(90 days)
Not Found
No
The device description focuses solely on the physical components and placement of EEG electrodes for signal transmission, with no mention of data processing, analysis, or interpretation using AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is used to transmit electrophysiological signals for data collection and evaluation, which is diagnostic, not therapeutic.
Yes
The device "transmits electrophysiological signals from an individual to data collection devices" and the "electrical activity of the brain is transferred via the electrolyte to the electrode and then to the EEG equipment for evaluation." The "Intended Use / Indications for Use" states that it "is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired," clearly indicating its role in collecting physiological data for diagnostic purposes (EEG).
No
The device description clearly details physical hardware components (spandex caps, silver/silver chloride electrodes, connectors, etc.) and performance studies related to electrical safety and biocompatibility, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Disposable EEG Electrodes described here are used to transmit electrophysiological signals from an individual to data collection devices. They are placed on the surface of the body (the scalp) to measure electrical activity directly from the brain.
- No Specimen Analysis: The device does not analyze any biological specimens taken from the body. It is a sensor that captures electrical signals from the body.
Therefore, the function and intended use of these EEG electrodes fall outside the scope of an In Vitro Diagnostic device. They are considered medical devices used for physiological monitoring.
N/A
Intended Use / Indications for Use
Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired.
Product codes (comma separated list FDA assigned to the subject device)
GXY
Device Description
Disposable EEG Electrodes includes three models: DL, E-CAP, FLEX-CAP.
The models E-CAP and FLEX-CAP are EEG electrode positioning systems used to place a number of EEG electrodes in a uniform and consistent manner on the head in order to transmit electrophysiological signals from an individual to data collection devices. The model E-CAP is made from spandex type material with silver/silver chloride-plated ABS electrodes in silicone base attached to the cap. The model FLEX-CAP is made from spandex type material with silver/silver chloride ink printed electrodes on PET in silicone base attached to the cap, the cap covering the entire scalp and is held in place with chin straps. The spandex type material holds the electrodes securely in position during an EEG recording. The electrodes on the caps connect to the EEG equipment either through an adapter cable or in some instances, special connector on match EEG equipment. The electrical activity of the brain is transferred via the electrolyte to the electrode and then to the EEG equipment for evaluation. The models E-CAP and FLEX-CAP have been built with the placement of 2-128 electrodes, the size of cap is from 26 to 66 cm.
The model DL is a silver/silver chloride-plated ABS electrode with shrink tubing and connector, which is used on the model E-CAP. In addition, model DL can be used alone on the scalp for EEG monitoring.
The electrodes on the Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) are positioned according to the International Ten-Twenty System (10-20) of Electrode Placement. In addition, Disposable EEG Electrodes (MODEL: DL, FLEX-CAP) with as a few as 2 or as many as 128 electrodes, have been mounted in a place according to the 10-10 American Electroencephalographic Society positioning system. Disposable EEG Electrodes (MODEL: DL, FLEX-CAP) can also be custom-made, in which the numbers of electrodes and placement of electrodes are made under an instruction from customs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
On the head
Indicated Patient Age Range
Adults and Children
Intended User / Care Setting
Neurologists / routine clinical settings
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)
Clinical test: Clinical testing is not required.
Non-clinical data Performance: The design of the Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) is in conformance with subclause 8.5.2.3 of AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (consolidated text) Medical electrical equipment -Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, mod). The performance test and shelf life validation were carried out according to the and ANSI EC12-2000 Disposable ECG electrodes.
Biocompatibility:
- ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
- ISO 10993-5 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
The subject device met the performance requirements of FDA guidance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Performance requirements for the subject device:
- Resistance
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).
0
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.
April 21, 2020
Wuhan Greentek Pty Ltd. Yarong Liu Rm 03-2, Floor 3, Dingye Bldg, Phase III International Enterprise Center, Special No.1 Guanggu Ave Donghu New Technology Development Zone Wuhan, Hubei, 430074 China
Re: K200162
Trade/Device Name: Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: January 1, 2020 Received: January 22, 2020
Dear Yarong Liu:
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.
1
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 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 (QS) 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.
