(396 days)
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.
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 or 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.
The provided FDA 510(k) summary (K232779) for the QUEX ED and QUEX S device describes the regulatory submission for an electrophysiological system, specifically for EEG and GSR measurements. While it details acceptance criteria for various technical aspects like electrical safety and electromagnetic compatibility, and states that “All samples passed the acceptance criteria” for these tests, it does not describe a clinical study meeting the criteria of a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm-only performance study on a test set with an established ground truth assessed by multiple experts.
The submission focuses on establishing substantial equivalence to a predicate device (Neurosteer Inc. Neurosteer EEG Recorder K221563) primarily through technical comparisons and bench testing. The "performance data" mentioned in the conclusion refers to these bench tests, not a clinical study involving human readers or algorithmic performance against a clinical ground truth.
Therefore, many of the requested details about acceptance criteria and study designs are not present in this document because the device's substantial equivalence was established through technical specifications and bench testing, not through a clinical performance study as typically seen with AI/ML-driven diagnostic devices.
Here's an attempt to answer the questions based only on the provided text, highlighting what is present and what is absent:
1. A table of acceptance criteria and the reported device performance
The document provides acceptance criteria and performance for various bench tests, not for a clinical diagnostic performance study.
| Test Category | Specific Test / Characteristic | Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 ed 3.1 and EN/IEC 60601-2-26 (retested per IEC 80601-2-26) | Not explicitly detailed, but implied to meet the requirements of the standards. | "All samples passed the acceptance criteria. The subject device is as safe as the predicates with respect to electrical safety." |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2:2014+A1:2020 (EN 60601-1-2:2015+A1:2021) and IEC TS 60601-4-2:2024 | Not explicitly detailed, but implied to meet the requirements of the standards. | "All samples passed the acceptance criteria for each test. The subject device is as safe as the predicates with respect to EMC." |
| EEG Essential Performance | Compliance with EN/IEC 60601-2-26 and EN/IEC 80601-2-26 | Not explicitly detailed, but implied to meet the requirements of the standards. | "All samples passed the acceptance criteria. The subject device is as effective as the predicates with respect to EEG performance." |
| GSR Measurements | Evaluation of resistance measurement within specified limits. | Range: 1 Kohm - 1 Mohm | "The test sample is passed the tests." (Implies it met the 1Kohm-1Mohm range +/- 10% as specified in the technical specifications table). |
| Accuracy of Signal Reproduction (EEG) | Difference less than ± 20% | "difference less than ± 20% acc to IEC 80601-2-26, 201.12.1.102" | (Not explicitly stated in the "Results" section for bench tests, but implicitly covered by "All samples passed the acceptance criteria" for EEG Essential Performance, which references this standard.) |
| Input Dynamic Range and Maximum Offset Voltage (EEG) | Less than ± 10% | "less than ± 10% acc to IEC 80601-2-26, 201.12.1.103" | (Not explicitly stated in the "Results" section for bench tests, but implicitly covered by "All samples passed the acceptance criteria" for EEG Essential Performance, which references this standard.) |
| Frequency Range and Bandwidth (EEG) | 0.5 Hz - 50 Hz, relative output within 71% to 110% of the output at 5Hz | "0,5 Hz - 50 Hz, relative output within 71% to 110% of the output at 5Hz" (This is a specification of the device, implied to be the benchmark for testing.) | (Not explicitly stated in the "Results" section for bench tests, but implicitly covered by "All samples passed the acceptance criteria" for EEG Essential Performance, which would ensure the device meets its own stated frequency characteristics.) |
| GSR Measurement Range | 1k - 1MΩ +/- 10% | "Measurement Range: 1k - 1MΩ +/- 10%" (This is a specification of the device, implied to be the benchmark for testing.) | "Passed the tests" (referencing the 1Kohm-1Mohm evaluation). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes bench tests on hardware/software samples, not a clinical study with a test set of patient data. The sample size is referred to as "All samples." No patient data provenance is applicable given the nature of the tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No ground truth based on expert consensus for clinical diagnosis was established as this was not a clinical performance study. The tests focused on electrical, EMC, and signal performance according to industry standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set and human readers for adjudication were involved.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was performed or described. The product is an electrophysiological system for recording and displaying signals to assist trained medical staff in making neurological diagnoses, and it "does not provide any diagnoses conclusion about the subject's condition and does not provide any automated alerts of an adverse clinical event." Therefore, there is no AI component assisting human readers in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was performed or described. The device is a signal acquisition and display system for human interpretation, not an automated diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for the non-clinical tests was the adherence to specified engineering standards and the device's own technical specifications.
