Predicate Devices

K061744, K122067, K092373, K083861, K070696

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard audiometric and physiological hearing tests and mentions "signal statistics" for evaluation, but there is no mention of AI, ML, or related concepts like deep learning or neural networks. The "image-based" methods (MAGIC, MATCH) are mentioned but not described in a way that suggests AI/ML is used for image analysis or interpretation.

Therapeutic

No
The device is described as an "audiometric examination platform" intended for "diagnostics, monitoring and follow-up" of hearing. It offers various test methods for "screening or diagnostic purposes" and the results are used to "make further recommendations regarding appropriate intervention strategies." This indicates a diagnostic rather than therapeutic function.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states "Sentiero is a portable instrument to diagnose all ages or hearing loss" and "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 disorders." It also lists "Diagnostics, monitoring and follow-up after newborn hearing screening" and "ENT diagnostics" as part of its design purpose.

SaMD (Software as a Medical Device)

No

The device description explicitly states that 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." This indicates it is a hardware device with accompanying software, not a software-only medical device.

IVD (In Vitro Diagnostic)

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 intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
Sentiero's Function: The Sentiero device directly interacts with the patient's ear to measure physiological responses (OAE, ABR, ASSR, Tympanometry, Acoustic Reflex) and behavioral responses (audiometry). It does not analyze specimens derived from the body.
Intended Use: The intended use clearly states that the device is used to diagnose hearing loss and evaluate the function of the middle and outer ear by applying stimuli and measuring responses directly from the patient.

Therefore, Sentiero falls under the category of a medical device used for direct physiological measurement and behavioral testing, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Sentiero is a portable instrument to diagnose all ages or hearing loss. The instrument offers different test methods which can be configured to fit the professional's needs for screening or diagnostic purposes. It offers physiological test methods such as:

· Distortion Product Otoacoustic Emissions (DPOAE)
· Transient Evoked Otoacoustic Emissions (TEOAE)
· Auditory Brainstem Response (ABR)
· Auditory Steady State Response (ASSR)
· Auditory Impedance and acoustic reflex (TYMP)

Additionally if offers standard audiometry (psycho-acoustical).

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 disorders. Estimation of cochlear hearing thresholds (DPTHRESH) is possible at various frequencies without the need of cooperative interaction with the patient. Acoustic reflex and tympanometry (TYMP) are featured to evaluate the function of the middle and outer ear. For each method, several protocols can be configured. The results are to be used to make further recommendations regarding appropriate intervention strategies. Therefore, Sentiero is intended for use by trained personnel such as audiologists. pediatricians. ENT doctors and other health care professionals in a medical or home environment. In the United States of America. Federal law restricts this device to sale by or on the order of a licensed physician.

Available psycho-acoustical methods on Sentiero are especially indicated for use with cooperative patients starting at the age of 2 years or adequate development age, which enables them to do play/interactive audiometry. All other 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 designed for:

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
b) Tympanometry and acoustic reflex
c) Auditory Brainstem Responses
d) Auditory Steady State Responses

Sentiero must not be used in cases of external otitis (outer ear canal infection) or in any case which vields to pain when inserting the ear probe or applying any other transducer.

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. All connectors and transducers have a special plug in order to ensure the correct connection to the device. All plugs of the transducers have a memory chip inside which stores the information about the respective transducer (including type of connector, calibration table). As a result, the Sentiero instrument can be connected flexibly to different kind of transducers while enabling the instrument to 'know' the features of the connected transducer. This information is used within the different modules (test methods which are configured) to guide the user (feedback via display) and help to ensure correct performance of the test methods.

Sentiero is available in two different models: handheld or desktop version. The desktop version is labeled Sentiero (Type Desktop). Both versions are standalone examination platforms and can be connected to a personal computer (PC) via USB for data review and management. The handheld version is portable and is meant to be mainly used as mobile device. The desktop version is portable as well but is meant to be mainly used as stationary device. Both models base on a common hardware platform (printed circuit board, PCB) but with different configurations. Materials in contact with humans are selected to be biocompatible.

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 of modules described in the following intended use.

The measurement application is controlled from a self-contained firmware (software installed on the instrument). 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 is displayed for the user's evaluation.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Ear

Indicated Patient Age Range

All ages, with specific considerations:

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 disorders. Estimation of cochlear hearing thresholds (DPTHRESH) is possible at various frequencies without the need of cooperative interaction with the patient. Acoustic reflex and tympanometry (TYMP) are featured to evaluate the function of the middle and outer ear. For each method, several protocols can be configured. The results are to be used to make further recommendations regarding appropriate intervention strategies. Therefore, Sentiero is intended for use by trained personnel such as audiologists. pediatricians. ENT doctors and other health care professionals in a medical or home environment. In the United States of America. Federal law restricts this device to sale by or on the order of a licensed physician.
Available psycho-acoustical methods on Sentiero are especially indicated for use with cooperative patients starting at the age of 2 years or adequate development age, which enables them to do play/interactive audiometry. All other 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

Intended for use by trained personnel such as audiologists, pediatricians, ENT doctors and other health care professionals in a medical or home environment. In the United States of America. Federal law restricts this device to sale by or on the order of a licensed physician.

