QUEX ED; QUEX S

K232779 · Qx World, Ltd. · OMC · Oct 11, 2024 · Neurology

Device Facts

• Record ID: K232779
• Device Name: QUEX ED; QUEX S
• Applicant: Qx World, Ltd.
• Product Code: OMC · Neurology
• Decision Date: Oct 11, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended Use

The QUEX ED and QUEX S device is indicated for use as an Electrophysiological System. The Electrophysiological System is made up of the following Items which are functions of the QUEX ED and S device: 1. Two channel EEG: The QUEX ED and S Device is intended to record and store EEG signals, and to present the EEG signals in visual formats in real time. The visual signals assist trained medical staff to make neurological diagnoses. The EEG device does not provide any diagnoses conclusion about the subject's condition and does not provide any automated alerts of an adverse clinical event. The QUEX ED AND S Device is intended to be used in a professional healthcare facility environment. 2. GSR [galvanic skin response measuring] The QUEX ED and S device is intended for use by trained healthcare professionals, to detect and monitor electrical signals produced by the body skin conductance by using electrodes placed on the skin.

Device Story

System records two-channel EEG and GSR signals; inputs acquired via head harness (EEG) and limb electrodes (GSR). Hardware performs signal gain and A/D conversion; data transmitted via USB to PC/laptop running QUEX Monitor software. Software displays raw waveforms in real-time for clinician review. Used in professional healthcare environments by trained therapists/physicians. Output assists clinical neurological diagnosis; device provides no automated diagnostic conclusions or clinical alerts. Benefits include real-time physiological monitoring to support professional decision-making.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included electrical safety (IEC 60601-1, IEC 80601-2-26), electromagnetic compatibility (IEC 60601-1-2), EEG essential performance, and GSR resistance measurement accuracy (1k-1MΩ range).

Technological Characteristics

Two-channel EEG (10-100 µV) and GSR (1k-1MΩ) measurement. Hardware connects via USB (5V DC). EEG features: 8-bit ADC, 0-100 Hz LP filter, 50/60 Hz notch filter, >10 MΩ input impedance. Uses Ag/AgCl electrodes. Software (QUEX Monitor) runs on Windows PCs. Complies with IEC 60601-1, IEC 80601-2-26, and IEC 62368.

Indications for Use

Indicated for use by trained healthcare professionals in professional healthcare facilities to record/store/display EEG signals and monitor galvanic skin response (GSR) via skin electrodes. Does not provide diagnostic conclusions or automated alerts.

Regulatory Classification

Identification

An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

Predicate Devices

• Neurosteer EEG Recorder (K221563)

Submission Summary (Full Text)

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October 11, 2024

OX World Ltd Lilla Strobel QA Advisor Tinodi utca 1-3 A.ep, IV.em, 93 Budapest, Hungary 1095 Hungary

Re: K232779

Trade/Device Name: Quex Ed; Quex S Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMC, GZO Dated: September 11, 2024 Received: September 11, 2024

Dear Lilla Strobel:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

Image /page/2/Picture/3 description: The image shows the name "Patrick Antkowiak -S" in a simple, sans-serif font. The name is likely associated with a person, possibly an employee or individual affiliated with an organization. To the left of the name is a faded FDA logo.

for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine 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) K232779

Device Name QUEX ED and S

#### Indications for Use (Describe)

The QUEX ED and QUEX S device is indicated for use as an Electrophysiological System. The Electrophysiological System is made up of the following Items which are functions of the QUEX ED and S device:

1. Two channel EEG:

The QUEX ED and S Device is intended to record and store EEG signals, and to present the EEG signals in visual formats in real time. The visual signals assist trained medical staff to make neurological diagnoses. The EEG device does not provide any diagnoses conclusion about the subject's condition and does not provide any automated alerts of an adverse clinical event. The QUEX ED AND S Device is intended to be used in a professional healthcare facility environment. 2. GSR [galvanic skin response measuring]

The QUEX ED and S device is intended for use by trained healthcare professionals, to detect and monitor electrical signals produced by the body skin conductance by using electrodes placed on the skin.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### Submitter information:

#### Company:

QX WORLD Ltd. Tinódi street 1-3. A building 4. floor 93. door Budapest H-1095, Hungary

#### Contact name:

CEO: Ms. Andreea Taflan OX WORLD LTD phone:[phone]; mobile:[phone] Tinodi street 1-3, A building 4th floor / 93, Budapest, HUNGARY-1095 Email: [e-mail]

