(396 days)
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No
The summary describes a system for recording and displaying EEG and GSR signals for trained medical staff to interpret. It explicitly states the device does not provide diagnoses or automated alerts, and there is no mention of AI, ML, or related concepts in the device description or performance studies.
No.
The device is intended to record and display EEG and GSR signals for diagnostic purposes, not to provide therapy.
Yes
The device records and stores EEG signals and presents them visually to assist trained medical staff in making neurological diagnoses, and it detects and monitors electrical signals produced by body skin conductance, both of which are diagnostic functions.
No
The device description explicitly lists hardware components such as the "QUEX ED or QUEX S hardware," "USB - USB cable," "EEG electrodes," "Electrodes for GSR measurements," and "Cable harnesses." The software is described as being "exclusively used for QUEX ED and QUEX S as part of the system," indicating it is integrated with and dependent on the hardware.
Based on the provided information, the QUEX ED and QUEX S device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens taken from the human body. The QUEX ED and S device directly measures physiological signals (EEG and GSR) from the body using electrodes placed on the skin. It does not analyze blood, urine, tissue, or other samples collected from the patient.
- The intended use is for recording and presenting physiological signals. The device is described as an "Electrophysiological System" intended to record and store EEG and GSR signals and present them visually. While this information assists trained medical staff in making diagnoses, the device itself does not perform any diagnostic tests on biological specimens.
- The device description focuses on hardware and software for signal acquisition and display. The components listed are related to acquiring and processing electrical signals from the body, not analyzing biological samples.
In summary, the QUEX ED and QUEX S device is a physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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:
- 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.
Product codes (comma separated list FDA assigned to the subject device)
OMC, GZO
Device Description
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body skin (for GSR), forehead (for EEG)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional healthcare facility environment; trained medical staff/healthcare professionals
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 tests performed:
Bench tests: Electrical Safety
Test Method Summary: The QUEX ED and QUEX S devices are tested according to IEC 60601-1 ed 3.1 and EN/IEC 60601-2-26 standards. Retesting was performed acc.to the most current EEG Standard: IEC 80601-2-26. the tests were performed by national accredited testing laboratories.
Results: All samples passed the acceptance criteria. The subject device is as safe as the predicates with respect to electrical safety.
Bench tests: Electromagnetic Compatibility (EMC)
Test Method Summary: IEC 60601-1-2:2014+A1:2020 (EN 60601-1-2:2015+A1:2021): Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests IEC TS 60601-4-2:2024: Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems. The device to be used in professional healthcare environment.
Results: All samples passed the acceptance criteria for each test. The subject device is as safe as the predicates with respect to EMC.
Bench tests: EEG Essential Performance
Test Method Summary: The essential performance of the QUED ED and S devices is accessed according to the EN/IEC 60601-2-26 and EN/IEC 80601-2-26.
Results: All samples passed the acceptance criteria. The subject device is as effective as the predicates with respect to EEG performance.
Bench tests: GSR measurements
Test Method Summary: The device is tested in accordance a test plan for evaluation of the resistance measurement within the specified limits 1Kohm-1Mohm.
Results: The test sample is passed the tests.
Biocompatibility: 510(k) approved electrodes and cables are used.
EEG electrode performance: 510(k) approved electrodes and cables are used.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.1400 Electroencephalograph.
(a)
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.(b)
Classification. Class II (performance standards).
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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:
- 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:+1 (989) 681-1063; mobile:+36 70 618 8508 Tinodi street 1-3, A building 4th floor / 93, Budapest, HUNGARY-1095 Email: andreea@gxworldltd.com
QA Advisor: Ms. Lilla Strobel Phone: +36-30-9251906 Email: strobel.lilla@gmail.com
Device:
Name of Device: 1) QUEX ED Electrophysiological Device
- 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 |
- A/D Conversion: 8 bit ADC
- Max Sampling Rate: 1ms
- Sensitivity: User definable 10 $ \mu V $ /mm, 20 $ \mu V $ /mm, 100 $ \mu V $ /mm
- LP filter: 0 - 100 Hz (8 degree digital filter)
- Notch Filter: 50/60 Hz
- Input impedance: > 10 M ohm
- CMRR: > 100 $ \mu V $
- Noise level :