Patient Cables and Leadwires , Disposable ECG Leadwires

K182327 · Orantech, Inc. · DSA · Jan 30, 2019 · Cardiovascular

Device Facts

• Record ID: K182327
• Device Name: Patient Cables and Leadwires , Disposable ECG Leadwires
• Applicant: Orantech, Inc.
• Product Code: DSA · Cardiovascular
• Decision Date: Jan 30, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2900
• Device Class: Class 2

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 Story

Device consists of patient cables and leadwires used to transmit ECG signals from electrodes affixed to a patient's body to an ECG monitor. Leadwires connect to electrodes at one end and a trunk cable at the other. Available in disposable and reusable configurations. Used in clinical settings by healthcare professionals for general monitoring and diagnostic evaluation. Facilitates signal acquisition for clinical decision-making.

Clinical Evidence

No clinical data. Bench testing only. Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10, IEC 60601-1, and ANSI/AAMI EC53 verified design specifications.

Technological Characteristics

Materials: PA6, PA66, TPU, ABS, PC, TPE. Patient end terminations: Clip, Snap. Electrical safety: IEC 60601-1, ANSI/AAMI EC53. Biocompatibility: ISO 10993-1, -5, -10. Non-sterile.

Indications for Use

Indicated for patients requiring ECG monitoring or diagnostic evaluation. Used by healthcare professionals to connect electrodes placed on the patient to an ECG monitor.

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

• Cable/lead-wire (K120010)

Submission Summary (Full Text)

{0}------------------------------------------------

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

{1}------------------------------------------------

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

{2}------------------------------------------------

# 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)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 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]

{4}------------------------------------------------

#### 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

{5}------------------------------------------------

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.

{6}------------------------------------------------

### 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<br>ECG. The lead wire is used to connect<br>electrodes placed at appropriate sites<br>on the patient to ECG for general<br>monitoring and/or diagnostic<br>evaluation by health care<br>professional. | | Shenzhen Med-link Cable/lead-wire are<br>intended to be used with ECG, EKG, SpO2<br>and invasive Blood Pressure monitoring<br>devices. The Cable/lead-wire are used to<br>connect electrodes, catheters, and/or<br>sensors placed at appropriate sites on the<br>patient to a monitoring device for general<br>monitoring and/or diagnostic evaluation by<br>health care professional. | |
| Anatomical sites | Attached to electrodes placed at<br>standard specified locations on chest<br>or extremities | | Attached to electrodes placed at standard<br>specified locations on chest wall | |
| Patient end termination | Clip, Snap | | Clip, Snap | |
| Sterile | Non sterile | | Non sterile | |
| Leadwire<br>material | PA6/PA66/TPU/ABS/PC/TPE | | Shielded & Unshielded Copper with PVC<br>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.