 2.51%N1 latency: Day 1: 1.85%, Day 2: 1.21%Interpeak latency: Day 1: 5.40%, Day 2: 5.40%Interpeak Amplitude: Day 1: 11.48%, Day 2: 7.08% |
| Reliability (oVEMP) | Low variation in P1/N1 latency and interpeak latency; Medium variation in interpeak amplitude. (Inferred) | P1 latency: 2.98%N1 latency: 2.38%Interpeak latency: 10.86%Interpeak Amplitude: 23.64% |
| Reliability (cVEMP) | Low variation in P1/N1 latency and interpeak latency; Medium variation in interpeak amplitude. (Inferred) | P1 latency: 3.32%N1 latency: 4.05%Interpeak latency: 11.15%Interpeak Amplitude: 18.80% |
| General Suitability | Must be suitable for recording VEMPs to assist ENT Doctors in diagnosis. | "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." |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: 16 normal hearing adults.
- Data Provenance: Not explicitly stated, but the submission is from a German company (Path Medical GmbH, Germering, Bavaria, Germany), implying that the clinical evaluation data likely originated from Europe, potentially Germany. The study is prospective as it describes "conducted tests" with "test subjects."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable in the context of AI/ML algorithm evaluation for this device. The device itself is an audiometric instrument that records physiological signals (VEMPs). The "ground truth" for VEMP measurements is the actual physiological response (P1, N1 latencies, interpeak amplitude). The device's role is to accurately capture and display this response. Interpretation of these results for diagnosis is explicitly stated to be performed by an "ENT specialist."
4. Adjudication method for the test set
Not applicable. Since the device measures physiological signals, there's no diagnostic "ground truth" adjudicated by multiple experts for the device's output itself. The measurements (latencies, amplitudes) are derived from the recorded waveforms.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device does not incorporate AI to assist human readers/clinicians in interpretation or diagnosis. It is a measurement tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is an instrument operated by a healthcare professional. There is no AI algorithm that performs a standalone diagnosis or interpretation. The performance tested is the accuracy and consistency of its measurements as a medical device.
7. The type of ground truth used
The "ground truth" is the physiological VEMP response itself, measured by the device. The study design ("Repeatability [Coefficient of variation]" and "Reliability [Coefficient of variation]") indicates that the device's ability to consistently and accurately measure these expected physiological parameters (P1 latency, N1 latency, Interpeak latency, Interpeak Amplitude) from repeated tests was evaluated. The comparison is against established academic literature for typical VEMP findings.
8. The sample size for the training set
Not applicable. This is a medical device that measures physiological signals, not an AI/ML model that requires a "training set" in the computational sense. The core technology is signal acquisition and processing based on established audiometry principles.
9. How the ground truth for the training set was established
Not applicable. (See point 8).
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
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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
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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 GmbHLandsberger Str. 6582110 GermeringGermanyPhone: ++49-89-80076502Fax: ++49-89-80076503 |
| Contact Person: | Dr. Johann Oswald, DirectorLandsberger Str. 6582110 GermeringGermanyPhone: ++49-89-80076502Fax: ++49-89-80076503Email: oswald@pathme.de |
II. DEVICE INFORMATION
| Device Name: | SENTIERO |
|---|---|
| Device Trade Names: | Sentiero, Sentiero Screening, SentieroDiagnostic, Sentiero Advanced, SentieroDesktop, 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 TesterFDA 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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Image /page/6/Picture/0 description: The image shows the logo for Path Medical. The logo consists of a red square with a white curved line inside, followed by the words "PATH" in bold black letters and "MEDICAL" in smaller black letters below it. The logo is simple and modern, with a focus on the company's name.
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 otologicdisorders throughevoked potentials (EP) byAudiologists, ear-nose-throat (ENT) doctors, andother hearing healthcare professionals andaudiologically trainedtechnicians. | Detection of vestibulardisorders through evokedpotentials (EP) byAudiologists, ear-nose-throat (ENT) doctors, andother hearing/ENT healthcare professionals andpersonnel trained on theavailable test modules. | Similar, both detectinner ear disordersthrough EvokedPotentials. IntendedUser is the same. |
| Indications for Use | Devices of the Sentierodevice families offerdifferent test methodswhich can be configuredto fit the professional'sneeds for hearingscreening or diagnostics.Available psycho-acoustical methods onSentiero are especiallyindicated for use withcooperative patientsstarting at the age of twoyears or adequatedevelopment age, whichenables them to doplay/interactiveaudiometry. All otherphysiological modulesare suitable to be usedfor all ages elder thaninfants from 34 weeks(gestational age) thatare ready for dischargefrom the hospital. | Devices of the Sentierodevice families offerdifferent test methods whichcan be configured to fit theprofessional's needs forhearing screening ordiagnostics and vestibulardiagnostics (SentieroAdvanced only).Available psycho-acousticalmethods on Sentiero devicesare especially indicated foruse with cooperativepatients starting at the ageof two years or adequatedevelopment age, whichenables them to doplay/interactive audiometry.Physiological modules whichrequire active patientparticipation (e.g. VEMP) areindicated for use withcooperative patients whoare mentally and physicallyable to perform the requiredtask. All other physiologicalmodules are suitable to be | Similar. Newindications for usealso lists VEMP; bothdiagnosticsperformed by ENTspecialists to detectinner ear disordersthrough EPs. |
| Sentiero ABR(without VEMP) | Sentiero VEMP | Equivalency | |
| used for all ages elder thaninfants from 34 weeks(gestational age) that areready for discharge from thehospital. | |||
| Physiological features | |||
