Who is the manufacturer of Disposable EEG cable?

Shenzhen Changke Connect Electronics Co., Ltd. filed the 510(k) submission for Disposable EEG cable (K213884).

What is the FDA product code for Disposable EEG cable?

GXY. It is classified under 21 CFR 882.1320 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Disposable EEG cable?

510(k) clearance (submission type: Abbreviated).

Who can help prepare an FDA 510(k) submission like Disposable EEG cable?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Disposable EEG cable

Q: What are the predicate devices for Disposable EEG cable?

Disposable Gold Cup EEG Electrodes (K192564).

K213884 · Shenzhen Changke Connect Electronics Co., Ltd. · GXY · May 6, 2022 · Neurology

Device Facts

Record ID	K213884
Device Name	Disposable EEG cable
Applicant	Shenzhen Changke Connect Electronics Co., Ltd.
Product Code	GXY · Neurology
Decision Date	May 6, 2022
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 882.1320
Device Class	Class 2
Attributes	Pediatric

Intended Use

The Disposable EEG cable is intended for non-invasive use with recording and monitoring equipment,(active and reference), of Electroencephalograph (EEG), electromyography (EMG), and Evoked Potentials (EP).

Device Story

Disposable EEG cable consists of cutaneous electrodes connected to lead wires; used for non-invasive acquisition of physiological signals (EEG, EMG, EP). Device applied to clean, intact scalp skin by healthcare professionals in clinical settings; conductive paste (user-supplied) provides adhesion and electrical conductivity. Signals transmitted via lead wires to external recording/monitoring equipment for clinical analysis. Benefits include reliable signal acquisition for diagnostic monitoring. Device is non-sterile, single-use, and features gold-plated brass cups with PVC-insulated copper lead wires and standard 1.5 mm DIN connectors.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (cytotoxicity, sensitization, irritation) and electrical safety/performance testing per AAMI/ANSI ES60601-1 and ANSI AAMI EC12:2000/(R)2015.

Technological Characteristics

Gold-plated brass cup electrodes; PVC-insulated tin-plated copper lead wires; 10 mm cup diameter; 1.5 mm DIN 42-802 touch-proof connectors. Non-sterile. Complies with AAMI/ANSI ES60601-1:2005/(R)2012 and ANSI AAMI EC12:2000/(R)2015.

Indications for Use

Indicated for adults and children requiring non-invasive recording and monitoring of EEG, EMG, and EP signals in healthcare settings.

Regulatory Classification

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.

Predicate Devices

Disposable Gold Cup EEG Electrodes (K192564)

Related Devices

K192564 — Disposable Gold Cup EEG Electrodes · Dymedix Diagnostics, Inc. · Jan 21, 2020
K200540 — BRAINSTREAM Disposable Deep Cup EEG Electrodes · Conmed Corporation · Jun 1, 2020
K180232 — DAEHAN Disposable CUP Electrodes · Daehan Medical Systems Co., Ltd. · Apr 3, 2019
K073532 — DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES · Technomed Europe · May 1, 2008
K123915 — DE48-PLUS · Grass Technologies, an Astro-Med, Inc. Product Gro · Apr 24, 2013

Submission Summary (Full Text)

