Quick-20m

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. CGX, LLC % Prithul Bom Regulatory Technology Services, LLC 1000 Westgate Drive, Suite #510k Saint Paul, Minnesota 55114 Re: K203331 Trade/Device Name: Quick-20m Regulation Number: 21 CFR 882.1835 Regulation Name: Physiological signal amplifier Regulatory Class: Class II Product Code: GWL, GXY Dated: May 4, 2021 Received: May 5, 2021 Dear Prithul Bom: 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 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 {1}------------------------------------------------ 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 (OS) 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 medical devices and radiation-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). Sincerely, 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K203331 Device Name Quick-20m Indications for Use (Describe) The Quick-20m is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer. 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. 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The letters "CGX" are white and positioned in the center of the circle, with each letter taking up roughly one-third of the space. ### 510(k) Summary | Submitter: | CGX, LLC | |------------------------|------------------------------------------------------| | Address: | 8445 Camino Santa Fe, Suite 104, San Diego, CA 92121 | | Phone number: | 858-864-9400 | | Contact person: | Spencer Linton | | Phone number: | (858) 864-9400 | | Email: | Spencer@CGXSystems.com | | Date prepared: | June 23, 2020 | | Trade name: | Quick-20m | | Common name: | Physiological Signal Amplifier | | Product Code, Primary: | GWL, GXY | | Regulation: | 21 CFR 882.1835 | Substantial equivalence claimed to: g.tec medical engineering GmbH g.Nautilus PRO, K171669, a Class II device. ## Device Description: The Quick-20m is a wireless, battery-operated 10-20 montage EEG headset utilizing dry sensor technology. The headset provides an integrated approach to the wireless acquisition of EEG signals. A seated patient is free to exhibit natural movements while real-time data is collected. The Quick-20m includes advanced amplification and shielding to reject ambient electrical noise. The headset obtains high-quality EEG with minimal scalp preparation. Patented mechanisms and a range of replaceable dry sensors align to various head shapes and sizes, maintaining sensor positions in a standard 10-20 layout. EEG channels are digitized with 24 bits of resolution at 500 Hz. The Quick-20m is suitable for general-purpose EEG. ## Principle of Operation The Quick-20m headset is a wireless physiological signal amplifier that integrates cutaneous electrodes in a 10-20 montage. The headset captures EEG from the electrodes with 24 bits of resolution at 500 Hz, amplifies the signal and sends the data to a computer for further analysis by a healthcare professional. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows a logo with the letters 'CGX' inside a circle that is split vertically into two halves. The left half of the circle is a light teal color, while the right half is a darker blue. The letters 'CGX' are white and are positioned in the center of the circle, with 'C' on the left half and 'GX' on the right half. The overall design is simple and modern. The environment of use for this device is in a home or healthcare facility setting, such as a doctor's office. The device is not sterile. The CGX Quick-20m works in the same manner as the predicate device, the g.tec medical engineering GmbH g.Nautilus PRO (K171669), with no safety concerns. ## Intended Use(s) The CGX Quick-20m is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer. ## Technological Characteristics The CGX Quick-20m is substantially equivalent to the predicate device, the g.tec medical engineering GmbH g.Nautilus PRO for wireless transmission of EEG to a computer. It utilizes dry sensors on 20 monopolar channels to acquire EEG data via a headset worn on the head and transmits this data, via 24-bit Delta-Sigma A/D conversion at a sampling rate of 500 Hz/channel, wirelessly to a computer. The Quick-20m is battery powered with exactly the same CMRR, noise and power-on LED indicators as the predicate. The CGX Quick-20m meets all the applicable safety standards as the predicate, as listed in the Substantial Equivalence Table below with the same system components, patient connections/inputs and firmware/driver software as the predicate. | Item | CGX Quick-20m<br>This Submission | g.tec medical<br>engineering GmbH<br>g.Nautilus PRO | Substantial<br>Equivalence<br>Comments | |--------------|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------| | Intended Use | The Quick-20m is<br>intended to be used to<br>acquire the<br>electroencephalogram<br>(EEG) and transmit it<br>wirelessly to a<br>computer | The g.Nautilus PRO is<br>intended to be used to<br>acquire the<br>electroencephalogram<br>(EEG) and transmit it<br>wirelessly to a<br>computer | Same as predicate | {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows a logo with the letters "CGX" inside of a circle. The circle is divided vertically into two halves. The left half is a light teal color, and the right half is a darker blue color. The letters "CGX" are white and are placed in the center of the circle, overlapping both halves. | EEG/Polygraphic<br>Channels | 20 monopolar<br>channels. Electrode<br>grid