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 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.

AI/ML Overview

This is a 510(k) premarket notification for an ECG Cable/Leadwires device. The document states that no clinical tests were performed, which means no studies were done to establish the acceptance criteria for device performance or to prove the device meets those criteria in a clinical setting.

The provided information focuses on demonstrating substantial equivalence to a predicate device (K120010) through nonclinical testing.

Here's a breakdown of the requested information based on the provided document:

A table of acceptance criteria and the reported device performance

Acceptance Criterion (Standard)	Reported Device Performance
Electrical Performance and Safety:
IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012 (Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance)	Comply
AAMI/ANSI EC53:2013 (ECG Trunk Cables and Patient Leadwires)	Comply
Biocompatibility:
ISO 10993-1:2009 (Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process)	No cytotoxicity, No irritation, No sensitization (Implied)

Note: The document states that the device "Comply with" these standards for electrical performance and safety, and lists biocompatibility results for "No cytotoxicity, No irritation, No sensitization," implying these are the acceptance criteria met through testing following ISO 10993-1.

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for non-clinical tests.
- Data Provenance: Not specified, but generally, bench testing (non-clinical) is conducted by the manufacturer or a contracted lab. The manufacturer is Shenzhen Coreray Technology Co., Ltd. in P.R China. The testing would be prospective in nature for device validation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as this is a medical device (ECG Cable/Leadwires) undergoing non-clinical bench testing for electrical safety, performance, and biocompatibility, not an AI/diagnostic software that requires expert ground truth for interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for non-clinical bench testing. Adjudication methods are typically used in clinical studies or for establishing ground truth in diagnostic accuracy studies.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. A MRMC comparative effectiveness study was not done. This device is an ECG cable/leadwire, which is a hardware component for signal transmission, not an AI-powered diagnostic tool for interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is an ECG cable/leadwire, a hardware component for signal transmission. It is not an algorithm or AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical tests, the "ground truth" is defined by the technical specifications and requirements outlined in the referenced international and national standards (IEC 60601-1, AAMI/ANSI EC53, ISO 10993-1). Compliance with these standards indicates the device adequately performs its intended function and is safe.
The sample size for the training set
- Not applicable. This is a hardware medical device; there is no "training set" in the context of machine learning or AI.
How the ground truth for the training set was established
- Not applicable for the same reason as above.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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 Summaryprepared	Aug 17, 2017
Manufacturerinformation	Company title: Shenzhen Coreray TechnologyCo., 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: +86-755-28839229
	Fax: +86-755-28839229
	E-mail: manager@core-ray.com
SubmissionCorrespondent	Shenzhen Joyantech Consulting Co., Ltd.Address: Room 1122#, International MayorsCommunication Centre, NO. 55 Shizhou middle
	road , Nanshan District, Shenzhen
	Contact person: Mr. Field Fu
	E-Mail: field@cefda.com; cefda13485@163.com

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

5.5 Intended Use/ Indications for Use

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 ofComparison	Proposed device	Predicate deviceK120010	Remarks
Product Code	DSA	DSA	Same
RegulationNumber	870.2900	870.2900	Same
Classification	II	II	Same
Indication for Use	Shenzhen Coreray ECGCable/Leadwires is intended tobe used with ECG. The ECGCable/Leadwires is used toconnect electrodes placed atappropriate sites on the patientto ECG for general monitoringand/or diagnostic evaluation byhealth care professional.	Shenzhen Med-linkCable/lead-wire are intendedto be used with ECG, EKG,SpO2 and invasive BloodPressure monitoring devices.The Cable/lead-wire are usedto connect electrodes,catheters, and/or sensorsplaced at appropriate sites onthe patient to a monitoringdevice for general monitoringand/or diagnostic evaluation byhealth care professional.	Same asECG/EKG cable/lead-wire.
Patent Usage	Reusable	Reusable	Same
Anatomical sites	Attached to electrodes placedat standard specified locationson chest wall	Attached to electrodes placedat standard specified locationson chest wall	Same
Patient endtermination	Clip, Snap	Clip, Snap	same
Leadwirematerial	TPU	Shielded & Unshielded Copperwith PVC or TPU Jacket	TPU issame.
Sterile	Non sterile	Non sterile	same
Biocompatibility	No cytotoxicity,No irritation,No sensitization	No cytotoxicity,No irritation,No sensitization	SE
ElectricalPerformance andSafety	Comply with AAMI/ANSIEC53: 2013 IEC 60601-1:2005+CORR.1: 2006+CORR.2:2007+AM1: 2012	Comply with ANSI/AAMI EC53:1995/(R)2001 IEC 60601-1:1998: 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.

Regulation Number and Section

§ 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).