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

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance tests were also conducted on a test bench. For this reason a simulator device, which simulates TEOAE, DPOAE or ABR output was used for proof of validity of the derived signal. The same simulator device was distributed by Natus Europe GmbH as a testing device for the predicate devices AccuScreen and Cochlea-Scan.

The device under test (DUT) had to be connected to deliver the stimulus (via insert earphone or ear probe) into a cavity of the simulator. The simulator was connected to the electrode cable of the DUT to record the test result. The stimulator was able to deliver noise or dedicated normative answers derived from literature. The same simulator was used for Sentiero as well as the predicate devices Cochlea-Scan and AccuScreen. The simulator was developed by the same engineers who developed the Cochlea-Scan as well as the AccuScreen. Passing the requirements given by the simulator was part of the acceptance criteria for the verification phase of the device development cycle. Consequently the performance of the test modules TEOAE, DPOAE, DPTHRES. ABR were validated in comparison to the predicate devices during the in-house validation phase of Sentiero. The test protocol is attached in the Appendix.

In preparation of the first application for receiving the CE mark for Sentiero, additional test sites were asked to evaluate the performance of relevant test modules and the handling of the instrument. To state clearly: all implemented modules on Sentiero are derived from well-known algorithms, which are described in detail in published literature. The design process of Sentiero included in-house verification tests also with respect to the mentioned literature and and establishment of normative data. In addition, external potential users were asked to validate the measurement results and the usage of the device and test modules (usability tests and performance tests). Comparison measurements had to be done with predicate devices and normal hearing patients with hearing loss. Minimum number of participants per evaluation was 20. Multiple users should be involved to verify usability of the device in comparison to experience level of the user.

No tests were conducted with respect to animal testing.

The test sites, which participated in the evaluation of test modules on Sentiero are shown in Table 10-4. Please note that not all these testers and studies did receive financial support from PATH medical. Most of the evaluation data and feedback was contributed by initiative from the tester. The tester a financial arrangement with PATH medical - except the two sites mentioned in section 9 of this document, where PATH was the sponsor and initiator of the study.

Sentiero Module	Predicate device	Tester
PTA class 3	Cochlea-Scan (DPOAE threshold estimation)	Prof. Dr. med. Annerose Keilmann Center of Communication Disorders, ENT Clinic, University Medical Center of the Johannes-Guttenberg-University Mainz, Mainz, Germany
MAGIC (image-based pure tone audiometry)		Center of Communication Disorders, ENT Clinic, University Medical Center of the Johannes-Guttenberg-University Mainz, Mainz, Germany
MATCH (image-based speech test)	Established speech tests (e.g. Mainzer speech test for children)	Center of Communication Disorders, ENT Clinic, University Medical Center of the Johannes-Guttenberg-University Mainz, Mainz, Germany
DPTHRES (DPOAE threshold estimation)		Center of Communication Disorders, ENT Clinic, University Medical Center of the Johannes-Guttenberg-University Mainz, Mainz, Germany
ABR	Chartr EP 200	Ph.D. Stavrous Hatzopoulos Department of Audiology and Speech Therapy, University of Ferrara, Ferrara, Italy
TEOAE	AccuScreen (TEOAE, DPOAE)	Prof. Dr. med. Hans Peter Niedermeyer ENT Clinic, Klinikum rechts der Isar, Technische Universität München, Munich, Germany
DPQUICK (DPOAE at fixed levels)		ENT Clinic, Klinikum rechts der Isar, Technische Universität München, Munich, Germany
DPTHRES (DPOAE threshold estimation)		ENT Clinic, Klinikum rechts der Isar, Technische Universität München, Munich, Germany
ASSR	Cochlea-Scan (DPOAE threshold estimation)	Dr. Thomas Rosner ENT Clinic, Klinikum rechts der Isar. Technische Universität München, Munich, Germany
ABR	ABR device, unknown type.	PD Dr. med. Nicolas Schmuziger ENT Clinic, Kantonsspital Liestal, Liestal, Switzerland
PTA	EchoScreen/AccuScreen and CochleaScan	Prof. Dr. Katrin Neumann Department of Phoniatry and Pedaudiology. ENT Clinic, St .- Elisabeth-Hospital, Bochum, Germany
MAGIC (image-based pure tone audiometry)		Department of Phoniatry and Pedaudiology. ENT Clinic, St .- Elisabeth-Hospital, Bochum, Germany
TEOAE		Department of Phoniatry and Pedaudiology. ENT Clinic, St .- Elisabeth-Hospital, Bochum, Germany
DPQUICK (DPOAE at fixed levels)		Department of Phoniatry and Pedaudiology. ENT Clinic, St .- Elisabeth-Hospital, Bochum, Germany
DPTHRES (DPOAE threshold estimation)		Department of Phoniatry and Pedaudiology. ENT Clinic, St .- Elisabeth-Hospital, Bochum, Germany
ABR		Department of Phoniatry and Pedaudiology. ENT Clinic, St .- Elisabeth-Hospital, Bochum, Germany

