Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)

{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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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<br>Enterprise Center, Special No.1, Guanggu Avenue, Donghu New<br>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)<br>Number | - | K112319 | - | | Indication<br>for Use | Disposable EEG<br>Electrodes (MODEL:<br>DL, E-CAP, FLEX-<br>CAP) is intended for<br>use in routine clinical<br>settings where rapid<br>placement of a number<br>of EEG electrodes is<br>desired. | The Electro-Cap is<br>intended for use in routine<br>clinical settings where<br>rapid placement of a<br>number of EEG electrodes<br>is desired. | Same | | Classifica<br>tion | Class II per<br>21CFR882.1320, | Class II per<br>21CFR882.1320, | Same | {5}------------------------------------------------ | Regulatio<br>n | cutaneous electrode | cutaneous electrode | | |---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product<br>Code | GXY, Electrode,<br>cutaneous | GXY, Electrode,<br>cutaneous | Same | | Environm<br>ent of<br>use | Electrophysiological | Electrophysiological | Same | | Intended<br>user | Neurologists | Neurologists | Same | | Target<br>patient | Adults and Children | Adults and Children | Same | | Where<br>used | On the head | On the head | Same | | Number<br>of<br>contacts | 2-128 | 2-256 | The placement of the<br>electrodes is according to the<br>International (10-20) System of<br>Electrode Placement or (10-<br>10) American<br>Electroencephalographic<br>Society positioning system.<br>The number of the electrodes<br>in use is according to the<br>needs of clinic practice. By<br>using 19 electrodes and 32<br>electrodes (or 19 channels and<br>32 channels can meet majority<br>needs, while using channels<br>up to 128 can satisfy most<br>medical applications as the<br>predicate K112319 does. The<br>disposable electrodes can<br>adapt to most EEG equipment<br>as the predicate K112319<br>does. Both of the subject<br>device and the predicate<br>device are applied to record<br>EEG signals on patients' scalp,<br>and the bioelectrical signals<br>are in microvolts-level. The<br>electrodes only transfer tiny<br>bioelectrical signals to the<br>EEG recording equipment. The<br>doctors can read the signals<br>according the channels<br>assigned, such as 19 channels<br>or 32 channels. The safety<br>issue only concerns the bio- | | | | | compatibility of the electrode<br>materials, while the<br>effectiveness mainly concerns<br>the electrode surface<br>materials. The number of<br>electrodes in the products is<br>irrelevant to the safety and<br>also doesn't affect the<br>effectiveness compared to<br>predicate devices. Therefore,<br>the difference in numbers of<br>electrodes does not raise any<br>new safety risk or<br>effectiveness issue. | | Size of<br>Caps | Various - babies to<br>large 26cm to 66cm | Various - babies to large<br>26cm to 66cm | Same | | Style of<br>Caps | Full head cap | Full head cap | Same | | Ear Slits | Yes | Yes | Same | | Cap<br>material | Spandex | Spandex | Same | | Electrode<br>Mounts | Silicone | Polyethylene | The mount base used in the<br>Disposable Electrodes is<br>designed for fastening the<br>electrodes on the cap fabric,<br>and the base don't involve in<br>the bioelectrical signal<br>recording. Silicone is a<br>common material used in<br>medical device. The silicone<br>mount base can be made soft<br>than the base made by<br>polyethylene in the predicate<br>device. Therefore, by using<br>silicone materials as the mount<br>base offers more comfortable<br>experience to the users.<br>Furthermore, the silicone<br>mount bases used in this<br>Disposable Electrodes have<br>passed the bio-compatibility<br>test. Thus, the use of silicone<br>as electrode mount base does<br>not raise new safety and<br>effectiveness issues. | | Cable<br>Length | 0.1 m - 3.0 m | Various - 3 to 5 feet | The length of the cable in the<br>Disposable electrodes is<br>different from the predicate<br>device but it doesn't raise new<br>safety and effectiveness issue.