(182 days)
Not Found
No
The description focuses on the physical cable and its function of transmitting electrical signals, with no mention of data processing or analysis using AI/ML.
No.
The device is an ECG cable which transmits signals for monitoring and diagnostic evaluation, but it does not directly treat a medical condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the ECG Cable is used for "diagnostic evaluation by health care professional," and the "Device Description" also mentions its use for "diagnostic and monitoring purposes."
No
The device description explicitly states it is an "external device" and describes physical components like "leadwires," "trunk cable," and plugs, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The ECG Cable's function is to transmit electrical signals from electrodes placed on the patient's body to an ECG monitor. It does not analyze or process biological specimens.
- Intended Use: The intended use clearly states it's for connecting electrodes to an ECG for monitoring and diagnostic evaluation by a health care professional. This involves the direct measurement of physiological signals from the patient.
Therefore, the ECG Cable falls under the category of a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ECG Cable is intended to be used with ECG. The ECG Cable is used to connect electrodes placed at appropriate sites on the patient to ECG for general monitoring and/or diagnostic evaluation by health care professional.
Product codes
DSA
Device Description
The ECG Cable is an external device used to transmit ECG signals from electrodes that are affixed to the patient's body for both diagnostic and monitoring purposes. One end of each leadwire is attached to ECG patient electrodes; the other end is affixed / molded into one end of the trunk cable which are plug into an ECG monitor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Attached to electrodes placed at appropriate sites on the patient.
Attached to electrodes placed at standard specified locations on chest or extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professional.
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
Not Found
Summary of Performance Studies
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing: The biocompatibility evaluation for the Changke ECG Cables 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 battery of testing included the following tests: Cytotoxicity, Sensitization, and Irritation. The subject devices are considered surface contacting for a duration of exceed 24 hours but not 30 days.
Non-clinical data: The Changke ECG Cables have been tested according to the following standards:
- IEC 60601-1: 2005+CORR.1: 2006+CORR.2: 2007+A1: 2012, Medical Electrical Equipment-Part 1: General requirements for basic safety and essential performance
- ANSI/AAMI EC53: 2013 ECG Trunk Cables and Patient Leadwires.
The test was selected to show substantial equivalence between the subject device and the predicate.
Clinical data: No clinical study is included in this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2900 Patient transducer and electrode cable (including connector).
(a)
Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 27, 2019
Shenzhen Changke Connect Electronics Co., Ltd. Yahui Zhou General Manager A2-4th floor of Xiang dali Technology Park No.87 of HengPing Road, Henggang Longgang District, Shenzhen, CN
Re: K191428
Trade/Device Name: ECG Cable Regulation Number: 21 CFR 870.2900 Regulation Name: Patient transducer and electrode cable (including connector) Regulatory Class: Class II Product Code: DSA Dated: November 14, 2019 Received: November 14, 2019
Dear Yahui Zhou:
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 (OS) 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 mediation-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.
for Jessica Paulsen Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name ECG Cables
Indications for Use (Describe)
The ECG Cable is intended to be used with ECG. The ECG Cable is used to connect electrodes placed at appropriate sites on the patient to ECG for general monitoring and/or diagnostic evaluation by health care professional.
| 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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510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: 2019/05/22
1. Submission sponsor
Name: Shenzhen Changke Connect Electronics Co., Ltd. Address: A2-4th floor of Xiang dali Technology Park, No.87 of HengPing Road, Henggang, Longgang District, Shenzhen, 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: No. A415, Block A, NanShan Medical devices Industrial Park Nanshan District, Shenzhen, Guangdong, P.R. China 518067 Contact person: Kevin Wang E-mail: kevin@chonconn.com Tel: +86-755 33941160
| Trade/Device Name | ECG Cable |
|---|---|
| Common Name | ECG Wire |
| Classification Name | Cable, Transducer and Electrode, Patient |
| Classification | Class II |
| Regulation Number | 870.2900 |
| Product Code | DSA |
| Review Panel | Cardiovascular |
| Submission type | Traditional 510(K) |
Subject Device Information 3.