Out of these studies reports were generated or published, which indicated that Sentiero is an equivalence to the given predicate devices with respect to clinical application/usage.

Key results:

Sentiero can be used by professionals as efficiently as the respective predicate devices.
The nonclinical tests shows that Sentiero is as similar safe, as effective and as performant as the predicate devices.
Sentiero successfully passed the tests and checklists of the aforementioned standards. Thus it is shown that Sentiero is as safe, efficient and performing as the predicate devices which also fulfill the standards as mentioned in the comparison table above.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

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.

K061744, K122067, K092373, K083861, K070696

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.

K100661, K131141

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

Regulation Number and Section

§ 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.

Summary

0

510(k) Summary

SUBMISSION INFORMATION

Date of preparation:	May 4th, 2014
510(k) Submitter:	PATH medical GmbH
Landsberger Str. 63
82110 Germering
Germany
Phone: ++49-89-80076502
Fax: ++49-89-80076503
Contact Person:	Dr. Johann Oswald, Director
Landsberger Str. 63
82110 Germering
Germany
Phone: ++49-89-80076502
Fax: ++49-89-80076503
Email: oswald@pathme.de

DEVICE INFORMATION

Device Name:	Sentiero
Device Trade Names:	Sentiero Basic, Sentiero Advanced, Sentiero Desktop
Device Identification Codes:	SOH100098, SOH100360, SOD100497
Common Name:	Evoked Response Auditory Stimulator
Classification Name:	Evoked Response Auditory Stimulator, Audiometer, Auditory
Impedance Tester
FDA 21 CFR section 882.1900 and 874.1050 and 874.1090

PREDICATE DEVICES

Cochlea-Scan	510(k) number: K061744
AccuScreen	510(k) number: K122067
Chartr EP 200	510(k) number: K092373
TITAN IMP440	510(k) number: K083861
Eclipse	510(k) number: K070696

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. All connectors and transducers have

a special plug in order to ensure the correct connection to the device. All plugs of the transducers have a memory chip inside which stores the information about the respective transducer (including type of

1

connector, calibration table). As a result, the Sentiero instrument can be connected flexibly to different kind of transducers while enabling the instrument to 'know' the features of the connected transducer. This information is used within the different modules (test methods which are configured) to guide the user (feedback via display) and help to ensure correct performance of the test methods.

Sentiero is available in two different models: handheld or desktop version. The desktop version is labeled Sentiero (Type Desktop). Both versions are standalone examination platforms and can be connected to a personal computer (PC) via USB for data review and management. The handheld version is portable and is meant to be mainly used as mobile device. The desktop version is portable as well but is meant to be mainly used as stationary device. Both models base on a common hardware platform (printed circuit board, PCB) but with different configurations. Materials in contact with humans are selected to be biocompatible.

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 of modules described in the following intended use.

The measurement application is controlled from a self-contained firmware (software installed on the instrument). 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 is displayed for the user's evaluation.

INTENDED USE

Sentiero is a portable instrument to diagnose all ages or hearing loss. The instrument offers different test methods which can be configured to fit the professional's needs for screening or diagnostic purposes. It offers physiological test methods such as:

. Distortion Product Otoacoustic Emissions (DPOAE)
. Transient Evoked Otoacoustic Emissions (TEOAE)
· Auditory Brainstem Response (ABR)

2

· Auditory Steady State Response (ASSR)
· Auditory Impedance and acoustic reflex (TYMP)

Additionally if offers standard audiometry (psycho-acoustical).

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 disorders. Estimation of cochlear hearing thresholds (DPTHRESH) is possible at various frequencies without the need of cooperative interaction with the patient. Acoustic reflex and tympanometry (TYMP) are featured to evaluate the function of the middle and outer ear. For each method, several protocols can be configured. The results are to be used to make further recommendations regarding appropriate intervention strategies. Therefore, Sentiero is intended for use by trained personnel such as audiologists. pediatricians. ENT doctors and other health care professionals in a medical or home environment. In the United States of America. Federal law restricts this device to sale by or on the order of a licensed physician.

