ECG Cable

K191428 · Shenzhen Changke Connect Electronics Co., Ltd. · DSA · Nov 27, 2019 · Cardiovascular

Device Facts

• Record ID: K191428
• Device Name: ECG Cable
• Applicant: Shenzhen Changke Connect Electronics Co., Ltd.
• Product Code: DSA · Cardiovascular
• Decision Date: Nov 27, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2900
• Device Class: Class 2

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.

Device Story

ECG Cable transmits electrical signals from patient-affixed electrodes to ECG monitoring equipment. Device consists of leadwires and a trunk cable; one end connects to electrodes via banana or snap terminations; other end plugs into ECG monitor. Used in clinical settings by healthcare professionals for general monitoring and diagnostic evaluation. Benefits include reliable signal transmission for cardiac assessment. Device is reusable and non-sterile.

Clinical Evidence

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

Technological Characteristics

Reusable ECG cable assembly. Materials: TPU, PET, Nickel-plated brass. Connectivity: Wired connection between patient electrodes and ECG monitor. Standards: IEC 60601-1 (electrical safety), ANSI/AAMI EC53 (performance), ISO 10993-5/10 (biocompatibility). Non-sterile.

Indications for Use

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

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

• Shenzhen Med-link Electronics Tech Co., Ltd., Cable / lead-wire (K120010)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: underline;"></span>Prescription Use (Part 21 CFR 801 Subpart D) </span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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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: [e-mail] Tel: [phone]

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

| 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:

1. 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

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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<br>Co., Ltd. | Shenzhen Med-link Electronics Tech<br>Co., Ltd. |
| Classification<br>Regulation | 21CRF 870.2900 | 21CRF 870.2900 |
| Classification<br>and Code | Class II, DSA | Class II, DSA |
| Intended use | The ECG Cable is intended to be used<br>with ECG. The ECG Cable is used to<br>connect electrodes placed at appropriate<br>sites on the patient to ECG for general<br>monitoring and/or diagnostic evaluation<br>by health care professional. | Shenzhen Med-link Cable / lead-wire are<br>intended to be used with ECG, EKG,<br>SpO2 and Invasive Blood Pressure<br>monitoring devices. The Cable / lead-<br>wire are used to connect electrodes,<br>catheters, and/or sensors placed at<br>appropriate sites on the patient to a<br>monitoring device for general<br>monitoring and/or diagnostic evaluation<br>by heath care professional. |
| Usage | Reusable | Reusable |
| Anatomical<br>sites | Attached to electrodes placed at standard<br>specified locations on chest or<br>extremities | Attached to electrodes placed at standard<br>specified locations on chest wall |
| Patient end<br>termination | Banana, Snap | Clip, Snap |
| Sterile | No | No |
| Leadwire<br>material | TPU, PET, Nickel plated brass | Shielded & Unshielded Copper with<br>PVC or TPU Jacket |
| Electrical<br>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.