For Vivek Pinto, PhD Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200162
Device Name
Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)
Indications for Use (Describe)
Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired.
| 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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3
510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: March 8, 2020
1. Submitter's Information
The submitter of this pre-market notification is:
| Name: | Wuhan Greentek Pty Ltd |
|---|---|
| Address: | Room 03-2, Floor 3, Dingye Building, Phase III, International |
| Enterprise Center, Special No.1, Guanggu Avenue, Donghu New | |
| Technology Development Zone, Wuhan, CHINA 430074 | |
| Contact person: | Yarong Liu |
| Title: | Manager |
| E-mail: | lyr@gtsensor.com |
| Tel: | +86-27-88185488 |
2. Device Identification
| Trade/Device Name: | Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) | |
|---|---|---|
| Models: | DL, E-CAP, FLEX-CAP | |
| Common Name | Disposable EEG Electrodes system | |
| Regulation Number: | 21 CFR 882.1320 | |
| Regulation Name: | cutaneous electrode | |
| Regulation Class: | Class II | |
| Product Code: | GXY |
3. Predicate Device
| 510(K) number: | K112319 |
|---|---|
| Trade Name: | Electro-Cap System |
| Common Name | EEG electrode positioning system |
| Manufacturer: | Electro-Cap International, Inc. |
| Regulation Number: | 21 CFR 882.1320 |
| Regulation Name: | cutaneous electrode |
| Regulation Class: | Class II |
| Product Code: | GXY |
4. Device Description
Disposable EEG Electrodes includes three models: DL, E-CAP, FLEX-CAP.
4
The models E-CAP and FLEX-CAP are EEG electrode positioning systems used to place a number of EEG electrodes in a uniform and consistent manner on the head in order to transmit electrophysiological signals from an individual to data collection devices. The model E-CAP is made from spandex type material with silver/silver chloride-plated ABS electrodes in silicone base attached to the cap. The model FLEX-CAP is made from spandex type material with silver/silver chloride ink printed electrodes on PET in silicone base attached to the cap, the cap covering the entire scalp and is held in place with chin straps. The spandex type material holds the electrodes securely in position during an EEG recording. The electrodes on the caps connect to the EEG equipment either through an adapter cable or in some instances, special connector on match EEG equipment. The electrical activity of the brain is transferred via the electrolyte to the electrode and then to the EEG equipment for evaluation. The models E-CAP and FLEX-CAP have been built with the placement of 2-128 electrodes, the size of cap is from 26 to 66 cm.
The model DL is a silver/silver chloride-plated ABS electrode with shrink tubing and connector, which is used on the model E-CAP. In addition, model DL can be used alone on the scalp for EEG monitoring.
The electrodes on the Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) are positioned according to the International Ten-Twenty System (10-20) of Electrode Placement. In addition, Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) with as a few as 2 or as many as 128 electrodes, have been mounted in a place according to the 10-10 American Electroencephalographic Society positioning system. Disposable EEG Electrodes (MODEL: DL, FLEX-CAP) can also be custom-made, in which the numbers of electrodes and placement of electrodes are made under an instruction from customs.
5. Indication for use
Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired.
6. Comparison to Predicate Device
Compared to the predicate devices, the subject device has same intended use, similar product design, and same performance effectiveness as the predicate device as summarized in the following table.
| Feature | Subject device | Predicate device | Discussion |
|---|---|---|---|
| 510(k) | |||
| Number | - | K112319 | - |
| Indication | |||
| for Use | Disposable EEG | ||
| Electrodes (MODEL: | |||
| DL, E-CAP, FLEX- | |||
| CAP) is intended for | |||
| use in routine clinical | |||
| settings where rapid | |||
| placement of a number | |||
| of EEG electrodes is | |||
| desired. | The Electro-Cap is | ||
| intended for use in routine | |||
| clinical settings where | |||
| rapid placement of a | |||
| number of EEG electrodes | |||
| is desired. | Same | ||
| Classifica | |||
| tion | Class II per | ||
| 21CFR882.1320, | Class II per | ||
| 21CFR882.1320, | Same |
5
| Regulatio
| n | cutaneous electrode | cutaneous electrode | |
|---|---|---|---|
| Product | |||
| Code | GXY, Electrode, | ||
| cutaneous | GXY, Electrode, | ||
| cutaneous | Same | ||
| Environm | |||
| ent of | |||
| use | Electrophysiological | Electrophysiological | Same |
| Intended | |||
| user | Neurologists | Neurologists | Same |
| Target | |||
| patient | Adults and Children | Adults and Children | Same |
| Where | |||
| used | On the head | On the head | Same |
| Number | |||
| of | |||
| contacts | 2-128 | 2-256 | The placement of the |
| electrodes is according to the | |||
| International (10-20) System of | |||
| Electrode Placement or (10- |
- American
Electroencephalographic
Society positioning system.
