Caremed patient cable and leadwires

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human profiles facing to the right, stacked on top of each other. The profiles are depicted with simple, curved lines, creating a sense of unity and connection. October 24, 2016 Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Shenzhen Caremed Medical Technology Co., Ltd. Xinlin Xiao, QA Manager Zone B. 3/f. 11 Building, Hebei Industrial Area, Longhua Office, Longhua New D Shenzhen, 518021 CHINA Re: K153188 Trade/Device Name: Caremed Patient Cable and Leadwires, Models: 2585P, MQB5-90S, MQ-2586, E10R-SH1-N, E10R-MQ and MQ10-LN Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer And Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: September 2, 2016 Received: September 16, 2016 Dear Xinlin Xiao: 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. Mada Jellman 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) K153188 Device Name Caremed patient cable and leadwires, Models 2585P, MQB5-90S, MQ-2586, E10R-SH1-N, E10R-MQ, MQ10-LN #### Indications for Use (Describe) The subject device is intended for use only by trained healthcare professionals for measurement of a patient's ECG for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment. Type of Use (Select one or both, as applicable): | <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</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}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for Caremed. The logo consists of the letters "CM" in red and gray, followed by the word "caremed" in red. Below the word "caremed" are two Chinese characters in gray. The logo is simple and modern, and the colors are eye-catching. ## Section 5 # 510(K) Summary #### 1. Prepared Date: 2016/9/2 #### 2. Submitter Information | Name | Shenzhen Caremed Medical Technology Co., Ltd. | |---------|-------------------------------------------------------------------------------------------------------| | Address | Zone B, 3/F, 11 Building, Hebei Industrial Area, Longhua office, Longhua New District, Shenzhen,China | | Tel | 0086-755-27184369 | | Fax | 0086-755-27186486 | #### 3. Contact Person | Contact person | Xinlin Xiao | |----------------|--------------------------------------------------------------------------------------------------------| | Title | QA manager | | Address | Zone B, 3/F, 11 Building, Hebei Industrial Area, Longhua office, Longhua New District, Shenzhen, China | | Tel | 0086-755-27184369 | | Fax | 0086-755-27186486 | | E-mail | cm001@szcaremed.com | #### 4. Proposed Device Information | Trade Name | Caremed patient cable and leadwires | |-----------------------|--------------------------------------------------------------| | Model | 2585P, MQB5-90S, MQ-2586, E10R-SH1-N, E10R-MQ, MQ10-LN | | Common name | Patient Transducer and electrode cable (including connector) | | Regulatory class | II | | Production regulation | 21 CFR §870.2900 | | Product code | DSA | | Panel | Cardiovascular | #### 5. Predicate Device Information | 510(K)No. | Trade Name/model | Submitter | |-----------|----------------------------------|---------------------------------| | K142489 | Unimed Disposable ECG lead wires | Unimed Medical<br>Supplies,Inc. | #### 6. Device description The Caremed patient cable and lead wires including trunk cable and leadwires, are intended use for transmitting signals from patient surface electrodes to various Caremed patient cable and lead wires -510(k) Submission {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for Caremed. The logo consists of a stylized "CM" in red and gray, followed by the word "caremed" in red. Below the word "caremed" are two Chinese characters in gray. electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. The type of devices are common to both industry and to most medical establishments. The system is designed to provide a family of lead wires that will link the patient and the compatible patient trunk cable system. ### 7. Intended use The subject device is intended for use only by trained healthcare professionals for measurement of a patient's ECG for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment. | Comparison<br>item | Subject Device<br>Applied present | Predicate Device<br>K142489 | |------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use<br>&Indications<br>for Use | The subject device are intended<br>for