Available psycho-acoustical methods on Sentiero are especially indicated for use with cooperative patients starting at the age of 2 years or adequate development age, which enables them to do play/interactive audiometry. All other 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 designed for:

1. Diagnostics, monitoring and follow-up after newborn hearing screening
1. Pre-school, school, and adult hearing screening
1. ENT diagnostics based on measurement of
a) Otoacoustic emissions
b) Tympanometry and acoustic reflex
c) Auditory Brainstem Responses
- d) Auditory Steady State Responses

Sentiero must not be used in cases of external otitis (outer ear canal infection) or in any case which vields to pain when inserting the ear probe or applying any other transducer.

COMPARISON TO PREDICATE DEVICES

In terms of technology, workflow, and accessories, the predicate device AccuScreen shares most of the characteristics of Sentiero. In contrast to AccuScreen, which is a screening device, Sentiero provides diagnostic features based on sophisticated algorithms.

With respect to the intended use, combining psycho-acoustical and physiological test modules in a single handheld device, the Cochlea-Scan is similar.

With respect to diagnostic features on evoked potentials, Chartr EP 200 (ABR and ASSR) and Eclipse (OAE, ABR, and ASSR) can be seen as predicate devices.

With respect to the auditory impedance and acoustic reflex (TYMP), the Titan IMP440 can be seen as predicate device.

In order to facilitate the comparison, first the device setup and technical features and then the modules' features are compared.

Device setup and technical features (including accessories)

Design and working principles of Sentiero are very similar to Cochlea-Scan as well as AccuScreen. The similarity can be attributed to the fact that the same engineers at Fischer-Zoth Diagnosesvsteme GmbH (Germany), who designed the Cochlea-Scan at that time, also designed the Sentiero as well as the AccuScreen at PATH medical GmbH. Accessories like probe and cables were designed and are used for both AccuScreen and Sentiero identically. These two systems were also designed in the same period of time using the same technology standards. In contrast thereto, Cochlea-Scan uses older technology standards. Therefore, the comparison to the predicate device with respect to technological characteristics is focused on the comparison between AccuScreen and Sentiero. Non-clinical performance data are also considered substantially equivalent: the development process was conducted by the same engineers and the resulting devices were tested to be compliant to the same standards by independent laboratories.

3

Both systems, Sentiero and AccuScreen, are battery driven handheld devices with the user interface on a 3.5" touch screen (Sentiero type MOD 100497: 5.0"). Probes and electrode cables are connected to the devices with similar plugs. Probes, electrode cables, ear coupler cable to the PC (USB) are identical.

Sentiero and AccuScreen provide the same measurement methods (DPOAE, TEOAE and ABR) in order to provide statistically sound results. In contrary to the AccuScreen, which provides a pass/refer result as an automated screening result, the signal processing information is used in Sentiero only as an indicator (traffic light or indicator for valid response). In addition, wave forms (ABR) or frequency domain information (TEOAE and DPOAE) are provided together with additional diagnosic information and environmental information of the measurement to inform the user about the quality of the measurement.

The primary mechanical difference between AccuScreen and Sentiero is the housing which contains the printed circuit board (PCB) and the charging of the built-in rechargeable batteries. AccuScreen can be connected to a docking station for charging and data transfer. In contrast thereto, Sentiero must be connected to a custom made plug for connecting to the charger is possible via a USB cable connected directly to the device. Both housings are made of biocompatible material to fulfill the standards accordingly.

Both devices, Sentiero and AccuScreen, show similar performance data and compliance to the following standards:

· IEC 60601-1:2005
· IEC 60601-1-2:2007
· IEC 60601-1-4:1996
· IEC 62304:2006
· ISO 10993-1:2009

Safety Electromagnetic compatibility Programmable electrical systems Software lifecycle Biocompatibility

In conclusion, Sentiero is substantially equivalent to the predicate device AccuScreen with respect to technological characteristics and non-clinical performance data.

2) Device measurement features

From a measurement perspective, the methods of predicting a behavioral threshold by means of DPOAE are similar to the predicate device Cochlear-Scan. Also the feature to combine psycho-acoustical test methods like pure tone audiometry and TEOAE or DPOAE on a diagnostic level is similar between both devices. Again, this is supported by the fact, that the same engineers developed both devices. In comparison to Cochlea-Scan, the most significant difference is the technological improvements added to the design of Sentiero. Nevertheless, substantial equivalence is given with respect to the diagnostic features of OAE measurements and hearing threshold predictions.

Additional diagnostic features and measurement techniques were added to Sentiero in comparison to AccuScreen or Cochlea-Scan, which are similar to Chartr EP 200 and Eclipse. Namely the ABR and ASSR features of Sentiero are similar to these predicate devices.

