(197 days)
Not Found
No
The summary describes automated evaluation based on signal statistics and a simple "PASS", "REFER", or "INCOMPLETE" result, which does not indicate the use of AI/ML. There are no mentions of AI, ML, deep learning, training data, or complex algorithms typically associated with AI/ML.
No
Explanation: The device is described as a "hearing screener" intended for recording and automated evaluation of Otoacoustic Emissions (OAE) and Auditory Brainstem Responses (ABR). It is used for diagnosis and screening, not for treatment or therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the QSCREEN device is a "hearing screener intended for recording and automated evaluation of Otoacoustic Emissions (OAE) and Auditory Brainstem Responses (ABR)." These tests are used to "obtain objective evidence of peripheral auditory function" and "peripheral and retro-cochlear auditory function," which are diagnostic purposes to identify potential hearing issues. The device evaluates results and provides "PASS", "REFER", or "INCOMPLETE" outputs, indicating its role in diagnosing or identifying a condition.
No
The device description explicitly states it is a hand-held and portable audiometric examination device with a touch screen display, battery power, and various physical accessories (Docking Station, Ear Coupler Cable, Ear probe, Insert earphone, Electrode cable). It also mentions hardware testing like electrical safety, EMC, mechanical, and acoustic testing. This indicates it is a hardware device containing software, not a software-only medical device.
Based on the provided information, the QSCREEN device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for "recording and automated evaluation of Otoacoustic Emissions (OAE) and Auditory Brainstem Responses (ABR)." These are physiological responses measured from the patient.
- Device Description: The device description details how it measures these responses using probes and electrodes placed in or on the body.
- Evaluation of Results: The device performs an "automated evaluation" of the collected data, resulting in a "PASS," "REFER," or "INCOMPLETE" outcome. This evaluation is based on the physiological signals measured.
While the device itself is a medical device used to collect physiological data, the evaluation of that data to determine a "PASS" or "REFER" outcome based on the measured OAE and ABR signals falls under the scope of in vitro diagnostics. It's analyzing biological signals to provide information about a patient's health status (in this case, hearing function).
The fact that it doesn't involve analyzing samples like blood or urine doesn't preclude it from being an IVD. The definition of IVD includes devices used to examine specimens derived from the human body, and physiological signals like OAE and ABR can be considered a type of specimen derived from the body's function.
Therefore, the QSCREEN device, with its automated evaluation of physiological responses for diagnostic purposes, fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The QSCREEN device is a hand-held, portable hearing screener intended for recording and automated evaluation of Otoacoustic Emissions (OAE) and Auditory Brainstem Responses (ABR). Distortion Product Otoacoustic Emission (DPOAE) and Transient Evoked Otoacoustic Emission (TEOAE) tests are applicable to obtain objective evidence of peripheral auditory function. ABR tests are applicable to obtain objective evidence of peripheral and retro-cochlear auditory function including the auditory nerve and the brainsten. QSCREEN is intended to be used in subjects of all ages. It is especially indicated for use in testing individuals for whom behavioral results are deemed unreliable.
Product codes
GWJ, EWO
Device Description
The QScreen is a hand-held and portable audiometric examination device offering test methods for the measurement of Otoacoustic Emissions (OAE) including transitory evoked otoacoustic emissions (TEOAE), distortion product otoacoustic emissions (DPOAE) and Auditory Evoked Responses like Auditory Brainstem Responses (ABR) in patients of all ages. It has a touch screen display and can be used with different accessories, such as its Docking Station, Ear Coupler Cable, Ear probe, Insert earphone, and Electrode cable.
QScreen is a battery powered device which is charged by the Docking Station wirelessly and communicates with the Docking Station via Bluetooth. The Docking Station can be connected to a personal computer (PC) via USB cable on which patient and test data can be reviewed and managed with the optional software. Additionally, device and user profile configurations can be conducted with the software. Printing the data is also possible and carried out by a label printer that can be connected to the Docking Station. The QScreen device also contains a camera on the back side to read linear bar codes and QR codes. All materials that come into contact with human skin are selected to be biocompatible.
