Med-link Reusable Blood Pressure Cuff

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Shenzhen Med-link Electronics Tech Co., Ltd. Baihan Feng Regulatory Affairs Specialist 4th Floor, Building A Yingtailong Industrial Park Dalang South Road, Longhua District Shenzhen, China 518109 Re: K173869 Trade/Device Name: Med-link Reusable Blood Pressure Cuff Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXQ Dated: June 25, 2018 Received: June 25, 2018 Dear Baihan Feng: 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 807); labeling (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.htm); 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 medical devices and radiation-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 (1-800-638-2041 or 301-796-7100). Sincerely. M.A. Hillemann Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K173869 Device Name Med-link Reusable Blood Pressure Cuff ### Indications for Use (Describe) Med-link Reusable Blood Pressure Cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------| | <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | 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 MEDLINKET. The logo has the word "MED" in red, with a blue arc above it. There is a red circle to the right of the word "MED", and the word "LINKET" in blue to the right of the circle. The letters "TM" are in small black font above the letters "KET". # 510(k) Summary This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92. Type of submission: Traditional The assigned 510(k) number is:_ ### 1. Submitter information Manufacturer Name: Shenzhen Med-link Electronics Tech Co., Ltd. Address: 4th Fl, Bldg A, Yingtailong Industrial Park, Dalang South Road, Longhua District, Shenzhen, Guangdong, CHINA, 518109 Tel: 0086-755-61120299 Fax:0086-755-61120055 Establishment Registration Number: 3006636961 #### 2. Contact Person Baihan Feng (Regulatory Affairs Specialist) E-mail: mdl001@medlinket.com #### 3. Data of Submission 15th, Dec. 2017 #### Identification of the Device 4. Trade Name: Med-link Reusable Blood Pressure Cuff | | Table 1 Device Model | | |--|----------------------|--| | | | | | Device Name/Type | Device Model | |---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Reusable Blood<br>Pressure Cuff | Y000N1, Y000N2, Y000I1, Y000I2, Y000C1, Y000C2, Y000S1, Y000S2, Y000A1, Y000A2, Y000L1, Y000L2, Y000T1, Y000T2, Y000RC1, Y000RC2, Y000RSA1, Y000RSA2, Y000RA1, Y000RA2, Y000RAL1, Y000RAL2, Y000RLA1, Y000RLA2, Y000RT1, Y000RT2 | Common Name: Non-invasive Blood Pressure Cuff Classification Name: Blood Pressure Cuff Classification Regulation: 21 CFR 870.1120 Product Code: DXQ - న. Identification of the Predicate Device {4}------------------------------------------------ Image /page/4/Picture/1 description: The image contains a logo for MedLinket. The logo has the word "MED" in red, with a blue arc underneath it. There is a red circle to the right of "MED", and the word "LINKET" in blue to the right of the circle. There is a "TM" symbol in the upper right corner of the word "LINKET". | No. | Device Name | Common Name | Manufacture | Classification and Code | Classification regulation | 510(k) number | |---------------------|-----------------------------------------|----------------------------------|------------------------------------------|-------------------------|---------------------------|---------------| | Primary Predicate | Disposable/Reusable Blood Pressure Cuff | Non-invasive Blood pressure cuff | XUZHOU MAICUFF<br>TECHNOLOGY<br>CO.,LTD. | Class II, DXQ | 21 CFR 870.1120 | K151290 | | Secondary Predicate | Unimed Blood Pressure Cuff | Non-invasive Blood pressure cuff | Unimed Medical supplies Inc. | Class II, DXQ | 21 CFR 870.1120 | K112544 | Table 2 Predicate Device Information #### 6. Intended Use and Indications for Use of the Subject device Med-link Reusable Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in neonatal, infant, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated. ### 7. Device Description The proposed device, Med-link Reusable Blood Pressure Cuffs is rectangle soft inelastic sleeve with bladder, to which a single-tube or twin-tube is connected. It is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to a non-invasive blood pressure measurement system. It is available in various sizes for different limb range. It is provided non-sterile. | No. | Model | Intended Limb Range<br>(Unit: cm) | |-----|--------|-----------------------------------| | 1 | Y000N1 | 6-11 | | 2 | Y000N2 | 6-11 | | 3 | Y000I1 | 10-15 | | 4 | Y000I2 | 10-15 | | 5 | Y000C1 | 14-21 | | 6 | Y000C2 | 14-21 | | 7 | Y000S1 | 20.5-28 | | 8 | Y000S2 | 20.5-28 | Table 3 Intended Limb Range for Each Model {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for MEDLINKET. The logo has the word "MED" in red, with a blue swoosh underneath it. To the right of the word "MED" is a red circle, followed by the word "LINKET" in blue. The letters "TM" are in superscript to the right of the word "LINKET". | 9 | Y000A1 | 27-35 | |----|----------|-------| | 10 | Y000A2 | 27-35 | | 11 | Y000L1 | 34-43 | | 12 | Y000L2 | 34-43 | | 13 | Y000T1 | 42-54 | | 14 | Y000T2 | 42-54 | | 15 | Y000RC1 | 15-22 | | 16 | Y000RC2 | 15-22 | | 17 | Y000RSA1 | 17-25 | | 18 | Y000RSA2 | 17-25 | | 19 | Y000RA1 | 24-32 | | 20 | Y000RA2 | 24-32 | | 21 | Y000RAL1 | 28-37 | | 22 | Y000RAL2 | 28-37 | | 23 | Y000RLA1 | 32-42 | | 24 | Y000RLA2 | 32-42 | | 25 | Y000RT1 | 42-50 | | 26 | Y000RT2 | 42-50 | ### 8. Non-clinical Testing A series of safety, essential performance and biocompatibility tests were performed to assess the safety and effectiveness of Med-link Reusable Blood Pressure Cuff. The tests listed below were conducted in accordance with ISO 81060-1, non-invasive sphygmomanometers - part 1: requirements and test methods for non-automated measurement type. IEC 80601-2-30 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers Biological Evaluation of medical devices-Part 5: Test for in vitro cytotoxicity ISO 10993-5 ISO 10993-10 Biological evaluation of medical devices- Part 10: Tests For Irritation And Skin Sensitization - Cytotoxicity Test - Skin irritation Test - Skin Sensitization Test #### Substantial Equivalence Determination 9. Table 4 Comparison to Predicate Devices {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for MED LINKET. The logo has the word "MED" in red, with the letters stacked on top of each other. A blue swoosh starts below the word "MED" and curves to the right, ending at a red circle. To the right of the red circle is the word "LINKET" in blue, with the letters in a straight line. The letters "TM" are in superscript to the right of the word "LINKET". | Item | Proposed Device | Predicate Device | Secondary Predicate<br>Device | | |-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------| | Trade name | Med-link Reusable Blood<br>Pressure Cuff | Reusable Blood Pressure<br>Cuff | Unimed Disposable Blood<br>Pressure Cuff | | | 510(K)<br>Submitter | Shenzhen Med-link<br>Electronics Tech Co.,<br>Ltd. | XUZHOU MAICUFF<br>TECHNOLOGY<br>CO.,LTD. | Unimed Medical supplies<br>Inc. | | | 510(K) Number | - | K151290 | K112544 | | | Classification<br>Regulation | 21CRF 870.1120 | 21CRF 870.1120 | 21CRF 870.1120 | | | Classification<br>and Code | Class II,<br>DXQ | Class II,<br>DXQ | Class II,<br>DXQ | | | Common name | Non-invasive Blood<br>Pressure Cuff | Non-invasive Blood<br>Pressure Cuff | Non-invasive Blood<br>Pressure Cuff | | | Intended use | Med-link Reusable Blood<br>Pressure<br>Cuff is an<br>accessory used in<br>conjunction with<br>non-invasive blood<br>pressure measurement<br>systems. The cuff is<br>non-sterile. It is available<br>in neonatal, infant,<br>pediatric and adult sizes.<br>The cuff is not designed,<br>sold, or intended for use<br>except as indicated. | The reusable blood<br>pressure cuff is an<br>accessory used in<br>conjunction with<br>noninvasive blood<br>pressure measurement<br>systems. The cuff is<br>non-sterile and may be<br>reused. It is available in<br>infant, pediatric and adult<br>sizes. | The Unimed disposable<br>blood pressure cuff is an<br>accessory used in<br>conjunction with<br>noninvasive blood pressure<br>measurement systems. The<br>cuff is non-sterile and may<br>be reused. It is available in<br>pediatric and adult sizes.<br>The cuff is not designed,<br>sold, or intended for use<br>except as indicated. | | | Patient<br>populations | Adults/Pediatrics | Adults/Pediatrics | Adults/Pediatrics | | | Material<br>Contacting<br>patient | Cuff: Nonwoven Polyester<br>with TPU laminate<br>Air hose: PVC tap and<br>Silicone tube | Cuff: nylon TPU<br>Air hose: PVC | Cuff: Pu Synthetic Leather<br>Air Tubing: PVC | | | Tube<br>configuration | One or two tube | One or two tube | One or two tube | | | Item | Proposed Device | Predicate Device | Secondary Predicate<br>Device | | | Size | Conform to AHA bladder<br>sizes recommendations<br>Neonatal (6-11cm)<br>Infant (10-15cm)<br>Pediatric (14-22cm)<br>Small Adult (17-28cm)<br>Adult (24-37cm)<br>Large Adult (32-43cm)<br>Adult Thigh (42-54cm) | Conform to AHA bladder<br>sizes recommendations<br>Infant (9-14.5cm)<br>Pediatric (13-21.5cm)<br>Small Adult (21-27cm)<br>Adult (26-35.5cm)<br>Large Adult (35-45cm) | Conform to AHA bladder<br>sizes recommendations<br>Neonatal (6-11cm)<br>Infant (10-19cm)<br>Pediatric (18-26cm)<br>Small Adult (20-28 cm)<br>Adult (25-35 cm)<br>Large Adult (33-47cm)<br>Large Adult Long<br>(33-47cm)<br>Thigh (46-66cm) | | | | Pressure limit | 0-300mmHg | 0-300mmHg | 0-300mmHg | | | Sterile | No | No | No | | | Biocompatibility | Comply with ISO 10993-5<br>and ISO 10993-10<br>biocompatibility<br>evaluation | Comply with ISO 10993-5<br>and ISO 10993-10<br>biocompatibility<br>evaluation | Comply with ISO 10993-5<br>and ISO 10993-10<br>biocompatibility<br>evaluation | {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for MED LINKET. The logo has the letters "MED" in red, with a blue swoosh underneath. To the right of the letters is a red circle, followed by the word "LINKET" in blue. The letters "TM" are in the upper right corner of the word "LINKET". Med-link Reusable Blood Pressure Cuff has the same intended use, basic construction and technology specification as the predicate device. They are wrapped around the patient's arm or thigh and secured by a hook and loop fastener commonly called Velcro. We extend the size to satisfy some special patients, such as different neonatal size, overweight. Based on the performance testing in this submission, the slight difference on the range of these blood pressure cuffs does not raise any safety or effectiveness issue. ### 10. Conclusion Based on the comparison and analysis above, it can be concluded that: Med-link Reusable Blood Pressure Cuff are as safe and effective as the predicate devices.