SURFLASH SAFETY I.V. CATHETER

{0}------------------------------------------------ # MAY 3 0 2014 ### 510(k) SUMMARY # A. SUBMITTER INFORMATION (807.92(a)(1)) Prepared by: Phillip Michael Lester · Regulatory Affairs Specialist Terumo Medical Corporation Tel. (410) 392-7321 Fax (410) 398-6079 Prepared for: Owner/Operator Terumo Corporation 44-1, 2-Chome, Hatagaya Shibuya-Ku, Tokyo, Japan 151-0072 Registration Number: 8010026 ### Manufacturer and Sterilization Facility Kofu Factory of Terumo Corporation 1727-1, Tsuijiarai, Showa-Cho Nakakoma-Gun, Yamanashi, Japan 409-3853 Registration Number: 9681835 Contact Person: Phillip Michael Lester Regulatory Affairs Specialist Terumo Medical Corporation 950 Elkton Boulevard Elkton, MD 21921 Tel. (410) 392-7321 Fax (410) 398-6079 E-mail: philmichael.lester@terumomedical.com Date prepared: May 1, 2014 {1}------------------------------------------------ # B. DEVICE NAME (807.92(a)(2)) | Proprietary Name: | SURFLASH® Safety I.V. Catheter | |----------------------|-----------------------------------------------------------------------| | Common Name: | Intravascular Catheter | | Classification Name: | Catheter, Intravascular, Therapeutic, Short-Term Less Than<br>30 Days | | Regulation Number: | 21 CFR 880.5200 | | Regulatory Class: | II | | Review Panel: | General Hospital | | Product Code: | FOZ | # C. PREDICATE DEVICE (807.92(a)(3)) The legally marketed device to which substantial equivalence is claimed is the current device, SURFLASH® Safety I.V. Catheter (K122544), manufactured by Kofu Factory of Terumo Corporation. # D. REASON FOR 510(K) SUBMISSION This Special 510(k) is being submitted due to a design modification to the previously cleared device to extend the range of product offering to include 14G and 16G catheters and a new length of 51 mm (2"). # E. DEVICE DESCRIPTION (807.92(a)(4)) # (SUMMARY OF TECHNOLOGICAL CHARACTERISTICS) ### Principle of Operation/Technology The SURFLASH® Safety I.V. Catheter is manually operated and contains a passive safety feature that automatically activates as the needle is withdrawn from the catheter. ### Design/Construction The SURFLASH® Safety I.V. Catheter is a device consisting of catheter assembly (catheter, caulking pin, and catheter hub), needle assembly (needle, needle housing, transparent flash chamber (needle connecting part) with filter, and needle protector) and a passive needle-shielding mechanism (shutter and needle shaft cover consisting of inner cylinder, outer cylinder, and junction cylinder). The devices are an over-the needle, peripheral catheter made of a slender, flexible, {2}------------------------------------------------ radio-opaque plastic with a hub that is inserted into the patient's vascular system for short term (<30 days) use to withdraw blood samples, administer fluids intravenously, or monitor blood pressure by attaching a monitoring line. The grooved cannula, which allows the clinician to visualize flashback detection through the groove, indicates that there is confirmation of vessel entry. The whole length of the cannula, including the sharp end of the cannula, is covered by the needle shielding mechanism as the needle is withdrawn from catheter's hub to aid in the prevention of needle stick injuries. ### Material The stainless steel cannula is placed in the catheter to maintain rigidity and is withdrawn after the catheter is placed in the vascular system. The catheter that is advanced into the vessel is made of polyurethane. #### Specifications The modified SURFLASH® Safety I.V. Catheter is available in 3 sizes, with combinations of 14 and 16 gauge catheter diameters and 32 and 51 mm (1 1/2' and 2'') lengths. # F. INTENDED USE (807.92(a)(5)) The SURFLASH® Safety I.V. Catheter is inserted into the patient's vascular system for short term use (<30 days) to withdraw blood samples, administer fluid intravenously, or monitor blood pressure by attaching a monitoring line. The needle shaft cover and tip shield feature aids in the prevention of needle stick injuries. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy. The 18 to 22 gauge catheters are suitable for use with power injectors rated for a maximum of 325 psi. Note: This intended use is identical to the predicate device, K122544. # G. TECHNOLOGICAL CHARACTERISTIC COMPARISON (807.92(a)(6)) The SURFLASH® Safety I.V. Catheter, subject of this Special 510(k), has the same technological characteristics as the SURFLASH® Safety I.V. Catheter (K122544) in {3}------------------------------------------------ terms of operation principle, design/construction, material and specifications. A comparison of the technological characteristics is summarized on the table below. | | Comparison of the technological characteristics to predicate device | | |-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | Modified<br>SURFLASH® Safety I.V. Catheter<br>(subject of this 510(k)) | Current<br>SURFLASH® Safety I.V. Catheter<br>(K122544) | | Manufacturer | Terumo Corporation | Terumo Corporation | | Operation<br>principle | Conduit as fluid pathway.