Sentiero uses up to two channels of data recording to run several diagnostic protocols and modalities. The firmware can be configured to run ABR with a traditional click stimulus but also with a tone burst stimulus to predict frequency specific behavioral hearing thresholds. This is similar to the predicate devices Chartr EP 200 and Eclipse. Besides that, Eclipse also provides similar run-time compensated stimuli - similar as Sentiero does (time-delay compensation of the traveling wave on the basilar membrane).

Sentiero can conduct ASSR with a 40 or 80 Hz repetition rate. Several stimuli can be combined together simultaneously and also on both ears to assess responses to various frequencies at the same lime. The evoked response spectrum can yield the information about the presence of the response to stimuli so that ASSR thresholds are supposed to hold a predictable relationship to behavioral thresholds that is dependent on stimulus frequency and the presence or degree of hearing loss. This is similar to the predicate devices Chartr EP 200 and Eclipse.

Besides the difference of dimensions, another difference is that Sentiero can do ABR or ASSR measurements as a standalone system and is therefore not dependent on a PC during the measurement. Chartr EP 200 and Eclipse are all PC-controlled devices.

In a first clinical evaluation in 2011, Sentiero and the predicate device Chartr EP 200 have been tested on the same test persons by different users (trained technicians in audiology). Morphology and latencies of

4

wave V have been analyzed. Furthermore, the usage of the device was evaluated by the feedback of the users. All results have been evaluated by an expert in audiology. Both systems, Sentiero and Chartr EP 200, were described as reliable clinical ABR devices, which supports the substantial equivalence between both instruments with respect to clinical performance. The run time compensated stimuli and algorithms are similar between Sentiero and Eclipse as they were taken out of the descriptions in published literature.

Sentiero also complies to the relevant standards 60645-1, 60645-7 which displays that TEOAE, DPOAE and evoked potentials can be recorded as safe and as effective as the predicate devices.

Sentiero (Type MOD 100497) can also be configured to allow measurements of auditory impedance and acoustic reflex, which are also present on the predicate device TITAN IMP 440. The other types of Sentiero cannot be configured to use the TYMP module. The stimulus is transmitted via the EarProbe EP-DP in conjunction with a silicon tube in parallel to the probe to deliver the air pressure, which is produced by a pump inside the housing of Sentiero. The TYMP is conform to a IEC 60645-5 / ANSI S3.39 Type 1 acoustic impedance instrument.

In order to facilitate the comparison, the device setup and technical features are compared in the following table to the respective predicate device.

| Parameter for

Comparison	Cochlea-Scan	AccuScreen	Chartr EP 200	Eclipse
Intended Use	Same:
Hearing
screening and
diagnostics by
means of OAE
and pure tone
audiometry.	Same:
Hearing screening
with statistical
evaluation of
results by means
of OAE and ABR.
Different:
Limited purpose
(screening) and
age group
(newborns).	Same:
Hearing
diagnostics with
ABR and ASSR.
Different:
No screening, no
OAE tests for
specific
examination of
inner ear hearing
status.	Same:
Hearing
diagnostics and
neurological
screening with
OAE, ABR, and
ASSR.
Patient
Population	Same:
All ages	Different:
Newborns only	Same:
All ages	Same:
All ages
Device
Hardware Setup	Same:
Standalone,
handheld /
portable device,
battery-
powered.	Same:
Same touch
screen display
with same
resolution,
connectors to
cables and
transducers.
Different:
Housing, docking
station	Different:
Connected to PC,
not standalone.	Different:
Connected to PC,
not standalone.
Ear Probe	Same:
See K131141.	Same:
Same probe,
special plugs
Parameter for
Comparison	Cochlea-Scan	AccuScreen	Chartr EP 200	Eclipse
		including memory.
Electrode Cable	Same:	Same:
Same cable,
special plugs
including memory.
Headphones,
Insert
Earphones	Same:
Additional
headphones or
inserts available

automatic
detection
through memory
in plug | Different:
No headphone or
insert earphone to
be connected. | | |
| Safety,
Characteristics,
Performance | Same:
IEC 10993-1,
IEC 60601-1,
IEC 60601-1-2,
IEC 60601-1-4,
EN 1041, ISO
980 (ISO
15223-1), IEC
60645-1, | Same:
IEC 10993-1, IEC
60601-1, IEC
60601-2, 60601-
1-4, IEC 60645-6,
IEC 606045-7,
IEC 62304, IEC
62366 (IEC
60601-1-6) | Same:
IEC 60601-1-2, IEC
60601-2-40
Different:
No
encephalography
application is
mentioned for the
predicate device.
Nevertheless, the
predicate device is
compliant with IEC
60601-2-26.
Sentiero does not
comply with EN
60601-2-26 as
intended use is not
for cerebral
monitoring or
electro-
encephalography. | Same:
IEC 60601-1, IEC
60601-2, IEC
60645-1,
Different:
IEC 60645-3
(only relevant to
click stimuli -
predicate to time
compensated
stimuli is not
affected by this
standard)
IEC 60601-2-26
(see Chartr EP