The operating system on the QScreen is a self-contained firmware. The user is guided by the menu on the touch screen through the measurement. The results are evaluated on the base of signal statistics. The device offers an automatically created result, which can have the values "PASS" (Clear Response), "REFER" (No Clear Response) or "INCOMPLETE" (Test aborted).
The following accessories are available to conduct a measurement:
- EP-LT (Longitudinal ear probe)
- EP-DP
- PIEP (PATH Insert Earphone)
- PECC (PATH Ear Coupler Cable) with Ear Couplers .
- Electrode cable (shielded, passive cable to connect the instrument to electrodes)
- Headphone
These accessories can be connected to QScreen using special colored and mechanical coded plugs with memory chips, which hold the information about the connected transducer / cable, such as its correct and supported connection to the device and further stored information like calibration data and the status of the cable. By that, the firmware can make use of this information and adapt the measurement procedure according to calibration values or provide information to the user via its display.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral auditory function, auditory nerve, brainstem.
Indicated Patient Age Range
subjects of all ages
Intended User / Care Setting
audiologists, ear-nose-throat (ENT) doctors, and other hearing health care professionals, nurses and audiologically trained personnel. It is not intended to be operated by lay users.
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)
Non-Clinical Performance Data:
Biocompatibility testing: The biocompatibility evaluation was conducted according to ISO 10993-1:2018. Following tests were applied: Cytotoxicity according to ISO 10993-5:2009, Sensitization according to ISO 10993-10:2010, Irritation according to ISO 10993-10:2010.
Electrical safety and electromagnetic compatibility (EMC): The QScreen 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 (including Bluetooth and wireless charging features), IEC 60601-2-40: 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 life cycle standard IEC 62304:2015 was applied during the development process.
Usability Testing: The QScreen has been developed and tested according to the Usability standard EN 62366:2015 including extensive risk assessment and mitigation, user interface evaluations, and identification of the primary operating functions.
Mechanical and Acoustic Testing: Maximum possible sound level will remain below a possibly threatening level even under electrical failure. Push, Drop, and Mould Stress Relief test. Frequency content, timing, sound level, and repetition rate of the stimuli equivalent to the predicate Sentiero's stimuli.
Literature Review: A clinical evaluation of the QScreen showed that the implementation of ABR and OAE screening on the subject device matches the current state of the art.
Clinical Performance Data: No clinical performance data was collected for the subject device QScreen. Substantial equivalence was shown through bench testing and compliance to international standards (IEC 60645-6:2009 (OAE) and IEC 60645-7:2009 (ABR)).
Bench testing was performed for relevant audiological characteristics of the stimulus delivered to the patient as well as interpretation of the recorded potential. These tests included frequency, timing and sound level of the stimulus as well as noise resistance and the lowest response signal detectable by the device. The results show the substantial equivalence of the subject device to the predicate device in terms of non-clinical performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1900 Evoked response auditory stimulator.