<br>Operated manually. | Conduit as fluid pathway.<br>Operated manually. | | Design /<br>Construction | Identical to the current K122544<br>a. Catheter assembly (Catheter*, caulking pin* and catheter hub*)<br>b. Needle assembly (Needle*, Needle housing and Transparent flash chamber (needle connecting part))<br>c. Needle shield assembly (Shutter, Inner cylinder, Outer cylinder, Junction cylinder)<br>d. Filter (Filter cap not available)<br>e. Needle protector<br>* Contacting patient body directly or indirectly | a. Catheter assembly (Catheter*, caulking pin* and catheter hub*)<br>b. Needle assembly (Needle*, Needle housing and Transparent flash chamber (needle connecting part))<br>c. Needle shield assembly (Shutter, Inner cylinder, Outer cylinder, Junction cylinder)<br>d. Filter (Filter cap not available)<br>e. Needle protector<br>* Contacting patient body directly or indirectly | | Needle Shape /<br>Material | Identical to the current K122544<br>Notched cannula. Ditch on the cannula surface from the heel of the bevel to rear of the catheter tip.<br>Stainless steel | Notched cannula. Ditch on the cannula surface from the heel of the bevel to rear of the catheter tip.<br>Stainless steel | | Flashback | Identical to the current K122544<br>When catheter and needle are properly placed inside vessel, flashback can be confirmed after blood flows through ditch on the cannula surface. | When catheter and needle are properly placed inside vessel, flashback can be confirmed after blood flows through ditch on the cannula surface. | | Catheter<br>material. | Identical to the current K122544<br>Polyurethane<br>Biocompatibility of material confirmed. | Polyurethane<br>Biocompatibility of material confirmed. | | Radiopaque<br>medium | Identical to the current K122544<br>Yes (Barium sulfate) | Yes (Barium sulfate) | | | Comparison of the technological characteristics to predicate device | | | Trade Name | Modified<br>SURFLASH® Safety I.V. Catheter<br>(subject of this 510(k)) | Current<br>SURFLASH® Safety I.V. Catheter<br>(K122544) | | Safety<br>mechanism | * Passive needle shielding<br>* A needle shield passively covers the<br>inner needle when the needle is<br>withdrawn from the catheter.<br>* Whole length cannula including cannula<br>tip is shielded. | * Passive needle shielding<br>* A needle shield passively covers the<br>inner needle when the needle is<br>withdrawn from the catheter.<br>* Whole length cannula including cannula<br>tip is shielded. | | Color code of<br>catheter hub | Identical to the current K122544<br>In accordance with ISO 10555-5 | In accordance with ISO 10555-5 | | Package | Identical to the current K122544<br>Sterility barrier: Blister package,<br>Cast Polypropylene(CPP)<br>/Polyethylene(PE)<br>two layer laminated film and paper<br>Unit box<br>Cardboard | Sterility barrier: Blister package<br>Cast Polypropylene(CPP)<br>/Polyethylene(PE)<br>two layer laminated film and paper<br>Unit box<br>Cardboard | | Sterilization<br>method | Identical to the current K122544<br>Ethylene oxide | Ethylene oxide | | Range of Sizes | Identical to the current K1225400<br>14 and 16G, 1 ¼"-2" | 18-24G, ¾" - 1 ¼" | {4}------------------------------------------------ # H. NON CLINICAL TESTS (807.92(b)(1)) # Performance Performance testing was conducted to ensure the safety and effectiveness of the SURFLASH® Safety I.V. Catheter throughout the shelf life, verify conformity to the applicable part of ISO standards, and demonstrate substantial equivalence to the predicate device. Additionally, performance testing other than to the ISO Standards was performed on the device to verify the modified device against the current. The device complies with the acceptance criteria established based on the predicate. No new issues of safety and effectiveness were raised with the testing performed. Performance testing demonstrates that the SURFLASH® Safety I.V. Catheter conforms to the ISO standards, is substantially equivalent to the predicate device, and is acceptable for clinical use throughout the shelf life. The following performance tests were performed on the