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 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 non - sterile and are available in disposable version.

AI/ML Overview

The request asks for specific details about the acceptance criteria and study proving a device meets them. However, the provided text is an FDA 510(k) clearance letter for a "Disposable EEG cable", which is a Class II device.

The document states that a clinical study was not required for this device, and the evaluation for substantial equivalence was based on bench performance testing and biocompatibility testing. This type of device (a cable and electrode) does not involve complex algorithms or AI assistance, which are the typical contexts for the detailed performance studies outlined in the prompt (e.g., MRMC studies, training/test sets, expert adjudication, effect sizes).

Therefore, I cannot provide the requested information regarding:

Acceptance criteria table and device performance: The document only refers to compliance with standards for electrical safety and biocompatibility, not specific performance metrics in the context of an AI/algorithm-based device.
Sample size for test set and data provenance: No test set in the sense of an algorithm evaluation.
Number of experts and qualifications: No expert review panels for ground truth establishment.
Adjudication method: Not applicable.
MRMC comparative effectiveness study: Not applicable as there's no AI component or human reader interpretation being improved.
Standalone performance: Not applicable.
Type of ground truth: Not applicable.
Sample size for training set: No training set as there's no AI/algorithm.
Ground truth for training set: Not applicable.

The document confirms that this device is a simple medical device (a cable with electrodes) and not a software/AI-based medical device.

What the document does provide regarding performance:

Biocompatibility testing: Conducted using ISO 10993-1, including Cytotoxicity, Sensitization, and Irritation tests.
Electrical safety: 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).
Performance test: Carried out according to "<Cutaneous Electrodes for Recording Purposes - Performance Criteria for Safety and Performance Based Pathway>" and ANSI AAMI EC12:2000/(R)2015 Disposable ECG electrodes.

In summary, the provided text does not contain the information required to answer the prompt, as the device in question is a simple medical cable and not an AI/algorithm-driven device evaluated through the types of studies described in the prompt.

Summary

{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)

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

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	K192564Disposable Gold CupEEG Electrodes
Applicant	Shenzhen ChangkeConnect ElectronicsCo., Ltd.	Dymedix Diagnostics,Inc.	/
ClassificationRegulation	21CFR 882. 1320	21CFR 882. 1320	Same
Classificationand Code	Class II, GXY	Class II, GXY	Same
Indication forUse	The Disposable EEGcable is intended fornon-invasive use withrecording andmonitoringequipment,(active andreference), ofElectroencephalograph(EEG),electromyography(EMG), and EvokedPotentials (EP).	The Disposable GoldCup EEG Electrodesare intended for non-invasive used withrecording andmonitoring equipment,(active and reference),ofElectroencephalograph(EEG),Electromyography(EMG), and EvokedPotentials (EP)	Same
Anatomicalsites	Scalp	Scalp	Same
Cup Diameter	10 mm	10 mm	Same
Lead wireLength(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 tinplated copper	PVC insulated tinplated copper	Same
Features	Subject Device	Predicate DeviceK192564	Comparison
	Disposable EEG cable	Disposable Gold CupEEG 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
SterilizationMethod	Non Sterilization	Non Sterilization	Same
Patientpopulations	Adults and children	Adults and children	Same
Environmentof Use	health care setting	health care setting	Same
OTC or Rx	Rx only	Rx only	Same
Method ofConnection tothe Patient	Conductive paste(providedby the user) provideselectrode adhesive andconductivity.Additionaladhesive tapes may beused	Conductive paste(providedby the user) provideselectrode adhesive andconductivity.Additionaladhesive tapes may beused	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.

Regulation Number and Section

§ 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).