8. The sample size for the training set
Not applicable. This document pertains to the regulatory clearance of a medical device based on its functional and safety performance, not the training of an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable. No training set or ground truth for such a set is mentioned.
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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.
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: 22. A/D Conversion: 8 bit ADC3. Max Sampling Rate: 1ms4. Sensitivity: User definable 10 $ \mu V $ /mm, 20 $ \mu V $ /mm, 100 $ \mu V $ /mm5. LP filter: 0 - 100 Hz (8 degree digital filter)6. Notch Filter: 50/60 Hz7. Input impedance: > 10 M ohm8. CMRR: > 100 $ \mu V $9. Noise level : < 5 $ \mu V $ RMS |
| accuracy of signal reproduction; | difference less than $ \pm $ 20 %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 within71% 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:Neurosteer EEGRecorder (K221563) | QUEX ED and QUEX SEEG and GSR devcice | Comparison |
|---|---|---|---|
| Device class andregulation | Class II per 882.1400 | Class II per 882.1400 | Same |
| Product codes | OMC | OMC, GZO | Same. |
| Indications for use | The Neurosteer EEGRecorder is intended torecord and store EEG signals,and to present the EEGsignals in visual formats inreal time. The visual signalsassist trained medical staff tomake neurologicaldiagnoses. The EEG Recorderdoes not provide anydiagnostic conclusion aboutthe subject's condition anddoes not provide anyautomated alerts of anadverse clinical event. TheEEG Recorder is intended tobe used in a professionalhealthcare facilityenvironment. | 1. Two channel EEG:The QUEX ED Device isintended to record and storeEEG signals, and to present theEEG signals in visual formats inreal time. The visual signalsassist trained medical staff tomake neurological diagnoses.The EEG device does not anydiagnoses conclusion about thesubject's condition and doesnot provide any automatedalerts of an adverse clinicalevent. The QUEX ED Device isintended to be used in aprofessional healthcare facilityenvironment.2. GSR [galvanic skin responsemeasuring resistance]The QUEX ED device isintended for use by trainedhealthcare professionals, touse of sensors or electrodesplaced on the skin to detect andmonitor electrical signalsproduced by the body skinconductance. | Substantiallyequivalent |
| Classification | Review Panel NeurologyProduct Code OMCRegulation Number 882.1400Device Class 2Submission Type 510(k) | ||
| Device Galvanic SkinResponse MeasurementReview Panel NeurologyProduct Code GZORegulation Number 882.1540Device Class 2Submission Type 510(K)Exempt | |||
| Systemcomponents | EEG electrodes withconductive hydrogelEEG sensorPortable EEG monitor todisplay EEG data in real timein visual format and transferEEG recording files to cloudstorage platform viainternet connection Cloudstorage platformBrowser-based EEG viewingsoftware | EEG electrodes with cables andsecuring strips.Main box for acquiring anddigitalizing the analogphysiological signals as EEGand skin resistance for GSR.Application-based EEGviewing software running ondesktop and laptops | Substantiallyequivalent |
| Measurement ofphysiologicaldata | EEG recording only | EEG and GSR recording | SubstantiallyequivalentGSR function is510(k) exempt |
| Channels | 1 | 2 | Substantiallyequivalent |
| EEG presentationformat(s) | Visual only (raw EEGwaveform, spectrogram,metrics and bar graph views) | Visual only (raw EEFwaveform) | Substantiallyequivalent |
| Data transfermethod(s) | Bluetooth 2.4 GHz andinternet connection (ethernetor Wi-Fi) | USB cable, | No additional riskto patient, morereliableconnection. |