|
| Workflow,
Menu | Same:
General
workflow
Different:
Lower screen
resolution,
additional keys
to enter data | Same:
General workflow,
online information
and device control
via header/footer | Different:
PC-controlled with
separate
measurement
platform. | Different:
PC-controlled with
separate
measurement
platform. |
| Parameter for
Comparison | Cochlea-Scan | AccuScreen | Chartr EP 200 | Eclipse |
| Available
modules: | Same:
DPOAE,
TEOAE,
DPTHRESHO
LD, Standard
Audiometry | Same:
TEOAE, DPOAE,
ABR
Different:
Sentiero offers
diagnostic
features instead
of screening only | Same:
ABR, ASSR | Same:
ABR, ASSR |
| Interface to
Computer,
Software on
Computer | Same:
USB/RS232
connection | Same:
USB.connection,
data transfer to
PC
Different: docking
station. | Different:
Runs on PC | Different:
Runs on PC |

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6

Table 6-1: Comparison of device setup and technical features (Sentiero against different predicate devices)

1

.

Feature / Comparison	Titan with IMP440 (Predicate) 510(k) No. K083861	Sentiero	Comments
Indications for use	The Titan Impedance System is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conduction diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry and acoustic reflexes.	Sentiero features tympanometry and acoustic reflexes.	Same
Target population	The devices are suitable for all populations including new-born infants	The devices are suitable for all populations including new-born infants	Same
Intended user	The devices are to be used by trained personnel only	The devices are to be used by trained personnel only	Same
Safety standard	IEC 60601-1	IEC 60601-1	Same
EMC standard	IEC 60601-1-2	IEC 60601-1-2	Same
Standards for impedance audiometry	IEC 60645-5/ANSI S3.39, Type 1	IEC 60645-5/ANSI S3.39, Type 1	Same
Test signal	IEC 60645-1/ANSI S3.6, IEC 60645-3	IEC 60645-1/ANSI S3.6, IEC 60645-3	Same
Probe tone frequency (tympanometry)	226 Hz. Optional 678 Hz, 800 Hz and 1000 Hz	226 Hz. 678 Hz, 800 Hz and 1000 Hz optionally available	Same

7

| Probe tone level

(tympanometry)	69 dB HL with AGC	69 dB HL with AGC	Same
Pressure safety limits	-750...+550 daPa	-700...+500 daPa	Equivalent
Safety limits need to be
within the range of -
800...+600 daPa
according to IEC
60645-5/ANSI S3.39, a
smaller range means
increased safety
Transducers	Ear probe for
tympanometry, ear
probe and
headphone/insert ear
phone for reflex
measurement	Ear probe for
tympanometry, ear
probe and
headphone/insert ear
phone for reflex	Equivalent
Different models of ear
probe and headphones
are used, all of them
generating test signals
complying to IEC
60645-5/ANSI S3.39
standards
Reflex stimuli	Pure tones at
audiometric
frequencies, narrow
and wide band noise	Pure tones at
audiometric
frequencies, narrow
and wide band noise	Same

TABLE 6-3: COMPARISON OF TEST MODULE TYMP

OVERALL CONCLUSION

The clinical tests showed that Sentiero can be used by professionals as efficiently as the respective predicate devices. The nonclinical tests shows that Sentiero is as similar safe, as effective and as performant as the predicate devices.

| Target population | The devices are
suitable for all
populations including
new-born infants | The devices are
suitable for all
populations including
new-born infants | Same |
|------------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended user | The devices are to be
used by trained
personnel only | The devices are to be
used by trained
personnel only | Same |
| Safety standard | IEC 60601-1 | IEC 60601-1 | Same |
| EMC standard | IEC 60601-1-2 | IEC 60601-1-2 | Same |
| Standards for
impedance
audiometry | IEC 60645-5/ANSI
S3.39, Type 1 | IEC 60645-5/ANSI
S3.39, Type 1 | Same |
| Test signal | IEC 60645-1/ANSI
S3.6, IEC 60645-3 | IEC 60645-1/ANSI
S3.6, IEC 60645-3 | Same |
| Probe tone frequency
(tympanometry) | 226 Hz. Optional 678
Hz, 800 Hz and 1000
Hz | 226 Hz. 678 Hz, 800
Hz and 1000 Hz
optionally available | Same |
| Probe tone level
(tympanometry) | 69 dB HL with AGC | 69 dB HL with AGC | Same |
| Pressure safety limits | $-750...+550$ daPa | $-700...+500$ daPa | Equivalent
Safety limits need to be
within the range of -
$-800...+600$ daPa
according to IEC
60645-5/ANSI S3.39, a
smaller range means
increased safety |
| Transducers | Ear probe for
tympanometry, ear
probe and
headphone/insert ear | Ear probe for
tympanometry, ear
probe and
headphone/insert ear | Equivalent
Different models of ear
probe and headphones
are used, all of them |