(a)
Identification. An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 3, 2022
PATH MEDICAL GmbH Johann Oswald Managing Director Landsberger Strasse 65 Germering, Bavaria 82110 Germany
Re: K220139
Trade/Device Name: QScreen Regulation Number: 21 CFR 882.1900 Regulation Name: Evoked Response Auditory Stimulator Regulatory Class: Class II Product Code: GWJ, EWO Dated: January 12, 2022 Received: July 7, 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrl-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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220139
Device Name QScreen
Indications for Use (Describe)
The QSCREEN device is a hand-held, portable hearing screener intended for recording and automated evaluation of Otoacoustic Emissions (OAE) and Auditory Brainstem Responses (ABR). Distortion Product Otoacoustic Emission (DPOAE) and Transient Evoked Otoacoustic Emission (TEOAE) tests are applicable to obtain objective evidence of peripheral auditory function. ABR tests are applicable to obtain objective evidence of peripheral and retro-cochlear auditory function including the auditory nerve and the brainsten. QSCREEN is intended to be used in subjects of all ages. It is especially indicated for use in testing individuals for whom behavioral results are deemed unreliable.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| > Prescription Use (Part 21 CFR 801 Subpart D) | __ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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
SUBMISSION INFORMATION
| Date of preparation: | August 3, 2022 |
|---|---|
| 510(k) Submitter: | PATH MEDICAL GmbH |
| Landsberger Str. 65 | |
| 82110 Germering | |
| Germany | |
| Phone: ++49-89-80076502 | |
| Fax: ++49-89-80076503 | |
| Contact Person: | Dr. Johann Oswald, Managing Director |
| Landsberger Str. 65 | |
| 82110 Germering | |
| Germany | |
| Phone: ++49-89-80076502 | |
| Fax: ++49-89-80076503 | |
| Email: oswald@pathme.de |
DEVICE INFORMATION
| Device Name: | QScreen |
|---|---|
| Device Trade Names: | QScreen |
| Device Identification Codes: | PM1610 |
| Common Name: | Evoked Response Auditory Stimulator |
| Classification Name: | Evoked Response Auditory Stimulator |
| Classification Name: | FDA 21CFR882.1900 & 21CFR874.1050 |
PREDICATE DEVICE
| Sentiero | 510(k) Number: K133012 |
|---|---|
| ---------- | ------------------------ |
DEVICE DESCRIPTION
The QScreen is a hand-held and portable audiometric examination device offering test methods for the measurement of Otoacoustic Emissions (OAE) including transitory evoked otoacoustic emissions (TEOAE), distortion product otoacoustic emissions (DPOAE) and Auditory Evoked Responses like Auditory Brainstem Responses (ABR) in patients of all ages. It has a touch screen display and can be used with different accessories, such as its Docking Station, Ear Coupler Cable, Ear probe, Insert earphone, and Electrode cable.
4
Image /page/4/Picture/1 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, the word "PATH" is written in bold, black letters above the word "MEDICAL", which is also written in black letters, but is smaller than the word "PATH".
QScreen is a battery powered device which is charged by the Docking Station wirelessly and communicates with the Docking Station via Bluetooth. The Docking Station can be connected to a personal computer (PC) via USB cable on which patient and test data can be reviewed and managed with the optional software. Additionally, device and user profile configurations can be conducted with the software. Printing the data is also possible and carried out by a label printer that can be connected to the Docking Station. The QScreen device also contains a camera on the back side to read linear bar codes and QR codes. All materials that come into contact with human skin are selected to be biocompatible.
The operating system on the QScreen is a self-contained firmware. The user is guided by the menu on the touch screen through the measurement. The results are evaluated on the base of signal statistics. The device offers an automatically created result, which can have the values "PASS" (Clear Response), "REFER" (No Clear Response) or "INCOMPLETE" (Test aborted).
The following accessories are available to conduct a measurement:
- EP-LT (Longitudinal ear probe) ●
- EP-DP ●
- PIEP (PATH Insert Earphone)
- PECC (PATH Ear Coupler Cable) with Ear Couplers .
- Electrode cable (shielded, passive cable to connect the instrument to electrodes) ●
- Headphone
These accessories can be connected to QScreen using special colored and mechanical coded plugs with memory chips, which hold the information about the connected transducer / cable, such as its correct and supported connection to the device and further stored information like calibration data and the status of the cable. By that, the firmware can make use of this information and adapt the measurement procedure according to calibration values or provide information to the user via its display.
COMPARISON TO THE PREDICATE DEVICE:
| QScreen
(subject) | | Sentiero
(predicate) | Equivalency |
|--------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended purpose | | | |
| Intended Use | The QScreen offers methods for
Screening for OAEs (TEOAE and
DPOAE) and ABR.
