Disposable Non-invasive EEG Sensor

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size, also in blue. The logo is simple and professional, and it is easily recognizable. January 19, 2023 Shenzhen Med-link Electronics Tech Co., Ltd. Yi Liu Regulatory Affairs Specialist 4th and 5th Floor, Building Two, Hualian Industrial Zone, Xinshi Community, Dalang Street Shenzhen, Guangdong 518109 China Re: K220448 Trade/Device Name: Disposable Non-invasive EEG Sensor (Models: B-BIS-6A, B-BIS-6A-02, B-BIS-6A-01, B-BIS-6A-03, B-BIS-5A, B-BIS-5A-01, B-BIS-4A, B-BIS-4A-01, B-BIS-4P, B-BIS-4P-01, B-BIS-3A, B-BIS-3A-02, B-BIS-3A-01, B-BIS-3A-03, B-BIS-3AL, B-BIS-3AL-01, B-BIS-3AR, B-BIS-3AR-01) Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: February 11, 2022 Received: February 16, 2022 Dear Yi 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, # Tushar Bansal -S for Heather Dean, PhD Assistant Director THT5B3: Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine 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) K220448 #### Device Name Disposable Non-invasive EEG Sensor (Device Models: B-BIS-6A-02, B-BIS-6A-01, B-BIS-6A-03, B-BIS-5A, B-BIS-5A, 01. B-BIS-4A. B-BIS-4A-01, B-BIS-4P. B-BIS-4P-01. B-BIS-3A, B-BIS-3A-01, B-BIS-3A-03. B-BIS-3AL, B-BIS-3AL-01, B-BIS-3AR, B-BIS-3AR-01) #### Indications for Use (Describe) Disposable Non-invasive EEG Sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals. 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Submitter information Manufacturer Name: Shenzhen Med-link Electronics Tech Co., Ltd. Address: 4th and 5th Floor, Building Two, Hualian Industrial Zone, Xinshi Community, Dalang Street, Longhua District, 518109 Shenzhen, PEOPLE'S REPUBLIC OF CHINA Tel: 0086-755-61568825 Fax: 0086-755-61120055 Establishment Registration Number: 3006636961 ### 2. Correspondent Yi Liu (Regulatory Affairs Specialist) E-mail: user22(@med-linket.com #### 3. Data of Preparation 11. Feb. 2022 #### 4. Identification of the Device Trade Name: Disposable Non-invasive EEG Sensor (Device Models: B-BIS-6A-02, B-BIS-6A-01, B-BIS-6A-03, B-BIS-5A, B-BIS-5A-01, B-BIS-4A, B-BIS-4A-01, B-BIS-4P-01, B-BIS-3A, B-BIS-3A-02, B-BIS-3A-01, B-BIS-3A-03, B-BIS-3AL, B-BIS-3AL-01, B-BIS-3AR, B-BIS-3AR-01) Common Name: EEG Sensor Classification Regulation: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Product Code: GXY Class: II Review Panel: Neurology {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for MedLinket. The logo is composed of the company name, "MedLinket", with the first letter, "M", in orange and the rest of the letters in blue. The font is sans-serif and the letters are connected. #### 5. Identification of the Predicate Device | No. | Device<br>Name | Common<br>Name | Manufacturer | Classification<br>and Product<br>Code | Classification<br>Regulation | 510(k)<br>Number | |-----|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------|---------------|---------------------------------------|------------------------------|------------------| | 1 | Covidien<br>BIS Sensors<br>(BIS Quatro<br>Sensor, BIS<br>Extend, BIS<br>Pediatric<br>Sensor, BIS<br>Bilateral<br>Sensor) | Electrode,<br>Cutaneous<br>Electrode | Medtronic Plc | Class II,<br>GXY | 21 CFR<br>882.1320 | K143506 | | 2 | GE Entropy<br>Sensor | Entropy<br>Sensor | GE Healthcare | Class II,<br>GXY | 21 CFR<br>882.1320 | K062580 | Table 1 Predicate Device Information #### 6. Intended Use and Indications for Use of the Subject Device Disposable Non-invasive EEG Sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals. #### 7. Device Description Disposable Non-invasive EEG Sensor is a sensor assembly with pre-gelled electroencephalogram (EEG) electrodes. The Sensor is applied to the skin of the patient to record electrophysiological (such as EEG) signals. It is a low impedance, single patient use, non-sterile disposable electrode sensor that is designed for application to areas including forehead, temporal, above eyebrow and mastoid process. The Sensor is designed to provide ease of use and electrode placement accuracy. It is used in conjunction with a monitor with an EEG module. The sensor design is constructed using FPC (Flexible Printed Circuit Board) and medical foam. Place