Patient Cables and Leadwires , Disposable ECG Leadwires

• K Number: K182327
• Device Name: Patient Cables and Leadwires , Disposable ECG Leadwires
• Manufacturer: Orantech Inc.
• Date Cleared: 2019-01-30 ( 156 days)
• Product Code: DSA
• Regulation Number: 870.2900

Intended Use

The device is 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 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 trunk cable which are plug into an ECG monitor. The proposed devices are available in disposable and reusable two types.

Predicate Devices

K120010

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the physical components and function of ECG lead wires, with no mention of AI or ML capabilities.

Therapeutic

No
The device is a lead wire that transmits ECG signals from electrodes to an ECG monitor for diagnostic and monitoring purposes. It does not exert a therapeutic effect on the patient.

Diagnostic

Yes
The "Intended Use / Indications for Use" section states the lead wire is used in conjunction with ECG "for general monitoring and/or diagnostic evaluation by health care professional." The "Device Description" also mentions it's for "diagnostic and monitoring purposes."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "lead wire" which is a physical component used to connect electrodes to an ECG monitor. It also mentions disposable and reusable types, further indicating a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
• Device Function: The description clearly states the device is a lead wire used to connect electrodes placed on the patient to an ECG machine. It transmits electrical signals from the patient's body.
• Lack of Sample Analysis: There is no mention of the device analyzing any biological samples. Its function is purely to facilitate the transmission of electrical signals from the body to a diagnostic/monitoring device (the ECG).

Therefore, this device falls under the category of a medical device used for physiological monitoring, not an in vitro diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The device is 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.

Product codes

DSA

Device Description

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 trunk cable which are plug into an ECG monitor. The proposed devices are available in disposable and reusable two types.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Attached to electrodes placed at standard specified locations on chest or extremities

Indicated Patient Age Range

Not Found

Intended User / Care Setting

health care professional.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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

• ISO10993-1:2009 Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing within a Risk Management Process

• ISO10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Tests for in Vitro Cytotoxicity;

• ISO10993-10:2009 Biological Evaluation of Medical Devices-Part10: Tests for Irritation and Skin Sensitization;

• 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;;

• ANSI/AAMI EC53:2013 ECG Trunk Cables and Patient Leadwires;
  No clinical study is included in this submission.

Key Metrics

Not Found

Predicate Device(s)

K120010

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 30, 2019

Orantech Inc. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 China

Re: K182327

Trade/Device Name: Patient Cables and Leadwires, Disposable ECG Leadwires Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer and Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: December 26, 2018 Received: December 31, 2018

Dear 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. 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.

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

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requirements, including, but not limited to: registration and listing (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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 [phone] or 301-796-7100).

Sincerely.

Jessica E. Paulsen -S

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)

K182327

Device Name

Patient Cables and Leadwires, Disposable ECG Leadwires

Indications for Use (Describe)

The device is 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.

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)

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Tab #7 510(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: K182327

• 1. Date of Preparation: 01/30/2019
• 2. Sponsor Identification

Orantech Inc

Zone # A, 4F, 1st Bld, 7th Industrial Zone, Yulv Community, Guangming New District, Shenzhen, China 518106

Establishment Registration Number: 3013783488

Contact Person: Hsin.xiong Position: General Manager Tel: [phone] Fax: [phone] Email: yunxi.xiong@@orantech.cn

• 3. Designated Submission Correspondent
     Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone] Fax: [phone] Email: [e-mail]

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Identification of Proposed Device 4.

Trade Name: Patient Cables and Leadwires Disposable ECG Leadwires Common Name: ECG Wire

Regulatory Information

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

Intended Use Statement:

The device is 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 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 trunk cable which are plug into an ECG monitor. The proposed devices are available in disposable and reusable two types.

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

6. Non-Clinical Test Conclusion

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

• ISO10993-1:2009 Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing within

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a Risk Management Process

• ISO10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Tests for in Vitro Cytotoxicity;

• ISO10993-10:2010 Biological Evaluation of Medical Devices-Part10: Tests for Irritation and Skin Sensitization;

• 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;;

• ANSI/AAMI EC53:2013 ECG Trunk Cables and Patient Leadwires;

• 7. Clinical Test Conclusion

No clinical study is included in this submission.

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Substantially Equivalent (SE) Comparison 8.

Item	Proposed Device		Predicate Device
			K120010
Product Code	DSA		DSA
Regulation Number	870.2900		870.2900
Classification	II		II
Intended Use	The device is 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.		Shenzhen Med-link Cable/lead-wire are
intended to be used with ECG, EKG, SpO2
and invasive Blood Pressure monitoring
devices. The Cable/lead-wire are used to
connect electrodes, catheters, and/or
sensors placed at appropriate sites on the
patient to a monitoring device for general
monitoring and/or diagnostic evaluation by
health care professional.
Anatomical sites	Attached to electrodes placed at
standard specified locations on chest
or extremities		Attached to electrodes placed at standard
specified locations on chest wall
Patient end termination	Clip, Snap		Clip, Snap
Sterile	Non sterile		Non sterile
Leadwire
material	PA6/PA66/TPU/ABS/PC/TPE		Shielded & Unshielded Copper with PVC
or TPU Jacket
Biocompatibility	Irritation	No irritation	Skin Irritation	No irritation
	Skin Sensitization	No sensitization	Sensitization	No sensitization
	Cytotoxicity	No cytotoxicity	Cytotoxicity	No cytotoxicity
Electrical Safety	Comply with IEC 60601-1 and EC53		Comply with IEC 60601-1 and EC53

Table 1 Comparison of Technology Characteristics

9. Substantially Equivalent (SE) Conclusion

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