JMS SAFE WING CATH (SWC)

{0}------------------------------------------------ K121488 # 510(k) Summary ## 807.92(c) MAR 0 5 2013 ## 807.92(a)(1) SPONSOR JMS North America Corp. Company Name: 22320 Foothill Blvd., Suite 350 Company Address Hayward, CA 94541 510-888-9090 Telephone: 510-888-9099 Fax: Contact Person: Sho Hosoki Summary Preparation Date: April 9, 2012 ## DFVICF NAME | DEVICE NAME | 807.92(a)(2) | |----------------------|--------------------------| | Trade Name: | JMS Safe Wing Cath (SWC) | | Common/Usual Name: | Intravascular Catheter | | Classification Name: | Intravascular Catheter | | Regulation Number: | 21 CFR 880.5200 | | Product Code: | FOZ | | Device Class: | Class II | ### PREDICATE DEVICE ### 807.92(a)(3) Legally Marketed Equivalent Devices | K Number | Product | Company | |----------|--------------------------------------|---------------------------------------------| | K102520 | BD Nexiva™ Closed IV Catheter System | Dickinson Infusion Therapy<br>Systems, Inc. | | K895481 | SHAMROCK Winged Needle Infusion Set | Smiths Medical | | K110157 | SysLoc Mini V3 | JMS Singapore Pte Ltd | ## DEVICE DESCRIPTION ### 807.92(a)(4) JMS Safe Wing Cath (SWC) is a single lumen intravenous catheter device for vascular access incorporating an anti-needle stick safety feature. The anti-needle stick feature is integrated in the Safe Wing Cath (SWC) body and functions during retraction of the needle, after vascular access is accomplished (there is a stopper to prevent unwanted retraction of needle during insertion). During retraction, the needle will slide into the body and will lock at the final locking position. An audible clicking sound is heard or locking force is felt when the needle is fully retracted into the final locking position. The entire needle is encapsulated within the body and prevents needle-stick injuries, while the catheter still has vascular access for intravenous fluid administration. {1}------------------------------------------------ ## DEVICE INTENDED USE ## 807.92(a)(5) JMS Safe Wing Cath (SWC) is intended for short-term (less than 30 days) access to patient's vascular system for intravascular fluid administration and to sample blood, and to monitor blood pressure. The device is intended for single use only and has an anti-stick feature integrated which aids in prevention of needle-stick injuries. | Device | Modified Device | Currently Legally Marketed Predicate Device (Predicate 1) | |---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacture | JMS Safe Wing Cath (SWC)<br>JMS Japan | BD Nexiva Closed IV Catheter System<br>Becton, Dickinson and Company | | 510(K) # | --- | K102520 | | Classification | Class II | Class II | | Intended Use | JMS Safe Wing Cath (SWC) is<br>intended for short-term (less than<br>30 days) access to patient's vascular<br>system for intravascular fluid<br>administration, to sample blood,<br>and to monitor blood pressure. The<br>device is intended for single use<br>only and has an anti-stick feature<br>integrated which aids in prevention<br>of needle-stick injuries. | The NexivaTM4 intravascular catheter is<br>inserted into a patient's vascular system<br>for a short-term use (less than 30 days) to<br>sample blood, monitor blood pressure, or<br>administer fluids intravascularly. The<br>needle-shielding feature and luer access<br>port, aid in the prevention of needle-stick<br>injuries. Blood is contained within the<br>device during the catheter insertion<br>process aiding in the prevention of blood<br>exposure. This catheter may be used for<br>any patient population with consideration<br>given to adequacy of vascular anatomy<br>and appropriateness of procedure.