ECG Disposable Lead Wire

{0}------------------------------------------------ ### 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K170536 Device Name ECG Disposable Lead Wires Indications for Use (Describe) 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. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------| | <span style="text-decoration: underline;"><b>☑</b></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: underline;">□</span> 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}------------------------------------------------ # 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 - 2. 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 - 3. 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 {4}------------------------------------------------ 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: 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. - 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: {5}------------------------------------------------ ### 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 - 6. Clinical Test Conclusion No clinical study is included in this submission. {6}------------------------------------------------ # K170536 Page 4 of 5 #### 7. Substantially Equivalent (SE) Comparison | Item | Proposed Device | Predicate Device<br>K120010 | Remark | | | |-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|------------------------------------------------------|------| | Product Code | DSA | DSA | SE | | | | Regulation<br>Number | 870.2900 | 870.2900 | SE | | | | Classification | II | II | SE | | | | Indication for<br>Use | The ECG Disposable Lead Wires<br>are intended to be used with ECG.<br>The lead wire is used to connect<br>electrodes placed at appropriate<br>sites on the patient to ECG for<br>general monitoring and/or<br>diagnostic evaluation by health<br>care professional. | Shenzhen Med-link<br>Cable/lead-wire are intended to be<br>used with ECG, EKG, SpO2 and<br>invasive Blood Pressure<br>monitoring devices. The<br>Cable/lead-wire are used to<br>connect electrodes, catheters,<br>and/or sensors placed at<br>appropriate sites on the patient to<br>a monitoring device for general<br>monitoring and/or diagnostic<br>evaluation by health care<br>professional. | Similar | | | | Anatomical sites | Attached to electrodes placed at<br>standard specified locations on<br>chest wall or extremities | Attached to electrodes placed at<br>standard specified locations on<br>chest wall | Similar | | | | Patient end<br>termination | Clip, Snap | Clip, Snap | Same | | | | Leadwire<br>material | Polyvinyl chloride (PVC) | Shielded & Unshielded Copper<br>with PVC or TPU Jacket | Similar | | | | Sterile | Non sterile | Non sterile | Same | | | | Biocompatibility | Cytotoxicity<br>Skin Irritation<br>Sensitization | No cytotoxicity<br>No irritation<br>No sensitization | Cytotoxicity<br>Skin Irritation<br>Sensitization | No cytotoxicity<br>No irritation<br>No sensitization | Same | | Electrical<br>Performance<br>and Safety | Comply with<br>AAMI/ANSI EC53: 2013<br>IEC 60601-1:2005+CORR.1:<br>2006+CORR. 2:2007+AM1:<br>2012 | Comply with<br>ANSI/AAMI EC<br>53:1995/(R)2001<br>IEC 60601-1:1998; Am1;<br>A2:1995 | Same | | | # Table 1 Comparison of Technology Characteristics {7}------------------------------------------------ - 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.