<br>Because the cable is used for<br>transferring EEG signals (the<br>tiny bioelectrical signal in ~<br>several ten microvolts peak to<br>peak) from the patients' scalp<br>to the data record devices. The<br>cable is designed in<br>conformance with AAMI / ANSI<br>ES60601-1:2005/(R)2012 and<br>A1:2012, C1:2009/(R)2012<br>and A2:2010/(R)2012<br>(consolidated text) Medical<br>electrical equipment - Part 1:<br>General requirements for basic<br>safety and essential<br>performance (IEC 60601-<br>1:2005, mod). | | Type of<br>Cables | Standard ribbon cable<br>and lead wires | Standard ribbon cable and<br>lead wires | Same | | Electrode<br>Metal | 1. FLEX-CAP:<br>silver/silver chloride ink<br>printed electrodes on<br>PET (Polyethylene<br>terephthalate)<br>2. DL and E-CAP:<br>silver/silver chloride –<br>plated ABS base | Pure tin, silver, silver/silver<br>chloride, gold plated | Electrode material need to<br>have good electrical<br>conducting and non-polarized<br>characteristic on the surface<br>(low interface impedance). The<br>predicate device has four<br>electrode materials, but the<br>best electrode material is<br>silver/silver chloride as it<br>possesses non-polarized<br>surface. The surface material<br>of disposable electrodes is<br>silver/silver chlorides, which is<br>printed or plated on plastic<br>(PET, Polyethylene<br>terephthalate or ABS). The<br>plastic provides a supporting<br>substrate, the surface<br>silver/silver chloride provide<br>electrode function as electrical<br>conducting and low impedance<br>as the one of the best<br>electrodes in the predicate<br>devices. These plastics don't | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ | Type of<br>Connecto<br>rs | Touch-proof safety<br>socket DIN42-802<br>( $ Φ $ =1.5mm) | D-Sub connectors, touch<br>proof DIN sockets and<br>special connectors on<br>match EEG equipment<br>and computers | contact to scalp and don't<br>involve in bioelectrical signal<br>recording either.<br>Further, the electrodes with<br>silver/silver chloride ink printed<br>on PET substrate and<br>silver/silver chloride plated on<br>ABS substrate have passed<br>bio-compatibility tests in<br>accordance with ISO 10993-1<br>and as well as performance<br>test in accordance with ASTM<br>EC 12. The test result shows<br>that subject device meets the<br>performance requirements of<br>FDA guidance, so the<br>difference in materials does<br>not raise new safety and<br>effectiveness issues. | |-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Biocomp<br>atibility<br>test | ISO 10993-1,<br>ISO 10993-5,<br>ISO 10993-10 | None was conducted | The subject device has been<br>performed biocompatibility test<br>according to the FDA<br>guidance, this difference does<br>not raise any new safety or<br>effectiveness. | | Performa<br>nce<br>requirem<br>ents | 1. Resistance <100 Ω<br>2. AC impedance <2<br>kΩ (at 10 Hz)<br>3. DC offset voltage<br><100 mV<br>4. Combined offset<br>instability and internal<br>noise: <150 µV<br>5. Bias current<br>tolerance <100 mV | Needs to transmit<br>electrophysiological<br>signals from an individual<br>to data collection devices<br>with a maximum<br>impedance of 5 K/Ohms.<br>Does not transmit<br>electrical current, nor are<br>they intended to be used<br>for stimulation. | The subject device was<br>performed electrode<br>characterization test according<br>to the FDA guidance, the<br>performance of subject device<br>met the requirements of FDA<br>guidance "Cutaneous<br>Electrodes for Recording<br>Purposes - Performance<br>Criteria for Safety and<br>Performance Based Pathway".<br>we have done more details in<br>tests according to the FDA<br>guidance. | All the differences do not affect the safety and effectiveness of the subject device which is concluded after all the required testing, so there are no safety and effectiveness issues relating to the subject system. {9}------------------------------------------------ # 7. Performance Data #### Clinical test: Clinical testing is not required. #### Non-clinical data Performance: We performed electrical safety. 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). We carried out the performance test and shelf life validation according to the <Cutaneous Electrodes for Recording Purposes - Performance Criteria for Safety and Performance Based Pathway: Draft Guidance for Industry and Food and Drug Administration Staff> and ANSI EC12-2000 Disposable ECG electrodes. Biocompatibility: - 1. ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process - 2. ISO 10993-5 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity - 3. 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.