| Data file format | Edf | Reusable | Same |
| Type of use | Reusable | Reusable | Same |
| Power source | Lithium polymer battery –rechargeable with 100-240 VAC power adapter (devicedoes not work whenconnected to AC to recharge) | USB connected to a computer,5V DC, to be used IEC 62368compliance computer. | Same level ofelectrical safety.No risk from thelithium battery inthe device |
| Charging | Micro-USB charging cable; ifconnected to a computer, allEEG acquisition functions areautomatically disabled | No charging is necessary, to beused charged laptops orcomputer connected to mainssupply. | Substantiallyequivalent,no risk from thebatteryexhausting. |
| Electrode type | Passive silver/silver-chloride(Ag/AgCl) | Same | |
| Number / locations ofelectrodes | 3 (Locations: Fp1, Fpz, Fp2) | 5 (Fp1:F7; Fp2:F8; Fpz) | Substantiallyequivalent |
| Conductiveelectrolyte gel | Semi-solid hydrogel isincluded in a layer integratedinto each electrode assembly. | Substantiallyequivalent | |
| Patient contact | Patient forehead (intact skin) | Patient forehead (intact skin) | Same |
| Securing method | Integrated adhesive layer | EEG strip | Substantiallyequivalent |
| Available sizes anddimensions | One size (10.5 cm) | One size | Substantiallyequivalent |
| Type of use | Single use, non-sterile,disposable | Reusable electrodes, single useelectrodes can be used | Substantiallyequivalent |
| Connector | Integrated single-cableconnector to connect to anEEG recording device | The electrodes connected viaconnector fit for device inlets. | Same |
| Compatibility | Compatible with theNeurosteer EEG Recorderonly | The device can be used withown software only (QUEXMonitor) | Substantiallyequivalent |
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Non-clinical tests performed:
| Test | Test Method Summary | Results |
|---|---|---|
| Bench tests:Electrical Safety | The QUEX ED and QUEX S devices are testedaccording to IEC 60601-1 ed 3.1 and EN/IEC60601-2-26 standards. Retesting wasperformed acc.to the most current EEGStandard: IEC 80601-2-26. the tests wereperformed by national accredited testinglaboratories. | All samples passed the acceptancecriteria. The subject device is as safe asthe predicates with respect toelectrical safety. |
| Bench tests:ElectromagneticCompatibility(EMC) | IEC 60601-1-2:2014+A1:2020 (EN 60601-1-2:2015+A1:2021): Medical electricalequipment - Part 1-2: General requirementsfor basic safety and essential performance -Collateral Standard: Electromagneticdisturbances - Requirements and testsIEC TS 60601-4-2:2024: Medical electricalequipment - Part 4-2: Guidance andinterpretation - Electromagnetic immunity: | All samples passed the acceptancecriteria for each test. The subjectdevice is as safe as the predicates withrespect to EMC. |
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| performance of medical electrical equipmentand medical electrical systems | ||
|---|---|---|
| The device to be used in professionalhealthcare environment. | ||
| Bench tests:EEG EssentialPerformance | The essential performance of the QUED EDand S devices is accessed according to theEN/IEC 60601-2-26 and EN/IEC 80601-2-26. | All samples passed the acceptancecriteria. The subject device is aseffective as the predicates withrespect to EEG performance. |
| Bench tests:GSR measurments | The device is tested in accordance a testplan for evaluation of the resistancemeasurement within the specified limits1Kohm-1Mohm. | The test sample is passed the tests. |
| Biocompatibility | 510(k) approved electrodes and cables areused. | |
| EEG electrodeperformance | 510(k) approved electrodes and cables areused. |
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.
§ 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).