Who is the manufacturer of QScreen?

Path Medical GmbH filed the 510(k) submission for QScreen (K220139).

What is the FDA product code for QScreen?

GWJ. It is classified under 21 CFR 882.1900 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for QScreen?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like QScreen?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

QScreen

K220139 · Path Medical GmbH · GWJ · Aug 3, 2022 · Neurology

Device Facts

Record ID	K220139
Device Name	QScreen
Applicant	Path Medical GmbH
Product Code	GWJ · Neurology
Decision Date	Aug 3, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1900
Device Class	Class 2
Attributes	Pediatric

Intended 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.

Device Story

Hand-held, portable hearing screener; records/evaluates OAE (DPOAE/TEOAE) and ABR. Input: physiological signals via ear probes/electrodes. Operation: touch screen menu guides user; device performs automated signal processing/statistical evaluation. Output: PASS/REFER/INCOMPLETE result. Used by audiologists, ENT doctors, nurses, and trained personnel in clinical settings. Battery-powered; charges via docking station; communicates via Bluetooth. Data managed on PC via optional software. Camera on back reads barcodes/QR codes. Benefits: objective hearing assessment for patients unable to perform behavioral tests.

Clinical Evidence

No clinical performance data collected. Substantial equivalence demonstrated via bench testing, compliance with international standards (IEC 60645-6:2009, IEC 60645-7:2009), and literature review confirming ABR/OAE implementation matches state-of-the-art.

Technological Characteristics

Hand-held, battery-powered (Li-Ion). Touch screen interface. Connectivity: Bluetooth, USB (via docking station). Biocompatible materials (ISO 10993). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-40. Accessories: ear probes, insert earphones, electrode cables with memory chips for calibration/transducer identification. Firmware-based signal processing.

Indications for Use

Indicated for hearing screening in subjects of all ages, particularly those with unreliable behavioral audiometric results. Used to obtain objective evidence of peripheral auditory function (via OAE) and peripheral/retro-cochlear auditory function (via ABR).

Regulatory Classification

Identification

An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.

Predicate Devices

Sentiero (K133012)

Related Devices

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K171506 — Easyscreen · Maico Diagnostics GmbH · Aug 29, 2017
K143395 — Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit · Otodynamics, Ltd. · Feb 23, 2015
K172403 — GSI Novus · Grason-Stadler, Inc. · Oct 20, 2017
K240430 — Otoport Pro · Otodynamics, Ltd. · Mar 15, 2024

Submission Summary (Full Text)

{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) | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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: 1. Diagnostics, monitoring and follow-up after newborn hear- ing screening 2. Pre-school, school, and adult hearing screening 3. 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.…