the foam plate and conductive gel on the FPC board. The bottom of the foam is covered with medical grade pressure sensitive adhesive for skin adhesion. A printed circuit board, which is part of the FPC board and printed with conductive silver chloride, is pasted on the other side of the foam. The {5}------------------------------------------------ # Medlinket flexible foam wrapped with conductive gel is used to contact the skin. When the flexible foam contacts the skin, the conductive gel will connect the skin with the FPC board to form a conductive bridge. The silver/silver chloride circuit provides signal continuity from each electrode to the monitor. The FPC board is attached to site like forehead and transmits EEG signals. | Item | Proposed Device | Predicate Device #1 | Predicate Device #2 | Discussion | |------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Trade<br>name | Disposable<br>Non-invasive EEG<br>Sensor | Covidien BIS Sensors<br>(BIS Quatro Sensor,<br>BIS Extend, BIS<br>Pediatric Sensor, BIS<br>Bilateral Sensor) | GE Entropy Sensor | N/A | | 510(K)<br>Submitter | Shenzhen Med-link<br>Electronics Tech Co.,<br>Ltd. | Medtronic Plc | GE Healthcare | N/A | | 510(K)<br>Number | K220448 | K143506 | K062580 | N/A | | Classification<br>Regulation | 21 CFR 882.1320 | 21 CFR 882.1320 | 21 CFR 882.1320 | Same | | Classification<br>and Code | Class II,<br>GXY | Class II,<br>GXY | Class II,<br>GXY | Same | | Common<br>Name | EEG sensor | Electrode, Cutaneous<br>Electrode | Entropy sensor | N/A | | Type of Use | Prescription | Prescription | Prescription | Same | | Indications for<br>Use | Disposable Non-<br>invasive EEG Sensor is<br>applied directly to the<br>patient's skin to<br>enable recordings of<br>electrophysiological<br>(such as EEG) signals. | The BIS Sensor is<br>applied directly to the<br>patient's skin to enable<br>recordings of<br>electrophysiological<br>(such as EEG) signals. | The GE Entropy Sensor<br>is intended to be used<br>for adults with GE<br>Entropy measurement<br>devices to enable<br>recording of<br>physiological signals<br>(such as EEG). To<br>connect this sensor to the<br>measurement device,<br>use the GE Entropy<br>Cable. | Same | ## 8. Comparison to the Predicate Device {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "Medlinket" in a sans-serif font. The "M" is orange, while the rest of the letters are light blue. The letters are all connected, giving the word a sense of unity. The image is simple and clean, with a white background. | Number of<br>Electrodes | 3/4/5/6 | 4/6 | 3 | Different note<br>1 | |--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|---------------------------|--------------------------------------| | Application Site | Forehead/temporal/above<br>eyebrow/mastoid<br>process | Frontal/temporal area | Frontal/temporal area | Different note<br>2 | | Duration of Use | Maximum 24 hours | Not publicly<br>available | Not publicly<br>available | Different note<br>3 | | Usage | Disposable | Disposable | Disposable | Same | | Applicable<br>Population | Adult and pediatric | Adult and pediatric | Adults only | Same as<br>Predicate<br>Device<br>#1 | | Operation<br>Environment | Temperature: 5℃~40℃<br>Humidity:0~80%RH, non-<br>condensing atmospheric<br>pressure: 86kPa~106kPa | Not publicly available | Not publicly available | Different<br>note 4 | | Storage<br>Environment | Temperature:<br>-10°C~40°C Humidity:0~<br>80% RH, non-condensing<br>atmospheric pressure:86<br>kPa〜106 kPa | Not publicly available | Not publicly available | Different<br>note 4 | | Material | FPC, 3M Foam Tape (Silicone<br>coated paper liner, Foam<br>backing, Acrylate Adhesive),<br>AgCl electrode, and conductive<br>gel (a mixture of the following<br>components: | Not publicly available | Not publicly available | Different<br>note 3 | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for MedLinket. The logo is in blue, except for the first letter, "M", which is in orange. The text is simple and modern. | | Water, Sodium Chloride, Gum Acacia, Guar Gum, and Xanthan Gum, Potassium Bitartrate, Glycerin, Methylparaben and Propylparaben.) | | | | |----------------------|----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|-----------------------------------| | Electrical<br>Safety | Complies with<br>ANSI/AAMI<br>ES60601-1 | Performed. Specific<br>standard not specified in<br>510(k) Database. | Complies with<br>EN 60601-1 | Different<br>note 5 | | Performance | Complies with<br>ANSI/AAMI EC 12 | Complies with<br>ANSI/AAMI EC 12 | Complies with<br>ANSI/AAMI EC 12 | Same | | Biocompatibility | All the patient-contacting<br>materials are evaluated<br>by the biocompatibility<br>standards ISO10993-5,<br>ISO 10993-10. | Performed. Specific<br>standard not specified in<br>510(k) Database. | All the patient-contacting<br>materials are evaluated<br>by the biocompatibility<br>standards ISO10993-5.<br>ISO 10993-10. | Same as<br>Predicate<br>Device #2 | | Sterilization | Non-sterile | Not publicly available | Non-sterile | Same as<br>Predicate<br>Device #2 | Note 1 The number of 4/6 electrodes is the same as Predicate #1. The number of 3 electrodes is the same as Predicate #2. The number of 5 electrodes falls within the possible customizable number of electrodes of Predicate #1 (between 4 to 6 electrodes). The difference of the number of electrodes of the proposed device does not affect its safe and effective usage in monitoring of EEG signals. The device has been tested in accordance with electrical safety and performance tests, and the tests passed. Thus, such a difference among the proposed device and the predicate devices does not affect substantial equivalence. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for MedLinket. The logo is composed of the word "MedLinket" in a sans-serif font. The "M" is orange, while the rest of the letters are light blue. ### Note 2 Although the description of application sites of the proposed device are different from those of the predicate devices, the application sites are actually the same among three devices regarding frontal area. The actual use and application of the predicate devices on frontal area involve forehead and above eyebrow, with the description of the proposed device being more detailed. Regarding the additional application site of mastoid process that the proposed device specifies, it does not raise different questions of safety and effectiveness as the device meets safety and performance requirements. #### Note 3 Although the usage time and material of the two predicate devices are not publicly available in the 510(k) Database, biocompatibility tests have been performed on the proposed device and the tests passed. Therefore, such a difference does not affect substantial equivalence among the proposed device and two predicate devices. #### Note 4 The proposed device and the predicate devices all comply with electrical safety standards and performance standards. Therefore, absence of the information concerning Operation and Storage Environment of the two predicate devices does not raise questions of safety and effectiveness for the proposed device. #### Note 5 Both the proposed device and the Predicate Device #2 performed electrical safety tests in accordance with 60601-1 standards.. Thus, the difference does not raise different questions of safety and effectiveness. The two devices are substantially equivalent regarding electrical safety. #### 9. Non-clinical Test The safety and effectiveness of the subject device are demonstrated through testing following ANSI/AAMI ES60601-1 General requirements for basic safety and essential performance and ANSI/AAMI EC12: 2000/(R)2015 Disposable ECG Electrodes. The results of bench testing provides reasonable assurance that the proposed device has been designed and validated to assure conformance to the requirements for its indication for use. Package integrity and functional performance testing were completed on the subject device following Accelerated aging test to support the proposed shelf life. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the word "Medlinket" in a stylized font. The "M" is orange, while the rest of the letters are light blue. The font is sans-serif and appears to be slightly rounded. ### 10. Conclusion Based on the comparison and analysis in this submission, it can be concluded that the Disposable Non-invasive EEG Sensor is substantially equivalent to the predicate devices.