8

| | phone for reflex
measurement | phone for reflex | generating test signals
complying to IEC
60645-5/ANSI S3.39
standards |
|----------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Reflex stimuli | Pure tones at
audiometric
frequencies, narrow
and wide band noise | Pure tones at
audiometric
frequencies, narrow
and wide band noise | Same |

TABLE 10-3: COMPARISON OF TEST MODULE TYMP

OVERALL CONCLUSION

Sentiero shows similar safety, effectiveness and performance data as the respective predicate devices.

CONCISE SUMMARY OF PERFORMANCE TESTING

Sentiero (all types and accessories) was tested by independent external laboratories with respect to the following standards:

· IEC 60601-1:1988
· IEC 60601-1:2005
· · IEC 60601-1-2:2007
- · IEC 60601-2-40:1998

Safety Safety Electromagnetic compatibility Safety of electromyographs and devices for evoked potentials

PATH medical GmbH is certified according to Medical Device Directive 93/42 ECC and holds certificates for compliance with respect to the following standards:

· ISO 9001:2008 Quality management system
· ISO 13485:2003 Quality management system (medical devices)

Basing on this, reqular audits and compliance checks are performed by the following notified bodies:

· Notified body for certification in Europe: DEKRA Certification GmbH (Germany), (see certificate in the Appendix).
· Notified body for certification in Canada: DEKRA Certification B.V. (Netherlands), (see certificate in the Appendix).

Performance tests were also conducted on a test bench. For this reason a simulator device, which simulates TEOAE, DPOAE or ABR output was used for proof of validity of the derived signal. The same simulator device was distributed by Natus Europe GmbH as a testing device for the predicate devices AccuScreen and Cochlea-Scan.

The device under test (DUT) had to be connected to deliver the stimulus (via insert earphone or ear probe) into a cavity of the simulator. The simulator was connected to the electrode cable of the DUT to record the test result. The stimulator was able to deliver noise or dedicated normative answers derived from literature. The same simulator was used for Sentiero as well as the predicate devices Cochlea-Scan and AccuScreen. The simulator was developed by the same engineers who developed the Cochlea-Scan as well as the AccuScreen. Passing the requirements given by the simulator was part of the acceptance criteria for the verification phase of the device development cycle. Consequently the performance of the test

modules TEOAE, DPOAE, DPTHRES. ABR were validated in comparison to the predicate devices during the in-house validation phase of Sentiero. The test protocol is attached in the Appendix.

Additionally Sentiero was tested against the following standards to show compliance and performance as follows:

· ISO 10993-1:2009 Biocompatibility
· IEC 60601-1-4:1996 Programmable electrical system
· IEC 60601-2-40:1998 Safety of electromyographs and devices for evoked potentials
· IEC 62304:2006 Software lifecycle

9

· IEC 60645-1:2001 Pure-tone audiometer
· IEC 60645-6:2009 Otoacoustic emissions
· IEC 60645-7:2009 Acoustically evoked potentials
· ISO 389-1:1998 Reference levels for pure tones and supra aural headphones
· ISO 389-2:1994 Reference levels for pure tones and insert earphones
· ISO 389-3:1994 Reference force levels for pure tones and bone conductors
· ISO 389-4:1994 Reference levels for narrow band masking noise
· ISO 389-5:2006 Reference levels for pure tones from 8 to 16 kHz
· ISO 389-8:2004 Reference levels for pure tones and circumaural headphones

Sentiero successfully passed the tests and checklists of the aforementioned standards. Thus it is shown that Sentiero is as safe, efficient and performing as the predicate devices which also fulfill the standards as mentioned in the comparison table above.

In preparation of the first application for receiving the CE mark for Sentiero, additional test sites were asked to evaluate the performance of relevant test modules and the handling of the instrument. To state clearly: all implemented modules on Sentiero are derived from well-known algorithms, which are described in detail in published literature. The design process of Sentiero included in-house verification tests also with respect to the mentioned literature and and establishment of normative data. In addition, external potential users were asked to validate the measurement results and the usage of the device and test modules (usability tests and performance tests). Comparison measurements had to be done with predicate devices and normal hearing patients with hearing loss. Minimum number of participants per evaluation was 20. Multiple users should be involved to verify usability of the device in comparison to experience level of the user.

No tests were conducted with respect to animal testing.