QA Advisor: Ms. Lilla Strobel Phone: [phone] Email: [e-mail]

### Device:

Name of Device: 1) QUEX ED Electrophysiological Device

2) QUEX S Electrophysiological Device

Common or Usual Name: Electrophysiological Device

Classification Name: reduced- montage standard electroencephalograph,

electroencephalograph (21 CFR 882.1400)

Regulatory Class: II Product Code: OMC, GZO

## Predicate device

Manufacturer: Neurosteer Inc. Neurosteer EEG Recorder (K221563)

## Device Description

Device identification:

QUEX ED or QUEX S devices are contains the following components:

- QUEX ED or QUEX S hardware.
- I QUEX Monitor software
- . USB - USB cable for data communication and power supply.
- EEG electrodes (head electrodes)
- Electrodes for GSR measurements (limbs)
- I Cable harnesses for head and limbs.

The QUEX Monitor software is exclusively used for QUEX ED and QUEX S as part of the system.

The EEG electrodes and the electrodes used for GSR measurements are connected to the QUEX ED or S devices. The device makes the necessary gain on the analog signals and digitalize the signals. The digitalized information is acquired and displayed by the QUEX Monitor software. The QUEX monitor software can run on PCs, notebooks with Windows OS.

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Electroencephalography (EEG), measures brain wave activity. The system uses the head harness and electrodes to acquire the signals. The QUEX Devices are measures brain activity on two channels. The EEG wave recording electrodes are connected to the forehead with dry electrodes.

The galvanic skin response (GSR, which falls under the umbrella term of electrodermal activity, or EDA) refers to changes in sweat gland activity.

The GSR recording is done via limb electrodes attached to the wrists and ankles.

### Device characteristics:

### EEG

- Two channel EEG -
- -Measurement on the scalp
- -10 µV to 100 µV signal measurement

#### GSR (Galvanic Skin Response)

- skin conductance change measurement effected by changes by sweat gland activity, -
- measurement with DC current for skin resistance,
- measuring range: 1 Kohm 1 Mohm, -

### Environment:

The device to be used in professional healthcare environment.

### Indications for use

The QUEX ED and S device is indicated for use as an Electrophysiological System. The Electrophysiological System is made up of the following Items which are functions of the OUEX ED and S device:

### 1. Two channel EEG:

The QUEX ED and S Device is intended to record and store EEG signals, and to present the EEG signals in visual formats in real time. The visual signals assist trained medical staff to make neurological diagnoses. The EEG device does not any diagnoses conclusion about the subject's condition and does not provide any automated alerts of an adverse clinical event. The OUEX ED and S Device is intended to be used in a professional healthcare facility environment.

### 2. GSR [galvanic skin response measuring]

The QUEX ED and S device is intended for use by trained healthcare professionals, to detect and monitor electrical signals produced by the body skin conductance by using electrodes placed on the skin.

Intended user:

Professional use (Therapist)

The device itself does not generate any stimulation to the patient. External visual, audible, or other stimulation shall be used based on the trained operator (physician) decision. The QX Word does not take the responsibility of the possible adverse effect of an external stimulation.

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| Technical specification of QUEX ED and QUEX S Electrophysiological Device | | | | |
|---------------------------------------------------------------------------|--|--|--|--|
|---------------------------------------------------------------------------|--|--|--|--|

| Electrical characteristics | |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Voltage [power supply] | 5V DC (Port USB) |
| Maximum consumption | 1200 mA |
| Time to change the signal | Max. 300 ms |
| Time to change the channel | Max. 100 ms |
| Rated output current | Max. 1 mA |
| EEG Characteristics | |
| Digital sampling rate per channel | Programable |
| Calibration signals | programable, 0-200 $ \mu V $ |
| Number of channels | 2 |
| EEG channel characteristics | 1. No. of channels: 2<br>2. A/D Conversion: 8 bit ADC<br>3. Max Sampling Rate: 1ms<br>4. Sensitivity: User definable 10 $ \mu V $ /mm, 20 $ \mu V $ /mm, 100 $ \mu V $ /mm<br>5. LP filter: 0 - 100 Hz (8 degree digital filter)<br>6. Notch Filter: 50/60 Hz<br>7. Input impedance: > 10 M ohm<br>8. CMRR: > 100 $ \mu V $<br>9. Noise level : < 5 $ \mu V $ RMS |
| accuracy of signal reproduction; | difference less than $ \pm $ 20 %<br>acc to IEC 80601-2-26, 201.12.1.102 |
| input dynamic range and maximum offset voltage | less than $ \pm $ 10 % acc to IEC 80601-2-26, 201.12.1.103 |
| frequency range and bandwidth | 0,5 Hz - 50 Hz, relative output within<br>71% to 110% of the output at 5Hz |
| a description of waveform displays | EEG signals are displayed |
| Skin resitance | |
| Galvanic Skin Response data acquisition | Measurement Range: 1k - 1MΩ +/- 10% |
| Output Voltage | 0 - 4 V DC |