<br><br>The 18-22 gauge NexivaTM catheters are<br>suitable for use with power injectors rated<br>for a maximum of 300 psi when the luer<br>access port(s) is removed and a direct<br>connection is made. | | Catheter ID (mm) | 20G: 0.8 (0.7 ~ 0.9)<br>22G: 0.6 (0.5 ~ 0.7)<br>24G: 0.5 (0.4 ~ 0.6) | 20G: 0.83<br>22G: 0.67<br>24G: 0.53 | | Catheter OD (mm) | 20G: 1.1 (0.950 ~ 1.149)<br>22G: 0.9 (0.750 ~ 0.949)<br>24G: 0.7 0.650 ~ 0.749) | 20G: 1.10<br>22G: 0.90<br>24G: 0.71 | | Length of Exposed<br>Catheter | All gauges: 19.0 (±8%) mm<br>0.76 Inches | 20G: 1.00, 1.25, or 1.75 Inches<br>22G: 1.00 Inches<br>24G: 0.56 or 0.75 Inches | | Number of Lumens | 1 | 1 | | Distal End Configuration | Needle and catheter | Needle and catheter | | Intended Anatomical<br>Location of Distal End | Peripherals | Peripherals | | Proximal End<br>Configuration | Luer Lock | 2 ports: Luer Access Split Septum & Vent<br>Plug | | Water Flow Rate | 20G: 38 | 20G: 1.00 catheter length: 54 | | (mL/min) | 22G: 28<br>24G: 16 | 22G: 1.00 catheter length: 27<br>24G: 0.75 catheter length: 13 | | Catheter Body Tensile<br>Strength | 20G: 29.3N<br>22G: 21.5 N<br>24G: 14.3N | 20G: 28.6 N<br>22G: 21.6 N<br>24G: 12.8 N | | Catheter to Catheter Hub<br>Strength | 20G: 19.9N<br>22G: 14.7N<br>24G: 12.6N | 20G: 19.3N<br>22G: 15.4N<br>24G: 9.7N | | Catheter Stiffness (Elastic<br>Modulus) | 20G: 487.9 MPa<br>22G: 440.7 MPa<br>24G: 401.0 MPa | 20G: 487.9 MPa<br>22G: 405.8 MPa<br>24G: 423.0 MPa | | Catheter Tensile<br>Elongation | 20G: 951.6%<br>22G: 717.7%<br>24G: 779.4% | 20G: 815.0%<br>22G: 772.8%<br>24G: 453.6% | | Flexural Modulus | 22G: 734.3 MPa | 22G: 582 MPa | | Tubing to Hub Tensile<br>Strength | 20G: 35.4N<br>22G: 32.9N<br>24G: 34.5N | 20G: 56.6N<br>22G: 46.7N<br>24G: 42.1N | | Tubing to Female<br>Connector Tensile<br>Strength | Same for All Gauges: 32.2N | 20G: 65.6N<br>22G: 51.8N<br>24G: 42.0N | | Needle to Need Hub<br>Strength | 20G: 128.4N<br>22G: 92.3N<br>24G: 72.4N | 20G: 118.8N<br>22G: 66.5N<br>24G: 38.2N | | Leakage at Hub | None (at 150kPA for 15min) | None | | Catheter Burst Pressure | 22G: 2.22MPa | 22G: 2.66MPa<br>24G: 2.84MPa | | Catheter Collapse<br>Pressure | Tested up to -99.3MPa with no<br>leakage | Tested up to -99.3MPa with no leakage | | Open or Closed System | Closed System | Closed System | | Labels | Similar to Predicate(Refer to<br>Section 13) | Refer to Section 13 | #### comparison of technical Characteristics 807.92(a)(6) {2}------------------------------------------------ ## Side by Side Comparison of Substantial Equivalent Appearance and Safety Feature, with Legally Marketed Device with Comparable Patient Exposure Please note that the predicate 2 does not have a catheter, but has substantial equivalence with the JMS SWC due to its appearance, safety mechanism feature, and intended use. Please consider JMS SWC device as a modification of predicate 2 with a catheter, in which has substantial equivalence to predicate 1. Also, please note that SysLoc Mini v3 is a legally marketed device with comparable patient exposure and this device is used to show material biocompatibility in section 15. | Device | Modified Device | Legally Marketed Predicate Device<br>(Predicate 2) | Legally Marked Device<br>with Comparable Patient<br>Exposure | |----------------|-----------------------------|---------------------------------------------------------------------------------|--------------------------------------------------------------| | | JMS Safe Wing Cath<br>(SWC) | SHAMROCK Winged Needle<br>Infusion Set | SysLoc Mini V3 | | Manufacture | JMS Japan | Smiths Medical ( JMS Singapore Pte<br>Ltd provide unfinished medical<br>device) | JMS Singapore Pte Ltd | | 510(K) # | --- | K895481 | K110157 | | Classification | Class II | Class II | Class II | | Intended Use | JMS Safe Wing Cath | This device is used by the healthcare | SysLoc@ MINI( V3) is | {3}------------------------------------------------ | | (SWC) is intended for<br>short-term (less than 30<br>days) access to patient's<br>vascular system for<br>intravascular fluid<br>administration, to<br>sample blood, and to<br>monitor blood pressure.