(144 days)
Not Found
No
The document describes a disposable EEG cable, which is a passive component for signal acquisition, and does not mention any processing or analysis capabilities that would involve AI/ML.
No.
The device is described for "recording and monitoring equipment" and "acquisition of signals for the purpose of monitoring and recording," which indicates a diagnostic or measurement function rather than a therapeutic one (treatment or direct patient intervention).
No
The device is a cable and electrodes used for the acquisition of signals for monitoring and recording EEG, EMG, and EP. It does not perform the analysis or interpretation of these signals to make a diagnosis itself; it is a component of a larger system that might be used for diagnostic purposes.
No
The device description explicitly states it is a "Disposable EEG cable, which is cutaneous electrodes connected to lead wires," indicating a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Disposable EEG cable is used to acquire electrical signals from the surface of the body (the scalp) for monitoring and recording purposes. It does not analyze or test any bodily fluids or tissues.
- Intended Use: The intended use clearly states it's for "non-invasive use with recording and monitoring equipment" of EEG, EMG, and EP. This involves measuring electrical activity directly from the body.
Therefore, the function and intended use of this device fall outside the scope of In Vitro Diagnostics. It is a medical device used for physiological signal acquisition.
N/A
Intended Use / Indications 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).
Product codes
GXY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Scalp
Indicated Patient Age Range
Adults and children
Intended User / Care Setting
health care setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 .
Non-clinical data:
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).
Performance test: Carried out according to the and ANSI AAMI EC12:2000/(R)2015 Disposable ECG electrodes.
Clinical data: Clinical testing is not required.
Key results: Performance testing and compliance with voluntary standards demonstrate that the proposed subject device is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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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)
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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 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.