# Comparison with predicate device

The QUEX ED and QUEX S EEG and GSR recorder and the predicate devices have the same intended use and very similar technological features, including software intended for recording and viewing EEG signals. The differences between the Neurosteer EEG Recorder and QUEX S devices raise no new issues of safety or effectiveness. Performance testing confirms that the device functions as intended, supporting substantial equivalence. The characteristics of the subject and predicate device are summarized in the following table:

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| Attribute | Predicate Device:<br>Neurosteer EEG<br>Recorder (K221563) | QUEX ED and QUEX S<br>EEG and GSR devcice | Comparison |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Device class and<br>regulation | Class II per 882.1400 | Class II per 882.1400 | Same |
| Product codes | OMC | OMC, GZO | Same. |
| Indications for use | The Neurosteer EEG<br>Recorder is intended to<br>record and store EEG signals,<br>and to present the EEG<br>signals in visual formats in<br>real time. The visual signals<br>assist trained medical staff to<br>make neurological<br>diagnoses. The EEG Recorder<br>does not provide any<br>diagnostic conclusion about<br>the subject's condition and<br>does not provide any<br>automated alerts of an<br>adverse clinical event. The<br>EEG Recorder is intended to<br>be used in a professional<br>healthcare facility<br>environment. | 1. Two channel EEG:<br>The QUEX ED Device is<br>intended to record and store<br>EEG signals, and to present the<br>EEG signals in visual formats in<br>real time. The visual signals<br>assist trained medical staff to<br>make neurological diagnoses.<br>The EEG device does not any<br>diagnoses conclusion about the<br>subject's condition and does<br>not provide any automated<br>alerts of an adverse clinical<br>event. The QUEX ED Device is<br>intended to be used in a<br>professional healthcare facility<br>environment.<br><br>2. GSR [galvanic skin response<br>measuring resistance]<br><br>The QUEX ED device is<br>intended for use by trained<br>healthcare professionals, to<br>use of sensors or electrodes<br>placed on the skin to detect and<br>monitor electrical signals<br>produced by the body skin<br>conductance. | Substantially<br>equivalent |
| Classification | Review Panel Neurology<br>Product Code OMC<br>Regulation Number 882.1400<br>Device Class 2<br>Submission Type 510(k) | | |
| | | Device Galvanic Skin<br>Response Measurement<br>Review Panel Neurology<br>Product Code GZO<br>Regulation Number 882.1540<br>Device Class 2<br>Submission Type 510(K)<br>Exempt | |
| System<br>components | EEG electrodes with<br>conductive hydrogel<br>EEG sensor<br>Portable EEG monitor to<br>display EEG data in real time<br>in visual format and transfer<br>EEG recording files to cloud<br>storage platform via<br>internet connection Cloud<br>storage platform<br>Browser-based EEG viewing<br>software | EEG electrodes with cables and<br>securing strips.<br>Main box for acquiring and<br>digitalizing the analog<br>physiological signals as EEG<br>and skin resistance for GSR.<br>Application-based EEG<br>viewing software running on<br>desktop and laptops | Substantially<br>equivalent |
| Measurement of<br>physiological<br>data | EEG recording only | EEG and GSR recording | Substantially<br>equivalent<br>GSR function is<br>510(k) exempt |
| Channels | 1 | 2 | Substantially<br>equivalent |
| EEG presentation<br>format(s) | Visual only (raw EEG<br>waveform, spectrogram,<br>metrics and bar graph views) | Visual only (raw EEF<br>waveform) | Substantially<br>equivalent |
| Data transfer<br>method(s) | Bluetooth 2.4 GHz and<br>internet connection (ethernet<br>or Wi-Fi) | USB cable, | No additional risk<br>to patient, more<br>reliable<br>connection. |
| Data file format | Edf | Reusable | Same |
| Type of use | Reusable | Reusable | Same |
| Power source | Lithium polymer battery –<br>rechargeable with 100-240 V<br>AC power adapter (device<br>does not work when<br>connected to AC to recharge) | USB connected to a computer,<br>5V DC, to be used IEC 62368<br>compliance computer. | Same level of<br>electrical safety.<br>No risk from the<br>lithium battery in<br>the device |
| Charging | Micro-USB charging cable; if<br>connected to a computer, all<br>EEG acquisition functions are<br>automatically disabled | No charging is necessary, to be<br>used charged laptops or<br>computer connected to mains<br>supply. | Substantially<br>equivalent,<br>no risk from the<br>battery<br>exhausting. |
| Electrode type | Passive silver/silver-chloride<br>(Ag/AgCl) | | Same |
| Number / locations of<br>electrodes | 3 (Locations: Fp1, Fpz, Fp2) | 5 (Fp1:F7; Fp2:F8; Fpz) | Substantially<br>equivalent |
| Conductive<br>electrolyte gel | Semi-solid hydrogel is<br>included in a layer integrated<br>into each electrode assembly. | | Substantially<br>equivalent |
| Patient contact | Patient forehead (intact skin) | Patient forehead (intact skin) | Same |
| Securing method | Integrated adhesive layer | EEG strip | Substantially<br>equivalent |
| Available sizes and<br>dimensions | One size (10.5 cm) | One size | Substantially<br>equivalent |
| Type of use | Single use, non-sterile,<br>disposable | Reusable electrodes, single use<br>electrodes can be used | Substantially<br>equivalent |
| Connector | Integrated single-cable<br>connector to connect to an<br>EEG recording device | The electrodes connected via<br>connector fit for device inlets. | Same |
| Compatibility | Compatible with the<br>Neurosteer EEG Recorder<br>only | The device can be used with<br>own software only (QUEX<br>Monitor) | Substantially<br>equivalent |