device: {5}------------------------------------------------ . | Performance test | Testing | | | Testing by internal<br>standard | |-------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|--------------|--------------|---------------------------------| | | ISO 23908 | ISO 10555-1 | ISO 10555-5 | | | Force to needle breaking shutter<br>(Puncture resistance of needle shield) | X | Not required | Not required | Required by ISO | | Tensile strength of needle shaft and<br>needle housing (Break strength of safety<br>mechanism) | X | Not required | Not required | Required by ISO | | Force to release shutter and reactive<br>force when the shutter opens to cover<br>the cannula tip (Reaction force<br>generated by the activation mechanism) | Not required | Not required | Not required | X | | Force to detach needle shaft cover from<br>catheter hub (Force to activate safety<br>feature) | X | Not required | Not required | Required by ISO | | Simulated maximum pressure | Not required | Not required | Not required | X | | Burst pressure ( whole device) | Not required | X | Not required | Required by ISO | | Collapse (under negative pressure) | Not required | X | Not required | Required by ISO | | Catheter to catheter hub tensile strength<br>(Force at break of catheter / hub) | Not required | X | Not required | Required by ISO | | Strength of union between transparent<br>flash chamber (needle connecting part)<br>and needle | Not required | Not required | X | Required by ISO | | Needle attachment to catheter (Initial<br>sliding friction) | Not required | Not required | Not required | X | | Detection of flashback at catheter tip | Not required | Not required | Not required | X | | Detection of flashback at transparent<br>flash chamber (needle connecting part) | Not required | Not required | X | Required by ISO | | Flow rate | Not required | Not required | X | Required by ISO | | Vent fitting | Not required | Not required | X | Required by ISO | | Drop test | Not required | Not required | Not required | X | | Conical fittings of catheter hub | Not required | X | Not required | Required by ISO | | Pressure monitoring | Not required | Not required | Not required | X | | Simulated use study | X | Not required | Not required | Required by ISO | | Surface | Not required | X | Not required | Required by ISO | | Corrosion resistance | Not required | X | Not required | Required by ISO | | Radio-detectatbility | Not required | Not required | X | Required by ISO | | Catheter unit | Not required | Not required | X | Required by ISO | | Material | Not required | Not required | X | Required by ISO | | Needle point | Not required | Not required | X | Required by ISO | | Catheter body tensile strength (Force at<br>break) | Not required | X | Not required | Required by ISO | | Catheter Stiffness | Not required | Not required | Not required | X | | Catheter Elongation | Not required | Not required | Not required | X | . X: Confirmed the conformance to the standard. {6}------------------------------------------------ No deviations from ISO standards were identified in the testing to standards. ### Simulated Use Study An additional simulated use study was conducted in accordance with FDA's Guidance for Industry and Staff, Medical Devices with Sharps Injury Prevention Features, issued on August 9, 2005 and ISO 23908: 2011, Sharps injury protection-Requirements and test methods-Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling. The objectives of this study were designed to confirm that study participants are able to read and follow the Instructions for Use to safely and effectively operate the safety feature of the modified device. The objectives were: - 1. Verify that proper activation of the sharps injury prevention feature of the device can be accomplished in simulated clinical environments by healthcare workers who use these types of Safety I.V. Catheters. - 2. Determine if the Instructions for Use are adequate for proper activation of the sharps injury prevention feature. All safety features activated effectively and there were no de-activations after discarding. All participants were able to read and activate the catheter safety feature without further explanation or training. Conclusion: The safety feature of the device operates safely and effectively as intended. Users with various levels of experience can read the IFU and operate the device safely and effectively. #### Biocompatibility In accordance with ISO 10993-1, the SURFLASH® Safety I.V. Catheter is classified as: - Catheter and lubricant: Externally Communicating