{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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. May 6, 2022 Shenzhen Changke Connect Electronics Co., Ltd. % Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, Guangdong 518067 China Re: K213884 Trade/Device Name: Disposable EEG cable Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: December 10, 2021 Received: December 13, 2021 Dear Kevin Wang: 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. Heather Dean, PhD Assistant Director, 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) K213884 Device Name Disposable EEG cable Indications for Use (Describe) The Disposable EEG cable is intended for non-invasive use with recording and monitoring equipment, active and reference), of Electroencephalograph (EEG), electromyography (EMG), and Evoked Potentials (EP). 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) ### 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." Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. {3}------------------------------------------------ # 510(K) Summary Prepared in accordance with the requirements of 21 CFR Part 807.92 ## Prepared Date: 2022/03/27 #### 1. Submission sponsor Name: Shenzhen Changke Connect Electronics Co., Ltd. Address: A1-2nd and A2 4th floor of factory building, No.87 of Hengping Road, Baoan Community, Yuanshan Street, Longgang District, Shenzhen City, Guangdong, 518115 P.R. China Contact person: Yahui Zhou Title: General manager E-mail: zhouyahui@szcklt.com Tel: +86 136 1301 2560 #### 2. Submission correspondent Name: Chonconn Medical Device Consulting Co., Ltd. Address: Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P. R. China 518067 Contact person: Kevin Wang E-mail: kevin@chonconn.com Tel: +86-755 33941160 | Trade/Device Name | Disposable EEG cable | |-------------------|---------------------------------------------| | Common Name | Cutaneous electrodes | | Regulatory Class | Class II | | Classification | 21CFR 882.1320 / Electrode, cutaneous / GXY | | Submission type | Abbreviated 510(K) | #### 3. Subject Device Information #### Predicate Device 4. Dymedix Diagnostics, Inc., Disposable Gold Cup EEG Electrodes, K192564 #### 5. Device Description The Disposable EEG cable, which is cutaneous electrodes connected to lead wires, is noninvasive, single use electrodes intended to be used on normal, healthy, clean, intact skin for recording purposes. In other words, the Disposable EEG cable is used in the acquisition of signals for the purpose of monitoring and recording Electroencephalograph(EEG), Electromyograph(EMG), and Evoked Potentials(EP). The Disposable EEG cable is delivered Section 5_510(k) Summary {4}------------------------------------------------ non - sterile and are available in disposable version. #### Intended use & Indication for use 6. The Disposable EEG cable is intended for non-invasive use with recording and monitoring equipment,(active and reference), of Electroencephalograph (EEG), electromyography (EMG), and Evoked Potentials (EP). | Features | Subject Device | Predicate Device | Comparison | |-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | | Disposable EEG cable | K192564 Disposable Gold Cup EEG Electrodes | | | Applicant | Shenzhen Changke Connect Electronics Co., Ltd. | Dymedix Diagnostics, Inc. | / | | Classification Regulation | 21CFR 882. 1320 | 21CFR 882. 1320 | Same | | Classification and Code | Class II, GXY | Class II, GXY | Same | | Indication for Use | The Disposable EEG cable is intended for non-invasive use with recording and monitoring equipment,(active and reference), of Electroencephalograph (EEG), electromyography (EMG), and Evoked Potentials (EP). | The Disposable Gold Cup EEG Electrodes are intended for non- invasive used with recording and monitoring equipment, (active and reference), of Electroencephalograph (EEG), Electromyography (EMG), and Evoked Potentials (EP) | Same | | Anatomical sites | Scalp | Scalp | Same | | Cup Diameter | 10 mm | 10 mm | Same | | Lead wire Length(m) | 3.05 | 1.0, 1.5, 2.0, 2.5 | Different | | Cup material | Gold Plated brass | Gold Plated brass | Same | | Lead wire | PVC insulated tin plated copper | PVC insulated tin plated copper | Same | | Features | Subject Device | Predicate Device K192564 | Comparison | | | Disposable EEG cable | Disposable Gold Cup EEG Electrodes | | | Connectors | Molded touch proof 1.5 mm DIN connector (DIN 42-802) | Molded touch proof 1.5 mm DIN connector (DIN 42-802) | Same | | Sterilization Method | Non Sterilization | Non Sterilization | Same | | Patient populations | Adults and children | Adults and children | Same | | Environment of Use | health care setting | health care setting | Same | | OTC or Rx | Rx only | Rx only | Same | | Method of Connection to the Patient | Conductive paste (provided by the user) provides electrode adhesive and conductivity. Additional adhesive tapes may be used | Conductive paste (provided by the user) provides electrode adhesive and conductivity. Additional adhesive tapes may be used | Same | #### 7. Comparison to the Predicate Device Section 5_510(k) Summary {5}------------------------------------------------ In conclusion, the differences in technological characteristics do not raise new questions of safety and effectiveness. #### 8. Performance Data The following performance data were provided in support of the substantial equivalence determination. ### Biocompatibility testing The biocompatibility evaluation for the Disposable EEG cable was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The biocompatibility testing included the following tests: - Cytotoxicity . - Sensitization ● - Irritation . Section 5 510(k) Summary {6}------------------------------------------------ ### Non-clinical data We performed electrical safety. The design of the Disposable EEG Electrodes 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 according to the <Cutaneous Electrodes for Recording Purposes - Performance Criteria for Safety and Performance Based Pathway > and ANSI AAMI EC12:2000/(R)2015 Disposable ECG electrodes. # Clinical data Clinical testing is not required. #### 9. Conclusion Performance testing and compliance with voluntary standards demonstrate that the proposed subject device is substantially equivalent to the predicate device.