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 brainstem. 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.

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).

AI/ML Overview

The provided text is a 510(k) summary for the PATH MEDICAL GmbH's QScreen device. It states that "No clinical performance data was collected for the subject device QScreen. Substantial equivalence was shown through bench testing and compliance to international standards..." As such, the document does not contain the information required to answer the prompt regarding acceptance criteria and the study that proves the device meets the acceptance criteria (specifically clinical performance data).

Therefore, I cannot provide:

A table of acceptance criteria and the reported device performance
Sample sized used for the test set and the data provenance
Number of experts used to establish the ground truth
Adjudication method
If a multi reader multi case (MRMC) comparative effectiveness study was done
If a standalone performance study was done
The type of ground truth used
The sample size for the training set
How the ground truth for the training set was established

The document explicitly states that no clinical performance data was collected to demonstrate the device meets acceptance criteria via a clinical study. Instead, substantial equivalence to a predicate device (Sentiero) was shown through:

Bench testing: This included tests for "frequency, timing and sound level of the stimulus as well as noise resistance and the lowest response signal detectable by the device."
Compliance to international standards: IEC 60645-6:2009 (OAE) and IEC 60645-7:2009 (ABR).
Biocompatibility testing: According to ISO 10993-1:2018 (Cytotoxicity, Sensitization, Irritation).
Electrical safety and electromagnetic compatibility (EMC) testing: According to IEC 60601-1:2005/AMD1:2012, IEC 60601-1-2:2014, IEC 60601-2-40: 2016.
Software Verification and Validation Testing: According to FDA's guidance and IEC 62304:2015.
Usability Testing: According to EN 62366:2015.
Mechanical and Acoustic Testing: Including maximum sound level, push, drop, and mould stress relief tests, and frequency content, timing, sound level, and repetition rate of stimuli.
Literature Review: Citing publications on ABR algorithm and automated infant screening.

The comparison to the predicate device focuses on technical characteristics, intended use (where QScreen is a subset of Sentiero's functionality), and accessories, stating that these differences "do not raise different question of safety or effectiveness."

Summary

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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

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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

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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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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 GmbHLandsberger Str. 6582110 GermeringGermanyPhone: ++49-89-80076502Fax: ++49-89-80076503
Contact Person:	Dr. Johann Oswald, Managing DirectorLandsberger Str. 6582110 GermeringGermanyPhone: ++49-89-80076502Fax: ++49-89-80076503Email: 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

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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".

