(189 days)
Not Found
No
The summary describes a device for acquiring and transmitting EEG signals. It mentions advanced amplification and shielding, digitization, and dry sensor technology. There is no mention of AI, ML, or any algorithms that process or interpret the EEG data using these technologies. The performance studies focus on bench testing, human factors, and usability, not on the performance of any AI/ML algorithms.
No.
The device is used to acquire and transmit EEG signals for diagnostic purposes, not to treat a condition.
No.
The device is intended to acquire and transmit EEG signals, it does not analyze or interpret the data to provide a diagnosis.
No
The device description clearly details a physical headset with sensors, amplification, shielding, and digitization hardware. It is not solely software.
Based on the provided information, the Quick-20m is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer." This describes a device that measures electrical activity of the brain in vivo (within the living body).
- Device Description: The description details a headset that is placed on the head to collect EEG signals. This is a direct measurement from the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to examine specimens, including blood, urine, and tissue, taken from the human body to provide information for diagnosis, monitoring, or screening purposes. The Quick-20m does not analyze specimens taken from the body; it measures a physiological signal from the body directly.
Therefore, the Quick-20m falls under the category of a medical device that measures physiological signals in vivo, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Quick-20m is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
Product codes (comma separated list FDA assigned to the subject device)
GWL, GXY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
On the head
Indicated Patient Age Range
One size for adults: 52-62 cm
Intended User / Care Setting
The environment of use for this device is in a home or healthcare facility setting, such as a doctor's office.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 882.1835 Physiological signal amplifier.
(a)
Identification. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).(b)
Classification. Class II (performance standards).
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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
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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)
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Image /page/3/Picture/1 description: The image shows a logo with the letters "CGX" inside a circular shape. The circle is divided vertically into two halves, with the left half in a gradient of light to dark teal and the right half in a solid blue color. 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.
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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
This Submission | g.tec medical
engineering GmbH
g.Nautilus PRO | Substantial
Equivalence
Comments |
|--------------|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Intended Use | The Quick-20m is
intended to be used to
acquire the
electroencephalogram
(EEG) and transmit it
wirelessly to a
computer | The g.Nautilus PRO is
intended to be used to
acquire the
electroencephalogram
(EEG) and transmit it
wirelessly to a
computer | Same as predicate |
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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
Channels | 20 monopolar
channels. Electrode
grid is standard 10-20
layout | Up to 32 monopolar
channels, different
electrode grids
available providing 8,
16 or 32 channels and
32 or 16 channels CSP
layout on predefined
positions | Fewer maximum
number of channels
but equivalent in
safety and
effectiveness |
|-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| DC Channel | All | All | Same as predicate |
| Full Scale Input
Range | ± 300 mV | ± 187.5 mV to
± 2.25 V | Fixed range but
equivalent in safety
and effectiveness |
| A/D Conversion | 24-Bit Delta-Sigma | 24 Bit Delta-Sigma | Same as predicate |
| Sampling Rate | 500 Hz/channel | User selectable (250,
500 Hz/channel) | Similar to predicate
but equivalent in
safety and
effectiveness |
| CMRR | >90 dB at 60 Hz | >90 dB at 60 Hz | Same as predicate |
| Noise | 100 MOhm | >100 MOhm | Same as predicate |
| Filters | DC up to 131 Hz | DC up to 200 Hz
(depending on
sampling frequency) | Fewer digital filters
but equivalent in
safety and
effectiveness |
| Frequency
Response | Linear between 0.1
and 100 Hz | Linear between 0.1
and 100 Hz | Same as predicate |
| Environment Of
Use | Electrophysiological | Electrophysiological | Same as predicate |
| Where Used | On the head | On the head | Same as predicate |
| Number Of
Possible Electrodes | 20 Channels in
standard 10-20 head
map | Different electrode
grids available
providing 8, 16 or 32
channels and 32 or 16
channel CSP layout on
predefined positions | Fewer number of
possible electrodes
but equivalent in
safety and
effectiveness |
| Size Of Caps | One size for adults:
52-62 cm | Various for infants,
children (mini, midi,
maxi) and adults
(small, medium,
large), head
circumference: 32-62
cm | Smaller range of
sizes but equivalent
in safety and
effectiveness |
| Style Of Caps | Cap is full mechanical
headset | Full head cap | Different style of
construction but
similar in safety and
effectiveness |
| Performance
Requirements | Needs to transmit
electrophysiological
signals from an
individual to data
collection device | Needs to transmit
electrophysiological
signals from an
individual to data
collection device | Same as predicate |
| Cap Material | HP Multi-Jet Fusion
PA11 and PA12 | Oeko-Tex certificate | Other material but
equivalent in safety
and effectiveness |
| Biocompatibility
Testing On Patient
Contact Materials | Evaluation done | Evaluation done | Same as predicate |
| Type Of Electrodes | Active dry | Active, wet and dry | Same as predicate
for dry |
| Reprocessing | Cleaning of all
components with
isopropyl based wipes | Cleaning with
multistage enzymatic
cleaner of cap and wet
electrodes | Similar
reprocessing but
equivalent in safety
and effectiveness |
| | | Disinfection of cap
and wet electrodes
with low level
disinfectant based on
Glucoprotamin | |
| | | Cleaning of dry
electrodes with
cleaning wipe | |
| | | Disinfection of dry
electrodes with
disinfection wipe | |
| Safety Standards | IEC 60601-1 / AAMI
ANSI ES60601-1 | IEC 60601-1 / AAMI
ANSI ES60601-1 | Similar to predicate
but equivalent in
safety and
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
applicable) | IEC 60601-2-40 | |
| | ISO 14971 | ISO 14971 | |
| | IEC 62304 / AAMI
ANSI IEC 62304 | IEC 62304 / AAMI
ANSI IEC 62304 | |
| | AAMI ANSI ISO
10993-1 | AAMI ANSI ISO
10993-1 | |
| | AAMI ANSI IEC
62366 | AAMI ANSI IEC
62366 | |
| | IEEE 2010-2012 | IEEE 2010-2012 | |
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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.
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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.
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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.
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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.
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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.