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# Non-clinical tests performed:

| Test | Test Method Summary | Results |
|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Bench tests:<br>Electrical Safety | The QUEX ED and QUEX S devices are tested<br>according to IEC 60601-1 ed 3.1 and EN/IEC<br>60601-2-26 standards. Retesting was<br>performed acc.to the most current EEG<br>Standard: IEC 80601-2-26. the tests were<br>performed by national accredited testing<br>laboratories. | All samples passed the acceptance<br>criteria. The subject device is as safe as<br>the predicates with respect to<br>electrical safety. |
| Bench tests:<br>Electromagnetic<br>Compatibility<br>(EMC) | IEC 60601-1-2:2014+A1:2020 (EN 60601-1-<br>2:2015+A1:2021): Medical electrical<br>equipment - Part 1-2: General requirements<br>for basic safety and essential performance -<br>Collateral Standard: Electromagnetic<br>disturbances - Requirements and tests<br>IEC TS 60601-4-2:2024: Medical electrical<br>equipment - Part 4-2: Guidance and<br>interpretation - Electromagnetic immunity: | All samples passed the acceptance<br>criteria for each test. The subject<br>device is as safe as the predicates with<br>respect to EMC. |

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| | performance of medical electrical equipment<br>and medical electrical systems | |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| | The device to be used in professional<br>healthcare environment. | |
| Bench tests:<br>EEG Essential<br>Performance | The essential performance of the QUED ED<br>and S devices is accessed according to the<br>EN/IEC 60601-2-26 and EN/IEC 80601-2-<br>26. | All samples passed the acceptance<br>criteria. The subject device is as<br>effective as the predicates with<br>respect to EEG performance. |
| Bench tests:<br>GSR measurments | The device is tested in accordance a test<br>plan for evaluation of the resistance<br>measurement within the specified limits<br>1Kohm-1Mohm. | The test sample is passed the tests. |
| Biocompatibility | 510(k) approved electrodes and cables are<br>used. | |
| EEG electrode<br>performance | 510(k) approved electrodes and cables are<br>used. | |

### Conclusions

The QUEX ED and QUEX S has the same intended use and similar indications for use, technological characteristics, and principles of operation as the predicate devices. The minor technological differences between the QUEX ED and QUEX S and its predicate devices raise no new or different questions of safety or effectiveness. Performance data demonstrate that the QUEX ED and QUEX S r is as safe and effective as the predicate devices. Thus, the QUEX ED and QUEX S are substantially equivalent.