The ECG Disposable Lead Wires are intended to be used with ECG. The lead wire 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 Disposable Lead Wires are comprised of patient end termination, leadwire and patient leadwire 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 lead wire connector plugs into one end of the external trunk cable which are plug into an ECG monitor.

AI/ML Overview

The provided document is a 510(k) premarket notification for an ECG Disposable Lead Wires device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria in the context of an AI/ML algorithm or diagnostic accuracy testing.

Therefore, many of the requested details regarding acceptance criteria, study design for proving performance (e.g., sample size for test sets, expert involvement, MRMC studies, ground truth establishment), and specific performance metrics for an AI/ML device are not applicable to this type of submission.

The document states:

"No clinical study is included in this submission." This explicitly means there isn't a study designed to prove clinical performance or diagnostic accuracy in the way described in your request.
The "Non-Clinical Test Conclusion" section lists compliance with various electrical and biocompatibility standards, not performance against clinical acceptance criteria.
The "Substantially Equivalent (SE) Comparison" table details similarities in product codes, regulations, classification, indications for use, anatomical sites, physical components, and compliance with general safety and performance standards for medical electrical equipment. It does not provide accuracy metrics or clinical performance data.

Given this, I can only extract information relevant to the device's characteristics and the basis for its marketing clearance, which is substantial equivalence to an existing legally marketed device, not a new performance claim based on a dedicated clinical study or AI algorithm validation.

Here's a breakdown based on the provided text, highlighting what is not available from this document:

Acceptance Criteria and Device Performance (as understood from a 510(k) for a conventional medical device)

The acceptance criteria for this device are largely implied by its substantial equivalence to the predicate device and compliance with recognized standards. The "performance" is demonstrated through meeting these standards and having similar characteristics to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Category/Characteristic	Acceptance Criteria (Demonstrated by)	Reported Device Performance
Biocompatibility	Compliance with ISO 10993-1, -5, -10 (no cytotoxicity, irritation, sensitization)	Met: Cytotoxicity, Skin Irritation, Sensitization tests were conducted, aligning with the predicate's "No cytotoxicity, No irritation, No sensitization." (Implied successful test results as per "Same" in comparison table)
Electrical Performance & Safety	Compliance with AAMI/ANSI EC53: 2013 and IEC 60601-1:2005+CORR.1,2:2007+AM1:2012	Met: Proposed device "Comply with" these standards. (Indicated as "Same" as predicate in terms of compliance for these standards, though predicate references slightly older versions of the same standards.)
Functional Equivalence	Similar Indications for Use, Anatomical Sites, Patient end termination, Leadwire material (PVC vs. Shielded/Unshielded Copper with PVC/TPU Jacket), Sterility.	Similar/Same:- Indications for Use: "The ECG Disposable Lead Wires are intended to be used with ECG. The lead wire 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." (Similar to predicate's broader use with ECG, EKG, SpO2, invasive BP monitoring devices)- Anatomical sites: "Attached to electrodes placed at standard specified locations on chest wall or extremities." (Similar to predicate's "Attached to electrodes placed at standard specified locations on chest wall")- Patient end termination: Clip, Snap (Same as predicate)- Leadwire material: Polyvinyl chloride (PVC) (Similar to predicate's Shielded & Unshielded Copper with PVC or TPU Jacket)- Sterile: Non sterile (Same as predicate)

Information NOT available from the document (as it pertains to AI/ML or diagnostic performance studies):

2. Sample size used for the test set and the data provenance: Not applicable. No test set for AI/ML performance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for AI/ML performance is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission for ECG Disposable Lead Wires is for a conventional medical device, not an AI/ML-driven diagnostic tool. Therefore, the "study" described is a series of non-clinical bench tests and a comparison to a predicate device to demonstrate substantial equivalence to legally marketed devices, rather than a clinical trial proving specific diagnostic accuracy or AI performance metrics.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 24, 2017

APK Technology Co., Ltd. % Ms. Diana Hong General Manager Mid-link Consulting Co., Ltd. P.O. Box 120-119 Shanghai, 200120 CN

Re: K170536

Trade/Device Name: ECG Disposable Lead Wires Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer And Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: February 20, 2017 Received: February 23, 2017

Dear Ms. Diana Hong:

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. 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 (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M.A. Hillemann

for

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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Indications for Use

510(k) Number (if known) K170536

Device Name ECG Disposable Lead Wires

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 C)

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K170536

Page 1 of 5

510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K170536

1. Date of Preparation: 03/02/2017
1. Sponsor Identification

APK Technology Co., Ltd.

6Floor, B2 Building, Industry of Hengfeng, Hezhou, Xixiang, Bao'an Distric, Shenzhen, China

Establishment Registration Number: 3007699081

Contact Person: Caifang Wang Position: Management Representative Tel: +86-755-27325581 Fax: +86-755-27325585 Email: caifang@apk-technology.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Ying Fu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net

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K170536 Page 2 of 5

Trade Name: ECG Disposable Lead Wires Common Name: ECG Wire

Regulatory Information

Classification Name: Cable, Transducer and Electrode, Patient, (Including Connector) Classification: II; Product Code: DSA Regulation Number: 870.2900 Review Panel: Cardiovascular

Indication for Use:

Device Description

Identification of Predicate Device 4.
510(k) Number: K120010 Product Name: Cable/lead-wire

5. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

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K170536 Page 3 of 5

ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process
ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5: Tests For In Vitro Cytotoxicity.
ISO 10993-10:2010 Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and A Skin Sensitization.
AAMI/ANSI EC53: 2013 ECG Trunk Cables and Patient Leadwires
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
1. Clinical Test Conclusion

No clinical study is included in this submission.

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K170536 Page 4 of 5

7. Substantially Equivalent (SE) Comparison

Item	Proposed Device	Predicate DeviceK120010	Remark
Product Code	DSA	DSA	SE
RegulationNumber	870.2900	870.2900	SE
Classification	II	II	SE
Indication forUse	The ECG Disposable Lead Wiresare intended to be used with ECG.The lead wire is used to connectelectrodes placed at appropriatesites on the patient to ECG forgeneral monitoring and/ordiagnostic evaluation by healthcare professional.	Shenzhen Med-linkCable/lead-wire are intended to beused with ECG, EKG, SpO2 andinvasive Blood Pressuremonitoring devices. TheCable/lead-wire are used toconnect electrodes, catheters,and/or sensors placed atappropriate sites on the patient toa monitoring device for generalmonitoring and/or diagnosticevaluation by health careprofessional.	Similar
Anatomical sites	Attached to electrodes placed atstandard specified locations onchest wall or extremities	Attached to electrodes placed atstandard specified locations onchest wall	Similar
Patient endtermination	Clip, Snap	Clip, Snap	Same
Leadwirematerial	Polyvinyl chloride (PVC)	Shielded & Unshielded Copperwith PVC or TPU Jacket	Similar
Sterile	Non sterile	Non sterile	Same
Biocompatibility	CytotoxicitySkin IrritationSensitization	No cytotoxicityNo irritationNo sensitization	CytotoxicitySkin IrritationSensitization	No cytotoxicityNo irritationNo sensitization	Same
ElectricalPerformanceand Safety	Comply withAAMI/ANSI EC53: 2013IEC 60601-1:2005+CORR.1:2006+CORR. 2:2007+AM1:2012	Comply withANSI/AAMI EC53:1995/(R)2001IEC 60601-1:1998; Am1;A2:1995	Same

Table 1 Comparison of Technology Characteristics

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Substantially Equivalent (SE) Conclusion 8.
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.

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).