4. Predicate Device
By submission of the Traditional 510(k), Shenzhen Changke Connect Electronics Co., Ltd. is requesting clearance for ECG Cable. It is comparable to the following legally marketed system:
- Shenzhen Med-link Electronics Tech Co., Ltd., Cable / lead-wire under K120010.
5. Device Description
The ECG Cable is an external device used to transmit ECG signals from electrodes that are affixed to the patient's body for both diagnostic and monitoring purposes. One end of each leadwire is attached to ECG patient electrodes; the other end is affixed / molded into one end of the trunk cable which are plug into an
4
ECG monitor.
Intended use & Indication for use 6.
The ECG Cable is intended to be used with ECG. The ECG Cable is used to connect electrodes placed at appropriate sites on the patient to ECG for general monitoring and/or diagnostic evaluation by health care professional.
| Features | Subject Device | Predicate Device |
|---|---|---|
| Changke ECG Cables | K120010 | |
| Applicant | Shenzhen Changke Connect Electronics | |
| Co., Ltd. | Shenzhen Med-link Electronics Tech | |
| Co., Ltd. | ||
| Classification | ||
| Regulation | 21CRF 870.2900 | 21CRF 870.2900 |
| Classification | ||
| and Code | Class II, DSA | Class II, DSA |
| Intended use | The ECG Cable is intended to be used | |
| with ECG. The ECG Cable is used to | ||
| connect electrodes placed at appropriate | ||
| sites on the patient to ECG for general | ||
| monitoring and/or diagnostic evaluation | ||
| by health care professional. | Shenzhen Med-link Cable / lead-wire are | |
| intended to be used with ECG, EKG, | ||
| SpO2 and Invasive Blood Pressure | ||
| monitoring devices. The Cable / lead- | ||
| wire are used to connect electrodes, | ||
| catheters, and/or sensors placed at | ||
| appropriate sites on the patient to a | ||
| monitoring device for general | ||
| monitoring and/or diagnostic evaluation | ||
| by heath care professional. | ||
| Usage | Reusable | Reusable |
| Anatomical | ||
| sites | Attached to electrodes placed at standard | |
| specified locations on chest or | ||
| extremities | Attached to electrodes placed at standard | |
| specified locations on chest wall | ||
| Patient end | ||
| termination | Banana, Snap | Clip, Snap |
| Sterile | No | No |
| Leadwire | ||
| material | TPU, PET, Nickel plated brass | Shielded & Unshielded Copper with |
| PVC or TPU Jacket | ||
| Electrical | ||
| Safety | Complied with IEC 60601-1 and EC53 | Complied with IEC 60601-1 and EC53 |
| Biocompatibility | ||
| Cytotoxicity | Complied with ISO 10993-5 | Complied with ISO 10993-5 |
| Skin Irritation | Complied with ISO 10993-10 | Complied with ISO 10993-10 |
| Features | Subject Device | Predicate Device |
| Changke ECG Cables | K120010 | |
| Sensitization | Complied with ISO 10993-10 | Complied with ISO 10993-10 |
7. Comparison to the Predicate Device
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Performance Data 8.
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the Changke ECG Cables 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 battery of testing included the following tests:
- . Cytotoxicity
- Sensitization .
- Irritation .
The subject devices are considered surface contacting for a duration of exceed 24 hours but not 30 days.
Non-clinical data
The Changke ECG Cables have been tested according to the following standards:
- . IEC 60601-1: 2005+CORR.1: 2006+CORR.2: 2007+A1: 2012, Medical Electrical Equipment-Part 1: General requirements for basic safety and essential performance
- . ANSI/AAMI EC53: 2013 ECG Trunk Cables and Patient Leadwires.
The test was selected to show substantial equivalence between the subject device and the predicate.
Clinical data
No clinical study is included in this submission.
9. Conclusion
Performance testing and compliance with voluntary standards demonstrate that the proposed subject device is substantially equivalent to the predicate device.