| Biosignal | Evoked potential | Evoked potential | Same |
| Electrode position | Head and neck | Head, neck andsternoclavicular junction(cVEMP) or extraocularmuscle (oVEMP) | Not exactly thesame positions butsimilar |
| Stimulation target | Cochlea | Circular ducts | Similar, both arestructures of theinner ear |
| Biosignal Generator | Auditory pathway | Myogenic system | Similar |
| Patient cooperation | Calm and relaxedposture to minimizemyogenic noise. | Calm and relaxed posture tominimize myogenic noise.Patient should turn head tocontractsternocleidomastoid muscle(cVEMP) or keep an upwardgaze of 35° to contractextraocular muscle (oVEMP). | Same. Movementshould be kept at aminimum to reducenoise. The turning ofthe head or theupward gaze is justone additional partof the initial setup. |
| Hardware | |||
| Hardware | Sentiero Advanced | Sentiero Advanced | Same |
| Transducer | Headphone / Insertphone, bone conductor,ear coupler cable, or earprobe | Headphone / Insert phone,bone conductor | Same (subset) |
| Potential recording | EEG sensors and PATHMEDICAL electrode cable | EEG sensors and PATHMEDICAL electrode cable | Same |
| EEG recordingchannels, number ofelectrode contacts | 1, 3 | 1, 3 | Same |
| Communicationinterfaces | 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 (labelprinter only) | ||
| Applied standards | All relevantbiocompatibility,electrical safety,usability, audiologicaland medical devicemanufacturing standards | All relevant biocompatibility,electrical safety, usability,audiological and medicaldevice manufacturingstandards | Same |
| Implementation Details | |||
| Stimuli | Click, Chirp, Tone Burst | Click, Chirp, Tone Burst | Same |
| Stimulus repetitionrate | 10-100 Hz | 2-10 Hz | Similar (adjacentrange) |
| Stimulus levels | 0-100 dB nHL | 20-110 dB nHL | Similar |
| Result representation | Time domain waveformplot with wave I, III, Vmarkers, plot range: 0-25 ms | Time domain waveform plotwith P1, N1 markers, plotrange: 40-100 ms | Similar (markershave differentnames, different plotrange) |
| 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 DeviceEclipse with VEMP | Subject DeviceSentiero VEMP | Equivalency | |
|---|---|---|---|
| Indications for Use | The Eclipse with VEMP(Vestibular Evoked MyogenicPotential) is intended forvestibular evoked myogenicpotential testing to assist inthe assessment of vestibularfunction. The targetpopulation for Eclipse withVEMP includes patients agedfrom 8 years and up. Thedevice is to be used only byqualified medical personnel | Devices of the Sentierodevice families offerdifferent test methods whichcan be configured to fit theprofessional's needs forhearing screening ordiagnostics and vestibulardiagnostics (SentieroAdvanced only).Available psycho-acousticalmethods on Sentiero devices | Similar, bothdevices are(amongst others)indicated for usein vestibulardiagnostics. Thedifference inpatient age doesnot raise anyconcernsregarding safetyor effectiveness |
| with prior knowledge of themedical and scientific factsunderlying the procedure. | are especially indicated foruse with cooperativepatients starting at the ageof two years or adequatedevelopment age, whichenables them to doplay/interactive audiometry.Physiological modules whichrequire active patientparticipation (e.g. VEMP) areindicated for use withcooperative patients whoare able to perform therequired task. All otherphysiological modules aresuitable to be used for allages elder than infants from34 weeks (gestational age)that are ready for dischargefrom the hospital. | as the limitingfactor has beenshown to bepatientcooperation andnot age. Patientcooperation isensured throughEMG Monitor andtrained,professionalusers. | |
| EEG recordingchannels, number ofelectrode contacts | 2, 4 | 1, 3 | Similar, SentieroVEMP requiressequentialtesting if bothsides are tested. |
| Available transducers | Headphones, InsertEarphones, bone conductor,OAE probe, speakers | Headphone / InsertEarphone, bone conductor | Similar, subset |
| EMG monitor | Range indicating the currentand optimal EMG readings. | Range indicating the currentand 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, bothcover the rangeusually used forVEMP. |
| Polarity | Rarefaction, Condensation,Alternating | Rarefaction, Condensation,Alternating, Randomized | Similar,Randomized isjust one of theother three |
| Frequency range | 125 Hz- 16000 Hz | 500 Hz - 4000 Hz | Smaller range,covers the mostrelevant |
| frequency rangefor VEMPs | |||
| Filter | Rectangular, Hann,Blackman, Gaussian,Trapezoidal, ExtendedCosine, Barlett, CosineCubed, 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 plotwith P1, N1 markers | Time domain waveform plotwith P1, N1 markers | Same |
| Automatic asymmetrycalculation | Yes | Yes | Same |
| Result interpretation | Only presentation ofrecorded potential andasymmetry. No diagnosis bythe device. ENT specialistinterprets the results. | Only presentation ofrecorded potential andasymmetry. No diagnosis bythe device. ENT specialistinterprets the results. | Same |
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Image /page/9/Picture/0 description: The image is a logo for Path Medical. The logo consists of a red square on the left side with a white curved line running through it. To the right of the square is the word "PATH" in large, bold, black letters, and below that is the word "MEDICAL" in smaller, black letters.
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Image /page/10/Picture/0 description: The image is a 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".
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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Image /page/11/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, and the words "PATH" and "MEDICAL" in black on the right side. The word "PATH" is above the word "MEDICAL".
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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Image /page/12/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 curved line running through it. To the right of the square, the word "PATH" is written in bold, black letters above the word "MEDICAL", which is also written in black letters, but in a smaller font size.
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[%] | InterpeakAmplitude[%] | |
|---|---|---|---|---|
| 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[%] | InterpeakAmplitude[%] | |
|---|---|---|---|---|
| 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.
§ 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.