QScreen is to be used by audiolo-
gists, ear-nose-throat (ENT) doc-
tors, and other hearing health
care professionals, nurses and au-
diologically trained personnel. It is
not intended to be operated by
lay users. | All physiological test methods
are especially indicated for use
in defining the type and con-
figuration of hearing loss partic-
ularly for individuals whose be-
havioral audiometric results are
deemed unreliable or to assist
in the diagnosis of otologic dis-
orders.
In addition, the Sentiero offers | Different:
Sentiero offers
more test mod-
ules.
The modules
available on the
QScreen are a
subset of the
modules availa-
ble on the Sen-
tiero. |
| | QScreen | Sentiero | Same/Different |
| Indications for Use | QScreen is intended for indoor-
use only and must be operated at
defined environmental conditions.
QScreen is not intended for use in
oxygen-rich environments.
The QScreen device is a hand- held, portable hearing screener intended for recording and automated evaluation of Otoacoustic Emissions (OAE) and Auditory Brainstem Responses (ABR). Distortion Product Otoa- coustic Emission (DPOAE) and Transient Evoked Otoacoustic Emission (TEOAE) tests are applicable to obtain objective evidence of peripheral auditory function. ABR tests are applicable to obtain objective evidence of peripheral and retro-cochlear auditory function including the auditory nerve and the brainstem.
QScreen is intended to be used in subjects of all ages. It is especially indicated for use in testing individ- uals for whom behavioral audio- metric results are deemed unrelia- ble. | DPOAE) as well as diagnostics
(Audiometry, OAE, AEP
measurements, Tympa- nometry).
Sentiero is intended for use by trained personnel such as audiologists, pediatricians, ENT doctors and other health care professionals.
Sentiero is a portable instru- ment to diagnose all ages for hearing loss.
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.
Available psycho-acoustical methods on Sentiero are especially indicated for use with cooperative patients start- ing at the age of 2 years or ad- equate development age, which enables them to do play/interactive audiometry. All other modules are suitable to be used for all ages.
Sentiero is designed for:
- Diagnostics, monitoring and follow-up after newborn hear- ing 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 Re- sponses
d. Auditory Steady State Responses | Different:
QScreen IFU is a subset of Sen- tiero. The diag- nostic modules in the Sentiero are not availa- ble in the QScreen. |
| Physiological features | | | |
| Biosignal | Evoked potential, Evoked emissions | Evoked potential, Evoked emissions | Same |
| | | | |
| Electrode position | Forehead, nape of neck and
cheek | Forehead, nape of neck and
cheek | Same |
| Stimulation
target | Cochlea | Cochlea | Same |
| EEG record-
ing channels,
number of
electrode
contacts | 1,3 | 1,3 | Same |
| Accessories | | | |
| Transducer | Ear probes, Insert earphones, Ear
coupler cable, Headphones
manufactured by PATH MEDICAL | Ear probes, Insert earphones,
Ear coupler cable, Head-
phones manufactured by
PATH MEDICAL | Same |
| Electrode
Cable | PATH MEDICAL Electrode Cable
(shielded, 3 clamps) | PATH MEDICAL Electrode Ca-
ble, (shielded, 3 clamps) | Same |
| Electrodes | Snap Hydrogel-electrodes | Snap Hydrogel-electrodes | Same |
| Ear Coupler | PATH MEDICAL Ear Coupler | PATH MEDICAL Ear Coupler | Same |
| Probe Tips +
Ear Tips | PATH MEDICAL Probe tips + Ear
Tips | PATH MEDICAL Probe tips + Ear
Tips | Same |
| Implementation details | | | |
| Measuring
method ABR | • Chirp stimulus
• 85 Hz ± 10% stimulus repetition
rate (randomized)
• 30, 35, 40, 45 dB nHL stimulus
level
• noise-weighted averaging and
template matching with statistical
evaluation
• Result interpretation: By the
device | • Chirp stimulus
• 85 Hz ± 10% stimulus repetition
rate (randomized)
• 30, 35, 40, 45 dB nHL stimulus
level
• noise-weighted averaging
and template matching with
statistical evaluation
• Result interpretation: By the
device | Different:
More stimuli and
protocols
available on the
Sentiero for di-
agnostic ABR.
