ECG Cable/Leadwires

K172797 · Shenzhen Coreray Technology, Ltd. · DSA · Feb 28, 2018 · Cardiovascular

Device Facts

• Record ID: K172797
• Device Name: ECG Cable/Leadwires
• Applicant: Shenzhen Coreray Technology, Ltd.
• Product Code: DSA · Cardiovascular
• Decision Date: Feb 28, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2900
• Device Class: Class 2

Intended Use

The ECG Cable/Leadwires is intended to be used with ECG. The ECG Cable/Leadwires 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

Device consists of plug, cable/leadwires, and connector. Transmits ECG signals from patient-affixed electrodes to ECG monitoring equipment. Used in clinical settings by healthcare professionals for general monitoring and diagnostic evaluation. Reusable device; connects to standard chest wall electrodes via clip or snap terminations.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including electrical performance, safety, and biocompatibility assessments.

Technological Characteristics

Materials: TPU. Sensing: Passive electrical signal transmission. Connectivity: Wired connection between electrodes and ECG monitor. Standards: AAMI/ANSI EC53:2013, IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012, ISO 10993-1:2009. Non-sterile.

Indications for Use

Indicated for use with ECG monitoring devices to connect patient-placed electrodes for general monitoring and diagnostic evaluation 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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February 28, 2018

Shenzhen Coreray Technology Co., Ltd. % Field Fu Consultant Shenzhen Joyantech Consulting Co., Ltd. No. 55 Shizhou zhong Road Nanshan District, Shenzhen Guangdong, China 518100

Re: K172797

Trade/Device Name: ECG Cable/Leadwires Regulation Number: 21 CFR 870.2900 Regulation Name: Patient transducer and electrode cable (including connector) Regulatory Class: Class II Product Code: DSA Dated: January 24, 2018 Received: January 30, 2018

Dear Field Fu:

We have reviewed vour 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. 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 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); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

M.A. Wilhelmsen

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Druq Administration

### Indications for Use

510(k) Number (if known) K172797

Device Name ECG Cable/Leadwires

Indications for Use (Describe)

The ECG Cable/Leadwires is intended to be used with ECG. The ECG Cable/Leadwires 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)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# VOL 05 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted As Required by requirements of SMDA and 21 CFR § 807.92.

## 5.1 Administrative Information

| Date of Summary<br>prepared | Aug 17, 2017 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer<br>information | Company title: Shenzhen Coreray Technology<br>Co., Ltd |
| | Company address: |
| | ChuangYe Technology Park, 1th Dong Huan |
| | Road, Longhua New District, Shenzhen, 510000 |
| | P.R China. P.C.:518109 |
| | Contact person: Simon Fan |
| | Phone: [phone] |
| | Fax: [phone] |
| | E-mail: [e-mail] |
| Submission<br>Correspondent | Shenzhen Joyantech Consulting Co., Ltd.<br>Address: Room 1122#, International Mayors<br>Communication Centre, NO. 55 Shizhou middle |
| | road , Nanshan District, Shenzhen |
| | Contact person: Mr. Field Fu |
| | E-Mail: [e-mail]; [e-mail] |

### Establishment registration number

#### 5.2 Device Information

Type of 510(k) Traditional submission: Trade Name: ECG Cable/Leadwires Model: Classification name: | Cable, Transducer And Electrode, Patient,

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(Including Connector) Cardiovascular Review Panel: Product Code: DSA Device Class: -870.2900 Requlation Number:

#### 5.3 Predicate Device Information

SHENZHEN MED-LINK ELECTRONICS TECH CO., Sponsor: LTD. Device: CABLE/ LEAD-WIRE K120010 510(K) Number:

#### 5.4 Device Description

The ECG Cable/Leadwires is comprised of Plug, cable/leadwires and connector. The device is used to transmit ECG signals from electrodes which are affixed to the patient's body for both diagnostic and monitoring purposes. Each lead wire is attached to ECG patient electrodes. The leadwires connector plugs into one end of the external trunk cable which is plug into an ECG monitor.

#### 5.5 Intended Use/ Indications for Use

The ECG Cable/Leadwires is intended to be used with ECG. The ECG Cable/Leadwires 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.

## 5.6 Technological characteristics of the subject device compared to the predicate device

#### Predicate Device Information:

| 510(K) No.: | K120010 |
|------------------------|-----------------------------------------------------------------|
| Common name: | Cable / lead-wire |
| Classification name: | Cable, Transducer and Electrode, Patient, (Including Connector) |
| Production regulation: | 21 CFR §870.2900 |

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| Product code: | DSA |
|---------------|----------------|
| Panel: | Cardiovascular |

| Elements of<br>Comparison | Proposed device | Predicate device<br>K120010 | Remarks |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| Product Code | DSA | DSA | Same |
| Regulation<br>Number | 870.2900 | 870.2900 | Same |
| Classification | II | II | Same |
| Indication for Use | Shenzhen Coreray ECG<br>Cable/Leadwires is intended to<br>be used with ECG. The ECG<br>Cable/Leadwires is used to<br>connect electrodes placed at<br>appropriate sites on the patient<br>to ECG for general monitoring<br>and/or diagnostic evaluation by<br>health care professional. | Shenzhen Med-link<br>Cable/lead-wire are intended<br>to be used with ECG, EKG,<br>SpO2 and invasive Blood<br>Pressure monitoring devices.<br>The Cable/lead-wire are used<br>to connect electrodes,<br>catheters, and/or sensors<br>placed at appropriate sites on<br>the patient to a monitoring<br>device for general monitoring<br>and/or diagnostic evaluation by<br>health care professional. | Same as<br>ECG/EK<br>G cable/<br>lead-<br>wire. |
| Patent Usage | Reusable | Reusable | Same |
| Anatomical sites | Attached to electrodes placed<br>at standard specified locations<br>on chest wall | Attached to electrodes placed<br>at standard specified locations<br>on chest wall | Same |
| Patient end<br>termination | Clip, Snap | Clip, Snap | same |
| Leadwire<br>material | TPU | Shielded & Unshielded Copper<br>with PVC or TPU Jacket | TPU is<br>same. |
| Sterile | Non sterile | Non sterile | same |
| Biocompatibility | No cytotoxicity,<br>No irritation,<br>No sensitization | No cytotoxicity,<br>No irritation,<br>No sensitization | SE |
| Electrical<br>Performance and<br>Safety | Comply with AAMI/ANSI<br>EC53: 2013 IEC 60601-<br>1:2005+CORR.1: 2006+CORR.<br>2:2007+AM1: 2012 | Comply with ANSI/AAMI EC<br>53:1995/(R)2001 IEC 60601-<br>1:1998: Am1: A2:1995 | SE |

## Comparison to predicate device:

## 5.7 Brief discussion of the nonclinical tests

ECG Cable/Leadwires conforms to the following standards:

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IEC 60601-1:2005+CORR.1:2006+CORR.2007+A1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance.

AAMI / ANSI EC53:2013, ECG Trunk Cables and Patient Leadwires.

ISO 10993-1:2009, Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process.

## 5.8 Brief discussion of clinical tests

N/A.

5.9 Other information (such as required by FDA guidance/Test) N/A.

### 5.10 Conclusions

Based on the above information, the subject device and the predicate device have the same intended use and same technological characteristics; we conclude the subject device, ECG Cable/ Leadwires, is substantially equivalent to the predicate device.