The ECG Cables and Leadwires is intended to be used with ECG. The ECG Cables and 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 Cables and Leadwire 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for "ECG Cables and Leadwires" by Xinkang Medical Instrument Co., Ltd. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving novel effectiveness.

Therefore, the document does not contain the kind of information requested for many of your points, as it pertains to a device whose function is to transmit signals, not to generate diagnostic outputs that would require extensive clinical studies with ground truth, expert adjudication, or MRMC studies.

Here's a breakdown based on the provided text, addressing what is available and noting what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily based on adherence to recognized electrical and biocompatibility standards, and demonstrating substantial equivalence to a predicate device. Performance is framed in terms of meeting these standards.

Acceptance Criteria (Standards Adherence)	Reported Device Performance
Electrical Performance and Safety:	Comply with AAMI/ANSI EC53:2013; IEC 60601-1:2005+CORR.1:2006+CORR. 2:2007+AM1: 2012
AAMI/ANSI EC53:2013 (ECG Trunk Cables and Patient Leadwires)	Device conforms to AAMI/ANSI EC53:2013
IEC 60601-1:2005+CORR.1:2006+CORR.2007+A1:2012 (Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance)	Device conforms to IEC 60601-1:2005+CORR.1:2006+CORR.2007+A1:2012
Biocompatibility:	Passed (Stated as complying with ISO 10993-1:2018)
Cytotoxicity testing	Tested for Cytotoxicity
Irritation testing	Tested for Irritation
Sensitization testing	Tested for Sensitization
ISO 10993-1:2018 (Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process)	Device conforms to ISO 10993-1:2018
Intended Use Equivalence:	Same as predicate device.
Connect electrodes to ECG for general monitoring/diagnostic evaluation.	Intended to be used with ECG to connect electrodes for general monitoring and/or diagnostic evaluation.
Material / Usage Characteristics Equivalence:	Similar or equivalent to predicate device.
Reusable	Reusable
Non-sterile	Non-sterile
Specific patient end terminations (Clip, Snap, Banana)	Clip, Snap, Banana

2. Sample size used for the test set and the data provenance:

Not Applicable. The submission is for ECG cables and leadwires, which are accessories for ECG devices. The evaluation here is based on engineering and biocompatibility standards rather than a clinical "test set" of patient data for diagnostic accuracy. No human subject data (e.g., retrospective or prospective) is described for a "test set" of performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. As per point 2, there is no "test set" in the context of diagnostic performance that would require ground truth established by experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not Applicable. There is no "test set" as defined in the context of diagnostic accuracy assessment.

5. 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:

Not Applicable. This device is ECG cables and leadwires, not an AI-powered diagnostic tool. MRMC studies for AI assistance are not relevant to this submission.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not Applicable. The "ground truth" for this device's acceptance is its adherence to established electrical, safety, and biocompatibility standards, and its functional equivalence to a legally marketed predicate device. This is determined through laboratory testing and engineering analysis, not medical ground truth from patient data.

8. The sample size for the training set:

Not Applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established:

Not Applicable. Not an AI/machine learning device.

Summary

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October 01, 2020

Xinkang Medical Instrument Co., Ltd % Field Fu Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square Nanshan District Shenzhen, GuangDong 518100 China

Re: K201359

Trade/Device Name: ECG Cables and Leadwires Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer And Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: August 25, 2020 Received: August 31, 2020

Dear Field Fu:

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 medical devices and radiation-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

Jennifer Shih Kozen 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) K201359

Device Name ECG Cables and Leadwires

Indications for Use (Describe)

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 G)

|| | Prescription Use (Part 21 CFR 801 Subpart D)

|_ | Over-The-Counter Use (21 CFR 801 Subpart C)

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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 prepared	April 10, 2020
Manufacturer information	Company: Xinkang Medical Instrument Co., Ltd.Company address:2 Floor, Puhua Science and Technology Park,Tongsheng Community Dalang Street, LonghuaDistrict, 518109 Shenzhen, People's Republic ofChinaContact person: Xu ChangshengPhone: +86-755-23776681Fax: +86-755-23776861E-mail: 751857289@qq.com
Submission Correspondent	Shenzhen Joyantech Consulting Co., Ltd.Address: 1713A, 17th Floor, Block A,Zhongguan Times Square, Nanshan District,ShenzhenContact person: James TsaiE-Mail: james_tsai@cefda.com,joyce@cefda.com,
Establishment registration number
5.2 Device Information
Type of 510(k) submission:	Traditional
Trade Name:	ECG Cables and Leadwires
Model:	G2202B10A, E2101C5A,E2101C3A, E2101S3AE2101S5A, G2202C10A, G2202S10A
Classification name:	Cable, Transducer And Electrode, Patient,(Including Connector)
510(K) No.:	K120010
Common name:	ECG Cable / Leadwires
Classification name:	Cable, Transducer and Electrode, Patient, (Including Connector)
Production regulation:	21 CFR § 870.2900
Product code:	DSA
Panel:	Cardiovascular

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Product: ECG Cables and Leadwires

Version: A/0

Review Panel:	Cardiovascular
Product Code:	DSA
Device Class:	II
Regulation Number:	870.2900

5.3 Predicate Device Information

Shenzhen Med-link Electronics Tech Co.,Ltd. Sponsor: Cable / Lead-wire Device: | 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:

Comparison to predicate device:

Comparisonitem	Subject Device	Predicate Device (K120010)
Applicant	Xinkang Medical Instrument Co.,Ltd.	Shenzhen Med-link Electronics TechCo., Ltd.

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Xinkang Medical Instrument Co., Ltd. Product: ECG Cables and Leadwires

Version: A/0

Product name	ECG Cables and Leadwires	ECG Cables /Leadwires
Product Code	DSA	DSA
RegulationNumber	21CRF 870.2900	21CRF 870.2900
Classification	Class II	Class II
Intendeduse &Indications for Use	The ECG Cables and Leadwires isintended to be used with ECG. TheECG Cables and Leadwires is usedto connect electrodes placed atappropriate sites on the patient toECG for general monitoring and/ordiagnostic evaluation by healthcare professional.	Shenzhen Med-link Cable / lead-wireare intended to be used with ECG,EKG, SpO2 and Invasive BloodPressure monitoring devices. TheCable / leadwire are used to connectelectrodes, catheters, and/or sensorsplaced at appropriate sites on thepatient to a monitoring device forgeneral monitoring and/or diagnosticevaluation by heath care professional.
Usage	Reusable	Reusable
Anatomicalsites	Attached to electrodes placed atstandard specified locations onchest or extremities	Attached to electrodes placed atstandard specified locations on chestor extremities
Patient endtermination	Clip,Snap, Banana	Clip, Snap
Sterile	No	No
Leadwirematerial	TPU	Shielded & Unshielded Copper withPVC or TPU Jacket
Biocompatibility	CytotoxicityIrritationSensitization	CytotoxicityIrritationSensitization
ElectricalPerformanceand Safety	Comply with AAMI/ANSI EC53:2013 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

The subject device and the predicate device have the same intended use and similar technological characteristics; they both measure ECG signals for the patients. Thus the subject device is substantially equivalent to the predicate devices.

5.7 Brief discussion of the nonclinical tests

ECG Cables and Leadwires conforms to the following standards: IEC 60601-1:2005+CORR.1:2006+CORR.2007+A1:2012 Medical Electrical

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Xinkang Medical Instrument Co., Ltd.

Equipment - Part 1: General Requirements For Basic Safety And Essential Performance.

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

ISO 10993-1:2018, 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 Cables and 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).