<br>The device is intended<br>for single use only and<br>has an anti-stick feature<br>integrated which aids in<br>prevention of needle-<br>stick injuries. | professional to administer I.V. fluids<br>to a patient. The materials used in the<br>manufacture of this device (See<br>Exhibit VIII) are comparable to<br>similar on the market. The parallel of<br>similar materials from this device to<br>existing devices will allow the<br>healthcare worker to administer the<br>same I.V. fluids which are currently<br>being administered. The uniqueness<br>of the device of this submission lies<br>in the ability of the user to retract the<br>needle, after use, into the wings. Thus<br>reducing the probability of accidental<br>needle sticks.<br>Hospital policy will determine the<br>length of time that this device, or<br>currently marketed devices, may be<br>used prior to changing. The similarity<br>of the materials used in this device to<br>currently marketed devices will allow<br>the healthcare worker to maintain the<br>same procedure which they are<br>currently following. Neither this<br>device, nor the currently marketed<br>devices for the same intended use<br>make any claims or recommendations<br>for length of administration prior to<br>set change. | intended for temporary<br>cannulation (non-<br>implantable, less than 30<br>days) to vascular access<br>for extracorporeal blood<br>treatment. The device is<br>intended for single use<br>only and has an anti-stick<br>feature integrated as part<br>of the Needle Set which<br>aids in prevention of<br>needle-stick injuries. | |----------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Material | Refer to section 15.<br>Most of the material<br>used in this device is<br>from K895481 and<br>K110157 | Refer to K895481 | Refer to K110157 | #### 807.92(b) SAFETY AND EFFICACY Biocompatibility | Biocompatibility Testing | | | |--------------------------------------------|--------------|---------| | Test | Test Method | Results | | Cytotoxicity | ISO 10993-5 | Pass | | Sensitization | ISO 10993-10 | Pass | | Irritation Or Intracutaneous<br>Reactivity | ISO 10993-10 | Pass | | Systemic Toxicity (Acute) | ISO 10993-11 | Pass | | Subchronic Toxicity | ISO 10993-6 | Pass | | (Subacute Toxicity) | ISO 10993-11 | | | Genotoxicity | ISO 10993-3 | Pass | | Implantation | ISO 10993-6 | Pass | | Hemocompatibility | ISO 10993-4 | Pass | {4}------------------------------------------------ ## Sterilization Sterilization conditions have been validated according to ANSI/AAMI/ISO 11135, Sterilization of Health Care Products – Part 1; Requirements for development validation and routine control of sterilization process for medical devices to provide a Sterility Assurance Level (SAL) of 10°. Residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) residuals will meet requirements for limited exposure devices (contact up to 24 hours) prior to use, based on ANSI/AAMI/ISO 10993-7, Biological Evaluation of medical device – Part 7; Ethylene Oxide Sterilization residuals. Residual EO will not exceed 4 mg per device and residual ECH will not exceed 9 mg per device. #### PERFORMANCE ### Conformance to ISO 10555-1 The JMS SWC successfully passed the following performance tests, demonstrating conformance with ISO-10555-1: | ISO 10555-1 Compliance Testing of the JMS Safe Wing Cath (SWC) | | | |-------------------------------------------------------------------------------------|------------------------------|---------| | Test | Test methods | Results | | Surface inspection | ISO 10555-1 | Passed | | Corrosion resistance | ISO 10555-1 | Passed | | Force at break (catheter and hub, tubing and female connector, tubing to needle hub | ISO 10555-1 | Passed | | Freedom for leakage (Positive pressure) | ISO 10555-1 & JIS T3223:2011 | Passed | | Test Method of Air Leakage into Hub Assembly during Aspiration (Negative Pressure) | ISO 10555-1 | Passed | | Flow rate | ISO 10555-1 | Passed | | Catheter under X-Ray | ISO 10555-1 | Passed | | Determination of Strength of Union Hub and Needle tube | ISO 10555-1 | Passed | | Leakage Needle hub/Tubing/Female Connector | ISO 10555-1 & JIS T3223:2011 | Passed | | Additional Tests | | | | Catheter under X-Ray | | Passed | ## 2. Simulated Use and Device Performance A Simulated Clinical Use Test for the JMS Safe Wing Cath was conducted comprising 43 healthcare workers from the Washington /Baltimore area to