The available
protocols and
stimuli on the
QScreen are a
subset of the
Sentiero. |
| Measuring
method OAE | • TEOAE: Click stimulus
• DPOAE: Sinusoidal tones
• TEOAE: 59-76 Hz stimulus
repetition rate (randomized)
• TEOAE: 85 dB peSPL stimulus
level
• noise-weighted averaging with
statistical evaluation
• Result interpretation: By the
device | • TEOAE: Click stimulus
• DPOAE: Sinusoidal tones
• TEOAE: 59-76 Hz stimulus
repetition rate (randomized)
• TEOAE: 85 dB peSPL stimulus
level
• noise-weighted averaging
with statistical evaluation
• Result interpretation: By the
device | Different:
More stimuli and
protocols
available on the
Sentiero for di-
agnostic OAE.
The available
protocols and
stimuli on the
QScreen are a
subset of the
Sentiero. |
| Screening
options | Each ear individually or
simultaneously | Each ear individually or
simultaneously | Same |
| Result inter-
pretation | By the device | By the device | Same |
| Result repre-
sentation | PASS/REFER/INCOMPLETE | PASS/REFER/INCOMPLETE | Same |
| Technological details | | | |
| Hardware
setup | Standalone,
handheld / portable
device, battery powered.
Operated via Touch Screen.
Can be charged using a Docking
Station. | Standalone,
handheld / portable
device, battery powered.
Operated via Touch Screen. | Different:
Identical
except the
Sentiero does
not use a
docking station.
Electrical safety
tests included
the docking
station. |
| Workflow | Operation via Touch Screen.
Screen layout: header, main
panel, footer for navigation.
GUI: The home screen: 3x3 tile lay-
out having access to the main
features of the device. | Operation via Touch Screen.
Screen layout: header, main
panel, footer for navigation.
GUI: List layout | Different:
QScreen uses
grid layout due
to the reduced
number of
available
options
compared to
the Sentiero. |
| Interface to
Computer,
Software on
Computer | Data Transfer via Bluetooth to
Docking Station and USB data
transfer from Docking station to
PC. | Data Transfer via USB cable to
PC. | Different:
The QScreen
additionally uses
an FCC certified
Bluetooth
module. |
| Device Firm-
ware: | The firmware architecture is
based on a proprietary operating
system: runtime-model based on
a graphical user interface library,
which processes user input and
updates the touch screen.
Firmware is based on PATH's
Sentiero device family. Basic
functionalities like measurement
algorithms, patient and user
management, communication
protocols, localization, etc. share
common code.
QScreen specific modules (i.e.
barcode reader) are added to
the basic firmware. | The firmware architecture is
based on a proprietary operat-
ing system: runtime-model
based on a graphical user in-
terface library, which processes
user input and updates the
touch screen.
Firmware is based on PATH's
Sentiero device family. Basic
functionalities like measure-
ment algorithms, patient and
user management, communi-
cation protocols, localization,
etc. share common code. | Different:
QScreen mod-
ules are a sub-
set of the Sen-
tiero modules.
Barcode scan-
ner has no influ-
ence on safety
or effectiveness
of the device. |
| PC Software | PC Software for data analysis and
archiving | PC Software for data analysis
and archiving | Same |
| Battery,
Charger | Battery- driven using Li-Ion tech-
nology (10.4Wh), medical grade
charger, no user-exchangeable
battery. | Battery-driven NiMH (7.2Wh) in
Sentiero Handheld/ Li-Ion
(9.6Wh) in Sentiero Desktop,
medical grade charger, no
user-exchangeable battery. | Same type as
Sentiero Desk-
top. Slightly
higher capacity
will have no ef-
fect on safety or
effectiveness. |
5
Image /page/5/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. To the right of the square is the word "PATH" in black, bold letters. Below the word "PATH" is the word "MEDICAL" in smaller, black letters.
