Disposable ECG Cable

K200026 · Shenzhen Changke Connect Electronics Co., Ltd. · DSA · May 12, 2020 · Cardiovascular

Device Facts

• Record ID: K200026
• Device Name: Disposable ECG Cable
• Applicant: Shenzhen Changke Connect Electronics Co., Ltd.
• Product Code: DSA · Cardiovascular
• Decision Date: May 12, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2900
• Device Class: Class 2

Intended Use

The disposable ECG cable is intended to be used with ECG. The device 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.

Device Story

Disposable ECG cable transmits electrical signals from patient-affixed electrodes to ECG monitoring equipment. Device consists of leadwires with clips at the patient end and a trunk cable connector for the monitor. Used in clinical settings by healthcare professionals for general monitoring and diagnostic evaluation. Device facilitates signal transmission to enable ECG waveform visualization and clinical decision-making. Benefits include disposable design to reduce cross-contamination risks compared to reusable cables.

Clinical Evidence

No clinical data included. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1, ANSI/AAMI EC53) and biocompatibility (ISO 10993-5, ISO 10993-10).

Technological Characteristics

Disposable ECG cable; TPU and gold-plated brass construction. Connects via clips to electrodes and via trunk cable to ECG monitor. Complies with IEC 60601-1 and ANSI/AAMI EC53 standards. Biocompatibility per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (skin irritation and sensitization).

Indications for Use

Indicated for patients requiring ECG monitoring or diagnostic evaluation. Used by healthcare professionals to connect electrodes placed on the patient's chest or extremities to an ECG monitor.

Regulatory Classification

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.

Predicate Devices

• ECG Cable (K191428)

Submission Summary (Full Text)

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May 12, 2020

Shenzhen Changke Connect Electronics Co., Ltd. % Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. No. A415, Block A, NanShan Medical Devices Industrial Park Nanshan District Shenzhen, 518067. China

Re: K200026

Trade/Device Name: Disposable 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: April 2, 2020 Received: April 8, 2020

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.

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for

Jennifer Shih Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K200026

Device Name Disposable ECG Cable

Indications for Use (Describe)

The disposable ECG cable is intended to be used with ECG. The device 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) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X 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: 2020/01/02

#### 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: [e-mail] Tel: [phone]

#### Submission correspondent 2.

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: [e-mail] Tel: [phone]

| Trade/Device Name | Disposable 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) |

#### 3. Subject Device Information

#### Predicate Device 4.

Manufacturer: Shenzhen Changke Connect Electronics Co., Ltd. Device: ECG Cable K#: K191428

#### 5. Device Description

The device 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

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monitor. The proposed device is disposable.

#### Intended use & Indication for use 6.

The disposable ECG cable is intended to be used with ECG. The device 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<br>Changke Disposable ECG<br>Cables | Predicate Device<br>K191428 | Comparison |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Applicant | Shenzhen Changke Connect<br>Electronics Co., Ltd. | Shenzhen Changke Connect<br>Electronics Co., Ltd. | Same |
| Classification<br>Regulation | 21CRF 870.2900 | 21CRF 870.2900 | Same |
| Classification<br>and Code | Class II, DSA | Class II, DSA | Same |
| Intended use | The disposable ECG cable is<br>intended to be used with ECG.<br>The device is used to connect<br>electrodes placed at appropriate<br>sites on the patient to ECG for<br>general monitoring and/or<br>diagnostic evaluation by health<br>care professional. | The ECG Cable is intended to be<br>used with ECG. The ECG Cable<br>is used to connect electrodes<br>placed at appropriate sites on the<br>patient to ECG for general<br>monitoring and/or diagnostic<br>evaluation by health care<br>professional. | Same |
| Usage | Disposable | Reusable | Different 1) |
| Anatomical<br>sites | Attached to electrodes placed at<br>standard specified locations on<br>chest or extremities | Attached to electrodes placed at<br>standard specified locations on<br>chest or extremities | Same |
| Patient end<br>termination | Clip | Banana, Snap | Different 2) |
| Sterile | No | No | Same |
| Leadwire<br>material | TPU, Gold plated brass | TPU, PET, Nickel plated brass | Different 3) |
| Electrical<br>Safety | Complied with IEC 60601-1 and<br>EC53 | Complied with IEC 60601-1 and<br>EC53 | Same |
| Biocompatibility | | | |
| Cytotoxicity | Complied with ISO 10993-5 | Complied with ISO 10993-5 | Same |
| Skin Irritation | Complied with ISO 10993-10 | Complied with ISO 10993-10 | Same |
| Sensitization | Complied with ISO 10993-10 | Complied with ISO 10993-10 | Same |

#### 7. Comparison to the Predicate Device

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Justifications for differences between proposed device and the predicate device are shown as below:

Different (1): The proposed device is disposable and the predicate device is reusable. The proposed device was tested according to IEC 60601-1 and EC53. Therefore, this difference does not raise new questions of safety and effectiveness for subject device.

Different (2): The patient end termination is different. This end is intended to connect the electrodes. The proposed device was tested according to IEC 60601-1 and EC53. Therefore, this difference does not raise new questions of safety and effectiveness for subject device.

Different (3): The material is different. The proposed device was tested according to ISO 10993-5 and ISO 10993-10. Therefore, this difference does not raise new questions of safety and effectiveness for subject device.

#### 8. Performance Data

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

The intended use and technological features of the proposed subject device do not substantially differ from the legally marketed predicate device. Disposable ECG cable and the predicate device have substantially equivalent intended uses and methods of operation.