is standard 10-20<br>layout | Up to 32 monopolar<br>channels, different<br>electrode grids<br>available providing 8,<br>16 or 32 channels and<br>32 or 16 channels CSP<br>layout on predefined<br>positions | Fewer maximum<br>number of channels<br>but equivalent in<br>safety and<br>effectiveness | |-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------| | DC Channel | All | All | Same as predicate | | Full Scale Input<br>Range | ± 300 mV | ± 187.5 mV to<br>± 2.25 V | Fixed range but<br>equivalent in safety<br>and effectiveness | | A/D Conversion | 24-Bit Delta-Sigma | 24 Bit Delta-Sigma | Same as predicate | | Sampling Rate | 500 Hz/channel | User selectable (250,<br>500 Hz/channel) | Similar to predicate<br>but equivalent in<br>safety and<br>effectiveness | | CMRR | >90 dB at 60 Hz | >90 dB at 60 Hz | Same as predicate | | Noise | <0.6 µV RMS,<br>1-30 Hz | <0.6 µV RMS | Same as predicate | | Power Supply | Battery, 3.0 V DC<br>(Two 1.5 V AAA) | Battery, 3.7 V DC | Different battery<br>chemistry but<br>equivalent in safety<br>and effectiveness | | Rated Power<br>Consumption | 0.3 VA | 0.5 VA | Less power<br>consumption but<br>equivalent in safety<br>and effectiveness | | Amplifier-PC<br>Interface | Wireless to receiver,<br>USB to computer | Wireless to receiver,<br>USB to computer | Same as predicate | | Other Interfaces | Power on LED | Power on LED | Same as predicate | | Use Standard<br>Sensors And<br>Electrodes | Electrodes are<br>included (Ag/AgCl) -<br>Commercially<br>available sensors | Electrodes and cap are<br>included (Ag/AgCl or<br>golden dry electrodes,<br>elastic cap with certain<br>electrode positions) | Similar to predicate<br>but equivalent in<br>safety and<br>effectiveness | | Dimension | 20 (L) x 18 (W) x 19<br>(H) cm | 80 (L) x 60 (W) x 27<br>(H) mm | Larger dimensions<br>but similar in safety<br>and effectiveness | | Weight | <600 g | <200 g | More weight but<br>equivalent in safety<br>and effectiveness | | Isolation | wireless, patient<br>isolation | wireless, patient<br>isolation | Same as predicate | | System<br>Components | Amplifier/Digitization/<br>Electrodes/Cap<br>Charging Device +<br>USB cable Receiver +<br>USB cable | Amplifier/Digitization/<br>Electrodes/Cap<br>Charging Device +<br>USB cable Receiver +<br>USB cable | Same as predicate | | Firmware / Driver<br>Software | Resident | Resident / CD | Same as predicate | | Digital<br>Inputs/Outputs | 16 inputs, all patient<br>separated, no outputs | 8 inputs, all patient<br>separated, no outputs | More digital inputs<br>but equivalent in<br>safety and<br>effectiveness | | Stimulation Unit<br>Input/Output | Not available | Not available | Same as predicate | | Patient Connection<br>And Inputs | Receiver:<br>USB - 1 connector<br>DIGITAL IN - 1<br>connector | Receiver:<br>USB - 1 connector<br>DIGITAL IN - 1<br>connector | Same as predicate | | Type Of Applied<br>Part | BF | BF | Same as predicate | | Impedance<br>Measurement | Performed with<br>125 Hz | Performed with 10 Hz | Impedance check<br>performed at<br>different frequency<br>but similar in safety<br>and effectiveness | | Input Impedance | >100 MOhm | >100 MOhm | Same as predicate | | Filters | DC up to 131 Hz | DC up to 200 Hz<br>(depending on<br>sampling frequency) | Fewer digital filters<br>but equivalent in<br>safety and<br>effectiveness | | Frequency<br>Response | Linear between 0.1<br>and 100 Hz | Linear between 0.1<br>and 100 Hz | Same as predicate | | Environment Of<br>Use | Electrophysiological | Electrophysiological | Same as predicate | | Where Used | On the head | On the head | Same as predicate | | Number Of<br>Possible Electrodes | 20 Channels in<br>standard 10-20 head<br>map | Different electrode<br>grids available<br>providing 8, 16 or 32<br>channels and 32 or 16<br>channel CSP layout on<br>predefined positions | Fewer number of<br>possible electrodes<br>but equivalent in<br>safety and<br>effectiveness | | Size Of Caps | One size for adults:<br>52-62 cm | Various for infants,<br>children (mini, midi,<br>maxi) and adults<br>(small, medium,<br>large), head<br>circumference: 32-62<br>cm | Smaller range of<br>sizes but equivalent<br>in safety and<br>effectiveness | | Style Of Caps | Cap is full mechanical<br>headset | Full head cap | Different style of<br>construction but<br>similar in safety and<br>effectiveness | | Performance<br>Requirements | Needs to transmit<br>electrophysiological<br>signals from an<br>individual to data<br>collection device | Needs to transmit<br>electrophysiological<br>signals from an<br>individual to data<br>collection device | Same as predicate | | Cap Material | HP Multi-Jet Fusion<br>PA11 and PA12 | Oeko-Tex certificate | Other material but<br>equivalent in safety<br>and effectiveness | | Biocompatibility<br>Testing On Patient<br>Contact Materials | Evaluation done | Evaluation done | Same as predicate | | Type Of Electrodes | Active dry | Active, wet and dry | Same as predicate<br>for dry | | Reprocessing | Cleaning of all<br>components with<br>isopropyl based wipes | Cleaning with<br>multistage enzymatic<br>cleaner of cap and wet<br>electrodes | Similar<br>reprocessing but<br>equivalent in safety<br>and effectiveness | | | | Disinfection of cap<br>and wet electrodes<br>with low level<br>disinfectant based on<br>Glucoprotamin | | | | | Cleaning of dry<br>electrodes with<br>cleaning wipe | | | | | Disinfection of dry<br>electrodes with<br>disinfection wipe | | | Safety Standards | IEC 60601-1 / AAMI<br>ANSI ES60601-1 | IEC 60601-1 / AAMI<br>ANSI ES60601-1 | Similar to predicate<br>but equivalent in<br>safety and<br>effectiveness | | | IEC 60601-1-2 | IEC 60601-1-2 | | | | IEC 60601-2-26 | IEC 60601-2-26 | | | | IEC 80601-2-26 | | | | | IEC 60601-2-40 (not<br>applicable) | IEC 60601-2-40 | | | | ISO 14971 | ISO 14971 | | | | IEC 62304 / AAMI<br>ANSI IEC 62304 | IEC 62304 / AAMI<br>ANSI IEC 62304 | | | | AAMI ANSI ISO<br>10993-1 | AAMI ANSI ISO<br>10993-1 | | | | AAMI ANSI IEC<br>62366 | AAMI ANSI IEC<br>62366 | | | | IEEE 2010-2012 | IEEE 2010-2012 | | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows a logo with the letters "CGX" inside of a circle. The circle is split vertically into two halves. The left half is a light teal color, and the right half is a darker blue color. The letters "CGX" are white and are placed in the center of the circle, overlapping both halves. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows a logo with the letters "CGX" inside a circle. The circle is divided vertically into two halves, with the left half being a light teal color and the right half being a darker blue color. The letters "CGX" are white and are positioned in the center of the circle, spanning both halves. {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows a logo with the letters "CGX" inside of a circle. The circle is divided vertically into two halves. The left half is a light teal color, and the right half is a darker blue color. The letters "CGX" are white and are placed in the center of the circle, with each letter appearing to be in its own quadrant. {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows a logo with the letters "CGX" inside of a circle. The circle is divided vertically into two halves. The left half is a light teal color, and the right half is a darker blue color. The letters "CGX" are white and are placed in the center of the circle, with the "C" on the left side and the "GX" on the right side. ### Substantial Equivalence Discussion The CGX Quick-20m is substantially equivalent to the g.Nautilus PRO based on indications for use and comparison of functional and technological characteristics. Both devices are intended to provide the healthcare professional with an electroencephalogram (EEG) and transmit this data wirelessly to a computer. Both products fit on the head, utilize dry sensors and have the same amplifier/PC interface. The minor differences between the CGX Quick-20m and the g.Nautilus PRO do not raise new safety or effectiveness concerns or questions. These differences are discussed below and in the substantial equivalence table. The CGX Quick-20m is slightly larger than the g.Nautilus PRO (predicate), has slightly less input range (+/- 300 mV), a 500 Hz/channel sampling rate versus the user selectable sampling rate of 250 or 500 Hz/channel on the predicate, a battery chemistry of 3.0V DC versus the 3.7V DC of the predicate, and consumes slightly less power than the predicate. None of the aforementioned differences impact safety nor effectiveness. Further, the g.Nautilus PRO (predicate) offers both wet and dry sensors, while the Quick-20m offers dry sensors. The CGX Quick-20m device was evaluated by a third party (Intertek) for all applicable safety standards and passed without anomalies. Further, the company completed human factors and usability evaluation according to applicable versions of IEC 62366 and applicable FDA guidance, and the device demonstrated usability across sizes and positioning, resulting in quality, usable EEG data. Specifically, the human factors usability program consisted of three components. An In-Field Human Factors test, six published academic studies, and service and repair data. Bench testing on the Ouick-20m includes Intertek certifications to 80601-2-26. in addition to internal company design verification testing that successfully demonstrated compliance to user inputs, and in accordance with 21 CFR 820.40. Clinical testing on the Quick-20m was not applicable. ## Animal Studies This submission does not require nor include data on animal testing. ## Clinical Studies Clinical studies were not required to demonstrate that this device is as effective and at least as safe as the predicate device. {10}------------------------------------------------ Image /page/10/Picture/1 description: The image shows a logo with the letters "CGX" inside of a circle. The circle is divided vertically into two halves. The left half is a light blue-green color, and the right half is a darker blue color. The letters "CGX" are white and are placed in the center of the circle, overlapping both halves. ## Conclusion: CGX has been commercializing this EEG technology for research purposes (i.e. not clinical use) since 2015 and in over tens of thousands of uses there have been no safety related customer complaints or quality concerns. This customer experience was leveraged as the platform for the development of the medical device version - the CGX Quick-20m. A majority of the characteristics of the CGX Quick-20m are identical to those of the g.Nautilus PRO (predicate). The minor differences discussed above and in the Substantial Equivalence Table raise no safety concerns and do not impact effectiveness of the acquisition of EEG. The CGX Quick-20m performs as effectively as the predicate device for the same intended use with no safety concerns.