6
Image /page/6/Picture/0 description: The image shows the logo for Path Medical. The logo consists of a red square on the left with a white curved line running through it. To the right of the square is the word "PATH" in large, bold, black letters, with the word "MEDICAL" in smaller, black letters underneath.
7
Image /page/7/Picture/0 description: The image contains the logo for Path Medical. The logo consists of a red square on the left with a white curved line running through it. 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.
8
Image /page/8/Picture/0 description: The image contains the logo for PATH Medical. The logo consists of a red square on the left side with a white curved design inside. To the right of the square, the word "PATH" is written in large, bold, black letters, with the word "MEDICAL" written in smaller, black letters directly below it.
Table 5. 1 Comparison to predicate device
Non-Clinical Performance Data:
Biocompatibility testina:
The biocompatibility evaluation was conducted according to ISO 10993-1:2018. Following tests were applied:
- Cytotoxicity according to ISO 10993-5:2009 ।
- Sensitization according to ISO 10993-10:2010 -
- -Irritation according to ISO 10993-10:2010
Electrical safety and electromagnetic compatibility (EMC):
The QScreen 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 (including Bluetooth and wireless charging features), IEC 60601-2-40: 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 life cycle standard IEC 62304:2015 was applied during the development process.
Usability Testing:
The QScreen has been developed and tested according to the Usability standard EN 62366:2015 including extensive risk assessment and mitigation, user interface evaluations, and identification of the primary operating functions.
Mechanical and Acoustic Testing:
- Maximum possible sound level will remain below a possibly threatening level even . under electrical failure
- . Push, Drop, and Mould Stress Relief test
- . Frequency content, timing, sound level, and repetition rate of the stimuli equivalent to the predicate Sentiero's stimuli
Literature Review:
A clinical evaluation of the QScreen showed that the implementation of ABR and OAE screening on the subject device matches the current state of the art.
The template and basic ABR algorithm implemented on Sentiero and QScreen devices are discussed in the following publications:
9
Image /page/9/Picture/1 description: The image is a logo for Path Medical. The logo has a red square on the left side with a white curved line going through it. To the right of the square is the word "PATH" in bold black letters, with the word "MEDICAL" underneath it in smaller black letters.
Peters, J. G. "An automated infant screener using advanced evoked response technology." The Hearing Journal 39 (1986): 25-30.
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Clinical Performance Data:
No clinical performance data was collected for the subject device QScreen. Substantial equivalence was shown through bench testing and compliance to international standards (IEC 60645-6:2009 (OAE) and IEC 60645-7:2009 (ABR)).
SUBSTANTIAL EQUIVALENCE
The QScreen device utilizes the same methods, stimulus parameters and accessories to evoke, record, process and detect ABR and OAE responses as implemented in the predicate Sentiero.
Bench testing was performed for relevant audiological characteristics of the stimulus delivered to the patient as well as interpretation of the recorded potential. These tests included frequency, timing and sound level of the stimulus as well as noise resistance and the lowest response signal detectable by the device. The results show the substantial equivalence of the subject device to the predicate device in terms of non-clinical performance.
Additionally, biocompatibility, electrical safety, and EMC testing was conducted by independent laboratories to demonstrate that the subject device is as safe and as effective as the predicate device.
The QScreen uses the same material and manufacturers for the housing, sockets, plugs, charger, display, PCB and the accessories as the predicate Sentiero device.
OVERALL CONCLUSION
The comparison between QScreen and the predicate Sentiero reveal comparable technical characteristics such as test parameters, recording techniques, and accessories. As the QScreen has a subset of the functionality of the Sentiero device, differences in the scope of testing and indications for use do not raise different question of safety or effectiveness.
The QScreen can be considered substantially equivalent to the predicate Sentiero in terms of technological aspects and indications for use.