The test sites, which participated in the evaluation of test modules on Sentiero are shown in Table 10-4. Please note that not all these testers and studies did receive financial support from PATH medical. Most of the evaluation data and feedback was contributed by initiative from the tester. The tester a financial arrangement with PATH medical - except the two sites mentioned in section 9 of this document, where PATH was the sponsor and initiator of the study.

Sentiero Module	Predicate device	Tester
PTA class 3	Cochlea-Scan
(DPOAE
threshold
estimation)	Prof. Dr. med. Annerose Keilmann
MAGIC (image-
based pure tone
audiometry)		Center of Communication Disorders, ENT Clinic,
University Medical Center of the Johannes-
Guttenberg-University Mainz, Mainz, Germany
MATCH (image-
based speech test)	Established
speech tests
(e.g. Mainzer
speech test for
children)
DPTHRES (DPOAE
threshold estimation)
ABR	Chartr EP 200	Ph.D. Stavrous Hatzopoulos
		Department of Audiology and Speech Therapy,
University of Ferrara, Ferrara, Italy
TEOAE	AccuScreen
(TEOAE, DPOAE)	Prof. Dr. med. Hans Peter Niedermeyer
DPQUICK (DPOAE
at fixed levels)		ENT Clinic, Klinikum rechts der Isar, Technische
DPTHRES (DPOAE
threshold estimation)		Universität München, Munich, Germany
ASSR	Cochlea-Scan
(DPOAE
threshold
estimation)	Dr. Thomas Rosner
	ECLIPSE	ENT Clinic, Klinikum rechts der Isar. Technische

10

Sentiero Module	Predicate device	Tester
		Universität München, Munich, Germany
ABR	ABR device,
unknown type.	PD Dr. med. Nicolas Schmuziger
		ENT Clinic, Kantonsspital Liestal, Liestal, Switzerland
PTA	EchoScreen/Accu
Screen and
CochleaScan	Prof. Dr. Katrin Neumann
MAGIC (image-
based pure tone
audiometry)		Department of Phoniatry and Pedaudiology. ENT
Clinic, St .- Elisabeth-Hospital, Bochum, Germany
TEOAE
DPQUICK (DPOAE
at fixed levels)
DPTHRES (DPOAE
threshold estimation)
ABR

Table 10-4: List of external tests including tested module and the corresponding tester

Out of these studies reports were generated or published, which indicated that Sentiero is an equivalence to the given predicate devices with respect to clinical application/usage.

11

Image /page/11/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines that suggest movement and dynamism. The bird is positioned above a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring. MD 20993-002

June 9, 2014

PATI Medical GmbH c/o Dr. Johann Oswald Director of PATH Medical GmbH Landsberger Str.63 Germering. Bavaria GM D-82110

Rc: K133012

Trade/Device Name: Sentiero Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO. GWJ. ETY Dated: May 1. 2014 Received: May 6. 2014

Dear Dr. Oswald:

We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28. 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into cither 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.

12

Page 2 - Dr. Johann Oswald

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

13

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

Device Name

Sentiero

MICRO

Indications for Use (Describe)

Sentiero is a portable instrument to diages for hearing loss. The instrument offers different test nethods which can be configured to fit the professional's needs for screening or diagnostic purposes. It offers physiological test methods such as:

· Distortion Product Otoacoustic Emissions (DPOAF)

· Transient Evoked Otoacoustic Emissions (TEOAF)

· Auditory Brainstem Response (ABR)

· Auditory Steady State Response (ASSR)

· Auditory Impedance and acousiic relles (TYMP) Additionally if offers standard audiometry (psycho-acousiveal). 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 disorders. Estination of cochlear hearing thresholds (DP THRESI) is possible at various frequencies without the need of cooperative interaction with the pairent. Acoussic rellex and tympanomery (TYMP) are featured the functional condition of the middle and outer car. For each method, several protocols can be configured. The results are to be used to make further recommendations regarding appropriate interention strategies. Therefore, Sentiero is intended for use by trained personnel such as audiologiss, pediatricians. ENT doctors and other health care professionals. In the United States of America. Federal law restricts this device to sale by or on the order of a licensed physician.

A vailable psycho-acoustical methods on Sentiero are especially indicated for use with cooperative parting at the age of 2 years or adequate development age, which enables them to do playinters. All other modules are suitable to be used for all ages.

Sentiero is designed for:

Diagnostics, monitoring and follow-up after newborn hearing screening
Pre-school, school. and adult hearing screening
ENT diagnostics based on measurement of

· Otoacoustic emissions

· Tympanometry and acoustic reflex

· Auditory Brainstem Responses

· Auditory Steady State Responses

Sentiero must not be used in cases of external otitis (outer car canal intection) or in any case which yields to pain when inserting the ear probe or applying any other transducer.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpan D)

Over-The-Counter Use (21 CFR 801 Subpart C)

14

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