Device, Circulating Blood, . Prolonged Exposure (24 hours to 30 days). - All other materials contacting with patient's body: Externally Communicating . Device, Blood Path Indirect, Prolonged Exposure (24 hours to 30 days). As mentioned in the below table, the device's materials contacting with the patient's {7}------------------------------------------------ body were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO - 10993, Biological Evaluation of Medical Devices part 1: Evaluation and Testing. Screening tests were performed on accelerated aged whole devices to show that the biocompatibility is maintained throughout the shelf life of the product. Results of the testing demonstrate that the materials contacting with patient's body are biocompatible throughout the shelf life of the product. | Test | |------------------------------------| | Cytotoxicity | | Sensitization | | Intracutaneous reactivity | | Systemic toxicity (acute) | | Pyrogen | | Genotoxicity | | Implantation / Subchronic toxicity | | Hemolysis | | Physicochemical | | Characterization | Biocompatibility of the device and materials was established under K122544 for the current SURFLASH® Safety I.V. Catheter, manufactured by Kofu Factory of Terumo Corporation. None of the data raises any new issues of safety and effectiveness. No changes have been made since 510(k) clearance that would require re-testing; therefore, biocompatibility established under K122544 is still applicable. #### Sterilization The sterility of the device is assured using a sterilization method validated in accordance with Method C: Half-cycle method in Annex B of EN ISO11135-1: 2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. The SURFLASH® Safety I.V. Catheter is sterilized to provide a Sterility Assurance Level (SAL) of 10-0. {8}------------------------------------------------ # Risk Analysis A Product Risk Analysis was conducted in accordance with ISO 14971: 2007, taking into account the modifications to the previous device, and it was determined that there were no new issues of safety or effectiveness. ### I. CLINICAL TESTS (807.92(b)(2)) This 510(k) does not include data from clinical tests. #### J. CONCLUSION (807.92(b)(3)) In summary, the SURFLASH® Safety I.V. Catheter, subject of this Special 510(k), is substantially equivalent in its intended use, technology / principal of operation, materials, and performance to the current device: SURFLASH® Safety I.V. Catheter (K122544), manufactured by Kofu Factory of Terumo Corporation, Japan. There is no significant difference that raises any new issues of safety and effectiveness. {9}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Public Health Service May 30. 2014 Terumo Medical Corporation Mr. Phillip Lester Regulatory Affairs Specialist 950 Elkton Boulevard Elkton, MD 21921 Re: K141138 Trade/Device Name: SURFLASH® Safety I.V. Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: May 1, 2014 Received: May 2, 2014 Dear Mr. Lester: 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 warrantics. 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. {10}------------------------------------------------ Page 2 - Mr. Lester 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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/Resourcesfor You/Industry/default.htm. Sincerely yours, MarySTBunner-S Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {11}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K141138 #### Device Name SURFLASH® Safety I.V. Catheter #### Indications for Use (Describe) The SURFLASH® Safety I.V. Catheter is inserted into the patient's vascular system for short term use (<30 days) to withdraw blood samples, administer fluid intravenously, or monitor blood pressure by attaching a monitoring line. The needle shaft cover and tip shield feature aids in the prevention of needle stick injuries. These cathers may patient population with consideration given to adequacy of vasular anatony and appropriateness for the solution being infused and duration of therapy. The 18 to 22 gauge catheters are suitable for use with power injectors rated for a maximum of 325 psi. Type of Use (Select one or both, as applicable) [ Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page. # PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FOR FOR FDA USE ONLY -. . . . . . ﭘﮍ ﮨﮯ ﮐﮧ ﻣ Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure) Digitally signed by Richard C. Chapman -S Date: 2014.05.30 09:43:53 -04'00' {12}------------------------------------------------ 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."