DAEHAN Disposable CUP Electrodes

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To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" below. April 3, 2019 Daehan Medical Systems Co., Ltd. Da Roo Ha RA Manager 250 Okgucheondong-Ro Siheung-City, Gyeonggido, Republic of Korea, 15084 Re: K180232 Trade/Device Name: DAEHAN Disposable CUP Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: March 12, 2019 Received: March 13, 2019 Dear Da Roo Ha: 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 {2}------------------------------------------------ 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Carlos L. Peña. PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Image /page/3/Figure/0 description: The image shows the word "DAEHAN" in a stylized, sans-serif font. The letters are all connected, and the color is a light blue. Above the word is a small, abstract symbol that looks like four squares arranged in a circular pattern. To the right of the word is the trademark symbol. # 510(k) Summary [As required by 21 CFR 807.92] #### Date Prepared [21 CFR 807.92(a)(a)] 1. Dec. 26. 2017 #### Submitter's Information [21 CFR 807.92(a)(1)] 2. | • | Name of Sponsor: | Daehan Medical Systems Co., Ltd. | |---|------------------|---------------------------------------------------------------------------| | - | Address: | 250 Okgucheondong-ro, Siheung-City Gyeonggido<br>15084, Republic of Korea | | • | Contact Name: | Da Roo Ha / RA Manager | | - | Telephone No.: | +82-31-432-6275 | | - | Fax No.: | +82-31-432-6276 | | - | Email Address: | drha@dmsleadwire.com | - . Establishment Registration No.: 3002893037 - . Name of Manufacturer: Same as Sponsor Same as Sponsor -Address: #### 3. Trade Name, Regulation Name, Classification [21 CFR 807.92(a)(2)] - . Trade Name: DAEHAN Disposable CUP Electrodes - Regulation Name: Cutaneous Electrode - Classification: ● | Classification Panel | Neurology | |---------------------------|-----------------| | Classification Regulation | 21 CFR 882.1320 | | Product Code | GXY | | Device Class | II | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "DAEHAN" in blue font. Above the word is a small blue symbol that looks like four squares connected in the middle. The letters are all capitalized and the font is sans-serif. There is a trademark symbol in the bottom right corner of the word. #### 4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)] The identified predicate device within this submission is shown as follow; ## Primary predicate device - 510(k) Number: K072016 - Applicant: Technomed Europe ● - Regulation Name: Cutaneous Electrode - Disposable EEG Cup Electrode . Device Name: # Secondary predicate device - 510(k) Number: K032278 - Applicant: Ambu, INC. ● - Regulation Name: Cutaneous Electrode - Device Name: Single Patient EEG/EP Cup Electrode ● There are no significant differences between the DAEHAN Disposable CUP Electrodes and the predicate devices that would adversely affect the use of the product. It is substantially equivalent to these devices in design, function, and technical characteristics. #### 5. Description of the Device [21 CFR 807.92(a)[4]] A cutaneous electrode is an electrode that is applied directly to a patient's skin to record physiological signals. In other words cutaneous devices are used in the acquisition of signals for the purpose of monitoring and recording Electroencephalograph(EEG), Electromyograph(EMG), and Evoked Potentials(EP) and the electroencephalograph/evoked potentials reading is completely non-invasive procedure that can be applied to children and adult patients. The electrodes are delivered non-sterile and are available in disposable version. DAEHAN Disposable CUP electrodes are for single patient use only. The electrodes have a disc manufactured of molded ABS, Ag/agcl plated. The disc is permanently adhered to a lead wire. The insulated lead wires terminate using a molded touch proof connector (DIN 42 802) for electrical safety. ## General Information {5}------------------------------------------------ Image /page/5/Figure/0 description: The image shows the word "DAEHAN" in a stylized, sans-serif font. The letters are all in blue, and the "A" is stylized with a horizontal line through the middle. Above the word "DAEHAN" is a small, blue, geometric design that looks like four stylized flowers. To the right of the word "DAEHAN" is the trademark symbol. #### Intended Use [21 CFR 807.92(a)(5)] 6. The CUP Electrodes are intended for non-invasive use with recording and monitoring equipment,(active and reference), of Electroencephalograph (EEG), electromyography (EMG)and Evoked Potentials(EP). #### Technological Characteristics [21 CFR 807.92(a)(6)] 7. DAEHAN Disposable CUP Electrodes are based on a technical feature comparison, the proposed device was found to be similar to predicate device with regard to design, function, and technical characteristics. | | Proposed Device | Primary Predicate Device | Secondary Predicate Device | |------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K Number | | K072016 | K032278 | | Model | DAEHAN Disposable CUP Electrode | Disposable Cup electrodes | Single Patient EEG/EP Cup Electrode | | Manufacturer | Daehan Medical Systems Co., Ltd. | Technomed Europe | Ambu, Inc | | Device Class | Class II | Class II | Class II | | Product code | GXY | GXY | GXY | | Intended Use | The CUP electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electroencephalograph (EEG), electromyograph (EMG) and Evoked Potentials(EP). | The CUP electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electroencephalograph (EEG), electromyograph (EMG) and Evoked Potentials(EP). | The CUP electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals for example: Electroencephalograph (EEG) and Nerve potentials signals. The electrodes are for single patient use only | | Anatomical sites | Scalp | Scalp | Scalp | | Cup | 10mm | 10mm | 10mm | General Information DAEHAN Disposable CUP Electrode {6}------------------------------------------------ | | Proposed Device | Primary Predicate Device | Secondary Predicate Device | |----------------------|-------------------------------------------|-------------------------------------------|-------------------------------------------| | Diameter | | | | | Leadwire Length | 1.0, 1.5, 2.0, 2.5, 3.0M | 1.0, 1.5, 2.0M | 1.0, 1.5, 2.0M | | Cup material | Ag/AgCl plated ABS | Ag/AgCl plated ABS | Ag/AgCl plated ABS | | Lead wire | PVC insulated tin plated copper | PVC insulated tin plated copper | PVC insulated tin plated copper | | Connectors | DIN 42802 1.5mm and Touch proof connector | DIN 42802 1.5mm and Touch proof connector | DIN 42802 1.5mm and Touch proof connector | | Sterilization Method | Non Sterilization | Non Sterilization | Non Sterilization | # Non-Clinical Test Summary: - 1) Biocompatibility - Identical materials are used in legally marketed device - 2) Performance Testing - Bond Test ● - Electrical Properties Test - AAMI/ANSI EC12 : Disposable ECG Electrodes ● - IEC 60601-1 Ed3.1 CL 8.5.2.3 : Patient Leads - 3) Shelf-life Testing - ASTM F1980-02, Standard Guide for Accelerated Aging of Sterile Medical Device Package. #### Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92] 8. When compared to the predicate devices (K072016 and K032278), DAEHAN Disposable CUP Electrode in this submission presented the substantial equivalence in terms of: - Intended use - Device design - Components and materials ● General Information DAEHAN Disposable CUP Electrode {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "DAEHAN" in a stylized, sans-serif font. The letters are all in blue, and the "A" in the middle of the word is stylized to look like the mathematical symbol "element of". Above the word is a small, blue, four-pointed star-like symbol. To the right of the word, there is a small "TM" symbol, indicating that the word is a trademark. - Technological characteristics #### 9. Conclusion [21 CFR 807.92(b)(3)] In according with the Federal Food & drug and cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Daehan Medical Systems Co., Ltd., concludes that DAEHAN Disposable CUP Electrodes are substantially equivalent to predicate devices as described herein.