use only by trained healthcare<br>professionals for measurement of<br>a patient's ECG for both<br>diagnostic and monitoring<br>purposes. Use is limited by the<br>indications for use of the<br>connected monitoring or<br>diagnostic equipment. | The unimed disposable ECG lead<br>wires are intended for use only by<br>trained healthcare professionals<br>for measurement of a patient's<br>ECG for both diagnostic and<br>monitoring purposes. Use is<br>limited by the indications for use<br>of the connected monitoring or<br>diagnostic equipment. These<br>leadwires are intended for<br>short-term use only (an average<br>patient stay of 5 days). | | Anatomical<br>Sites | Attached to electrodes placed at<br>standard specified locations on<br>chest wall and<br>extremities | Attached to electrodes placed at<br>standard specified locations on<br>chest wall and<br>extremities | | Design<br>/Appearance | Cables with<br>"grabber,snap&needle"<br>configuration of ECG electrode<br>connector (distal connector) and<br>common "header" connection<br>(proximal connector) | Cables with "grabber/snap"<br>configuration of ECG electrode<br>connector (distal connector) and<br>common "header" connection<br>(proximal connector) | | Sterility | Supplied non-sterile | Supplied non-sterile | | Usage | Reusable | Single patient use | | Material | PA66,PVC,ABS | PA66,PVC,ABS | | Cable Length | 0.9m/3.4m/2.5m/2.4m | 0.9m/3.4m | | Caremed patient cable and lead wires -510(k) Submission<br>Page 2 of 4 | | | ### 8. Comparison to predicate device {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for Caremed. The logo consists of a stylized "CM" in red and gray, followed by the word "caremed" in red. Below the word "caremed" are two Chinese characters. | Cable<br>Construction | Flexible shielded multi conductor<br>electrical cable | Flexible shielded multi conductor<br>electrical cable | |---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------| | Wire Color | Grey | White | | Leadwire<br>Construction | Shielded copper leadwire with<br>polymer jacket | Shielded copper leadwire with<br>polymer jacket | | Lead number | 5&10 | 3,5&6 | | Proximal<br>connector<br>Design | Compatible to MultiLink<br>yoke design | Compatible to MultiLink<br>yoke design | | Distal<br>connector<br>Design | "Grabber","Snap"&"Needle"elect<br>rode<br>connectors<br>labeled<br>LL(red),RA(white),RL(green),LA(<br>black)&,V(brown) or socket<br>connecting with lead wires | "Grabber"or"Snap"electrode<br>connectors are labeled<br>LL(red),RA(white),RL(green),LA(<br>black)&,V(brown) | | Conformance<br>standard | IEC60601-1(Safety)<br>EC53(Performance)<br>ISO10993-5,-10(Biocompatibilit<br>y) | IEC60601-1(Safety)<br>EC53(Performance)<br>ISO10993-5,-10(Biocompatibilit<br>y) | From the comparison form above, both devices have the same Intended use &Indications for Use Anatomical Sites, Design /Appearance, Sterility, Material,Cable Construction,& Conformance standard. But in Usage,cable length, Lead number& Distal connector Design item,both devices have some difference,But these units meet the requirements of EC53 and IEC60601-1, so these difference does not bring any safety and effectiveness problem. #### 9. Clinical test data Not applied ## 10. Substantial Equivalence Statement The subject device meets the following the recognized standards: - ANSI/ANMM EC53-1995 (R)2001, R(2008) ECG Cables and Leadwires ● (except4.3.1) - ANSI/AAMI EC13 Cardiac monitors, heart rate meters and alarms (only product markings, chapter 4.1.1.5),2002 - Part 898: Performance Standard for Electrode Lead Wires and Patient Cables ● - IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for Safety, 1988+A1:1991+A2:1995 - ISO 10993-5, Biological evaluation of medical devices-Part 5: Tests for In Vitro cytotoxicity, 2009 - ISO 10993-10, Biological evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity, 2010 Caremed patient cable and lead wires -510(k) Submission {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for Caremed. The logo consists of a stylized "CM" in red and gray, followed by the word "caremed" in red, and two Chinese characters in gray below. The logo is simple and modern, and the colors are eye-catching. ### 11. Discussion Based on the comparison ,analysis, and the submitted performance data, the proposed device is claimed to be Substantially Equivalent (SE) to the predicate devices in K142489.