The number of the electrodes
in use is according to the
needs of clinic practice. By
using 19 electrodes and 32
electrodes (or 19 channels and
32 channels can meet majority
needs, while using channels
up to 128 can satisfy most
medical applications as the
predicate K112319 does. The
disposable electrodes can
adapt to most EEG equipment
as the predicate K112319
does. Both of the subject
device and the predicate
device are applied to record
EEG signals on patients' scalp,
and the bioelectrical signals
are in microvolts-level. The
electrodes only transfer tiny
bioelectrical signals to the
EEG recording equipment. The
doctors can read the signals
according the channels
assigned, such as 19 channels
or 32 channels. The safety
issue only concerns the bio- |
| | | | compatibility of the electrode
materials, while the
effectiveness mainly concerns
the electrode surface
materials. The number of
electrodes in the products is
irrelevant to the safety and
also doesn't affect the
effectiveness compared to
predicate devices. Therefore,
the difference in numbers of
electrodes does not raise any
new safety risk or
effectiveness issue. |
| Size of
Caps | Various - babies to
large 26cm to 66cm | Various - babies to large
26cm to 66cm | Same |
| Style of
Caps | Full head cap | Full head cap | Same |
| Ear Slits | Yes | Yes | Same |
| Cap
material | Spandex | Spandex | Same |
| Electrode
Mounts | Silicone | Polyethylene | The mount base used in the
Disposable Electrodes is
designed for fastening the
electrodes on the cap fabric,
and the base don't involve in
the bioelectrical signal
recording. Silicone is a
common material used in
medical device. The silicone
mount base can be made soft
than the base made by
polyethylene in the predicate
device. Therefore, by using
silicone materials as the mount
base offers more comfortable
experience to the users.
Furthermore, the silicone
mount bases used in this
Disposable Electrodes have
passed the bio-compatibility
test. Thus, the use of silicone
as electrode mount base does
not raise new safety and
effectiveness issues. |
| Cable
Length | 0.1 m - 3.0 m | Various - 3 to 5 feet | The length of the cable in the
Disposable electrodes is
different from the predicate
device but it doesn't raise new
safety and effectiveness issue.
Because the cable is used for
transferring EEG signals (the
tiny bioelectrical signal in ~
several ten microvolts peak to
peak) from the patients' scalp
to the data record devices. The
cable is designed in
conformance with AAMI / ANSI
ES60601-1:2005/(R)2012 and
A1:2012, C1:2009/(R)2012
and A2:2010/(R)2012
(consolidated text) Medical
electrical equipment - Part 1:
General requirements for basic
safety and essential
performance (IEC 60601-
1:2005, mod). |
| Type of
Cables | Standard ribbon cable
and lead wires | Standard ribbon cable and
lead wires | Same |
| Electrode
Metal | 1. FLEX-CAP:
silver/silver chloride ink
printed electrodes on
PET (Polyethylene
terephthalate)
- DL and E-CAP:
silver/silver chloride –
plated ABS base | Pure tin, silver, silver/silver
chloride, gold plated | Electrode material need to
have good electrical
conducting and non-polarized
characteristic on the surface
(low interface impedance). The
predicate device has four
electrode materials, but the
best electrode material is
silver/silver chloride as it
possesses non-polarized
surface. The surface material
of disposable electrodes is
silver/silver chlorides, which is
printed or plated on plastic
(PET, Polyethylene
terephthalate or ABS). The
plastic provides a supporting
substrate, the surface
silver/silver chloride provide
electrode function as electrical
conducting and low impedance
as the one of the best
electrodes in the predicate
devices. These plastics don't |
6
7
8
| Type of
Connecto
rs | Touch-proof safety
socket DIN42-802
( $ Φ $ =1.5mm) | D-Sub connectors, touch
proof DIN sockets and
special connectors on
match EEG equipment
and computers | contact to scalp and don't
involve in bioelectrical signal
recording either.
Further, the electrodes with
silver/silver chloride ink printed
on PET substrate and
silver/silver chloride plated on
ABS substrate have passed
bio-compatibility tests in
accordance with ISO 10993-1
and as well as performance
test in accordance with ASTM
EC 12. The test result shows
that subject device meets the
performance requirements of
FDA guidance, so the
difference in materials does
not raise new safety and
effectiveness issues. |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocomp
atibility
test | ISO 10993-1,
ISO 10993-5,
ISO 10993-10 | None was conducted | The subject device has been
performed biocompatibility test
according to the FDA
guidance, this difference does
not raise any new safety or
effectiveness. |
| Performa
nce
requirem
ents | 1. Resistance and ANSI EC12-2000 Disposable ECG electrodes.
Biocompatibility:
-
- ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
-
- ISO 10993-5 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
-
- ISO 10993-10 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
8. Conclusion
Based on the comparison with predicate device, our Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) has the same intended use, structure, and technologies, which is substantially equivalent to predicated device.