evaluate product performance and {5}------------------------------------------------ usability. Performance Testing on over 500 samples was 100% success with no device failures and all devices performing as intended. ## 3. Comparison to predicate The following in-house bench testing was conducted to demonstrate equivalent performance with the predicate device. | Test | Result | |---------------------------------------------------------------------------------|---------------------------| | Catheter (Elastic Modulus in Tension, Tensile Strength, and Tensile Elongation) | No significant difference | | Catheter Flexural Modulus (Three Point Bend) | No significant difference | | Force Break of Tubing and Female Connector | No significant difference | | Force Break of tubing to needle hub | No significant difference | | Force Break needle and needle hub | No significant difference | | Determine maximum positive pressure for Nexvia & SWC . | Pressure determined | | Catheter collapse Pressure test | No significant difference | | Priming volume determination | Volumes determined | ## CONCLUSION ## 807.92(b)(3) The JMS SWC is a modification of predicate 2 into a catheter equivalent that of predicate 1. The JMS SWC has similar appearance and safety anti needle stick feature as predicate 2. As a catheter, the JMS SWC has fewer applications than that of predicate 1, but for the intended applications, it has equivalence in intended use and mechanical / performance specifications. The appearance of JMS SWC is different from predicate 1 device, but they are both closed I.V. catheter systems. All specifications addressed have been analyzed, verified and validated with supporting data enclosed in this 510(k) document and there are no issue on the safety and effectiveness of the device performance if used as intended. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The emblem is accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the emblem. The text is in uppercase letters and is positioned to encircle the emblem. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 5. 2013 JMS North America Corporation C/O Ms. Yolanda Smith Regulatory Consultant Smith Associates 1468 Harwell Avenue CROFTON MD 21114 Re: K121488 Trade/Device Name: JMS Safe Wing Cath (SWC) Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: February 19, 2013 Received: February 25, 2013 Dear Ms. Smith: 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. {7}------------------------------------------------ Page 2 - Ms. Smith 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 Actor 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-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 go to http://www.fda.goy/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 vours. Image /page/7/Picture/6 description: The image contains a stylized signature or logo. It features the word "for" at the top left, followed by a looping design that connects to the name "Nich Urowitz". To the right of the name, there is a triangular shape with parallel lines inside, resembling a stylized letter "A". The overall design is intricate and appears to be hand-drawn. Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ # Indications for Use 510(k) Number (if known): _ 12 | 488 Device Name: JMS Safe Wing Cath (SWC) Indications for Use: JMS Safe Wing Cath (SWC) is intended for short-term (less than 30 days) access to patient's vascular system for intravascular fluid administration and to sample blood, and to monitor blood pressure. The device is intended for single use only and has an anti-stick feature integrated which aids in prevention of needle-stick injuries. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Image /page/8/Picture/10 description: The image shows the name "Alan M. Stevens" in a large font on the left side. On the right side, the word "Date:" is written above the date "2013.03.04", the time "14:01:29", and the timezone "-05'00". The date, time, and timezone are enclosed in a geometric shape. as Sinn eslology, General Hospital \$10(k) Number Page __ of