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 forScreening for OAEs (TEOAE andDPOAE) and ABR.QScreen is to be used by audiolo-gists, ear-nose-throat (ENT) doc-tors, and other hearing healthcare professionals, nurses and au-diologically trained personnel. It isnot intended to be operated bylay users.	All physiological test methodsare especially indicated for usein defining the type and con-figuration of hearing loss partic-ularly for individuals whose be-havioral audiometric results aredeemed unreliable or to assistin the diagnosis of otologic dis-orders.In addition, the Sentiero offers	Different:Sentiero offersmore test mod-ules.The modulesavailable on theQScreen are asubset of themodules availa-ble on the Sen-tiero.
	QScreen	Sentiero	Same/Different
Indications for Use	QScreen is intended for indoor-use only and must be operated atdefined environmental conditions.QScreen is not intended for use inoxygen-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, AEPmeasurements, 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:1. Diagnostics, monitoring and follow-up after newborn hear- ing screening2. Pre-school, school, and adult hearing screening3. ENT diagnostics based on measurement ofa. Otoacoustic emissionsb. Tympanometry and acoustic reflexc. Auditory Brainstem Re- sponsesd. 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 andcheek	Forehead, nape of neck andcheek	Same
Stimulationtarget	Cochlea	Cochlea	Same
EEG record-ing channels,number ofelectrodecontacts	1,3	1,3	Same
Accessories
Transducer	Ear probes, Insert earphones, Earcoupler cable, Headphonesmanufactured by PATH MEDICAL	Ear probes, Insert earphones,Ear coupler cable, Head-phones manufactured byPATH MEDICAL	Same
ElectrodeCable	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 + EarTips	PATH MEDICAL Probe tips + EarTips	Same
Implementation details
Measuringmethod ABR	• Chirp stimulus• 85 Hz ± 10% stimulus repetitionrate (randomized)• 30, 35, 40, 45 dB nHL stimuluslevel• noise-weighted averaging andtemplate matching with statisticalevaluation• Result interpretation: By thedevice	• Chirp stimulus• 85 Hz ± 10% stimulus repetitionrate (randomized)• 30, 35, 40, 45 dB nHL stimuluslevel• noise-weighted averagingand template matching withstatistical evaluation• Result interpretation: By thedevice	Different:More stimuli andprotocolsavailable on theSentiero for di-agnostic ABR.The availableprotocols andstimuli on theQScreen are asubset of theSentiero.
Measuringmethod OAE	• TEOAE: Click stimulus• DPOAE: Sinusoidal tones• TEOAE: 59-76 Hz stimulusrepetition rate (randomized)• TEOAE: 85 dB peSPL stimuluslevel• noise-weighted averaging withstatistical evaluation• Result interpretation: By thedevice	• TEOAE: Click stimulus• DPOAE: Sinusoidal tones• TEOAE: 59-76 Hz stimulusrepetition rate (randomized)• TEOAE: 85 dB peSPL stimuluslevel• noise-weighted averagingwith statistical evaluation• Result interpretation: By thedevice	Different:More stimuli andprotocolsavailable on theSentiero for di-agnostic OAE.The availableprotocols andstimuli on theQScreen are asubset of theSentiero.
Screeningoptions	Each ear individually orsimultaneously	Each ear individually orsimultaneously	Same
Result inter-pretation	By the device	By the device	Same
Result repre-sentation	PASS/REFER/INCOMPLETE	PASS/REFER/INCOMPLETE	Same
Technological details
Hardwaresetup	Standalone,handheld / portabledevice, battery powered.Operated via Touch Screen.Can be charged using a DockingStation.	Standalone,handheld / portabledevice, battery powered.Operated via Touch Screen.	Different:Identicalexcept theSentiero doesnot use adocking station.Electrical safetytests includedthe dockingstation.
Workflow	Operation via Touch Screen.Screen layout: header, mainpanel, footer for navigation.GUI: The home screen: 3x3 tile lay-out having access to the mainfeatures of the device.	Operation via Touch Screen.Screen layout: header, mainpanel, footer for navigation.GUI: List layout	Different:QScreen usesgrid layout dueto the reducednumber ofavailableoptionscompared tothe Sentiero.
Interface toComputer,Software onComputer	Data Transfer via Bluetooth toDocking Station and USB datatransfer from Docking station toPC.	Data Transfer via USB cable toPC.	Different:The QScreenadditionally usesan FCC certifiedBluetoothmodule.
Device Firm-ware:	The firmware architecture isbased on a proprietary operatingsystem: runtime-model based ona graphical user interface library,which processes user input andupdates the touch screen.Firmware is based on PATH'sSentiero device family. Basicfunctionalities like measurementalgorithms, patient and usermanagement, communicationprotocols, localization, etc. sharecommon code.QScreen specific modules (i.e.barcode reader) are added tothe basic firmware.	The firmware architecture isbased on a proprietary operat-ing system: runtime-modelbased on a graphical user in-terface library, which processesuser input and updates thetouch screen.Firmware is based on PATH'sSentiero device family. Basicfunctionalities like measure-ment algorithms, patient anduser 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 safetyor effectivenessof the device.
PC Software	PC Software for data analysis andarchiving	PC Software for data analysisand archiving	Same
Battery,Charger	Battery- driven using Li-Ion tech-nology (10.4Wh), medical gradecharger, no user-exchangeablebattery.	Battery-driven NiMH (7.2Wh) inSentiero Handheld/ Li-Ion(9.6Wh) in Sentiero Desktop,medical grade charger, nouser-exchangeable battery.	Same type asSentiero Desk-top. Slightlyhigher capacitywill have no ef-fect on safety oreffectiveness.

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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.

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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 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.

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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.

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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:

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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.

Cabana-Pérez, I.M.; et al. "Automatic ABR detection at near-threshold intensities combining template-based approach and energy analysis." VII Latin American Congress on Biomedical Engineering CLAIB 2016

Herrmann, Barbara S., Aaron R. Thornton, and Janet M. Joseph. "Automated infant hearing screening using the ABR: development and validation." American Journal of Audiology 4.2 (1995): 6-14.

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.

Regulation Number and Section

§ 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).